# EDGAR Filing Document

**Accession Number:** 0001828316
**File Stem:** 0001828316-26-000019
**Filing Date:** 2026-4
**Character Count:** 933369
**Document Hash:** e1525e6d51f3a1cdde9b03cd06094b1b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001828316-26-000019.hdr.sgml**: 20260413

**ACCESSION NUMBER**: 0001828316-26-000019

**CONFORMED SUBMISSION TYPE**: 20-F/A

**PUBLIC DOCUMENT COUNT**: 186

**CONFORMED PERIOD OF REPORT**: 20251231

**FILED AS OF DATE**: 20260413

**DATE AS OF CHANGE**: 20260413

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Pharming Group N.V.
- **CENTRAL INDEX KEY:** 0001828316
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** P7
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 20-F/A
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39822
- **FILM NUMBER:** 26856764

**BUSINESS ADDRESS:**
- **STREET 1:** DARWINWEG 24
- **CITY:** LEIDEN
- **STATE:** P7
- **ZIP:** 2333 CR
- **BUSINESS PHONE:** 31 (0)71 5247 400

**MAIL ADDRESS:**
- **STREET 1:** DARWINWEG 24
- **CITY:** LEIDEN
- **STATE:** P7
- **ZIP:** 2333 CR

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Pharming Group Group N.V.
- **DATE OF NAME CHANGE:** 20201014

?xml version='1.0' encoding='ASCII'? pharm-20251231

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 20-F/A**

**(Amendment No. 1)**

**(Mark One)**

☐ **REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934**

**OR**

☒ **ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**

**For the fiscal year ended December 31, 2025**

**OR**

☐ **TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**

**For the transition period from to**

**OR**

☐ **SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**

**Date of event requiring this shell company report__________**

**Commission file number 001-39822** 

**Pharming Group N.V.**

**(Exact name of registrant as specified in its charter)**

---

| | | |
|:---|:---|:---|
| **The Netherlands** | **2834** | **Not applicable** |
| **(Jurisdiction of incorporation or organization)** | **(Primary Standard Industrial Classification Code Number)** | **(Translation of Registrant's**<br>**name into English)** |

---

**Pharming Group N.V.**

**Darwinweg 24**

**2333 CR Leiden**

**The Netherlands**

**(Address of principal executive offices)**

**Mr. Fabrice Chouraqui, CEO**

**+31 71 5247 400**

**E: investor@pharming.com**

**Pharming Group N.V.** 

**Darwinweg 24**

**2333 CR Leiden**

**The Netherlands**

**(Name, telephone, e-mail and/or facsimile number, and address of company contact person)**

**Securities registered or to be registered pursuant to Section 12(b) of the Act.**

---

| | | |
|:---|:---|:---|
| **Title of each class** | Trading Symbol(s) | **Name of each exchange on which registered** |
| **American Depositary Shares, each representing ten ordinary shares, nominal value EUR 0.01 per share <br>Ordinary shares, nominal value EUR 0.01 per share\*** | PHAR | **The Nasdaq Stock Market LLC**<br>**The Nasdaq Stock Market LLC\*** |

---

**Securities registered or to be registered pursuant to Section 12(g) of the Act. None**

------

**Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None**

Indicate the number of outstanding shares of each of the issuer's classes of capital or common stock as of the close of the period covered by the annual report.

701,680,440 ordinary shares, nominal value €0.01 per share, as of December 31, 2025.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☒ Yes ☐ No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒ No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of "large accelerated filer," "accelerated filer," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☒ Non-accelerated filer ☐ Emerging growth company ☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐

† The term "new or revised financial accounting standard" refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the

registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP ☐ International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ Other ☐

If "Other" has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

**\*** listed not for trading or quotation purposes, but only in connection with the registration of American Depository Shares representing such ordinary shares pursuant to the requirements of the Securities and Exchange Commission. The American Depository Shares are registered under the Securities Act of 1933, as amended, pursuant to a separate registration statement on Form F-6 (File No. 333-251421).

------

**Explanatory Note** This Amendment No. 1 on Form 20-F/A, or the Amendment, amends the Annual Report on Form 20-F of Pharming Group N.V., or the Company, for the year ended December 31, 2025, as filed with the U.S. Securities and Exchange Commission, or the SEC, on April 2, 2026, or the Original Report, and is being filed for the purpose of correcting and re-filing the certifications by the Principal Executive Officer and Principal Financial Officer in Exhibits 13.1 and 13.2, or the Section 906 Certifications. Due to an inadvertent administrative error, the Section 906 Certifications filed with the Original Report referenced an incorrect fiscal period.

The Section 906 Certifications have been corrected and are re-filed as Exhibits 13.1 and 13.2 to this Amendment.

Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Amendment also includes, as Exhibits 12.1 and 12.2, the certifications of the Principal Executive Officer and Principal Financial Officer of the Company pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Except as described above, and to include an updated consent of Deloitte Accountants B.V., this Amendment does not amend, update or change any other items or disclosures contained in the Original Report, and accordingly, this Amendment does not reflect or purport to reflect any information or events occurring after the original filing date of the Original Report or modify or update those disclosures affected by subsequent events. Accordingly, this Amendment should be read in conjunction with the Original Report and the Company's other filings with the SEC.

------

---

| | | |
|:---|:---|:---|
| **TABLE OF CONTENTS** | **TABLE OF CONTENTS** | **TABLE OF CONTENTS** |
| | | <u>PAGE</u> |
| Part I | | |
| Item 1. | <u>[IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS](#i8209414efd9e4d5f8081c614b690fc9f_13)</u> | <u>[7](#i8209414efd9e4d5f8081c614b690fc9f_13)</u> |
| Item 2. | <u>[OFFER STATISTICS AND EXPECTED TIMETABLE](#i8209414efd9e4d5f8081c614b690fc9f_16)</u> | <u>[7](#i8209414efd9e4d5f8081c614b690fc9f_16)</u> |
| Item 3. | <u>[KEY INFORMATION](#i8209414efd9e4d5f8081c614b690fc9f_19)</u> | <u>[8](#i8209414efd9e4d5f8081c614b690fc9f_19)</u> |
| | <u>[A. \[RESERVED\]](#i8209414efd9e4d5f8081c614b690fc9f_22)</u> | <u>[8](#i8209414efd9e4d5f8081c614b690fc9f_22)</u> |
| | <u>[B. CAPITALIZATION AND INDEBTEDNESS](#i8209414efd9e4d5f8081c614b690fc9f_25)</u> | <u>[8](#i8209414efd9e4d5f8081c614b690fc9f_25)</u> |
| | <u>[C. REASONS FOR THE OFFER AND USE OF PROCEEDS](#i8209414efd9e4d5f8081c614b690fc9f_28)</u> | <u>[8](#i8209414efd9e4d5f8081c614b690fc9f_28)</u> |
| | <u>[D. RISK FACTORS](#i8209414efd9e4d5f8081c614b690fc9f_31)</u> | <u>[8](#i8209414efd9e4d5f8081c614b690fc9f_31)</u> |
| Item 4. | <u>[INFORMATION OF THE COMPANY](#i8209414efd9e4d5f8081c614b690fc9f_34)</u> | <u>[42](#i8209414efd9e4d5f8081c614b690fc9f_34)</u> |
| | <u>[A. HISTORY AND DEVELOPMENT OF THE COMPANY](#i8209414efd9e4d5f8081c614b690fc9f_37)</u> | <u>[42](#i8209414efd9e4d5f8081c614b690fc9f_37)</u> |
| | <u>[B. BUSINESS OVERVIEW](#i8209414efd9e4d5f8081c614b690fc9f_40)</u> | <u>[43](#i8209414efd9e4d5f8081c614b690fc9f_40)</u> |
| | <u>[C. ORGANIZATIONAL STRUCTURE](#i8209414efd9e4d5f8081c614b690fc9f_43)</u> | <u>[84](#i8209414efd9e4d5f8081c614b690fc9f_43)</u> |
| | <u>[D. PROPERTY, PLANT AND EQUIPMENT](#i8209414efd9e4d5f8081c614b690fc9f_46)</u> | <u>[85](#i8209414efd9e4d5f8081c614b690fc9f_46)</u> |
| Item 4 A. | <u>[UNRESOLVED STAFF COMMENTS](#i8209414efd9e4d5f8081c614b690fc9f_49)</u> | <u>[86](#i8209414efd9e4d5f8081c614b690fc9f_49)</u> |
| Item 5. | <u>[OPERATING AND FINANCIAL REVIEW AND PROSPECTS](#i8209414efd9e4d5f8081c614b690fc9f_52)</u> | <u>[86](#i8209414efd9e4d5f8081c614b690fc9f_52)</u> |
| | <u>[A. OPERATING RESULTS](#i8209414efd9e4d5f8081c614b690fc9f_55)</u> | <u>[86](#i8209414efd9e4d5f8081c614b690fc9f_55)</u> |
| | <u>[B. LIQUIDITY AND CAPITAL RESOURCES](#i8209414efd9e4d5f8081c614b690fc9f_58)</u> | <u>[98](#i8209414efd9e4d5f8081c614b690fc9f_58)</u> |
| | <u>[C. RESEARCH AND DEVELOPMENT, PATENT AND LICENSES, ETC](#i8209414efd9e4d5f8081c614b690fc9f_61)</u>. | <u>[100](#i8209414efd9e4d5f8081c614b690fc9f_61)</u> |
| | <u>[D. TREND INFORMATION](#i8209414efd9e4d5f8081c614b690fc9f_64)</u> | <u>[101](#i8209414efd9e4d5f8081c614b690fc9f_64)</u> |
| | <u>[E. CRITICAL ACCOUNTING ESTIMATES](#i8209414efd9e4d5f8081c614b690fc9f_67)</u> | <u>[101](#i8209414efd9e4d5f8081c614b690fc9f_67)</u> |
| Item 6. | <u>[DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](#i8209414efd9e4d5f8081c614b690fc9f_70)</u> | <u>[101](#i8209414efd9e4d5f8081c614b690fc9f_70)</u> |
| | <u>[A. DIRECTORS AND SENIOR MANAGEMENT](#i8209414efd9e4d5f8081c614b690fc9f_73)</u> | <u>[101](#i8209414efd9e4d5f8081c614b690fc9f_73)</u> |
| | <u>[B. COMPENSATION](#i8209414efd9e4d5f8081c614b690fc9f_76)</u> | <u>[105](#i8209414efd9e4d5f8081c614b690fc9f_76)</u> |
| | <u>[C. BOARD PRACTICES](#i8209414efd9e4d5f8081c614b690fc9f_79)</u> | <u>[113](#i8209414efd9e4d5f8081c614b690fc9f_79)</u> |
| | <u>[D. EMPLOYEES](#i8209414efd9e4d5f8081c614b690fc9f_82)</u> | <u>[114](#i8209414efd9e4d5f8081c614b690fc9f_82)</u> |
| | <u>[E. SHARE OWNERSHIP](#i8209414efd9e4d5f8081c614b690fc9f_85)</u> | <u>[115](#i8209414efd9e4d5f8081c614b690fc9f_85)</u> |
| | <u>[F. DISCLOSURE OF A REGISTRANT'S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION](#i8209414efd9e4d5f8081c614b690fc9f_88)</u> | <u>[115](#i8209414efd9e4d5f8081c614b690fc9f_85)</u> |
| Item 7. | <u>[MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](#i8209414efd9e4d5f8081c614b690fc9f_91)</u> | <u>[115](#i8209414efd9e4d5f8081c614b690fc9f_91)</u> |
| | <u>[A. MAJOR SHAREHOLDERS](#i8209414efd9e4d5f8081c614b690fc9f_94)</u> | <u>[115](#i8209414efd9e4d5f8081c614b690fc9f_94)</u> |
| | <u>[B. RELATED PARTY TRANSACTIONS](#i8209414efd9e4d5f8081c614b690fc9f_97)</u> | <u>[116](#i8209414efd9e4d5f8081c614b690fc9f_97)</u> |
| | <u>[C. INTERESTS OF EXPERTS AND COUNSEL](#i8209414efd9e4d5f8081c614b690fc9f_100)</u> | <u>[117](#i8209414efd9e4d5f8081c614b690fc9f_100)</u> |
| Item 8. | <u>[FINANCIAL INFORMATION](#i8209414efd9e4d5f8081c614b690fc9f_103)</u> | <u>[117](#i8209414efd9e4d5f8081c614b690fc9f_103)</u> |
| | <u>[A.](#i8209414efd9e4d5f8081c614b690fc9f_106)</u> <u>[CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION](#i8209414efd9e4d5f8081c614b690fc9f_106)</u> | <u>[117](#i8209414efd9e4d5f8081c614b690fc9f_106)</u> |
| | <u>[B. SIGNIFICANT CHANGES](#i8209414efd9e4d5f8081c614b690fc9f_109)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_109)</u> |
| Item 9. | <u>[THE OFFER AND LISTING](#i8209414efd9e4d5f8081c614b690fc9f_112)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_112)</u> |
| | <u>[A. OFFER AND LISTING DETAILS](#i8209414efd9e4d5f8081c614b690fc9f_115)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_115)</u> |
| | <u>[B. PLAN OF DISTRIBUTION](#i8209414efd9e4d5f8081c614b690fc9f_118)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_118)</u> |
| | <u>[C. MARKETS](#i8209414efd9e4d5f8081c614b690fc9f_121)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_121)</u> |

---

------

---

| | | |
|:---|:---|:---|
| **TABLE OF CONTENTS** | **TABLE OF CONTENTS** | **TABLE OF CONTENTS** |
| | | <u>PAGE</u> |
| | <u>[D. SELLING SHAREHOLDERS](#i8209414efd9e4d5f8081c614b690fc9f_124)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_124)</u> |
| | <u>[E. DILUTION](#i8209414efd9e4d5f8081c614b690fc9f_127)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_127)</u> |
| | <u>[F. EXPENSE OF THE ISSUE](#i8209414efd9e4d5f8081c614b690fc9f_130)</u> | <u>[118](#i8209414efd9e4d5f8081c614b690fc9f_130)</u> |
| Item 10. | <u>[ADDITIONAL INFORMATION](#i8209414efd9e4d5f8081c614b690fc9f_133)</u> | <u>[119](#i8209414efd9e4d5f8081c614b690fc9f_133)</u> |
| | <u>[A. SHARE CAPITAL](#i8209414efd9e4d5f8081c614b690fc9f_136)</u> | <u>[119](#i8209414efd9e4d5f8081c614b690fc9f_136)</u> |
| | <u>[B. MEMORANDUM AND ARTICLES OF ASSOCIATION](#i8209414efd9e4d5f8081c614b690fc9f_139)</u> | <u>[119](#i8209414efd9e4d5f8081c614b690fc9f_139)</u> |
| | <u>[C. MATERIAL CONTRACTS](#i8209414efd9e4d5f8081c614b690fc9f_142)</u> | <u>[119](#i8209414efd9e4d5f8081c614b690fc9f_142)</u> |
| | <u>[D. EXCHANGE CONTROLS](#i8209414efd9e4d5f8081c614b690fc9f_145)</u> | <u>[120](#i8209414efd9e4d5f8081c614b690fc9f_145)</u> |
| | <u>[E. TAXATION](#i8209414efd9e4d5f8081c614b690fc9f_148)</u> | <u>[120](#i8209414efd9e4d5f8081c614b690fc9f_148)</u> |
| | <u>[F. DIVIDENDS AND PAYING AGENTS](#i8209414efd9e4d5f8081c614b690fc9f_151)</u> | <u>[128](#i8209414efd9e4d5f8081c614b690fc9f_151)</u> |
| | <u>[G. STATEMENT BY EXPERTS](#i8209414efd9e4d5f8081c614b690fc9f_154)</u> | <u>[128](#i8209414efd9e4d5f8081c614b690fc9f_154)</u> |
| | <u>[H. DOCUMENTS ON DISPLAY](#i8209414efd9e4d5f8081c614b690fc9f_157)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_157)</u> |
| | <u>[I. SUBSIDIARY INFORMATION](#i8209414efd9e4d5f8081c614b690fc9f_160)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_160)</u> |
| | <u>[J. ANNUAL REPORT ON SECURITY HOLDER](#i8209414efd9e4d5f8081c614b690fc9f_163)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_160)</u> |
| Item 11. | <u>[QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](#i8209414efd9e4d5f8081c614b690fc9f_166)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_166)</u> |
| Item 12. | <u>[DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES](#i8209414efd9e4d5f8081c614b690fc9f_169)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_169)</u> |
| | <u>[A. DEBT SECURITIES](#i8209414efd9e4d5f8081c614b690fc9f_172)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_172)</u> |
| | <u>[B. WARRANTS AND RIGHTS](#i8209414efd9e4d5f8081c614b690fc9f_175)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_175)</u> |
| | <u>[C. OTHER SECURITIES](#i8209414efd9e4d5f8081c614b690fc9f_178)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_178)</u> |
| | <u>[D. AMERICAN DEPOSITARY SHARES](#i8209414efd9e4d5f8081c614b690fc9f_181)</u> | <u>[129](#i8209414efd9e4d5f8081c614b690fc9f_181)</u> |
| Part II | | |
| Item 13. | <u>[DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES](#i8209414efd9e4d5f8081c614b690fc9f_184)</u> | <u>[131](#i8209414efd9e4d5f8081c614b690fc9f_184)</u> |
| Item 14. | <u>[MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS](#i8209414efd9e4d5f8081c614b690fc9f_187)</u> | <u>[131](#i8209414efd9e4d5f8081c614b690fc9f_187)</u> |
| Item 15. | <u>[CONTROLS AND PROCEDURES](#i8209414efd9e4d5f8081c614b690fc9f_190)</u> | <u>[131](#i8209414efd9e4d5f8081c614b690fc9f_190)</u> |
| Item 16. | <u>[\[RESERVED\]](#i8209414efd9e4d5f8081c614b690fc9f_193)</u> | <u>[134](#i8209414efd9e4d5f8081c614b690fc9f_196)</u> |
| Item 16A. | <u>[AUDIT COMMITTEE FINANCIAL EXPERT](#i8209414efd9e4d5f8081c614b690fc9f_196)</u> | <u>[134](#i8209414efd9e4d5f8081c614b690fc9f_196)</u> |
| Item 16B. | <u>[CODE OF ETHICS](#i8209414efd9e4d5f8081c614b690fc9f_199)</u> | <u>[134](#i8209414efd9e4d5f8081c614b690fc9f_202)</u> |
| Item 16C. | <u>[PRINCIPAL ACCOUNTANT FEES AND SERVICES](#i8209414efd9e4d5f8081c614b690fc9f_202)</u> | <u>[134](#i8209414efd9e4d5f8081c614b690fc9f_202)</u> |
| Item 16D. | <u>[EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES](#i8209414efd9e4d5f8081c614b690fc9f_205)</u> | <u>[135](#i8209414efd9e4d5f8081c614b690fc9f_208)</u> |
| Item 16E. | <u>[PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS](#i8209414efd9e4d5f8081c614b690fc9f_208)</u> | <u>[135](#i8209414efd9e4d5f8081c614b690fc9f_211)</u> |
| Item 16F. | <u>[CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT](#i8209414efd9e4d5f8081c614b690fc9f_211)</u> | <u>[135](#i8209414efd9e4d5f8081c614b690fc9f_214)</u> |
| Item 16G. | <u>[CORPORATE GOVERNANCE](#i8209414efd9e4d5f8081c614b690fc9f_214)</u> | <u>[135](#i8209414efd9e4d5f8081c614b690fc9f_214)</u> |
| Item 16H. | <u>[MINE SAFETY DISCLOSURE](#i8209414efd9e4d5f8081c614b690fc9f_217)</u> | <u>[136](#i8209414efd9e4d5f8081c614b690fc9f_217)</u> |
| Item 16I. | <u>[DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTION](#i8209414efd9e4d5f8081c614b690fc9f_220)</u> | <u>[136](#i8209414efd9e4d5f8081c614b690fc9f_217)</u> |
| Item 16J. | <u>[INSIDER TRADING](#i8209414efd9e4d5f8081c614b690fc9f_223)</u> | <u>[136](#i8209414efd9e4d5f8081c614b690fc9f_217)</u> |
| Item 16K. | <u>[CYBERSECURITY](#i8209414efd9e4d5f8081c614b690fc9f_226)</u> | <u>[136](#i8209414efd9e4d5f8081c614b690fc9f_217)</u> |
| Part III | | |
| Item 17. | <u>[FINANCIAL STATEMENTS](#i8209414efd9e4d5f8081c614b690fc9f_229)</u> | <u>[137](#i8209414efd9e4d5f8081c614b690fc9f_229)</u> |
| Item 18. | <u>[FINANCIAL STATEMENTS](#i8209414efd9e4d5f8081c614b690fc9f_232)</u> | <u>[138](#i8209414efd9e4d5f8081c614b690fc9f_232)</u> |
| Item 19. | <u>[EXHIBITS](#i8209414efd9e4d5f8081c614b690fc9f_235)</u> | <u>[139](#i8209414efd9e4d5f8081c614b690fc9f_235)</u> |

---

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GENERAL INFORMATION

In this Annual Report on Form 20-F, or Annual Report, the terms "Pharming," "Pharming Group," "Pharming Group N.V.," "the Group," "the Company," "we," "us" and "our" refer to Pharming Group N.V. together with its subsidiaries, except where the context otherwise requires.

"**Joenja®**" is the global registered trademark for leniolisib. When discussing the U.S. market or the commercialized product in the U.S., or other countries where the product has received regulatory approval, we generally use the trademarked name Joenja® instead of leniolisib.

"**leniolisib**" is the term we generally use when discussing clinical trials or studies or when discussing the product as related to markets outside of where regulatory approvals have been received.

TRADEMARKS, TRADE NAMES AND SERVICE MARKS

We own or have rights to trademarks, service marks and trade names that we use in connection with the operation of our business, including our corporate name, logos and website names. We own the trademarks RUCONEST® and Joenja® among others, as well as the graphic trademark found on our website. There are trademarks, service marks and trade names appearing in this Annual Report that are the property of their respective owners. Solely for convenience, some of the trademarks, service marks and trade names referred to in this Annual Report are listed without the® symbol, but we will assert, to the fullest extent under applicable law, our rights to our trademarks, service marks and trade names.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "estimate", "predict", "potential", "continue" and "ongoing", or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this Annual Report are based upon information available to us as of the date of this Annual Report and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include, but are not limited to, statements about:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our expected revenues and net profit related to sales of RUCONEST® and Joenja®;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the positioning, differentiation and clinical role of RUCONEST® and Joenja®, including their status as

on-demand or targeted therapies, and our expectation regarding their continued use, demand and

competitive position in the market;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to obtain regulatory approval of Joenja® in additional jurisdictions and our plans to

commercialize Joenja® in such jurisdictions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the development of our product candidates, including statements regarding the timing of initiation, completion and the outcome of clinical trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to obtain and maintain regulatory approval of our product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our plans to collaborate, or statements regarding the ongoing collaborations, with third parties;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our plans to research, develop, manufacture and commercialize our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the timing of our regulatory filings for our products and product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the size and growth potential of the markets for our products and product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our commercialization, sales and marketing and manufacturing capabilities and strategy;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to successfully acquire new products and product candidates and successfully integrate those

------

we acquire;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our expectations regarding our ability to obtain and maintain intellectual property protection;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to attract and retain qualified employees and key personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our estimates regarding future revenues, expenses and needs for additional financing;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to raise additional capital;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our belief that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements as we currently expect; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• regulatory developments in the United States, the Netherlands, other European Union, or EU Member States, Japan and other jurisdictions including tax matters.

You should refer to the section of this Annual Report titled "Item 3 — D. Risk Factors" for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to this Annual Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

This Annual Report contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties such as investment banking analysts, industry, medical and general publications, government data and similar sources. Although we believe these sources are reliable, we do not guarantee the accuracy or completeness of this information and we have not independently verified this information. In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled "Item 3 — D. Risk Factors." These and other factors could cause our future performance to differ materially from our assumptions and estimates.

**APPLICATION OF INTERNATIONAL FINANCIAL REPORTING STANDARDS**

We adopted International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. Unless otherwise stated, all information presented herein has been prepared in accordance with IFRS and all prior period amounts have been prepared in accordance with IFRS.

**CURRENCY**

Unless otherwise stated, "$", when used in this Annual Report, refers to U.S. dollars and "€" refers to Euros.

**Item 1. Identity of Directors, Senior Management and Advisers** 

Not applicable.

**Item 2. Offer Statistics and Expected Timetable**

Not applicable.

------

**Item 3. Key Information** 

**A. [Reserved]**

**B. Capitalization and Indebtedness**

Not applicable.

**C. Reasons for the Offer and Use of Proceeds**

Not applicable.

**D. Risk Factors**

*Our business faces significant risks and uncertainties. You should carefully consider all of the information set forth in this Annual Report and in other documents we file with or furnish to the Securities and Exchange Commission, or SEC, including the following risk factors, before deciding to invest in or to maintain an investment in our securities. Our business, as well as our reputation, financial condition, results of operations, and share price, could be materially adversely affected by any of these risks, as well as other risks and uncertainties not currently known to us or not currently considered material.*

**Summary of Selected Risks Associated with Our Business**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The development and commercialization of pharmaceuticals and biologics is highly competitive. In particular, RUCONEST® faces competition from other products (acute and prophylactic) used to treat Hereditary Angioedema, or HAE. There are several products from competitors that have been approved in the U.S. for the treatment of HAE attacks. Additional products to treat or prevent HAE attacks and potential gene therapy products are in development. Consequently, we may not maintain sufficient market penetration with RUCONEST® or a sufficient level of sales of the product to remain profitable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are heavily dependent on sales of RUCONEST® in the United States. If we are unable to continue to further commercialize RUCONEST®, our business could be materially harmed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Joenja® is a newly approved drug in the U.S., the U.K., Japan, Australia and Israel and could develop unexpected safety or efficacy concerns, which would likely have a material adverse effect on us.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The commercial success of our approved products depends, and the commercial success of any product candidate will depend, upon the degree of market acceptance by physicians, patients, payors and others in the medical community.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• If we are unable to maintain and grow our sales and marketing capabilities, particularly outside of the United States, or enter into agreements with third parties to market and sell our products outside of the United States and Europe, our business will be adversely affected.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Revenue from our approved products depends, and the successful commercialization of our product candidates will depend, in part, on the extent to which governmental authorities and health insurers maintain or establish, as applicable, adequate coverage, reimbursement levels and pricing policies. Failure to maintain or obtain coverage and adequate reimbursement for our approved products and our product candidates, if approved, could limit our ability to market those products and decrease revenue generating ability.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential than our current product candidates due to limited resources available.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The costs and timing of potential clinical trials, filings and approvals, and the potential therapeutic scope of the development and commercialization of our products involve a high degree of uncertainty and risk which make it difficult to predict the time and costs of product development of novel approaches.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We rely on third parties for the conduct of significant aspects of our preclinical studies and clinical trials and intend to rely on third parties in the future. If these third parties do not successfully carry out their contractual duties, and on a timely basis, our business may be adversely impacted.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We conduct clinical trials for certain of our product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may not be able to obtain or maintain orphan drug exclusivity for our products or product candidates. If our competitors are able to obtain orphan drug exclusivity for their products, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The results from our clinical trials may not be sufficiently robust to support the submission of marketing approval for our product candidates. Before we submit our product candidates for marketing approval, the FDA, the EMA, or any other regulatory body may require us to conduct additional clinical trials or evaluate patients for an additional follow-up period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We depend on our information technology systems and have been and may in the future be the victim of cyberattacks, which may compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition*.***

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Any contamination in the manufacturing process for our recombinant products, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules and significantly impact commercially available goods.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are dependent on a limited number of suppliers for some of the components and materials used in our product candidates and products. Any disruption in the supply of these materials could adversely affect our ability to deliver product or complete clinical trials. Other studies of product candidates, regulatory applications or commercializing product candidates in a timely and commercially valuable manner, may be adversely affected, should supply be disrupted.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We depend on third-party manufacturers for the production of Joenja® and for the production of rhC1INH for commercial supply and for use in clinical trials of RUCONEST®, as well as our product candidates for clinical trials. Interruption in supply could materially and adversely affect sales.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We experience significant customer concentration, with a limited number of customers accounting for a significant portion of our revenues.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our success is dependent on our ability to obtain and protect rights to proprietary technology and to develop our technology and products without infringing the proprietary rights of third parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our patents may be challenged, deemed unenforceable, invalidated or circumvented, and if we do not obtain or maintain patent protection for the products, our business may be materially harmed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Changes in trade policies, including tariffs and other import or export restrictions, could adversely affect our business.

**Risks Related to Our Business**

***The development and commercialization of pharmaceuticals and biologics is highly competitive. In particular, RUCONEST® faces intense competition from other products used to treat Hereditary Angioedema, or HAE. There are several products from competitors that have been approved in the U.S. for the treatment of HAE attacks. Additional products to treat or prevent HAE attacks and potential gene therapy products are in development. Consequently, we may not maintain sufficient market penetration with RUCONEST® or a sufficient level of sales of the product to remain profitable.***

The development and commercialization of pharmaceuticals and biologics is highly competitive. In particular, RUCONEST® faces intense competition from other products used to treat HAE. We face the risk that RUCONEST® may no longer be competitive and accepted by physicians, patients, payors and others in the medical community within acute HAE market. Prophylactic therapies are increasingly used and the U.S. Food

and Drug Administration, or the FDA, approved new prophylacic therapies in 2025, which may result in HAE patients requiring less acute rescue medicine. RUCONEST® is not approved for prophylactic use.

Several products have been approved in the U.S. and Europe for the treatment of HAE attacks, including human blood plasma derived C1-inhibitor, or C1INH, products. In addition, EKTERLY® (sebetralstat), an oral treatment for acute HAE attacks, was approved in the U.S. in the third quarter of 2025. Oral products for the treatment and prevention of HAE attacks are also being developed. Consequently, we may not maintain sufficient market penetration with RUCONEST® or a sufficient level of sales of the product to allow it to remain profitable. In addition, new technologies from competitors, including potential gene therapies, may make RUCONEST® obsolete.

------

Our competitors include major international pharmaceutical companies as well as smaller or regional specialty pharmaceutical and biotechnology companies. Many of our competitors are larger and have greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, prosecuting intellectual property rights and marketing approved products than we do. Such competitors may be better equipped to withstand adverse changes in economic and industry conditions. Smaller or early stage companies may also be significant competitors, particularly through collaborative arrangements with large, established companies. Key competitive factors affecting the commercial success of our products and any other products that we develop or acquire are likely to be safety, efficacy, tolerability profile, reliability, convenience of dosing, price and reimbursement. We may also face future competition from companies selling generic alternatives to RUCONEST® in countries where we do not have patent coverage, orphan drug status or another form of data or marketing exclusivity or where patent coverage or data or marketing exclusivity has expired, is not enforced, or may, in the future, be challenged.

***We are heavily dependent on sales of RUCONEST® in the United States. If we are unable to continue to effectively commercialize RUCONEST®, our business could be materially harmed.***

We have, to date, been substantially focused on the development and commercialization of RUCONEST®, and we expect to continue to be dependent primarily on revenues from RUCONEST® sales in the near term. Although we have commercialized Joenja® in the United States and the United Kingdom, RUCONEST® sales accounted for approximately 85% of our total revenues in 2025, and we expect it to continue to make up the majority of our revenues for the foreseeable future. Accordingly, any adverse events or findings regarding the properties, efficacy or safety of RUCONEST®, or material constraints on the manufacturing of RUCONEST®, may have a material impact on our financial results and operations.

Our ability to meet expectations with respect to sales of RUCONEST®, generate revenues from such sales, and attain and maintain positive cash flow from operations, in the time periods anticipated, or at all, will depend on a number of factors, including, among others:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the ability to maintain and grow market acceptance for RUCONEST® among healthcare professionals and patients in the United States, for the treatment of approved indications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to maintain regulatory approvals without onerous restrictions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to obtain pricing and reimbursement approvals at adequate levels, where required, on a timely basis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• presence of side effects or other safety issues associated with the use of RUCONEST® that could require us or our distributors to modify or halt commercialization;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• whether we will be required by regulatory agencies to conduct additional studies regarding the safety and efficacy of RUCONEST®, which we have not planned or anticipated;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• increased competition from competitors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• obtaining and maintaining patent protection and regulatory exclusivity; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• adequately investing in the manufacturing, sales, marketing, market access, medical affairs and other functions that are supportive of our commercialization efforts.

***Joenja***® ***is a newly approved drug in the U.S., the U.K., Japan, Australia and Israel and could develop unexpected safety or efficacy concerns, which would likely have a material adverse effect on us.***

Joenja® was granted approval by the Ministry of Health, Labour and Welfare, or MHLW, in Japan on March 23, 2026, the Therapeutic Goods Administration, or TGA, in Australia on March 18, 2025, by the Medicines & Healthcare products Regulatory Agency, or MHRA, in the U.K. on September 25, 2024, by the Israeli Ministry of Health in Israel on April 30, 2024 and by the FDA in the U.S. in late March 2023. In these countries, especially in the U.S. and U.K. where the product is commercially available, Joenja® is now being used by a larger number of patients, potentially for longer periods of time, and we and others (including regulatory agencies and private payors) collect extensive information on the efficacy and safety of Joenja® by monitoring its use in the marketplace. New safety or efficacy data from market surveillance may result in negative consequences including the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Modification to product labeling or promotional statements, such as additional boxed or other warnings or contraindications, or the issuance of additional "Dear Doctor Letters" or similar communications to healthcare professionals;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Required changes in the administration of Joenja®;

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Imposition of additional post-marketing surveillance, post-marketing clinical trial requirements, distribution restrictions or other risk management measures, such as a risk evaluation and mitigation strategy;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Suspension or withdrawal of regulatory approval or delays or declination of regulatory approval outside of the United States;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Suspension of, or imposition of restrictions on, our operations, including costly new manufacturing requirements with respect to Joenja®; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Voluntary or mandatory product recalls or withdrawals from the market and costly product liability claims.

Any of these circumstances could reduce Joenja's® market acceptance and would be likely to materially adversely affect our business.

***The commercial success of our approved products depends, and the commercial success of any product candidate will depend, upon the degree of market acceptance by physicians, patients, payors and others in the medical community.***

The commercial success of our approved products depends, and of our product candidates will depend, in part, on the medical community, patients, and payors accepting them as effective, safe and cost-effective. If our product candidates do not achieve an adequate level of acceptance, we may struggle to continue to generate significant product revenues and may not in the future generate any profits from operations. The degree of market acceptance of our approved products, in particular Joenja®, or our product candidates, if approved for commercial sale, will depend on a number of factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the potential efficacy and potential advantages over alternative treatments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the frequency and severity of any side effects, including any limitations or warnings contained in a product's approved labeling;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the frequency and severity of any side effects resulting from the conditioning regimen or follow-up requirements for the administration of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the relative convenience and ease of administration;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the strength of marketing and distribution support and timing of market introduction of competitive products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• publicity concerning our products or competing products and treatments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• continued demand from two U.S. specialty pharmacies that in 2025 represented 77% of our revenues; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• sufficient third-party insurance coverage or reimbursement.

Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product, if approved for commercial sale, will not be known until after it is launched. Our efforts to educate the medical community and payors on the benefits of our products, particularly Joenja® given its recent approval, and product candidates may require significant resources and may never be successful. Such efforts to educate the marketplace may require more resources than are required by the conventional technologies marketed by our competitors.

***If we are unable to maintain and grow our sales and marketing capabilities, particularly outside of the United States, or enter into agreements with third parties to market and sell our products outside of the United States and Europe, our business will be adversely affected.***

We are currently preparing for the launch of leniolisib in Japan, Germany, France, Italy, Spain, Canada and Australia. Establishing and maintaining internal medical and commercial capabilities, as we are doing for Joenja®, carries an element of risk. For example, recruiting and training an integrated medical and commercial organization can be expensive and time consuming and could delay any product launch. Furthermore, if the commercialization of a product is delayed, establishing a commercial organization prematurely would result in the need to restructure the organization.

Factors that may inhibit our efforts to commercialize our products on our own include:

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the inability to recruit, train and retain adequate numbers of effective medical, access, sales and marketing personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• inability to obtain appropriate regulatory approval and subsequent reimbursement coverage

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future product that we may develop;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• unforeseen costs and expenses associated with creating an independent sales and marketing organization.

We enter into arrangements with a variety of third-parties to perform a range of activities including medical affairs, regulatory and reimbursement support and, sales, marketing and distribution services outside of the United States and Europe. We have made leniolisib available for activated phosphoinositide 3-kinase delta, or PI3Kδ, syndrome, or APDS, patients in a select number of large markets. Where viable, following regulatory approval, we intend to market leniolisib directly in Germany, France, Italy, Spain, Canada and Australia and we have entered into an agreement with OrphanPacific, Inc. who are responsible for supply and distribution in Japan. Prior to regulatory approval in certain markets, we will make leniolisib available via a variety of access schemes.

In addition, we have granted the China State Institute of Pharmaceutical Industry, or the CSIPI, an exclusive license to commercialize rhC1INH in China, and the CSIPI is collaborating with the Chengdu Institute of Biological Products Co, Ltd, or the CDIBP, and we are solely dependent on their efforts to commercialize rhC1INH in that territory. On December 15, 2023, the CDIBP announced that it received the clinical trial permit from the Center for Drug Evaluation of the National Medical Product Administration for the clinical development of rhC1INH in China. We may receive certain regulatory and manufacturing-associated milestones, and we are eligible to receive low to mid-single digit royalties from sales in China by the CSIPI, affiliates of the CSIPI and sublicensees of the CSIPI. Dependence on distribution arrangements to commercialize our products in certain jurisdictions subjects us to a number of risks.

We do not have control over such third parties and any of them may fail to devote the necessary resources and attention to distribute our products effectively. In addition, any potential non-compliance with applicable laws and regulations by such third parties would potentially expose us to sanctions. If such third-party arrangements are terminated or allowed to expire, the marketing and sales of a product in that jurisdiction may be interrupted, which could adversely affect our revenues. In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are favorable to us. See "Item 3 – D. Risk Factors – We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic markets. We can face criminal liability and other serious consequences for violations, which can harm our business" of this Annual Report.

***Revenue from our approved products depends, and the successful commercialization of our product candidates will depend, in part, on the extent to which governmental authorities and health insurers maintain or establish, as applicable, adequate coverage, reimbursement levels and pricing policies. Failure to maintain or obtain coverage and adequate reimbursement for our approved products and our product candidates, if approved, could limit our ability to market those products and decrease revenue generating ability.***

The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors is essential for many patients to be able to afford prescription medications such as RUCONEST® and Joenja® and potential product candidates, assuming regulatory approval is obtained. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations fundamentally impacts the potential success of RUCONEST® and Joenja® and potential product candidates. Assuming we obtain coverage for our product candidates by third-party payors, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the United States, the U.K., the EU Member States, or elsewhere will be maintained for our approved products or available for our product candidates or any product that we may develop, and any reimbursement that may be or become available may be decreased or eliminated in the future. There is an increasing tendency of health insurers to reduce healthcare costs by limiting both the coverage and

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breadth of reimbursement for new therapeutic products and in some cases by refusing to provide coverage altogether.

Because coverage and reimbursement determinations are made on a payor-by-payor basis, obtaining coverage and adequate reimbursement from a third-party payor does not guarantee that we will obtain similar coverage or reimbursement from another third-party payor. Reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any products for which we obtain marketing approval. Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors, or delays in processing approvals by those payors, could result in the loss of sales, loss of customers, or reputational damage, which could have a material adverse effect on our business, financial condition and operating profit.

Further, it is possible that a third-party payor may consider our products or product candidates as similar to alternative treatment options and only offer to reimburse patients for a less expensive product. In some cases this can involve a requirement that patients try the less expensive product first, only approving other therapies after the patient does poorly on the less expensive product. Even if we show improved efficacy or convenience of administration with our products or product candidates compared to products marketed by our competitors and the prevailing standard of care, the pricing of existing therapies may still limit the amount we could charge. Third-party payors may deny or revoke the reimbursement status of any given product or establish new prices for existing marketed products that inhibit us from realizing an appropriate return on our investment in the product candidates. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates, and may not be able to obtain a satisfactory financial return on them.

In the United States, the Center for Medicare and Medicaid Innovation, or CMMI, has announced two new mandatory models that propose Most-Favored-Nation, or MFN, pricing using specified international benchmarks for certain products covered by Medicare and one new voluntary model that proposes MFN pricing for products covered by Medicaid. These models, or other models announced by CMMI, could result in significantly lower reimbursement for products. These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our products for which we may obtain regulatory approval or the frequency with which any such product is prescribed or used. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importing from other countries and bulk purchasing.

We expect to experience pricing pressures in connection with the sale of any of our products or product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs, surgical procedures and other treatments, is expected to continue. Further, to the extent that the United States operates an MFN pricing regime that references the prices achieved in other markets, we may be restricted from seeking regulatory approval for our product candidates or supplying our products in those other markets to avoid a negative impact on the prices for our products in the United States.

Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada, and other countries has and will continue to put pressure on the pricing and usage of our products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to set their own prices for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to justify commercialization.

***We may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential than our product candidates due to limited resources available.***

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Our spending on current and future research and development programs may not yield any commercially viable product candidates. If we do not accurately evaluate the commercial potential for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaborations, licensing or other arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. If any of these events occur, we may be forced to abandon our development efforts with respect to a particular product candidate or fail to develop a potentially successful product candidate.

***The costs and timing of potential clinical trials, filings and approvals, and the potential therapeutic scope of the development and commercialization of our products involve a high degree of uncertainty and risk which make it difficult to predict the time and costs of product development of novel approaches.***

New product development and indication expansions of existing products is very expensive and involves a high degree of uncertainty and risk. Only a small number of research and development programs result in the commercialization of a new product. Furthermore, the development of novel approaches for the treatment of diseases, including development efforts in new and innovative modalities present additional challenges and risks. Clinical trial data and results are subject to differing interpretations by regulatory authorities. We may view data as sufficient to support the safety, effectiveness, or approval of an investigational therapy, while regulatory authorities may disagree and may require additional data, may limit the scope of an approval or may deny approval altogether. There can be difficulty in predicting the time and cost of product development of novel approaches for the treatment of diseases across regulatory approval authorities.

Success in preclinical work or early-stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. The results of clinical trials may indicate that our product candidates lack efficacy, have harmful side effects, result in unexpected adverse events or raise other concerns that may significantly reduce the likelihood of regulatory approval. This may result in terminated programs, significant restrictions on use and safety warnings in an approved label, adverse placement within the treatment paradigm or significant reduction in the commercial potential of the product candidate.

Even if we could successfully develop new products or indications, we may make a strategic decision to discontinue development of a product candidate or indication if, for example, we believe commercialization will be difficult relative to the standard of care or other opportunities in our pipeline.

***We rely on third parties for the conduct of significant aspects of our preclinical studies and clinical trials and intend to rely on third parties in the future. If these third parties do not successfully carry out their contractual duties, and on a timely basis, our business may be adversely impacted.***

We rely on third parties for the conduct of significant aspects of our preclinical studies and clinical trials. These third parties include contract research organizations, or CROs, medical institutions, clinical investigators and contract laboratories. Although we design the clinical trials for our product candidates, we depend on these third parties for aspects of performing the trials. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our regulatory or contractual responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial.

The third parties we rely upon may fail to successfully carry out their contractual duties or meet expected deadlines, which may cause delays in the conduct of our preclinical and clinical studies.

If the CROs do not perform preclinical studies and clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with regulatory requirements and other compliance obligations, the development, regulatory approval and commercialization of our product candidates may be delayed, we may not be able to obtain regulatory approval and commercialize our product candidates, or our development programs may be materially and irreversibly harmed. If we are unable to rely on preclinical and clinical data collected by our CROs, we could be required to repeat, extend the duration of, or increase the size of any clinical trials we conduct and this could significantly delay commercialization and require significantly greater expenditures. See "Item 3 – D. Risk Factors – We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal

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standards could impair our ability to compete in domestic markets. We can face criminal liability and other serious consequences for violations, which can harm our business" of this Annual Report.

***We conduct clinical trials for certain of our product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations.***

We and the investigators conducting clinical trials for certain of our product candidates study our product candidates outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of these data is subject to conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful.

In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S. laws and regulations. If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and would delay or permanently halt our development of the applicable product candidates or indications. In addition, in order to commence a clinical trial in the United States, we are required to seek FDA acceptance of an Investigational New Drug application, or IND, for each of our product candidates. We cannot be certain that any IND we submit to the FDA, or any similar Clinical Trial Application, or CTA, we submit in other countries, will be accepted. We may also be required to conduct additional preclinical testing prior to submitting an IND for any of our product candidates, and the results of any such testing may not be positive. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to a New Drug Application, or NDA, or Biologics License Application, or BLA, submission and approval of our product candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing our product candidates.

***We may not be able to obtain or maintain orphan drug exclusivity for our products or product candidates. If our competitors are able to obtain orphan drug exclusivity for their products, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.***

Regulatory authorities in some jurisdictions, including the United States, the EU and the United Kingdom, may designate drugs for relatively small patient populations as orphan drugs. We obtained orphan drug designation for RUCONEST® from the FDA for the treatment of acute HAE attacks. Joenja® has also received this designation from the FDA, the European Medicines Agency, or the EMA, and the MHLW in Japan. However, no assurances can be made for our product candidates.

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of market exclusivity, which, subject to certain exceptions, precludes the acceptance or approval by a regulatory authority in the EU of another marketing application for a similar medicinal product or the approval by the FDA of another marketing application for the same drug for the same indication for that time period. The FDA defines "same drug" as a drug or biologic that contains the same active moiety and is intended for the same use. The applicable market exclusivity period for orphan drugs is ten years in the EU and the United Kingdom and seven years in the United States. The EU and United Kingdom exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation.

In the EU and the United Kingdom, a "similar medicinal product" is a medicinal product containing a similar active substance or substances as contained in a currently authorized orphan medicinal product, and which is intended for the same therapeutic indication. A "similar active substance" is "an identical active substance, or an active substance with the same principal molecular structural features (but not necessarily all of the same molecular structural features) and which acts via the same mechanism. However, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances shall be assessed on the basis of the biological and functional characteristics." Obtaining orphan drug exclusivity for our product candidates is important to the product

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candidate's success. If a competitor obtains orphan drug exclusivity for, and approval of, a product with the same indications as our product candidates before we do and if the competitor's product is the same drug or a similar medicinal product as ours, we could be excluded from the market for a certain period of time. If another product has obtained a marketing authorization for the same indication, we would have to prepare a similarity report (addressing the possible similarity between the authorized product and our product), which will take additional time.

Although we have obtained orphan drug designation for Joenja® from the FDA, the EMA, and the MHLW, we may not be able to maintain it. For example, if a competitive product that is the same drug or a similar medicinal product as our product or product candidate is shown to be clinically superior to our product or product candidate, as applicable, any orphan drug exclusivity we have obtained will not block the approval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that is the same drug as our product or product candidate if the applicable regulatory agency finds that we cannot assure the availability of sufficient quantities of the drug to meet the needs of the persons with the disease or condition for which the drug was designated in the relevant jurisdiction.

The FDA Reauthorization Act of 2017 authorizes the FDA to impose additional clinical trial requirements on manufacturers seeking orphan drug designation and/or pediatric indications. Additionally, it should be noted that the European Commission is currently reviewing the EU general pharmaceutical legislation. While any revisions to the legislation will not be applicable for a number of years, the European Commission intends to make changes to the rules on orphan medicinal products including potentially reducing the duration of data and market exclusivity available.

***The results from our clinical trials may not be sufficiently robust to support the submission of marketing approval for our product candidates. Before we submit our product candidates for marketing approval, the FDA, the EMA, or any other regulatory body may require us to conduct additional clinical trials or evaluate patients for an additional follow-up period.***

The results from our clinical trials may not be sufficiently robust to support the submission for marketing approval for our product candidates. The FDA normally requires two registrational trials to approve a drug or biologic product, and thus the FDA may require that we conduct additional clinical trials of our product candidates prior to a BLA or NDA submission. The FDA typically does not consider a single clinical trial to be adequate to serve as a registrational trial unless among other things, it is well-controlled and demonstrates a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease with potentially serious outcome, and a confirmatory study would be practically or ethically impossible. Additionally, while the FDA recognizes the potential for natural history models to augment the need for placebo arms in trials for drugs that target very rare disease, where trial recruitment can be especially challenging, the FDA has found the use of natural history data as a historical comparator to be unsuitable for adequate and well-controlled trials in many circumstances. The FDA generally finds trials using historical controls to be credible only when the observed effect is large in comparison to variability in disease course. Like the FDA, the EMA and other regulatory bodies also expect applicants to submit sufficient clinical data, which is usually generated from clinical studies, to demonstrate the safety and efficacy of the medicinal product.

Due to the nature of the indications our product candidates are designed to treat, and the limited number of patients with these conditions, a placebo-controlled and blinded study may not be practicable for ethical and other reasons. It is possible the FDA, EMA and/or other regulatory bodies will not consider our comparisons to natural history data and, where available, historical transplant data, to provide clinically meaningful results. Additionally, even though a product candidate may have achieved the primary endpoints in a registrational clinical trial, it is possible that the FDA, EMA and/or other regulatory bodies may require us to conduct additional registrational trials, possibly involving a larger sample size or a different clinical trial design, especially if the FDA, EMA and/or other regulatory bodies do not find the results from these trials to be sufficiently persuasive to support a BLA/NDA or Marketing Authorization Application, or MAA, submission, as applicable. The FDA, EMA and/or other regulatory bodies may also require that we conduct a longer follow-up period of post-market surveillance of patients treated with our product candidates prior to accepting our BLA/NDA or MAA submission, as applicable.

In addition, data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. There can be no assurance that the FDA, EMA or other

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regulatory bodies will find the efficacy endpoints in our registrational trials or any efficacy endpoint we propose in future registrational trials to be sufficiently validated and clinically meaningful, or that our product candidates will achieve the pre-specified endpoints in current or future registrational trials to a degree of statistical significance, and with acceptable safety profiles. We also may experience regulatory delays or rejections as a result of many factors, including serious adverse events involving our product candidates, changes in regulatory policy or changes in requirements during the period of our product candidate development. Any such delays could materially and adversely affect our business, financial condition, results of operations and prospects.

We expect that the FDA, EMA and/or other regulatory bodies will assess the totality of the safety and efficacy data from our product candidates in reviewing any future BLA, NDA, or MAA, submissions. Based on this assessment, the FDA, EMA and/or other regulatory bodies may require that we conduct additional preclinical studies or clinical trials prior to submitting or approving a BLA, NDA, or MAA, for our target indications.

If the FDA, EMA and/or other regulatory bodies requires additional trials, we would incur increased costs and delays in the marketing approval process, which may require us to expend more resources than we have available. In addition, it is possible that the FDA, EMA and/or other regulatory bodies may have divergent opinions on the elements necessary for a successful BLA/NDA and MAA, respectively, which may cause us to alter our development, regulatory and/or commercialization strategies.

***Our past acquisitions and any future acquisitions may expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies or successfully integrate them.***

As a part of our growth strategy, we have made and may in the future make acquisitions of complementary businesses, products or research. For example, we completed the acquisition of Abliva AB in March 2025. Our past acquisitions and any future acquisition may involve numerous risks and operational, financial and managerial challenges, including the following, any of which could adversely affect our business, financial condition or results of operations:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• limited support and user knowledge for legacy systems of acquired companies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• problems maintaining uniform procedures, controls and policies with respect to our financial accounting systems;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• difficulties in managing geographically dispersed operations, including risks associated with entering foreign markets in which we have no or limited prior experience;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• underperformance of any acquired technology, product or business relative to our expectations and the price we paid;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• negative near-term impacts on financial results after an acquisition, including acquisition-related earnings charges;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the potential loss of key employees, customers and strategic partners of acquired companies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• claims by terminated employees and shareholders of acquired companies or other third parties related to the transaction;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the assumption or incurrence of additional debt obligations or expenses, or use of substantial portions of our cash;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the issuance of equity securities to finance or as consideration for any acquisitions that dilute the ownership of our shareholders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• any collaboration, strategic alliance and licensing arrangement may require us to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• diversion of management's attention and company resources from existing operations of the business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• inconsistencies in standards, controls, procedures and policies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the impairment of intangible assets as a result of technological advancements, or worse-than-expected performance of acquired companies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• assumption of, or exposure to, historical liabilities of the acquired business, including unknown contingent or similar liabilities that are difficult to identify or accurately quantify;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our inability to generate revenues from acquired technology or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• risks associated with acquiring intellectual property, including potential disputes regarding acquired companies' intellectual property;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• difficulty integrating the new business or asset; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• failures of diligence and the resulting development of previously unidentified liabilities.

There can be no assurance that any of the acquisitions we made in the past or we may make in the future will be successful or will be, or will remain, profitable. Our failure to successfully address the foregoing risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all.

***Negative public opinion and increased regulatory scrutiny of transgenic manufacturing techniques, or activism regarding the ethical treatment of livestock, may damage public perception of RUCONEST® and our product candidates, which may adversely affect sales of our products and our ability to obtain marketing approvals for our product candidates.***

Public perception may be influenced by negative public statements regarding our transgenic manufacturing technology. Our transgenic manufacturing technology platform involves the genetic engineering of animals for the production of recombinant proteins. Genetic modification of food and livestock are a common subject of debate and negative publicity. In addition, animal rights activists commonly engage in campaigns to reduce or eliminate the use of animals in the commercialization of pharmaceutical products.

Negative publicity regarding genetic modification in general, and our transgenic manufacturing techniques in particular, or activism regarding the treatment of our livestock could result in reduced market acceptance for our products, increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates. If any such adverse events occur, commercialization of RUCONEST® or further advancement of our clinical trials could be halted or delayed, which would have a material adverse effect on our business and operations.

***Our assumptions and estimates regarding prevalence and the addressable markets for our products and product candidates may be inaccurate, which could have a material adverse effect on our revenues and cash position.***

If there are fewer actual patients than estimated, or if any product approval is based on narrower definitions of patient populations, our revenues and cash position could be materially and adversely affected. The patient population for the diseases that our products treat is very small, and networking, data gathering and support channels are not as established as those for more prevalent and researched disease indications. There are limited patient registries and other methods of establishing with precision the actual number of patients of our existing and potential future indications in any geography. Estimating the prevalence of a rare disease is difficult and we therefore must rely on assumptions, beliefs and an amalgam of information from multiple sources, resulting in potential under or over-reporting. There is no guarantee that our assumptions and beliefs are correct, or that the methodologies used and data collected have generated or will continue to generate accurate estimates. There is therefore uncertainty around the estimated total potential addressable patient population for treatment with RUCONEST® and Joenja® worldwide. In addition, the potential market opportunity for our product candidates that we may develop is difficult to estimate precisely, particularly given that the orphan drug markets which are targeted are, by their nature, relatively unknown. Our estimates of the potential market opportunity for each of these product candidates are predicated on several key assumptions, such as industry knowledge and publications, third-party research reports and other surveys. If any of our assumptions prove to be inaccurate, then the actual market for RUCONEST®, Joenja®, or our product candidates, could be smaller than our estimates of the potential market opportunity. If that turns out to be the case, our product revenue may be limited, and we may be unable to achieve or maintain profitability, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

***We depend on our information technology systems and have been and may in the future be the victim of cyberattacks, which may compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition.***

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We collect and maintain data and information that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business, including systems infrastructure operated and maintained by our third-party suppliers or providers. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. It is critical that we do so in a secure manner to maintain the privacy, security, confidentiality and integrity of such confidential information. We have established physical, electronic and organizational measures to safeguard and secure our systems and facilities to prevent an information compromise, and rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result, a number of third-party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage or unauthorized access or use resulting from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, denial-of-service attacks, cyber-attacks or cyber-intrusions over the Internet, hacking, phishing and other social engineering attacks, attachments to emails, persons inside our organization (including employees or contractors), lost or stolen devices, or persons with access to systems inside our organization. We have been, and may in the future be, subject to cyberattacks.

A breach may require notification to governmental agencies, supervisory bodies, credit reporting agencies, the media or individuals pursuant to various federal, state and foreign data protection, privacy and security laws, regulations and guidelines, if applicable. These may include without being limited to state breach notification laws, and the General Data Protection Regulation, or GDPR. Accordingly, a data security breach or privacy violation that leads to unauthorized access to, disclosure or modification of personal information (including protected health information), that prevents access to personal information or materially compromises the privacy, security, or confidentiality of the personal information, could result in fines, increased costs or loss of revenue and we could incur liability, our competitive position could be harmed and the further development and commercialization of our product candidates could be delayed. Furthermore, federal, state and international laws and regulations, such as the GDPR, can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail.

***We rely on third parties for all quality control procedures.***

The release of finished product to the market is dependent on the satisfaction of a set of quality control procedures. Some of these procedures, although validated, are very sensitive and complex (specifically for the protein platform). While ensuring and maintaining Good Manufacturing Practice, or GMP, activities at our partnered contract manufacturing organization, or CMO, sites we do not have our own GMP certified analytical laboratory capable of performing the quality control procedures needed for the release of product, and we rely on third parties for this task. We have started a program to challenge and reassess all currently used quality control procedures with the aim to improve or replace those by more robust, and easier to perform analyses and where possible create a more robust external partnership management process.

***Any contamination in the manufacturing process for our recombinant products, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules and significantly impact commercially available goods.***

We use living mammals as the source for our recombinant proteins. Our transgenic manufacturing platform bears the risk of failure due to contamination of the produced milk, diseases of the producing livestock, or a breakdown of the facilities. Any contamination could adversely affect our ability to produce, release, or administer our recombinant products on schedule and could, therefore, harm our results of operations and cause reputational damage. Additionally, although our recombinant products are tested for contamination prior to release, if a contaminated product was administered to a patient, it could result in harm to the patient. A raw material shortage, contamination, recall or restriction on the goods we use in the manufacture of our products could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could adversely affect our clinical development timelines and availability of finished goods for commercial use, impacting patient access, our business, financial condition, results of operations, and prospects.

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***We are dependent on a limited number of suppliers for some of our components and materials used in our product candidates and products. Any disruption in the supply of these materials could adversely affect our ability to deliver product or complete clinical trials. Other studies of product candidates, regulatory applications or commercializing product candidates in a timely and commercially valuable manner, may be adversely affected, should supply be disrupted.***

We rely on a limited number of suppliers for certain essential materials incorporated into, or used in the manufacture of, products and product candidates. Since RUCONEST® is authorized for use in rare and ultra-rare diseases, it might be difficult to find suppliers that can or are willing to handle small-scale quantities, which may also limit our negotiation power with these suppliers.

Many component suppliers are based in Europe, while now, RUCONEST® sales are only conducted in the U.S. If international shipping is disrupted, we may not be able to supply sufficient quantities of RUCONEST® for sale in the U.S. Any disruption in the supply of these materials could adversely affect our ability to deliver product or complete clinical trials. In addition, studies of product candidates, regulatory applications and our ability to commercialize product candidates in a timely and commercially valuable manner, may be adversely affected, should supply be disrupted.

We cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose. Our use of a limited number of suppliers of raw materials, components and finished goods exposes us to several risks, including disruptions in supply, price increases, late deliveries and an inability to meet customer demand. There are, in general, relatively few alternative sources of supply for these components. These vendors may be unable or unwilling to meet our future demands for our clinical trials or commercial sale. Establishing additional or replacement suppliers for these components could take a substantial amount of time and it may be difficult to establish replacement suppliers who meet regulatory requirements. Any disruption in supply from any supplier or manufacturing location could lead to supply delays or interruptions which would damage our business, financial condition, results of operations and prospects.

If we are required to switch to a replacement supplier, the manufacture and delivery of our product and product candidates could be interrupted for an extended period, adversely affecting our business. Establishing additional or replacement suppliers may not be accomplished quickly. If we are able to find a replacement supplier, the replacement supplier would need to be qualified and may require additional regulatory authority approval, which could result in further delay. For example, the FDA or EMA could require additional supplemental data, manufacturing data and comparability data if we rely upon a new supplier. While we seek to maintain adequate inventory of the components and materials used in our product candidates, any interruption or delay in the supply of components or materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to conduct our clinical trials and, if our product candidates are approved, to meet the demand of our customers and cause them to cancel orders.

In addition, as part of the FDA's approval of our product candidates, the FDA must review and approve the individual components of our production process, which includes raw materials, the manufacturing processes and facilities of our suppliers. Our reliance on these suppliers subjects us to a number of risks that could harm our reputation, business, and financial condition, including, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the interruption of supply resulting from modifications to or discontinuation of a supplier's operations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• delays in product shipments resulting from defects, reliability issues, or a supplier's variation in a component;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a lack of long-term supply arrangements for key components with our suppliers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially reasonable terms;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• difficulty and cost associated with locating and qualifying alternative suppliers for our components in a timely manner;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• production delays related to the evaluation and testing of products from alternative suppliers, and corresponding regulatory qualifications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a delay in delivery due to our suppliers prioritizing other customer orders over ours;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• damage to our reputation caused by defective components produced by our suppliers; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• fluctuation in delivery by our suppliers due to changes in demand from us or their other customers.

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If any of these risks materialize, costs could significantly increase and our ability to conduct our clinical trials and meet demand for our products could be impacted.

***We depend on third-party manufacturers for the production of Joenja® and for the production of rhC1INH for commercial supply and for use in clinical trials of RUCONEST®, as well as our product candidates for clinical trials. Interruption in supply could materially and adversely affect sales.***

We have entered into (downstream) manufacturing and supply agreements for Joenja® and RUCONEST® with, among others, Sanofi S.A., or Sanofi, and BioConnection Investments B.V. (formerly BioConnection B.V.), or BioConnection, since we do not have GMP drug substance and drug product manufacturing and lab facilities to produce and test the product. A failure of these suppliers to supply our needs would be difficult to overcome as contracting additional manufacturing capacity on a timely basis could be difficult or impossible and have significant adverse effect on our business.

***We experience significant customer concentration, with a limited number of customers accounting for a significant portion of our revenues.***

Two U.S. customers (namely specialty pharmacies) accounted for $290.9 million, or 77%, of our revenues for the year ended December 31, 2025, and $227.7 million, or 77%, of our revenues for the year ended December 31, 2024. Inherent risks exist when a large percentage of total revenues is concentrated with a limited number of specialty pharmacies. With specialty products, the pharmacies provide patient support services that exceed those provided by retail pharmacies, and effective communication and relations between our hub and these pharmacies are important in maintaining timely and consistent filling of prescriptions for RUCONEST®.

It is not possible for us to predict the future level of demand for our products that will be handled by these specialty pharmacies or the level of service they will provide to patients and healthcare practitioners. In addition, revenues from these large customers may fluctuate from time to time based on market demand for our products among prescribing physicians, patients and payors, the level which may be affected by market conditions or other factors, some of which may be outside of our control. Further, our contracts with these large specialty pharmacies do not contain purchase commitments or otherwise obligate them to buy a minimum or fixed volume of products from us (and allow these specialty pharmacies to return product to us for a variety of reasons). If either of our major customers experience declining or delayed sales of our products to consumers due to market, economic or competitive conditions, we could be pressured to reduce the prices we charge for our products, reduce the volume of products we supply to such customers, we could lose the customer or have a substantial amount of product returned to us. Additionally, although historically, our reserves for doubtful accounts have not been material, if either of our large customers were to suffer financial instability, they could refuse or delay payment of outstanding receivables. Any such development may have a material adverse effect on our business, results of operations and financial condition.

***Our future success depends on our ability to hire and retain key executives and to attract, retain and motivate qualified personnel.***

Our future success depends on our ability to attract and retain key management personnel and scientific and technical personnel. Experienced employees in the biopharmaceutical and biotechnology industries are in high demand and competition for their talents can be intense, especially in the Netherlands, where we maintain our principal operations. We have entered into employment agreements with executive officers and other key employees, but any employee may terminate his or her employment at any time or may be unable to continue in his or her role. The loss of any executive or key employee, or an inability to recruit desirable candidates or find adequate third parties to perform such services on reasonable terms and on a timely basis, could have a material adverse effect on our business, financial condition, results of operations and prospects. If we are not able to attract, retain and motivate necessary personnel to accomplish our business objectives, we may experience constraints that could significantly impede our ability to achieve our development and commercial objectives, our ability to raise additional capital and our ability to implement our business strategy.

***Our business, products or product pricing could be subject to negative publicity, which could have a material adverse effect on our reputation, business, financial position, results of operations, liquidity and cash flows.***

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In recent years, the pharmaceutical industry has been the subject of public complaints and significant publicity regarding the pricing of pharmaceutical products, including publicity and pressure resulting from prices charged by competitors and peer companies for new products as well as price increases by competitors and peer companies on older products that the public has deemed excessive. We may experience downward pricing pressure on the price of RUCONEST®, Joenja® and any other future approved products due to social or political pressure to lower the cost of drugs, which could reduce our revenue and future profitability. Orphan drugs in particular have received recent negative publicity for the perceived high prices charged for them by their manufacturers, and as a result orphan drug developers such as us may be negatively impacted by such publicity and any U.S. or other government regulatory response. Due to these factors, we may suffer public criticism and negative publicity in media coverage, by industry trade associations and legislators.

Any of the events or developments described above could result in reputational harm and reduced market acceptance and demand for our products, could harm our ability to market our products in the future, could cause us to incur significant expense, could cause our senior management to be distracted from execution of our business strategy, and could have a material adverse effect on our business, reputation, financial condition, results of operations, liquidity, cash flows, and/or share price.

These developments could also cause additional downward pressure on pharmaceutical pricing. CMMI has announced two new mandatory models that propose MFN pricing using specified international benchmarks for certain products covered by Medicare and one new voluntary model that proposes MFN pricing for products covered by Medicaid. These models, or other models announced by CMMI, could result in significantly lower reimbursement for products. These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our products for which we may obtain regulatory approval or the frequency with which any such product is prescribed or used. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importing from other countries and bulk purchasing. Downward pressure on pharmaceutical pricing could expand to other programs or otherwise increase based on these developments.

***Future legislation regarding energy consumption and waste regulations might hamper efficiency of our operations.***

Our facilities consume a significant amount of electricity in connection with the operation of our business and our production processes have a high consumption of consumables and liquid process waste. While we proactively improve processes where feasible with the aim to reduce use of energy and reduce the consumption of materials, our efforts to reduce energy consumption may not be successful. Additionally, we process waste such as chemicals for cleaning equipment (which need to be neutralized before disposing), milk waste, and fluids containing heavy metals. Legislation related to waste regulations or legislation requiring our facilities to reduce our energy consumption may have a material impact on our business.

***Our global operations subject us to significant tax risks.***

We are subject to tax rules in the jurisdictions in which we operate. Changes in tax rates, tax relief and tax laws, changes in practice or interpretation of the law by the relevant tax authorities, increasing challenges by relevant tax authorities or any failure to manage tax risks adequately could result in increased charges, financial loss, penalties and reputational damage. Tax authorities may pursue additional taxes based on retroactive changes to tax laws which could result in a material restatement to our tax position. Any of these factors could have a negative impact on our business, financial condition, results of operations and prospects.

**Risks Related to Intellectual Property**

***Our success is dependent on our ability to obtain and protect rights to proprietary technology and to develop our technology and products without infringing the proprietary rights of third parties.***

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We rely, and will continue to rely, on a combination of patents, trademarks and confidentiality agreements with employees, consultants, collaborators, advisors and other third parties to protect the intellectual property related to our current and future product candidates. We use patents and licensing to protect our products and technology. We try to be careful to develop products that don't infringe on the proprietary rights of third parties. Currently, we have over a hundred patent applications granted and pending in countries including the U.S., Europe and Japan. The patent positions of pharmaceutical companies can be uncertain and may involve complex legal and factual questions.

The patents that we own and have license rights to now or the patents and patent applications that we may own or in-license in the future may not have valid or patentable claims that protect our current and future product candidates in the relevant jurisdictions where we intend to commercialize such products. There is no assurance that we are aware of all potentially relevant prior art relating to current patents or current or future patent applications. As such, patent examiners may find prior art that can prevent a patent from issuing from a pending patent application, or patent offices or courts may find the claims of our issued patents to be invalid. During the patent examination process, we may be required to narrow the pending claims to overcome prior art, a process that may limit the scope of patent protection. Even if patents do successfully issue based on our future patent applications, and even if the issued patents cover our current and future product candidates, including their compositions, formulation, method of manufacture, and method of use, third parties may challenge our issued patents' validity, enforceability or scope, which may result in such patents being narrowed so that they no longer cover competitors' products that are considered to infringe, invalidated or held unenforceable. Any successful opposition or post-grant challenges to these patents or any other patents owned by or licensed to us in the future could deprive us of rights necessary for the successful commercialization of any of our current or future product candidates, if approved. Further, if we encounter delays in regulatory approvals, any period of time during which we could market a product candidate under patent protection could be further reduced.

If the patent applications we may own or in-license with respect to our current and future product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for any of our current or future product candidates, it could dissuade other companies from collaborating with us to develop future product candidates, and threaten our ability to commercialize our current and future product candidates. Notably, pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Any such outcome could have an adverse effect on our business.

Moreover, our technologies and products may infringe on third-party intellectual property rights. As a result, we may face litigation or other legal proceedings concerning such intellectual property. These processes can be time-consuming and costly. In the event of an unfavorable ruling in patent or intellectual property litigation, we could be subject to significant liabilities to third parties, or be required to cease developing, manufacturing or selling the affected products or technology. Each of these outcomes may adversely affect our financial position. We may also be confronted with claims which are raised with the main aim of exploiting the nuisance value of publicly raised claims. In order to prevent the infringement of third-party intellectual property rights, we may need to acquire licenses for patents held by third parties to re-establish or maintain freedom to operate for our products, possibly on unfavorable terms. A failure to obtain licenses for patents held by third parties, or failure to obtain them on favorable terms, may have a material adverse effect on our financial and operational position. Our business could be harmed if in litigation a prevailing party does not offer us a license on commercially reasonable terms.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. Furthermore, publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the

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patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

In addition, if the breadth or strength of protection provided by our patents and patent applications, whether owned or in-licensed now or in the future, is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed patents may be challenged in the courts or patent offices in the United States. Such challenges may result in loss of exclusivity or in patent claims being narrowed so that they no longer cover competitors' products that are considered to infringe, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or unduly limit the duration of the patent protection of our technology and products. Moreover, patents have a limited lifespan. In the United States, a patent will expire generally 20 years after the filing of the earliest non-provisional application to which the patent claims priority, assuming the patent is not subject to any patent term extension or adjustment or disclaimer of term. Various extensions may be available; however, the exclusivity and protection afforded by a patent is nevertheless limited. Further, the relevant authorities may not grant the patent extensions or adjustments we expect, which would further limit the term of our expected patent exclusivities. We may be required to disclaim a portion of patent term in order to overcome double patenting rejections from the patent office, thus potentially shortening any period of patent exclusivity. Without patent protection for our current or future product candidates, we may be open to competition from generic versions of such products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

***We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.***

Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that an asserted patent is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that the asserted patent does not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of asserted patents regarding which we have rights at risk of being invalidated or interpreted narrowly and could put a related patent application at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as assertions that our patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory and other requirements, including novelty, non-obviousness, enablement, written description, lack of double patenting, incorrect inventorship and statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the U.S. Patent and Trademark Office, or the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte re-examinations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. Third parties may also make it more difficult to obtain patents to our valuable technologies by engaging in pre-issuance submissions of prior art to the USPTO and in analogous proceedings in other jurisdictions. The outcome following legal assertions of invalidity and unenforceability is unpredictable. We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we currently license or may license in the future, we may have limited or no right to participate in the defense of any such licensed patents against challenges by third parties. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates. Such a loss of patent protection could harm our business.

We may not be able to detect or prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United

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States. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during such litigation. Public disclosure of the outcomes of hearings, motions or other interim proceedings or developments is common. If securities analysts or investors perceive these outcomes to be unfavorable to us, it could have an adverse effect on the price of our ordinary shares.

***We may infringe or be alleged to infringe the intellectual property rights of others, which may prevent or delay product development and commercialization efforts, requiring us to expend resources on litigation or other resolutions, which may materially and adversely affect our business.***

Our success depends, in part, on our ability to operate without infringing the intellectual property rights and other proprietary rights of third parties. Identification of third-party patent rights that may be relevant to our products and proprietary technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases, a set period of time, usually 18 months, from the filing of patent applications before their publication and the difficulty and uncertainty in assessing the meaning or scope of protection of patent claims. There could be issued patents covering our products of which we are not aware. There also could be patents that we believe we do not infringe, but that we may ultimately be found to infringe. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products infringe. For example, pending applications may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes. We may also be confronted with the assertion of intellectual property rights that have the purpose of exploiting the nuisance value of publicly raised claims.

Proceedings involving our patents or patent applications or those of others could:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• put one or more of our patents at risk of being invalidated, rendered unenforceable or interpreted narrowly so that they do not cover competitors' products that we had considered to infringe;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• adversely impact the patentability of our inventions relating to our products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• result in monetary damages, injunctive relief or otherwise harm our competitive position, including by limiting or terminating marketing and selling activities, increasing the risk for generic competition, limiting development and commercialization activities or requiring us to obtain licenses to use the relevant technology (which licenses may not be available on commercially reasonable terms, if at all); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• otherwise negatively impact the inventorship, ownership, enforceability, validity or scope of protection of the patents relating to our products.

We may not have the resources to adequately defend such claims, and even if successful in any such proceedings, we would incur substantial costs and divert management's time and attention in pursuing these proceedings, putting further strain on our resources, which could have a material adverse effect on our business, financial condition, results of operations and prospects. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court or other venue, and we may not succeed. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion.

In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid or unenforceable, we may:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• incur substantial monetary damages;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• encounter significant delays in expanding the market of our products; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• be precluded from manufacturing or selling our products; which, in each case, could have a material adverse effect on our business, financial condition, results of operations and prospects.

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***Our patents may be challenged, deemed unenforceable, invalidated or circumvented, and if we do not obtain or maintain patent protection for the products, our business may be materially harmed.***

The patent positions of biotechnology and pharmaceutical companies involve complex legal and factual questions and, therefore, validity and enforceability cannot be predicted with certainty. U.S. patents and patent applications also may be subject to interference proceedings, ex parte reexamination, inter partes review, or IPR, and post-grant review proceedings, derivation proceedings and supplemental examination and may be challenged in district courts. Patents granted in other countries may be subjected to opposition or comparable proceedings lodged in various national and regional patent offices. These proceedings could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application (so that, for example, they no longer cover competitors' products that we consider to infringe our intellectual property rights). In addition, such interference, re-examination, opposition, post-grant review, IPR, derivation proceedings, supplemental examination or revocation proceedings may be costly, and we may be unable to undertake them. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies are covered by valid and enforceable patents that we are able to enforce, or are effectively maintained as trade secrets that we are able to enforce. The degree of future protection for our products and proprietary rights is uncertain, and it cannot be guaranteed that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we will be able to successfully develop or commercialize our product before some or all of the relevant patents or regulatory exclusivity expire, or in countries where we do not have patent protection or exclusivity;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we or our licensors were the first to make the inventions covered by each of the pending patent applications and patents;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we or our licensors were the first to file patent applications for these inventions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• others will not independently develop similar or alternative technologies or duplicate any of our technologies without infringing any of our intellectual property rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• any of our pending patent applications or those that we have licensed will result in issued patents;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• any of our patents or those we have licensed will be found to be valid or enforceable, or have sufficient scope to achieve our business objectives;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we will be able to license the patents or pending patent applications necessary or desirable to protect our products or avoid infringement on commercially reasonable terms or at all;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• any patents issued to us or our licensors or collaborators will provide a basis for protection of any existing or additional commercially viable products, will provide us with any competitive advantages or will not be successfully challenged by third parties;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we will be able to develop additional proprietary technologies that are patentable; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the patents or patent applications of others will not have an adverse effect on our business.

***Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.***

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. For example, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, made a number of significant changes to United States patent laws. These include provisions that affect the way patent applications are prosecuted and challenged at the USPTO and may also affect patent litigation. The USPTO has developed and continues to develop new regulations and procedures to govern administration of the Leahy-Smith Act. Accordingly, it remains unclear what impact the Leahy-Smith Act, subsequent rule-making, and judicial interpretation of the Leahy-Smith Act and regulations will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have an adverse effect on our business and financial condition. Moreover, future changes to the patent laws of the United States and foreign jurisdictions may adversely affect the inventorship, ownership, term, scope, validity and enforceability of our or our licensors' patent rights. For example, a 2019 bill (Terminating the Extension of Rights Misappropriated Act, or TERM Act, H.R. 3199) in the United States Congress aimed to reduce the term of certain drug patents in order to ease generic entry and increase competition. Changing political priorities could potentially drive more such initiatives.

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In addition, the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have issued numerous precedential opinions in recent years narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this mix of judicial and administrative decisions, and legislative changes has created uncertainty with respect to the strength and value of patents, once obtained. Depending on actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future. The U.S. federal government retains certain rights in inventions produced with its financial assistance under the Bayh-Dole Act. The federal government retains a ''nonexclusive, non-transferable, irrevocable, paid-up license'' for its own benefit. The Bayh-Dole Act also provides federal agencies with ''march-in rights.'' March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a ''nonexclusive, partially exclusive, or exclusive license'' to a ''responsible applicant or applicants.'' If the patent owner refuses to do so, the government may grant the license itself. Such laws and rules in the U.S. and analogous laws and rules in other jurisdictions can dilute or render ineffective our intellectual property rights.

***We enjoy only limited geographical protection with respect to certain patents.***

Filing and prosecuting patent applications and defending patents covering product candidates in all countries throughout the world would be prohibitively expensive. For this reason, we may not obtain patents protecting our products and/or services in all jurisdictions where we offer them. Competitors may use our and our licensors' technologies in jurisdictions where patent protection has not yet been obtained to develop their own products or may export infringing products to territories where enforcement rights are not as strong as in the United States or EU, or where enforcement rights do not exist. These products may compete with our product candidates, and our intellectual property rights may not be effective or sufficient to prevent such products from competing. Patent applications may be issued in some non-U.S. jurisdictions with different scope or they may be outright refused in certain jurisdictions, such as, for example, China, India, Brazil, which have different requirements for patentability.

Proceedings to enforce our patent rights in other jurisdictions, whether or not successful, could result in substantial costs and divert efforts and attention from other aspects of the business. They could also put our patents and patent applications at risk of being invalidated, denied or interpreted narrowly, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits or have damages or other remedies awarded to us, or such damages or other remedies may not be commercially meaningful. Accordingly, our intellectual property rights as enforced may be inadequate to obtain a significant commercial advantage and our efforts to protect our intellectual property rights may be unsuccessful or inadequate, which may adversely affect our ability to successfully commercialize our product candidates, and which may have a material adverse effect on our business, financial condition, results of operations and prospects. Furthermore, while we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully commercialize our drug candidates in all of our expected, significant international markets.

Many countries also have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties or laws limiting the enforceability of patents against government agencies or government contractors under certain circumstances. In those countries, a patent owner may have limited recourse, which could materially diminish the value of such patents. If we or any of our licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be adversely affected.

***If intangible assets and goodwill that we record in connection with our acquisitions become impaired, we may have to take significant charges against earnings.***

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In connection with the accounting for our acquisitions, a significant value may be recognized in respect of intangible assets, including developed technology and customer relationships relating to the acquired product lines, and goodwill. Under IFRS, we must assess, at least annually and potentially more frequently, whether the value of intangible assets and goodwill has been impaired. We expect to assess intangible assets and goodwill for impairment in the event of an impairment indicator. Any reduction or impairment of the value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders' equity in future periods.

**Risks Related to Government Regulation Compliance, Legal Matters, and Reputation**

***We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Non-compliance with these legal standards could impair our ability to compete in domestic markets. We can face criminal liability and other serious consequences for violations, which can harm our business.***

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, antitrust and competition laws, various economic and trade sanctions regulations administered by the U.S. Treasury Department's Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, or the FCPA, the United States domestic bribery statute contained in 18 U.S.C. § 201, the United States Travel Act, the USA PATRIOT Act, certain prohibitions under the Dutch Criminal Code (Wetboek van Strafrecht), the Dutch Economic Offences Act (Wet op Economische Delicten), the U.K. Bribery Act, and other state and national anti-bribery, medicines advertising and anti-money laundering laws in the countries in which we conduct activities or countries that are otherwise relevant for our activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors and other partners from authorizing, promising, offering, or providing, directly or indirectly, payments, or anything else of value to recipients in the public or private sector (in relation to an act or omission (to be or having been) by the recipient). We may have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other partners, even if we do not explicitly authorize or have actual knowledge of such activities, and we may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA, the U.K. Bribery Act or local anti-corruption laws. We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United States and authorities in the EU, including applicable export control regulations, economic sanctions and embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements, and currency exchange regulations.

Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, disgorgement, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

***If we fail to comply with United Kingdom, EU or U.S. privacy and data security laws and regulations, we may be subject to civil and criminal penalties and other liability.***

We are also subject to laws and regulations covering data privacy and the protection of health-related and other personal information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which may affect our business, including recently enacted laws in many jurisdictions where we operate. The collection and use of personal data (including health data) in the EU is primarily governed by the provisions of the GDPR, which the EU Member States can vary or supplement to a certain extent. This regulation, which is wide-ranging in scope and includes extraterritoriality provisions that apply to certain entities located outside of the EU, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, notification of personal data breaches to the competent national data protection authorities and the security and confidentiality of the personal data, and substantial fines for breaches of the data protection rules. The GDPR also imposes strict rules on the transfer of personal data out of the EU to other countries (including the United States). Failure to comply with the requirements of the GDPR and the related national data protection laws of the EU Member States, and the United Kingdom (which has implemented the

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GDPR into its domestic law as noted below) may result in large fines and other administrative penalties: a failure to comply could result in fines up to the greater of 4% of annual worldwide turnover for the preceding financial year or €20 million, with infringements being grouped into tiers which trigger different maximum fine levels. Turnover in this context may include not only the entity in breach but also other group entities where they form part of the same undertaking. Recent enforcement actions against multinational companies have resulted in significant fines.

Following the United Kingdom's formal departure from the EU on January 31, 2020, the United Kingdom adapted and implemented the GDPR into its national law, as a result of the United Kingdom's Data Protection Act 2018, or DPA. The DPA supplements the GDPR, and in particular sets out specific requirements related to the processing of ''special categories of personal data'', including personal data related to health, genetic information and personal data related to criminal offenses or convictions. The DPA also creates a number of criminal offenses (punishable by uncapped fines) for organizations and in certain cases their directors and officers. Since the United Kingdom left the EU and the transition period has expired, the United Kingdom became a "third country" for the purposes of EU data protection law.

A "third country" is a country other than the EU Member States and the three additional European Economic Area, or EEA, countries (Norway, Iceland and Liechtenstein) that have adopted a national law implementing the GDPR. Under the GDPR, personal data can only be transferred to third countries in compliance with specific conditions for cross-border data transfers. Unless an exemption applies, appropriate safeguards are required to enable transfers of personal data from the EU and EEA Member States. However, on June 28, 2021, the European Commission adopted an adequacy decision in relation to the United Kingdom. With this decision, the European Commission considers that personal data benefits from an essentially equivalent level of protection under UK law to that guaranteed under EU law, and thus allows personal data to flow freely from the EEA to the United Kingdom. This adequacy decision is however limited in time, and its renewal will depend on whether the United Kingdom continues to ensure an adequate level of data protection. In late 2025, the European Commission extended the United Kingdom's adequacy status until December 27, 2031 by means of Commission Implementing Decision. Similarly, the European Commission adopted its adequacy decision for the EU-U.S. Data Privacy Framework on July 10, 2023, allowing the transfer of personal data from the EEA to U.S. companies participating in the EU-U.S. Data Privacy Framework. In January 2025, the Trump Administration dismissed three Democratic members of the Privacy and Civil Liberties Oversight Board, or PCLOB, an independent body responsible for ensuring transparency and accountability in U.S. surveillance practices that plays an essential role under the EU-U.S. Data Privacy Framework. As a result, the PCLOB no longer has the sufficient quorum to function effectively and it is unclear what the impact of this decision will be on the validity of the EU-U.S. Data Privacy Framework.

Under the GDPR regulations, we are generally considered a controller of personal data processing and are subject to several legal obligations. In particular, we are obligated to place importance on collection and processing of special categories of personal data which, for our purposes, is data that is genetic data or data concerning health. While we have taken steps to comply with the GDPR and the DPA, we cannot assure you that our efforts to achieve and remain in compliance have been or will continue to be fully successful. The GDPR regulations and the DPA may impose additional responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with these or new data protection rules. This may be onerous and adversely affect our business, financial condition, results of operations and prospects.

In addition, we obtain patient health information from most healthcare providers that prescribe our products and research institutions with which we collaborate, and they are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, or HIPAA, in the United States. Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. There are also state laws on patient health information, such as the California Confidentiality of Medical Information Act, which we are more directly subject to. As more states consider implementing such laws, we may face an ever-expanding patchwork of data privacy regulations.

Failure to comply with healthcare laws and laws and regulations covering data privacy and the protection of health-related and other personal information could result in government enforcement actions, which could

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include civil or criminal penalties, private litigation and adverse publicity and could negatively affect our business, financial condition, results of operations and prospects.

***Our current and future relationships with healthcare professionals, customers and third-party payors are subject to applicable anti-kickback, fraud and abuse, privacy and security, transparency, and other healthcare laws and regulations, which could expose us to significant penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.***

We are subject to healthcare statutory and regulatory requirements and enforcement by the U.S. federal government and the states and foreign governments in the jurisdictions in which we conduct our business. Third-party payors play a primary role in the approval of prescriptions for RUCONEST® and Joenja®, and we expect will do so for any product candidates for which we obtain marketing approval. Our current and future arrangements with third-party payors, healthcare practitioners and patients may expose us to broadly applicable fraud and abuse, medicines advertising and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research as well as market, sell and distribute any products for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations in the United States include the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or paying remuneration, directly or indirectly, in cash or in-kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the federal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; in addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• HIPAA imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the federal physician payment transparency requirements, sometimes referred to as the "Sunshine Act" under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or, collectively, the ACA, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children's Health Insurance Program to report to Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value to physicians and other healthcare professionals (such as physicians, assistants and nurse practitioners), as defined by such law, and teaching hospitals, and the ownership and investment interests of physicians and their immediate family members in such manufacturers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates, and their subcontractors, that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• ACA, analogous state and foreign laws and regulations, such as state anti-kickback, medicines advertising and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• some state and foreign laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance codes and guidelines and the relevant compliance guidance promulgated by governments and industry bodies and may require drug manufacturers to report

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information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• state and local laws that require the registration of pharmaceutical sales representatives;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• state and foreign laws also govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• competition laws in the U.S. and globally that may govern our interactions with competitors, customers, distributors, and suppliers; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the FCPA prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to it, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, public procurement, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

***If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs that we participate in, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.***

We have certain price reporting obligations to the Medicaid Drug Rebate Program. Under the Medicaid Drug Rebate Program, we are required to pay a rebate to each state Medicaid program for RUCONEST® and Joenja®, and expect to do so for any new approved products. Those rebates are based on pricing data we have to report on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug Rebate Program. These data include, among other things, the Average Manufacturing Price, or AMP, and the Best Price, or BP, which, in general, represents the lowest price available from the manufacturer to any entity in the U.S. in any pricing structure, calculated to include all sales and associated rebates, discounts and other price concessions. On December 31, 2020, CMS promulgated a final rule that, among other things, changed the methodology for calculating and reporting of AMP and BP in order to encourage manufacturers and states to enter into value-based purchasing arrangements. We are liable for errors associated with our submission of pricing data and for any overcharging of government payors. For example, failure to submit monthly/quarterly AMP and BP data on a timely basis could result in a civil monetary penalty for each day the submission is late beyond the due date. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the Federal False Claims Act and other laws and regulations. Any required refunds to the U.S. government or responding to a government investigation or enforcement action would be expensive and time consuming and could have a material adverse effect on our business, results of operations and financial condition.

U.S. federal law requires that any company that participates in the Medicaid Drug Rebate Program also participate in the 340B program in order for federal funds to be available for the manufacturer's drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B "ceiling price" for the manufacturer's covered outpatient drugs. These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low- income patients. The ACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals, but exempts "orphan drugs" from the ceiling price requirements for these covered entities. The 340B ceiling price is calculated using a statutory formula based on the AMP and rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program, and in general, products subject to Medicaid price

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reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement. Any additional future changes to the definition of AMP and the Medicaid rebate amount under the ACA or other legislation or regulation could affect our 340B ceiling price calculations and negatively impact our results. In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.

***RUCONEST® has been approved by the FDA for the treatment of HAE attacks. Joenja® is approved in the United States, United Kingdom, Japan, Australia and Israel for the treatment of APDS. Regulatory approval is limited to the specific indication for which approval has been granted and, unless we seek regulatory approval for additional indications, we will be prohibited from marketing our products for other indications. We may be subject to significant fines, penalties or injunctions if we are determined to have promoted or be promoting the use of either of our products for unapproved or "off-label" uses, resulting in damage to our reputation and business.***

RUCONEST® is approved by the FDA, for the treatment of HAE attacks, and Joenja® is approved in the United States, United Kingdom, Japan, Australia and Israel for the treatment of APDS, but these products are not currently approved for the treatment of other indications. Regulatory authorities strictly regulate the promotional claims that may be made about prescription products, and our products may not be promoted for uses that are not approved, as reflected in its approved labeling. If we are not able to obtain regulatory approval for any desired future indications for our products and product candidates, our ability to effectively market and sell our products may be reduced and our business may be adversely affected.

While physicians may choose, in their independent medical judgment, to prescribe products for uses that are not described in the product's labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, we are prohibited from marketing and promoting the products for indications that are not specifically approved by the regulatory authorities. These "off-label" uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances. Regulatory authorities in the United States and in other jurisdictions generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine. Regulatory authorities do, however, restrict communications by biotechnology or pharmaceutical companies on off-label use. If the FDA or another regulator determines that our promotional activities constitute promotion of an off-label use, it could request that we modify our promotional materials and subject us to regulatory or enforcement actions as well as actions by other agencies, including issuance of warning letters or untitled letters, suspension or withdrawal of an approved product from the market, mandatory or voluntary recalls, and could result in the imposition of significant criminal, civil, and administrative penalties such as civil fines, disgorgement of money, imprisonment, exclusion from participation in federal health care programs (e.g., Medicare and Medicaid), operating restrictions, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement, injunctions or criminal prosecution, any of which could significantly harm our business.

***Current and future healthcare legislative reform measures may have a material adverse effect on our business and results of operations.***

In the United States and in some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and regulatory changes and proposed changes intended to broaden access to healthcare, improve the quality of healthcare and contain or lower the cost of healthcare. For example, the ACA substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. pharmaceutical industry. The ACA, among other things, subjects biological products to potential competition by lower-cost biosimilars, expands the types of entities eligible for the 340B drug discount program, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs and creates a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, or BBA, effective as of January 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D.

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Since its enactment, there have been numerous judicial, administrative, executive and legislative challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. In addition, the implementation of the ACA is ongoing, and the law appears likely to continue the downward pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs. Litigation and legislation related to the ACA are likely to continue, with unpredictable and uncertain results.

In addition, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several congressional inquiries and proposed legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient assistance programs and reform government program reimbursement methodologies for pharmaceutical and biological products. At the federal level, the FDA released a final rule on September 24, 2020, effective November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. On January 5, 2024, the FDA authorized the state of Florida to import certain prescription drugs from Canada.

Further, on November 20, 2020, the U.S. Department of Health and Human Services, or HHS, finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The implementation of the rule has been delayed by the Inflation Reduction Act of 2022, or IRA, until 2032.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, the implementation of which has also been delayed by the IRA until January 1, 2032. Further, authorities in Canada have passed rules designed to safeguard the Canadian drug supply from shortages. If implemented, importation of drugs from Canada may materially and adversely affect the price we receive for any of our product candidates. Additionally, on July 9, 2021, President Biden issued an executive order directing the FDA to, among other things, continue to clarify and improve the approval framework for generic drugs and identify and address any efforts to impede generic drug competition.

On August 16, 2022, President Biden signed the IRA into law. The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated "maximum fair price" under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions have taken effect progressively starting in fiscal year 2023, although they have been subject to legal challenges. Officials appointed by the Trump administration to oversee the implementation of the IRA may take a different approach from the previous administration, and the administration and Congress could also pursue statutory changes to the program, either of which could negatively affect our revenues.

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our services by our partners or for our current or future drug candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or

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if we or such third parties are not able to maintain regulatory compliance, our drug candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

***Our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers, and other vendors may engage in misconduct or other illegal activity.***

Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.

Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA and other similar regulatory bodies, including those laws that require the reporting of true, complete and accurate information to such regulatory bodies; manufacturing standards; U.S. federal and state healthcare fraud and abuse laws, data privacy and security laws and other similar non-U.S. laws; or laws that require the true, complete and accurate reporting of financial information or data. Sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs, and other business arrangements. Such misconduct also could involve the improper use or misrepresentation of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, the creation of fraudulent data in our preclinical studies or clinical trials, or illegal misappropriation of product, which could result in regulatory sanctions and cause serious harm to our reputation.

It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. In addition, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and financial results, including, without limitation, the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare, Medicaid, and other U.S. federal healthcare programs or healthcare programs in other jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

***Our business and operations may be negatively impacted by the failure, or perceived failure, of achieving environmental, social and governance, or ESG, objectives.***

We continue to work towards operating our business in an environmentally responsible and socially inclusive manner. Stakeholders, including our stockholders and our employees, have increasingly focused on our ESG practices. If our ESG practices fail to meet these stakeholders' expectations and standards, there could be a material adverse effect on our reputation, business and, ultimately, our stock price.

Achieving our ESG goals requires long-term investments and broad, coordinated collaboration which may require us to incur additional costs or allocate additional resources towards monitoring, reporting, and implementing our ESG practices. Furthermore, we may fail to accurately assess our stakeholders' ESG priorities, as such priorities have evolved and will continue to evolve. Any failure or perceived failure to meet our ESG program priorities could result in a material adverse effect on our reputation, business, and stock price.

**Risks Related to Financial Conditions, Market Environment and General Economic Trends**

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***Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets, including inflation, fuel price increases and supply disruption.***

A domestic or global financial crisis can cause extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our product candidates or an inability to purchase necessary supplies on acceptable terms, if at all. A weak or declining economy due to geopolitical issues could strain our suppliers, increase fuel costs and possibly disrupt or supply chain. In addition, ongoing geopolitical tensions and conflicts, including the conflict in the Middle East and Ukraine, has had significant ramifications on global financial markets, which may adversely impact our ability to raise capital on favorable terms or at all. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

***Changes in trade policies, including tariffs and other import or export restrictions, could adversely affect our business.***

Trade policy developments in the jurisdictions in which we sell our products are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations.

Recently, trade and tariff policies among the United States and other countries have been unsettled and are subject to frequent changes. The U.S. government has imposed tariffs and other trade restrictions on goods across a range of industries, and such actions have at times prompted retaliatory measures by affected countries. While tariffs with certain countries have been temporarily reduced or paused, the imposition of new tariffs will likely be met with further reciprocal tariffs, thus increasing the possibility of a global trade war. If further tariffs are imposed on a broader range of imports, or if retaliatory trade measures are enacted by affected countries, these factors could significantly increase the cost of material and drug supply for our clinical trials and products, adversely affect the commercial sale of RUCONEST® and Joenja®, and harm our competitive position in key markets. Additionally, ongoing trade tensions and uncertainty regarding future trade policies could negatively impact global economic conditions and consumer confidence, further affecting our global operations.

***Due to the international scope of our operations, fluctuations in exchange rates, particularly between the Euro and the U.S. dollar, may adversely affect us.***

While we are headquartered in the Netherlands, we source materials, products and services from several countries outside the EU that are paid in local currencies. As a result of the commercialization of Joenja® in the United States, Europe, the U.K., Japan, Australia and Israel, and RUCONEST® in the United States we will also receive payments and generate costs in U.S. dollars and other currencies. As a result, our business may be affected by fluctuations in foreign exchange rates between the Euro and the U.S. dollar, as well as other currencies.

Since the majority of our sales are invoiced and paid in U.S. dollars, and the majority of our costs and liabilities are valued in Euros, any change in the relevant exchange rate means a corresponding change in the Euro value of sales and a corresponding change in the loan balance in Euros. While we maintain U.S. dollar cash deposits, the functional currency of the Dutch Pharming entities is the Euro, so any change in the U.S. dollar-Euro exchange rate means a corresponding change in the Euro value of U.S. dollar cash deposits.

***Adverse capital and credit market conditions may significantly affect the ability to meet liquidity needs, access to capital and cost of capital.***

We utilize cash flow from operations to invest in our future projects. However, prolonged exposure to liquidity risk or inability to generate enough income for the currently contemplated projects, could lead to the inability to meet our financial obligations, which could increase the risk of insolvency.

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Additionally, adverse developments in the capital and credit markets, for example as the result of rising interest rates globally, would affect our ability to finance our operations and could materially impact our results of operations.

**Risks Related to the ADSs** 

***As a "foreign private issuer," we are exempt from a number of rules under the U.S. securities laws and the Nasdaq Stock Market LLC, or Nasdaq, rules, and we are permitted to file less information with the SEC than are U.S. companies. In addition, we are permitted to follow certain home country corporate governance practices in lieu of certain Nasdaq requirements applicable to domestic issuers. This may make our ADSs and ordinary shares less attractive to investors.***

We are a "foreign private issuer," as defined in the rules and regulations of the SEC, and, consequently, we are not subject to all of the disclosure and governance requirements applicable to companies organized within the United States. For example, we are exempt from certain rules under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act.

Effective March 18, 2026, pursuant to the Holding Foreign Insiders Accountable Act, officers and directors of foreign private issuers generally became required to comply with the beneficial ownership reporting requirements of Section 16(a) of the Exchange Act. However, on March 5, 2026, the SEC issued an exemptive order allowing officers and directors already making similar reports under certain qualifying regulations, including the European Market Abuse Regulation, to be exempt from such requirements. Our officers and directors do not file reports pursuant to Section 16(a) of the Exchange Act in reliance on such order. In addition, our officers and directors are exempt from the "short-swing" profit recovery provisions of Section 16(b) of the Exchange Act and related rules with respect to their purchases and sales of our securities.

We are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies. Accordingly, there may be less publicly available information concerning our Company than there is for U.S. public companies.

As a foreign private issuer traded on Euronext Amsterdam, we are permitted to follow certain home country corporate governance practices in lieu of certain requirements of the Nasdaq. The rights of holders of ordinary shares and, therefore, certain of the rights of holders of the ADSs, are governed by Dutch law, including the provisions of the Dutch Corporate Governance Code, or the DCGC, and by our Amended and Restated Articles of Association, which may provide less protection than is afforded to investors under Nasdaq rules applicable to domestic issuers.

In particular, we follow Dutch law instead of Nasdaq practice in the following ways:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We do not follow Nasdaq Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders as long as we are not a domestic issuer and absent another mandatory obligation to such effect. Such quorum requirements are not required under Dutch law. In accordance with generally accepted business practice, our Amended and Restated Articles of Association provide alternative quorum requirements that are generally applicable to meetings of shareholders.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We do not follow Nasdaq Rule 5605(b)(2), which requires that independent directors regularly meet in an executive session, where only independent directors are present. The independent directors may choose to meet in an executive session at their discretion.

As a result of the above, holders of the ADSs do not have the same protections afforded to shareholders of companies that are not foreign private issuers.

***If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding the ADSs adversely, the price and/or trading volume of the ADSs could be affected.***

The trading market for the ADSs representing our ordinary shares may be influenced by the research and reports that industry or securities analysts publish about us or our business. If one or more of the analysts who cover us

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or our industry downgrade the shares in a research report, the market price of the shares may decline and if one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, we could lose visibility in the financial markets, which could cause the market price and/or trading volume of the shares to decline.

***The price and trading volume of the ADSs and ordinary shares may be volatile, and purchasers of the ADSs or ordinary shares could incur substantial losses.***

The market price of the ADSs is likely to be volatile and could decline significantly. The stock market in general, and the market for biotechnology and emerging pharmaceutical companies in particular, have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for the ADSs and ordinary shares may be influenced by a variety of factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• actual or anticipated variations in our financial condition and operating profit;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• actual or anticipated changes in our growth rate relative to our competitors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• announcements of technological partnerships, innovations or new products by us or our competitors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the success of competitive products or technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• changes in management and members of our board of directors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• changes in financial estimates or recommendations by securities analysts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• changes in the trading volume of the ADSs on the Nasdaq and of our ordinary shares on Euronext Amsterdam;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• sales of the ADSs or our ordinary shares by executive officers or future holders of our equity securities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• announcements or expectations of additional debt or equity financing efforts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• unanticipated losses or gains due to unexpected events, including events related to the success of our clinical trials or regulatory approvals;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• significant acquisitions or business combinations, strategic partnerships, joint ventures or capital commitments by or involving us or our competitors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• changes in our accounting policies or practices;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• changes in government regulations, including any changes that may affect pricing or reimbursement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• conditions in the financial markets or changes in general economic conditions.

These and other market and industry factors may cause the market price and demand for the ADSs and ordinary shares to fluctuate substantially.

Moreover, securities of life science companies, and stock markets in general, have from time to time experienced extreme price and volume fluctuations that may be unrelated or disproportional to the operational performance of any particular companies.

***We have incurred and will continue to incur increased costs as a result of simultaneously having the ADSs listed in the United States and our ordinary shares admitted to trading on Euronext Amsterdam in the Netherlands, and our senior management have been and will be required to devote substantial time to new compliance initiatives and corporate governance practices.***

As a company whose securities are publicly listed in the United States, we have incurred significant legal, accounting and other expenses, even though our ordinary shares are admitted to trading on Euronext Amsterdam. Our senior management and other personnel need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations have increased our legal and financial compliance costs and have made some activities more time-consuming and costly. For example, these rules and regulations have made it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our board of directors.

However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by

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regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Further, being a U.S. listed company and a Dutch public company with ordinary shares admitted to trading on Euronext Amsterdam impacts the disclosure of information and requires compliance with two sets of applicable rules. From time to time, this may result in uncertainty regarding compliance matters and result in higher costs necessitated by legal analysis of dual legal regimes, ongoing revisions to disclosure and adherence to heightened governance practices. As a result of the enhanced disclosure requirements of the U.S. securities laws, business and financial information that we report is broadly disseminated and highly visible to investors, which we believe may increase the likelihood of threatened or actual litigation, including by competitors and other third parties, which could, even if unsuccessful, divert financial resources and the attention of our management and key employees from our operations.

***Future sales of our ordinary shares or ADSs, or the perception that such sales may occur, could depress the prices of such ordinary shares or ADSs.***

Sales of a substantial number of the ADSs in the public market, or the perception that these sales might occur, could depress the market price of the ADSs and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our ADSs.

***We are a Dutch public company with limited liability. The rights of our shareholders and ADS holders may be different from the rights of shareholders in companies governed by the laws of U.S. jurisdictions and may not protect investors in a similar fashion afforded by incorporation in a U.S. jurisdiction.***

We are a public company (naamloze vennootschap) organized under the laws of the Netherlands. Our corporate affairs are governed by our Amended and Restated Articles of Association, the rules of our board of directors and by the laws governing companies incorporated in the Netherlands. However, there can be no assurance that Dutch law will not change in the future or that it will serve to protect investors in a similar fashion afforded under corporate law principles in the United States, which could adversely affect the rights of investors.

The rights of shareholders and ADS holders and the responsibilities of directors may be different from the rights and obligations of shareholders, ADS holders and directors in companies governed by the laws of U.S. jurisdictions. In the performance of their duties, our directors are required by Dutch law to consider the interests of our Company, its shareholders, its employees and other stakeholders, in all cases with due observation of the principles of reasonableness and fairness. It is possible that some of these parties will have interests that are different from, or in addition to, your interests as an ADS holder.

For more information on relevant provisions of Dutch corporation law and of our Amended and Restated Articles of Association, see "Description of Securities" included as Exhibit 2.1 to this Annual Report.

***Provisions of our Amended and Restated Articles of Association or Dutch corporate law might deter acquisition bids for us that might be considered favorable and prevent, delay or frustrate any attempt to replace or remove the members of our board of directors.***

Under Dutch law, various protective measures are possible and permissible within the boundaries set by Dutch law and Dutch case law. Currently we have no such protective measures in place.

Certain provisions of our Amended and Restated Articles of Association may make it more difficult or less attractive for a third party to acquire control of us or to effect a change in our board of directors. These provisions include: the provision that our directors are appointed on the basis of a binding nomination prepared by our board of directors which can only be overruled by a simple majority of votes cast representing at least one third of our issued share capital; the provision that our directors may only be removed by the general meeting of shareholders by a simple majority of votes cast representing at least one third of our issued share capital; and the requirement that certain matters, including an amendment of our Amended and Restated Articles of Association, may only be brought to our shareholders for a vote upon a proposal by our board of directors.

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***Shareholders and ADS holders may not be able to exercise preemptive rights and, as a result, may experience substantial dilution upon future issuances of ordinary shares.***

In the event of an issuance of ordinary shares, subject to certain exceptions, each shareholder will have a pro rata preemptive right in proportion to the aggregate nominal value of the ordinary shares held by such holder. These preemptive rights may be restricted or excluded by a resolution of the general meeting or by another corporate body designated by the general meeting. For example, at our 2025 Annual General Meeting, our shareholders approved a proposal to exclude preemptive rights for up to 10% of our issued share capital for general corporate purposes and for up to 10% of our issued share capital for financing of mergers, acquisitions, and strategic alliances, each for a period of eighteen months. The issuance of additional equity securities in the absence of preemptive rights would cause existing shareholders to experience dilution of their interest in us.

***We are not obligated to, and do not, comply with all best practice provisions of the Dutch Corporate Governance Code.***

We are subject to the DCGC. The DCGC contains both principles and best practice provisions for boards of directors, shareholders and general meetings, auditors, disclosure, compliance and enforcement standards. As a Dutch company listed on a stock exchange, we are subject to the DCGC and are required to disclose in our annual board report to what we extent comply with the principles and best practice provisions of the DCGC, and where we do not (for example, because of a conflicting Nasdaq requirement or otherwise), we must state why and to what extent we deviate in our Annual Report. We do not comply with all best practice provisions of the DCGC. See "Description of Securities" included as Exhibit 2.1 to this Annual Report. This may affect your rights as a shareholder or ADS holder and you may not have the same level of protection as a shareholder or ADS holder in a Dutch company that fully complies with the DCGC.

***We have never declared or paid dividends on our ordinary shares since our ordinary shares were listed on Euronext Amsterdam, and we do not anticipate paying dividends in the foreseeable future.***

We have never declared or paid cash dividends on our ordinary shares since our ordinary shares were listed on Euronext Amsterdam. We intend to retain any earnings for use in our business and do not currently intend to pay dividends on our ordinary shares. Subject to restrictions under applicable law, any future determination to pay dividends or other distribution will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, cash requirements, financial condition, future prospects, contractual restrictions, any future debt agreements, restrictions under applicable laws and other factors that our board of directors may deem relevant. We do not anticipate paying any cash dividends or other distributions on our ordinary shares in the foreseeable future. As a result, a return on any investment will only occur if the price of our ordinary shares or the ADSs increases.

***ADS holders may not receive distributions on the ordinary shares represented by the ADSs or any value for such distribution if it is illegal or impractical to make them available to ADS holders.***

While we do not anticipate paying any dividends or other distributions on our ordinary shares in the foreseeable future, if such a dividend or distribution is declared, the depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses, including any applicable withholding taxes. You will receive these distributions in proportion to the number of ordinary shares your ADSs represent. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical to make a distribution available to ADS holders. We have no obligation to take any other action to permit the distribution of the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that you may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make them available to you. These restrictions may have a material adverse effect on the value of your ADSs.

***Dividends distributed by us on the ordinary shares or ADSs to certain related parties in low-taxed jurisdictions might in the future become subject to an additional Dutch withholding tax on dividends.***

Under current Dutch tax law, dividends paid on ordinary shares or ADSs are in principle subject to Dutch dividend withholding tax at a rate of 15% under the Dutch Dividend Withholding Tax Act 1965 (Wet op de

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dividendbelasting 1965), unless a domestic or treaty exemption or reduction applies. Since January 1, 2024, the Dutch government has introduced an additional withholding tax on dividends paid to related entities in jurisdictions that have a corporate tax rate below 9% or to jurisdictions included on the EU's blacklist of non-cooperative jurisdictions and in certain abusive situations. The legislative proposal has been published by the Dutch government on March 24, 2021. Pursuant to the proposal, the conditional withholding tax on dividend payments will be an addition to the conditional withholding tax on interest and royalty payments pursuant to the Dutch Withholding Tax Act 2021 (Wet bronbelasting 2021). The rate will be as high as the highest Dutch corporate income tax rate (currently 25.8%) at the time of the dividend payment, which will be the statutory rate applicable to interest and royalty payments to related entities in jurisdictions that have a corporate tax rate below 9% or to jurisdictions included on the EU's blacklist of non-cooperative jurisdictions, to hybrid entities and in certain abusive situations. At the same time, the current Dutch dividend withholding tax regime is anticipated to remain in place. However, if the dividend withholding tax and the conditional withholding tax on dividends cumulate, the conditional withholding tax will be reduced by the dividend withholding tax levied. As a result, if the shareholder being a related entity is established in a jurisdiction that has a corporate tax rate below 9% or in a jurisdiction included on the EU's blacklist of non-cooperative jurisdictions, the tax rate on dividends may rise from 15% to 25.8%.

***ADS holders must act through the depositary to exercise their voting rights and, as a result, may be unable to exercise their voting rights on a timely basis.***

We do not treat holders of the ADSs (rather than the ordinary shares underlying the ADSs) as shareholders, and they are not able to exercise shareholder rights, except through our depositary and except that the ADS holders have the right to attend our general meetings. The depositary is the holder of the ordinary shares underlying the ADSs, and ADS holders are able to exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the deposit agreement relating to the ADSs. There are practical limitations on the ability of ADS holders to exercise their voting rights due to the additional procedural steps involved in communicating with these holders. For example, holders of our ordinary shares are able to exercise their voting rights by either attending the shareholders meeting in person or voting by proxy. ADS holders, by comparison, do not receive any notice directly from us. Instead, in accordance with the deposit agreement, we do use commercially reasonable efforts to provide at least 30 days' notice to the depositary of any such shareholders' meeting and details concerning the matters to be voted on in advance of the meeting date. If we so instruct, the depositary distributes to ADS holders the notice of the meeting and a statement as to the manner in which voting instructions may be given, or deemed given, in accordance with the deposit agreement by holders as soon as practicable after receiving notice from us of any such meeting. To exercise their voting rights, ADS holders must then instruct the depositary as to voting the ordinary shares represented by their ADSs. Due to these procedural steps involving the depositary, the process for exercising voting rights may take longer for ADS holders than for holders of ordinary shares. The ordinary shares represented by ADSs for which the depositary fails to receive timely voting instructions are not voted.

***The trading of our ordinary shares on Euronext Amsterdam and of our ADSs on the Nasdaq may adversely affect the liquidity and value of our ADSs.***

Our ordinary shares are traded on Euronext Amsterdam and our ADSs are traded on the Nasdaq. The price of our ADSs could be adversely affected by trading in our ordinary shares on Euronext Amsterdam and the price of our ordinary shares traded on Euronext Amsterdam could be adversely affected by trading in ADSs on the Nasdaq. The speed by which ADSs can be exchanged for ordinary shares and subsequently traded on Euronext Amsterdam and vice versa might cause differences between the market price for an ADS and the market price for an ordinary share. Additionally, our ordinary shares are quoted in Euros on Euronext Amsterdam, and the ADSs are quoted in U.S. dollars on Nasdaq. Movements in the Euro-U.S. dollar exchange rate may adversely affect the U.S. dollar price of the ADSs on Nasdaq or the Euro price on Euronext Amsterdam. For example, if the Euro weakens against the U.S. dollar, the U.S. dollar price of the ADSs could decline, even if the price of our ordinary shares in Euros increases or remains unchanged. Investors might arbitrate between stock exchanges to exploit such differences, exacerbating potential volatility in our market price.

***ADS holders may have difficulty in effecting service of process on our Company and certain directors or officers in the United States in enforcing U.S. judgments in the Netherlands or in enforcing U.S. securities laws in Dutch courts.***

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We are incorporated and located outside the United States and certain of our directors and officers are located outside of the United States. As a result, it may not be possible for ADS holders to effect service of process within the United States upon all such persons or our Company, or to obtain discovery of relevant documents and/or the testimony of witnesses. ADS holders based in the United States may also have difficulty enforcing in courts outside the United States judgments obtained in U.S. courts against our Company or our directors (including actions under the civil liability provisions of the U.S. securities laws). ADS holders may also have difficulty enforcing liabilities under the U.S. securities laws in legal actions originally brought in jurisdictions located outside the United States.

***ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable results to the plaintiff(s) in any such action.***

The deposit agreement governing our ADSs provides that owners and holders of ADSs irrevocably waive the right to a trial by jury in any legal proceeding arising out of or relating to the deposit agreement or the ADSs, including claims under U.S. federal securities laws, against us or the depositary to the fullest extent permitted by applicable law. As the waiver relates to claims arising as a matter of contract in relation to the ADSs, we believe that, as a matter of construction of the clause, the waiver would likely to continue to apply to ADS holders who withdraw the ordinary shares represented by the ADSs from the ADS facility with respect to claims arising before the withdrawal, and the waiver would most likely not apply to ADS holders who subsequently withdraw the ordinary shares represented by ADSs from the ADS facility with respect to claims arising after the withdrawal. However, to our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the United States Supreme Court. If this jury trial waiver provision is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement with a jury trial. Although we are not aware of a specific federal decision that addresses the enforceability of a jury trial waiver in the context of U.S. federal securities laws, it is our understanding that jury trial waivers are generally enforceable. Moreover, insofar as the deposit agreement is governed by the laws of the State of New York, New York laws similarly recognize the validity of jury trial waivers in appropriate circumstances. In determining whether to enforce a jury trial waiver provision, New York courts and federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent such that a party has knowingly waived any right to trial by jury. We believe that this is the case with respect to the deposit agreement and the ADSs.

In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable set off or counterclaim of fraud or one which is based upon a creditor's negligence in failing to liquidate collateral upon a guarantor's demand, or in the case of an intentional tort claim (as opposed to a contract dispute). No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with any provision of U.S. federal securities laws and the rules and regulations promulgated thereunder.

If any owner or holder of the ADSs, including purchasers of ADSs in secondary market transactions, brings a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under U.S. federal securities laws, such owner or holder may incur increased costs of bringing a claim and may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us or the depositary. Any legal suit, action or proceeding against or involving us brought by the depositary or any holder or beneficial owner of ADSs, arising out of or based upon the deposit agreement, the ADSs, the American Depositary Receipts, or ADRs, or the transactions contemplated therein or thereby, may be instituted only in any state or federal court in New York, New York. Any legal suit, action or proceeding against or involving the depositary brought by us, arising out of or based upon the deposit agreement, the ADSs, the ADRs or the transactions contemplated therein or thereby, may only be instituted in a state or federal court in New York, New York.

***ADS holders may be subject to limitations on transfer of the ADSs.***

The ADSs are only transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deem it advisable to

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do so because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason.

***We cannot assure you that we will not be a passive foreign investment company, or PFIC, for U.S. federal income tax purposes for any taxable year, which could result in adverse U.S. federal income tax consequences to holders of our ordinary shares or ADSs.***

A non-U.S. corporation will be a Passive Foreign Investment Company, or PFIC, for any taxable year if either (i) at least 75% of its gross income for such year consists of certain types of "passive" income or (ii) at least 50% of the value of its assets (generally based on an average of the quarterly values of the assets) during such year is attributable to assets that produce passive income or are held for the production of passive income. If we are a PFIC for any taxable year during which a U.S. Holder (as defined in "Material Income Tax Considerations - Material U.S. Federal Income Tax Considerations") holds our ordinary shares or ADSs, the U.S. Holder may be subject to adverse tax consequences, including (1) the treatment of all or a portion of any gain on disposition as ordinary income, (2) the application of an interest charge with respect to such gain and certain dividends and (3) compliance with certain reporting requirements. Based on our estimated income, assets and market capitalization for 2025, we do not believe we were classified as a PFIC for 2026. However, whether we are treated as a PFIC is a factual determination that must be made on an annual basis after the close of each taxable year. This determination will depend on, among other things, the ownership and the composition of our income and assets, as well as the value of our assets (which may fluctuate with our market capitalization) and our subsidiaries' assets from time to time. The United States Internal Revenue Service, or IRS, or a court may disagree with our expectations. Therefore, we cannot assure you that we will not be a PFIC for the current taxable year or for any future taxable year.

***If a United States person is treated as owning at least 10% of the value or voting power of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.***

Depending upon the aggregate value and voting power of our ordinary shares that United States persons are treated as owning (directly, indirectly or constructively), we could be treated as a controlled foreign corporation, or CFC. Additionally, because our group includes one or more U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as CFCs, regardless of whether or not we are treated as a CFC. If a United States person (as defined in the United States Internal Revenue Code of 1986, as amended, or the Code) is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our shares, such person may be treated as a "United States shareholder" with respect to each CFC in our group (if any), which may subject such person to adverse U.S. federal income tax consequences. Specifically, a United States shareholder of a CFC may be required to report annually and include in its U.S. taxable income its pro rata share of each CFC's "Subpart F income," "global intangible low-taxed income" and certain investments of earnings in "United States property" by CFCs, whether or not we make any distributions of profits or income of a CFC to such United States shareholder. If you are treated as a United States shareholder of a CFC, failure to comply with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of limitations with respect to your U.S. federal income tax return for the year for which reporting was due from starting. Additionally, a non-corporate U.S. shareholder would generally be denied certain tax deductions or foreign tax credits in respect of its income that may otherwise be allowable to a United States shareholder that is a U.S. corporation. We cannot provide any assurances that we will assist holders of our ordinary shares in determining whether we or any of our non-U.S. subsidiaries are treated as CFCs or whether any holder of our ordinary shares is treated as a United States shareholder with respect to any such CFC, nor do we expect to furnish to any United States shareholders information that may be necessary to comply with the aforementioned reporting and tax paying obligations. The Internal Revenue Service, or IRS, has provided limited guidance on situations in which investors may rely on publicly available information to comply with their reporting and taxpaying obligations with respect to foreign-controlled CFCs. U.S. holders of our ordinary shares should consult their advisors regarding the potential application of these rules to their investment in our ordinary shares.

**Item 4. Information on the Company.**

**A. History and Development of the Company** 

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We were incorporated as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) under the laws of the Netherlands on November 11, 1988 under the name GENFARM B.V. On May 29, 1997, the Company was converted from a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) into a public company (naamloze vennootschap) named Pharming Holding N.V. Effective July 2, 1998, Pharming Holding N.V. was renamed Pharming Group N.V.

We are registered with the Dutch Chamber of Commerce under number 28048592. Our ordinary shares are traded on Euronext Amsterdam under the symbol "PHARM." As of December 22, 2020, our ADSs were admitted for listing on the Nasdaq under the symbol "PHAR" and began trading on Nasdaq Global Market. The address of our registered office is Darwinweg 24, 2333 CR Leiden, the Netherlands. The telephone number of the registered office is +31 (0)71 5247 400. Our agent for service of process in the United States is Pharming Healthcare Inc. The Pharming Healthcare Inc. office is located at 10 Independence Blvd, Suite 401, Warren, New Jersey 07059. The telephone number is +1 908 524 0888.

Our actual capital expenditures for the years ended December 31, 2025, 2024 and 2023 amounted to $0.7 million, $0.8 million and $1.4 million, respectively. Our capital expenditures primarily consist of property, plant and equipment, such as investments in new machinery and equipment in the Netherlands.

We maintain a website at www.pharming.com. The reference to our website is an inactive textual reference only and the information contained in, or that can be accessed through, our website is not a part of this Annual Report. The SEC maintains an Internet site that contains reports and other information that we file electronically with the SEC at http://www.sec.gov.

**B. Business Overview** 

Pharming Group is a global biotechnology company that develops and commercializes innovative therapies for rare and ultra-rare diseases with significant unmet need. We focus on immunological and genetic conditions where our scientific and commercial expertise can help advance care over the long term.

Patients are at the heart of everything we do. Their insights along with those of caregivers and the scientific community shape our strategy, guide our clinical study designs, and influence how we manage our approved therapies.

Our teams combine deep scientific, medical, and operational expertise in rare disease drug development and commercialization. We leverage proven and efficient clinical development, supply chain, and commercial infrastructure to advance and expand our portfolio and pipeline and increase access for patient communities that currently lack adequate treatment options.

We execute with discipline and urgency, pursuing strategic growth with focused resource allocation. By strengthening our commercial portfolio and advancing high-value pipeline programs, we aim to deliver sustainable long-term value for patients, healthcare providers, employees, partners, and shareholders.

 **I. BUSINESS AND STRATEGIC DIRECTION**

**1. Our business**

Pharming is an integrated biotechnology company with proven capabilities across clinical development, manufacturing, regulatory affairs, and commercialization. Our model supports us in efficiently developing and delivering innovative therapies to expand treatment options and improve outcomes for rare disease communities with significant unmet needs.

Through disciplined execution across our commercial portfolio and pipeline, we aim to deliver sustainable growth while continuing to invest in innovation and long-term value creation for patients, healthcare providers and shareholders.

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***A) Commercial*** We currently commercialize two approved therapies for distinct rare and ultra-rare disease areas.

RUCONEST®, our first approved product, is the first and only recombinant C1 esterase inhibitor, or rhC1-INH, protein replacement therapy indicated for the treatment of acute hereditary angioedema, or HAE, attacks in adult and adolescent patients. It has received regulatory approval in the European Economic Area (2010), the United Kingdom (2010) and the United States (2014).

Our commercial focus for RUCONEST® is the United States. In other approved regions, we continue to support patients where appropriate.

Joenja® (leniolisib), our second marketed therapy, is an oral, selective phosphoinositide 3-kinase delta, or PI3Kδ, inhibitor approved in the United States, United Kingdom, Australia, and Israel as the first and only targeted treatment indicated for activated phosphoinositide 3-kinase delta syndrome, or APDS, an ultra-rare primary immunodeficiency, or PID, in adult and pediatric patients 12 years of age and older. and in Japan for adult and pediatric patients aged 4 years and older.

We currently commercialize Joenja® in the United States and the United Kingdom through our own sales and marketing infrastructure.

***B) Pipeline***

Pharming is advancing a focused pipeline centered on rare immunological and genetic diseases.

*a. Leniolisib for APDS*

To expand access and generate evidence for broader use, we have active regulatory and clinical development efforts aimed at making leniolisib available to APDS patients across all age groups in key markets. In addition, we are working to further characterize the disease-causing impact of mutations in the APDS causing genes, currently classified as variants of uncertain significance, or VUSs, and are undertaking further research to determine the overall prevalence of APDS.

*b. Leniolisib for PIDs with immune dysregulation*

Beyond APDS, leniolisib is being evaluated in two Phase II studies targeting additional PIDs with immune dysregulation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Genetically confirmed PIDs linked to altered PI3Kδ signaling

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Common variable immunodeficiency, or CVID, with immune dysregulation, regardless of underlying genetic confirmation

These programs provide the opportunity to address significantly larger patient populations that currently lack targeted therapeutic options.

*c. Napazimone (KL1333) for primary mitochondrial disease* In 2025, our late-stage pipeline was strengthened through the acquisition of Abliva AB and its lead asset, KL1333. Napazimone (KL1333), the newly named compound, is a potential first-in-disease therapy for mitochondrial DNA, or mtDNA,-driven primary mitochondrial disease, or PMD. It is currently in a pivotal clinical trial, designed to support regulatory approval, which passed a futility analysis on its two primary end points.

 **2. Our commitment to rare diseases**

Pharming is committed to advancing care for people living with rare and ultra-rare diseases. We focus on areas of significant unmet need where our scientific and commercial expertise may make a meaningful difference - and where specialist care, diagnostic readiness, and reimbursement pathways enable responsible patient identification and sustainable access.

We align our clinical development, business development, and capital allocation decisions around rare diseases

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where we can build competitive advantage and create durable growth - strengthening our potential to deliver long-term value while expanding access for patients who often have limited or no treatment options.

***A) HAE*** HAE is a rare, potentially life-threatening genetic condition characterized by unpredictable swelling attacks that may affect the skin, gastrointestinal tract, and upper airway (laryngeal edema). Global prevalence is estimated at approximately 1 in 50,000 to approximately 1 in 10,000. Symptoms are driven by excess bradykinin resulting from uncontrolled kallikrein activity, which leads to fluid leakage into tissues. Despite broader use of prophylactic therapies, breakthrough attacks remain common, and clinical guidelines recommend ready access to effective on-demand treatment for all patients, including those on prophylaxis.

*a. Pharming's market emphasis*

We are focused on the U.S. HAE market as the core commercial opportunity for acute treatment.

*b. Market size & growth (U.S.)* The U.S. HAE market continues to expand, driven by improved disease awareness, broader specialist access, and new therapeutic options across both prophylactic and on-demand classes. Recent real-world U.S. claims analyses indicated that the diagnosed patient population may be larger than historically assumed at 2.67 per 100,000. This larger-than-expected patient base reinforces the need for robust prophylaxis and reliable on-demand options.

By the end of 2024, the U.S. market included multiple FDA-approved options across both acute treatment and long-term prophylaxis. In 2025, the therapeutic landscape broadened further with FDA approvals introducing new mechanisms and modalities, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an activated Factor XII, or FXIIa, inhibitor for prophylaxis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a prekallikrein-directed antisense oligonucleotide for prophylaxis; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an oral plasma kallikrein inhibitor for on-demand treatment of acute attacks.

Collectively, these developments are expanding therapeutic choice and increasing the complexity of treatment decision-making across both prophylactic and acute settings.

*c. Competitive dynamics (acute & prophylaxis)*

The U.S. HAE market spans therapies that target C1 esterase inhibitor, or C1-INH, replacement and key components of the contact activation system, including plasma kallikrein and FXIIa, delivered via intravenous, subcutaneous, and oral modalities.

Long-term prophylaxis has become the dominant treatment paradigm. In a U.S. patient survey, approximately 68.5% reported having received or currently receiving long-term prophylaxis, or LTP. However, increased prophylaxis uptake has not eliminated the need for acute therapy.

The U.S. HAEA Medical Advisory Board guidelines emphasize that patients must have ready access to effective on-demand medication, and that all patients with laboratory-confirmed HAE should have access to at least two standard doses of an FDA-approved on-demand therapy.

Breakthrough attacks remain clinically meaningful and common despite the widespread adoption of LTP. Randomized studies indicate that approximately 50% of patients receiving prophylaxis continue to experience breakthrough attacks, and many patients treated with prophylaxis also report attacks in controlled settings. In addition, certain acute therapies may require re-dosing, highlighting persistent unmet needs in acute management and reinforcing the need for therapies that restore functional C1-INH activity.

*d. Role of RUCONEST® (recombinant C1-INH, IV)* RUCONEST® is the first and only recombinant C1-INH protein replacement therapy, providing a differentiated on-demand treatment for acute attacks in patients with Type I, Type II, and normal C1-INH HAE. By restoring functional C1-INH, RUCONEST® addresses the underlying deficiency that triggers attacks and regulates the

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contact activation system through inhibition of Factor XII and kallikrein, reducing downstream bradykinin and related mediators. This mechanism supports its positioning as targeting the root cause of HAE across multiple biological pathways rather than a single cascade.

Its intravenous administration provides immediate, complete bioavailability, enabling rapid, high-dose intervention to halt attack progression. In a market increasingly shaped by prophylaxis, RUCONEST® continues to serve as a cornerstone on-demand treatment, particularly for patients experiencing more severe or frequent attacks or those who continue to experience breakthrough attacks despite prophylactic treatment.

***B) PIDs*** PIDs are a heterogeneous group of rare immune disorders that lead to recurrent infections and immune dysregulation. The global PID therapeutics market is estimated at approximately $8 billion in 2025, with steady growth expected at a compound annual growth rate of approximately 6% to approximately $14 billion by 2034, supported by earlier genetic diagnosis, better care pathways, and sustained demand for immunoglobulin and targeted therapies. Underdiagnosis remains significant, and expanded testing continues to increase the identifiable patient population.

*a. APDS* APDS (activated PI3Kδ syndrome) is an ultra-rare, progressive PID first characterized in 2013. Literature estimates prevalence at approximately 1.5 patients per million. Emerging evidence suggests that the prevalence may be much higher, underscoring the importance of efforts to further characterize the disease, and understand the impact of mutations in the APDS causing genes currently classified as VUSs.

APDS presents with a clinically heterogeneous profile that may include severe and recurrent sinopulmonary infections; persistent or recurrent herpesvirus infections (notably EBV and CMV); lymphadenopathy, hepatosplenomegaly, and nodular lymphoid hyperplasia; autoimmune cytopenias; enteropathy; and bronchiectasis. Patients also face a heightened risk of malignancy, particularly lymphoma, due to dysregulated lymphoproliferation.

Delayed diagnosis can lead to the accumulation of irreversible organ damage, and published analyses indicate that survival probability may be up to 28% lower than the general population, with lymphoma and infections representing the leading causes of mortality.

Despite increased awareness since its identification, APDS continues to be under-recognized and misdiagnosed, particularly outside specialist care settings.

There are currently over 1,800 known U.S. patients with a VUS in the *PIK3CD* and *PIK3R1* genes implicated in APDS. In 2025, new peer-reviewed research published in leading journal *Cell* demonstrated that functional characterization of PI3Kδ pathway variants can support the reclassification of certain VUSs to APDS. We expect to provide an estimate of how many of these patients may be diagnosed with APDS following completion of new experiments planned to generate the data needed for genetic testing laboratories to evaluate VUSs identified in patients who have undergone genetic testing for APDS or other immunodeficiencies.

A second conclusion of this research was that APDS may have a broader clinical presentation and significantly higher prevalence than previously assumed, an important consideration for long-term market growth. Further research is on-going on this topic.

i. Market size & growthThe APDS market remains at an early stage, reflecting the ultra-rare nature of the disease, limited historical diagnostic pathways, and the absence, until recently, of targeted therapeutic options.

However, multiple indicators point to durable market expansion:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• New functional genomics evidence indicates that APDS may be more prevalent than previously understood, as increased PI3Kδ pathway activity was identified in variants of the APDS causing genes that have not so far been reported in APDS patients, prompting further investigation into the true size of the APDS population.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Expanded genetic testing and reclassification of VUSs are expected to increase the identifiable patient population.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Growing understanding of disease burden, including risk of lymphoma and early mortality, is raising clinical urgency and supporting early targeted therapy adoption.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• APDS remains the first genetically defined PID with a precision therapy, anchoring a category with long-term growth potential.

Collectively, these trends position APDS as a small but structurally expanding rare-disease market with significant diagnostic uplift ahead.

*ii. Competition* Joenja*®* is currently the only approved therapy for APDS and selective PI3Kδ inhibition remains the defining approach within this therapeutic category. Based on public information, we are not aware of any active clinical development programs in APDS.

*b. PIDs with immune dysregulation beyond APDS* 

PIDs with immune dysregulation represent an area of significant unmet medical need, commonly presenting with lymphoproliferation, autoimmune manifestations, and organ-specific inflammation.

Beyond the rare APDS population, several genetically defined PIDs with immune dysregulation linked to altered PI3Kδ signaling affect an estimated 7.5 patients per million, offering the potential to reach meaningfully broader patient groups.

CVID with immune dysregulation represents an even larger segment within the PID landscape. As the most common symptomatic PID, approximately half of CVID patients develop inflammatory or autoimmune complications, corresponding to a target population of approximately 39 per million. Many exhibit APDS-like clinical and immunologic features, reinforcing the rationale for PI3Kδ pathway modulation and importance to address the substantial unmet need across a wider spectrum of immune dysregulation disorders beyond APDS.

We are conducting Phase II studies in both PIDs with immune dysregulation linked to altered PI3Kδ signaling, and CVID with immune dysregulation. Both studies are fully enrolled and we expect top line data in the second half of 2026.

***C) Primary mitochondrial disease***

PMDs are rare, multisystem disorders caused by impaired cellular energy generation, leading to chronic fatigue, muscle weakness, neurological manifestations, and substantial functional limitations. Affecting both children and adults, PMD encompasses a broad and heterogenous spectrum of symptoms reflecting the essential role of mitochondria in cellular metabolism. With no approved therapies that directly address the underlying bioenergetic defect, current care remains largely supportive, underscoring the significant unmet need across this patient population.

Within this broader landscape, mtDNA–driven mitochondrial disease represents a genetically defined subgroup with a well-characterized pathophysiology and considerable disease burden in adults. These patients commonly experience severe fatigue and myopathy that impair daily functioning and quality of life, making this population particularly suited to targeted therapeutic approaches.

Across the U.S., EU4 (France, Germany, Italy, Spain), and the U.K., more than 30,000 diagnosed patients fall into this subgroup, highlighting both the scale of unmet need and the opportunity for a therapy that directly improves mitochondrial energy production. Napazimone (KL1333), designed to modulate cellular NAD⁺/NADH balance, aims to address this core bioenergetic dysfunction and potentially deliver the first disease-targeted option for mtDNA-driven mitochondrial disease.

 **3. Our strategy** Our vision is to develop a leading global rare disease company with a diverse portfolio and presence in

large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.

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We continue to build on strong foundations, anchored by our established U.S. commercial platform, expanding access to our therapies in key markets, and progressing a high-value pipeline that we expect will power future growth.

We are strengthening and diversifying our portfolio with a goal to deliver long-term, sustainable growth, with anticipated continued growth and durability for RUCONEST®, midterm momentum driven by Joenja® and disciplined advancement of key pipeline assets leniolisib and napazimone (KL1333). We expect our robust infrastructure and deep collaborations across the rare disease ecosystem to support reliable execution and the cash flow required to fund future innovation and expand access in priority geographies.

Our culture is central to how we execute. We are united by a commitment to improving outcomes for people living with rare and life-threatening conditions. We collaborate across disciplines, combine our expertise, and encourage each other to go the extra mile. Our core values 'We put patients at the heart', 'We make it simple', 'We get it done' and 'We act with urgency' guide how we work, strengthen our ability to execute with discipline, and empower our teams to make a meaningful impact on patients and their families.

***A) 2025 strategic progress*** In 2025, we advanced our strategic agenda with discipline and focus. We reinforced the resilience and growth potential of our rare disease therapies in the U.S. and prepared for further geographic expansion. We expanded access and progressed regulatory pathways to broaden the reach of Joenja® in priority markets and continued to strengthen patient identification to enable appropriate treatment.

We advanced our innovation ambitions through disciplined late-stage development and targeted investments in programs aligned to our scientific expertise, while deepening collaboration with clinical experts and rare disease communities.

Across the business, we sharpened capital allocation and enhanced cross-functional capabilities to support future portfolio growth and scalable execution. These actions strengthened our foundations for long term, sustainable growth and set clear momentum into 2026.

*a. Our competitive advantage* Our competitive advantage is built on a focused rare disease strategy, a patient-focused commercial platform, and a high-value pipeline addressing significant unmet needs. We combine deep scientific expertise with disciplined execution to identify, develop, and commercialize therapies in areas where biology is well understood and patient needs remain substantial.

Our commercial portfolio supports both resilience and growth momentum. RUCONEST® continues to play an important role in the acute HAE market, supported by its differentiated profile and established position in U.S. care.

Joenja® is the first and only approved targeted therapy for APDS and represents a clinically validated proof-of-concept for PI3Kδ inhibition in immune dysregulation. With ongoing development in PIDs with immune dysregulation beyond APDS, Joenja® has the potential to address a substantially larger patient population with limited treatment options.

Looking ahead, our late-stage pipeline further strengthens our competitive positioning. Napazimone (KL1333) is being developed for mtDNA-driven PMD, an area of significant unmet medical need with no approved disease-modifying therapies. If successful, napazimone (KL1333) has the potential to become the first treatment targeting the underlying biology of this condition.

These commercial assets and pipeline programs are supported by our rare disease expertise, scalable infrastructure, and the strength of our balance sheet and operating cash flows. Together, we expect these strengths to create a solid foundation for growth and long-term impact for people living with rare diseases.

*b. People and capabilities* Our ability to execute our strategy relies on the expertise and commitment of our people. Across the organization we continued to strengthen specialist capabilities, develop leadership, and embed cross-functional collaboration that support rare disease excellence. This focus on skills, culture and agility supports us in scaling

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effectively, sustaining quality and compliance, and delivering better outcomes for patients and other stakeholders.

***B) Strategic priorities*** *a. Strengthen and sustain our marketed rare disease therapies* In 2025, we focused on enhancing the performance and long-term relevance of our marketed therapies. This included reinforcing the clinical and commercial positioning of our products, maintaining reliable supply, supporting appropriate use, and optimizing our geographic footprint. A key priority during the year was expanding the addressable APDS population and driving uptake of Joenja®, while shaping an efficient, scalable organization to support sustained anticipated future growth.

During the year, we reinforced our franchise through sustained commercial execution. RUCONEST® continued to demonstrate resilient and growing U.S. demand, while Joenja® uptake accelerated, supported by increased patient identification and ongoing efforts to broaden the diagnosed APDS population. Following a strategic review, we made the decision to withdraw RUCONEST® from commercialization in non-U.S. markets, enabling a more focused operating model centered on the United States. This action strengthened capital allocation and sharpened our focus on key growth drivers and pipeline advancement.

*b. Expand global access for Joenja® in APDS* In 2025, we continued executing on our strategy to broaden global access to Joenja® by advancing regulatory submissions, enabling launches in priority markets, and expanding the eligible patient population through pediatric label expansion. We also maintained focus on improving diagnosis and identification of APDS patients, including continued efforts to resolve VUSs, and convert identified patients to commercial therapy in the U.S.

During the year, we achieved important regulatory and commercial milestones. We filed for approval in Japan for adult and pediatric patients, and successfully launched Joenja® in the United Kingdom. In the United States, we submitted a supplemental New Drug Application, or sNDA, for pediatric patients aged 4–11 years and received Priority Review designation. We also progressed the clinical program evaluating Joenja® in younger patients (1–6 years), supporting future regulatory submissions and potential label expansion.

*c. Advance our clinical-stage rare disease pipeline* In 2025, we advanced high-value clinical programs in rare diseases with significant unmet need through rigorous science, operational excellence, and discipline. Our priorities were to broaden the long-term potential of leniolisib beyond APDS, into larger PID populations impacted by immune dysregulation, and to progress the pivotal development of napazimone (KL1333) in PMD.

We advanced two Phase II proof-of-concept clinical trials evaluating leniolisib in genetically defined PIDs linked to PI3K signaling and in CVID with immune dysregulation, with both studies on track for top-line data readouts in the second half of 2026. We also started and progressed Wave 2 of the pivotal FALCON clinical study evaluating napazimone (KL1333) in mtDNA-driven primary mitochondrial disease, following the completion of the Abliva acquisition. Wave 2 enrollment continued during the year, supporting a planned 2027 readout.

These advancements reflect disciplined execution across our late-stage programs and reinforce our commitment to building a diversified, high-value rare disease pipeline.

*d. Pursue value-accretive business development* We maintained a disciplined approach to business development in 2025, focusing on rare disease assets that align with our scientific expertise and leverage our proven clinical development, regulatory, and commercial infrastructure.

During the year, we strengthened our rare disease pipeline through the acquisition of Abliva AB, adding KL1333 — now named napazimone (KL1333) — a late-stage asset in mtDNA-driven primary mitochondrial disease. The transaction, initiated in late 2024, culminated in Abliva's delisting from Nasdaq Stockholm in March 2025 and our subsequent acquisition of the remaining minority shares, resulting in 100% ownership by June 18, 2025. This acquisition expanded our presence into mitochondrial disease, added a pivotal-stage

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program with significant long-term value potential, and reinforced our strategy of acquiring differentiated, science-driven assets in areas of high unmet need.

We also continued evaluating additional external innovation opportunities aligned with our strategic priorities, applying disciplined financial and strategic criteria to all opportunities assessed.

*e. Shape an efficient and scalable organization*

In 2025, we focused on developing an operating model that supports anticipated sustained portfolio growth, disciplined capital allocation, and future launches. We strengthened cross-functional capabilities, reinforced our core values, and worked to foster a culture of accountability and operational excellence.

During the year 2025, the first year under Fabrice Chouraqui's leadership, the organization was further aligned around clear strategic priorities and a performance-driven culture focused on execution. The October appointment of Kenneth Lynard as Chief Financial Officer further strengthened financial oversight and discipline as we continue to scale the business.

We advanced initiatives to optimize our cost structure and enhance organizational efficiency, including measures to reduce general & administrative expenses by $9 million annually. This plan included a 20% net reduction in non-commercial and non-medical headcount. These actions enabled a more streamlined operating model, enhanced financial discipline and prioritized investments in commercial growth and pipeline advancement.

*f. Operate responsibly and sustainably*

In 2025, we continued our sustainability journey, embedding quality, compliance, and responsible business practices across our operations. We delivered new initiatives across Environmental, Social and Governance themes, from 'Compliance Day' that communicated updates to policies, broadening and deepening our culture of business integrity, to renewable energy contracts implemented at 2 more sites, reducing our greenhouse gas emissions. Such actions have strengthened our risk management processes and support the sustainable growth of Pharming.

Further detail on progress across our commercial portfolio and pipeline programs is provided in the "Commercial Portfolio Review" and "Pipeline Review" sections below.

*g. Translating strategy into impact* We translate strategy into impact by aligning commercial portfolio growth with disciplined development, focused market expansion, and an enabling culture. We progress our pipeline where our capabilities create the most value — broadening leniolisib into additional primary immunodeficiencies and advancing late-stage assets like napazimone (KL1333) — while strengthening access for APDS through regulatory progress, targeted launches, and improved diagnosis. We maintain RUCONEST® as a reliable, growing, and cash-generating U.S. franchise, supported by reliable supply. Evidence generation, from clinical programs to real-world data and health economic insights, underpins regulatory interactions and market access in large geographies.

Across development, supply chain, and commercial operations, we embed quality, compliance, and capital discipline, and we work collaboratively with clinicians, patient organizations, and genetic laboratories.

Our core values guide our teams every day, helping us execute on our strategy and enable earlier diagnosis, broader access and better outcomes for patients, and durable, re-investable cash flow.

*h. Near-term focus for 2026* In 2026, we intend to grow Joenja® in APDS through intensified patient-finding and ex-U.S. approvals and launches while pursuing pediatric label expansion; reinforce RUCONEST®'s distinctive value proposition in a more competitive HAE market; advance leniolisib beyond APDS via Phase II proof-of-concept trial execution in additional PIDs with immune dysregulation and alignment on registrational routes; progress napazimone (KL1333) for PMD through pivotal trial execution and integrated CMC readiness; and strengthen platform enablers — quality, supply reliability, data and analytics — while maintaining financial discipline.

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**II. COMMERCIAL PORTFOLIO REVIEW** 

Our portfolio is designed to deliver meaningful impact for people living with rare and potentially life-threatening conditions while generating durable cash flow that enables continued investment in innovation.

In 2025, we focused on disciplined execution across our marketed therapies, emphasizing appropriate use, strong operational performance, and high-quality evidence generation in support of patients and their families, clinicians, payers, and regulators.

Throughout the year, we strengthened commercial excellence and patient identification initiatives, maintained dependable product quality and supply assurance, and expanded real world evidence and health economic insights in preparation for key regulatory and access engagements. We also deepened our collaboration with clinicians, patient organizations, and genetic laboratories to help support earlier diagnosis and more informed treatment decisions.

This section reviews performance across our marketed portfolio, including RUCONEST®, a rhC1-INH for acute HAE, and Joenja® (leniolisib), the first approved targeted treatment for APDS. It highlights how consistent execution, reliable supply, strengthened diagnostic and patient identification efforts, and effective payer engagement enable timely treatment for eligible patients while reinforcing the Company's long-term strategic and financial objectives.

**1. RUCONEST® for the treatment of HAE**

RUCONEST® remains an established on-demand treatment for adults and adolescents experiencing acute HAE attacks. As the first and only rhC1-INH protein replacement therapy, RUCONEST® restores functional C1-INH activity and addresses the underlying deficiency driving bradykinin-mediated swelling. In a landscape increasingly shaped by long-term prophylaxis — where breakthrough attacks remain clinically meaningful — RUCONEST® continued to serve as a cornerstone acute therapy in 2025, particularly for patients requiring dependable, rapid control.

With more than a decade of U.S. availability and a longstanding prescriber base, RUCONEST® serves a clearly defined patient population and generates reliable cash flow to support Joenja® (leniolisib) commercialization and broader pipeline investment.

A) ***Product overview*** RUCONEST® is a rhC1-INH approved for the treatment of acute HAE attacks in adults and adolescents. Produced using our transgenic technology platform, it provides a recombinant source of functional C1-INH to help control the inflammatory pathways that drive acute HAE symptoms. The therapy is administered intravenously and is used at the onset of an attack to help halt its progression.

With more than a decade of availability in the United States, RUCONEST® has an established role in acute HAE care, supported by consistent real-world use, dependable supply, and a mature safety profile. The therapy has a long-standing position with physicians and patients in this rare disease community.

***B) 2025 performance overview***

RUCONEST® delivered another year of strong performance in 2025, reflecting the product's stable role in the U.S. acute HAE landscape. Revenue for the full year 2025 reached a record $317.9 million, representing a 26% increase compared to 2024.

In the U.S. market, we continued to expand our patient and prescriber base throughout the year. Revenue growth over the prior year reflects the benefit of a larger patient base, including patients with HAE with normal C1-INH. RUCONEST® remains an established on-demand treatment option for patients experiencing more severe or frequent attacks who have failed other on-demand medications. During the year, we increased the RUCONEST® physician prescriber base by 6%. Unit sales volume in the U.S. increased by 20% for the full year.

Throughout 2025, RUCONEST® maintained steady utilization within the acute segment, supported by new patient enrollments and consistent clinical engagement. Operational execution remained strong, with continued

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supply, enabled by stable manufacturing throughput and robust quality oversight. Product quality and safety indicators remained consistent with historical performance.

RUCONEST® continued to be a dependable source of cash flow, supporting ongoing investment in Joenja® (leniolisib) commercialization and our broader development pipeline. Our priorities remain focused on maintaining reliable supply, responsible lifecycle management, and operational efficiency.

RUCONEST® maintained steady utilization among prescribers and patients who rely on rapid, reliable control of acute attacks and it is commercialized exclusively in the United States through our direct commercial organization.

In November 2025, following a strategic review, we announced the withdrawal of RUCONEST® from commercialization in all non-U.S. markets. These markets represented less than 2% of RUCONEST® revenue and were not financially sustainable long-term.

Throughout this transition, our highest priority has been ensuring continuity of care for affected patients. To support this, RUCONEST® remains accessible in certain countries outside the United States through the HAEi Global Access Program, subject to local regulatory frameworks and individual eligibility assessments.

With this transition complete, RUCONEST®'s commercial footprint is now fully focused on the U.S. market, supported by dedicated commercial, medical, supply, and patient-services teams.

For a breakdown of total revenues by categories of geographic market for each of the last three financial years, see "Item 5—A. Operating Result" of this Annual Report.

***C) RUCONEST® manufacturing*** Our proprietary transgenic manufacturing technology platform is the foundation upon which we started our company. We have developed a unique and scalable, current Good Manufacturing Practices, or cGMP, validated methodology for the production of c1-esterase inhibitor (recombinant human protein). By law, the use of animals to produce (recombinant) therapeutic proteins is only allowed when production methods that do not make use of an animal model are unavailable, as is the case for Pharming as well.

Our manufacturing process utilizes transgenic animals, specifically rabbits, to produce this human recombinant protein in their milk. This process enables the production of the protein in the milk of the animals without the animals being subjected to unnecessary discomfort or being altered in other aspects of their biology.

We raise the rabbits at specialized and regulator approved facilities with high standards of animal husbandry, welfare and security. These facilities further incorporate protections against contamination from the outside environment.

All institutions using animals for research or production of medicinal products must comply with EU and national regulations regarding experimental animals. Before commencing any activity involving animals, a project license application must be approved by the Dutch regulatory ethics committee for the Netherlands, and by the Ministry of Higher Education & Research and the Ethics Committee in Animal Experimentation in France.

We have a comprehensive Policy on the Use of Animals, which not only enforces strict regulatory control over our transgenic biological materials and animals, with regard to the environment and particularly the continuous well-being of our animals, but also emphasizes our commitment to treat animals respectfully, refining procedures and reducing discomfort and stress as much as possible.

We ensure that the "3 R principles" (Reduction, Replacement and Refinement) as outlined by EU legislation are considered prior and during the course of an experiment (such as the routine production of therapeutic protein), which includes the care, handling and treatment of animals meeting their species-specific needs as much as possible. Furthermore, an Animal Welfare Body consisting of a minimum of one qualified scientist, two biotechnicians and the designated or the company veterinarian, is established in every country where we operate animal facilities.

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We have multiple "upstream" manufacturing facilities of our own. The "downstream" processes include the purification, involving standard technologies such as various chromatography and filtration steps, followed by formulation and sterile filling into lyophilized powder product in vials ready for reconstitution. We have entered into manufacturing and supply agreements for RUCONEST® with, among others, Sanofi S.A., or Sanofi, and BioConnection Investments B.V. (formerly BioConnection B.V.), or BioConnection, for these downstream processes, as we do not have a GMP-certified production facility or lab capable of performing the manufacturing and quality control procedures necessary for the release of product.

***D) Intellectual property and exclusivity*** RUCONEST® has patent protection in the United States and European Union until October 7, 2026, and biologics reference product exclusivity in the United States through July 16, 2026.

Beyond formal exclusivity, RUCONEST® benefits from a proprietary recombinant production platform and specialized manufacturing processes that are complex and capital-intensive.

As a complex biologic produced using transgenic technology, the product requires highly specific technical capabilities, validated purification processes and regulatory oversight that may present meaningful barriers to entry. Development of a biosimilar would require substantial investment, validated manufacturing capabilities and regulatory approval — and would carry significant execution risk.

To date, we are not aware of any pending biosimilar applications referencing RUCONEST® in the United States or European Union. While competition cannot be ruled out following expiry of exclusivity periods, we believe the scientific complexity of recombinant biologics, combined with manufacturing know-how and established physician familiarity, may limit near-term biosimilar risk.

As of December 31, 2025, we solely owned 69 granted patents related to RUCONEST®, of which five are U.S.-issued, and four pending patent applications, of which two are U.S. pending patent applications. Our granted patents and pending patent applications include the making of RUCONEST® in the milk of transgenic mammals. In addition, our granted patents and pending patent applications also include claims for the use of C1-INH in the prevention of pre-eclampsia and the use of C1-INH in the treatment of corona virus-induced respiratory distress. In May 2026, 14 granted patents will lapse; in October 2026, 1 granted patent will lapse and in December 2026, 5 granted patents will lapse, due to the end of their lifetime.

**2. Joenja® (leniolisib) for the treatment of APDS**

Our second commercialized product, Joenja®, is an oral small molecule PI3Kẟ inhibitor approved in the United States, United Kingdom, Australia and Israel, as the first and only targeted treatment indicated for APDS, in adult and pediatric patients 12 years and older, and in Japan for adult and pediatric patients aged 4 years and older. This represents the first global approval of Joenja® for children aged 4 to 11.

***A) Product overview*** As a disease modifying therapy, Joenja® targets the root cause of APDS, by selectively inhibiting PI3Kδ, supporting a more balanced pathway and addressing immune dysregulation characteristic of the disease. Joenja® inhibits production of phosphatidylinositol-3-4-5-trisphosphate, a cellular messenger that regulates processes including proliferation, differentiation, cytokine production, survival, metabolism, and cell migration/trafficking.

Joenja®'s efficacy and safety in APDS were established in a Phase II/III randomized, placebo-controlled trial and an open-label extension, or OLE, study. The Phase II/III trial was composed of two sequential parts. The first part included six patients in an open-label dose escalation study designed to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of leniolisib.

The first part of the study showed that oral leniolisib led to a dose-dependent reduction in PI3K/AKT pathway activity assessed ex-vivo and improved immune dysregulation. We observed normalization of circulating transitional and naive B-cells, reduction in PD-11CD41 and senescent CD571CD42 T cells and decreases in elevated serum immunoglobulin M and inflammatory markers including interferon g, tumor necrosis factor, CXCL13, and CXCL10. After 12 weeks of treatment, all patients showed amelioration of lymphoproliferation with lymph node sizes and spleen volumes reduced by 39% (mean; range, 26%-57%) and 40% (mean; range,

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13%-65%), respectively. Leniolisib was well tolerated and improved laboratory and clinical parameters in APDS, supporting the specific inhibition of PI3Kδ as a potential therapy in APDS and other diseases characterized by over-activation of the PI3Kδ pathway.

The second part was a randomized, blinded, placebo-controlled study, which enrolled 31 patients with APDS who were 12 years of age or older. Patients were randomized 2:1 to receive either leniolisib 70mg twice daily or placebo for 12 weeks. Following this, patients were permitted to roll over to an open-label extension study to evaluate long-term safety, tolerability, and efficacy of leniolisib. Primary outcome measures were differences from baseline in lymph node size and in percentage of naïve B cells in peripheral blood, assessed as proxies for immune dysregulation and deficiency.

The primary efficacy results demonstrated clinical efficacy of leniolisib over placebo with a statistically significant reduction in the size of the lymph nodes (p=0.0006) and normalization of immune dysfunction, as evidenced by increased proportion of naïve B cells (p=0.0002). Key secondary evaluations were supportive, including patient and physician global assessment tools which showed increased well-being and less disease activity, respectively, of patients randomized to leniolisib as compared to placebo.

In the study, leniolisib was generally well-tolerated. The majority of reported adverse events in both treatment groups were classified as mild. There were no adverse events that led to discontinuation of study treatment, there were no deaths, and the incidence of serious adverse events, or SAEs, was lower in the leniolisib group than the placebo group. None of the SAEs were suspected to be related to study treatment.

The OLE with data from APDS patients 12 years and older taking Joenja® for up to 6 years was published in 2024 and completed in 2025, reported improvements in health-related quality of life (HRQoL) and a reduction in the severity of certain clinical manifestations over time. The study also noted decreases in prescribed medications for several patients, reflecting sustained clinical benefit throughout long-term follow-up.

***B) 2025 performance overview*** Joenja® continued to expand its presence in 2025 with approvals in Australia and the UK alongside securing reimbursement in the UK. During the year, we focused on strengthening the foundations needed for long-term, sustainable adoption: deepening patient identification, supporting appropriate initiation, and advancing reimbursement and regulatory submissions to broaden access.

*a. Financial performance* Joenja® delivered solid financial performance in 2025, with uptake accelerating in the U.S. and a strong start to the UK launch, as rising patient identification continued to expand the diagnosed APDS population. Revenue for the full year 2025 increased to $58.2 million, a 29% increase compared to 2024. Revenue growth in the fourth quarter of 2025 was driven by a significant increase in patients on paid therapy in the U.S. and increased demand in international markets, including strong patient uptake in the U.K. following the April 2025 launch and purchases under government-supported access programs.

The United States contributed 86% of 2025 Joenja® revenues, generating $50.1 million in sales compared to $40.5 million in 2024.

International markets outside the United States contributed 14% of 2025 Joenja® revenues, largely driven by initial uptake in the United Kingdom following positive reimbursement decisions by the National Institute for Health and Care Excellence, or NICE, the Scottish Medicines Consortium, or SMC, and implementation through the National Health Service , or NHS, and by early access in additional regions.

Across all markets, performance benefited from uninterrupted supply, reliable patient services and continued diagnostic testing support, which together contributed to sustained patient identification and treatment initiation. Inventory levels, manufacturing schedules, and logistics remained aligned with increasing global demand, and no material supply constraints or inventory build affected revenue in 2025.

Looking ahead, revenue growth is expected to be influenced by the pace of new patient identification, country specific reimbursement timelines, and ongoing regulatory progress, including activities related to the supplemental U.S. submission for patients aged 4–11 years. We remain focused on scaling access in approved markets, advancing new market launches, and supporting appropriate use among eligible APDS patients.

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For a breakdown of total revenues by categories of geographic market for each of the last three financial years, see "Item 5—A. Operating Result" of this Annual Report.

*b. Patients on therapy* As of December 31, 2025, 120 patients in the United States were receiving Joenja® through commercial channels, representing a 25% increase from the 96 patients at the end of 2024. The number of patients on paid therapy in the U.S. increased by 24 during 2025, compared to an increase of 16 in 2024.

*c. Patient identification*Globally, 998 diagnosed APDS patients of all ages had been identified by year-end, including 274 patients in the U.S. and 382 in core markets outside of the U.S. The number of U.S. patients diagnosed with APDS that we have identified increased by 40 in 2025 compared to an increase of 18 in 2024. Of these identified patients in the U.S., 181 patients are 12 years of age or older and currently eligible for treatment with Joenja® under the approved label, while 52 are between 4 and 11 years of age.

As of year-end 2025, there are 175 APDS patients in either a leniolisib Expanded Access Program (compassionate use), an ongoing clinical study, or a paid access program. Many of these patients may transition to commercial therapy following regulatory approvals in their respective markets.

*d. APDS patient diagnostic support*

Launched on March 2, 2021, navigateAPDS (U.S./Canada) is our sponsored program that provides no-charge, panel-based genetic testing and third-party genetic counseling to eligible individuals with suspected primary immunodeficiency, as well as familial variant testing for blood relatives after a positive molecular diagnosis. The program is designed to reduce barriers to definitive diagnosis for APDS by combining broad immunodeficiency gene panels, expert pre- and post-test counseling, and family cascade testing. In Europe, we continue to intensify patient-finding through collaborations with immunology centers of excellence and national networks focused on rare immune disorders.

Earlier and accurate diagnosis can help clinicians distinguish APDS from other immunodeficiencies and immune dysregulation syndromes and inform appropriate management, including consideration of Joenja® where approved. By supporting family cascade testing, the program also helps identify previously undiagnosed relatives who may be affected.

We continued to advance multiple initiatives in 2025 to support earlier and more accurate diagnosis of APDS. Alongside our sponsored genetic testing program in the U.S. and Canada, we expanded collaborations with genetic testing companies, clinicians, and patient communities to reduce barriers to testing and increase appropriate family cascade evaluation. As APDS is an inherited condition, we believe that many of the more than 270 identified U.S. patients may have undiagnosed relatives, and as such family cascade testing is being offered to help identify related individuals who may also be affected.

*e. VUS patient reclassification and APDS prevalence*

APDS diagnosis requires integration of clinical presentation, immune function, and genetic testing, with a pathogenic or likely pathogenic, or P/LP, variant in the *PIK3CD* or *PIK3R1* gene needed to confirm the diagnosis. However, many patients with clinical features consistent with APDS, receive a VUS genetic finding, where the disease relevance is not yet known.

Data from our navigateAPDS program show that VUSs in *PIK3CD/PIK3R1* occur roughly four times more frequently than currently known P/LP variants. This underscores both the scale of diagnostic uncertainty and the potential impact of resolving VUSs on the number of patients who may eventually receive a confirmed diagnosis.

As of December 31, 2025, approximately 1,800 individuals in the U.S. are known to carry a VUS in one of the APDS implicated genes. When a VUS is reclassified as P/LP, clinicians can establish a definitive APDS diagnosis, allowing patients to be considered for Joenja® treatment if they meet the approved label criteria.

In June 2025, leading peer-reviewed journal *Cell* published results from a high-throughput functional screening study conducted by Columbia University, evaluating portions of *PIK3CD* and *PIK3R1*. The research demonstrated that numerous previously uncharacterized variants — including existing VUSs — exhibited

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PI3Kδ hyperactivity, a hallmark of APDS biology. Functional data of this type is recognized by expert bodies such as American College of Medical Genetics and Genomics and ClinGen as one component that can contribute to variant classification, alongside clinical, genetic, and computational evidence.

Based on evaluation of the data from this study by genetic testing laboratories, additional complementary evidence will be required to enable variant interpretation by genetic testing laboratories. We are planning new experiments to generate the data needed for genetic testing laboratories to evaluate VUSs identified in patients who have undergone genetic testing for APDS or other immunodeficiencies. We expect to provide an estimate of how many of these patients may be diagnosed with APDS following completion of these experiments. To generate this data, we have initiated a broader collaboration with Columbia University to extend functional testing to the remaining regions of both APDS genes using next-generation screening technologies. This expanded effort is designed to evaluate many more VUSs than the initial study, enabling a more complete understanding of the mutational landscape associated with PI3Kδ hyperactivation.

A second conclusion of the research conducted by Columbia University was that APDS may have a broader clinical presentation and significantly higher prevalence than previously assumed, an important consideration for long-term market growth. Further research is on-going on this topic.

We remain committed to supporting the full diagnostic journey for individuals and families affected by APDS and will continue to work with laboratories, clinicians, and academic partners to generate and interpret the evidence needed to resolve both novel variants and existing VUS.

*f. Operational performance* Operational readiness remained a key driver of Joenja® performance during 2025. Supply remained uninterrupted across all commercial markets.

***C) Joenja® manufacturing*** Pursuant to our agreement with Novartis relating to Joenja®, we have agreed to manufacture both the drug substance as well as the drug product via our own Contract Manufacturing Organizations, or CMOs. For the drug substance, Ardena Holding N.V., or Ardena, has been chosen as the CMO. For the film coated tablets, Skyepharma Production SAS, or Skyepharma, has been chosen as the CMO and a second supplier is being qualified. The 70mg film coated tablet manufactured by Skyepharma have been launched for patients 12 years of age and older. In addition, two pediatric formulations are also being developed; the first, lower strengths tablets that also will be manufactured at Skyepharma, and the second, film coated granules that are being developed by Almac Group.

As we continue to expand the capacity and range of products, it is uncertain whether and to what extent we will be able to enter into manufacturing partnerships or agreements on a timely basis and on acceptable terms. We have established a contract and supplier relationship management process to facilitate the timely onboarding of new contractors or the expansion of contracts at current contractors. Even if a partnership or agreement has been concluded, the possibility exists that these partners will fail to live up to the agreements made with them or that we are unable to maintain such agreements. A failure to develop and/or sufficiently contract additional manufacturing capacity on a timely basis could have significant consequences for our business, to our financial position, results of operations, prospects and as result may also have a negative effect on the market price of our shares.

***D) Access and regulatory progress***

In 2025, we made significant progress advancing global access to Joenja® (leniolisib) for people living with APDS.

*a. United States*

Joenja® is approved in the United states as the first and only targeted treatment for APDS patients 12 years of age and older. During 2025, we continued to expand patient identification, supporting increasing uptake in the U.S.

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*b. United Kingdom* On September 25, 2024, the MHRA granted marketing authorization for Joenja® for the treatment of APDS in adult and adolescent patients 12 years of age and older. Joenja® was the first new medicine approved by the MHRA via the International Recognition Procedure, or IRP, using the FDA as reference regulator. We launched Joenja® in the U.K. in April 2025.

i. England & Wales

On April 23, 2025, the NICE issued positive final guidance recommending Joenja® for routine reimbursement and use within the NHS in England and Wales for the treatment of APDS in adult and pediatric patients aged 12 years and older. This followed NICE's positive final draft guidance published on March 13, 2025.

In England, Joenja® is funded through the Innovative Medicines Fund, enabling immediate access for eligible patients, while in Wales it is funded through the NHS in designated specialist centers.

ii. Scotland

In Scotland, on December 8, 2025, the SMC published its initial ultra-orphan assessment for Joenja®. From March 5, 2026, Joenja® can be prescribed within the ultra-orphan pathway while further evidence on its effectiveness is generated over a period of up to three years. The first patient in Scotland is now receiving treatment, with data collection ongoing to support a future reassessment and a decision on routine use within NHS Scotland.

*c. Australia*

In March 2025, we received positive feedback from the Australian Advisory Committee on Medicines, and we received approval for Joenja® from the TGA for the treatment of APDS in adult and adolescent patients 12 years of age and older.

In July 2025, the Australian Pharmaceutical Benefits Advisory Committee recommended the listing of leniolisib on the Pharmaceutical Benefits Scheme and reimbursement negotiations are ongoing.

*d. Israel* In April 2024, the Israeli Ministry of Health granted marketing authorization for Joenja® for the treatment of APDS in adult and pediatric patients 12 years of age and older.

We continue to work with Kamada Ltd. as our commercial partner for Joenja® in Israel; leniolisib is listed on Kamada's product portfolio for adults and adolescents ≥12 years (weight-based per local label). Discussions with health authorities on reimbursement have been progressing.

*e. Japan*

In March 2026, the Japanese Ministry of Health, Labour and Welfare, or MHLW, granted marketing authorization for Joenja® for the treatment of APDS in adult and pediatric patients aged 4 years and older, following a positive recommendation from the Japanese Pharmaceutical Affairs Council. Joenja® is the first approved treatment for APDS in Japan and first therapy approved anywhere globally for children aged 4 to 11.

Japan remains a strategically important market, supported by its advanced rare disease infrastructure and strong clinical engagement. The Japanese Pharmaceuticals and Medical Devices Agency reviewed the application under the Priority Review pathway, following Orphan Drug Designation granted by the MHLW in May 2023. In August 2023, the first patient was enrolled in a local Phase III clinical trial to support regulatory approval in Japan. An interim analysis completed in 2025 showed safety and efficacy findings consistent with the global Phase II/III program, supporting the regulatory submission, which was submitted in June 2025. Eligible patients from the clinical study will continue to receive leniolisib through an open-label extension period to further assess long-term safety and tolerability.

Under an agreement with Pharming, OrphanPacific, Inc. serves as the marketing authorization holder for Joenja® in Japan and, in collaboration with Pharming, is responsible for product supply and distribution. Commercial launch is expected following agreement with the MHLW on the National Health Insurance drug price.

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For more information our regulatory activities in other regions, please refer to "the Leniolisib for APDS: global regulatory filings in additional markets" within "the Pipeline review" section below.

*f. Named-patient and early-access programs* In countries where leniolisib is not yet commercially available, physicians can request access for eligible patients through named-patient or early-access routes, subject to local health authority regulations and approvals.

***E) Intellectual property and exclusivity*** Joenja® (leniolisib) is protected worldwide by the Novartis composition-of-matter patent family (e.g., U.S. Patent No. 8,653,092, European patent EP2590974B1, which provides patent protection for Joenja®, such as treatment of APDS in the United States and the European Union through July 2036). A six-month pediatric extension, if granted, could extend U.S. patent protection to January 2037.

In the United States, the patent term was adjusted by the USPTO at grant to account for regulatory review delays, and we have applied for a patent term extension following FDA approval of Joenja®. In the European Union, we intend to seek a Supplementary Protection Certificate following EU marketing authorization. Together, these adjustments and extensions are expected to support patent protection through July 2036 (or January 2037 with a pediatric extension).

In addition to patent protection, Joenja® benefits from regulatory exclusivity in Europe. Upon EU marketing authorization, Joenja® would be eligible for ten years of orphan medicinal product market exclusivity. Following successful completion of the agreed Pediatric Investigation Plan, this period may be extended by up to two additional years. We therefore anticipate that patent protection is expected to extend beyond the period of orphan market exclusivity in Europe, supporting long-term protection for Joenja®.

As of December 31, 2025, we have an exclusive license from Novartis to 157 granted patents related to leniolisib, of which three are U.S.-issued and eight are pending patent applications, including one pending patent application in the U.S.

**III. PIPELINE REVIEW**

In 2025, we continued to advance our high-value rare disease pipeline, progressing clinical programs designed to address serious and underserved immune and mitochondrial conditions. Our progress reflected disciplined execution across global development and regulatory pathways, strong scientific foundations, and sustained investment in areas of significant unmet medical need.

Across the portfolio, we worked to advance leniolisib beyond its approved indication in APDS. During the year, we supported global regulatory submissions for APDS in additional markets and progressed two Phase II proof-of-concept studies evaluating leniolisib in broader PIDs with immune dysregulation, including CVID. These studies build on the established mechanism of action and clinical experience in APDS and represent the next phase of development aimed at addressing substantially larger patient populations.

In parallel, we continued advancing napazimone (KL1333) in the pivotal FALCON study for mtDNA-driven PMD. Following the integration of Abliva AB, we progressed global site expansion and patient recruitment throughout 2025. The program builds on the positive interim futility analysis completed in 2024 and remains on track for a 2027 readout.

Together, these programs form the core of our high-value clinical-stage pipeline and position the Company for a series of important potential clinical and regulatory milestones in 2026, including anticipated regulatory decisions for APDS in key markets and topline results from the two Phase II leniolisib studies in PIDs with immune dysregulation.

 **1. Leniolisib for APDS: global regulatory filings in additional markets - expanding patient access to the first targeted therapy for APDS**

Joenja® (leniolisib) is the first and only targeted therapy approved for the treatment of APDS in patients 12 years of age and older. Its approval in multiple jurisdictions is supported by robust clinical data demonstrating

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meaningful improvements in lymphoproliferation and immunophenotype correction. During 2025, we advanced regulatory filings to expand access for patients across key regions.

***A) European Economic Area*** In May 2024, the European Medicines Agency's, or EMA's, Committee for Medicinal Products for Human Use, or CHMP, affirmed the positive clinical benefit and safety profile of leniolisib, consistent with the assessment provided by the EMA's Ad-hoc Expert Group and identified one outstanding chemistry, manufacturing and controls, or CMC, item related to the definition of regulatory starting materials for leniolisib's manufacturing process.

In 2025, the CHMP maintained this position and we completed all required manufacturing activities and quality controls and, within the extended deadline of January 2026, submitted a comprehensive response including supporting data to the EMA. On March 26, 2026, the CHMP adopted a positive opinion recommending marketing authorization for leniolisib in adult and pediatric patients aged 12 years and older. A final decision by the European Commission, or EC, on the marketing authorization for Joenja® (leniolisb) under exceptional circumstances is expected within approximately two months. If approved, Joenja® (leniolisib) would become the first approved treatment for APDS in the European Union. The centralized marketing authorization would be valid in all 27 European Union Member States, as well as Norway, Iceland and Liechtenstein.

Current status: Received CHMP positive opinion, awaiting EC approval decision in the second quarter of 2026.

***B) Canada***

Our regulatory pathway in Canada continued to progress in 2025:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A regulatory submission for APDS (12+) was filed in the third quarter of 2023.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In July 2024, we submitted a response to a Notice of Deficiency.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In January 2025, Health Canada issued a Notice of Non-Compliance requesting additional CMC data.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Health Canada granted us an extension to February 2026 to submit the required information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We submitted a response with additional CMC data to Health Canada at the end of January 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A decision on the regulatory submission is expected by mid-year 2026.

Current status: Review ongoing; response submitted and decision expected by mid-year 2026.

***C) Additional markets***

a. *Saudi Arabia*

We submitted an NDA to the Saudi Food & Drug Authority, or SFDA, in November 2024 for patients aged 12 years and older. The review is aligned with the SFDA reliance pathway, which leverages FDA decisions. A regulatory decision is expected following completion of the reliance-based assessment.

Current status: Review ongoing.

*b. South Korea* In May 2024, South Korea granted Orphan Drug Designation for leniolisib in APDS. In March 2025, we submitted an NDA for patients aged 12 years and older to the Ministry of Food and Drug Safety.

Current status: Review ongoing.

**2. Leniolisib for APDS: Pediatric label expansion - driving toward earlier intervention for children living with APDS**We are committed to ensuring that children with APDS have equitable access to targeted treatment as early as possible in their disease journey. In 2025, substantial progress was made across our two pediatric clinical development programs, covering children 4–11 years and 1–6 years of age.

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Our pediatric strategy builds on the robust efficacy and safety profile demonstrated in adolescents and adults, as well as regulatory recognition of the significant unmet medical need in younger APDS patients. Global regulatory authorities, including the EMA and MHRA, have already endorsed our Pediatric Investigation Plans, or PIPs, supporting the structured expansion of leniolisib into younger age groups.

***A) APDS in children 4 to 11 years of age*** *a. Clinical Development Progress*

In 2024, we completed a global Phase III study evaluating leniolisib in children aged 4 to 11 years of age with confirmed APDS, supporting the potential expansion into this younger patient population. Twenty-one patients were enrolled and completed the 12-week treatment period. The study applied a weight-based dosing strategy to ensure appropriate pediatric exposure and utilized endpoints consistent with the pivotal adolescent and adult program, enabling meaningful cross-study comparison.

The trial demonstrated improvements across the co-primary endpoints, including reduction in index lymph node size and an increase in the percentage of naïve B cells, reflecting modulation of the underlying immune dysregulation characteristic of APDS. Health-related quality of life measures were also assessed to capture broader functional outcomes in this pediatric population. The safety profile was consistent with prior experience; all treatment-emergent adverse events were mild to moderate in severity, and no drug-related serious adverse events were observed.

Collectively, we believe these data support the clinical rationale for extending leniolisib to younger APDS patients and formed the basis for regulatory submissions.

*b. Regulatory Progress*

i. United States

In July 2025, we submitted an sNDA to the FDA seeking approval of Joenja® (leniolisib) for children aged 4 to 11 years of age. The application was accepted for review in October 2025 and granted Priority Review designation, reflecting the significant unmet need in the pediatric APDS population.

On January 30, 2026, the FDA issued a Complete Response Letter, or CRL. The CRL requested additional pediatric pharmacokinetic, or PK, data to further support dosing in lower-weight pediatric patients, as well as clarification related to an analytical method used in production batch testing. The FDA did not identify any new safety concerns, and the currently approved indication for patients aged 12 years and older remains unaffected.

We have engaged with the FDA to address the clinical pharmacology and batch testing methodology issues outlined in the letter. We held a Type A meeting with the FDA on March 26, 2026, to discuss the FDA's feedback and align on a path forward for resubmission. We expect to receive written feedback from the FDA in the form of meeting minutes, which will inform our next steps, including the timing of a resubmission.

Current status: Type A meeting held on March 26, 2026, awaiting written feedback in form of meeting minutes.

ii. Japan

In March 2026, the MHLW granted marketing authorization for Joenja® (leniolisib) for the treatment of APDS in adult and pediatric patients aged 4 years and older. The approval of Joenja® is the first anywhere globally for children aged 4 to 11.

Current status: Approved in March 2026

***B) APDS in children 1 to 6 years of age***

a. *Clinical Development Progress* Children aged 1-6 years represent the youngest segment of the pediatric APDS population and are often those who stand to benefit most from early intervention. In 2025:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Enrollment in the global Phase III trial was completed in April 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• This trial utilizes a bespoke pediatric granulated formulation of leniolisib designed to ensure age-appropriate administration and optimized tolerability.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The trial evaluates safety, tolerability, and efficacy in 15 patients, using the same core endpoints leveraged in earlier studies:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Lymphoproliferation measured by imaging

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Immunophenotype correction through naïve B-cell assessment; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Secondary measures including patient- and caregiver-reported quality-of-life metrics

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ As in the 4–11 cohort, this trial includes an open-label extension period enabling continued treatment for a minimum of one additional year following the initial 12-week assessment period.

Topline results from this trial are anticipated following database lock and analysis beyond 2025.

Current status: Pending supportive results, we intend to pursue regulatory approvals for this younger age group.

*b. Regulatory Foundations & Global Framework*

Both pediatric programs are conducted under EMA- and MHRA-approved Pediatric Investigation Plans, enabling harmonized global development aligned with regulatory expectations for clinical trial design, dosing, safety monitoring, and benefit-risk assessment.

The unified design across the 1–6 and 4–11 studies is intended to ensure that pediatric data packages are scientifically coherent and directly comparable to the adolescent/adult evidence base. The pediatric expansion also supports our broader mission to ensure equitable access to targeted therapy across all age groups living with APDS.

**3. Leniolisib for primary immunodeficiencies with immune dysregulation (investigational) - expanding therapeutic potential to broader immune dysregulation disorders**

In 2025, we advanced two Phase II proof-of-concept studies evaluating leniolisib beyond APDS:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)Genetically identifiable PIDs with immune dysregulation linked to altered PI3Kδ signaling, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)CVID with immune dysregulation identified independently of genetics.

Both studies address substantially larger patient populations than APDS and build on the validated PI3Kδ mechanism, a key regulator of immune cell activation and survival. The studies are designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and exploratory clinical efficacy to inform potential Phase III development beyond APDS. Topline results for both studies are anticipated in the second half of 2026.

Leniolisib has demonstrated clinically meaningful efficacy and a favorable safety and tolerability profile in APDS, with sustained improvements in lymphoproliferation and disease-relevant immunologic biomarkers. We believe the consistent modulation of the PI3Kδ pathway provides a strong scientific rationale for investigating leniolisib in broader primary immunodeficiencies characterized by immune dysregulation.

Expanding into these high-unmet-need immune dysregulation populations represents a central pillar of our pipeline strategy and is supported by regulatory recognition, including Fast Track designation for PI3Kδ-linked PIDs and Orphan Drug Designation for CVID.

***A) Genetically identifiable PIDs with immune dysregulation linked to altered PI3Kδ signaling***

a. *Rationale and patient population* Building on APDS biology and experience, leniolisib is being evaluated as a potential treatment in PIDs where enhanced PI3Kδ pathway signaling drives immune dysregulation. Target conditions include ALPS-FAS, CTLA4 haploinsufficiency, NFKB1 haploinsufficiency, and PTEN deficiency, which often present with lymphoproliferation, cytopenias, and/or organ-specific autoimmune/inflammatory manifestations.

*b. Epidemiology context* 

The combined targeted PID population for this study is estimated at approximately 7.5 patients per million,

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compared with approximately 1.5 patients per million for APDS, reinforcing the opportunity to address larger patient groups if the benefit-risk profile is supportive.

*c. Study design*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Type: Phase II, single-arm, open-label, dose-range–finding study (approximately 12 patients).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Key eligibility: one of the following genetic mutations linked to PI3Kd signaling: SOCS1, PTEN, CTLA4, NFKB1-GOF, or FAS (germline or somatic) or RALD (somatic NRAS or KRAS) plus at least one clinical symptom of: Cytopenia, splenomegaly, lymphadenopathy or GLILD.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Objectives: Safety/tolerability, PK/PD, exploratory clinical efficacy; to inform a potential Phase III program.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Site & leadership: NIAID/NIH; PI: Gulbu Uzel, M.D.; Co-I: V. Koneti Rao, M.D., FRCPA (ALPS Clinic).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Milestones:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ First patient dosed October 29, 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ FDA Fast Track designation granted February 2025 enabling enhanced U.S. regulatory interaction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Timing: Top-line results expected in the second half of 2026.

***B) CVID with immune dysregulation***

*a. Rationale and patient population*

CVID is the largest symptomatic PID group; an estimated ~50% of patients exhibit immune-dysregulation manifestations - such as splenomegaly/lymphadenopathy, autoimmune cytopenias, interstitial lung disease, or ILD, and enteropathy - that are associated with higher morbidity and mortality than primarily infectious phenotypes. The unmet need for these patients is high with an 11 times higher risk of early death than CVID patients who do not have immune dysregulation and there are no approved or effective treatments.

Many patients display APDS-like clinical and immunologic features, supporting shared pathophysiology and the rationale for PI3Kδ modulation with leniolisib.

*b. Epidemiology context* The targeted CVID with immune dysregulation prevalence is approximately 39 per million, representing a substantially larger opportunity to address unmet need if clinical benefit-risk is demonstrated.

*c. Regulatory engagement and study initiation*

We engaged with the FDA and EMA prior to launch and initiated the Phase II study in March 2025.

*d. Study design*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Type: Phase II, single-arm, open-label, dose-range–finding, multi-center study (approximately 20 patients, ≥12 years).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Key eligibility: CVID diagnosis with lymphoproliferation and ≥1 additional immune-dysregulation manifestation (e.g., ILD, autoimmune cytopenias, enteropathy).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Objectives: Safety/tolerability, PK/PD, exploratory clinical efficacy to guide Phase III.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Sites & leadership: Lead Investigator: Jocelyn Farmer, M.D./Ph.D. (Lahey Hospital & Medical Center / Beth Israel Lahey Health), with additional sites in the U.S., U.K., and EU.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Milestones: First patient dosed in March 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Timing: Top-line results expected in the second half of 2026.

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 **4. Napazimone (KL1333) for primary mitochondrial disease (investigational) - advancing a pivotal program in mtDNA-driven PMD**In 2025, following the completion of the acquisition of Abliva AB, KL1333 (now napazimone) became a core component of our rare disease pipeline. The transaction, initiated in late 2024 and concluded with our full ownership in June 2025, strengthened our presence in mtDNA-driven PMD and added a late-stage clinical asset with the potential to address significant unmet medical need.

During 2025, we advanced the pivotal FALCON study, a global, randomized, placebo-controlled trial, designed to support regulatory approval, evaluating napazimone (KL1333) in adults with genetically confirmed PMD experiencing severe fatigue and myopathy. The study builds on a positive blinded interim futility analysis completed in 2024, prior to the acquisition, in which both FDA-agreed alternative primary endpoints passed futility and the Data Monitoring Committee recommended continuation. In 2025, we initiated Wave 2 of the study, expanded global site activation, and continued patient recruitment, maintaining momentum toward the anticipated late 2027 readout.

Napazimone (KL1333) is an oral modulator of NAD⁺/NADH designed to address the impaired cellular energy production characteristic of mtDNA-driven multisystemic PMD. The program targets clinically meaningful, patient-prioritized manifestations of disease, including myopathy and fatigue that significantly affect daily functioning and quality of life.

***A) Study design and endpoints***FALCON is a pivotal study (3:2 napazimone vs placebo) enrolling approximately 180 adults for 48 weeks of twice-daily dosing (total daily dose 50–100 mg). The trial includes two alternative primary efficacy endpoints:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i.PROMIS® Fatigue Mitochondrial Disease Short Form; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii.30-second Sit-to-Stand test

of which one must be positive to support a potential marketing application.

A positive blinded interim futility analysis conducted following the first wave of recruitment confirmed acceptable safety to date and demonstrated that both primary endpoints passed futility, indicating potential for benefit at final analysis and supporting progression to the second recruitment wave.

***B) Regulatory designations and addressable population***Napazimone (KL1333) has received U.S. Fast Track designation for PMD and Orphan Drug Designation in both the U.S. and EU. Across the U.S., EU4 (France, Germany, Italy, Spain), and the U.K., more than 30,000 diagnosed patients with mtDNA-driven PMD are potentially addressable if development is successful and regulatory approvals are obtained.

***C) Next milestones***Pivotal read-out from FALCON is anticipated in late 2027. Subject to clinical outcomes and health authority interactions, regulatory submissions could follow thereafter.

***D) Intellectual property and exclusivity*** As of December 31, 2025, we solely owned 50 granted patents related to napazimone (KL1333) and the treatment of mitochondrial diseases, of which 3 are U.S.-issued patents; in addition, 6 patent applications are pending. We also have an exclusive license from YungJin Pharm Co., Ltd., or Yungjin Pharmaceutical, to 34 granted patents related to KL1333, of which 2 are U.S.-issued and to 1 pending patent application. We co-owned with Yungjin Pharmaceutical 2 granted patents and 12 pending patent applications related to the use of KL1333 for the treatment of mitochondrial diseases.

Commercially or strategically important non-U.S. jurisdictions in which we hold issued or pending patent applications include (in addition to Europe): the United Kingdom, India, South Korea, China, Japan, Canada, Israel, Australia and New Zealand.

***E) Summary***

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Indication: mtDNA-driven PMD (adults) — severe fatigue & myopathy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Mechanism: NAD⁺/NADH modulation (oral).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Trial: FALCON pivotal trial (randomized, placebo controlled; approximately 180 patients; 48 weeks). Continued global site activation and enrollment-controlled; approximately 180 patients; 48 weeks).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Endpoints: PROMIS® Fatigue (PMD Short Form); 30-sec Sit-to-Stand (alternative primaries).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Interim analysis: interim futility passed on both endpoints.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Designations: Fast Track (U.S.); Orphan Drug Designation (U.S./EU).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Population: >30,000 diagnosed mtDNA-PMD patients potentially addressable across U.S., EU4, U.K. (if approved).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Next milestone: Readout expected late 2027.

**IV. COMPETITION**

The life sciences industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. We face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions. Any product candidates that we successfully develop and commercialize will compete with existing products and new products that may become available in the future. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and patient registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs.

Companies that complete clinical trials, obtain required health authority approvals and commence commercial sale of their drugs before their competitors may achieve a significant competitive advantage, and our commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop and commercialize. Our competitors may also obtain FDA, European Commission, or other regulatory approval for their products more rapidly than we obtain approval, which could result in our competitors establishing a strong market position for either the product or a specific indication before we are able to enter the market. Drugs resulting from our research and development efforts or from our joint efforts with collaboration partners therefore may not be commercially competitive with our competitors' existing products or products under development.

We anticipate that we will face increasing competition as new products and therapies enter the market and advanced technologies become available in both the HAE and APDS space and relating to upcoming pipeline projects. We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, delivery, patient convenience, price and the availability of reimbursement from government and other third-party payors.

For additional details on competition in the HAE market see "Item 3-D. Risk Factors" of this Annual Report.

We consider several companies to be our current and future competitors in the HAE space, including, but not limited to, BioCryst, BioMarin, CSL Behring, Intellia, Ionis, Kalvista, Pharvaris and Takeda. To the extent these companies develop treatments that are more efficacious, less expensive, more convenient or produce fewer side effects, our market opportunity would be reduced.

Joenja® is currently the only approved therapy for APDS and selective PI3Kδ inhibition remains the defining approach within this therapeutic category. Based on public information, we are not aware of any active clinical development programs in APDS.

**V. INTELLECTUAL PROPERTY**

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 **1. Patents** 

Patents, know-how, trade secrets and other intellectual property rights are important to the success of our business. We use patents and licensing to protect our products and technology and are careful to develop products that don't infringe on the intellectual property rights of third parties. The patent positions of pharmaceutical companies can be uncertain and may involve complex legal and factual questions.

It is uncertain whether pending patent applications will be successful, that these patents will afford adequate protection and that existing and future granted patents will not be challenged. Failure to obtain patents may result in expensive, protracted and possible futile proceedings to defend our proprietary rights. The success of our Company also depends, in part, on the ability of our licensors to obtain, maintain and enforce their intellectual property rights to the extent required for us to develop and commercialize our products.

We actively seek to protect the intellectual property and proprietary technology that we believe is important to our business, including seeking, maintaining, enforcing and defending patent rights and protecting know-how for our technology platform and related therapeutics and processes, whether developed internally or licensed to or from third parties. Our success will depend on our ability to obtain and maintain patent and other protections including data/market exclusivity for our product candidates and platform technology, preserve the confidentiality of our know-how and operate without infringing the valid and enforceable patents and proprietary rights of third parties. See "Item 3 – D. Risk Factors – Risks Related to Intellectual Property" of this Annual Report.

Our policy is to seek to protect our proprietary position early, generally by filing an initial priority filing in the European Patent Office. This is often followed by the filing of an international patent application under the Patent Cooperation Treaty, or PCT, claiming priority from the initial application(s) and then filing regional and national applications for patent grant in territories including, for example, the United States and Europe. In each case, we determine the strategy and territories required after discussion with our patent attorneys, and, where applicable, collaboration partners so that we obtain relevant coverage in territories that are commercially important to our technologies and product candidates. With respect to our product candidates and related methods that we intend to develop and commercialize in the normal course of business, we will seek patent protection covering composition of matter, formulation, the indicated use, and/or the method of administration. We may also pursue patent protection with respect to manufacturing and drug development processes when possible. We intend to additionally rely on data exclusivity, market exclusivity, other regulatory exclusivities and patent term extensions when available. We also rely on trade secrets and know-how relating to our underlying platform technology and product candidates. In each case, we seek to balance the value of patent protection against the advantage of keeping know-how confidential.

Issued patents can provide exclusivity on claimed subject matter for varying periods of time, typically starting on the date of patent grant and expiring at the end of the legal term of a patent in the country in which it is granted, subject to term extensions, adjustments and any disclaimers of term. Provisional protection may be available for issue patents from the date of publication of the underlying application, depending on the relevant jurisdiction. In general, patents provide exclusionary rights for 20 years from the filing date of a non-provisional patent application in a particular country, or for a PCT international patent application, from the international filing date, assuming all maintenance fees are paid, and subject to term extensions, adjustments and any disclaimers of term. In some instances, patent terms may be increased or decreased, depending on the laws and regulations of the country or jurisdiction that grants the patent. In the United States, a patent term may be shortened if a patent is terminally disclaimed over another patent or as a result of delays in patent prosecution by the patentee. A U.S. patent's term may be lengthened by a patent term adjustment which compensates a patentee for administrative delays by the USPTO in granting a patent. The patent term of a European patent is 20 years from its filing date, which is not subject to patent term adjustments in the same way as U.S. patents. In some cases, when a priority filing is made in a certain jurisdiction, the priority year can be added to the patent term of 20 years from the filing for a patent granted in that jurisdiction; the patent term may thus be up to 21 years from the priority date, subject to term extensions, adjustments and any disclaimers of term.

The level of protection afforded by a patent may vary and depends upon many factors, including the type of patent, the scope of its claim coverage, claim interpretation and patent law in the country or region that granted

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the patent, the validity and enforceability of the patent under such laws, and the availability of legal remedies in each particular country.

In certain regions or countries, regulatory-related patent extensions may be available to extend the term of a patent that claims a regulatorily approved product or method. Regulatory-based patent term extensions allow patentee to recapture a portion of patent term effectively lost as a result of the regulatory review period for a product candidate. The term of a United States patent that covers an FDA-approved drug or biologic, for example, may be eligible for patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, permits a patent term extension of up to five years beyond the expiration of the patent. Patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended. Similar provisions are available in Europe, Japan and other jurisdictions to extend the term of a patent that covers an approved drug, such as Supplementary Protection Certificates, or SPCs, in Europe. In particular, a maximum of five years of supplementary protection can be achieved in Europe for an active ingredient or combinations of active ingredients of a medicinal product protected by a basic patent, if a valid marketing authorization exists (which must be the first authorization to place the product on the market as a medicinal product) and if the product has not already been the subject of supplementary protection. A SPC in Europe may be extended for an additional six months based on an EMA-approved Pediatric Investigation Plan, where applicable. In the future, if and when our additional products receive FDA approval, we expect to apply for regulatory patent term extensions on patents covering those products. We anticipate that some of our issued patents may be eligible for patent term extensions in certain jurisdictions based on an approved product or method, but such extensions may not be available and therefore its commercial monopoly may be restricted solely to patent term, subject to term adjustments and disclaimers of term.

Commercially or strategically important non-U.S. jurisdictions in which we hold issued or pending patent applications include (in addition to Europe): the United Kingdom, India, South Korea, China, Japan, Canada, Israel, Australia and New Zealand.

**2. Trademarks** 

We currently have registered trademarks in the EU, the United States and key international markets we intend to focus on for our Company name "Pharming" with the associated logo, "RUCONEST®" with its associated logo, as well as for "Joenja®" and its associated logo. We have obtained trademark protection for other marks, including ones for patient support services associated with our products. With the assistance of outside counsel we regularly assess which marks we should register and where, and we have effective systems to ensure that renewals are timely filed. We also maintain watch services and ensure that our marks are not being infringed internationally.

**VI. GOVERNMENT REGULATION AND PRODUCT APPROVAL**

**1. United States**

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and non-U.S. statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the drug development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA's refusal to approve a pending New Drug Application, or NDA, or Biologics License Application, or BLA, withdrawal of an approval, imposition of a clinical hold, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

The process required by the FDA before a drug may be marketed in the United States generally involves:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA's good laboratory practice, or GLP, regulations;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• submission to the FDA of an IND, which must become effective before human clinical trials may begin;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• performance of adequate and well-controlled clinical trials, in accordance with good clinical practice, or GCP, requirements to establish the safety and efficacy of the proposed drug for each indication;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• payment of user fees, if applicable;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• submission to the FDA of a registration filing (i.e., NDA or BLA);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• satisfactory completion of an FDA inspection of selected clinical sites to assure compliance with GCPs and the integrity of the clinical data;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• satisfactory completion of an FDA advisory committee review; if applicable, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• FDA review and approval of the registration filing.

***A) Preclinical Studies*** Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy. An IND Sponsor must submit the results of the nonclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some nonclinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND Sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

***B) Clinical Trials*** Clinical trials involve the administration of the investigational new drug or biologic to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must continue to oversee the clinical trial while it is being conducted. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined. In Phase I, the drug or biologic is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an initial indication of its effectiveness. In Phase II, the drug or biologic is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. In Phase III, the drug or biologic is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the safety and efficacy of the product for registration approval, to establish the overall risk-benefit profile of the product and to provide adequate information for the labeling of the product.

Progress reports detailing the results of the clinical trials must be submitted, at least annually, to the FDA, and more frequently if SAEs occur. Phase I, Phase II and Phase III clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the Sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's requirements, or if the drug has been associated with unexpected serious harm to patients.

Drugs or biologics used in clinical trials must be manufactured in accordance with cGMP.

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During the development of a product, the FDA provides the opportunity for dialogue and guidance on the development program. There are several categories of formal meetings which are dependent upon the stage of development, and the product type. Advice from the FDA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical studies. Such advice is not legally binding with regard to any future registration applications of the product concerned but is helpful in product development and understanding FDA expectations.

***C) Marketing Approval*** Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product's chemistry, manufacture and controls, and proposed labeling, among other things, are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA or BLA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act, or PDUFA, the FDA has a goal of ten months from the date of "filing" of a standard NDA or BLA for a new molecular entity or biological entity, respectively, and to review and act on the submission of such. This review typically takes twelve months from the date the NDA or BLA is submitted to the FDA because the FDA has approximately two months to make a "filing" decision. A PDUFA goal date does not ensure that the FDA will make a decision on the application by that date, and does not guarantee a particular decision (an approval vs. issuance of a complete response letter detailing why the application cannot be approved in its current form).

The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools. A REMS plan can require significant additional expense and can reduce sales.

The FDA conducts a preliminary filing review of all NDAs or BLAs within the first 60 days after submission, before accepting them, to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA or BLA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing, which could take significant time and expense. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA or BLA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product's continued safety, quality and purity.

The FDA may refer an application to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving an NDA or BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA or BLA, the FDA will typically inspect one or more clinical trial sites to assure compliance with GCP requirements. Significant GCP findings could result in additional delay or expense, or in an application not being approved.

The testing and data acquisition process for an approvable NDA or BLA requires substantial time, effort and financial resources, and takes several years to complete. Data obtained from preclinical and clinical testing are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval of an NDA or BLA on a timely basis, or at all.

After evaluating the NDA or BLA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, if the product is not approved, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final

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approval of the NDA or BLA and may require additional clinical or preclinical testing in order for FDA to reconsider the application. The process of responding to a complete response letter can lead to significant delays and expense. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA's satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase IV clinical trials, be conducted to further assess a drug's safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and additional FDA review and approval procedures.

***D) Orphan Drug Designation*** Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals, there is no reasonable expectation that sales of the drug in the United States will be sufficient to offset the costs of developing and making the drug available in the United States. Orphan drug designation must be requested before submitting an NDA or BLA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. If the FDA approves a Sponsor's marketing application for a designated orphan drug for use in the rare disease or condition for which it was designated, the Sponsor is eligible for a seven-year period of marketing exclusivity, during which the FDA may not approve another Sponsor's marketing application for a drug with the same active moiety and intended for the same use or indication as the approved orphan drug, except in limited circumstances, such as if a subsequent Sponsor demonstrates its product is clinically superior. During a Sponsor's orphan drug exclusivity period, competitors, however, may receive approval for drugs with different active moieties for the same indication as the approved orphan drug, or for drugs with the same active moiety as the approved orphan drug, but for different indications. Orphan drug exclusivity could block the approval of one of our products for seven years if a competitor obtains approval for a drug with the same active moiety intended for the same indication, unless we are able to demonstrate that grounds for withdrawal of the orphan drug exclusivity exist, or that our product is clinically superior. Further, if a designated orphan drug receives marketing approval for an indication broader than the rare disease or condition for which it received orphan drug designation, it may not be entitled to exclusivity.

***E) Pediatric Development*** Under the Pediatric Research Equity Act, certain NDAs, BLAs or supplements to an NDA or BLA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation.

***F) Data Exclusivity*** In the U.S., applications for generic small molecule medicinal products may not need to include the results of preclinical and clinical trials, but instead can refer to the data included in the marketing authorization of a reference product for which regulatory data exclusivity has expired.

In the U.S., the Abbreviated New Drug Application, or ANDA, contains data which is submitted to FDA for the review and potential approval of a small molecule generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.

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***G) Post-approval Requirements*** Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, changes to the approved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and in many cases prior FDA review and approval. There also are continuing annual user fee requirements for marketed products and the establishments at which such products are manufactured, as well as application fees for supplemental applications with clinical data. Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, including a boxed warning, require that post-approval studies, including Phase IV clinical trials, be conducted to further assess a drug's safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. In addition, manufacturers and other entities involved in the manufacture and distribution of approved drugs or biologics are subject to periodic unannounced inspections by the FDA for compliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require adherence to strict requirements in manufacturing, including investigation and correction of any deviations from cGMP, and impose numerous reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• fines, warning letters or holds on post-approval clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• refusal of the FDA to approve pending NDAs, BLAs or supplements to approved NDAs, BLAs, or suspension or revocation of product approvals;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• product seizure or detention, or refusal to permit the import or export of products; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• injunctions or the imposition of civil or criminal penalties.

The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs or biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label, although physicians, in the practice of medicine, may prescribe approved products for unapproved indications. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

***H) Federal and State Fraud and Abuse, Data Privacy and Security, and Transparency Laws and Regulations*** In addition to FDA restrictions on marketing of pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry. These laws may impact, among other things, our current and future business operations, including our clinical research activities, and sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare

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providers and other parties through which we market, sell and distribute RUCONEST® and other products for which we obtain marketing approval. These laws include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including, without limitation, those laws described below.

The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term "remuneration" has been broadly interpreted to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exemptions and regulatory safe harbors protecting some common activities from prosecution, the exemptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Several courts have interpreted the statute's intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated.

A person or entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act or the civil monetary penalties statute, which imposes penalties against any person who is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.

Federal false claims laws, including the federal civil False Claims Act, prohibits any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes "any request or demand" for money or property presented to the U.S. government. Pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Additionally, pharmaceutical and other companies also have been prosecuted for causing false claims to be submitted because of the companies' marketing of products for unapproved, and thus non-reimbursable, uses.

The HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Also, many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, imposes specified requirements on certain types of individuals and entities, including covered entities (health plans, health clearinghouses, and certain healthcare providers) and their business associates and their subcontractors relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA's security standards directly applicable to "business associates", defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney's fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain

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circumstances, many of which are not pre-empted by HIPAA, differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with specific exceptions) to report annually to the CMS, information related to payments or other transfers of value made to physicians and other healthcare professionals (such as physicians assistants and nurse practitioners) as defined by such law, teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS, as well as ownership and investment interests held by the physicians and their immediate family members.

We may also be subject to state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, as well as state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Additionally, certain state and local laws require the registration of pharmaceutical sales representatives.

Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

***I) The FCPA, Dutch Anti- Bribery Laws and Other Laws*** The FCPA prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the Company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts.

Our operations are also subject to non-U.S. anti-corruption laws such as Dutch anti-bribery laws as contained in the Dutch Criminal Code (Wetboek van Strafrecht). These laws generally prohibit companies and persons (including us and our employees) and intermediaries from offering, providing, requesting or accepting, directly or indirectly, a gift promise or service, or anything else of value, to or from domestic or foreign government officials or to or from other persons employed or acting as an agent in relation to an act or omission to be committed or having been committed in the official's office or, as it concerns other persons employed or agents, in violation of the other person's duty.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the Netherlands and the United States and authorities in the EU, including, for example, applicable export control regulations, trade and economic sanctions and embargoes on certain countries, persons, groups, entities, projects or activities, anti-money laundering laws, import and customs requirements and currency exchange regulations, collectively referred to as trade control laws.

Failure to comply with the FCPA, Dutch anti-bribery laws and other anti-corruption laws and trade control laws could subject us and others involved to criminal and civil penalties, disgorgement and other sanctions and

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remedial measures, and legal expenses.

**2. European Union**

The process required by the EMA and EC before a medicinal product may be marketed, is similar to that described for the FDA, and it generally involves:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• completion of preclinical laboratory tests, animal studies and formulation studies in compliance with good laboratory practice, or GLP;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• CTA submissions, which must be approved by each Member State concerned before human clinical trials may begin;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• performance of adequate and well-controlled clinical trials, in accordance with good clinical practice, or GCP, requirements to establish the efficacy of the proposed drug for each indication;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• submission of an MAA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• satisfactory completion of an inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with GMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• satisfactory completion of an inspection of selected clinical sites to assure compliance with GCP and the integrity of the clinical data;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• EMA evaluation and CHMP opinion (and a supporting Committee for Advanced Therapies (CAT)

opinion for ATMPs) on the MAA; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• granting of the Marketing Authorization, or MA, by the EC based on the CHMP opinion.

Additionally, medicinal products, including advanced therapy medicinal products, or ATMPs, are subject to extensive pre- and post-market regulation by regulatory authorities at both the EU and national levels. ATMPs comprise gene therapy products, somatic-cell therapy products and tissue engineered products. Tissue engineered products are engineered cells and tissues (i.e., cells/tissues that have undergone substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved) that are presented has having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. RUCONEST® is regulated as an ATMP in the EU.

There is, furthermore, legislation at an EU level relating to the standards of quality and safety for the collection and testing of substances of human origin, blood and blood components for use in human cell-based therapies, which is applicable to the manufacturing of our human blood and/or cell based products. There is national legislation in various EU Member States, which may be more restrictive than the EU legislation. Differing national requirements of the EU Member States may make setting up compliant cross border supply chains challenging.

***A) Pharmaceutical and Preclinical Tests*** Applicants that submit full applications (i.e., they are not biosimilar or generic applications), must submit the results of pharmaceutical and pre-clinical tests. The pharmaceutical tests evaluate physico-chemical, biological and microbiological characteristics of the product. The pre-clinical tests consider the pharmacological and toxicological characteristics. These provide important information on the quality, safety and efficacy of the product. Such non-clinical data will form part of the MA application. Additionally, a Sponsor must submit the results of the non-clinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, in the CTA applications. Some non-clinical testing may continue even after the CTA has been granted. As discussed further below, before a clinical trial can commence, the competent authorities of the Member States in which clinical trials are performed will review the CTA applications and determine whether to approve the clinical trial. As such, issues with non-clinical test results may lead to competent authorities refusing to approve the clinical trials.

***B) Clinical Trials*** Clinical trials of medicinal products in the EU must be conducted in accordance with Clinical Trials Regulation (EU) No 536/2014, or CTR, and national regulations and the International Counsil for Harmonization, or ICH, guidelines on Good Clinical Practices, or GCP. Additional GCP guidelines from the EC, focusing in particular on traceability, apply to clinical trials of ATMPs. The sponsor must take out a clinical trial insurance policy, and

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in most EU Member States, the sponsor is liable to provide "no fault" compensation to any study subject injured in the clinical trial.

Prior to commencing a clinical trial, the Sponsor must obtain a clinical trial authorization from each Member State in which the trial is conducted. The Sponsor of the clinical trial must submit an application dossier via the EU Clinical Trials Information System, or the CTIS, which must include, among other things, a copy of the trial protocol, an investigator's brochure, documentation relating to compliance with GMP and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation.

The application entails a two-part assessment process where Part 1 is the scientific assessment by the competent authorities coordinated by a reporting member state, or RMS, and Part 2 is the member state specific ethical assessment. Clinical trial approvals for each Member State concerned will be released as a single decision following assessment of Part 1 by the relevant competent authority and of Part 2 by the relevant ethics committee for that Member State.

Medicinal products used in clinical trials must be manufactured in accordance with GMP. Other national and EU-wide regulatory requirements also apply.

During the development of a medicinal product, the EMA and national medicinal products competent authorities within the EU provide the opportunity for dialogue and guidance on the development program. At the EMA level, this is usually done in the form of scientific advice, which is given by the Scientific Advice Working Party of the CHMP. A fee is incurred with each scientific advice procedure. Advice from the EMA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical studies, and pharmacovigilance (also known as drug safety) plans and risk-management programs. Such scientific advice, in accordance with EMA policy, is not legally binding with regard to any future MAA of the product concerned however it is helpful in product development and understanding EMA expectations.

***C) Orphan Drug Designation and Exclusivity*** Regulation (EC) No. 141/2000 and as implemented by Regulation (EC) No. 847/2000 provides that a product can be designated as an orphan medicinal drug by the European Commission if its sponsor can establish: that the product is intended for the diagnosis, prevention or treatment of (1) a life-threatening or chronically debilitating condition affecting not more than five in ten thousand persons in the EU when the application is made, or (2) a life-threatening, seriously debilitating or serious and chronic condition in the EU and that without incentives it is unlikely that the marketing of the drug in the EU would generate sufficient return to justify the necessary investment. For either of these conditions, the applicant must demonstrate that there exists no satisfactory method of diagnosis, prevention, or treatment of the condition in question that has been authorized in the EU or, if such method exists, the applicant's medicinal product has to be of significant benefit compared to products available for the condition.

In the EU, an application for designation as an orphan product can be made any time prior to the filing of the MAA. Orphan medicinal product designation entitles an applicant to incentives such as fee reductions or fee waivers, protocol assistance, and access to the centralized MA procedure. The EMA then reassesses whether the product continues to meet the criteria for orphan designation in parallel with its review of the MA. Upon grant of an MA, orphan medicinal products are entitled to a ten-year period of market exclusivity for the approved therapeutic indication, which means that the EMA cannot accept another MAA, or grant an MA, or accept an application to extend an MA for a similar product for the same indication for a period of ten years. The period of market exclusivity is extended by two years for orphan medicinal products that have also completed pediatric clinical trials in compliance with an agreed PIP. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan medicinal products. Orphan medicinal product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product destination, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold. Additionally, an MA may be granted to a similar

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medicinal product with the same orphan indication during the ten-year period if: (i) the MA holder of the authorized product consents to a second original orphan medicinal product application, (ii) the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities; or (iii) the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior to the authorized orphan medicinal product. A company may voluntarily remove a product from the register of orphan products. A "similar medicinal product" is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal product, and which is intended for the same therapeutic indication. A "similar active substance" is "an identical active substance, or an active substance with the same principal molecular structural features (but not necessarily all of the same molecular structural features) and which acts via the same mechanism. However, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances shall be assessed on the basis of the biological and functional characteristics."

***D) Marketing Authorizations*** To obtain a MA for a product in the EU, an applicant must submit an MAA, either under a centralized procedure administered by the EMA, or one of the procedures administered by competent authorities in the EU Member States (decentralized procedure, national procedure or mutual recognition procedure). An MA may be granted only to an applicant established in the European Economic Area, or EEA.

The centralized procedure provides for the grant of a single MA by the European Commission that is valid for all EU and EEA, Member States. Pursuant to Regulation (EC) No 726/2004, the centralized procedure is compulsory for specific products, including for (i) medicinal products derived from biotechnological processes, (ii) products designated as orphan medicinal products, (iii) ATMPs, and (iv) products with a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases, diabetes, auto-immune and other immune dysfunctions and viral diseases. For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients' authorization through, the centralized procedure is optional on related approval.

Under the centralized procedure, the EMA's CHMP is responsible for conducting the initial assessment of a product. The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing MA.

Under the centralized procedure in the EU, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant in response to questions of the CHMP. Accelerated assessment may be granted by the CHMP in exceptional cases, when a medicinal product targeting an unmet medical need is expected to be of major interest from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation. If the CHMP accepts a request for accelerated assessment, the time limit of 210 days will be reduced to 150 days (not including clock stops). The CHMP can, however, revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment.

For the evaluation of ATMPs such as RUCONEST®, the Committee for Advanced Therapies, or CAT, is responsible in conjunction with the CHMP for their evaluation. The CAT is primarily responsible for the scientific evaluation of ATMPs and prepares a draft opinion on the quality, safety and efficacy of each ATMP for which an MAA is submitted. The CAT's opinion is then taken into account by the CHMP when giving its final opinion regarding the authorization of a product in view of the balance of benefits and risks identified. The CAT's opinion is submitted to the CHMP for final approval, as such the CHMP may depart from the opinion, if it provides detailed scientific justification. The CHMP and CAT are also responsible for providing guidelines on ATMPs and have published numerous guidelines, including specific guidelines on gene therapies and cell therapies. These guidelines provide additional guidance on the factors that the EMA will consider in relation to the development and evaluation of ATMPs and include, among other things, the preclinical studies required to characterize ATMPs; the manufacturing and control information that should be submitted in an MAA; and post-approval measures required to monitor patients and evaluate the long-term efficacy and potential adverse reactions of ATMPs.

Unlike the centralized authorization procedure, the decentralized MA procedure requires a separate application to, and leads to separate approval by, the competent authorities of each EU Member State in which the product is to be marketed. This application is identical to the application that would be submitted to the EMA for

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authorization through the centralized procedure. The applicant selects a so-called reference Member State that takes the lead on the review of the application on behalf of the other concerned Member States. The reference EU Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting assessment report is submitted to the concerned EU Member States who, within 90 days of receipt, must decide whether to approve the assessment report and related materials. If a concerned EU Member State cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the Heads of Medicines Agencies' Coordination Group for Mutual Recognition and Decentralized Procedures – Human, or CMDh. If the CMDh cannot reach an agreement within 60 days, the matter is brought to the attention of the CHMP. The CHMP will forward its opinion to the European Commission, who will then make a final decision. The subsequent decision of the European Commission is binding on all EU Member States.

The mutual recognition procedure allows companies that have a medicinal product already authorized in one EU Member State to apply for this authorization to be recognized by the competent authorities in other EU Member States. Like the decentralized procedure, the mutual recognition procedure is based on the acceptance by the competent authorities of the EU Member States of the MA of a medicinal product by the competent authorities of other EU Member States. The holder of a national MA may submit an application to the competent authority of an EU Member State requesting that this authority recognize the MA delivered by the competent authority of another EU Member State.

An MA granted by any route has an initial validity of five years in principle. The MA may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent national authority of the EU Member State in which the original MA was granted. To support the application, the MA holder must provide the EMA or the competent national authority with a consolidated version of the Common Technical Document, or the eCTD, providing up-to-date data concerning the quality, safety and efficacy of the product, including all variations introduced since the MA was granted, at least nine months before the MA ceases to be valid. The European Commission or the competent authorities of the EU Member States may decide on justified grounds relating to pharmacovigilance, to proceed with one further five year renewal period for the MA. Once subsequently definitively renewed, the MA shall be valid for an unlimited period. However, any authorization which is not followed by the actual placing of the medicinal product on the EU market (for a centralized MA) or on the market of the authorizing EU Member State within three years after authorization ceases to be valid (the so-called sunset clause).

Innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the Priority Medicines, or PRIME, scheme, which provides incentives similar to the breakthrough therapy designation in the U.S. PRIME is a voluntary scheme aimed at enhancing the EMA's support for the development of medicinal products that target unmet medical needs. Eligible products must target conditions for which there is an unmet medical need (there is no satisfactory method of diagnosis, prevention or treatment in the EU or, if there is, the new medicinal product will bring a major therapeutic advantage) and they must demonstrate the potential to address the unmet medical need by introducing new methods of therapy or improving existing ones. Benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted.

In the EU, a "conditional" MA may be granted in cases where all the required safety and efficacy data are not yet available. The European Commission may grant a conditional MA to medicinal products intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. A conditional MA can be granted if it is demonstrated that all of the following criteria are met: (i) the benefit-risk balance of the medicinal product is positive; (ii) it is likely that the applicant will be able to provide comprehensive data post-authorization; (iii) the medicinal product fulfills an unmet medical need; and (iv) the benefit of the immediate availability to patients of the medicinal product is greater than the risk inherent in the fact that additional data are still required. The conditional MA is subject to conditions to be fulfilled for generating the missing data or ensuring increased safety measures. It is valid for one year and must be renewed annually until all related conditions have been fulfilled. Once any pending studies are provided, the conditional MA can be converted into a standard MA. However, if the conditions are not fulfilled within the timeframe set by the EMA and approved by the European Commission, the MA will cease to be renewed.

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An MA may also be granted "under exceptional circumstances" where the applicant can show that it is unable to provide comprehensive data on efficacy and safety under normal conditions of use even after the product has been authorized and subject to specific procedures being introduced. These circumstances may arise in particular when the intended indications are very rare and, in the state of scientific knowledge at that time, it is not possible to provide comprehensive information, or when generating data may be contrary to generally accepted ethical principles. Like a conditional MA, an MA granted in exceptional circumstances is reserved to medicinal products intended to be authorized for treatment of rare diseases or unmet medical needs for which the applicant does not hold a complete data set that is required for the grant of a standard MA. However, unlike the conditional MA, an applicant for authorization in exceptional circumstances is not subsequently required to provide the missing data. Although the MA "under exceptional circumstances" is granted definitively, the risk-benefit balance of the medicinal product is reviewed annually and the MA will be withdrawn if the risk-benefit ratio is no longer favorable.

In addition to an MA, various other requirements apply to the manufacturing and placing on the EU market of medicinal products. Manufacture of medicinal products in the EU requires a manufacturing authorization, and import of medicinal products into the EU requires a manufacturing authorization allowing for import, collectively known as MIAs. The MIA holder must comply with various requirements set out in the applicable EU laws, regulations and guidance. These requirements include compliance with EU GMP standards when manufacturing medicinal products and APIs, including the manufacture of APIs outside of the EU with the intention to import the APIs into the EU. Similarly, the distribution of medicinal products within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for distribution granted by the competent authorities of the EU Member States. MA holders and/or MIA holders and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in cases of non-compliance with the EU or EU Member States' requirements applicable to the manufacturing of medicinal products.

EU Member States may adopt national legislation prohibiting or restricting the sale, supply or use of any medicinal product containing, consisting of or derived from a specific type of human or animal cell, such as embryonic stem cells. While the products we have in development do not make use of embryonic stem cells, it is possible that the national laws in certain EU Member States may prohibit or restrict us from commercializing our products, even if they have been granted an EU marketing authorization.

***E) Pediatric Development*** In the EU, companies developing a new medicinal product must agree to a PIP, covering all subsets of pediatric population, and must conduct pediatric clinical trials in accordance with that PIP, unless a deferral or waiver applies (for example, because the relevant disease or condition occurs only in adults). The MAA for the product must include the results of pediatric clinical trials conducted in accordance with the PIP, unless a waiver applies (in which case pediatric clinical trials need not be performed), or a deferral has been granted (in which case the pediatric clinical trials must be completed at a later date). Products that are granted a marketing authorization on the basis of the pediatric clinical trials conducted in accordance with the PIP are eligible for a six-month extension of the protection under a supplementary protection certificate (if any is in effect at the time of approval) or, in the case of orphan medicinal products, a two year extension of the orphan market exclusivity. This pediatric reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

***F) Data and Market Exclusivity*** The EU provides opportunities for data and market exclusivity related to MAs. Innovative medicinal products are generally entitled to benefit from eight years of data exclusivity and a further two years of market exclusivity (providing a total of 10 years of regulatory data protection). Data exclusivity prevents regulatory authorities in the EU from referencing the innovator's data to assess a generic application or biosimilar application for eight years from the date of first authorization of the innovative product. After this period has expired an MAA for a generic or biosimilar may be submitted, and the innovator's data may be referenced. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product (i.e., until 10 years have elapsed from the initial MA for the reference product in the EU). In general, only a single 10-year period of protection is available and MA holders do not benefit from additional periods of protection for new indications, dosage forms, routes of administration and other variations and line extensions. However, the market exclusivity period may be extended for a further year to a maximum of 11 years from the initial MA if, during the first eight years of those ten years, the MA holder obtains an authorization for one or

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more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will be considered by the EU's regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.

***G) Post-approval Requirements*** Similar to the post-approval process in the United States, drugs or biologics manufactured or distributed pursuant to marketing authorizations in the EU are subject to continuing regulation, including, among other things, requirements relating to periodic safety reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After authorization, changes to the approved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and prior EMA review and/or EC approval.

Additionally, the holder of a marketing authorization must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance, or QPPV, who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.

All new MAAs must include a risk management plan, or RMP, describing the risk management system that the Company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing authorization. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies. RMPs and PSURs are routinely available to third parties requesting access, subject to limited redactions.

***H) Advertising Regulation*** In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States' laws (as well as industry association codes of conduct that can be enforced on members of those associations) governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices. Although general requirements for advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in individual EU Member States and can differ from one country to another. For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product's Summary of Product Characteristics, or SmPC, as approved by the competent authorities in connection with an MA. The SmPC is the document that provides information to physicians concerning the safe and effective use of the product. Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU. Direct-to-consumer advertising of prescription medicinal products is also prohibited in the EU. Finally, EU medicines advertising rules also restrict the offer of transfers of value as an inducement to prescribe, administer or recommend a specific medicinal product.

***I) EU Pharmaceutical Legislation Review*** The European Commission is in the process of amending the EU's general pharmaceutical legislation. The European Parliament and the Council of the European Union announced on December 11, 2025 that they had reached political agreement on the revised legislation and the final text is expected to be formally published in the coming weeks.Although, the updated legislation will not enter into force for a number of years, it should be noted that there will be wide ranging changes to the laws as set out above. Notably, there will be significant changes to the rules on data protection/market exclusivity, orphan medicinal products and pediatric development.

**3. United Kingdom** 

On January 31, 2020, the United Kingdom left the EU (commonly referred to as Brexit) and accordingly is no longer an EU Member State. A transition period began on February 1, 2020, during which EU pharmaceutical law remained applicable to the United Kingdom, however this period ended on December 31, 2020. After this date, EU law no longer applied. On December 24, 2020, the United Kingdom and the EU announced that they

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had reached agreement on the terms of their future relationship as set out in the Trade and Cooperation Agreement, or the TCA. The EU and the United Kingdom had agreed to provisionally apply the terms of the TCA, while the formal execution was still ongoing. The TCA formally entered into force on May 1, 2021. While the TCA governs tariff and quota free trade between the United Kingdom and the EU markets, it does not provide for regulatory alignment. The regulatory framework for medicinal products in the United Kingdom is predominantly derived from EU law.

As the United Kingdom is no longer an EU Member State, the United Kingdom's participation in the European Medicines Regulatory Network has ceased and the MHRA has assumed the functions that were previously undertaken by the EU institutions for human medicines on the United Kingdom market. This is, with the exception of Northern Ireland, which, pursuant to the Protocol on Ireland/Northern Ireland has remained aligned with EU regulations; however, following the UK Government and European Commission's political agreement in principle on the Windsor Framework, the MHRA is responsible for all medicinal products placed on the market anywhere in the United Kingdom. The MHRA has published detailed guidance for industry and organizations that is updated as the United Kingdom's regulatory position on medicinal products evolves over time.

Under the Northern Ireland Protocol, the EU centralized MAs did not apply in Great Britain but did apply in Northern Ireland. However, the Windsor Framework provides that from 2025 all MAs in the United Kingdom (including those for Northern Ireland) require the MHRA to grant a UK MA. The United Kingdom now offers new assessment procedures to obtain marketing authorization in the United Kingdom.

The new assessments include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The international recognition procedure, or IRP, which allows a company to submit an MAA for a product on an abbreviated review timeline if the same product has already received approval from one of the MHRA's specified RRs, including the EMA, the national regulators of the EU Member States and the FDA. A positive CHMP opinion is deemed to be an RR approval for these purposes. If the RR approval was granted within the past 2 years and the manufacturing supply chain for the UK is identical to that approved under the RRA approval, the product may be eligible for Recognition Route A, which gives the MRHA 60 days from the date the IRP submission is validated to reach a decision, and there is no possibility of a clock-stop. For other products, including all ATMPs, the MAA will be assessed under Recognition Route B, which gives the MHRA 110 days from the date the IRP submission is validated to reach a decision, and the MHRA may impose a 60-day clock stop if necessary to request additional information from the applicant;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A full assessment as a national authorization, that industry can choose for new active substances, with high-quality new MAAs with a timeline of no more than 150 days (excluding clock-off periods where further information is requested) which can lead to the grant of a United Kingdom marketing authorization. If the application includes Northern Ireland then it must comply with the relevant EU requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Unfettered Access Procedure for medicines already approved in Northern Ireland via the EU procedures or via the Northern Ireland national route which if successful will lead to a United Kingdom marketing authorization. This procedure means that the MHRA will recognize such MAs in the United Kingdom within 67 days of MAA validation, unless a major objection is identified; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A "rolling review", for new active substances and biosimilars, which would allow companies to make an application in stages, throughout the product's development, to better manage development risk which can lead to the grant of a marketing authorization in the United Kingdom.

Domestic UK law provided that all existing EU law in force on December 31, 2020 was retained in UK national law, subject to certain revisions that have become necessary as a result of Brexit. However, the Retained EU Law (Revocation and Reform) Act 2023 came into force on January 1, 2024. This revoked some retained EU laws (although not any relating to medicines regulation). All other retained EU laws have been renamed as "assimilated laws" and are no longer subject to the EU principles of interpretation. Thus, while at least initially the United Kingdom and the European Union laws relating to medicines are largely aligned, there is the potential for further divergence in the future.

**4. Rest of World, or ROW**

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Similar to that in the U.S. and in Europe, countries around the globe have their own health authority(ies), legal basis of regulation of medicinal products, and independent clinical trial and registration procedures and processes. Conformance and compliance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, or ICH, is typically acceptable in countries worldwide with additional local particulars.

In general, from a clinical trial perspective, requirements for conduct of a trial are similar to that of the U.S. and EU and consist of a CTA and Ethics Committee review.

In both the United States and the EU, there are dedicated regulatory pathways for biosimilars, or biological medicinal products that are highly similar to a reference medicinal product but that do not meet the definition of a generic medicinal product, for example, because of inherent biological differences present in such biological systems. For such products, the results of appropriate preclinical or clinical trials must be provided, and guidelines from FDA or EMA detail the type of quantity of additional nonclinical, clinical and CMC data to be provided for submission of a highly similar biological product. Given the complexity of the requirements in the biosimilar route when compared to the generic drug pathway(s), there have been limited biosimilar approvals globally, however this pathway appears to be gaining momentum as innovator companies leverage the process to develop and market their own biosimilars of their own biologic product.

**5. EU and UK Data Privacy** 

In May 2018, the EU General Data Protection Regulation (EU) 2016/679, or GDPR, went into effect in the EEA. The GDPR imposes stringent data protection requirements for processing the information of individuals in the EEA. In the United Kingdom, the GDPR continues to form part of law in the United Kingdom following the United Kingdom's withdrawal from the EU, as the UK GDPR, (by virtue of Section 3 of the EU (Withdrawal) Act 2018, as amended (including by the various Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations)), thus imposing similarly stringent data protection requirements in the United Kingdom, as in the EEA. To date, the GDPR and UK GDPR have increased compliance burdens on us, such as requiring the following: processing personal data only for specified, explicit and legitimate purposes for which personal data were collected; establishing a legal basis for processing personal data; creating obligations for controllers and processors to appoint data protection officers in certain circumstances; increasing transparency obligations to data subjects for controllers (including presentation of certain information in a concise, intelligible and easily accessible form about how their personal data is used and their rights vis-à-vis that data and its use); introducing the obligation to carry out so-called data protection impact assessments in certain circumstances; establishing limitations on collection and retention of personal data through "data minimization" and "storage limitation" principles; establishing obligations to implement "privacy by design"; introducing obligations to honor increased rights for data subjects (such as rights for individuals to be "forgotten," rights to data portability, rights to object etc. in certain circumstances); formalizing a heightened and codified standard of data subject consent; establishing obligations to implement certain technical and organizational safeguards to protect the security and confidentiality of personal data; introducing obligations to agree to certain specific contractual terms and to take certain measures when engaging third party processors and joint controllers; introducing the obligation to provide notice of certain significant personal data breaches to the relevant supervisory authority or authorities and affected individuals; and mandating the appointment representatives in the United Kingdom and/or EU in certain circumstances. The processing of sensitive personal data, such as health information, may impose heightened compliance burdens under the GDPR/UK GDPR and is a topic of active interest among foreign regulators. The GDPR/UK GDPR increases our obligations with respect to clinical trials conducted in Europe (including the EEA and United Kingdom) by expressly expanding the definition of personal data to include "pseudonymized" or key-coded data and requiring changes to informed consent practices and more detailed notices for clinical trial subjects and investigators. Further guidance on how to comply with these obligations in the context of clinical trials may be provided by European regulators in the future, as the European Data Protection Board, or EDPB, announced in 2021 that it was working on guidelines on the processing of personal data for scientific research purposes. Those guidelines have yet to appear and are long overdue.

The GDPR/UK GDPR also provides for more robust regulatory enforcement and greater penalties for non-compliance than previous data protection laws, including fines of up to €20 million or 4% of global annual revenue of any non-compliant company for the preceding financial year, whichever is higher. In addition to administrative fines, a wide variety of other potential enforcement powers are available to competent

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supervisory authorities in respect of potential and suspected violations of the GDPR, including extensive audit and inspection rights, and powers to order temporary or permanent bans on all or some processing of personal data carried out by non-compliant actors. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

European data protection laws, including the GDPR/UK GDPR, generally restrict the transfer of personal data from Europe, including the EEA, United Kingdom and Switzerland, to the United States and most other countries unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data. For transfers to the U.S. an EU-U.S. framework known as the Data Privacy Framework, or DPF, was adopted in 2023 to allow participating U.S. companies to transfer personal data from Europe to the U.S. The DPF entered into force in July 2023 for transfers from the EEA to the U.S., and in October 2023 for transfers from the United Kingdom to the U.S. As a result, U.S. companies who have certified to the DPF can rely on their certification to import personal data from the EEA and the United Kingdom. The recent dismissal of three PCLOB members, an independent body playing an essential role under the DPF, has raised concerns as to the future of the DPF. While the Swiss-U.S. DPF Principles have technically been effective since July 2023, the Swiss Federal Council only recognized the Swiss-U.S. DPF as an adequate safeguard for the transfer of Swiss personal data to the U.S. under Swiss data protection laws in August 2024. Following the official recognition, companies can rely on the Swiss-U.S. DPF to transfer personal data from Switzerland to the U.S.

The CJEU's decision in a case referred to as Schrems II, which invalidated two data transfer frameworks pre-dating the DPF, also raised questions about whether another commonly used data transfer mechanism, namely, the European Commission's Standard Contractual Clauses, can lawfully be used for personal data transfers from Europe to the United States or other third countries that are not the subject of an adequacy decision of the European Commission. While the CJEU upheld the adequacy of the Standard Contractual Clauses in principle in Schrems II, it made clear that reliance on those Clauses alone may not necessarily be sufficient in all circumstances.

Use of the Standard Contractual Clauses must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular regarding applicable surveillance laws and relevant rights of individuals with respect to the transferred data. In the context of any given transfer, where the legal regime applicable in the destination country may or does conflict with the intended operation of the Standard Contractual Clauses and/or applicable European law, the decision in Schrems II and subsequent guidance from the EDPB would require the parties to that transfer to implement certain supplementary technical, organizational and/or contractual measures to rely on the Standard Contractual Clauses as a compliant "transfer mechanism." However, the EDPB recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data, as last adopted on June 18, 2021 conclude that no combination of such measures could be sufficient to allow effective reliance on the Standard Contractual Clauses in the context of transfers of personal data "in the clear" to recipients in countries where the power granted to public authorities to access the transferred data goes beyond that which is "necessary and proportionate in a democratic society" – which may, following the CJEU's judgment in Schrems II on relevant powers of United States public authorities and commentary in that draft EDPB guidance, include the United States in certain circumstances (e.g., where Section 702 of the U.S. Foreign Intelligence Surveillance Act applies). A White House Executive Order, issued by the Biden Administration, Executive Order (E.O.) 14086 of October 7, 2022, on Enhancing Safeguards for United States Signals Intelligence Activities, addressed some of these concerns, although it is possible that this Order will be rescinded under the Trump Administration, which likely would create issues for parties transferring personal data to the U.S. in future.

The decision in Schrems II also indirectly affects transfers from the United Kingdom to the United States. As such, if we are unable to implement a valid solution for personal data transfers from Europe, including, for example, obtaining individuals' explicit consent to transfer their personal data from Europe to the United States or other countries, we will face increased exposure to regulatory actions, substantial fines and injunctions against processing personal data from Europe. Inability to import personal data from the EEA, United Kingdom or Switzerland may also restrict our clinical trials activities in Europe; limit our ability to collaborate with contract research organizations as well as other service providers, contractors and other companies subject to European data protection laws; and require us to increase our data processing capabilities in Europe at significant expense. Additionally, other countries outside of Europe have enacted or are considering enacting similar cross-border data transfer restrictions and laws requiring local data residency, which could increase the

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cost and complexity of delivering our services and operating our business. The type of challenges we face in Europe will likely also arise in other jurisdictions that adopt laws similar in construction to the GDPR or regulatory frameworks of equivalent complexity.

The GDPR applies across the EEA and, by virtue of the UK GDPR in the United Kingdom, in a broadly uniform manner. However, the GDPR provides that EEA countries may make their own further laws and regulations to introduce specific requirements related to the processing of "special categories of personal data," including personal data related to health, biometric data used for unique identification purposes and genetic information; as well as personal data related to criminal offences or convictions – in the United Kingdom, the DPA complements the UK GDPR in this regard, and the United Kingdom recently enacted the Data (Use and Access) Act 2025, which supplements the United Kingdom's data protection framework. This may lead to greater divergence on the law that applies to the processing of such data types across the EEA and/or United Kingdom, compliance with which, as and where applicable, may increase our costs and could increase our overall compliance risk. Such country-specific regulations could also limit our ability to collect, use and share data in the context of our EEA and/or United Kingdom establishments (regardless of where any processing in question occurs), and/or could cause our compliance costs to increase, ultimately having an adverse impact on our business, and harming our business and financial condition.

Further, the United Kingdom's vote in favor of exiting the EU and ongoing developments in the United Kingdom have created uncertainty with regard to data protection regulation in the United Kingdom. At present, the data protection obligations of the GDPR continue to apply in substantially unvaried form and fashion under the UK GDPR. In the future, however, there will be increasing scope for divergence in application, interpretation and enforcement of the data protection law as between the United Kingdom and the EEA. Furthermore, the relationship between the United Kingdom and the EEA in relation to certain aspects of data protection law remains unclear. However, on June 28, 2021, the European Commission adopted an adequacy decision in relation to the United Kingdom, which was renewed in December 2025 for a period of six years. This decision permits personal data to flow freely from the EEA to the United Kingdom where it benefits from an essentially equivalent level of protection to that guaranteed under EU law.

Additionally, other countries outside of Europe have enacted or are considering enacting similar cross-border data transfer restrictions and laws requiring local data residency, which could increase the cost and complexity of delivering our services and operating our business.

It is possible that the GDPR or other laws and regulations relating to privacy and data protection may be interpreted and applied in a manner that is inconsistent from jurisdiction to jurisdiction or inconsistent with our current policies and practices and compliance with such laws and regulations could require us to change our business practices and compliance procedures in a manner adverse to our business. We cannot guarantee that we are in compliance with all such applicable data protection laws and regulations and we cannot be sure how these regulations will be interpreted, enforced or applied to our operations.

Furthermore, other jurisdictions outside the EEA are similarly introducing or enhancing privacy and data security laws, rules, and regulations, which could increase our compliance costs and the risks associated with non-compliance. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices and our efforts to comply with the evolving data protection rules may be unsuccessful. We cannot guarantee that we, our third-party collaborators, or our vendors are in compliance with all applicable data protection and privacy laws and regulations as they are enforced now or as they evolve. Further, for example, our privacy policies may be insufficient to protect any personal information we collect, or may not comply with applicable laws. Our non-compliance could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. In addition to the risks associated with enforcement activities and potential contractual liabilities, our ongoing efforts to comply with evolving laws and regulations at the national, federal and state level may be costly and require ongoing modifications to our policies, procedures and systems. In addition, if we are unable to properly protect the privacy and security of protected health information, we could be found to have breached our contracts.

Our actual or perceived failure to adequately comply with applicable laws and regulations relating to privacy and data protection, or to protect personal data and other data we process or maintain, could result in regulatory enforcement actions against us, including fines, penalties, orders that require a change in our practices, additional reporting requirements and/or oversight, imprisonment of company officials and public censure,

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claims for damages by affected individuals, other lawsuits or reputational and damage, all of which could materially affect our business, financial condition, results of operations and growth prospects.

**6. Pricing and Reimbursement**

***A) United States***

The future commercial success of RUCONEST®, Joenja® and our product candidates or any of our collaborators' ability to commercialize any approved product candidates successfully will depend in part on the extent to which governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for our product candidates. Government health administration authorities, private health insurers and other organizations generally decide which drugs they will pay for and establish reimbursement levels for healthcare. In particular, in the United States, private health insurers and other third-party payors may provide reimbursement for products and services based on the level at which the government, through the Medicare or Medicaid programs, provides reimbursement for such treatments.

In the United States, the EU, and other potentially significant markets for our product candidates, government authorities and third-party payors are increasingly attempting to limit or regulate the price of medical products and services, particularly for new and innovative products and therapies, which often has resulted in average selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the United States will put additional pressure on product pricing, reimbursement and usage, which may adversely affect our future product sales and results of operations. These pressures can arise from rules and practices of managed care groups, judicial decisions and laws and regulations related to Medicare, Medicaid and healthcare reform, pharmaceutical coverage and reimbursement policies and pricing in general.

Third-party payors are increasingly imposing additional requirements and restrictions on coverage and limiting reimbursement levels for medical products. For example, federal and state governments reimburse covered prescription drugs at varying rates generally below average wholesale price. These restrictions and limitations influence the purchase of healthcare services and products. Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor's decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.

Further, one payor's determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. Additionally, coverage policies and third-party reimbursement rates may change at any time. Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future.

Legislative proposals to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for RUCONEST®, Joenja® and product candidates or exclusion of RUCONEST®, Joenja® or our product candidates from coverage. The cost containment measures that healthcare payors and providers are instituting and any healthcare reform could significantly reduce our revenues from the sale of any approved product candidates. We cannot provide any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for RUCONEST®, Joenja® and our product candidates in whole or in part.

There have been several U.S. government initiatives over the past few years to fund and incentivize certain comparative effectiveness research, including creation of the Patient-Centered Outcomes Research Institute under the ACA. It is also possible that comparative effectiveness research demonstrating benefits in a competitor's product could adversely affect the sales of our product candidates. If third-party payors do not consider RUCONEST®, Joenja® or our product candidates, once approved, to be cost-effective compared to

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other available therapies, they may not cover such products as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our product on a profitable basis.

In addition, there have been and continue to be a number of initiatives at the United States federal and state levels that seek to reduce healthcare costs. Furthermore, there has been heightened governmental scrutiny over specialty drug pricing practices, which has resulted in several congressional inquiries and executive orders designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

At the both the federal and state level, legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs are pervasive and a continuing theme subject to review and re-review for alignment with changes in administration(s), as well as with key stakeholders.

These and other healthcare reform initiatives within the U.S. may result in additional reductions in Medicare or other healthcare funding which may impact our ability to achieve the desired pricing for newly developed indications and/or products.

***B) European Union*** In the EU, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost effectiveness of a particular product candidate to currently available therapies (so-called health technology assessments) in order to obtain reimbursement or pricing approval. In general, governments influence the price of medicinal products in the EU through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.

Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other EU Member States allow companies to fix their own prices for medicinal products but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription medicines, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.

In various EU Member States, continuous cost-cutting measures, such as lower maximum prices, lower or lack of reimbursement coverage and incentives to use cheaper products as an alternative apply. Health Technology Assessment, or HTA, of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including countries representing major markets. The HTA process, which is primarily governed by the national laws of these countries, is the procedure according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of use of a given medicinal product in the national healthcare systems of the individual country is conducted. The outcome of HTA regarding specific medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States.

A new Health Technologies Assessment, or the HTA, Regulation entered into force on January 11, 2022 and applied from January 12, 2025. The Regulation is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products. It provides for the conduct of a joint clinical assessment under the authority of the Member State Coordination Group on Health Technology Assessment, which must be completed within 30 days after the grant of the marketing authorization. Member States must give due consideration to the joint clinical assessment report when conducting their own national HTAs. The HTA Regulation applied initially to new cancer medicines and ATMPs. It will apply to orphan medicines from January 2028 and to all new medicines from January 2030.

**C. Organizational Structure**

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Pharming Group N.V. is a limited liability public company. Pharming Group N.V. is the ultimate parent company of Pharming Group. A list of our significant subsidiaries at December 31, 2025, is provided in the table below:

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| | | |
|:---|:---|:---|
| **Entity** | **Registered office** | **Investment %** |
| Pharming Americas B.V. | The Netherlands | 100% |
| Pharming Intellectual Property B.V. | The Netherlands | 100% |
| Broekman Instituut B.V. | The Netherlands | 100% |
| Pharming Healthcare, Inc. | The United States | 100% |
| ProBio, Inc. | The United States | 100% |
| Pharming Technologies B.V. | The Netherlands | 100% |
| &nbsp;&nbsp; Pharming Research & Development B.V. | The Netherlands | 100% |
| &nbsp;&nbsp; Pharming Australia Pty Ltd | Australia | 100% |
| &nbsp;&nbsp; Pharming UK Ltd | The United Kingdom | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming Germany GmbH<sup>\*</sup> | Germany | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming France SAS<sup>\*</sup> | France | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Abliva AB<sup>\*\*</sup> | Sweden | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Abliva, Inc.<sup>\*\*\*</sup> | The United States | 100% |

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<sup>\*</sup> This entity was established in November 2025

<sup>\*\*</sup> This entity was acquired in February 2025

<sup>\*\*\*</sup> This entity is dissolved in January 2026

**D. Property, Plants and Equipment**

*Our Facilities*

In Leiden, the Netherlands, we have our administrative offices (including laboratories) and offices for executive management located on Darwinweg 24, 2333 CR, Leiden and Vondellaan 47, 2332 AA, Leiden, respectively. In the Leiden facilities, we occupy:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Approximately 1,877 square meters (equivalent to approximately 20,204 square feet) of office space under a lease that has an initial term that expires on June 1, 2029 and can be extended for a period of 5 years.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Approximately 1,295 square meters (equivalent to approximately 13,939 square feet) of laboratory space under a lease which will expire on June 30, 2026 and will automatically be renewed for an additional period of 5 years.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Approximately 76 square meters (equivalent to approximately 818 square feet) of storage space under a lease which will expire on June 30, 2026 and will automatically be renewed for an additional period of 5 years.

In addition, in the province of Noord Brabant, the Netherlands, we occupy approximately 3,459 square meters (equivalent to approximately 37,232 square feet), of which 2405 square meters (equivalent to approximately 25,887 square feet) is production space, 926 square meters (equivalent to approximately 9,967 square feet) is office space and 128 square meters (equivalent to approximately 1,378 square feet) is used for support purposes.

At our other production facility in the province of Noord Brabant, the Netherlands, we own approximately 950 square meters (equivalent to approximately 10,226 square feet) of production, warehouse and office space.

Beginning 2022, we leased approximately 4,514 square meters (equivalent to approximately 48,588 square feet) of production, warehouse and office space in the province of Noord Brabant. The intention for this facility was primarily to set up our independent production line, which was cancelled and the building remained empty and unused. We terminated the lease in 2025.

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At our research and development facility near Paris, France, we occupy approximately 1,106 square meters (equivalent to approximately 11,905 square feet) of office space under a lease which has an expiry date of March 30, 2030.

In New Jersey, United States, we occupy approximately 1,732.64 square meters (equivalent to approximately 18,650 square feet) of office space under a lease that runs through 2028.

**Item 4A. Unresolved Staff Comments**

None.

**Item 5. Operating and Financial Review and Prospects**

*You should read the following* "*Operating and Financial Review and Prospects*" *together with our financial statements and Notes included elsewhere in this Annual Report. The following discussion is based on our financial information prepared in accordance with IFRS® Accounting Standards as issued by the International Accounting Standards Board, or IASB, and as adopted by the European Union* 

*The statements in this discussion with respect to our plans and strategy for our business, including expectations regarding our future liquidity and capital resources and other non-historical statements, are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties, including the risks and uncertainties described in the section of this Annual Report titled "Risk Factors." Our actual results may differ materially from those contained in or implied by any forward-looking statements.* 

**A. Operating Results** 

**Overview** 

RUCONEST's® importance continued to be felt throughout 2025 as we increased the number of physicians prescribing RUCONEST®, as well as the number of patients. RUCONEST® revenues in 2025 increased by 26%, driven by revenue growth in the U.S.

With respect to Joenja® (leniolisib), we increased investment in the U.S. as we began commercialization. Since the launch in April 2023, we made strong and rapid progress transitioning known patients onto commercial therapy. Joenja® revenues in 2025 increased by 29% compared to 2024.

The U.S. launch of Joenja®, and preparations for launches in the United Kingdom, Australia and Israel as well as anticipated approvals in Japan, the European Economics Area and Canada, resulted in additional expenses in research and development, marketing and sales and payroll. Research and clinical development activities related to leniolisib were further focused on advancing Japan and pediatric clinical trials for APDS, to support regulatory filings and the Phase II clinical trial for leniolisib in PIDs with immune dysregulation to significantly expand the long-term commercial potential of leniolisib beyond APDS. We believe that these investments would support our continued growth following approvals.

In addition, research and clinical development activities were further focused as the program related to OTL-105 was discontinued in 2024. As such, we maintained a strong financial position in 2025.

We further intensified our business development activities for acquisition or in-licensing of additional clinical stage opportunities in rare diseases, which resulted in the completion of the acquisition of Abliva AB in March 2025, adding napazimone (KL1333) for mitochondrial DNA-driven primary mitochondrial diseases to our late-stage pipeline.

Other operating expenses increased primarily due to higher expenditures related to investment in the napazimone (KL1333) program following its acquisition, employee costs primarily due to bonuses tied to sales performance and the further expansion of the commercial organization and infrastructure in the U.S., Europe and other key global launch markets, in view of the anticipated approval by other regulatory authorities in 2026 and beyond.

**Components of our Results of Operations** 

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***Revenues***

We generate revenues primarily from the sale of RUCONEST® and Joenja®. Most of our contracts for revenues with customers are subject to chargebacks, discounts and/or rebates relating to customers or to reimbursement claims from government or insurance payers.

***Costs of Sales***

Costs of sales consist of cost of product sales, relating to actual product sales, royalty and sales milestone expenses and inventory impairments. The impairment stems from the cost of inventories compared to its net realizable value.

***Other income***

Other income is comprised largely of grants in the form of annual payroll-tax reimbursement granted by the Dutch and French governments for research and development activities that we conduct in those countries. In 2025, the gain on the early termination of the DSP facility lease at Pivot Park in Oss was also included. In comparative years, other income also related to the proceeds from the sale of a Pediatric Disease Priority Voucher, or PRV, to Novartis, as discussed below.

***Cost of research and development***

Research and development costs relate to the preparation and initiation of our product candidates lifecycle. Development expenditures that meet the capitalization criteria are capitalized. Expenditures which do not meet these criteria are recorded as expenses through the income statement.

***Cost of general and administrative activities***

Consists of costs related to administration resources, service fees, legal and due diligence costs and impairment and depreciation costs for property, plant and equipment and intangible assets.

***Cost of marketing and sales activities***

These costs relate to all expenses incurred to commercialize a product.

***Fair value gain (loss) on revaluation***

Fair value gain (loss) on revaluation comprise of fair value changes of our investment in debt instruments designated as Fair Value Through Profit or Loss, or FVTPL, being the owned preference share in BioConnection Investments B.V. and fair value changes of a derivative financial liability embedded in our new €100.0 million ($103.5 million) of senior unsecured convertible bonds due 2029 offered in April 2024, or the New Bonds. The New Bonds are classified as hybrid financial instruments under IAS 32 and pursuant to it the debt host contract and the embedded derivative for the fair value of the conversion rights into Pharming shares, or the conversion option, are recognized separately. Initial recognition values for the individual components were determined as follows:

The conversion option was measured at initial recognition using a pricing model. As we did not have sufficient placement capacity to fulfil conversion of the New Bonds into ordinary shares at the date of issue, the conversion option was recognized as a financial liability derivative. During the shareholder's meeting on May 21, 2024, we received shareholder approval to increase share capital to support the potential conversion. At the physical settlement notice date of June 11, 2024, when the New Bond holders were notified that the cash settlement alternative would no longer be available, the conversion option was reclassified to equity at fair value, which resulted in a fair value gain immediately prior to the reclassification. Subsequently, the value of this equity component is not remeasured, apart from currency revaluation, at December 31, 2025.

The debt host contract component was measured at initial recognition as the difference between the proceeds from the New Bond and the value of the conversion option at initial recognition. This debt host contract is

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subsequently measured at amortized cost.

***Other finance income / expense***

Other finance expense is comprised primarily of interest paid on our convertible bonds and our lease liabilities and foreign currency results. Other finance income comprise primarily of interest received from our marketable securities.

***Share of net profits (loss) in associates using the equity method***

Share of net profits (loss) in associates comprises the profits (loss) resulting from our investment in BioConnection and, in 2024, a recognized impairment on the net equity value of our equity investment.

In accordance with IAS 36, we review the carrying value of our investments accounted for using equity method for impairment whenever events or changes in circumstances indicate that the carrying value may not be recoverable. In 2024, based on a comprehensive review of the investee's performance, financial position, expected future cash flows and market conditions, we determined that an impairment is required. We will continue to monitor the performance of this investment and assess whether additional impairments may be necessary in future periods, depending on changes in circumstances or the performance of the investee.

***Income tax credit (expense)***

Income tax credit reflects credit/(expenses) of income tax. The income tax expense or credit for the period is the tax payable on the current period's taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses. The realization of deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are subject to uncertainties. Despite the loss in 2024, it is probable that going forward we will be able to use all our remaining net operating tax losses from previous years. During the years ended December 31, 2025, 2024 and 2023, we incurred state and federal income taxes in the United States, in which jurisdiction we have no remaining tax losses available, while in the Netherlands we continue to use up our accumulated tax losses. The tax shielding effect of those remaining tax losses is shown on the balance sheet as a deferred tax asset. The deferred tax asset is utilized by being written down by the amount of the tax charge each reporting period, instead of paying the tax due from cash. Once all the tax losses are used up, the deferred tax asset relating to these losses will be completely extinguished and the tax due thereafter will be paid.

**Results of Operations** 

The following table sets forth our results of operations for the periods presented.

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**CONSOLIDATED STATEMENT OF INCOME**

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| | | | |
|:---|:---|:---|:---|
| | **Years ended December 31,** | **Years ended December 31,** | **Years ended December 31,** |
| Amounts in $'000 | **2025** | **2024** | **2023** |
| **Revenues** | **376134** | **297200** | **245316** |
| **Costs of sales** | **(45500)** | **(35399)** | **(25212)** |
| **Gross profit** | **330634** | **261801** | **220104** |
| **Other income** | **6528** | **2177** | **23349** |
| Research and development | (100367) | (83147) | (68914) |
| General and administrative | (79958) | (70650) | (55877) |
| Marketing and sales | (130995) | (118802) | (124049) |
| **Other Operating Costs** | **(311320)** | **(272599)** | **(248840)** |
| **Operating profit / (loss)** | **25842** | **(8621)** | **(5387)** |
| Fair value gain (loss) on revaluation | 2345 | 4990 | (930) |
| Other finance income | 2176 | 6843 | 3663 |
| Other finance expenses | (18140) | (9944) | (9069) |
| **Finance (cost) / gain, net** | **(13618)** | **1889** | **(6336)** |
| **Share of net profits / (loss) in associates using the equity method** | **623** | **(1760)** | **(289)** |
| **Profit / (loss) before tax** | **12847** | **(8492)** | **(12012)** |
| Income tax (expense) / credit | (10310) | (3349) | 1464 |
| **Profit / (loss) for the year** | **2538** | **(11841)** | **(10548)** |
| Attributable to: |  |  |  |
| Equity holders of the parent | 2851 | (11841) | (10548) |
| Non-controlling interests | (313) |  |  |
| Basic (loss) / earnings per share ($) | 0.004 | (0.018) | (0.016) |
| Diluted (loss) / earnings per share ($) | 0.004 | (0.018) | (0.016) |

---

***Comparison of the Year Ended December 31, 2025 and 2024***

***Revenues***

Revenues increased by $78.9 million, or 26.6%, from $297.2 million for the year ended December 31, 2024, to $376.1 million for the year ended December 31, 2025. The increase in revenues was primarily driven by higher sales of RUCONEST® in the U.S. market ($311.7 million and $246.6 million in 2025 and 2024, respectively) and due to higher sales of Joenja® worldwide ($58.2 million in 2025 compared to $45.0 million in 2024). This increase was primarily driven by a 37% increase in volume.

Revenues of RUCONEST® in Europe and Rest of World (RoW) amounted to $6.2 million in 2025 compared to $5.6 million in 2024.

Revenues of Joenja® in Europe and Rest of World amounted to $8.1 million in 2025 compared to $4.5 million in 2024.These revenues included UK commercial sales and revenue from Named Patient Programs.

Two U.S. customers represented $290.9 million, or 77%, of our net revenues in 2025, with one representing $156.2 million and the other $134.7 million. In 2024, these two U.S. customers represented $227.7 million, or 77%, of our net revenues, at $134.8 million and $92.9 million, per customer, respectively. These customers are largely specialty pharmacies that are specialized in distribution of pharmaceuticals in our disease area and distribute our product.

------

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2025** | **2025** | **2024** | **2024** | **2024** |
|  | RUCONEST® | Joenja® | Total | RUCONEST® | Joenja® | Total |
| **Revenues:** |  |  |  |  |  |  |
| U.S. | 311672 | 50074 | 361746 | 246649 | 40500 | 287149 |
| Europe and RoW | 6249 | 8139 | 14388 | 5590 | 4461 | 10051 |
| **Total revenues** | **317921** | **58213** | **376134** | **252239** | **44961** | **297200** |
| **Gross profit:** |  |  |  |  |  |  |
| U.S. | 284542 | 39775 | 324317 | 221093 | 35136 | 256229 |
| Europe and RoW | (926) | 7243 | 6317 | 1126 | 4446 | 5572 |
| **Total gross profit** | **283616** | **47018** | **330634** | **222219** | **39582** | **261801** |

---

***Costs of sales***

Costs of sales increased by $10.1 million, or 28.5%, from $35.4 million for the year ended December 31, 2024, to $45.5 million for the year ended December 31, 2025. Cost of inventories recognized as expenses in 2025 amounted to $32.0 million compared to $25.6 million in 2024, primarily due to the higher unit sales volume. The remainder of the increase in cost of sales in 2025 stemmed primarily from the higher royalty payments to Novartis on Joenja® sales of $5.8 million (2024: $4.9 million) and the first sales milestone payment for Joenja® of $5.0 million (2024: $— million), partially offset by lower impairment charges on inventory of $2.7 million (2024: $4.8 million).

The following table summarizes the costs of sales for the years ended December 31, 2025 and 2024.

---

| | | |
|:---|:---|:---|
| | **Years ended December 31,** | **Years ended December 31,** |
| Amounts in $'000 | **2025** | **2024** |
| Cost of inventories recognized as expenses | (31972) | (25645) |
| Royalty fees | (5793) | (4907) |
| Sales milestone | (5000) |  |
| Obsolete inventory impairments | (2735) | (4847) |
| **Total** | **(45500)** | **(35399)** |

---

***Gross profit***

Gross profit increased by $68.8 million, or 26.3%, from $261.8 million for the year ended December 31, 2024, to $330.6 million for the year ended December 31, 2025. The primary driver for this increase was higher sales volumes of RUCONEST® and Joenja®.

The following table summarizes the geographical breakdown of our gross profit for the years ended December 31, 2025 and 2024.

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| | | |
|:---|:---|:---|
| | **Years ended December 31,** | **Years ended December 31,** |
| Amounts in $'000 | **2025** | **2024** |
| U.S. | 324317 | 256229 |
| Europe and RoW | 6317 | 5572 |
| **Total gross profit** | **330634** | **261801** |

---

***Other Income***

Other income increased by $4.4 million, or 199.9%, from $2.2 million for the year ended December 31, 2024, to $6.5 million for the year ended December 31, 2025. The increase was mainly driven by the gain on the early termination of the DSP facility lease at Pivot Park in Oss, the Netherlands of $3.9 million.

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***Cost of research and development***

Cost of research and development activities increased by $17.2 million, or 20.7%, from $83.1 million for the year ended December 31, 2024, to $100.4 million for the year ended December 31, 2025. The increase mainly reflected higher expenditures related to investment in the napazimone (KL1333) program following its acquisition, including integration of development activities and preparation for further clinical advancement.

***Cost of general and administrative activities***

Cost of general and administrative activities increased by $9.3 million, or 13.2%, from $70.7 million for the year ended December 31, 2024, to $80.0 million for the year ended December 31, 2025. Employee costs increased primarily due to severance expenses related to the acquired Abliva AB, restructuring activities, higher share-based compensation, and a higher average number of full-time equivalents for the full year. Direct operating expenses increased primarily due to costs associated with the public cash offer in 2025 to acquire all issued and outstanding shares of Abliva AB. Furthermore, in 2025 an additional impairment loss of $0.5 million was recognized in connection with the remaining right-of-use assets related to the cancelled downstream production capacity at Pivot Park in Oss, the Netherlands.

***Cost of marketing and sales activities***

Cost of marketing and sales activities increased by $12.2 million, or 10.3%, from $118.8 million for the year ended December 31, 2024, to $131.0 million for the year ended December 31, 2025. Employee costs increased primarily due to bonuses tied to sales performance. Direct operating expenses increased, mainly due to the further expansion of the commercial organization and infrastructure in the U.S., Europe and other key global launch markets, in view of the anticipated approval by other regulatory authorities in 2026 and beyond.

***Employee benefits***

Employee benefits are included in research and development costs, general and administrative costs, and marketing and sales costs based on the nature of the services provided by each employee. Hence, the employee benefits are not presented in the Consolidated Statement of Income as a separate line-item but are separately disclosed in the Notes to the Annual Financial Statements.

Employee benefits increased by $23.2 million, or 22.2%, from $104.2 million for the year ended December 31, 2024, to $127.4 million for the year ended December 31, 2025. The increase was primarily driven by currency effects, restructuring expenses and higher board remuneration as a result of the transition to a new CEO. The total number of full time employees slightly increased to 409 in 2025 from 404 in 2024.

The following table summarizes employee benefits for the years ended December 31, 2025 and 2024.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Salaries | (98526) | (80026) |
| Social security costs | (10484) | (9278) |
| Pension costs | (4582) | (3629) |
| Share-based compensation | (13767) | (11253) |
| **Total** | **(127359)** | **(104186)** |

---

***Fair value gain (loss) on revaluation*** 

Fair value gain (loss) on revaluation decreased by $2.6 million, or 53.0%, from a $5.0 million gain in 2024 to a gain of $2.3 million in 2025. The results remeasuring the fair value of our investments in debt instruments designated as at FVTPL improved by $4.4 million. The year ended December 31, 2024 included a fair value gain of $7.0 million upon the reclassification of the convertible bond-related derivative to equity.

***Other finance income***

------

Other finance income decreased by $4.7 million, or 68.2%, from $6.8 million for the year ended December 31, 2024, to $2.2 million for the year ended December 31, 2025. This decrease was primarily caused by a decrease in interest income from investments in marketable securities of $2.7 million as we reduced our investments in marketable securities during the year, as well as foreign currency effects.

The following table summarizes our other finance income for the years ended December 31, 2025 and 2024.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Interest income | 2176 | 4858 |
| Foreign currency gains |  | 1985 |
| **Other finance income** | **2176** | **6843** |

---

***Other finance expenses***

Other finance expenses increased by $8.2 million, or 82.4%, from $9.9 million for the year ended December 31, 2024, to $18.1 million for the year ended December 31, 2025. The increase was mainly driven by foreign currency effects, primarily the weakening of the U.S. dollar compared to the Euro.

The following table summarizes our other finance expenses for the years ended December 31, 2025 and 2024.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Amortization and interest on convertible bonds | (9685) | (7699) |
| Fees and expenses on repayment and issuance convertible bonds |  | (1151) |
| Interest leases | (1034) | (1038) |
| Other finance expenses | (196) | (56) |
| Foreign currency losses | (7225) |  |
| **Other finance expenses** | **(18140)** | **(9944)** |

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***Share of net profits (loss) in associates using the equity method***

Share of net profits (loss) in associates using the equity method increased by $2.4 million, or 135.4%, from a $1.8 million loss for the year ended December 31, 2024, to a $0.6 million gain for the year ended December 31, 2025. This is the result of a $1.8 million increase in our share of the results from BioConnection and an impairment on the investment of $0.6 million recorded in 2024.

***Income tax expense***

Income tax expense increased by $7.0 million, from $3.3 million for the year ended December 31, 2024, to $10.3 million for the year ended December 31, 2025. This tax expense mainly results from the profits of Pharming in the U.S. being taxed against a U.S. Federal and State combined tax rate of 27.96%, while the losses in the Netherlands only partly result in an offsetting tax credit, as the share-based compensation expenses and losses in associates are generally non-deductible based on Dutch tax law.

The following table summarizes Pharming's income tax expense for the years ended December 31, 2025 and 2024.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Total current tax credit (expense) | (8457) | (8972) |
| Total deferred tax credit (expense) | (1853) | 5623 |
| **Income tax credit (expense)** | **(10310)** | **(3349)** |

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***Comparison of the Year Ended December 31, 2024 and 2023***

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***Revenues***

Revenues increased by $51.9 million, or 21.1%, from $245.3 million for the year ended December 31, 2023 to $297.2 million for the year ended December 31, 2024. The increase in revenues was primarily driven by higher sales of RUCONEST® in the U.S. market ($246.6 million and $221.2 million in 2024 and 2023, respectively), and due to higher sales of Joenja® worldwide ($45.0 million in 2024 compared to $18.2 million in 2023). This increase was primarily driven by an increase in volume.

Revenues of RUCONEST® in Europe and Rest of World (RoW) amounted to $5.6 million in 2024 compared to $5.9 million in 2023.

Revenues of Joenja® in Europe and Rest of World was revenue through Named Patient Programs and amounted to $4.5 million in 2024 compared to $0.3 million in 2023.

Two U.S. customers represented $227.7 million, or 77%, of our net revenues in 2024, per customer $134.8 million and $92.9 million respectively. In 2023, these two U.S. customers represented $204.3 million, or 83%, of our net revenues, per customer $108.4 million and $95.9 million respectively. These customers are largely specialty pharmacies that are specialized in distribution of pharmaceuticals in our disease area and distribute our product.

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **2024** | **2024** | **2024** | **2023** | **2023** | **2023** |
|  | RUCONEST® | Joenja® | Total | RUCONEST® | Joenja® | Total |
| **Revenues:** |  |  |  |  |  |  |
| U.S. | 246649 | 40500 | 287149 | 221213 | 17894 | 239107 |
| Europe and RoW | 5590 | 4461 | 10051 | 5921 | 288 | 6209 |
| **Total revenues** | **252239** | **44961** | **297200** | **227134** | **18182** | **245316** |
| **Gross profit:** |  |  |  |  |  |  |
| U.S. | 221093 | 35136 | 256229 | 202441 | 15417 | 217858 |
| Europe and RoW | 1126 | 4446 | 5572 | 2026 | 220 | 2246 |
| **Total gross profit** | **222219** | **39582** | **261801** | **204467** | **15637** | **220104** |

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***Costs of sales***

Costs of sales increased by $10.2 million, or 40.4%, from $25.2 million for the year ended December 31, 2023 to $35.4 million for the year ended December 31, 2024. Cost of inventories recognized as expenses in 2024 amounted to $25.6 million compared to $21.4 million in 2023. In addition to the higher unit sales volume, the rise was primarily attributed to rising production costs for RUCONEST®. Cost of sales related to royalty fees to Novartis on Joenja® sales amounted to $4.9 million in 2024 compared to $2.1 million million in 2023. The remainder of costs in 2024 relate to obsolete inventory impairment as a result of products no longer eligible for commercial sales which required a reduction in the valuation of the inventories to the lower net realizable value. Impairments related to inventories designated for commercial activities amounted to a charge of $4.8 million in 2024 and $1.7 million in 2023.

The following table summarizes the costs of sales for the years ended December 31, 2024 and 2023.

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| | | |
|:---|:---|:---|
| | **Years ended December 31,** | **Years ended December 31,** |
| Amounts in $'000 | **2024** | **2023** |
| Cost of inventories recognized as expenses | (25645) | (21404) |
| Royalty fees | (4907) | (2145) |
| Obsolete inventory impairments | (4847) | (1663) |
| **Total** | **(35399)** | **(25212)** |

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***Gross profit***

------

Gross profit increased by $41.7 million, or 18.9%, from $220.1 million for the year ended December 31, 2023 to $261.8 million for the year ended December 31, 2024. The main reasons for this increase were higher sales of RUCONEST® and of Joenja®, offset by royalty fees to Novartis related Joenja® and inventory obsolescence impairments.

The following table summarizes the geographical breakdown of our gross profit for the years ended December 31, 2024 and 2023.

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| | | |
|:---|:---|:---|
| | **Years ended December 31,** | **Years ended December 31,** |
| Amounts in $'000 | **2024** | **2023** |
| U.S. | 256229 | 217858 |
| Europe and RoW | 5572 | 2246 |
| **Total gross profit** | **261801** | **220104** |

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***Other Income***

Other income decreased by $21.2 million, or 90.7%, from $23.3 million for the year ended December 31, 2023 to $2.2 million for the year ended December 31, 2024. The decrease was primarily the result of the sale of PRV during the year ended December 31, 2023. We were granted the PRV by the FDA in March 2023 in connection with the approval of Joenja®. The sale price was a contractually defined percentage of the PRV value pursuant to the terms of the August 2019 exclusive license agreement between Pharming and Novartis for leniolisib.

***Cost of research and development***

Cost of research and development activities increased by $14.2 million, or 20.7%, from $68.9 million for the year ended December 31, 2023 to $83.1 million for the year ended December 31, 2024. The increase in costs mainly related to the 2024 spend in research in leniolisib for the treatment of activated Phosphoinositide 3-kinase Delta syndrome (APDS) for patients under 12 years old, research on the use of leniolisib for additional primary immunodeficiencies (PIDs) beyond APDS and costs relating to activities in EU and the rest of the world for the purpose of receiving regulatory approval to commercialize Joenja® for APDS.

***Cost of general and administrative activities***

Cost of general and administrative activities increased by $14.8 million, or 26.4%, from $55.9 million for the year ended December 31, 2023 to $70.7 million for the year ended December 31, 2024. The increased costs were mainly related to the increased employee costs resulting from more staff employed following the growth of the organization. Direct operating expenses increased mainly due to one-off costs relating to the public cash offer to the shareholders of Abliva AB to acquire all issued and outstanding shares of Abliva AB, additional costs for (internal) audits and a general increase due to business growth. Other indirect general and administrative costs mainly increased due to additional contractor and consultant costs required for growth in the internal organization. Furthermore, during 2024, we recognized an additional impairment loss relating to impaired assets in connection with our cancelled downstream production capacity at Pivot Park in Oss, the Netherlands.

***Cost of marketing and sales activities***

Cost of marketing and sales activities decreased by $5.2 million, or 4.2%, from $124.0 million for the year ended December 31, 2023 to $118.8 million for the year ended December 31, 2024.

In 2023, Pharming paid $10.4 million in Development and Regulatory Milestone payments as a result of the first commercial sale of Joenja®, which was recorded as direct operating expenses.

Excluding the one-off milestone payment in 2023, the marketing and sales expenses increased, mainly due to the further expansion of the commercial organization and infrastructure in the U.S., Europe and other key global launch markets, in view of the FDA approval in March 2023, the approval by the Israeli Ministry of Health in

------

April 2024, U.K. MHRA approval in September 2024, and the anticipated approval by other regulatory authorities in 2025 and beyond.

***Employee benefits***

Employee benefits are included in research and development costs, general and administrative costs, and marketing and sales costs based on the nature of the services provided by each employee. Hence, the employee benefits are not presented in the Consolidated Statement of Income as a separate line-item but are separately disclosed in the Notes to the Annual Financial Statements.

Employee benefits increased by $11.7 million, or 12.6%, from $92.5 million for the year ended December 31, 2023 to $104.2 million for the year ended December 31, 2024. The increase was primarily driven by total salary expense as a result of total number of full time employees increased to 404 in 2024 from 382 in 2023.

The following table summarizes employee benefits for the years ended December 31, 2024 and 2023.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2024** | **2023** |
| Salaries | (80026) | (71690) |
| Social security costs | (9278) | (8604) |
| Pension costs | (3629) | (2980) |
| Share-based compensation | (11253) | (9251) |
| **Total** | **(104186)** | **(92525)** |

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***Fair value gain (loss) on revaluation*** 

Fair value gain (loss) on revaluation increased by $5.9 million, or 636.6%, from a $0.9 million loss in 2023 to a gain of $5.0 million in 2024. This increase was primarily driven by a fair value gain of $7.0 million in 2024 upon the reclassification of the convertible bond-related derivative to equity. This fair value gain was a result of the decrease in value of the option component classified as a derivative from issuance until the physical settlement date of the newly issued convertible bond. This is offset by a fair value loss of $2.1 million in 2024 on our investments in debt instruments designated as at FVTPL.

***Other finance income***

Other finance income increased by $3.2 million, or 86.8%, from $3.7 million for the year ended December 31, 2023 to $6.8 million for the year ended December 31, 2024. This increase was primarily caused by fluctuations in the U.S. dollar versus Euro during 2024 and 2023, which led to a foreign currency gain of $2.0 million. This had a particular impact on the bank balances in U.S. dollars, incorporated in our Dutch entities where the functional currency is Euro.

Since 2023, we have used excess cash to invest in Euro-denominated readily convertible S&P AAA-rated government treasury certificates with a maturity of six months or less from the date of acquisition. Since 2024, excess cash has also been used to invest in money market funds. As a result of these purchases, interest income has increased compared to 2023.

The following table summarizes our other finance income for the years ended December 31, 2024 and 2023.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2024** | **2023** |
| Interest income | 4858 | 3663 |
| Foreign currency gains | 1985 |  |
| **Other finance income** | **6843** | **3663** |

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***Other finance expenses***

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Other finance expenses increased by $0.9 million, or 9.6%, from $9.1 million for the year ended December 31, 2023 to $9.9 million for the year ended December 31, 2024. The increase mainly stemmed from our new convertible bond, for which increased interest expenses are applicable. This is offset by the foreign currency losses in 2023, which for 2024 reported a foreign currency gain.

The following table summarizes our other finance expenses for the years ended December 31, 2024 and 2023.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2024** | **2023** |
| Interest loans and borrowings | (7699) | (4876) |
| Fees and expenses on repayment and issuance convertible bonds | (1151) |  |
| Interest leases | (1038) | (1088) |
| Other financial expenses | (56) | (134) |
| Foreign currency losses |  | (2971) |
| **Other finance expenses** | **(9944)** | **(9069)** |

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***Share of net profits (loss) in associates using the equity method***

Share of net profits (loss) in associates using the equity method increased by $1.5 million, or 509.0%, from a $0.3 million loss for the year ended December 31, 2023 to a $1.8 million loss for the year ended December 31, 2024. This is the result of increased losses from BioConnection and a required impairment on the investment accounting for using the equity method.

***Income tax credit (expense)***

Income tax credit (expense) increased by $4.8 million, from $1.5 million credit for the year ended December 31, 2023 to a $3.3 million expense for the year ended December 31, 2024. This change resulted primarily from a combination of various smaller nondeductible items on the income statement and balance sheet movements across tax jurisdictions, which caused the income tax credit to shift into an expense.

The following table summarizes Pharming's income tax credit (expense) for the years ended December 31, 2024 and 2023.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **2024** | **2023** |
| Total current tax credit (expense) | (8972) | (5102) |
| Total deferred tax credit (expense) | 5623 | 6566 |
| **Income tax credit (expense)** | **(3349)** | **1464** |

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**Key Business and Non-GAAP Financial Measures** 

The success of Pharming is reflected in its operating and financial track record to date. We use EBIT, EBITDA, Adjusted EBITDA, Net Debt, and Operating Profit as measures to evaluate and manage our business on an ongoing basis. We believe these measures to be useful for investors to compare key financial data both within and across reporting periods. Specifically, we believe that EBIT, EBITDA, and Adjusted EBITDA provide investors with a supplemental measure of our operating performance and highlight trends in our core business that may not otherwise be apparent when relying solely on IFRS measures. Moreover, we believe that inclusion of Net Debt is appropriate to provide investors information on our ability to meet debt obligations by using cash and cash equivalents.

Some of these measures are not calculated in accordance with IFRS and we collectively refer to these as non-GAAP financial measures. These are defined as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• EBIT – Earnings before interest and tax. Defined as profit for the year adjusted to exclude income tax credit (expense), interest income and interest expenses on leases and the convertible bonds.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• EBITDA – Earnings before interest, tax, depreciation and amortization. Defined as profit for the year adjusted to exclude income tax credit (expense), interest income (expense), depreciation of property, plant and equipment, depreciation of right-of-use assets and amortization of intangible assets.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Adjusted EBITDA – Defined as profit for the year adjusted to exclude income tax credit (expense), interest income (expense), depreciation of property, plant and equipment, depreciation of right-of-use assets, amortization of intangible assets and impairments of right-of-use and intangible assets as defined.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Net Debt – Defined as current plus non-current convertible bonds minus cash and cash equivalents minus marketable securities and minus current and non-current restricted cash

To provide investors with additional information regarding our financial results we have provided a reconciliation below of EBIT, EBITDA and Adjusted EBITDA to profit for the year, the most directly comparable IFRS financial measure.

We have included EBIT, EBITDA, and Adjusted EBITDA in our Annual Report because we believe these measures are useful for investors to compare key financial data both within and across reporting periods. Specifically, we believe that these measures provide investors with a supplemental measure of our operating performance and highlights trends in our core business that may not otherwise be apparent when relying solely on IFRS measures. In particular, the exclusion of certain expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core business.

Our use of EBIT, EBITDA and Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. Some of these limitations are:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• They do not reflect changes in, or cash requirements for, our working capital needs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• They do not reflect tax payments that may represent a reduction in cash available to us; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Other companies, including companies in our industry, may calculate these measures differently, which reduces its usefulness as a comparative measure.

The table below presents a reconciliation of the non-GAAP measures to the measures disclosed in our Annual Report for the periods indicated:

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| | | | |
|:---|:---|:---|:---|
| | **Years ended December 31,** | **Years ended December 31,** | **Years ended December 31,** |
| Amounts in $'000 | **2025** | **2024** | **2023** |
| **Profit (loss) for the year** | **2538** | **(11841)** | **(10548)** |
| Income tax credit (expense) | (10310) | (3349) | 1464 |
| Interest income and interest expenses on leases and the convertible bonds<sup>(1)</sup> | (8543) | (3879) | (2301) |
| **EBIT** | **21390** | **(4613)** | **(9711)** |
| *Add*: Depreciation of PPE and RoU<sup>(1)</sup> | 4674 | 4769 | 5158 |
| *Add*: Amortization of intangible assets | 6541 | 6273 | 5852 |
| **EBITDA** | **32606** | **6429** | **1299** |
| *Add*: Impairment charges<sup>(2)</sup> | 491 | 5027 | 4916 |
| **Adjusted EBITDA** | **33097** | **11456** | **6215** |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) In order to better reflect and align with the definition of the non-GAAP measures EBIT, EBITDA and adjusted EBITDA, the comparative financial information for 2023 has been restated. This restatement ensures consistency in the presentation and enhances comparability with the current period. There was no impact on the underlying financial performance or position of the company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) The impairment charge in 2025 of $0.5 million and in 2024 of $5.0 million consists of impairment charges related to Right-of-Use assets for the downstream facility in Oss. The impairment charge in 2023 of $4.9 million primarily consists of impairment charges related to the same Right-of-Use assets of $4.7 million and intangible assets of $0.3 million. For further details, refer to Note 10, 11 and 12 in the Annual Financial Statements included elsewhere in this Annual Report.

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To provide investors with additional information regarding our financial results, we have disclosed in the table below Net Debt, a non-GAAP financial measure. We have provided a reconciliation below of Non-current convertible bonds to net debt, the most directly comparable IFRS financial measure. Net debt is a useful indicator of the Company's indebtedness, financial flexibility and capital structure because it indicates the level of debt after taking account of cash and cash equivalents and marketable securities within the Company's business that could be utilized to pay down the outstanding borrowings.

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| | | | |
|:---|:---|:---|:---|
| | **Years ended December 31,** | **Years ended December 31,** | **Years ended December 31,** |
| Amounts in $'000 | **2025** | **2024** | **2023** |
| **Non-current convertible bonds** | **92719** | **78154** | **136598** |
| Add: Current convertible bonds | 5336 | 4245 | 1824 |
| Less: Cash and cash equivalents | (145305) | (54944) | (61741) |
| Less: Marketable securities | (33796) | (112949) | (151683) |
| Less: Current and non-current restricted cash | (1988) | (1505) | (1528) |
| **Net Debt** <sup>(2)</sup> | **(83034)** | **(86999)** | **(75268)** |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) Amortised cost as per the balance sheet.

**B. Liquidity and Capital Resources**

***Liquidity and Capital Resources***

Cash and cash equivalents (excluding restricted cash) and marketable securities amounted to $179.1 million, as at December 31, 2025. During 2025, we financed the acquisition of Abliva AB and our operations primarily through sales of our commercial products. We expect that our marketing and sales, research and development and general and administrative costs will increase for the foreseeable future as we continue commercializing our approved products and advancing the clinical development of our product candidates. We expect that our research and development and sales, general and administrative costs will increase in connection with conducting clinical trials for our product candidates and any new product candidates we acquire or develop and due to the costs of seeking marketing approval for our product candidates in Europe, the United States and other jurisdictions.

The 2025 year-end balance of cash and cash equivalents (excluding restricted cash) and marketable securities of $179.1 million is expected to fund our operations for more than twelve months from the date of this Annual Report. The receipts from commercial supply of product to our partners in Latin America, South Korea and Israel and proceeds from direct sales in the United States and Europe currently generate more cash than we require for day-to-day expenses and to supply those sales, and thus the surplus cash generated will support our capital expenditure plans and financial reserves further.

Presently, however, no further assurance can be given on either the timing or size of future profits or whether consistent net profitability can be maintained on this basis. In addition, in the event that we need to raise capital by issuing additional shares, shareholders' equity interests may be diluted as to voting power, and their interests as to value will depend on the price at which such issues are made. We see no further need to raise capital to support our current operations, but may take an opportunity to do so in either equity issue, through an expansion of the current convertible debt or to raise debt, or through a combination of such instruments, to support an acquisition or in-licensing of additional assets, if appropriate terms can be obtained that are in the best interests of shareholders.

***Cash Flows***

The table below provides selected cash flow information for the years ended December 31, 2025, 2024 and 2023.

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---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Net cash flows generated from (used in) operating activities | 54708 | (1795) | (17302) |
| Net cash flows generated from (used in) investing activities | 26252 | 31618 | (129388) |
| Net cash flows generated from (used in) financing activities | 1495 | (34412) | (1039) |
| Exchange rate effects | 7907 | (2208) | 2128 |
| **Net change in cash and cash equivalents** | **90362** | **(6797)** | **(145601)** |

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*Operating Activities* 

Net cash flows from operating activities was $54.7 million for the year ended December 31, 2025, compared to net cash flows used in operating activities of $1.8 million for the year ended December 31, 2024. The increase of $56.5 million was mainly related to a significant increase in working capital of $20.5 million, mainly driven by an increase in payables and other non current liabilities and higher positive non-cash adjustments for other finance expenses (including unrealized foreign exchange results).

Net cash flows used in operating activities was $1.8 million for the year ended December 31, 2024, compared to net cash flows used in operating activities of $17.3 million for the year ended December 31, 2023. The decrease of $15.5 million was mainly related to a significant increase in working capital of $6.9 million and the negative impact of changes in non-cash adjustments related to the gain on disposal from the PRV sale of $21.3 million in 2023, which does not occur in 2024, partially offset by $15.6 million income taxes received in 2024.

*Investing Activities* 

Net cash flows generated from investing activities for the year ended December 31, 2025, were $26.3 million, compared to net cash flows generated from investing activities of $31.6 million for the year ended December 31, 2024. The decrease of $5.4 million was primarily due to the cash used for the acquisition of Abliva AB of $57.5 million (net of cash acquired), largely offset by higher (net) proceeds from investments in marketable securities of $54.7 million.

Net cash flows generated from investing activities for the year ended December 31, 2024, were $31.6 million, compared to net cash flows used in investing activities of $129.4 million for the year ended December 31, 2023. The increase of $161.0 million was primarily due to the proceeds from sale of marketable securities of $314.6 million, partially offset by the purchases of marketable securities of $284.3 million and the impact of the cash inflow of $21.3 million related to proceeds on the PRV sale in 2023, which did not occur in 2024.

*Financing Activities* 

Net cash flows generated from financing activities for the year ended December 31, 2025, were $1.5 million, compared to net cash flows used in financing activities of $34.4 million for the year ended December 31, 2024. This change of $35.9 million is mainly driven by a net outflow of $30.4 million occurring in 2024 related to the repurchase and issue of convertible bonds, as well as higher proceeds from the exercise of share-based compensation awards of $14.2 million, partially offset by cash flows for the acquisition of non-controlling interests in Abliva AB of $7.9 million.

Net cash flows used in financing activities for the year ended December 31, 2024, were $34.4 million, compared to $1.0 million for the year ended December 31, 2023. This change of $33.4 million was primarily related to the repurchase of convertible bonds of $134.9 million, offset by the net proceeds of issued convertible bonds of $104.5 million.

**Sources of Liquidity**

*Convertible bonds*

In April 2024, the Company offered €100.0 million ($103.5 million) of senior unsecured convertible bonds due 2029 (the "New Bonds") convertible into new and/or existing ordinary shares of the Company. The offer was

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fully subscribed. The net proceeds of the issue of the bonds were used for the repurchase of the outstanding €125.0 million ($129.4 million) 3.0% senior unsecured convertible bonds due 2025 issued on January 21, 2020 (ISIN: XS2105716554), which has been launched concurrently to the offering of the New Bonds to strengthen its financial position while enhancing flexibility for the continued execution of its business strategy over the next several years.

The New Bonds have a principal amount of €100,000 each. The New Bonds are issued at par and carry a coupon of 4.5% per annum payable semi-annually in arrears in equal installments on April 25 and October 25 of each year, commencing on October 25, 2024. Unless previously converted, redeemed or purchased and cancelled, the New Bonds will be redeemed at par on April 25, 2029.

The initial conversion price has been set at €1.2271 ($1.2700), representing a premium of 37.5% above the volume weighted average price (VWAP) of a Company ordinary share on Euronext Amsterdam between opening of trading on the launch date and the pricing of the offering (i.e., €0.8924 ($0.9236)). The initial conversion price of the New Bonds will be subject to customary adjustment provisions as set out in the terms and conditions. The number of ordinary shares initially underlying the New Bonds is 81,492,951, representing 12.0% of the Company's issued share capital at the time the New Bonds were issued. The New Bonds are listed on the Frankfurt Exchange (ISIN: XS2763018889).

The New Bonds are classified as hybrid financial instruments under IAS 32, pursuant to which the debt host contract and the embedded derivative for the fair value of the conversion rights into Company shares (the "conversion option") are recognized separately. Initial recognition values for the individual components were determined as follows:

The conversion option was at initial recognition measured using a pricing model. As the Company did not have sufficient placement capacity to fulfil conversion of the New Bonds into ordinary shares at the date of issue, the conversion option was recognized as a financial liability derivative. During the shareholder's meeting on May 21, 2024, the Company received shareholder approval to increase share capital to support the potential conversion. At the Physical settlement notice date of June 11, 2024, when the New Bond holders were notified that the cash settlement alternative would no longer be available, the conversion option was reclassified to equity at fair value, which resulted in a fair value gain of $7.0 million immediately prior to the reclassification. Subsequently, the value of this equity component is not remeasured, apart from currency revaluation, and amounts to $13.8 million, net of income tax effects, at December 31, 2025.

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| | | |
|:---|:---|:---|
| **Parameter** | **At initial recognition** | **Immediately prior to reclassification** |
| Share price | 0.8924 | 0.7690 |
| Conversion price per share | 1.2271 | 1.2271 |
| Dividend yield | —% | —% |
| Expected term in years | 5.00 | 4.85 |
| Risk-free rate | 2.90% | 3.01% |
| Volatility | 44.34% | 43.99% |
| Barrier price per share | 1.5952 | 1.5952 |

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The debt host contract component was measured at initial recognition as the difference between the proceeds from the bond and the value of the conversion option at initial recognition. This debt host contract is subsequently measured at amortized cost, which amounts to $98.1 million at December 31, 2025.

Direct costs associated with the issue of the New Bonds were allocated to the debt host contract ($2.2 million) and the conversion option ($0.6 million) in amounts proportional to the above mentioned initial value. They were accounted for respectively in the amortized cost (debt host contract) and in the income statement (conversion option).

**C. Research and Development, Patents and Licenses, etc.**

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Full details of our research and development activities and expenditures are given in "Item 4 - A. Business Overview" and "Item 5 - A. Operating Results" of this Annual Report.

**D. Trend Information**

See "Item 5 - A. Operating Results" of this Annual Report.

**E. Critical Accounting Estimates**

Our Annual Financial Statements have been prepared in accordance with IFRS as issued by the IASB. In the application of accounting policies, certain judgments, estimates and assumptions about the value of assets and liabilities for which there is no definitive third-party reference were required. The estimates and associated assumptions are based on historical experience and other factors that were considered to be relevant. Actual results may differ from these estimates. These estimates and assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revisions and future periods if the revision affects both current and future periods. For a discussion of the estimates and assumptions used by us in the preparation of our financial statements, see Note 2.5 of our Annual Financial Statements for the year ended December 31, 2025.

**Item 6. Directors, Senior Management and Employees** 

**A. Directors and Senior Management**

**Board Structure** 

We have a one-tier board structure, with a single board of directors consisting of executive directors and non-executive directors. Our Chief Executive Officer, or CEO, serves as our executive director.

Our senior management team is comprised of our executive director together with our executive officers and certain other senior personnel and is referred to as the Executive Committee.

**Senior management and Directors** 

The following table sets forth information regarding our members of senior management and directors, including their ages, as of December 31, 2025. We have determined that all members of senior management other than Maryana Reurings-Tsiganko are executive officers. Our executive director is also an executive officer.

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| | | | |
|:---|:---|:---|:---|
| **Name**<br>***Executive Directors:*** | **Age** | **Position(s)** | **Term Expiring** |
| Fabrice Chouraqui, PharmD, MBA | 55 | Chief Executive Officer, Chair Executive Committee | 2029 |
| ***Senior Management:*** |  |  |  |
| Kenneth Lynard, MSc, EMBA | 57 | Chief Financial Officer | n/a |
| Anurag Relan, MD, MPH | 53 | Chief Medical Officer | n/a |
| Leverne Marsh, BPharm | 49 | Chief Commercial Officer, <br>effective as of January 1, 2026 | n/a |
| Mireille Sanders, MSc | 57 | Chief Operations Officer | n/a |
| Ruud van Outersterp | 61 | Chief Legal & Compliance Officer | n/a |
| Alexander Breidenbach, PhD, MBA | 62 | Chief Business Officer | n/a |
| Inés Bernal | 48 | Chief People Officer | n/a |
| Maryana Reurings-Tsiganko, MBA, CIA, CISA, CFE | 37 | Vice President, Strategy & Operations | n/a |
| ***Non-Executive Directors:*** |  |  |  |
| Richard Peters, MD, PhD <sup>(3)(6)(8)</sup> | 63 | Chairperson | 2027 |
| Mark Pykett, PhD, VMD, MBA <sup>(2)(8)</sup> | 61 | Vice Chairperson | 2028 |
| Barbara Yanni, JD, LLM <sup>(3)(6)(7)</sup> | 71 | Non-Executive Director | 2028 |
| Leonard Kruimer, MBA, CPA <sup>(1)(8)</sup> | 67 | Non-Executive Director | 2029 |
| Jabine van der Meijs, PharmD, MSc, ACMA/CGMA <sup>(2)(3)(5)</sup> | 59 | Non-Executive Director | 2029 |
| Elaine Sullivan, PhD <sup>(2)(4)</sup> | 65 | Non-Executive Director | 2029 |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

<u>Notes:</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) Chair of the Audit Committee

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) Member of the Audit Committee

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) Member of the Remuneration Committee

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(4) Chair of the Remuneration Committee

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(5) Chair of the Corporate Governance Committee

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(6) Member of the Corporate Governance Committee

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(7) Chair of the Transaction Committee

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(8) Member of the Transaction Committee

***Executive Directors***

*Fabrice Chouraqui, PharmD, MBA.* Appointed Chief Executive Officer and Executive Director in March 2025, Fabrice is responsible for Pharming's strategy and day-to-day operations, guiding Pharming's continued growth as a global rare disease company. Fabrice also serves as an independent Board member of OranoMed. Fabrice brings more than 30 years of global biopharma experience across R&D, commercialization, and venture-backed innovation. Prior to joining Pharming, he was a CEO-Partner at Flagship Pioneering and served as Chief Executive Officer of Cellarity, Inc. He spent a decade at Novartis, including as President of Novartis Pharmaceuticals USA, and held senior global and regional leadership roles. Earlier in his career, he held international leadership positions at Bristol-Myers Squibb in Europe and across Asia-Pacific, after beginning in research and development roles within the Sanofi legacy organization. He holds an MBA from INSEAD, a Doctorate in Pharmacy, a postgraduate degree in Quality Assurance of Medicines, and an MSc in Biological and Medicinal Sciences from Université Paris Cité (University Paris V).

***Senior Management***

*Kenneth Lynard, MSc, EMBA.* Since October 2025, Kenneth has served as Chief Financial Officer, or CFO, of Pharming. Kenneth brings nearly three decades of international finance leadership, including more than 20 years in the global life sciences industry. He has held senior finance roles across the United States and Europe, supporting both established pharmaceutical companies and growth-stage biopharmaceutical organizations. Prior to joining Pharming, Kenneth served as CFO of Schoeller Allibert and previously held CFO positions at Zentiva and Affidea, both Private Equity backed companies. Earlier in his career at Gilead Sciences, he served as Senior

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Vice President Finance for Global Commercial Operations, R&D, and Manufacturing, contributing to a period of significant transformation and expansion into new therapeutic areas and markets. Kenneth began his career in public accounting at Arthur Andersen before moving into senior finance leadership roles at Medtronic, Coloplast, and Superfos. He holds a Master of Science (MSc) in Business Economics and Auditing from Copenhagen Business School and an Executive MBA from IMD in Lausanne, Switzerland.

 *Anurag Relan, MD, MPH*. Anurag Relan has been an integral part of Pharming for nearly two decades and was appointed Chief Medical Officer in June 2021. He leads the Pharming's global medical strategy, including clinical development, regulatory engagement, patient safety, and medical affairs. Previously, as Vice President of Clinical Research and Medical Affairs, Anurag began his career in clinical practice and academic medicine, teaching residents and medical students at the University of California, Los Angeles Medical Center, and he continues to practice as a physician. He has co-authored more than 30 publications in leading peer-reviewed medical journals, many focused on hereditary angioedema and rare disease. He holds an M.D. and a Master of Public Health (M.P.H.) from the University of California, Los Angeles, and a bachelor's degree in economics from the University of California, Berkeley.

*Leverne Marsh, BPharm.* Appointed Chief Commercial Officer in January 2026, Leverne leads Pharming's global commercial strategy across market access, marketing, sales, and lifecycle management. She combines deep commercial expertise with practical experience applying AI and analytics to shape customer insight, using those skills to strengthen the connection between Pharming and the patients it serves. Leverne brings nearly 30 years of life-sciences commercial leadership. She has held senior roles at Novartis, where she led major product launches and served as Chief Product Officer and Head of Strategy, and at Dexcom, where she was Executive Vice President, Marketing, driving growth and international expansion. A trained pharmacist, Leverne began her career in pharmacy and holds a BPharm from the University of Port Elizabeth, South Africa.

*Mireille Sanders, MSc.* Appointed Chief Operations Officer in 2020, Mireille oversees Pharming's end-to-end operations, from development and manufacturing to quality and distribution of commercial and clinical supplies. Mireille joined Pharming as Senior Vice President of Operations in 2019. She brings 30 years of operational leadership across the life-sciences sector, including senior roles at Janssen Pharmaceuticals (Head of Clinical Supply Chain Strategic Management and Systems) and MSD/Merck. Mireille also represents Pharming on the Supervisory Board of BioConnection, a Netherlands-based CDMO specializing in sterile injectable manufacturing. She holds an MSc in Chemical Engineering from the Technical University of Eindhoven (TU/e), the Netherlands.

*Ruud van Outersterp.* Appointed Chief Ethics and Compliance Officer in 2021, Ruud's role was updated in 2025 to Chief Legal and Compliance Officer and Company Secretary. He leads Pharming's global legal, compliance, and governance activities, ensuring Pharming operates with integrity across drug development and commercialization. Ruud first joined Pharming in 2020 as Company Secretary, and held that role until April 2022, strengthening corporate governance, board processes, and regulatory compliance. He brings more than 35 years of legal leadership experience across financial services, aerospace, and life sciences. Prior to Pharming, he held several senior roles at ABN AMRO and its predecessors, including Global Head of Legal and Company Secretary. In addition to his executive role, Ruud serves on the Supervisory Board of a Dutch healthcare institution providing a broad range of care services, primarily to elderly individuals and people with physical disabilities, and he teaches corporate governance at the Governance Academy in the Netherlands. He holds a Master of Laws (LLM) from the Vrije Universiteit Amsterdam.

*Alexander Breidenbach, PhD, MBA.* Appointed Chief Business Officer in September 2023, Alexander leads Pharming's growth strategy and business development agenda. He is responsible for evaluating and executing partnerships and transactions that strengthen Pharming's portfolio and long-term value. Alexander brings more than 25 years of global experience across partnering, R&D, and management in the biosciences sector. Prior to joining Pharming, he served as Chief Business and Chief Development Officer at ACM Biosciences AG and held a range of senior leadership roles at Roche Partnering, where he worked across global business development, due diligence, and deal execution, including in rare disease. Earlier in his career, he began as a senior scientist in pharmacology, grounding his work in the science behind the assets he evaluates. He holds a PhD in Biochemistry from the Tierärztliche Hochschule (University of Veterinary Medicine) Hannover, Germany, and an MBA from ESSEC Paris and Mannheim Business School.

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*Inés Bernal.* Inés has served as Pharming's Chief People Officer since December 2024. She leads the Pharming's global people and culture strategy, overseeing talent, leadership development, organizational effectiveness, and core HR capabilities—supporting teams to do their best work in service of patients. Inés brings more than 25 years of human resources leadership across global organizations. Prior to joining Pharming, she was Global Vice President, Human Resources at Celanese Corporation. Earlier, she held senior HR roles across a range of industries, including GlaxoSmithKline, Yum! Restaurants (KFC, Taco Bell, Pizza Hut), and The Boeing Company. Inés holds a postgraduate degree in Business Economics and Strategic Human Resources and a bachelor's degree in Industrial Relations and Human Resources from the University of New South Wales in Sydney, Australia.

*Maryana Reurings-Tsiganko, MBA, CIA, CISA, CFE.* Appointed Vice President, Strategy & Operations in November 2025, Maryana serves as a strategy partner to Pharming's leadership team. She oversees the development and execution of the company's long-term strategy and leads key cross-functional initiatives that strengthen how the organization operates and delivers. Maryana joined Pharming in May 2021 and has held several leadership roles across the business, most recently serving as Interim Head of Finance and IT and as Program Director for end-to-end process transformation. She brings more than 15 years of experience across corporate finance, strategic operations, risk management, IT security, and internal audit and control, with prior senior roles at Sherwin Williams, Avery Dennison, OCI N.V., PNC, and KeyBank. Maryana holds an MBA with a focus in Finance and Supply Chain and a BA in International Business from Cleveland State University (Ohio, U.S.). She also holds multiple professional certifications, including Certified Internal Auditor (CIA), Certified Information Systems Auditor (CISA), and Certified Fraud Examiner (CFE).

***Non-Executive Directors*** *Richard Peters, MD, PhD.* Richard has served as Chairman of Pharming's Board of Directors since September 25, 2023, and is a member of the Remuneration, Corporate Governance and Transaction committees. He brings more than 30 years of experience across life sciences leadership and academia, including as Global Head, Rare Diseases at Sanofi Genzyme and CEO of two Nasdaq-listed biotechnology companies, Merrimack Pharmaceuticals and Yumanity Therapeutics. Richard also serves as a Non-Executive Director of Aprea Therapeutics, Founder and Executive Chairman of TellBio, and a corporate advisor to Aura Biosciences. Earlier in his career, he held medical leadership roles at Amgen, Onyx Pharmaceuticals, Genzyme and Sanofi, and is a founder of X4 Therapeutics. He completed internal medicine training at Massachusetts General Hospital and a Howard Hughes post-doctoral fellowship at Harvard Medical School. He holds an M.D. and a Ph.D. in Pharmacology from the Medical University of South Carolina and began his medical studies at the Université Catholique de Louvain in Belgium.

*Mark Pykett, PhD, VMD, MBA.* Mark has served as a Non-Executive Director since December 2020. He is Vice Chairman of the Board and a member of the Audit and Transaction committees. He brings more than 30 years of leadership experience across the biotechnology sector, spanning scientific, operational, and executive roles. Mark is currently Chief Executive Officer and Director of Orogen Therapeutics and serves on the Board of the private company Myopax. He previously served as President and Chief Executive Officer of Myrtelle, Inc., Chief Scientific Officer of PTC Therapeutics, and President and Chief Executive Officer of Agilis Biotherapeutics until its acquisition by PTC Therapeutics in 2018. Earlier roles include CEO of Navidea Biopharmaceuticals and senior leadership positions at Alseres Pharmaceuticals, Cygenics, and Cytomatrix. He holds a Ph.D. in Molecular Biology and a V.M.D. from the University of Pennsylvania, a B.A. in Biology from Amherst College, and an MBA from Northeastern University.

*Barbara Yanni, JD, LLM..* Barbara has served as a Non-Executive Director since December 2020 and is the Chair of the Transaction Committee, and a member of the Remuneration and Corporate Governance committees. She brings deep expertise in licensing, corporate development, and healthcare strategy and finance. Barbara currently serves on the Board of Directors of Trevena, Inc., and two private biotechnology companies, Mesentech and Delsona Therapeutics. She previously served on the boards of several biotechnology companies including Oncorus, Inc. (2021–2023) and Vaccinex (2015–2025). She spent nearly three decades at Merck & Co., including as Vice President and Chief Licensing Officer (2001–2014), after earlier roles spanning corporate development, financial evaluation, and tax strategy. She began her career as a tax lawyer in New York City. She earned a J.D. from Stanford Law School and an A.B. from Wellesley College, and holds an LL.M. in Taxation from New York University.

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*Leonard Kruimer,MBA, CPA.* Leonard has served as a Non-Executive Director since May 2021. He is Chair of the Audit Committee and a member of the Transaction Committee. He brings more than 40 years of experience in corporate finance, planning and strategy, including 25 years in senior executive roles within private and publicly listed biotechnology companies. Leonard currently serves as Chairman of the Board at BioInvent International AB and serves as a board member of Zealand Pharma A/S and Basilea Pharmaceutica. He is also a Director of AI Global Investments (Netherlands) PCC Ltd. He previously served as CFO of Crucell N.V. (1997–2011) and held earlier roles including Managing Director at TIP Trailer (GE Capital), consultant at McKinsey & Company, and auditor at Price Waterhouse & Company in New York. He holds an MBA from Harvard Business School, a BBA from the University of Massachusetts Amherst, and is a Certified Public Accountant in New York State.

*Jabine van der Meijs, PharmD, MSc, ACMA/CGMA.* Jabine has served as a Non-Executive Director since May 2021. She is Chair of the Corporate Governance Committee and a member of the Audit and Remuneration committees. She brings more than 30 years of senior leadership experience across finance, strategy and HR in global energy and airport management, with executive roles in the Netherlands, Scotland, England, Brunei and Australia. She previously served as Executive Vice President and CFO of Royal Schiphol Group (2017–2021) and spent 25 years at Royal Dutch Shell, including as VP Finance Projects for Shell's Projects & Technology business. Jabine is a Non-Executive Director at VFS Global AG and Grundfos Holding A/S and serves on the Supervisory Boards of Chane and the Centre for Human Drug Research. She holds a PharmD and an MSc (Pharmacy) from Utrecht University and is ACMA/CGMA qualified.

*Elaine Sullivan, PhD.* Elaine has served as a Non-Executive Director since June 2025. She is Chair of the Remuneration Committee and a member of the Audit Committee. She brings more than 25 years of international experience in the pharmaceutical and biotechnology industry, spanning R&D leadership, business development, and company creation. Elaine currently serves as a Non-Executive Director at Zealand Pharma A/S, Senior Non-Executive Director at hVIVO, and a Non-Executive Director of Ochre Bio. She has extensive international board experience across public biotechnology companies in Europe, including Sweden, Norway, Denmark, Germany and the United Kingdom. She previously co-founded Carrick Therapeutics and served as its CEO. Earlier in her career, she held senior global R&D leadership roles at Eli Lilly and AstraZeneca, including Vice President, Global External R&D at Lilly and Vice President and Head of New Opportunities at AstraZeneca. Elaine holds a PhD in Molecular Virology from the University of Edinburgh and a BSc (Hons)

in Molecular Biology from the University of Glasgow.

**B. Compensation**

***Overview of our Remuneration Policy***

In accordance with Dutch law, the remuneration packages for the directors and executive officers are determined by the Board of Directors, without the involvement of the executive directors in the deliberations and decision-making concerning their own remuneration. The Board of Directors is authorized to determine the remuneration packages of the executive and non-executive directors in accordance with the remuneration policy that has to be adopted every four years by the General Meeting of Shareholders.

We have a remuneration policy that has been aligned with the revised European Union Shareholder Rights Directive, or "SRD II", and prevailing best practices, which has been approved at a General Meeting of Shareholders. Arrangements in the form of shares or rights to subscribe for shares will each time remain subject to the approval of the shareholders at the General Meeting, notwithstanding the adopted policy.

Our remuneration policy has been designed to support our continuous efforts aimed at improving the overall performance, facilitating growth and sustainable success and enhancing the other long-term value and interests of our Company, providing remuneration packages that are competitive to attract the required executive and non-executive talent and expertise for reaching these objectives in accordance with the long-term strategy.

The remuneration policy is based on the overarching principle that the average level of total remuneration of both the executive directors and officers is consistent with the position of our Company relative to the benchmark groups that are relevant to us. Every two years, an independent consultant makes a market comparison (remuneration benchmark). The peer group each time consists of a group of European and U.S. integrated and commercial stage listed companies active in Life Sciences, reflecting our Company's operating

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areas and the markets most relevant in relation to the recruitment and retention of top talent, including the important U.S. market.

EU and U.S. benchmark group:

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| | | | |
|:---|:---|:---|:---|
| Europe | Europe | U.S. | U.S. |
| ADC Therapeutics, Epalinges | Idorsia CH (NEW) | Akebia Therapeutics (NEW) | Ligand Pharmaceuticals |
| Autolus Therapeutics, London | Immunocore UK (NEW) | Anika Therapeutics | MannKind |
| Basilea Pharmaceutica, Basel | Kiniksa Pharmaceuticals UK (NEW) | Ardelyx (NEW) | Mirum Pharmaceuticals |
| Bavarian Nordic, Hellerup | Merus, Utrecht | BioCryst PharmaCeuticals | Rigel Pharmaceuticals |
| BioGaia, Stockholm | Oxford Biomedica, Oxford | Coherus BioSciences | Supernus Pharmaceuticals |
| Biotest, Dreieich | Santhere Pharmaceuticals CH (NEW) | Collegium Pharmaceutical | Travere Therapeutics |
| Cosmo Pharmaceuticals Dublin | uniQure Amsterdam | Esperion Therapeutics (NEW) | Vanda Pharmaceuticals |
| Formycon Planegg DE (NEW) | Valneva Saint-Herblain | Harmony Biosciences (NEW) | Xeris Biopharma (NEW) |
| Galapagos BE | | Heron Therapeutics | |

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The Remuneration Committee initiated a review of the peer group in 2025 to ensure the continued best fit of the included companies in terms of financial, market and business profile, sector, and business/product focus while taking into consideration Pharming's positioning among the peer group and in respective markets. This review resulted in the following changes:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• MorphoSys (EU), Immunogen (US), and Intercept Pharmaceuticals(US) were acquired by Novartis, AbbVie and Alfasigma, respectively, and were, therefore, removed from the peer group.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In addition, the following companies were removed:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ US peers:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Enanta Pharmaceuticals

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Ironwood Pharmaceuticals

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Karyopharm Therapeutics

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ European peers:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Alliance Pharma

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Camurus

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Innate Pharm

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Zealand Pharma

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Several new companies were added. These companies have been highlighted as "NEW" in the above overview.

A consistent and competitive remuneration structure, which applies across the workforce, is another core principle of our remuneration policy to promote a culture of shared purpose and performance, focusing all executive directors, other executive officers and staff members on delivering on our mission, vision and strategy and creating long-term stakeholder value.

We disclose information regarding remuneration paid to the executive and non-executive directors in our Dutch Annual Report of the Company, in line with the applicable rules and regulations. The remuneration amounts paid to individual executive officers are not required to be disclosed according to Dutch law. Total remuneration paid to the executive officers during the year ended December 31, 2025, was $14.4 million.

***Executive Directors and Officers***

The remuneration packages of the executive directors and officers consist of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Fixed remuneration in the form of an annual base salary;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Performance-based variable remuneration in the form of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Short-term incentives, in the form of an annual bonus of cash as a percentage of the fixed component, and;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Long-term incentives, in the form of the grant of restricted shares; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Others benefits, including contribution of pension premiums, travel allowance and holiday allowance.

The respective fixed and variable remuneration elements are explained below:

*Historical Remuneration* 

The following table reflects the remuneration amounts paid to the Executive Directors in the year ended December 31, 2025:

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Fixed remuneration** | **Short-term variable: annual bonus** | **Share-based payments** | **Post-employment benefits** | **Other** | **Total** |
| Mr. Fabrice Chouraqui, CEO and Executive Director from March 4, 2025 | 688 | 760 | 1335 | 8 | 388 | 3179 |
| Dr. Sijmen de Vries, CEO and Executive Director until March 4, 2025 | 724 | 132 | 858 | 176 | 36 | 1926 |
|  | **1411** | **893** | **2193** | **184** | **425** | **5105** |

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The short-term variable bonus of $0.9 million in 2025 is based on the 2025 annual salary of $1.4 million. The share-based payment remuneration is based on expenses incurred during the three-year performance period of historic grants, determined at the fair market value at date of the grant, adjusted for changes in the progress of completing strategic objectives. These strategic objectives are the basis to determine the actual pay-out after the performance period was completed.

The remuneration amounts paid to individual executive officers, other than the above mentioned individual, are not required to be disclosed according to Dutch law and accordingly are not disclosed herein.

*Share Option Plan* 

The Executive Directors did not hold options during 2025.

*Long Term Incentive* 

The long-term incentive program for the Executive Directors, as approved by our shareholders in December 2020, or the Executive LTI plan, is performance-related only. The on-target value of the conditional shares to be awarded to the CEO under the Executive LTI plan annually is set at 300% (individual level of 425% was approved by our shareholders in March 2025 for CEO, Mr. Fabrice Chouraqui) of the fixed base salary, and maximum performance value of shares is set at 450% of the fixed base salary (individual level of 637.5% was approved for the CEO, Mr. Fabrice Chouraqui). The Board of Directors undertakes to ensure equity plans for staff and the Executive Director will be prudently applied and that in any event grants of equity or equity rights under these equity plans will not result in Pharming exceeding 10% of all issued and outstanding shares of Pharming on a diluted basis. The total potential dilutive impact of all awards granted under share-based compensation plans (including awards to other participants) was 6.8% as of December 31, 2025 (as of December 31, 2024: 9.2%). This constitutes a significant decrease year-on-year and reflects Pharming commitment to continue to monitor the impact closely.

The below table reflects the number of Executive LTI shares granted and vested over the year for the CEO:

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| | **Year** | **Granted** | **Settled** | **Forfeited / Unvested** | **Reserved as at December 31, 2025** |
| Mr. Fabrice Chouraqui | 2025 | 3,614,572 |  |  | 3,614,572 |

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An overview of the number of Executive LTI shares granted in 2025 and in total as well as the fair value per share award is as follows:

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| | |
|:---|:---|
| **Participant category** | **2025** |
| Executive Members of the Board of Directors | 3614572 |
| Executive Committee | 6952793 |
| **Total** | **10567365** |
| Fair value per share award ($) | 0.636 |

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The following table provides an overview of Executive LTI shares granted, forfeited or issued from 2022 to 2025 as well as the number of Executive LTI shares reserved at December 31, 2025:

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| | | | | |
|:---|:---|:---|:---|:---|
| **Participant category** | **Granted** | **Issued** | **Forfeited / Unvested** | **Reserved at December 31, 2025** |
| Executive Members of the Board of Directors | 9484199 | 0 | (3621658) | 5862541 |
| Executive Committee | 21988045 | (4193981) | (4019809) | 13774255 |
| **Total** | **31472244** | **(4193981)** | **(7641467)** | **19636796** |

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This table includes LTI shares held by individuals who ceased employment during 2025.

*Remuneration Policy for Executive Directors and Officers* 

*Fixed Compensation* 

The following table reflects the gross annual base salary (fixed remuneration) of the Executive Director/CEO and former Executive Director/CEO paid in the financial year 2025:

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| | | |
|:---|:---|:---|
| **Position** | **Fixed remuneration amount ($'000)** | **Fixed remuneration amount (EUR '000)** |
| CEO | 688 | 611 |
| Former CEO | 724 | 643 |

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*Variable Compensation* 

The variable part of the remuneration of the executive directors and officers is linked to their performance against a set of financial and non-financial targets that is consistent with and supportive of the strategy and long-term interests of our Company. Risk alignment is also embedded in the target setting to promote sound and effective risk management. At the end of the relevant performance period, the Board of Directors, without the participation of the executive directors for their performance, will determine whether the targets have been achieved.

*Short-term Incentive* 

The individual on-target bonus for the CEO has been set at 70% of the gross annual salary and the maximum on-target bonus for the CEO has been set at 140% of the gross annual salary (individual level of 75% and 150% respectively was approved by EGM for the CEO, Mr. Fabrice Chouraqui). For other executive directors and officers, the individual on-target bonus has been set at 50% of the gross annual salary, and the maximum on-target bonus has been set at 140% of the gross annual salary.

*Settlement contractual rights Sijmen de Vries, as former Executive Director/CEO until March 4, 2025*

Sijmen de Vries, as former Executive Director/CEO, resigned from the Board of Directors effective

at the closing of the EGM on March 4, 2025. As announced to our shareholders in preparation for the EGM, it

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was agreed that Sijmen de Vries remained a strategic advisor to the new CEO until December 31, 2025. In that capacity, Sijmen de Vries continued to receive his monthly base salary, based on his 2024 base salary, up to and including December 31, 2025.

In recognition of Sijmen de Vries's dedicated commitment to Pharming over the past 16 years and his willingness to remain available as a strategic advisor to the new CEO to ensure a smooth transition in the best interest of Pharming, the Board of Directors granted Sijmen de Vries the status of Good Leaver as defined in his contract. Accordingly, as announced to our shareholders in preparation for the EGM in the Explanatory Notes to the agenda that can be found on www.pharming.com, the Board of Directors decided that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Sijmen de Vries will receive the gross amount in settlement of the Short-Term Incentive Plan for the year 2025 pro-rata for the period January 1, 2025, up to and including the date of the EGM, in accordance with the regular schedule (no accelerated payout) and subject to the score on the performance targets; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the restricted shares granted to Sijmen de Vries pursuant to the Long-Term Incentive Plan for the performance periods 2023-2025 and 2024-2026, will vest in the first quarter of the year 2026 and the first quarter of the year 2027, respectively. These vesting dates are in accordance

with the regular vesting schedule (no accelerated vesting). Vesting will be subject to the score on the performance targets and the vesting percentage will be calculated pro-rata up to and including June 11, 2025, (i.e., the originally scheduled date of the expiration of the mandate of Sijmen de Vries.

Sijmen de Vries waived his right to the grant of new restricted shares pursuant to the Long-Term Incentive Plan for the performance period 2025-2027 and has not received a severance payment. The described settlement of Sijmen de Vries's outstanding contractual rights ensured that the tax liabilities for Pharming are kept to a minimum. It has been assessed that no excessive tax levy (under article 32bb of the Dutch Wage Tax Act 1964) applies to Pharming in relation to the settlement agreed with Sijmen de Vries for the full year 2025. For 2026, a separate assessment will be performed to evaluate any LTI payouts made during that year.

*One-off compensation Fabrice Chouraqui, as new Executive Director*

As shared with our shareholders on our website on February 26, 2025, in preparation for the EGM, Fabrice Chouraqui, as new Executive Director/CEO, received one-off compensation, by way of a buy-out award arrangement, in the first quarter of 2025 for the cash bonus and equity awards that he forfeited due to his resignation from his previous role at Cellarity, Inc., to become the new CEO of Pharming, i.e., (like-for-like) cash compensation equal to the forfeited value of Fabrice Chouraqui's entitlement to a short-term incentive plan in cash and compensation in the form of shares for the loss of value of equity awards.

Based on the statement received from Cellarity, Inc., as verified by Pharming, the total forfeited value was $990,000, of which $110,000 represents the forfeited cash bonus and $880,000 the forfeited equity awards (i.e., share option rights with a four-year anticipated vesting period).

This total forfeited value is substantially lower than the maximum value of $3,200,000 as was mentioned in the Explanatory Notes for the EGM.

The Board of Directors decided to grant Fabrice Chouraqui the following one-off, like-for-like compensation, by way of buy-out award and in full and final settlement of his right to compensation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)$110,000 paid in cash for the 2024 annual incentive forfeiture; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)$880,000 awarded in Restricted Share Units, which are subject to vesting in four (4) equal annual tranches of 25% each.

These details were all already shared with our shareholders, both on our website on February 26, 2025, in preparation for the EGM, and also during the EGM. The first tranche of the one-off RSU award, as part of the buy-out award, vested on February 1, 2026, and resulted in the transfer to Fabrice Chouraqui of 161,425 unconditional shares (post-tax).

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*Long-term Incentive* 

Executive directors and officers will also participate in the revised (Executive) Long-term Incentive, or LTI, program. Under this program, our ordinary shares are granted, subject to the achievement of predefined long-term strategy oriented performance objectives and targets, which apply a defined weighting, that have been set at the start of a three-year performance period. The performance objectives include the Total Shareholder Return (40% weighing) and the achievement of long-term strategy oriented objectives (60% weighing). The peer group used to determine the Total Shareholder Return is composed of the companies included in the AMX Index and the Nasdaq Biotechnology Index, represented by the IBB ETF, respectively, equally weighted.

For the executive directors, the on-target value of the (restricted) shares to be awarded under the LTI at the start of the performance period is set at 300% of the gross annual salary for the CEO (individual level of 425% was approved by EGM for the CEO, Mr. Fabrice Chouraqui) and 200% for the other executive directors and officers. The maximum value of the shares that can vest under the LTI is set at 450% of the gross annual salary for the CEO (individual level of 637.5% was approved for the CEO, Mr. Fabrice Chouraqui, by the EGM) and 300% for other executive directors and officers. Executive directors are required to retain the shares awarded under the LTI for a minimum of five years from the date of grant. The Board of Directors undertakes to ensure equity plans for staff and the Executive Director will be prudently applied and that in any event grants of equity or equity rights under these equity plans will not result in Pharming exceeding 10% of all issued and outstanding shares of Pharming on a diluted basis. The total potential dilutive impact of all awards granted under share-based compensation plans (including awards to other participants) is 6.8% as of December 31, 2025 (as of December 31, 2024: 9.2%). This constitutes a significant decrease year-on-year and reflects Pharming commitment to continue to monitor the impact closely.

***Non-executive directors***

The remuneration of the non-executive directors is fixed and not linked to the performance of our Company to ensure independence in the discharge of their supervisory tasks and responsibilities, in accordance with prevailing best practices. Until 2020, the members of the former Board of Supervisory Directors (the non-executive directors as of December 11, 2020) were entitled to participate in the Company's LTIP scheme. From 2020 and onwards, the members of the former Board of Supervisory Directors will no longer participate in the LTIP.

*Historical Remuneration of our non-executive directors*

The below table provides an overview of the remuneration paid to the non-executives members of the former Board of Supervisory Directors, to the extent still in office, for the year ended December 31, 2025. Note that the dollar compensation was translated using a yearly average exchange rate applicable for the year, which was 1.1259 and 1.0804 in 2025 and 2024, respectively.

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---

| | | | | |
|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Year** | **Cash** | **Share-Based Payment** | **Total** |
| Dr. Richard Peters | 2025 | 122 | 45 | 167 |
|  | 2024 | 111 | 43 | 154 |
|  | 2023 | 26 | 20 | 46 |
| Mr. Paul Sekhri | 2025 |  |  |  |
|  | 2024 |  |  |  |
|  | 2023 | 55 | 32 | 87 |
| Ms. Deborah Jorn | 2025 | 30 | 15 | 45 |
|  | 2024 | 64 | 32 | 96 |
|  | 2023 | 55 | 32 | 87 |
| Ms. Barbara Yanni | 2025 | 80 | 34 | 114 |
|  | 2024 | 77 | 32 | 109 |
|  | 2023 | 62 | 32 | 94 |
| Dr. Mark Pykett | 2025 | 66 | 34 | 100 |
|  | 2024 | 63 | 32 | 95 |
|  | 2023 | 55 | 32 | 87 |
| Ms. Jabine van der Meijs | 2025 | 80 | 34 | 114 |
|  | 2024 | 77 | 32 | 109 |
|  | 2023 | 62 | 32 | 94 |
| Mr. Leonard Kruimer | 2025 | 75 | 34 | 109 |
|  | 2024 | 72 | 32 | 104 |
|  | 2023 | 58 | 32 | 90 |
| Mr. Steven Baert | 2025 | 36 | 15 | 51 |
|  | 2024 | 69 | 32 | 101 |
|  | 2023 | 58 | 32 | 90 |
| Dr. Elaine Sullivan | 2025 | 50 | 23 | 73 |
|  | 2024 |  |  |  |
|  | 2023 |  |  |  |
| Total | 2025 | 539 | 234 | 773 |
|  | 2024 | 533 | 235 | 768 |
|  | 2023 | 431 | 244 | 675 |

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*Remuneration Policy for Non-Executive Directors* 

The non-executive directors are entitled to the following annual remuneration, taking into consideration their responsibilities and time commitment as members of the Company's Board of Directors. Non-executive directors receive an annual retainer of €45,000 ($50,666) in cash and €30,000 ($33,777) of unrestricted shares. Our Chair of the Board of Directors receives an annual retainer of €90,000 ($101,331) in cash and €40,000 ($45,036) in unrestricted shares. Share remuneration is valued at the 20-day VWAP preceding the Annual General Meeting of Shareholders, without further restrictions for grant.

In addition, non-executive directors receive the following committee fees:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Audit Committee*: €7,500 ($8,444) per annum in cash (Chair €15,000 ($16,889));

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Remuneration Committee*: €6,250 ($7,037) per annum in cash (Chair €12,500 ($14,074));

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Corporate Governance Committee*: €6,250 ($7,037) per annum in cash (Chair €12,500 ($14,074)); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Transaction Committee*: €6,250 ($7,037) per annum in cash (Chair €12,500 ($14,074)).

An additional compensation of €1,000 ($1,126) per day may be paid in case of extraordinary activities, as determined by the Chair of the Board of Directors.

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The below table provides an overview of the total remuneration paid to the non-executive directors for the year ended December 31, 2025. Note that the dollar compensation was translated using a yearly average exchange rate applicable for the year, which was 1.1259 in 2025.

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| | | |
|:---|:---|:---|
| Amounts in $'000 | **Fixed remuneration** | **Share-based payment** |
| Dr. Richard Peters | 122 | 45 |
| Ms. Deborah Jorn | 30 | 15 |
| Ms. Barbara Yanni | 80 | 34 |
| Dr. Mark Pykett | 66 | 34 |
| Ms. Jabine van der Meijs | 80 | 34 |
| Mr. Leonard Kruimer | 75 | 34 |
| Mr. Steven Baert | 36 | 15 |
| Dr. Elaine Sullivan | 50 | 23 |

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The non-executive directors do not have an individual employment contract with us and are not entitled to participate in any benefits offered to management and staff, including but not limited to pension plans. Accordingly, there were no amounts set aside or accrued by us to provide pension, retirement or similar benefits to non-executive directors in the year ended December 31, 2025. No loans or other financial commitments will be made by or on behalf of the Company to any non-executive director.

***Share ownership***

Executive directors are required to acquire and hold shares in our Company. For the CEO, the value of the shares held in the Company should at least equal 400% of his or her annual base salary. For other executive directors, if any, the value of the shares held in the Company should at least equal 200% of their respective annual base salaries.

All executive directors may decide to accrue their required minimum shareholding over time by the vesting of after-tax performance shares from the LTI, without the requirement for own purchases, provided that the minimum shareholding is reached within five years following first appointment.

***Change of control***

Following a change of control that has been approved by the General Meeting of Shareholders becoming unconditional, the executive directors will be entitled to pro-rata vesting of outstanding but unallocated shares for the performance period that has lapsed at that moment, subject to the achievement of the applicable performance measures and targets. The remaining shares will vest in accordance with the predetermined schedule (i.e., no accelerated vesting) subject to the achievement of the applicable performance measures and targets.

In case of an unsolicited change of control becoming unconditional, share-based incentive plans do not vest automatically as result of the change of control becoming unconditional.

In case of an event resulting in a change of control or in case of the announcement of a proposed formal public offer for the shares in the Company, the Board of Directors, without the participation of the executive directors, can decide to settle the allocated shares for the members of the Board of Directors in cash.

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However, our shareholders approved on March 4, 2025, that Fabrice Chouraqui shall be entitled to a severance payment equal to 200% of his fixed annual base salary in the specific event of a termination of the mandate of Fabrice Chouraqui as Executive Director/CEO without cause (i.e., absent serious culpable conduct or gross negligence on his part) within twelve (12) months following a change of control of Pharming.

***Severance pay***

The executive directors are entitled to severance pay, subject to the following conditions in accordance with the DCGC and prevailing Dutch laws and regulations:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The maximum severance pay is 100% of the fixed annual remuneration;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Severance pay is not awarded in the event of failure;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Severance pay that can be classified as variable is not awarded.

Neither fixed nor variable severance pay may be awarded in the following cases:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• If a relationship is terminated early at the executive director's own initiative, except where this is due to serious culpable conduct or neglect on the part of the Company;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In the event of serious culpable conduct or gross negligence on the part of the executive director in the performance of his or her role.

Non-executive directors shall resign in accordance with the retirement schedule as adopted by the Board of Directors. No notice period, severance pay or other or termination fees are applicable.

**C. Board Practices**

For an overview of the foreign private issuer exemptions applicable to our Company, we refer to "Item 16G — Corporate Governance" in this Annual Report.

**Committees of our Board of Directors** 

The Board of Directors has appointed from among its non-executive members an Audit Committee, a Remuneration Committee, a Corporate Governance Committee and a Transaction Committee. The Board of Directors may, from time to time, establish additional committees.

*Audit Committee* 

Until August 28, 2025, the Audit Committee consisted of Leonard Kruimer (Chairperson), Deborah Jorn (until June 11, 2025), Barbara Yanni and Jabine van der Meijs. As of August 28, 2025, the Audit Committee consisted of Leonard Kruimer (Chairperson), Mark Pykett, Jabine van der Meijs and Elaine Sullivan. The composition of our Audit Committee is consistent with the best practice provisions of the DCGC and with applicable SEC and Nasdaq regulations. The Audit Committee supports the Board of Directors in monitoring and ensuring the integrity of the Company's financial reporting. The committee related tasks and responsibilities include, without limitation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the supervision and monitoring of the financial accounting process;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the monitoring of the effectiveness of the Company's internal management system, internal audit system, and internal risk management and control systems;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the review of intended material financial disclosures by the Company (including the Annual Report, quarterly results and the related draft press releases);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the review of disclosures in applicable filings as required by the U.S. Securities Act, the Exchange Act and their related rules;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the appointment of the Director Audit & Risk, the monitoring of the independence of the internal audit department and the annual evaluation of the internal audit department's performance;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the review of the internal audit plan and audit reports, respectively;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the nomination for (re)appointment or dismissal of the external auditor, the monitoring of the external auditor's independence and the annual evaluation of the external auditor's performance;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the review of the external auditor's audit plan, management letters and audit report, respectively;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the monitoring of the Company's funding, application of information and communication technology by the Company, including risks relating to cybersecurity, and the Company's tax policy; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the monitoring the Company's ESG initiatives and disclosure to ensure alignment with regulatory requirements, stakeholder expectations and the Company's strategic objectives.

The Audit Committee met five times in 2025 (2024: six times), either virtually or in person. The external auditor, Deloitte Accountants B.V. (Deloitte) attended each meeting of the Audit Committee. The CEO and, to the extent in office, the CFO attended all meetings of the Audit Committee as guests.

The Audit Committee is governed by a charter that complies with the best practice provisions of the DCGC and applicable SEC and Nasdaq requirements, which charter is available on our website at www.pharming.com. The charter was last updated on March 20, 2024, following an evaluation by the Audit Committee of the charter previously approved in December 2020.

*Remuneration Committee* 

Until August 28, 2025, the Remuneration Committee consisted of Steven Baert (Chairperson; until June 11, 2025), Deborah Jorn (until June 11, 2025), Mark Pykett, and Jabine van der Meijs (interim chair from June 11, 2025, onwards). Since August 28, 2025, the Remuneration Committee consisted of Elaine Sullivan (Chairperson), Jabine van der Meijs, Barbara Yanni and Richard Peters. The composition of our Remuneration Committee is consistent with the best practice provisions of the DCGC and SEC and Nasdaq requirements.

The Remuneration Committee met four times in 2025 (2024: five times), including a combined meeting with the Corporate Governance Committee.

The Remuneration Committee is governed by a charter that complies with the best practice provisions of the DCGC and applicable SEC and Nasdaq requirements, which charter is available on our website at www.pharming.com. The charter was last updated on March 20, 2024, following an evaluation by the Remuneration Committee of the charter previously approved in December 2020.

*Corporate Governance Committee* 

The Corporate Governance Committee was composed in 2025 of Jabine van der Meijs (Chairperson), Richard Peters, Barbara Yanni and, until June 11, 2025, Steven Baert. The composition of our Corporate Governance Committee is consistent with the best practice provisions of the DCGC and SEC and Nasdaq requirements.

The Corporate Governance Committee met four times in 2025 (2024: four times).

The Corporate Governance Committee is governed by a charter that complies with applicable SEC and Nasdaq requirements, which charter is available on our website at www.pharming.com. The charter was evaluated and the updated charter was approved on March 20, 2024.

*Transaction Committee* 

During the financial year 2025, the Transaction Committee consisted of Barbara Yanni (Chairperson), Richard Peters, Leonard Kruimer and Mark Pykett.

The Transaction Committee met two times in 2025 (2024: six times).

The Transaction Committee is governed by a charter that complies with the best practice provisions of the DCGC, which charter is available on our website at www.pharming.com. The charter was last updated on March 20, 2024, following an evaluation by the Transaction Committee of the charter previously approved in December 2022.

**D. Employees**

Throughout the year 2025, we employed an average full time equivalent of 409 people, compared to 404 and 382 for 2024 and 2023, respectively. Our business involves specific high-technology processes and requires the employment of highly skilled and motivated personnel. Therefore, it is important for us to create an attractive

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work environment that retains and motivates qualified personnel and attracts talent in a competitive and global marketplace. None of our employees are represented by any collective bargaining unit.

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| | | | |
|:---|:---|:---|:---|
| **Average full time equivalent** | **2025** | **2024** | **2023** |
| The Netherlands | 214 | 208 | 201 |
| Australia | 3 | 2 |  |
| France | 14 | 17 | 21 |
| Germany | 7 | 6 | 4 |
| Italy | 2 | 3 | 2 |
| United Kingdom | 19 | 17 | 15 |
| United States | 147 | 148 | 136 |
| Spain | 1 | 2 | 2 |
| Turkey | 1 | 1 | 1 |
| Sweden | 1 |  |  |
| **Total** | **409** | **404** | **382** |
| **Average full time equivalent** |  |  |  |
| General and administrative | 139 | 125 | 104 |
| Research and development | 119 | 129 | 131 |
| Marketing and sales | 111 | 109 | 100 |
| Production | 40 | 41 | 47 |
| **Total** | **409** | **404** | **382** |

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**E. Share Ownership**

The share ownership information with respect to the Board of Directors and Executive Committee is presented in "Item 7 — A. Major Shareholders" below.

**F. Disclosure of a Registrant's Action to Recover Erroneously Awarded Compensation**

Not applicable.

**Item 7. Major Shareholders and Related Party Transactions**

**A. Major Shareholders**

The below table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 31, 2026, by:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• each person, or group of affiliated persons, that beneficially owns 5% or more of our outstanding ordinary shares;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• each of our directors and executive officers; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• all of our directors and executive officers as a group.

Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include ordinary shares that can be acquired within 60 days of March 31, 2026. Percentage ownership calculations are based on 706,252,300 ordinary shares issued and outstanding as of March 31, 2026, plus, consistent with SEC rules on disclosure of beneficial ownership, ordinary shares that can be acquired within 60 days of March 31, 2026.

Except as otherwise indicated, all of the ordinary shares reflected in the table are ordinary shares and all persons listed below have sole voting and investment power with respect to the ordinary shares beneficially owned by them, subject to applicable community property laws. The information is not necessarily indicative of beneficial ownership for any other purpose. Unless otherwise indicated in the table below, addresses of the directors,

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executive officers and named beneficial owners are in care of Pharming Group N.V, Darwinweg 24, 2333 CR Leiden, the Netherlands.

As of March 31, 2026, there was no person known to us to be the beneficial owner of more than five percent (5%) of each class of our common shares issued and outstanding.

The voting rights of our major shareholders do not differ from the voting rights of holders of our ordinary shares who are not major shareholders.

The following table sets forth the number of our issued and outstanding ordinary shares that are held (beneficially owned) by record holders of March 31, 2026:

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| | | |
|:---|:---|:---|
| **Name of Beneficial Owner** | **Number of Ordinary Shares Beneficially** | **Percentage of Ordinary Shares Beneficially Owned** |
| *Executive Officers and Executive Directors:* | *3708089* | *0.5%* |
| Mireille Sanders, MSc (1) | 1232350 | \* |
| Anurag Relan, MD, MPH (2) | 985887 | \* |
| Ruud van Outersterp (3) | 784695 | \* |
| Alexander Breidenbach, PhD, MBA (4) | 417482 | \* |
| Fabrice Chouraqui, PharmD, MBA (5) | 161425 | \* |
| Inés Bernal (6) | 126250 | \* |
| Kenneth Lynard, MSc, EMBA | *—* | *—* |
| Leverne Marsh, BPharm | *—* | *—* |
| *Non-Executive Directors:* | *786105* | \* |
| Dr. Mark Pykett (7) | 177469 | \* |
| Ms. Barbara Yanni (8) | 177469 | \* |
| Mr. Leonard Kruimer (9) | 152631 | \* |
| Ms. Jabine van der Meijs (10) | 152631 | \* |
| Dr. Richard Peters (11) | 104742 | \* |
| Dr. Elaine Sullivan (12) | 21163 | \* |

---

.

\*Represents beneficial ownership of less than one percent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) Consists of 1,232,350 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) Consists of 985,887 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) Consists of 784,695 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(4) Consists of 417,482 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(5) Consists of 161,425 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(6) Consists of 126,250 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(7) Consists of 177,469 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(8) Consists of 177,469 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(9) Consists of 152,631 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(10) Consists of 152,631 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(11) Consists of 104,742 ordinary shares held as of March 31, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(12) Consists of 21,163 ordinary shares held as of March 31, 2026.

We estimate that as of March 31, 2026, approximately 12.0% of our outstanding ordinary shares are held by 37 institutional U.S. record holders.

 **B. Related Party Transactions**

We have engaged in the following transactions with our directors, executive officers, holders of more than 10% of our outstanding share capital and their affiliates, and certain entities that we may be deemed to control, which we refer to as our related parties.

**Transactions with BioConnection**

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We enter into transactions with BioConnection, our fill and finish partner, in the ordinary course of business. We are holding a stake of 23.0% in BioConnection. For the years ended December 31, 2025, 2024 and 2023, we paid BioConnection $5.4 million, $4.6 million and $4.7 million respectively, for fill and finish services. At December 31, 2025, the Company owed BioConnection $1.3 million for fill and finish services supplied. At December 31, 2024, the Company owed $1.5 million to BioConnection for fill and finish services. In addition, BioConnection owed $— million to the Company at December 31, 2025, and $0.3 million at December 31, 2024.

**Agreements with Our Executive Officers and Directors** 

We have entered into management contracts with certain executive officers (including our executive directors), while the other executive officers are employed by us. We have service contracts with certain non-executive directors. These agreements contain customary provisions and representations, including confidentiality, non-competition, non-solicitation and inventions assignment undertakings by the executive officers. However, the enforceability of the non-competition provisions may be limited under applicable law.

**Indemnification Agreements** 

The Articles of Association include an indemnity in favor of all members of our Board of Directors and executive officers. We have entered into indemnity agreements with each of our directors and executive officers, in line with the indemnity included in our Articles of Association. The indemnity agreements and our Articles of Association require us to indemnify our directors and executive officers to the fullest extent permitted by law.

The service contracts with our non-executive directors include a general indemnity.

**Related Party Transactions Policy** 

We have adopted a related party transaction policy, or the Related Person Policy, requiring that all related party transactions required to be disclosed by a foreign private issuer pursuant to the Exchange Act be approved by our Board of Directors or a designated committee thereof consisting solely of independent directors, including the Audit Committee. Our Board of Directors has also established an internal procedure to periodically assess whether related party transactions (as defined under Dutch law) are entered into in the ordinary course of business and under normal market conditions. In addition, under Dutch law, we are required to disclose material transactions with a related party (as defined under Dutch law and subject to certain exceptions) that were not entered into in the ordinary course of business and/or not under normal market conditions at the time the transaction was entered into and such transactions shall be subject to the approval of our Board of Directors.

In November 2025, the Audit Committee conducted its annual review of the existing related person transactions within the meaning of the Company's Related Person Policy. The Audit Committee concluded, based on the gathered information, that (i) each of the transactions in scope of that policy was entered into in the ordinary course of business, and (ii) without the involvement of the relevant related persons. Accordingly, the Audit Committee ratified these transactions in accordance with the prevailing policy.

**C. Interests of Experts and Counsel** 

Not applicable.

**Item 8. Financial Information**

**A. Consolidated Statements and Other Financial Information.**

**Consolidated Financial Statements**

Our consolidated financial statements are included at the end of this Annual Report, starting at page F-1. See "Item 17 — Financial Statements" of this Annual Report.

**Legal Proceedings** 

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From time to time, we may become involved in litigation or other legal proceedings relating to claims arising from the ordinary course of business.

Currently we are not a party to any material legal or administrative proceedings.

**Dividend Distribution Policy**

We have never declared or paid any dividends on our ordinary shares since our ordinary shares were listed on Euronext Amsterdam. We intend to retain any earnings for use in our business and do not currently intend to pay dividends on our ordinary shares. We may only pay dividends or distributions from our reserves to the extent our shareholders' equity (eigen vermogen) exceeds the sum of our paid-up and called-up share capital plus the reserves we must maintain by Dutch law or by our Articles of Association from time to time and (if it concerns a distribution of profits) after adoption of the annual accounts by our general meeting from which it appears that such distribution is allowed. Subject to such restrictions, any future determination to pay dividends or other distribution will be at the discretion of our Board of Directors and will depend upon a number of factors, including our results of operations, cash requirements, financial condition, future prospects, contractual restrictions, any future debt agreements, restrictions under applicable laws and other factors that our Board of Directors may deem relevant.

Under our Articles of Association, our Board of Directors may decide that all or part of our profits shall be added to our reserves and any remaining profit will be at the disposal of the general meeting at the proposal of our Board of Directors for distribution on our ordinary shares, subject to restrictions of Dutch law. Our Board of Directors is permitted, subject to certain requirements, to declare interim dividends without the approval of the general meeting.

**B. Significant Changes**

None.

**Item 9. The Offer and Listing**

**A. Offer and Listing Details**

Since December 22, 2020, our ADSs, each representing ten ordinary shares of Pharming Group N.V., have been quoted on the Nasdaq Global Market under the symbol "PHAR." Since December 21, 2009, our ordinary shares of Pharming Group N.V. have been quoted on Euronext Amsterdam under the symbol "PHARM."

**B. Plan of Distribution**

Not applicable.

**C. Markets**

Our ADSs, each representing ten ordinary shares of Pharming Group N.V., are listed on the Nasdaq Global Market under the symbol "PHAR."

Our ordinary shares are currently traded on Euronext Amsterdam under the symbol "PHARM."

**D. Selling Shareholders**

Not applicable.

**E. Dilution.**

Not applicable.

**F. Expenses of the Issue.**

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Not applicable.

**Item 10. Additional Information**

**A. Share Capital**

Not applicable.

**B. Memorandum and Articles of Association**

A copy of our Amended and Restated Articles of Association is filed as Exhibit 1.1 to this Annual Report. The information called for by this item is set forth in Exhibit 2.1 to this Annual Report and is incorporated by reference into this Annual Report.

**C. Material Contracts**

**Material Agreements** 

***License agreement for the development and commercialization of leniolisib***

On August 12, 2019, we entered into a License Agreement, or the Novartis License Agreement, with Novartis, pursuant to which Novartis granted to us an exclusive license to develop and commercialize leniolisib. Under the terms of the Novartis License Agreement, the license is exclusive even as to Novartis and its affiliates, and we are permitted to sublicense the exclusive license. Effective May 8, 2020, Novartis merged into Novartis Pharma AG. As a result, all assets and liabilities of Novartis, including the Novartis License Agreement, became assets and liabilities of Novartis Pharma AG.

Under the terms of the Novartis License Agreement, we made an upfront payment of $20 million to Novartis in August 2019. Novartis has completed all the preclinical and clinical work to date, including the OLE which has now concluded. We are commercializing leniolisib under the name Joenja® through our existing commercial infrastructure in the United States and expect to in Europe and other markets worldwide, subject to regulatory approval and as described elsewhere in this Annual Report. Pursuant to the Novartis License Agreement, we agreed to make certain milestone payments to Novartis in an aggregate amount of up to $200 million upon (i) the completion of certain regulatory milestones and (ii) the achievement of certain leniolisib sales milestones. We also agreed to make tiered royalty payments to Novartis, calculated as low double-digit to high-teen percentage of net sales of leniolisib. During 2025, we paid milestone payments to Novartis of $5.0 million (2024: none, 2023: $10.4 million).

The Novartis License Agreement will terminate on a licensed product-by-licensed product and country-by-country basis upon the expiration of the royalty term for such licensed product in such country, and will terminate in its entirety upon the expiration of the royalty term with respect to the last licensed product then being developed, manufactured or commercialized in all countries of the territory. The royalty term ends on the last to occur of (i) the expiration of the last to expire valid claim of the licensed patents that covers such licensed product in such country; (ii) the expiration of any regulatory exclusivity for such licensed product in such country; or (iii) the ten (10) year anniversary of the first commercial sale of the licensed product in such country. Either party may terminate the agreement upon a material breach by the other party that is not cured within a specified period after receiving written notice. We have the right to terminate the Novartis License Agreement for any reason upon specified prior written notice to Novartis.

***License agreement for the development and commercialization of napazimone (KL1333)***

Following acquisition of Abliva AB in February 2025, we became party to a license agreement with Yungjin Pharmaceutical, or Yungjin, dated April 28, 2017, to develop and commercialize KL1333, now known as napazimone, a small molecule treatment candidate for primary mitochondrial diseases. Pursuant to the license agreement, we received an exclusive license from Yungjin to 34 granted patents related to KL1333, of which 2 are U.S.-issued and to 1 pending patent application. We co-owned with Yungjin 2 granted patents and 12 pending patent applications related to the use of KL1333 for the treatment of mitochondrial diseases. Yungjin is

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eligible to receive development, regulatory and sales milestones in the low-triple digit millions of US dollars as well as mid-single to low double-digit royalty payments on future sales in certain regions.

**D. Exchange Controls**

Under the existing laws of the Netherlands, there are no exchange controls applicable to the transfer to persons outside of the Netherlands of dividends or other distributions with respect to, or of the proceeds from the sale of, shares of a Dutch company, subject to applicable restrictions under sanctions and measures, including those concerning export control, pursuant to EU regulations, the Sanctions Act 1977 (Sanctiewet 1977) or other legislation, applicable anti-boycott, anti-money-laundering or anti-terrorism regulations and similar rules. There are no special restrictions in the Articles of Association or Dutch law that limit the right of shareholders who are not citizens or residents of the Netherlands to hold or vote shares.

**E. Taxation**

**MATERIAL INCOME TAX CONSIDERATIONS** 

*The following summary contains a description of material U.S. and Dutch federal income tax considerations of the acquisition, ownership and disposition of our ordinary shares or ADSs. This summary should not be considered a comprehensive description of all the tax considerations that may be relevant to the decision to acquire ADSs representing our ordinary shares.* 

**Material U.S. Federal Income Tax Considerations for U.S. Holders** 

The following is a description of the material U.S. federal income tax considerations to the U.S. Holders described below of owning and disposing of our ordinary shares or ADSs. It is not a comprehensive description of all tax considerations that may be relevant to a particular person's decision to acquire securities. This discussion applies only to a U.S. Holder that holds our ordinary shares or ADSs as a capital asset within the meaning of Section 1221 of the Code, for tax purposes (generally, property held for investment). In addition, it does not describe all of the tax considerations that may be relevant in light of a U.S. Holder's particular circumstances, including state and local tax considerations, any U.S. federal non-income tax considerations such as estate or gift tax considerations, alternative minimum tax considerations, the Medicare contribution tax on net investment income, the special tax accounting rules under Section 451(b) of the Code, and tax considerations applicable to U.S. Holders subject to special rules, such as:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• banks, insurance companies, and certain other financial institutions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• dealers or traders in securities who use a mark-to-market method of tax accounting;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• persons holding ordinary shares or ADSs as part of a hedging transaction, "straddle," wash sale, conversion transaction or integrated transaction or persons entering into a constructive sale with respect to ordinary shares or ADSs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• persons whose "functional currency" for U.S. federal income tax purposes is not the U.S. dollar;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• brokers, dealers or traders in securities, commodities or currencies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• tax-exempt entities or government organizations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• S corporations, partnerships, or other entities or arrangements classified as partnerships or pass-throughs for U.S. federal income tax purposes (and investors therein);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• tax-qualified retirement plans;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• regulated investment companies, real estate investment trusts, corporations that accumulate income to avoid U.S. federal income tax;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• persons who acquired our ordinary shares or ADSs pursuant to the exercise of any employee stock option or otherwise as compensation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• persons that own or are deemed to own (including by attribution) ten percent or more of our shares (by vote or value); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• persons holding our ordinary shares or ADSs in connection with a trade or business, permanent establishment, or fixed base outside the United States.

If an entity or arrangement that is classified as a partnership for U.S. federal income tax purposes holds ordinary shares or ADSs, the U.S. federal income tax treatment of a partner will generally depend on the status of the partner and the activities of the partnership. Partnerships holding ordinary shares or ADSs and partners in such

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partnerships are encouraged to consult their tax advisers as to the particular U.S. federal income tax considerations of holding and disposing of ordinary shares or ADSs.

The discussion is based on the Code, judicial decisions, final, temporary and proposed Treasury Regulations, administrative pronouncements, and the income tax treaty between the Netherlands and the United States, or the Treaty, all as of the date hereof, changes to any of which may affect the tax consequences described herein—possibly with retroactive effect.

A "U.S. Holder" is a holder who, for U.S. federal income tax purposes, is a beneficial owner of ordinary shares or ADSs and is:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an individual who is a citizen or resident of the United States;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a corporation created or organized in or under the laws of the United States, any state therein or the District of Columbia, or any other entity taxable as a U.S. corporation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an estate the income of which is subject to U.S. federal income taxation regardless of its source; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a trust if (a) a U.S. court is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have authority to control all substantial decisions of the trust or (b) the trust has a valid election to be treated as a U.S. person under applicable U.S. Treasury Regulations.

U.S. Holders are encouraged to consult their tax advisers concerning the U.S. federal, state, local and non-U.S. tax consequences of owning and disposing of our ordinary shares or ADSs in their particular circumstances. The discussion below assumes that the representations contained in the deposit agreement are true and that the obligations in the deposit agreement and any related agreement will be complied with in accordance with their terms. Generally, a holder of an ADS should be treated for U.S. federal income tax purposes as holding the ordinary shares represented by the ADS. Accordingly, no gain or loss will be recognized upon an exchange of ADSs for ordinary shares.

***Passive Foreign Investment Company Rules***

A non-U.S. corporation will be classified as a PFIC, for any taxable year in which, after applying certain look-through rules, either:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• at least 75% of its gross income is passive income (such as interest income); or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• at least 50% of its gross assets (determined on the basis of a quarterly average) is attributable to assets that produce passive income or are held for the production of passive income (including cash).

For this purpose, cash is a passive asset and passive income generally includes dividends, interest, royalties and rents (other than royalties and rents derived in the active conduct of a trade or business and not derived from a related person). For purposes of this test, we will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation, the equity of which we own, directly or indirectly, 25% or more (by value).

Based on the estimated composition of our income, assets, operations and market capitalization for 2025, we do not believe that we were classified as a PFIC for U.S. federal income tax purposes for the taxable year ending December 31, 2025. However, no assurances can be provided that we will not be a PFIC for the current or any future taxable year or that we have not been a PFIC in any prior taxable years. The determination of whether we are a PFIC is a fact-intensive determination made on an annual basis and the applicable law is subject to varying interpretation. In particular, the characterization of our assets as active or passive may depend in part on our current and intended future business plans, which are subject to change. In addition, for our current and future taxable years, the total value of our assets for PFIC testing purposes may be determined in part by reference to the market price of our ordinary shares or ADSs from time to time, which may fluctuate considerably. Under the income test, our status as a PFIC depends on the composition of our income which will depend on a variety of factors that are subject to uncertainty, including the characterization of certain intercompany payments and payments from tax authorities, transactions we enter into in the future and our corporate structure. Even if we were to determine that we are not a PFIC for a taxable year, there can be no assurance that the IRS would not successfully challenge our position. Accordingly, our U.S. counsel expresses no opinion with respect to our PFIC status for any prior, current or future taxable year.

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If we are classified as a PFIC in any year with respect to which a U.S. Holder owns the ordinary shares or ADSs, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns the ordinary shares or ADSs, regardless of whether we continue to meet the tests described above unless (a) we cease to be a PFIC and the U.S. Holder has made a "deemed sale" election under the PFIC rules, or (b) the U.S. Holder (i) makes a "QEF Election" (defined below) or (ii) is eligible to make and makes a mark-to-market election (as described below), with respect to all taxable years during such U.S. Holder's holding period in which we are a PFIC. If such a deemed sale election is made, a U.S. Holder will be deemed to have sold the ordinary shares or ADSs the U.S. Holder holds at their fair market value as of the date of such deemed sale and any gain from such deemed sale would be subject to the rules described below. After the deemed sale election, so long as we do not become a PFIC in a subsequent taxable year, the U.S. Holder's ordinary shares or ADSs with respect to which such election was made will not be treated as shares in a PFIC and the U.S. Holder will not be subject to the rules described below with respect to any "excess distribution" the U.S. Holder receives from us or any gain from an actual sale or other disposition of the ordinary shares or ADSs. U.S. Holders should consult their tax advisers as to the possibility and consequences of making a deemed sale election if we cease to be a PFIC and such election becomes available.

For each taxable year we are treated as a PFIC with respect to U.S. Holders, U.S. Holders will be subject to special tax rules with respect to any "excess distribution" such U.S. Holder receives and any gain such U.S. Holder recognizes from a sale or other disposition (including a pledge) of ordinary shares or ADSs, unless (a) such U.S. Holder makes a "qualified electing fund" election, or QEF Election, with respect to all taxable years during such U.S. Holder's holding period in which we are a PFIC, or (b) our ordinary shares or ADSs constitute "marketable stock" and such U.S. Holder makes a mark-to-market election (as discussed below). Distributions a U.S. Holder receives in a taxable year that are greater than 125% of the average annual distributions a U.S. Holder received during the shorter of the three preceding taxable years or the U.S. Holder's holding period for the ordinary shares or ADSs will be treated as an excess distribution. Under these special tax rules:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the excess distribution or gain will be allocated ratably over a U.S. Holder's holding period for the ordinary shares or ADSs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the amount allocated to the current taxable year, and any taxable year prior to the first taxable year in which we became a PFIC, will be treated as ordinary income; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the amount allocated to each other year will be subject to the highest tax rate in effect for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year.

The tax liability for amounts allocated to years prior to the year of disposition or "excess distribution" cannot be offset by any net operating losses for such years, and gains (but not losses) realized on the sale of the ordinary shares or ADSs cannot be treated as capital gains, even if a U.S. Holder holds the ordinary shares or ADSs as capital assets.

If we are a PFIC, a U.S. Holder will generally be subject to similar rules with respect to distributions we receive from, and our dispositions of the stock of, any of our direct or indirect subsidiaries that also are PFICs, as if such distributions were indirectly received by, and/or dispositions were indirectly carried out by, such U.S. Holder. U.S. Holders should consult their tax advisers regarding the application of the PFIC rules to our subsidiaries.

If a U.S. holder makes a QEF Election covering all taxable years during which the holder holds ordinary shares or ADSs and in which we are a PFIC, distributions and gains will not be taxed as described above. If a U.S. Holder makes an effective QEF Election, the U.S. Holder will be required to include in gross income each year, whether or not we make distributions, as capital gains, such U.S. Holder's pro rata share of our net capital gains and, as ordinary income, such U.S. Holder's pro rata share of our earnings in excess of our net capital gains. If a U.S. holder makes a QEF Election with respect to us, any distributions paid by us out of our earnings and profits that were previously included in the U.S. holder's income under the QEF Election would not be taxable to the holder. A U.S. holder will increase its tax basis in its ordinary shares or ADSs by an amount equal to any income included under the QEF Election and will decrease its tax basis by any amount distributed on the ordinary shares or ADSs that is not included in the holder's income. If a U.S. holder has made a QEF Election with respect to its ordinary shares or ADSs, any gain or loss recognized by the U.S. holder on a sale or other disposition of such ordinary shares or ADSs will constitute capital gain or loss. In addition, if a U.S. holder makes a timely QEF Election, our ordinary shares or ADSs will not be considered shares in a PFIC in years in which we are not a PFIC, even if the U.S. holder had held ordinary shares or ADSs in prior years in which we were a PFIC. However, a U.S. Holder can only make a QEF Election with respect to ordinary shares or ADSs in

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a PFIC if we furnish such U.S. Holder with certain tax information annually. We do not currently expect to provide such information in the event that we are classified as a PFIC.

If we are a PFIC in any taxable year with respect to which a U.S. Holder owns our ordinary shares or ADSs, such U.S. Holders can avoid the interest charge on excess distributions or gain relating to our ordinary shares or ADSs by making a mark-to-market election with respect to the ordinary shares or ADSs, provided that the ordinary shares or ADSs are "marketable stock." Ordinary shares or ADSs will be marketable stock if they are "regularly traded" on a "qualified exchange." For these purposes, the ordinary shares or ADSs will be considered regularly traded during any calendar year during which they are traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. Any trades that have as their principal purpose meeting this requirement will be disregarded. Our ADSs (but not ordinary shares) are listed on the Nasdaq, which is a qualified exchange for these purposes. Consequently, if our ADSs remain listed on the Nasdaq and are regularly traded, we expect the mark-to-market election would be available to U.S. Holders of our ADSs if we are a PFIC. Each U.S. Holder should consult its tax advisor as to whether a mark-to-market election is available or advisable with respect to our ordinary shares or ADSs.

A U.S. Holder that makes a mark-to-market election must include in ordinary income for each year an amount equal to the excess, if any, of the fair market value of our ordinary shares or ADSs at the close of the taxable year over the U.S. Holder's adjusted tax basis in the ordinary shares or ADSs. An electing holder may also claim an ordinary loss deduction for the excess, if any, of the U.S. Holder's adjusted basis in the ordinary shares or ADSs over the fair market value of the ordinary shares or ADSs at the close of the taxable year, but this deduction is allowable only to the extent of any net mark-to-market gains for prior years. Gains from an actual sale or other disposition of the ordinary shares or ADSs will be treated as ordinary income, and any losses incurred on a sale or other disposition of the shares will be treated as an ordinary loss to the extent of any net mark-to-market gains for prior years. Once made, the election cannot be revoked without the consent of the IRS unless the ordinary shares or ADSs cease to be marketable stock.

However, a mark-to-market election generally cannot be made for equity interests in any lower-tier PFICs that we own, unless shares of such lower-tier PFIC are themselves "marketable stock." As a result, even if a U.S. Holder validly makes a mark-to-market election with respect to our ordinary shares or ADSs, the U.S. Holder may continue to be subject to the PFIC rules (described above) with respect to its indirect interest in any of our investments that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. U.S. Holders should consult their tax advisers as to the availability and desirability of a mark-to-market election, as well as the impact of such election on interests in any lower-tier PFICs.

Unless otherwise provided by the U.S. Treasury, each U.S. Holder of a PFIC is required to file an annual report containing such information as the U.S. Treasury may require. A U.S. Holder's failure to file the annual report will cause the statute of limitations for such U.S. Holder's U.S. federal income tax return to remain open with regard to the items required to be included in such report until three years after the U.S. Holder files the annual report, and, unless such failure is due to reasonable cause and not willful neglect, the statute of limitations for the U.S. Holder's entire U.S. federal income tax return will remain open during such period. U.S. Holders should consult their tax advisers regarding the requirements of filing such information returns under these rules.

**WE STRONGLY URGE YOU TO CONSULT YOUR TAX ADVISOR REGARDING THE IMPACT OF OUR PFIC STATUS ON YOUR INVESTMENT IN THE ORDINARY SHARES OR ADSs AS WELL AS THE APPLICATION OF THE PFIC RULES TO YOUR INVESTMENT IN THE ORDINARY SHARES OR ADSs.**

***Taxation of Distributions***

Subject to the discussion above under "Passive Foreign Investment Company Rules," distributions paid on ordinary shares or ADSs, other than certain pro rata distributions of ordinary shares or ADSs, will generally be treated as dividends to the extent paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Because we may not calculate our earnings and profits under U.S. federal income tax principles, we expect that distributions generally will be reported to U.S. Holders as dividends. Non-corporate U.S. holders may qualify for the preferential rates of taxation applicable to long term capital gains (i.e., gains from the sale of capital assets held for more than one year) with respect to dividends on ADSs if we are a "qualified foreign corporation." A non-United States corporation (other than a corporation that

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is classified as a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be considered to be a qualified foreign corporation (a) if it is eligible for the benefits of a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of these rules and which includes an exchange of information provision (which includes the Treaty), or (b) with respect to any dividend it pays on ADSs which are readily tradable on an established securities market in the United States. Therefore, subject to the discussion under "Passive Foreign Investment Company Rules," above, if the Treaty is applicable, or if the ADSs are readily tradable on an established securities market in the United States, such dividends will generally be "qualified dividend income" in the hands of non-corporate U.S. holders eligible for the preferential tax rates, provided that certain conditions are met, including conditions relating to holding period and the absence of certain risk reduction transactions. The amount of the dividend will be treated as foreign-source dividend income to U.S. Holders and will not be eligible for the dividends-received deduction generally available to U.S. corporations under the Code. Dividends will generally be included in a U.S. Holder's income on the date of the U.S. Holder's receipt of the dividend. The amount of any dividend income paid in foreign currency will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. Holder should not be required to recognize foreign currency gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt. Such gain or loss would generally be treated as U.S.-source ordinary income or loss. The amount of any distribution of property other than cash (and other than certain pro rata distributions of ordinary shares or ADSs or rights to acquire ordinary shares or ADSs) will be the fair market value of such property on the date of distribution. For foreign tax credit purposes, our dividends will generally be treated as passive category income. The rules relating to the determination of the U.S. foreign tax credit are complex, and U.S. Holders should consult their tax advisors regarding the availability of a foreign tax credit in their particular circumstances and the possibility of claiming a deduction (in lieu of the foreign tax credit) for any foreign taxes paid or withheld.

***Sale or Other Taxable Disposition of Ordinary Shares and ADSs***

Subject to the discussion above under "Passive Foreign Investment Company Rules," gain or loss realized on the sale or other taxable disposition of ordinary shares or ADSs will be capital gain or loss, and will be long-term capital gain or loss if the U.S. Holder held the ordinary shares or ADSs for more than one year. The amount of the gain or loss will equal the difference between the U.S. Holder's tax basis in the ordinary shares or ADSs disposed of and the amount realized on the disposition, in each case as determined in U.S. dollars. This gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes. The deductibility of capital losses is subject to limitations. If the consideration received by a U.S. Holder is not paid in U.S. dollars, the amount realized will be the U.S. dollar value of the payment received determined by reference to the spot rate of exchange on the date of the sale or other disposition. However, if the ordinary shares or ADSs are treated as traded on an "established securities market" and you are either a cash basis taxpayer or an accrual basis taxpayer that has made a special election (which must be applied consistently from year to year and cannot be changed without the consent of the IRS), you will determine the U.S. dollar value of the amount realized in a non-U.S. dollar currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. If you are an accrual basis taxpayer that is not eligible to or does not elect to determine the amount realized using the spot rate on the settlement date, you will recognize foreign currency gain or loss to the extent of any difference between the U.S. dollar amount realized on the date of sale or disposition and the U.S. dollar value of the currency received at the spot rate on the settlement date. U.S. Holders should consult their tax advisors regarding the tax consequences if foreign taxes are imposed on a taxable disposition of ordinary shares or ADSs and their ability to credit such foreign tax against their U.S. federal income tax liability.

***Information Reporting and Backup Withholding***

Payments of dividends and sales proceeds that are made within the United States or through certain U.S.-related financial intermediaries generally are subject to information reporting, and may be subject to backup withholding, unless (a) the U.S. Holder is a corporation or other exempt recipient or (b) in the case of backup withholding, the U.S. Holder provides a correct taxpayer identification number and a duly executed IRS Form W-9 or certification of other exempt status that it is not subject to backup withholding, unless the U.S. Holder otherwise establishes that it is exempt from such rules.

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Backup withholding is not an additional tax. The amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against the holder's U.S. federal income tax liability and may entitle it to a refund, provided that the required information is timely furnished to the IRS.

***Information with Respect to Foreign Financial Assets***

Individuals who own "specified foreign financial assets" with an aggregate value in excess of $50,000 (or higher depending on the filing status of the individual) may be required to file an information report on IRS Form 8938, "Statement of Specified Foreign Financial Assets," with respect to such assets with their tax returns. "Specified foreign financial assets" include any financial accounts maintained by foreign financial institutions, as well as any of the following, but only if they are not held in accounts maintained by financial institutions: (i) stocks and securities issued by non-U.S. persons; (ii) financial instruments and contracts held for investment that have non-U.S. issuers or counterparties; and (iii) interests in foreign entities. Such U.S. Holders who fail to timely furnish the required information may be subject to a penalty. Additionally, if a U.S. Holder does not file the required information, the statute of limitations with respect to tax returns of the U.S. Holder to which the information relates may not close until three years after such information is filed. U.S. Holders should consult their tax advisers regarding their reporting obligations with respect to their ownership and disposition of the ordinary shares or ADSs.

**Material Dutch Tax Considerations** 

***General***

The following is a general summary of certain material Dutch tax consequences of the acquisition, ownership and disposition of our ordinary shares or ADSs. This summary does not purport to describe all possible tax considerations or consequences that may be relevant to a holder or prospective holder of our ordinary shares or ADSs and does not purport to deal with the tax consequences applicable to all categories of investors, some of which (such as trusts or similar arrangements) may be subject to special rules. In view of its general nature, this general summary should be treated with corresponding caution.

This summary is based on the tax laws of the Netherlands, published regulations thereunder and published authoritative case law, all as in effect on the date hereof, and all of which are subject to change, possibly with retroactive effect. Where the summary refers to "the Netherlands" or "Dutch" it refers only to the part of the Kingdom of the Netherlands located in Europe.

This discussion is for general information purposes only and is not Dutch tax advice or a complete description of all Dutch tax consequences relating to the acquisition, ownership and disposition of our ordinary shares or ADSs. Holders or prospective holders of our ordinary shares or ADSs should consult their own tax advisors regarding the Dutch tax consequences relating to the acquisition, ownership and disposition of our ordinary shares or ADSs in light of their particular circumstances.

Please note that this summary does not describe the Dutch tax consequences for:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i.holders of ordinary shares or ADSs if such holders, and in the case of individuals, such holder's partner or certain of its relatives by blood or marriage in the direct line (including foster children), have a substantial interest (aanmerkelijk belang) or deemed substantial interest (fictief aanmerkelijk belang) in us under the Dutch Income Tax Act 2001 (Wet inkomstenbelasting 2001). Generally speaking, a holder of securities in a company is considered to hold a substantial interest in such company, if such holder alone or, in the case of individuals, together with such holder's partner (as defined in the Dutch Income Tax Act 2001), directly or indirectly, holds (a) an interest of 5% or more of the total issued and outstanding capital of that company or of 5% or more of the issued and outstanding capital of a certain class of shares of that company; or (b) rights to acquire, directly or indirectly, such interest; or (c) certain profit sharing rights in that company that relate to 5% or more of the company's annual profits or to 5% or more of the company's liquidation proceeds. A deemed substantial interest may arise if a substantial interest (or part thereof) in a company has been disposed of, or is deemed to have been disposed of, on a non-recognition basis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii.holders of ordinary shares or ADSs, if the ordinary shares or ADSs held by such holders qualify or qualified as a participation (deelneming) for purposes of the Dutch Corporate Income Tax Act 1969

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(Wet op de vennootschapsbelasting 1969). Generally, a holder's shareholding of 5% or more in a company's nominal paid-up share capital qualifies as a participation. A holder may also have a participation if such holder does not have a shareholding of 5% or more but a related entity (statutorily defined term) has a participation or if the company in which the shares are held is a related entity (statutorily defined term);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii.pension funds, investment institutions (fiscale beleggingsinstellingen), exempt investment institutions (vrijgestelde beleggingsinstellingen) (each as defined in the Dutch Corporate Income Tax Act 1969) and other entities that are, in whole or in part, not subject to or exempt from Dutch corporate income tax as well as entities that are exempt from corporate income tax in their country of residence, such country of residence being another state of the EU, Norway, Liechtenstein, Iceland or any other state with which the Netherlands has agreed to exchange information in line with international standards; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv.holders of ordinary shares or ADSs who are individuals for whom the ordinary shares or ADSs or any benefit derived from the ordinary shares or ADSs are a remuneration or deemed to be a remuneration for activities performed by such holders or certain individuals related to such holders (as defined in the Dutch Income Tax Act 2001).

***Withholding tax***

Dividends distributed by us generally are subject to Dutch dividend withholding tax at a rate of 15%. Generally, we are responsible for the withholding of such dividend withholding tax at source; the Dutch dividend withholding tax is for the account of the holder of ordinary shares or ADSs.

The expression "dividends distributed" includes, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• distributions in cash or in kind, deemed and constructive distributions and repayments of paid-in capital not recognized for Dutch dividend withholding tax purposes;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• liquidation proceeds, proceeds of redemption of ordinary shares or ADSs, or proceeds of the repurchase of ordinary shares or ADSs by us or one of our subsidiaries or other affiliated entities to the extent such proceeds exceed the average paid-in capital of those ordinary shares or ADSs as recognized for Dutch dividend withholding tax purposes;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an amount equal to the par value of ordinary shares or ADSs issued or an increase of the par value of ordinary shares or ADSs, to the extent that it does not appear that a contribution recognized for Dutch dividend withholding tax purposes has been made or will be made; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• partial repayment of the paid-in capital, recognized Dutch dividend withholding tax purposes, if and to the extent that we have net profits (zuivere winst), unless (a) the general meeting has resolved in advance to make such repayment and (b) the par value of the ordinary shares or ADSs concerned has been reduced by an equal amount by way of an amendment of the company's Articles of Association.

Individuals and corporate legal entities who are resident or deemed to be resident of the Netherlands for Dutch tax purposes ("Dutch Resident Individuals" and "Dutch Resident Entities," as the case may be), generally are entitled to an exemption of or a credit for any Dutch dividend withholding tax against their income tax or corporate income tax liability and to a refund of any residual Dutch dividend withholding tax. The same generally applies to holders of ordinary shares or ADSs that are neither resident nor deemed to be resident of the Netherlands if the ordinary shares or ADSs are attributable to a Dutch permanent establishment of such non-resident holder.

A holder of ordinary shares or ADSs resident of a country other than the Netherlands may, depending on such holder's specific circumstances, be entitled to exemptions from, reductions of, or full or partial refunds of, Dutch dividend withholding tax under Dutch national tax legislation or a double taxation convention in effect between the Netherlands and such other country.

*Remittance to the Dutch tax authorities* 

In general, we will be required to remit all amounts withheld as Dutch dividend withholding tax to the Dutch tax authorities. However, under certain circumstances, we are allowed to reduce the amount to be remitted to the Dutch tax authorities by the lesser of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 3% of the portion of the distribution paid by us that is subject to Dutch dividend withholding tax; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 3% of the dividends and profit distributions, before deduction of foreign withholding taxes, received by us from qualifying foreign subsidiaries in the current calendar year (up to the date of the distribution by the Company) and the two preceding calendar years, as far as such dividends and profit distributions have not yet been taken into account for purposes of establishing the above mentioned reduction.

Although this reduction reduces the amount of Dutch dividend withholding tax that we are required to remit to the Dutch tax authorities, it does not reduce the amount of tax that we are required to withhold on dividends distributed by us.

*Dividend stripping* 

Pursuant to legislation to counteract "dividend stripping," a reduction, exemption, credit or refund of Dutch dividend withholding tax is denied if the recipient of the dividend is not the beneficial owner as described in the Dutch Dividend Withholding Tax Act 1965 (Wet op de dividendbelasting 1965). This legislation generally targets situations in which a shareholder retains its economic interest in shares but reduces the withholding tax costs on dividends by a transaction with another party. It is not required for these rules to apply that the recipient of the dividends is aware that a dividend stripping transaction took place. The Dutch State Secretary of Finance takes the position that the definition of beneficial ownership introduced by this legislation will also be applied in the context of a double taxation convention.

***Taxes on income and capital gains***

*Dutch Resident Entities* 

Generally speaking, if the holder of ordinary shares or ADSs is a Dutch Resident Entity, any payment under the ordinary shares or ADSs or any gain or loss realized on the disposal or deemed disposal of the ordinary shares or ADSs is subject to Dutch corporate income tax at a rate of 19% with respect to taxable profits up to €200,000 and 25.8% with respect to taxable profits in excess of that amount (rates and brackets for 2025).

*Dutch Resident Individuals* 

If the holder of ordinary shares or ADSs is a Dutch Resident Individual, any payment on the ordinary shares or ADSs or any gain or loss realized on the disposal or deemed disposal of the ordinary shares or ADSs is taxable at the progressive Dutch income tax rates (with a maximum of 49.50% in 2025), if:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i.the ordinary shares or ADSs are attributable to an enterprise from which the holder of ordinary shares or ADSs derives a share of the profit, whether as an entrepreneur (ondernemer) or as a person who has a co-entitlement to the net worth (medegerechtigd tot het vermogen) of such enterprise without being a shareholder (as defined in the Dutch Income Tax Act 2001); or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii.the holder of ordinary shares or ADSs is considered to perform activities with respect to the ordinary shares or ADSs that go beyond ordinary asset management (normaal, actief vermogensbeheer) or derives benefits from the ordinary shares or ADSs that are taxable as benefits from other activities (resultaat uit overige werkzaamheden).

If the above-mentioned conditions (i) and (ii) do not apply to the individual holder of ordinary shares or ADSs, such holder will be taxed annually on a deemed return (with a maximum of 5.88% in 2025) on the individual's net investment assets (rendementsgrondslag) for the year, insofar the individual's net investment assets for the year exceed a statutory threshold (heffingvrij vermogen). The deemed return on the individual's net investment assets for the year is taxed at a rate of 36%. Actual income, gains or losses in respect of the ordinary shares or ADSs are as such not subject to Dutch income tax.

The net investment assets for the year are the fair market value of the investment assets less the allowable liabilities on January 1st of the relevant calendar year. The ordinary shares or ADSs are included as investment assets. For the net investment assets on January 1, 2025, the deemed return is 5.88%. The deemed return will be adjusted annually on the basis of historic market yields.

*Non-residents of the Netherlands* 

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A holder of ordinary shares or ADSs that is neither a Dutch Resident Entity nor a Dutch Resident Individual will not be subject to Dutch taxes on income or capital gains in respect of any payment under the ordinary shares or ADSs or in respect of any gain or loss realized on the disposal or deemed disposal of the ordinary shares or ADSs, provided that:

isuch holder does not have an interest in an enterprise or deemed enterprise (as defined in the Dutch Income Tax Act 2001 and the Dutch Corporate Income Tax Act 1969) which, in whole or in part, is either effectively managed in the Netherlands or carried on through a permanent establishment, a deemed permanent establishment or a permanent representative in the Netherlands and to which enterprise or part of an enterprise the ordinary shares or ADSs are attributable; and

iiin the event the holder is an individual, such holder does not carry out any activities in the Netherlands with respect to the ordinary shares or ADSs that go beyond ordinary asset management and does not derive benefits from the ordinary shares or ADSs that are taxable as benefits from other activities in the Netherlands.

***Gift and inheritance taxes***

*Residents of the Netherlands* 

Gift or inheritance taxes will arise in the Netherlands with respect to a transfer of ordinary shares or ADSs by way of a gift by, or on the death of, a holder of such ordinary shares or ADSs who is resident or deemed resident of the Netherlands at the time of the gift or the holder's death.

*Non-residents of the Netherlands* 

No gift or inheritance taxes will arise in the Netherlands with respect to a transfer of the ordinary shares or ADSs by way of gift by, or on the death of, a holder of ordinary shares or ADSs who is neither resident nor deemed to be resident of the Netherlands, unless:

iin the case of a gift of ordinary shares or ADSs by an individual who at the date of the gift was neither resident nor deemed to be resident of the Netherlands, such individual dies within 180 days after the date of the gift, while being resident or deemed to be resident of the Netherlands; or

iithe transfer is otherwise construed as a gift or inheritance made by, or on behalf of, a person who, at the time of the gift or death, is or is deemed to be resident of the Netherlands.

For purposes of Dutch gift and inheritance taxes, amongst others, a person that holds the Dutch nationality will be deemed to be resident of the Netherlands if such person has been resident in the Netherlands at any time during the ten years preceding the date of the gift or such person's death. Additionally, for purposes of Dutch gift tax, amongst others, a person not holding the Dutch nationality will be deemed to be resident of the Netherlands if such person has been resident in the Netherlands at any time during the twelve months preceding the date of the gift. Applicable tax treaties may override deemed residency.

***Value added tax (VAT)***

No Dutch VAT will be payable by a holder of ordinary shares or ADSs in respect of any payment in consideration for the ownership or disposition of the ordinary shares or ADSs.

***Other taxes and duties***

No Dutch registration tax, stamp duty or any other similar documentary tax or duty will be payable by a holder of ordinary shares or ADSs in respect of any payment in consideration for the ownership or disposition of the ordinary shares or ADSs.

**F. Dividends and Paying Agents**

Not applicable.

**G. Statement by Experts**

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Not applicable.

**H. Documents on Display**

We are subject to the informational requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC, including Annual Reports on Form 20-F and reports on Form 6-K. The SEC maintains an Internet website that contains reports and other information about issuers, like us, that file electronically with the SEC. The address of that website is http://www.sec.gov.

We also make available on our website, free of charge, our Annual Report and the text of our reports on Form 6-K, including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Our website address is www.pharming.com. The information contained on our website is not incorporated by reference in this Annual Report and our website address is included in this Annual Report as an inactive textual reference only.

**I.Subsidiary Information**

Not applicable.

**J. Annual Report on Security Holder**

Not applicable.

**Item 11. Quantitative and Qualitative Disclosures About Market Risk** 

***Quantitative and Qualitative Disclosures about Market Risk***

Our operations expose us to some financial risks arising from our use of financial instruments, the most significant ones being liquidity, market risk and credit risk. The Board of Directors is responsible for our risk management policies and while retaining responsibility for them it has delegated the authority for designing and operating processes that ensure the effective implementation of the objectives and policies to our finance function. Refer to Note 26 of the Annual Financial Statements.

**Item 12. Description of Securities Other than Equity Securities**

**A.Debt Securities**

Not applicable.

**B. Warrants and Rights**

Not applicable.

**C. Other Securities**

Not applicable.

**D. American Depositary Shares**

The depositary may charge each person to whom ADSs are issued, including, without limitation, issuances against deposits of shares, issuances in respect of share distributions, rights and other distributions, issuances pursuant to a stock dividend or stock split declared by us or issuances pursuant to a merger, exchange of securities or any other transaction or event affecting the ADSs or deposited securities, and each person surrendering ADSs for withdrawal of deposited securities or whose ADRs are cancelled or reduced for any other reason, $5.00 for each 100 ADSs (or any portion thereof) issued, delivered, reduced, canceled or surrendered, or upon which a share distribution or elective distribution is made or offered, as the case may be. The depositary

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may sell (by public or private sale) sufficient securities and property received in respect of a share distribution, rights and/or other distribution prior to such deposit to pay such charge.

The following additional charges will also be incurred by the ADR holders, the beneficial owners, by any party depositing or withdrawing shares or by any party surrendering ADSs and/or to whom ADSs are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock regarding the ADSs or the deposited securities or a distribution of ADSs), whichever is applicable:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a fee of $0.05 or less per ADS held for any cash distribution made, or for any elective cash/stock dividend offered, pursuant to the deposit agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an aggregate fee of $0.05 or less per ADS per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and will be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a fee for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian and expenses incurred on behalf of ADR holders in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) in connection with the servicing of the shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary's or its custodian's compliance with applicable law, rule or regulation (which fees and charges will be assessed on a proportionate basis against ADR holders as of the record date or dates set by the depositary and will be payable at the sole discretion of the depositary by billing such ADR holders or by deducting such charge from one or more cash dividends or other cash distributions);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a fee for the distribution of securities (or the sale of securities in connection with a distribution), such fee being in an amount equal to the $0.05 per ADS issuance fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities (treating all such securities as if they were shares) but which securities or the net cash proceeds from the sale thereof are instead distributed by the depositary to those ADR holders entitled thereto;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• stock transfer or other taxes and other governmental charges;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• cable, telex and facsimile transmission and delivery charges incurred at holders' request in connection with the deposit or delivery of shares, ADRs or deposited securities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• transfer or registration fees for the registration of transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement. To facilitate the administration of various depositary receipt transactions, including disbursement of dividends or other cash distributions and other corporate actions, the depositary may engage the foreign exchange desk within JPMorgan Chase Bank, N.A., or the Bank, and/or its affiliates in order to enter into spot foreign exchange transactions to convert foreign currency into U.S. dollars. For certain currencies, foreign exchange transactions are entered into with the Bank or an affiliate, as the case may be, acting in a principal capacity. For other currencies, foreign exchange transactions are routed directly to and managed by an unaffiliated local custodian (or other third party local liquidity provider), and neither the Bank nor any of its affiliates is a party to such foreign exchange transactions.

The foreign exchange rate applied to a foreign exchange transaction will be either (a) a published benchmark rate, or (b) a rate determined by a third party local liquidity provider, in each case plus or minus a spread, as applicable. The depositary will disclose which foreign exchange rate and spread, if any, apply to such currency on the "Disclosure" page (or successor page) of www.adr.com. Such applicable foreign exchange rate and spread may (and neither the depositary, the Bank nor any of their affiliates is under any obligation to ensure that such rate does not) differ from rates and spreads at which comparable transactions are entered into with other customers or the range of foreign exchange rates and spreads at which the Bank or any of its affiliates enters into foreign exchange transactions in the relevant currency pair on the date of the foreign exchange transaction. Additionally, the timing of execution of a foreign exchange transaction varies according to local market dynamics, which may include regulatory requirements, market hours and liquidity in the foreign exchange market or other factors. Furthermore, the Bank and its affiliates may manage the associated risks of their position in the market in a manner they deem appropriate without regard to the impact of such activities on the depositary, us, holders or beneficial owners. The spread applied does not reflect any gains or losses that may be earned or incurred by the Bank and its affiliates as a result of risk management or other hedging related activity.

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The depositary reimburses the Company for certain expenses incurred by the Company that are related to the maintenance of the ADR program upon such terms and conditions as the Company and the depositary agree from time to time. The depositary may make available to the Company a set amount or a portion of the depositary fees charged in respect of the ADR program or otherwise upon such terms and conditions as the Company and the depositary may agree from time to time.

**Item 13. Defaults, Dividend Arrearages and Delinquencies**

Not applicable.

**Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds**

Not applicable.

**Item 15. Controls and Procedures**

**A. Disclosure Controls and Procedures**

As required by Rules 13a-15(e) and 15d-15(e) under the Exchange Act, management, including our Chief Executive Officer ("CEO") and our Chief Financial Officer ("CFO"), has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report. Disclosure controls and procedures refer to controls and other procedures which are designed to ensure that information which requires disclosure in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.

Disclosure controls and procedures include, without limitations, controls and procedures designed to ensure that information required to be disclosed by us in our reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding our required disclosures.

Based on such evaluation and the effective remediation of prior year material weaknesses in our internal control over financial reporting, our CEO and our CFO have concluded that our disclosure controls and procedures are effective as of December 31, 2025, related to accounting for complex, non-routine transactions, and corporate income tax, as well as the material weaknesses in the components of the COSO framework (control environment, control activities, and monitoring).

**Remediation of Previously Disclosed Material Weaknesses**

As of December 31, 2025, we have effectively remediated the two material weaknesses previously disclosed in Form 20-F for the year-ended December 31, 2024 and the related material weaknesses in the COSO Framework.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

During the fiscal year ended December 31, 2025, we implemented a comprehensive remediation program which further strengthened our overall control environment. We actively took steps to execute our remediation plan using the following measures, amongst others:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We completed a root-cause analysis to assess the true reasons for prior failures, while proactively working with all stakeholders to address each issue at the core.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Using our risk assessment procedures, we identified areas requiring additional attention, and accordingly, we provided targeted focus and support to redesign the controls in these areas.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The control owners and preparers for the areas which caused prior year's material weaknesses were re-trained and as a result, there were enhanced control procedures and better-quality documentation.

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• All assumptions provided by external specialists and which were included in our position papers to address the accounting for complex, non-routine transactions and the calculation of corporate income tax provisions, were thoroughly reviewed by all control preparers and control owners, prior to subsequent discussions with our external auditors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Throughout the year, we coordinated and increased the number of cross-functional meetings with various stakeholders, including external consultants, to proactively help identify and address issues or errors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Provided additional training and guidance for relevant personnel performing control procedures in these areas.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Conducted testing of relevant internal control procedures in these areas earlier in the year, thereby confirming that they are operating as intended.

We believe that the above remediation measures address the material weaknesses in both the business process level controls related to accounting for complex, non-routine transactions, and corporate income tax, as well as the material weaknesses in the components of the COSO framework (control environment, control activities, and monitoring).

**B. Management's Annual Report on Internal Control over Financial Reporting**

Our management, under the supervision of our CEO and our CFO, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our system of internal control is designed to provide reasonable assurance as to the reliability of financial reporting and the preparation of the published financial statements under generally accepted accounting principles. For Pharming Group N.V., "generally accepted accounting principles" means IFRS Accounting Standards as issued by the International Accounting Standards Board and as adopted by the European Union.

As of December 31, 2025, our management assessed the effectiveness of our internal controls over financial reporting. In making this assessment, we used the criteria established in the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission ("the COSO framework"). As of December 31, 2025, and based on our assessment under these criteria, including an assessment of the five components of the COSO framework (control environment, risk management, control activities, information and communication and monitoring), at the entity level and across our business and IT processes, management has determined that, our internal controls over financial reporting were effective.

 **C. Attestation Report of the Registered Public Accounting Firm**

This Annual Report includes an attestation report of the registered public accounting firm on the effectiveness of the Company's internal control over financial reporting.

------

**REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**

To the shareholders and the Board of Directors of Pharming Group N.V.

**Opinion on Internal Control over Financial Reporting**

We have audited the internal control over financial reporting of Pharming Group N.V. and subsidiaries (the "Company") as at December 31, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as at and for the year ended December 31, 2025, of the Company and our report dated April 1, 2026, expressed an unqualified opinion on those financial statements.

**Basis for Opinion**

The Company's management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company's internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

**Definition and Limitations of Internal Control over Financial Reporting**

A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ Deloitte Accountants B.V.

Eindhoven, The Netherlands

April 1, 2026

------

**D. Changes in Internal Controls Over Financial Reporting**

Other than as discussed above, there has been no change in our internal control over financial reporting during the period covered by this Annual Report that has materially affected, or is reasonably likely to materially affect, internal control over financial reporting.

**Item 16. Reserved**

**Item 16 A. Audit Committee Financial Expert**

Our board of directors has determined that Mr. Leonard Kruimer, the Chairman of the Audit Committee, is an "audit committee financial expert" as defined by SEC rules and has the requisite financial sophistication under the applicable rules and regulations of the Nasdaq. Mr. Kruimer is independent, as such term is defined in Rule 10A-3 under the Exchange Act and under the listing standards of Nasdaq.

**Item 16 B. Code of Ethics**

We have adopted a Code of Conduct, which outlines the principles of legal and ethical business conduct under which we do business. The Code of Conduct applies to all of our Executive Committee members, Board of Directors members and our affiliates and employees. The full text of the Code of Conduct is available on our website at https://www.pharming.com. The information and other content appearing on our website are not part of this Annual Report and our website address is included in this Annual Report as an inactive textual reference only.

We intend to disclose any amendment to the Code of Conduct, or any waivers of its requirements, in our Annual Reports on Form 20-F. For the year ended December 31, 2025, we did not grant any waivers of the Code of Conduct.

**Item 16 C. Principal Accountant Fees and Services**

Deloitte Accountants B.V., or Deloitte, has served as our independent registered public accounting firm for 2025 and 2024. Our accountants billed the following fees to us for professional services in each of those fiscal years:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Audit Fees | (1906) | (1690) |
| Audit Related Fees |  |  |
| Tax Fees | **—** | **—** |
| All Other Fees | **—** | **—** |
| **Total** | **(1906)** | **(1690)** |

---

*"Audit Fees"* consist of fees billed for the annual audit of our consolidated financial statements. Audit Fees also include services that only our independent external auditor can reasonably provide, such as the review of documents filed with the SEC. For the fiscal year ended December 31, 2025, and 2024, the aggregate fees billed for audit services by Deloitte were $1.9 million and $1.7 million, respectively.

*"Audit-Related Fees"* consist of fees billed for assurance and related services that are reasonably related to the performance of the audit or review of its financial statements or that are traditionally performed by the external auditor, and mainly include services such as comfort letters issued in connection with securities offerings, due diligence and agreed-upon or expanded audit procedures. For the fiscal years ended December 31, 2025 and 2024, there were no fees billed for assurance and related services by Deloitte.

*"Tax Fees"* consist of tax consultations, such as advice in connection with employees' taxation arising from share-based compensation. For the fiscal years ended December 31, 2025 and 2024, there were no fees billed for tax compliance and tax planning by Deloitte.

------

*"All Other Fees"* consist of advisory services such as the adoption or application of IFRS. For the fiscal years ended December 31, 2025 and 2024, there were no fees billed by Deloitte for other non-audit professional services.

*Pre-Approval Policies and Procedures*

The Audit Committee evaluates the qualifications, independence and performance of the independent auditor as well as pre-approves and reviews the audit and non-audit services to be performed by the independent auditor.

The Audit Committee reviewed and discussed the external auditor's 2025 audit plan (including proposed fees). The Audit Committee approved the 2025 audit plan at the meeting held on July 29, 2025. The 2025 Audit Plan was also shared and discussed with the full Board of Directors.

In accordance with the Audit Committee Charter, as published on the Company's website www.pharming.com/aboutus/corporategovernance, the Audit Committee monitors compliance with the Dutch and U.S. rules on non-audit services provided by an independent registered public accounting firm. Accordingly, the Audit Committee shall pre-approve all audit services to be provided to the Company, and all other services (review, attest and non-audit) to be provided to the Company by the external auditor, to the extent permitted under applicable law, provided, however, that de minimis non-audit services may instead be approved in accordance with applicable SEC rules. The Audit Committee did not have to approve non-audit services by Deloitte in 2025.

Deloitte was appointed by the general meeting of shareholders held on June 11, 2025, as external auditor for the financial year 2025. Deloitte has served as external auditor for seven years in total.

During its meeting on March 31, 2026, the Audit Committee discussed and confirmed the independence of the external auditor.

**Item 16 D. Exemptions from the Listing Standards for Audit Committees**

Not applicable.

**Item 16 E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers**

During the year ended December 31, 2025, no purchases of our equity securities were made by or on behalf of us or any affiliated purchaser.

**Item 16 F. Change in Registrant's Certifying Accountant**

Not applicable.

**Item 16 G. Corporate Governance**

**Foreign Private Issuer Exemption** 

We are a "foreign private issuer," as defined by the SEC. As a result, in accordance with Nasdaq rules, we comply with home country governance requirements and certain exemptions thereunder rather than complying with Nasdaq corporate governance standards. While we voluntarily follow most Nasdaq corporate governance rules, we have chosen, or may decide to choose, to take advantage of the following limited exemptions:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exemption from filing quarterly reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K upon the occurrence of specified significant events;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exemption from Section 16 under the Exchange Act, which requires insiders to file public reports of their securities ownership and trading activities and provides for liability for insiders who profit from trades in a short period of time;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exemption from the Nasdaq rules applicable to domestic issuers requiring disclosure within four business days of any determination to grant a waiver of the code of conduct and ethics to directors and officers;

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exemption from the requirement to obtain shareholder approval for certain issuances of securities, including shareholder approval of share option plans;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exemption from the requirement that our Audit Committee have review and oversight responsibilities over all "related party transactions," as defined in Item 7.B of Form 20-F;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exemption from the requirement that our board of directors has a compensation committee that is composed entirely of independent directors with a written charter addressing the committee's purpose and responsibilities; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exemption from the requirements that director nominees are selected, or recommended for selection by our board of directors, either by (a) independent directors constituting a majority of our board of director's independent directors in a vote in which only independent directors participate, or (b) a committee comprised solely of independent directors, and that a formal written charter or board resolution, as applicable, addressing the nominations process is adopted.

Furthermore, Nasdaq Rule 5615(a)(3) provides that a foreign private issuer, such as us, may rely on home country corporate governance practices in lieu of certain of the rules in the Nasdaq Rule 5600 Series and Rule 5250(d), provided that we nevertheless comply with Nasdaq's Notification of Noncompliance requirement (Rule 5625), the Voting Rights requirement (Rule 5640) and that we have an Audit Committee that satisfies Rule 5605(c) (3), consisting of committee members that meet the independence requirements of Rule 5605(c)(2)(A)(ii).

We comply with the Nasdaq corporate governance rules applicable to foreign private issuers, which means that we are permitted to follow certain corporate governance rules that conform to Dutch requirements in lieu of many of the Nasdaq corporate governance rules. Accordingly, our shareholders do not have the same protections afforded to shareholders of companies that are subject to all of the corporate governance requirements of Nasdaq. We may utilize these exemptions for as long as we continue to qualify as a foreign private issuer.

For an overview of some specific differences between corporate governance principles for a Netherlands public company, such as us, and those that are applicable to a Delaware corporation, see "Description of Securities" included as Exhibit 2.1 to this Annual Report. This also summarizes our implementation of the corporate governance principles in accordance with Dutch law and the DCGC. Finally, reference is made to the sections "Organizational Structure" and "Directors and Senior Management" for more details on our group structure and corporate governance structure. All referenced sections are incorporated in this section by reference.

**Item 16 H. Mine Safety Disclosure**

Not applicable.

**Item 16 I. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections**

Not applicable.

**Item 16 J. Insider trading policies**

On July 31, 2024, we adopted a new Market Abuse Prevention Policy, replacing our insider trading policy, to promote compliance with applicable securities laws and regulations, including those that prohibit insider trading. This policy applies to all persons working for the Company and/or any of its subsidiaries and affiliates, including employees, members of the Board, members of the Executive Committee, consultants, agent, interns, contractors, temporary workers, or any other person (each, an "Employee"), regardless of the duration of their (employment) contract or other relationship. The policy establishes guidelines and procedures for the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• No Trading: Employees shall not conduct a transaction in our securities, if this may reasonably cause the appearance that they had available or could have had available inside information when conducting the transaction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• No Tipping: Employees may not (attempt to) recommend or induce anyone to trade in our securities while in the possession of inside information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• No Comment: Employees may not disclose confidential information or inside information to anyone else, except where the disclosure is made in the normal exercise of their duties within the Company and

------

the recipient of the confidential information or inside information has an existing obligation to keep the received confidential information or inside information confidential.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• No Trading during closed periods: Employees may not trade during Closed Periods. A Closed Period is the period of 30 calendar days before the first publication of our annual, half year and quarterly results, or any other period announced as such by the compliance officer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are committed to upholding both the letter and the spirit of the laws in all jurisdictions in which we conduct business and have implemented these policies and procedures to ensure compliance with applicable securities laws and to protect the interests of our shareholders.

A copy of the Market Abuse Prevention Policy has been filed herewith as Exhibit 11.1.

**Item 16 K. Cybersecurity**

**Risk Management and Strategy**

We have established physical, electronic and organizational measures to safeguard and secure our systems and facilities to prevent an information compromise, and rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result, a number of third-party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage or unauthorized access or use resulting from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, denial-of-service attacks, cyber-attacks or cyber-intrusions over the Internet, hacking, phishing and other social engineering attacks, attachments to emails, persons inside our organization (including employees or contractors), lost or stolen devices, or persons with access to systems inside our organization. We also perform third-party cybersecurity risk assessments for service providers and others outside the organization. For instance, when a third-party vendor is involved in processing personal data, we assess their administrative, physical and technical to evaluate their compliance with our company policies and applicable regulatory requirements. We also review and assess internal initiatives that involve the processing of personal data.

We have been, and may in the future be, subject to cyberattacks. However, we have not identified any cybersecurity threats or incidents that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition.

Despite our efforts, we cannot eliminate all risks from cybersecurity threats or incidents, or provide assurances that we have not experienced an undetected cybersecurity incident. For more information about these risks, please see "Risk Factors – We depend on our information technology systems and have been and may in the future be the victim of cyberattacks, which may compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition."

**Governance**

Our Board of Directors holds oversight responsibility over the Company's strategy and risk management, including material risks related to cybersecurity threats. This oversight is executed directly by the Board of Directors and through its committees. The Audit Committee oversees the management of systemic risks, including cybersecurity, in accordance with its charter. The Audit Committee engages in regular discussions with management regarding the Company's significant financial risk exposures and the measures implemented to monitor and control these risks, including those that may result from material cybersecurity threats.

Our CFO oversees our cybersecurity risk management program and has primary responsibility for identifying, assessing and managing our exposure to cybersecurity threats and incidents. Our IT Director reports to our CFO with respect to the prevention, detection, mitigation and remediation of cybersecurity risks. The IT Director has over ten years of experience in similar roles.

**Item 17. Financial Statements**

------

See ''Item 18 — Financial Statements'' of this Annual Report.

**Item 18. Financial Statements**

See pages F-1 through F-61 of this Annual Report.

------

**Item 19. Exhibits**

**EXHIBIT INDEX** 

---

| | |
|:---|:---|
| **Exhibit Number** | **Description of Exhibit** |
| 1.1 | <u>[Amended and Restated Articles of Association of Pharming Group N.V. effective as of May 23, 2023 (English translation) (incorporated by reference to Exhibit 1.1 of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 4, 2024).#](https://www.sec.gov/Archives/edgar/data/1828316/000182831624000008/pharming-exhibit11_04apr24.htm)</u> |
| 1.2 | <u>[Board Rules of Pharming Group N.V. effective as of April 1, 2024. (incorporated by reference to Exhibit 1.2 of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 4, 2024).#](https://www.sec.gov/Archives/edgar/data/1828316/000182831624000008/pharming-exhibit12_04apr.htm)</u>  |
| 2.1 | <u>[Description of Securities (incorporated by reference to Exhibit 2.1 of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 4, 2024).#](https://www.sec.gov/Archives/edgar/data/1828316/000182831624000008/pharming-exhibit11_04apr24.htm)</u>  |
| 2.2 | <u>[Form of Deposit Agreement (incorporated by reference to Exhibit 4.1 of the Company's Registration Statement on Form F-1 (File No. 333-250984) filed with the SEC on December 17, 2020).#](https://www.sec.gov/Archives/edgar/data/1828316/000119312520320211/d25824dex41.htm)</u> |
| 2.3 | <u>[Form of American Depositary Receipt (incorporated by reference to Exhibit 4.2 of the Company's Registration Statement on Form F-1 (File No. 333-250984) filed with the SEC on December 17, 2020).#](https://www.sec.gov/Archives/edgar/data/1828316/000119312520320211/d25824dex41.htm)</u> |
| 2.4 | <u>[Trust Deed constituting €100,000,000 4.50 per cent Convertible Bonds due 2029, dated as of 25 April 2024, by and between the registrant and BNY Mellon Corporate Trustee Services Limited.](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[(incorporated by reference to Exhibit](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[2](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[.](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[4](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[of the Company's Annual Report on Form 20-F for the year ended December 31, 202](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[4](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[filed with the SEC on April](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[3](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[, 202](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[5](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)[).#](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex24_projectaur.htm)</u> |
| 4.1 | <u>[Revised Stock Option Plan for Employees (incorporated by reference to Exhibit 10.1 of the Company's Registration Statement on Form F-1 (File No. 333-250984) filed with the SEC on December 17, 2020).#\*](https://www.sec.gov/Archives/edgar/data/1828316/000119312520320211/d25824dex101.htm)</u> |
| 4.2 | <u>[Revised Stock Option Plan for Employees as amended and restated (incorporated by reference to Exhibit 99.1 of the Company's Registration Statement on Form S-8 (File No. 333-260557) filed with the SEC on October 28, 2021).#\*](https://www.sec.gov/Archives/edgar/data/0001828316/000119312521311326/d206237ds8.htm)</u> |
| 4.3 | <u>[Long Term Incentive Plan as amended and restated on October 26, 2022 (incorporated by reference to Exhibit 4.3 of the Company's Annual Report on Form 20-F for the year ended December 31, 2022 filed with SEC on April 5, 2023).#\*](https://www.sec.gov/Archives/edgar/data/1828316/000162828023010793/exhibit43ltip_26oct2022.htm)</u> |
| 4.4 | <u>[License Agreement, by and between the registrant and Novartis International Pharmaceutical AG, dated August 12, 2019 (incorporated by reference to Exhibit 10.5 of the Company's Registration Statement on Form F-1 (File No. 333-250984) filed with the SEC on November 25, 2020).#†+](https://www.sec.gov/Archives/edgar/data/1828316/000119312520303748/d25824dex105.htm)</u> |
| 4.5 | <u>[Form of Indemnity Agreement between the registrant and its directors and executive officers (incorporated by reference to Exhibit 10.8 of the Company's Registration Statement on Form F-1 (File No. 333-250984) filed with the SEC on November 25, 2020).#](https://www.sec.gov/Archives/edgar/data/1828316/000119312520303748/d25824dex108.htm)</u> |
| 4.6 | <u>[License and Collaboration Agreement, dated as of April 28, 2017, by and between YungJin Pharm Co., Ltd](ex462017-04x28_engxyungjin.htm)[.](ex462017-04x28_engxyungjin.htm)[and NEUROVIVE Pharmaceuticals AB (PUBL)†](ex462017-04x28_engxyungjin.htm)</u> |
| 8.1 | <u>[List of subsidiaries of the registrant as per December 31, 202](pharmingex81_subsidaries31.htm)[5](pharmingex81_subsidaries31.htm)</u> |
| 11.1 | <u>[Market Abuse Prevention Policy of the Company](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex111_marketabu.htm)[(incorporated by reference to Exhibit 11.1 of the Company's Annual Report on Form 20-F for the](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex111_marketabu.htm)[year ended December 31, 2024 filed with the SEC on April 3, 2025)](https://www.sec.gov/Archives/edgar/data/1828316/000182831625000017/pharming-ex111_marketabu.htm)</u> |
| 12.1 | <u>[Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.](ex121certificationbythepri.htm)</u> |
| 12.2 | <u>[Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.](ex122certificationbythepri.htm)</u> |
| 13.1 | <u>[Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.](ex131certificationbythepri.htm)</u> |
| 13.2 | <u>[Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.](ex132certificationbythepri.htm)</u> |
| 15.1 | <u>[Consent of Deloitte Accountant B.V., independent registered public accounting firm.](pharming-ex151xconsentlett.htm)</u> |

---

------

---

| | |
|:---|:---|
| 97.1 | <u>[Registrant Clawback Policy (incorporated by reference to Exhibit 1.2 of the Company's Registration Statement on Form 20-F for the year ended December 31, 2023, filed with the SEC on April 4, 2024).#](https://www.sec.gov/Archives/edgar/data/1828316/000182831624000008/pharming-exhibit971_04apr24.htm)</u> |
| 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| 104 | Cover Page Interactive Data File (Formatted as Inline XBRL and contained in Exhibit 101) |

---

† Portions of this exhibit have been excluded because they are both not material and are the type that the registrant treats as private or confidential.

+ Certain schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC.

# Previously filed.

\*&nbsp;&nbsp;&nbsp;&nbsp;Indicates management contract or compensatory plan

**SIGNATURES**

The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F/A and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.

**Pharming Group N.V.**

/s/ Fabrice Chouraqui, PharmD, MBA

——————————————

By: Fabrice Chouraqui, PharmD, MBA

Title: Chief Executive Officer

Date: April 13, 2026

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| |
|:---|
| **Index to Financial Statements** |
| **FINANCIAL SECTION** |
| Audited consolidated financial statements as of and for the years ended December 31, 2025, 2024, and 2023 |

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| | |
|:---|:---|
| **Contents** | **Contents** |
| <u>[Reports of Independent Registered Public Accounting Firm](#i8209414efd9e4d5f8081c614b690fc9f_247)</u> (PCAOB ID No. 1243) | F- <u>[2](#i8209414efd9e4d5f8081c614b690fc9f_247)</u> |
| <u>[Consolidated Statement of Income](#i8209414efd9e4d5f8081c614b690fc9f_250)</u> | F- <u>[4](#i8209414efd9e4d5f8081c614b690fc9f_250)</u> |
| <u>[Consolidated Statement of Comprehensive Income](#i8209414efd9e4d5f8081c614b690fc9f_253)</u> | F- <u>[5](#i8209414efd9e4d5f8081c614b690fc9f_253)</u> |
| <u>[Consolidated Balance Sheet](#i8209414efd9e4d5f8081c614b690fc9f_256)</u> | F- <u>[6](#i8209414efd9e4d5f8081c614b690fc9f_256)</u> |
| <u>[Consolidated Statement of Changes in Equity](#i8209414efd9e4d5f8081c614b690fc9f_259)</u> | F- <u>[7](#i8209414efd9e4d5f8081c614b690fc9f_259)</u> |
| <u>[Consolidated Statement of Cash Flows](#i8209414efd9e4d5f8081c614b690fc9f_262)</u> | F- <u>[8](#i8209414efd9e4d5f8081c614b690fc9f_262)</u> |
| <u>[Notes to the Consolidated Financial Statements](#i8209414efd9e4d5f8081c614b690fc9f_265)</u> | F- <u>[9](#i8209414efd9e4d5f8081c614b690fc9f_265)</u> |

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**REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**

To the shareholders and the Board of Directors of Pharming Group N.V.

**Opinion on the Financial Statements**

We have audited the accompanying consolidated balance sheets of Pharming Group N.V. and subsidiaries (the "Company") as at December 31, 2025 and 2024 the related consolidated statements of income, comprehensive income, changes in equity and cash flows, for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with IFRS Accounting Standards as issued by the International Accounting Standards Board, or IASB.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as at December 31, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated April 1, 2026, expressed an unqualified opinion on the Company's internal control over financial reporting.

**Basis for Opinion**

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

**Critical Audit Matter**

The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

***Intangible assets - Valuation of the KL1333 license acquired in a business combination - Refer to Notes 2.5, 3 and 10 to the financial statements***

*Critical Audit Matter Description*

The Company acquired 88.9% of the voting shares of Abliva AB on February 14, 2025, followed by the acquisition of the remaining shares on June 18, 2025. The Company accounted for the acquisition under the

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acquisition method of accounting for business combinations. Accordingly, the purchase price was allocated to the assets acquired and liabilities assumed based on their respective fair values. Through this acquisition, the Company obtained exclusive global rights, (excluding South Korea and Japan) to develop and commercialise napazimone (KL1333), valued at USD 61.1 million. The KL1333 licence was the principal intangible asset recognised in the purchase price allocation under IFRS 3 and was measured at fair value using a probability-adjusted discounted cash flow approach.

The initial fair value measurement of the acquired KL1333 licence required significant judgement and estimation. These significant assumptions and judgements include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Management's long-term revenue forecasts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The development timelines and commercialization prospects, which include the probability of regulatory success and the expected timing of obtaining regulatory approvals; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The discount rate applied to future cash flows.

Given the complexity of this estimate and the judgements necessary to develop this estimate, auditing this estimate required both extensive audit effort and a high degree of auditor judgement when performing auditing procedures and evaluating the results of those procedures, and therefore we identified the valuation of the KL1333 license as a critical audit matter.

*How the Critical Audit Matter Was Addressed in the Audit*

Our audit procedures related to the assumptions and judgements made by management in the initial determination of the valuation of the KL1333 license included the following, amongst others:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We tested the effectiveness of controls over the valuation of the intangible asset, including management's controls over the valuation model used, management's long-term revenue forecast, development timelines and commercialization prospects including the expected timing of obtaining regulatory approvals and selection of the discount rate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We held inquiries with management to understand management's business process for determining the initial valuation of the intangible asset.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We worked with our fair value specialists to assist us in testing the appropriateness of the Company's valuation model, method, date and assumptions used, to determine the initial fair value of the KL1333 license in accordance with IFRS 3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We tested the appropriateness of management's long-term revenue forecast by comparing these assumptions to underlying source data, market information and internal clinical information about the progress of the drug development.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We assessed management's estimates of the probability and timing of achieving regulatory approvals by comparing this assumption to publicly available research information for mitochondrial disease and regulatory approval timelines and success rates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We evaluated the Company's historical accuracy of estimating the forecasted performance of drugs in development through retrospective reviews by comparing the prior years' forecasts of Joenja and Ruconest to actual performance.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• With the assistance of our fair value specialists, we evaluated the reasonableness of the valuation methodology and discount rate by:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Testing the source information underlying the determination of the discount rate and testing the mathematical accuracy of the calculation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Developing a range of independent estimates and comparing those to the discount rate selected by management.

/s/ Deloitte Accountants B.V.

Eindhoven, the Netherlands

April 1, 2026

We have served as the Company's auditor since 2019.

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CONSOLIDATED STATEMENT OF INCOME

For the year ended December 31,

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| | | | | |
|:---|:---|:---|:---|:---|
| Amounts in $'000 | Notes | **2025** | **2024** | **2023** |
| Revenues | 5 | 376134 | 297200 | 245316 |
| Costs of sales | 7 | (45500) | (35399) | (25212) |
| **Gross profit** |  | **330634** | **261801** | **220104** |
| **Other income** | 6 | **6528** | **2177** | **23349** |
| Research and development |  | (100367) | (83147) | (68914) |
| General and administrative |  | (79958) | (70650) | (55877) |
| Marketing and sales |  | (130995) | (118802) | (124049) |
| **Other Operating Costs** | 7 | **(311320)** | **(272599)** | **(248840)** |
| **Operating profit / (loss)** |  | **25842** | **(8621)** | **(5387)** |
| Fair value gain (loss) on revaluation | 13, 18 | 2345 | 4990 | (930) |
| Other finance income | 8 | 2176 | 6843 | 3663 |
| Other finance expenses | 8 | (18140) | (9944) | (9069) |
| **Finance (cost) / gain, net** |  | **(13618)** | **1889** | **(6336)** |
| **Share of net profits / (loss) in associates using the equity method** | 13 | **623** | **(1760)** | **(289)** |
| **Profit / (loss) before tax** |  | **12847** | **(8492)** | **(12012)** |
| Income tax (expense) / credit | 9 | (10310) | (3349) | 1464 |
| **Profit / (loss) for the year** |  | **2538** | **(11841)** | **(10548)** |
| **Attributable to:** |  |  |  |  |
| Equity holders of the parent |  | 2851 | (11841) | (10548) |
| Non-controlling interests |  | (313) |  |  |
| Basic (loss) / earnings per share ($) | 27 | 0.004 | (0.018) | (0.016) |
| Diluted (loss) / earnings per share ($) | 27 | 0.004 | (0.018) | (0.016) |

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*The Notes are an integral part of these financial statements.*

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CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

For the year ended December 31,

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| | | | | |
|:---|:---|:---|:---|:---|
| Amounts in $'000 | Notes | **2025** | **2024** | **2023** |
| **Profit (loss) for the year** |  | **2538** | **(11841)** | **(10548)** |
| Currency translation differences | 28 | 29060 | (11980) | 5936 |
| **Items that may be subsequently reclassified to profit or loss** |  | **29060** | **(11980)** | **5936** |
| Fair value remeasurement investments | 13.3, 28 |  | 79 | 1167 |
| **Items that shall not be subsequently reclassified to profit or loss** |  | **—** | **79** | **1167** |
| **Other comprehensive income (loss), net of tax** |  | **29060** | **(11901)** | **7103** |
| **Total comprehensive income (loss) for the year** |  | **31598** | **(23742)** | **(3445)** |
| **Attributable to:** |  |  |  |  |
| Equity holders of the parent |  | 31828 | (23742) | (3445) |
| Non-controlling interests |  | (230) |  |  |

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*The Notes are an integral part of these financial statements.*

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CONSOLIDATED BALANCE SHEET

As at December 31,

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| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | Notes | **2025** | **2024** |
| **Non-current assets** |  |  |  |
| Intangible assets | 10 | 135538 | 61039 |
| Property, plant and equipment | 11 | 7233 | 7752 |
| Right-of-use assets | 12 | 16738 | 16382 |
| Long-term prepayments |  | 94 | 90 |
| Deferred tax assets | 9 | 31017 | 30544 |
| Investment accounted for using the equity method | 13 | 1944 | 466 |
| Investment in debt instruments designated as at FVTPL | 13 | 6703 | 3767 |
| Restricted cash | 15 | 1227 | 1505 |
| **Total non-current assets** |  | **200495** | **121545** |
| **Current assets** |  |  |  |
| Inventories | 16 | 64902 | 55724 |
| Trade and other receivables | 17 | 54704 | 54823 |
| Restricted cash | 15 | 761 |  |
| Marketable securities | 14 | 33796 | 112949 |
| Cash and cash equivalents | 15 | 145305 | 54944 |
| **Total current assets** |  | **299469** | **278440** |
| **Total assets** |  | **499963** | **399985** |
| **Equity** |  |  |  |
| Share capital |  | 8009 | 7769 |
| Share premium |  | 513257 | 488990 |
| Other reserves |  | 28819 | (209) |
| Accumulated deficit |  | (272983) | (275489) |
| **Total equity** | 28 | **277102** | **221061** |
| **Non-current liabilities** |  |  |  |
| Convertible bonds | 18 | 92719 | 78154 |
| Lease liabilities | 20 | 14351 | 26968 |
| **Total non-current liabilities** |  | **107070** | **105122** |
| **Current liabilities** |  |  |  |
| Convertible bonds | 18 | 5336 | 4245 |
| Provisions | 19 | 1187 |  |
| Trade and other payables | 21 | 105899 | 66611 |
| Lease liabilities | 20 | 3369 | 2946 |
| **Total current liabilities** |  | **115791** | **73802** |
| **Total equity and liabilities** |  | **499963** | **399985** |

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*The Notes are an integral part of these financial statements.*

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CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

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| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| | | **Attributable to equity holders of the parent** | **Attributable to equity holders of the parent** | **Attributable to equity holders of the parent** | **Attributable to equity holders of the parent** | **Attributable to equity holders of the parent** | | |
| Amounts in $'000 | Notes | **Share capital** | **Share premium** | **Other reserves** | **Accumulated deficit** | **Subtotal** | **Non-controlling interest** | **Total equity** |
| **Balance at January 1, 2023** |  | **7509** | **462297** | **(8737)** | **(256431)** | **204638** | **—** | **204638** |
| Profit (loss) for the year |  |  |  |  | (10548) | (10548) |  | (10548) |
| Other comprehensive income (loss) for the year |  |  |  | 7103 |  | 7103 |  | 7103 |
| **Total comprehensive income (loss) for the year** |  | **—** | **—** | **7103** | **(10548)** | **(3445)** | **—** | **(3445)** |
| Other reserves | 28 |  |  | (423) | 423 |  |  |  |
| Income tax benefit from excess tax deductions related to share-based payments |  |  |  |  | 204 | 204 |  | 204 |
| Share-based compensation | 22, 28 |  |  |  | 9251 | 9251 |  | 9251 |
| Options exercised / LTIP shares issued | 28 | 160 | 16134 |  | (8161) | 8133 |  | 8133 |
| **Total transactions with owners, recognized directly in equity** |  | **160** | **16134** | **(423)** | **1717** | **17588** | **—** | **17588** |
| **Balance at December 31, 2023** |  | **7669** | **478431** | **(2057)** | **(265262)** | **218780** | **—** | **218781** |
| Profit (loss) for the year |  |  |  |  | (11841) | (11841) |  | (11841) |
| Movement in reserves | 28 |  |  | 1555 | (1555) |  |  |  |
| Other comprehensive income (loss) for the year |  |  |  | (11901) |  | (11901) |  | (11901) |
| **Total comprehensive income (loss) for the year** |  | **—** | **—** | **(10346)** | **(13395)** | **(23741)** | **—** | **(23742)** |
| Income tax expense from excess tax deductions related to share-based payments | 28 |  |  |  | (66) | (66) |  | (66) |
| Movement in reserves | 28 |  |  | (31) | 31 |  |  |  |
| Share-based compensation | 22, 28 |  |  |  | 11248 | 11248 |  | 11248 |
| Options exercised / LTIP shares issued | 22 | 100 | 10559 |  | (8044) | 2615 |  | 2615 |
| Value of conversion rights of convertible bonds, net of tax | 18 |  |  | 12225 |  | 12225 |  | 12225 |
| **Total transactions with owners, recognized directly in equity** |  | **100** | **10559** | **12194** | **3169** | **26022** | **—** | **26022** |
| **Balance at December 31, 2024** |  | **7769** | **488990** | **(209)** | **(275489)** | **221061** | **—** | **221061** |
| Profit (loss) for the year |  |  |  |  | 2851 | 2851 | (313) | 2538 |
| Other comprehensive income (loss) for the year |  |  |  | 28977 |  | 28977 | 83 | 29060 |
| **Total comprehensive income (loss) for the year** |  | **—** | **—** | **28977** | **2851** | **31828** | **(230)** | **31598** |
| Income tax expense from excess tax deductions related to share-based payments | 28 |  |  |  | 1343 | 1343 |  | 1343 |
| Movement in reserves | 28 |  |  | (32) | 32 |  |  |  |
| Share-based compensation | 22, 28 |  |  |  | 13766 | 13766 |  | 13766 |
| Options exercised / LTIP shares issued | 22 | 241 | 24266 |  | (14581) | 9926 |  | 9926 |
| Acquisition of a subsidiary | 4 |  |  |  |  |  | 7285 | 7285 |
| Capital contributions to a subsidiary with non-controlling interests |  |  |  |  | (706) | (706) | 706 |  |
| Acquisition of non-controlling interests | 28 |  |  | 83 | (198) | (115) | (7761) | (7876) |
| **Total transactions with owners, recognized directly in equity** |  | **241** | **24266** | **51** | **(345)** | **24213** | **230** | **24443** |
| **Balance at December 31, 2025** |  | **8009** | **513257** | **28819** | **(272983)** | **277102** | **—** | **277102** |

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*The Notes are an integral part of these financial statements.*

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CONSOLIDATED STATEMENT OF CASH FLOWS

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| | | | | |
|:---|:---|:---|:---|:---|
| Amounts in $'000 | Notes | **2025** | **2024** | **2023** |
| **Profit (loss) before tax** |  | **12847** | **(8492)** | **(12012)** |
| ***Adjustments to reconcile net profit (loss) to net cash used in operating activities:*** |  |  |  |  |
| Depreciation, amortization, impairment of non-current assets | 7101112 | 11216 | 16070 | 15925 |
| Equity settled share based payments | 28 | 13766 | 11248 | 9251 |
| Fair value loss (gain) on revaluation | 13, 18 | (2345) | (4990) | 930 |
| Gain on disposal from PRV sale | 6 |  |  | (21279) |
| Loss (gain) on disposal of leases | 12, 20 | (3733) | 22 |  |
| Other finance income | 8 | (2176) | (6843) | (3663) |
| Other finance expenses | 8 | 17901 | 9887 | 9069 |
| Share of net losses (gains) in associates using the equity method | 13 | (623) | 1758 | 289 |
| Other |  |  |  | (1079) |
| **Operating cash flows before changes in working capital** |  | **46853** | **18660** | **(2569)** |
| ***Changes in working capital:*** |  |  |  |  |
| Inventories | 16 | (1288) | (503) | (14434) |
| Trade and other receivables | 17 | (3355) | (6783) | (18539) |
| Payables and other current liabilities | 21 | 14126 | (2769) | 16228 |
| Provisions | 19 | 1187 |  |  |
| Restricted cash | 15 | (285) | (17) | (216) |
| **Total changes in working capital** |  | **10385** | **(10072)** | **(16961)** |
| Interest received | 8 | 2069 | 5201 | 2883 |
| Income taxes received (paid) | 9 | (4599) | (15584) | (655) |
| **Net cash flows generated from (used in) operating activities** |  | **54708** | **(1795)** | **(17302)** |
| Capital expenditure for property, plant and equipment | 11 | (749) | (790) | (1437) |
| Proceeds on PRV sale | 6 |  |  | 21279 |
| Investment intangible assets | 10 | (6) | (6) | (27) |
| Disposal of investment designated as at FVOCI | 13 | 224 | 2098 |  |
| Investment in associates using the equity method | 13 | (739) |  |  |
| Purchases of marketable securities | 14 | (2) | (284314) | (382014) |
| Proceeds from sale of marketable securities | 14 | 85001 | 314630 | 232811 |
| Acquisition of a subsidiary, net of cash acquired | 4 | (57476) |  |  |
| **Net cash flows generated from (used in) investing activities** |  | **26252** | **31618** | **(129388)** |
| Payment of lease liabilities | 20 | (4245) | (4008) | (4038) |
| Interests on lease liabilities | 20 | (1130) | (1141) | (1088) |
| Net proceeds of issued convertible bonds | 18 |  | 104539 |  |
| Repurchase of convertible bonds | 18 |  | (134924) |  |
| Interests on convertible bonds | 18 | (5067) | (4457) | (4046) |
| Acquisition of non-controlling interests | 4 | (7876) |  |  |
| Exercise of share-based compensation awards | 22 | 19813 | 5579 | 8133 |
| **Net cash flows generated from (used in) financing activities** |  | **1495** | **(34412)** | **(1039)** |
| **Increase (decrease) of cash** |  | **82454** | **(4589)** | **(147729)** |
| Exchange rate effects |  | 7907 | (2208) | 2128 |
| Cash and cash equivalents at January 1 | 15 | 54944 | 61741 | 207342 |
| **Total cash and cash equivalents at December 31** |  | **145305** | **54944** | **61741** |

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*The Notes are an integral part of these financial statements.*

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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

&nbsp;&nbsp;&nbsp;&nbsp;1.CORPORATE INFORMATION

Pharming Group N.V., hereafter "the Company," "the Group" or "Pharming," is a global biotechnology company that develops and commercializes innovative therapies for rare and ultra-rare disease with significant unmet need. We focus on immunological and genetic conditions where out scientific and commercial expertise can help advance care over the long term. Pharming is headquartered in Leiden, the Netherlands, with a significant proportion of its employees based in the U.S.

The consolidated financial statements of Pharming for the year ended December 31, 2025 and were authorized for issue in accordance with a resolution of the Board of Directors on April 1, 2026. The financial statements are subject to adoption by the Annual General Meeting of shareholders, which has been scheduled for May 28, 2026.

The headquarters and registered office of Pharming Group N.V. are located at:

Darwinweg 24

2333 CR Leiden

The Netherlands

&nbsp;&nbsp;&nbsp;&nbsp;2.ACCOUNTING PRINCIPLES AND POLICIES

&nbsp;&nbsp;&nbsp;&nbsp;***2.1.BASIS OF PREPARATION AND GOING CONCERN ASSUMPTION***

The consolidated financial statements are prepared in accordance with the IFRS® Accounting Standards as issued by the International Accounting Standards Board, or IASB. The consolidated financial statements provide a general overview of our activities and the results achieved and have been prepared on a going concern basis.

Management exercises its judgment in the process of applying the Company's accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in Note 2.5 Material accounting judgments and estimates.

These financial statements are presented in U.S. Dollars (US$, USD), and rounded to the nearest thousand U.S. dollars ($'000), unless otherwise stated.

*Going Concern*

In preparing the consolidated financial statements, the Board of Directors is responsible for assessing the Group's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the Board of Directors either intends to liquidate the Group or to cease operations, or has no realistic alternative but to do so.

The Group's consolidated financial statements have been prepared on a going concern basis.

The 2025 year-end balance of cash and cash equivalents, restricted cash and marketable securities of $181.1 million is expected to fund the Company for more than twelve months from the date of this report.

During 2025, the Company's operating cash flows improved strongly compared to 2024, reflecting the continued strength of RUCONEST® revenues, sustained growth of Joenja® (leniolisib), and increased operational efficiencies. This improvement in underlying cash generation further supports the Group's assessment of its liquidity position.

Following regulatory approvals of Joenja® (leniolisib) and the acquisition of Abliva AB in early 2025, the Company has increased investments in strengthening its commercial function and pipeline development. While this investment initially reduced the overall cash position, they are expected to support long-term revenue

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growth and operational scalability. The Company expects to make further investments in the acquired pipeline over the coming years, which will temporarily reduce cash resources and affect results in 2026. The Company remains confident in the robustness of RUCONEST® sales, growth and expansion of Joenja® sales and the expansion of its pipeline.

Presently, however, no further assurance can be given on either the timing or size of future profits.

In addition, in the event that the Company needs to raise capital by issuing additional shares, shareholders' equity interests may be diluted as to voting power, and their interests as to value will depend on the price at which such issues are made. The Company sees no further need to raise capital to support its current operations, but may take an opportunity to do so in either equity issue or through an expansion of the current convertible debt or to raise debt, or through a combination of such instruments, to support an acquisition or in-licensing of additional assets, if appropriate terms can be obtained that are in the best interests of shareholders.

Macro-economic developments like pressure on energy supply, increased inflation and higher interest rates have an impact on Pharming and are managed by price increases on our products in line with CPI development and fixed interest on our convertible bond.

Overall, based on the outcome of this assessment, Pharming's 2025 financial statements have been prepared on the basis of a going concern assumption and no material uncertainties exist that may cast significant doubt on the Group's ability to continue as a going concern. Notwithstanding their belief and confidence that Pharming will be able to continue as a going concern, the Executive Directors and Officers emphasize that the actual cash flows may potentially ultimately deviate up or down from our projections due to various reasons. In the absence of unforeseen significant events outside of our control such as banning of the product from sale in a major market, the Executive Directors and Officers believe that the Company will have more than sufficient resources to meet all obligations within the next 12 months after the date of these financial statements.

&nbsp;&nbsp;&nbsp;&nbsp;***2.2.New and revised IFRS standards***

The Company applied for the first-time certain amendments, which are effective for annual periods beginning on or after January 1, 2025, as disclosed below.

• Amendments to IAS 21: The Effects of Changes in Foreign Exchange Rates titled Lack of Exchangeability

Its adoption has not had any material impact on the disclosures or on the amounts reported in these financial statements. The Company has not early adopted any other standard, interpretation or amendment that has been issued but are not yet effective.

The new and amended standards and interpretations that are issued, but are not yet effective, up to the date of issuance of the Group's financial statements, which the Group intends to adopt, if applicable, when they become effective, are disclosed below.

At the date of authorisation of these financial statements, the company has not applied the following new and revised IFRS Accounting Standards that have been issued but are not yet effective:

• Amendments to IFRS 9 and IFRS 7: Amendments to the Classification and Measurement of Financial Instruments

• Annual Improvements to IFRS Accounting Standards – Volume 11: Amendments to IFRS 1 First-time Adoption of International Financial Reporting Standards, IFRS 7 Financial Instruments: Disclosures and its accompanying Guidance on implementing IFRS 7, IFRS 9 Financial Instruments, IFRS 10 Consolidated Financial Statements, and IAS 7 Statement of Cash Flows

• Amendments to IFRS 9 and IFRS 7: Contracts Referencing Nature-dependent Electricity

• IFRS 18: Presentation and Disclosures in Financial Statements

• IFRS 19: Subsidiaries without Public Accountability: Disclosures

The Board of Directors does not expect that the adoption of the Standards listed above will have a material impact on the financial statements of the Company in future periods, except for IFRS 18 Presentation and Disclosures in Financial Statements.

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IFRS 18 replaces IAS 1, carrying forward many of the requirements in IAS 1 unchanged and complementing them with new requirements. In addition, some IAS 1 paragraphs have been moved to IAS 8 and IFRS 7. Furthermore, the IASB has made minor amendments to IAS 7 and IAS 33 Earnings per Share.

IFRS 18 introduces new requirements to:

• present specified categories and defined subtotals in the statement of profit or loss;

• provide disclosures on management-defined performance measures (MPMs) in the notes to the financial statements; and

• improve aggregation and disaggregation.

While recognition and measurement of items will remain unchanged, the presentation in the consolidated statement of income will be affected. In addition, the cash flow statement will also be effected, as well as the disclosures related to these statements. New disclosure requirements are expected to include the management-defined performance measures and a breakdown of the nature of expenses for line items presented by function in the operating category of the statement of profit or loss for certain nature expenses. Lastly, for the first annual period of application of IFRS 18, a reconciliation for each line item in the statements of profit or loss between the restated amounts presented by applying IFRS 18 and the amounts previously presented applying IAS 1.

An entity is required to apply IFRS 18 for annual reporting periods beginning on or after January 1, 2027, with earlier application permitted. The amendments to IAS 7 and IAS 33, as well as the revised IAS 8 and IFRS 7, become effective when an entity applies IFRS 18. IFRS 18 requires retrospective application with specific transition provisions.

The Board of Directors anticipate that the application of these amendments may have an impact on the group's consolidated financial statements in future periods.

***2.3.Basis of consolidation***

The consolidated financial statements include Pharming Group N.V. and its controlled subsidiaries, after the elimination of all intercompany transactions and balances. Subsidiaries are consolidated from the date the acquirer obtains effective control until control ceases.

An entity is considered effectively controlled if the Company, directly or indirectly, has the power to govern the financial and operating policies of an entity so as to obtain benefits from its activities. Acquisitions of subsidiaries are accounted for using the acquisition method of accounting. The financial statements of the subsidiaries are prepared for the same reporting year as Pharming Group N.V., using the same accounting policies. Intercompany transactions, balances and unrealized gains and losses on transactions between group companies are eliminated.

Non-controlling interests in subsidiaries are identified separately from the group's equity therein. The carrying amount of non-controlling interests is the amount of those interests at initial recognition plus the non-controlling interests' share of subsequent changes in equity. Profit or loss and each component of other comprehensive income are attributed to the owners of the parent entity and to the non-controlling interests. Changes in the group's interests in subsidiaries that do not result in a loss of control are accounted for as equity transactions. The carrying amount of the group's interests and the non-controlling interests are adjusted to reflect the changes in their relative interests in the subsidiaries. Any difference between the amount by which the non-controlling interests are adjusted and the fair value of the consideration paid or received is recognized directly in equity and attributed to the owners of the parent entity.

The following table provides an overview of the consolidated subsidiaries at December 31, 2025:

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| | | |
|:---|:---|:---|
| **Entity** | **Registered office** | **Investment %** |
| Pharming Americas B.V. | The Netherlands | 100% |
| Pharming Intellectual Property B.V. | The Netherlands | 100% |
| Broekman Instituut B.V. | The Netherlands | 100% |
| Pharming Healthcare, Inc. | The United States | 100% |
| ProBio, Inc. | The United States | 100% |
| Pharming Technologies B.V. | The Netherlands | 100% |
| &nbsp;&nbsp; Pharming Research & Development B.V. | The Netherlands | 100% |
| &nbsp;&nbsp; Pharming Australia Pty Ltd | Australia | 100% |
| &nbsp;&nbsp; Pharming UK Ltd | The United Kingdom | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming Germany GmbH<sup>\*</sup> | Germany | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming France SAS<sup>\*</sup> | France | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Abliva AB<sup>\*\*</sup> | Sweden | 100% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Abliva, Inc.<sup>\*\*\*</sup> | The United States | 100% |

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<sup>\*</sup> This entity was acquired in February 2025

<sup>\*\*</sup> This entity was established in November 2025

<sup>\*\*\*</sup> This entity is dissolved in January 2026

***2.4. Accounting principles and policies***

*Foreign currency translation*

In preparing the financial statements of the Group, transactions in currencies other than the entity's functional currency (foreign currencies) are recognized at the rates of exchange prevailing on the dates of the transactions. At each reporting date, monetary assets and liabilities that are denominated in foreign currencies are retranslated at the rates prevailing at that date. Non-monetary items carried at fair value that are denominated in foreign currencies are translated at the rates prevailing at the date when the fair value was determined. Non-monetary items that are measured in terms of historical cost in a foreign currency are not retranslated.

Exchange differences are recognized in profit or loss in the period in which they arise except for:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exchange differences on foreign currency borrowings relating to assets under construction for future productive use, which are included in the cost of those assets when they are regarded as an adjustment to interest costs on those foreign currency borrowings;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exchange differences on transactions entered into to hedge certain foreign currency risks

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exchange differences on monetary items receivable from or payable to a foreign operation for which settlement is neither planned nor likely to occur in the foreseeable future (therefore forming part of the net investment in the foreign operation), which are recognized initially in other comprehensive income and reclassified from equity to profit or loss on disposal or partial disposal of the net investment.

For the purpose of presenting consolidated financial statements in U.S. dollars, the assets and liabilities of the Group's operations having a different functional currency are translated at exchange rates prevailing on the reporting date. Income and expense items are translated at the average exchange rates for the period, unless exchange rates fluctuate significantly during that period, in which case the exchange rates at the date of transactions are used. Exchange differences arising, if any, are recognized in other comprehensive income and accumulated in a foreign exchange translation reserve. The following exchange rates were applied:

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | **December 31,<br>2025** | **Average 2025** | **December 31,<br>2024** | **Average 2024** | **December 31,<br>2023** | **Average 2023** |
| EUR/USD | 1.1713 | 1.1259 | 1.0350 | 1.0804 | 1.1002 | 1.0790 |
| AUD/USD | 0.6699 | 0.6442 | 0.6224 | 0.6596 | Not used | Not used |
| GBP/USD | 1.3455 | 1.3181 | 1.2488 | 1.2772 | Not used | Not used |
| SEK/USD | 0.1083 | 0.1018 | Not used | Not used | Not used | Not used |

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*Distinction between current and non-current*

An item is classified as current when it is expected to be realized (settled) within 12 months after the end of the reporting year. Liabilities are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the end of the reporting year.

*Intangible assets acquired separately*

Intangible assets, or IFA, acquired separately are measured at historical cost. The cost of intangible assets acquired in a business combination is recognized and measured at fair value as at the date of acquisition. Following initial recognition, intangible assets are carried at cost less any accumulated amortization and any accumulated impairment losses.

Intangible assets with finite lives are amortized over the useful life and assessed for impairment whenever there is an indication that the intangible assets may be impaired and at the end of each reporting period. The estimated useful lives, residual values and amortization method are reviewed at the end of each reporting period, with the effect of any changes in estimate accounted for on a prospective basis. Changes in the expected useful life, according to the straight-line method, or the expected pattern of consumption of future economic benefits embodied in the asset is accounted for by changing the amortization period or method, as appropriate, and treated as changes in accounting estimates. The amortization expense on intangible assets with finite lives is recognized in the statement of income in the relevant expense category consistent with the function of the intangible asset.

The remaining amortization periods for intangible assets at December 31, 2025 are:

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| | | | |
|:---|:---|:---|:---|
| | | **Amortization period** | **Amortization period** |
|<br>**Category** |<br>**Description** | **Total** | **Remaining** |
| RUCONEST® for HAE (EU) | RUCONEST® for HAE (EU) development costs | 10 years | Fully amortized |
| RUCONEST® license | RUCONEST® license for HAE (US) | 20 years | 11 years |
| RUCONEST® license | RUCONEST® license for HAE (EU) | 7 years | 1 year |
| JOENJA® license | JOENJA® license for APDS | 14 years | 11 years |
| KL1333 license | KL1333 license for mitochondrial disease | N/A | N/A |
| Goodwill | Goodwill on acquisition Abliva AB | N/A | N/A |
| Software | Software development costs | 3 to 5 years | 1 to 5 years |

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*Derecognition of intangible assets*

An intangible asset is derecognized on disposal, or when no future economic benefits are expected from use or disposal. Gains or losses arising from derecognition of an intangible asset, measured as the difference between the net disposal proceeds and the carrying amount of the asset, are recognized in profit or loss when the asset is derecognized.

*Property, plant and equipment*

Property, plant and equipment is stated at cost less accumulated depreciation charges and accumulated impairment charges. Generally, depreciation is calculated using a straight-line basis over the estimated useful life of the asset. The estimated useful lives, residual values and depreciation method are reviewed at the end of each reporting period, with the effect of any changes in estimate accounted for on a prospective basis. The

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carrying values of property, plant and equipment are reviewed for impairment when events or changes in circumstances indicate that the carrying value may not be recoverable.

An item of property, plant and equipment is derecognized upon disposal or when no future economic benefits are expected from its use or disposal.

Any gain or loss arising on derecognition of the asset (calculated as the difference between the net disposal proceeds and the carrying amount of the asset) is included in the statement of income in the year the asset is derecognized. Residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, at each financial year-end.

All costs that are directly attributable to bringing an asset to the location and condition necessary for it to be capable of operating in the manner intended by management, will be capitalized. These costs include direct employee benefits, rent and testing costs. Capitalization will be done until the asset is capable of operating in the manner intended by management.

The depreciation periods for property, plant and equipment are:

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| | |
|:---|:---|
| **Category** | **Depreciation period** |
| Operational facilities | 10-20 years |
| Leasehold improvements | 5-15 years |
| Machinery and equipment | 5-10 years |
| Other property, plant & equipment | 5-10 years |

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*Investments in associates*

An associate is an entity over which the Group has significant influence and that is neither a subsidiary nor an interest in a joint venture. Significant influence is the power to participate in the financial and operating policy decisions of the investee but is not control or joint control over those policies. The results and assets and liabilities of associates are incorporated in these financial statements using the equity method of accounting. Under the equity method, an investment in an associate is recognized initially in the consolidated statement of financial position at cost and adjusted thereafter to recognize the Group's share of the profit or loss and other comprehensive income of the associate.

When the Group's share of losses of an associate exceeds the Group's interest in that associate (which includes any long-term interests that, in substance, form part of the Group's net investment in the associate), the Group discontinues recognizing its share of further losses. Additional losses are recognized only to the extent that the Group has incurred legal or constructive obligations or made payments on behalf of the associate. The requirements of IAS 36 are applied to determine whether it is necessary to recognize any impairment loss with respect to the Group's investment in an associate.

When necessary, the entire carrying amount of the investment (including goodwill) is tested for impairment in accordance with IAS 36 as a single asset by comparing its recoverable amount (higher of value in use and fair value less costs of disposal) with its carrying amount. Any impairment loss recognized is not allocated to any asset, including goodwill that forms part of the carrying amount of the investment. Any reversal of that impairment loss is recognized in accordance with IAS 36 to the extent that the recoverable amount of the investment subsequently increases.

When a Group entity transacts with an associate of the Group, profits and losses resulting from the transactions with the associate or joint venture are recognized in the Group's consolidated financial statements only to the extent of interests in the associate or joint venture that are not related to the Group.

*Financial assets*

Financial assets are recognized when the Company becomes a party to the contractual provisions of a financial instrument. Financial assets are derecognized when the rights to receive cash flows from the financial assets expire, or if the Company transfers the financial asset to another party and does not retain control or

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substantially all risks and rewards of the asset. Purchases and sales of financial assets in the normal course of business are accounted for at settlement date (i.e., the date that the asset is delivered to or by the Company).

At initial recognition, the Company measures its financial assets at its fair value plus, in the case of a financial asset not at fair value through profit or loss, transaction costs that are directly attributable to the acquisition or issue of the financial asset.

After initial recognition, the Company classifies its financial assets as subsequently measured at either i) amortized cost, ii) fair value through other comprehensive income or iii) fair value through profit or loss on basis of both:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Company's business model for managing the financial assets;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The contractual cash flow characteristics of the financial asset.

Subsequent to initial recognition, financial assets are measured as described below. At each balance sheet date, the Company assesses whether there is objective evidence that a financial asset or a group of financial assets is impaired and recognizes a loss allowance for expected credit losses for financial assets measured at either amortized costs or at fair value through other comprehensive income. If, at the reporting date, the credit risk on financial instrument has not increased significantly since initial recognition, the Company measures the loss allowance for that financial instrument at an amount equal to 12 months of expected credit losses. If, at the reporting date, the credit risk on a financial instrument has increased significantly since initial recognition, the Company measures the loss allowance for the financial instrument at an amount equal to the lifetime expected credit losses.

*Financial assets at amortized cost*

Financial assets are measured at amortized cost if both i) the financial asset is held within a business model whose objective is to hold financial assets in order to collect contractual cash flows; and ii) the contractual terms of the financial asset give rise on specified dates to cash flows that are solely payments of principal and interest of on the principal amount outstanding.

A financial asset measured at amortized cost is initially recognized at fair value plus transaction cost directly attributable to the asset. After initial recognition, the carrying amount of the financial asset measured at amortized cost is determined using the effective interest method, less any impairment losses.

Financial assets held to maturity are measured at amortized cost in the manner described in N[ote](annualreport2025.htm#i80c0bd5a101c4da19bf7c928b9fd33d4_256-bookmark-32ed35df36414f1bb39370d9958b7881) 13. Investments.

*Financial assets at fair value through other comprehensive income, or FVTOCI*

On initial recognition, the Group may make an irrevocable election (on an instrument-by-instrument basis) to designate investments in equity instruments as at FVTOCI. Investments in equity instruments at FVTOCI are initially measured at fair value plus transaction costs.

Subsequently, they are measured at fair value with gains and losses arising from changes in fair value recognized in other comprehensive income and accumulated in the legal reserve fair value revaluation. The cumulative gain or loss is not reclassified to profit or loss on disposal of the equity investments, instead, it is transferred to retained earnings.

*Financial assets at fair value through profit and loss, or FVTPL*

Financial assets that do not meet the criteria for being measured at amortized cost or FVTOCI are measured at FVTPL.

Financial assets at FVTPL are measured at fair value at the end of each reporting period, with any fair value gains or losses recognized in profit or loss. The net gain or loss recognized in profit or loss includes any dividend or interest earned on the financial asset and is included in the 'fair value gain (loss) on revaluation' line item (Note 12. Investments). Fair value is determined in the manner described in Note 12. Investments.

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*Impairment of assets*

Assets that have an indefinite useful life and assets not yet available for use are not subject to depreciation or amortization and are tested at least annually for impairment. Assets that are subject to depreciation or amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.

An impairment loss is recognized for the amount by which the asset's carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset's fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows. Non-financial assets for which an impairment loss is recorded, are reviewed for possible reversal of the impairment at each reporting date.

*Inventories*

Inventories are stated at the lower of cost and net realizable value. Cost comprises direct materials and, where applicable, direct labor costs and those overheads that have been incurred in bringing the inventories to their present location and condition. Cost is calculated using the First in First out (FIFO) method. Net realizable value represents the estimated selling price less all estimated costs of completion and costs to be incurred in marketing, selling and distribution.

*Trade and other receivables* 

Trade and other receivables are recognized initially at transaction price. Subsequent measurement is at amortized cost using the effective interest method, less the expected credit loss. Trade receivables are amounts due from customers for goods sold in the ordinary course of business. They are generally due for settlement within 30 days and therefore are all classified as current. For trade receivables and contract assets, the Company applies a simplified approach in calculating expected credit loss. The Company assesses the expected credit loss that is based on its historical credit loss experience, adjusted for forward-looking factors specific to the debtors and the economic environment. Due to the short-term nature of the current receivables, their carrying amount is considered to be the same as their fair value.

*Cash and cash equivalents*

Cash and cash equivalents are defined as cash on hand, demand deposits and short-term, highly liquid investments (maturity less than 3 months) readily convertible to known amounts of cash and subject to insignificant risk of changes in value. Bank overdrafts are shown within borrowings in current liabilities on the statement of financial position. For the purpose of the statement of cash flow, cash and cash equivalents do not include restricted cash and the interest on cash is accounted for as operating cash flow.

*Marketable securities*

Marketable securities are financial assets held for short-term purposes which are principally traded in liquid markets and are classified within current assets on the consolidated balance sheet. Marketable securities are measured as financial assets as described above. The financial impacts related to Marketable securities are recorded in 'Other finance income' in the consolidated statement of income. The cash (re)payments relating to Marketable securities are classified as investing activities. The cash flows relating to interest from Marketable securities held at amortized cost are classified as cash flows generated from operating activities.

Marketable securities are measured as financial assets in the manner described in Note 14. Marketable securities.

*Equity*

The Company only has ordinary shares, and these are classified within equity upon issue. Shares transferred in relation to settlement of (convertible) debt are measured at fair value with fair value based on the closing price of the shares on the trading day prior to the settlement date. Equity is recognized upon the recognition of share-based payment expenses; shares issued upon exercise of such options are measured at their exercise price.

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Transaction costs associated with an equity transaction are accounted for as a deduction from equity to the extent they are incremental costs directly attributable to the equity transaction that otherwise would have been avoided. Transaction costs related to the issue of a compound financial instrument are allocated to the liability and equity components of the instruments in proportion to the allocation of proceeds.

*Financial liabilities*

Financial liabilities are classified as either financial liabilities at fair value through profit or loss (derivative financial liabilities) or financial liabilities at amortized cost (trade and other payables). All financial liabilities at amortized cost are initially recognized at the fair value of the consideration received less directly attributable transaction costs; transaction costs related to the issue of a compound financial instrument are allocated to the liability and equity components of the instruments in proportion to the allocation of proceeds. After initial recognition, financial liabilities are subsequently measured at amortized cost using the effective interest method.

Gains and losses are recognized in the statement of income when the liabilities are paid off or otherwise eliminated as well as through the amortization process. Purchases and sales of financial liabilities are recognized at settlement date.

A financial liability is derecognized when the obligation under the liability is discharged or cancelled or expired. Where an existing financial liability is replaced by another from the same lender on substantially different terms, or the terms of an existing liability are substantially modified, such an exchange or modification is treated as a derecognition of the original liability and the recognition of a new liability, and the difference in the respective carrying amounts is recognized in the statement of income.

*Convertible bonds*

The convertible bonds are classified as hybrid financial instruments under IAS 32 and pursuant to it the debt host contract and the embedded derivative for the fair value of the conversion rights into Pharming shares (the "conversion option") are recognized separately.

The component parts of convertible bonds issued by the Group are classified separately as financial liabilities and equity in accordance with the substance of the contractual arrangements and the definitions of a financial liability and an equity instrument. A conversion option that will be settled by the exchange of a fixed amount of cash or another financial asset for a fixed number of the Company's own equity instruments is an equity instrument. If, or until, this fixed-for-fixed criterion is not met, the conversion option is recognized as a financial liability derivative at fair value through profit or loss. When this fixed-for-fixed criterion is met at a later date, the conversion option is reclassified to equity at fair value, resulting in a fair value result immediately prior to the reclassification.

If the fixed-for-fixed criterion is met, at the date of issue, the fair value of the debt host contract is estimated using the prevailing market interest rate for a similar non-convertible instrument. This amount is recorded as a liability on an amortized cost basis using the effective interest method. The conversion option classified as equity at issuance is determined by deducting the amount of the liability component from the fair value of the compound instrument as a whole. This is recognized and included in equity, net of income tax effects, and is not subsequently remeasured.

If the fixed-for-fixed criterion is not met, the conversion option classified as a financial liability derivative at recognition is measured using a pricing model. Upon and in case of reclassification to equity when the fixed-for-fixed criterion is met at a later date, the conversion option is recognized and included in equity, net of income tax effects, and is not subsequently remeasured. The debt host contract is measured as the difference between the proceeds from the bond and the value of the conversion option at initial recognition. This debt host contract is subsequently measured at amortized cost.

Direct costs associated with the issue of the convertible bonds are allocated to the debt host contract and the conversion option in amounts proportional to the allocation of the gross proceeds. They are accounted for respectively in the amortized cost (debt host contract) and in equity (conversion option meeting fixed-for-fixed criterion at initial recognition), or in the income statement (conversion option not meeting fixed-for-fixed criterion at initial recognition).

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In the case the Company extinguishes the convertible bond before maturity through an early redemption or repurchase, the difference between the carrying amount of the debt host contract (or part of the debt host contract) extinguished or transferred to another party and the consideration paid, including any non-cash assets transferred or liabilities assumed, will be recognized in the income statement.

*Provisions*

Provisions are recognized when there is a present obligation (legal or constructive) as a result of a past event, it is probable that the Group will be required to settle that obligation and a reliable estimate can be made of the amount of the obligation. The amount recognized as a provision is the best estimate of the consideration required to settle the present obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. Where a provision is measured using the cash flows estimated to settle the present obligation, its carrying amount is the present value of those cash flows (when the effect of the time value of money is material). The expense relating to any provision is presented in the statement of income net of any reimbursement.

A restructuring provision is recognized when the Group has developed a detailed formal plan for the restructuring and has raised a valid expectation in those affected that it will carry out the restructuring by starting to implement the plan or announcing its main features to those affected by it. The measurement of a restructuring provision includes only the direct expenditures arising from the restructuring, which are those amounts that are both necessarily entailed by the restructuring and not associated with the ongoing activities of the Company.

*Trade and other payables*

Trade and other payables are initially recognized at fair value. Subsequent measurement is at amortized cost using the effective interest method.

*Revenue recognition*

In order to determine when to recognize revenue and at what amount, the Company applies the following five steps, based on transfer of control over goods to the customer:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.Identify the contract(s) with a customer;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.Identify the performance obligations in the contract. Performance obligations are promises in a contract to transfer to a customer goods that are distinct;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.Determine the transaction price. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer. If the consideration promised in a contract includes a variable amount, an entity must estimate the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods or services to a customer;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.Allocate the transaction price to each performance obligation on the basis of the relative stand-alone selling prices of each distinct good or service promised in the contract;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.Recognize revenue when a performance obligation is satisfied by transferring a promised good or service to a customer (which is when the customer obtains control of that good or service). A performance obligation may be satisfied at a point in time (typically for promises to transfer goods to a customer) or over time (typically for promises to transfer services to a customer). For a performance obligation satisfied over time, an entity would select an appropriate measure of progress to determine how much revenue should be recognized as the performance obligation is satisfied.

All of the Group's revenue from contracts with customers is derived from delivery of goods, specifically pharmaceutical products. The Group does not provide any additional services (including financing services) or equipment to its customers. In accordance with IFRS 15, revenue is recognized when the customer obtains control of the goods. For the Group's contracts the customer usually obtains control immediately after shipment of the product, which arrives at the customer within a short time frame.

The vast majority of the Group's contracts for revenue with customers are subject to chargebacks, discounts and/or rebates relating directly to customers or to ultimate reimbursement claims from government or insurance payers. These are accounted for on an estimated net basis, with any actual discounts and rebates used to refine

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the estimates in due course. These variable elements are deducted from revenue in the same period as the related sales are recorded. Due to the nature of these variable elements, it is not practicable to give meaningful sensitivity estimates due to the large volume of variables that contribute to the overall discounts, rebates and chargebacks accruals.

*Other income*

Other income consists of gains upon sales of investment in associates, income from government grants, gains from early termination or modification of lease agreements, and gain on the sale of the Rare Pediatric Disease Priority Review Voucher (PRV).

Pharming receives certain grants which support the Company's research efforts in defined research and development projects. These subsidies generally provide for reimbursement of approved costs incurred as defined in various grants. Subsidies are recognized if the Company can demonstrate it has complied with all attached conditions and it is probable that the grant amount will be received. Grants are recognized in profit or loss on a systematic basis over the periods in which the Group recognizes as expenses the related costs for which the grants are intended to compensate.

The Company includes income from grants under other income in the statement of income in order to enable comparison of its statement of income with companies in the life sciences sector.

Gains arising from the early termination or modification of lease arrangements are recognized in Other income in accordance with IFRS 16. Such gains represent the difference between the carrying amounts of the related right-of-use assets and lease liabilities derecognized and any consideration paid or received as part of the termination. Further details are provided in note 12. Right-of-use assets. If the termination or modification of lease arrangements result in a loss, it is included in Other operating cost.

Employee retention credits represent refundable government incentives designed to support employment. These amounts are recognized in Other income when the Company has complied with the relevant conditions and receipt is reasonably assured. As these credits do not relate to the Company's ordinary revenue-generating activities, they are presented within Other income.

Other income may also include incidental receipts such as regulatory milestone payments or similar items. Such income is recognized when the Company becomes entitled to the amount, the related performance obligations (if any) have been satisfied, and collection is probable.

Pharming was granted the PRV by the Food and Drug Administration (FDA) in March 2023 in connection with the approval of Joenja®. The sale price was a contractually defined percentage of the PRV value pursuant to the terms of the August 2019 exclusive license agreement between Pharming and Novartis for leniolisib. Management made an assessment on the classification of this transaction, taking into account the requirements in IAS 1 and concluded that it is most appropriate to classify the transaction in Other income.

*Costs of sales*

Costs of sales represent all production costs related to product sales, including production costs of the skimmed milk, external manufacturing costs, costs of vials used for product testing, royalties and other costs incurred in bringing the inventories to their present location and condition. The costs are measured at their actual costs based on FIFO and incurred to net realizable value if sales price is below actual costs.

*Research and development costs*

Research expenditure is recognized as an expense in the period in which it is incurred. An intangible asset arising from development expenditure on an individual project is recognized only when the following criteria are met:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The technical feasibility of completing the intangible asset so that it will be available for use or sale is not in doubt;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Company has the clear intention and resources to complete the asset, and to use or sell it;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Its ability to use or sell the asset is not in doubt;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The probability of future economic benefits is clear at the time of making the decision;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The availability of resources to complete the development required is not expected to change during the development process;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• It is possible to measure the expenditure reliably during the development.

Technical feasibility and ability to use or sell the asset are, in general, considered probable when the Company estimates that obtaining marketing approval is deemed likely. In practice this is only the case when we have either (i) completed a similar program before on the same therapeutic molecule or combination, or (ii) completed an identical program before on a similar molecule or combination. In other situations, the likelihood of success at each remaining level of clinical development and regulatory approval is assessed and, unless the collective probability is considered high, the criteria is difficult to meet in these circumstances.

Following the initial recognition of the development expenditure, the cost model is applied requiring the asset to be carried at cost less any accumulated amortization and accumulated impairment losses.

Any expenditure capitalized is amortized over the period of expected useful life of the related patents. The carrying value of development costs is reviewed for impairment annually when the asset is not yet in use or more frequently when an indication of impairment arises during the reporting year.

*Interest income*

Interest income is recognized as interest accrues, using the effective interest method. For the purpose of the consolidated statement of cash flows, interest income derived from cash and cash equivalents and marketable securities have been presented as operating cash flows.

*Operating costs*

Operating costs are expensed as incurred. Costs of research and development cover those activities that are carried out to gain new scientific or technical knowledge and understanding as well as the application of research findings or other knowledge to a plan or design for the production of new or substantially improved products. Costs of general and administrative nature apply to overhead expenses. Costs of marketing and sales relate to all expenses incurred to commercialize the product.

*Short-term employee benefits*

The Company does not provide any benefits based on financial measurement of the statement of income.

Liabilities for wages and salaries, including non-monetary benefits and accumulating sick leave that are expected to be settled wholly within 12 months after the end of the period in which the employees render the related service are recognized in respect of employees' services up to the end of the reporting period and are measured at the amounts expected to be paid when the liabilities are settled. The liabilities are presented under trade and other payables in the balance sheet.

*Pension plan*

For all Dutch employees, the Company participates in defined contribution pension plans with an independent insurance company. Defined contributions are expensed in the year in which the related employee services are rendered.

Employees in the United States are enabled to participate in a 401k plan, which also qualifies as a defined contribution plan. To become an eligible participant, an employee must complete 6 months of service and attain the age of 18 years. The employer matches 100% of the first 3% the employee contributes to their 401k plan and 50% of any amount over 3% up to 5%. Any employee contribution over 5% is not matched. Costs of the 401k plan are expensed in the year in which the related employee services are rendered.

*Share-based payment*

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The costs of option plans are measured by reference to the fair value of the options on the date on which the options are granted. The fair value is determined using the Black-Scholes model. The costs of these options are recognized in the income statement (other operating costs) during the vesting period, together with a corresponding increase in equity (other reserves). If required, the estimate of the number of equity instruments expected to vest is revised on a yearly basis. The impact of this revision is reflected in the statement of profit & loss (other operating costs) and statement of changes in equity. Share-based payment charges do not affect liabilities or cash flows in the year of expense since all transactions are equity-settled.

Pharming's employee option plan states that an employee is entitled to exercise the vested options within five years after the date of the grant. The period in which the options become unconditional is defined as the vesting period.

*Long Term Incentive Plan*

For a limited number of board members and officers, performance shares are granted free of charge. A maximum number of predetermined shares vest three years after the grant date, provided that the participant to the long-term incentive plan is still in service (continued employment condition), with actual shares to be transferred based on the relative achievement of Pharming's share price compared to a peer group.

The fair value is determined using Monte Carlo simulation. The costs of the LTIP are recognized in the income statement during the vesting period (other operating costs). The fair value at the grant date includes the market performance condition (relative total shareholder return performance) but excludes the three-year service condition. The performance includes Total Shareholder Return (40% weighing) and achievement of long-term strategy oriented objectives (60% weighing). The Total Shareholders Return is compared to a peer group.

The shares granted to the Executive Director under the LTIP, will vest in 3 years after the grant date, subject to the achievement of targets for a three-year performance period, their relative weightings and the pay-out limits. All shares will be subject to a retention period of 5 years from the date of grant. In order to fully become entitled to the shares vesting under the LTI conditions the participant must be a member of the Board of Directors as Executive Board Member at the vesting date.

The costs of the LTIP are recognized in the income statement during the vesting period.

*Restricted Stock Unit Plan*

For a limited number of employees, restricted stock units are granted free of charge. A maximum number of predetermined shares vest four years after the grant date, provided that the participant to the long-term incentive plan is still in service (continued employment condition).

The fair value is determined to be the market price at the grant date. The costs of the RSU grant are recognized in the income statement during the vesting period.

*Leases*

The Group assesses whether a contract is or contains a lease at the inception of the contract. The Group recognizes a right-of-use asset and a corresponding lease liability with respect to all lease arrangements in which it is a lessee, except for short-term leases (defined as leases with a lease term of 12 months or less) and leases of low value assets (such as tablets and personal computers, small items of office furniture and telephones). For these leases the Group recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease unless another systematic basis is more representative of the time pattern in which the economic benefits from the leased assets are consumed.

The lease liability is initially measured at the present value of the lease payments that are not paid at the commencement date, discounted by using the rate implicit in the lease. If this rate cannot be readily determined, the Company uses its incremental borrowing rate.

Lease payments included in the measurement of the lease liability comprise:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Fixed lease payments;

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Variable lease payments that depend on an index or rate, initially measured using the index or rate at the commencement date.

The lease liability is presented as a separate line in the consolidated balance sheet.

The lease liability is subsequently measured by increasing the carrying amount to reflect the interest on the lease liability (using the effective interest method) and by reducing the carrying amount to reflect the lease payments made.

The Group remeasures the lease liability (and makes a corresponding adjustment to the related right-of-use asset) whenever:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The lease term has changed or there is a significant event or change in circumstances resulting in a change in the assessment of exercise of a purchase option, in which case the lease liability is remeasured by discounting the revised lease payments using a revised discount rate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The lease payments change due to changes in an index or rate or a change in expected payment under a guaranteed residual value, in which case the lease liability is remeasured by discounting the revised lease payments using an unchanged discount rate (unless the lease payments change is due to a change in a floating interest rate, in which case, a revised discount rate is used).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A lease contract is modified, and the lease modification is not accounted for as a separate lease, in which case the lease liability is remeasured based on the lease term of the modified lease by discounting the revised lease payments using a revised discount rate at the effective date of modification.

The right-of-use assets comprise the initial measurement of the corresponding lease liability, lease payments made at or before commencement day, less any lease incentives received and any initial direct costs. They are subsequently measured at cost less accumulated depreciation and impairment losses.

Whenever the Group incurs an obligation for costs to dismantle and remove a leased asset, restore the site on which it is located or restore the underlying asset to the condition required by the terms and conditions of the lease, a provision is recognized and measured under IAS 37. To the extent that the costs relate to a right-of-use asset, the costs are included in the related right-of-use asset, unless those costs are incurred to produce inventories.

Right-of-use assets are depreciated over the shorter period of lease term and useful life of the underlying asset. If a lease transfers ownership of the underlying asset or the cost of the right-of-use asset reflects that the Group expects to exercise a purchase option, the related right-of-use asset is depreciated over the useful life of the underlying asset. The depreciation starts at the commencement date of the lease.

The right-of-use assets are presented as a separate line in the consolidated balance sheet.

The Group applies IAS 36 to determine whether a right-of-use asset is impaired and accounts for any identified impairment loss as described in the 'Property, Plant and Equipment' policy.

Variable rents that do not depend on an index or rate are not included in the measurement of the lease liability and the right-of-use asset. The related payments are recognized as an expense in the period in which the event or condition triggers those payments occur.

As a practical expedient, IFRS 16 permits a lessee not to separate non-lease components, and instead account for any lease and associated non-lease components as a single arrangement. The Group has not used this practical expedient. For contracts that contain lease components and one or more additional lease or non-lease components, the Group allocates the consideration in the contract to each lease component on the basis of the relative stand-alone price of the lease component and the aggregate stand-alone price of the lease component and the aggregate stand-alone price of the non-lease components. The Group had no such lease arrangements in 2025 and has none at the date of this report.

*Income taxes*

------

The income tax expense or credit for the period is the tax payable on the current period's taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses.

The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the end of the reporting period in the countries where the Company and its subsidiaries operate and generate taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions where appropriate based on amounts expected to be paid to the tax authorities.

Deferred income tax is provided in full, using the liability method on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. Deferred income tax is determined using tax rates that have been enacted or substantially enacted by the end of the reporting period and are expected to apply when the related deferred income tax asset is realized, or the deferred income tax liability is settled.

Deferred tax assets are recognized only if it is probable that future taxable amounts will be available to use those temporary differences and losses. The Company has assessed all its income tax amounts and provisions in the light of IFRIC 23 Accounting for Uncertain Income Taxes, and has concluded that it is probable that its particular tax treatment will be accepted in all relevant jurisdictions and thus it has determined taxable profit (tax loss), tax bases, unused tax losses, unused tax credits or tax rates consistently with the tax treatment included in its income tax filings.

Current and deferred tax is recognized in profit or loss, except to the extent that it relates to items recognized in other comprehensive income or directly in equity.

*Cash flow statement*

Operating cash flows in the statement of cash flows are reported using the indirect method. Under the indirect method the figure is produced by adjusting the profit and loss by removing the effects of non-cash items and changes in working capital. The Company has chosen the profit before tax as a starting point for the reconciliation as most of the other elements in the net result have a non-cash nature. Payments of the finance lease liabilities related to operating assets and equipment are included in the operating cash flows, whereas all other finance lease liabilities are included in financing cash flows. They are part of the manufacturing costs, thus part of the working capital. This way the statement properly reflects the cash flows.

*Earnings per share*

Basic earnings per share are calculated based on the weighted average number of ordinary shares outstanding during the period. Diluted earnings per share are computed based on the weighted average number of ordinary shares outstanding including the dilutive effect of shares to be issued in the future under certain arrangements such as option plans, warrants issued and convertible loan agreements.

*Segment reporting*

Operating segments are reported in a manner consistent with the internal reporting of segmental information provided to and used by the chief operating decision-maker function in managing that segment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;***2.5 Material accounting judgments and estimates***

The preparation of financial statements requires judgments and estimates that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities at the date of the financial statements. The resulting accounting estimates will, by definition, seldom equal the related actual results. The main estimates and assumptions that have a risk of causing an adjustment to the carrying amounts of assets and liabilities within the next financial year are addressed below.

**Judgments:**

------

*Biological Assets*

The Group's manufacturing process utilizes transgenic rabbits to produce this human recombinant protein in their milk. The rabbits are raised at specialized and regulator approved facilities with high standards of animal husbandry, welfare and security.

The Board of Directors has assessed the accounting for these biological assets under IAS 41: Agriculture, and concluded that the recognition criteria in IAS 41.10(c) are not met as the fair value or cost of the asset cannot be measured reliably due to their uniqueness and very special transgenic nature. The cost associated with raising, nurturing and milking the rabbits are expensed in profit or loss as incurred.

**Estimates:**

*Revenue - U.S. Revenue Rebate Accruals*

Revenue is recognized when control has been transferred to the customer. Revenue is reduced by chargebacks and rebates for government healthcare programs, discounts to specialty pharmacies and wholesalers, and product returns given or expected to be given, which vary by patient groups, which represent variable revenue constraints under IFRS 15. Chargebacks and rebates for healthcare programs depend upon the submission of claims sometime after the initial recognition of the sale. The liability for this variable consideration is made, at the time of sale, for the estimated chargebacks and rebates, mainly U.S. Medicaid, based on available market information and historical experience. Because the amounts are estimated they may not fully reflect the final outcome, and the amounts are subject to change dependent upon, amongst other things, the types of patient groups. As multiple variables impact the accrual, no sensitivity analysis has been performed. The level of these liabilities is being reviewed and adjusted regularly in the light of contractual and legal obligations, historical charges and trends, past experience and projected mixtures of patient groups. The Group acquires this information from both internal resources and external parties.

Future events could cause the assumptions on which the accruals are based to change, which could affect the future results of the Group.

*Identification and measurement of assets acquired and liabilities assumed on acquisition of Abliva AB*

In 2025, the Group completed the acquisition of Abliva AB (see Note 3). The identification and measurement of the identifiable assets acquired and liabilities assumed required the application of significant management judgment, particularly in determining the fair value of the napazimone (KL1333) license using a probability-adjusted discounted cash flow model. These estimates involved key assumptions regarding long-term revenue forecasts, development timelines, commercialization prospects, and discount rates as well as timing of regulatory approvals. Given the sensitivity of the valuation to these assumptions, the purchase price allocation represents an area of significant accounting judgment. Further details on the acquisition and the related purchase price allocation are included in Note 3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.BUSINESS COMBINATIONS AND ACQUISITIONS OF NON-CONTROLLING INTERESTS

**Acquisition of Abliva AB**

On February 14, 2025, the Group acquired 88.9% of the voting shares of Abliva AB ("Abliva"), a listed company based in Sweden. Abliva is a biotechnology company, based in Lund, Sweden, focused on developing medicines for the treatment of mitochondrial disease. Pharming acquired Abliva to further strengthen the clinical pipeline, aligning with our vision to become a leading global rare disease company. By June 18, 2025, Pharming obtained 100% of the shares of Abliva. This disclosure provides the financial information relating to the business combination.

At initial recognition, Pharming elected to measure the non-controlling interests in Abliva as a proportionate share of the identifiable assets.

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*Assets acquired and liabilities assumed*

The fair values of the identifiable assets and liabilities of Abliva as at the date of acquisition were:

---

| | |
|:---|:---|
| **Amounts in $'000** | **Fair value recognized on acquisition** |
| Intangible assets: KL1333 | 61114 |
| Intangible assets: Software | 75 |
| Deferred tax assets | 12397 |
| Investments in equity instruments designated at FVTOCI | 210 |
| Trade and other receivables | 1591 |
| Cash and cash equivalents | 2610 |
| **Assets** | **77997** |
| Deferred tax liability | (12397) |
| Trade and other payables | (1244) |
| **Liabilities** | **(13641)** |
| **Total identifiable net assets at fair value** | **64356** |
| Non-controlling interest | (7285) |
| Goodwill arising on acquisition | 2903 |
| **Purchase consideration transferred** | **59974** |

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Abliva's lead product, KL1333 (currently known as napazimone), a regulator of the essential co-enzymes NAD⁺ and NADH, is in a pivotal clinical study (FALCON) in adult patients with genetically confirmed primary mitochondrial disease (PMD) with mitochondrial DNA (mtDNA) mutations who experience consistent, debilitating fatigue and muscle weakness (myopathy), and reduced life expectancy. Over 30,000 patients diagnosed with mtDNA mitochondrial disease would be potentially addressable by napazimone (KL1333) in the U.S., EU4 (France, Germany, Italy, Spain) and the UK. Napazimone (KL1333) has shown positive clinical effects in a proof-of-concept Phase 1b study, and a pre-planned interim analysis of the ongoing pivotal FALCON trial demonstrated promising differences over placebo in both alternate primary efficacy endpoints. Napazimone (KL1333) has received Fast Track designation in the U.S. and Orphan Drug Designation for the treatment of PMD in the U.S. and EU.

The KL1333 license agreement was identified as the key intangible asset acquired in the Abliva transaction, reflecting its status as the primary source of future economic benefits. The fair value of this asset was determined using a probability-adjusted discounted cash flow approach (MEEM), incorporating long-term revenue expectations, milestone and royalty obligations. Identified intangible asset value of Abliva resides in the exclusive global commercialization rights embedded in the license agreement. This analysis resulted in a fair value of USD 61.1 million at the acquisition date.

As part of the acquisition of Abliva, Pharming obtained 84,444 shares in Isomerase Therapeutics Limited ("Isomerase"), representing approximately 10% of its outstanding shares. Isomerase is a privately held U.K.-based synthetic biology firm and a former strategic partner of Abliva AB. The investment was initially measured at fair value and subsequently sold to Isomerase in November 2025 for GBP 168,888 ($0.2 million) within the IFRS 3 measurement period.

Trade and other receivables primarily comprise short-term investments of surplus cash, placed in interest-bearing deposits with original maturities of three to nine months. These deposits matured in February 2025, at which point the funds were received as cash.

The deferred tax liability mainly arises from the recognition of the intangible asset napazimone (KL1333), reflecting the associated tax effects.

The goodwill recognized as a result of the business combination represents the optionality for Pharming to resume research projects outside of KL1333, as well as the fair value of the acquired workforce, which does not qualify for separate recognition on the balance sheet.

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Loss before tax generated by Abliva and included in the consolidated Statement of Income from February 14, 2025 to December 31, 2025 was $26.9 million. If the combination had taken place at the beginning of the year, the profit before tax for the Group would have been $27.4 million. Abliva did not contribute any revenue during 2025.

*Acquisition of remaining interest in Abliva*

In the period from February 14, 2025, to June 18, 2025, Pharming acquired the remaining 11.1% interest in the voting shares of Abliva, thereby increasing its ownership to 100%. A cash consideration of $7.9 million was paid to the non-controlling shareholders. Upon acquisition, the accumulated other comprehensive income from currency translation differences ($0.1 million) attributed to the non-controlling interest was reclassified to other reserves. The excess of the cash consideration paid over the carrying amount of the acquired non-controlling interest after reclassifying the accumulated other comprehensive income, an amount of $0.2 million, has been recognized directly in accumulated deficit in equity. Following the acquisition of the remaining interest in Abliva, the total consideration in cash amounts to $68.0 million in 2025 based on the price of SEK 0.45 paid per share.

*Analysis of cash flows on acquisition*

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| | |
|:---|:---|
| **Amounts in $'000** | |
| Acquisition of a subsidiary (included in cash flows from investing activities) | (60087) |
| Net cash acquired with the subsidiary (included in cash flows from investing activities) | 2611 |
| Acquisition-related costs of the acquisition (included in cash flows from operating activities) | (11263) |
| Acquisition of non-controlling interests (included in cash flows from financing activities) | (7876) |
| **Net cash flow on acquisition** | **(76615)** |

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Acquisition-related costs of $10.3 million were expensed in the period and included within other operating costs in the Consolidated Statement of Income. Moreover, acquisition-related costs of $1.0 million were expensed in the year ended December 31, 2024 related to this acquisition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.SEGMENT INFORMATION

Operating segments are components of the Company that engage in business activities from which it may incur expenses, for which discrete financial information is available and whose operating results are evaluated regularly by the Company's Chief Operating Decision Maker ("CODM") to make decisions about resources to be allocated to the segment and assess its performance. The Executive Members of the Board of Directors are considered the CODM.

CODM reviews the Company's results under four operating segments based on a combination of the products that the Company has launched - RUCONEST® and Joenja®, and the main geographies where sales are consummated - focused on the U.S. and reporting, in aggregate, Europe and Rest of the World ("RoW"). The four operating segments correspond to each of its four reportable segments for financial reporting purposes.

The CODM reviews revenues and gross profit to assess the performance of their operating segments. The CODM does not review financial information on a segmental basis below gross profit, and balance sheet information is not allocated to the company's reportable segments. There are no intersegment sales.

Total revenues and gross profit per each operating and reportable segment for the period ended for the years ended December 31, 2025, 2024 and 2023 are:

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| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2025** | **2025** | **2024** | **2024** | **2024** | **2023** | **2023** | **2023** |
|  | RUCONEST® | Joenja® | Total | RUCONEST® | Joenja® | Total | RUCONEST® | Joenja® | Total |
| **Revenues:** |  |  |  |  |  |  |  |  |  |
| US | 311672 | 50074 | 361746 | 246649 | 40500 | 287149 | 221213 | 17894 | 239107 |
| Europe and RoW | 6249 | 8139 | 14388 | 5590 | 4461 | 10051 | 5921 | 288 | 6209 |
| **Total revenues** | **317921** | **58213** | **376134** | **252239** | **44961** | **297200** | **227134** | **18182** | **245316** |
| **Gross profit:** |  |  |  |  |  |  |  |  |  |
| US | 284542 | 39775 | 324317 | 221093 | 35136 | 256229 | 202441 | 15417 | 217858 |
| Europe and RoW | (926) | 7243 | 6317 | 1126 | 4446 | 5572 | 2026 | 220 | 2246 |
| **Total gross profit** | **283616** | **47018** | **330634** | **222219** | **39582** | **261801** | **204467** | **15637** | **220104** |

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Non-current assets (excluding deferred tax assets) with a carrying amount of $163.9 million are located in the Netherlands and $5.6 million are located outside the Netherlands.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.REVENUE

The revenue fully relates to the transfer of goods and is recognized at a point in time when the goods have been delivered to the customer.

For the years ended December 31, 2025 and 2024, the sales of RUCONEST® in the U.S. market were $311.7 million and $246.6 million, respectively. In 2023, the sales of RUCONEST® in the U.S. market were $221.2 million. Revenues of RUCONEST® in Europe and Rest of the World amounted to $6.2 million in 2025, $5.6 million in 2024 and $5.9 million in 2023.

Sales of Joenja® worldwide in 2025 were $58.2 million compared to $45.0 million in 2024 and $18.2 million in 2023. Revenues of Joenja® in Europe and Rest of World amounted to $8.1 million in 2025 compared to $4.5 million in 2024 and $0.3 million in 2023.These revenues include UK commercial sales and revenue from Named Patient Programs.

Two U.S. customers represented approximately $290.9 million, or 77%, of our net revenues in 2025, per customer $156.2 million and $134.7 million respectively. In 2024 these two U.S. customers represented approximately $227.7 million, or 77%, of our net revenues, per customer $134.8 million and $92.9 million respectively. In 2023 these two U.S. customers represented approximately $204.3 million, or 83%, per customer $108.4 million and $95.9 million respectively. These customers are specialty pharmacies that are specialized in distribution of pharmaceuticals in our and competitors' disease area and distribute our product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.OTHER INCOME

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| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Gain on lease termination | 3877 |  |  |
| Grants | 1076 | 2106 | 1784 |
| Employee retention credit refunds | 1341 |  |  |
| Proceeds from PRV sale |  |  | 21279 |
| Other | 234 | 71 | 286 |
| **Total** | **6528** | **2177** | **23349** |

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The gain on lease termination relates to the early termination of the DSP facility lease at Pivot Park in Oss. Further information on the related right-of-use assets and lease arrangements is disclosed in Note 12. Right-of-use Assets.

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The received grants amounted to $1.1 million in 2025 ($2.1 million in 2024 and $1.8 million in 2023). The grants are annual payroll-tax reimbursement granted by the Dutch and French governments for research and development activities actually conducted by the Company in those countries.

In 2025, the Company received refunds of $1.3 million from the U.S. Treasury under the Employee Retention Credit (ERC) program. These refunds relate to claims filed for the 2020 tax year.

The employee retention credit funds relate to US Treasury checks for employee retention credit refunds for 2020

The remaining other income of $0.2 million consists primarily out of a regulatory milestone receipt for a clinical trial permit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.EXPENSES BY NATURE

***Costs of sales***

Costs of sales in 2025, 2024 and 2023 were as follows:

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| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Cost of inventories recognized as expenses | (31972) | (25645) | (21404) |
| Royalty fees | (5793) | (4907) | (2145) |
| Sales milestone | (5000) |  |  |
| Obsolete inventory impairments | (2735) | (4847) | (1663) |
| **Total** | **(45500)** | **(35399)** | **(25212)** |

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Pharming expensed royalty fees and sales milestones to Novartis on Joenja® sales, amounting to $10.8 million in 2025, $4.9 million in 2024 and $2.1 million in 2023. See Note 25. Commitments and contingencies for further information on the royalty fees to Novartis.

The sales milestone relates to achieving first-time annual net sales of $50.0 million for Joenja®. After a sales threshold has been reached for the first year, the milestone payment for that threshold does not recur, see Note 25. Commitments and contingencies.

Obsolete inventory impairment stems from products no longer eligible for commercial sales which required a reduction in the valuation of the inventories to the lower net realizable value. Impairments related to inventories designated for commercial activities in 2025, 2024 and 2023 amounted to a charge of $2.7 million, $4.8 million and $1.7 million, respectively.

***Other operating costs***

Other operating costs in 2025, 2024 and 2023 were as follows:

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| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Employee costs | (127359) | (104186) | (92524) |
| Amortization costs intangible assets | (6541) | (6273) | (5853) |
| Impairment losses intangible assets |  |  | (253) |
| Depreciation Property, plant and equipment and right of use assets | (4184) | (4769) | (5157) |
| Impairment losses property, plant and equipment and right of use assets | (491) | (5027) | (4663) |
| Direct Operating Expenses | (143199) | (123080) | (114832) |
| Other indirect costs | (29546) | (29264) | (25558) |
| **Total other operating costs** | **(311320)** | **(272599)** | **(248840)** |
| *As percentage of net sales* | *(83) %* | *(92) %* | *(101) %* |

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***Costs of research and development***

Research and development costs in 2025, 2024 and 2023 were as follows:

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Employee costs | (34853) | (29869) | (26830) |
| Amortization costs intangible assets | (256) | (232) | (218) |
| Impairment losses intangible assets |  |  | (253) |
| Depreciation Property, plant and equipment and right of use assets | (1260) | (1449) | (1636) |
| Direct Operating Expenses | (59381) | (47232) | (36226) |
| Other indirect research and development costs | (4617) | (4365) | (3751) |
| **Total research and development costs** | **(100367)** | **(83147)** | **(68914)** |
| *As percentage of net sales* | *(27) %* | *(28) %* | *(28) %* |

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Operating expenses for research and development activities in 2025, 2024 and 2023 were $100.4 million, $83.1 million and $68.9 million, respectively. The increase in costs for 2025 mainly reflects higher expenditures related to investment in the napazimone (KL1333) program following its acquisition, including integration of development activities and preparation for further clinical advancement. The increase in costs for 2024 mainly relates to current year's spend in research in leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) for patients under 12 years old, research on the use of leniolisib for additional primary immunodeficiencies (PIDs) beyond APDS and costs relating to activities in EU and the rest of the world for the purpose of receiving regulatory approval to commercialize Joenja® for APDS.

***Costs of general and administrative activities***

General and administrative costs for 2025, 2024 and 2023 were as follows:

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| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Employee costs | (36218) | (25526) | (21216) |
| Amortization costs intangible assets | (634) | (617) | (650) |
| Depreciation property, plant and equipment and right of use assets | (2447) | (2926) | (3118) |
| Impairment losses property, plant and equipment and right of use assets | (491) | (5027) | (4663) |
| Direct Operating Expenses | (21893) | (18790) | (11240) |
| Other indirect general and administrative costs | (18274) | (17764) | (14990) |
| **Total general and administrative costs** | **(79958)** | **(70650)** | **(55877)** |
| *As percentage of net sales* | *(21) %* | *(24) %* | *(23) %* |

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Other indirect general and administrative costs include insurance, compliance and other costs.

------

***Costs of marketing and sales activities***

Marketing and sales costs for 2025, 2024 and 2023 were as follows:

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Employee costs | (56288) | (48791) | (44478) |
| Amortization costs intangible assets | (5651) | (5424) | (4985) |
| Depreciation property, plant and equipment and right of use assets | (477) | (394) | (403) |
| Direct Operating Expenses | (61925) | (57058) | (67366) |
| Other indirect marketing and sales costs | (6655) | (7135) | (6817) |
| **Total marketing and sales costs** | **(130995)** | **(118802)** | **(124049)** |
| *As percentage of net sales* | *(35) %* | *(40) %* | *(51) %* |

---

Employee benefit costs for 2025, 2024 and 2023 were as follows:

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Salaries | (98526) | (80026) | (71690) |
| Social security costs | (10484) | (9278) | (8604) |
| Pension costs | (4582) | (3629) | (2980) |
| Share-based compensation | (13767) | (11253) | (9251) |
| **Total** | **(127359)** | **(104186)** | **(92525)** |

---

Salaries include holiday allowances and cash bonuses for staff.

***Depreciation and amortization charges***

Depreciation and amortization charges are included in:

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Property, plant and equipment | (1210) | (1395) | (1494) |
| Intangible assets | (6541) | (6273) | (5852) |
| **Total** | **(7751)** | **(7668)** | **(7346)** |
| Right of use assets | (3464) | (3374) | (3664) |
| **Total** | **(3464)** | **(3374)** | **(3664)** |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.OTHER FINANCE INCOME AND EXPENSES

------

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Interest income | 2176 | 4858 | 3663 |
| Foreign currency gains |  | 1985 |  |
| **Other finance income** | **2176** | **6843** | **3663** |
| Amortization and interest on convertible bonds | (9685) | (7699) | (4876) |
| Fees and expenses on repayment and issuance convertible bonds |  | (1151) |  |
| Interest leases | (1034) | (1038) | (1088) |
| Foreign currency losses | (7225) |  | (2971) |
| Other finance expenses | (196) | (56) | (134) |
| **Other finance expenses** | **(18140)** | **(9944)** | **(9069)** |
| **Total other finance income and expenses** | **(15964)** | **(3101)** | **(5406)** |

---

***Interest income***

Since 2023, the Company has used excess cash to invest in euro denominated readily convertible S&P AA1-rated government treasury certificates with a maturity of six months or less from the date of acquisition. Since 2024, excess cash has also been used to invest in money market funds. In 2025, interest income decreased compared to 2024, primarily due to a lower level of excess cash available for investments, as well as a decline in prevailing market interest rates. Reference is made to N<u>[ote](annualreport2025.htm#i80c0bd5a101c4da19bf7c928b9fd33d4_259-bookmark-24f1e73461424afb8d5c4c5f24f7bb5c)</u> 14. Marketable securities for more information on these investments.

***Foreign currency results***

Foreign currency results primarily arise from the revaluation of intercompany balances and transactions denominated in foreign currencies. The losses in 2025 mainly relate to currency differences arising within the Group where the functional currency of the entity differs from the currency in which intercompany balances and transactions are denominated.

***Expenses on convertible bonds***

Amortization and interest on convertible bonds in 2025, 2024 and 2023 relate to the amortized costs and coupons on the convertible bonds as disclosed in Note 18. Convertible bonds. The amortized costs are calculated at the effective rate of interest, which takes account of any equity component on recognition such as early repayment options. The fees and expenses on repayment and issuance of the convertible bonds relate to the premium paid over the current carrying amount upon repayment and to the direct costs allocated to the conversion option as disclosed in Note 18. Convertible bonds.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.INCOME TAX

***Income taxes on ordinary activities***

The following table specifies the current and deferred tax components of income taxes in the income statement:

------

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| **Income tax expense** |  |  |  |
| Current tax |  |  |  |
| Current tax on profit for the year | (7692) | (9287) | (5343) |
| Adjustments for current tax of prior periods | (765) | 315 | 241 |
| **Total current tax credit (expense)** | **(8457)** | **(8972)** | **(5102)** |
| Deferred income tax |  |  |  |
| Deferred tax on profit for the year | (2187) | 7469 | 6639 |
| Adjustments for deferred tax of prior periods | 334 | (1846) | (73) |
| **Total deferred tax credit (expense)** | **(1853)** | **5623** | **6566** |
| **Income tax credit (expense)** | **(10310)** | **(3349)** | **1464** |

---

***Effective income tax rate***

Pharming Group's effective rate in its consolidated income statement differed from the Netherlands' statutory tax rate of 25.8%. The following table reconciles the tax credit (expense) at the statutory rate to actual credit (expense) for the year in the consolidated income statement:

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2025** | **2024** | **2024** | **2023** | **2023** |
|  | **Amount** | **ETR %** | **Amount** | **ETR %** | **Amount** | **ETR %** |
| **Reconciliation of tax charge** |  |  |  |  |  |  |
| Profit, (loss) before taxation | 12847 |  | (8492) |  | (12012) |  |
| Profit, (loss) multiplied by standard rate of tax in The Netherlands | (3315) | 25.80 | 2190 | 25.80 | 3099 | 25.80 |
| Effects of: |  |  |  |  |  |  |
| Tax rate in other jurisdictions | 255 | 1.98 | 999 | (11.76) | 1123 | (9.35) |
| Non-taxable income | 1384 | 10.77 | 657 | (7.74) | 6 | (0.05) |
| Non deductible expenses | (2081) | (16.20) | (1527) | 17.98 | (266) | 2.21 |
| Share based payments | (1490) | (11.60) | (2510) | 29.56 | (2022) | 16.83 |
| Adjustments of prior periods | (426) | (3.32) | (1531) | 18.03 | 168 | (1.40) |
| Change in statutory applicable tax rate |  |  |  |  |  |  |
| (De)recognition of deferred tax assets | (3613) | (28.12) | (333) | 3.92 |  |  |
| U.S. State taxes and other | (1024) | (7.97) | (1294) | 15.24 | (644) | 5.36 |
| **Income tax credit (expense) for the year** | **(10310)** | **(80.25)** | **(3349)** | **39.44** | **1464** | **(12.19)** |

---

***Factors affecting current and future tax charges***

The primary difference between the nominal tax and the effective tax for the year 2025 stems from U.S. profits being taxed at a combined Federal and State tax rate of 29.4%, while a portion of the losses in the Netherlands does not result in an offsetting tax credit due to being partially attributable to non-deductible expenses.

***Deferred tax***

The balance of the net deferred tax assets/(liabilities) is therefore shown below:

------

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Total deferred tax assets | 41498 | 41923 |
| Total deferred tax liabilities | (10481) | (11379) |
| **Total net deferred tax assets /(liabilities)** | **31017** | **30544** |

---

The deferred tax assets and liabilities are offset since there is a legally enforceable right to set off current tax assets against current tax liabilities and to the extent the intention exists, to settle on a net basis or realize the asset and settle the liability simultaneously.

The significant components and annual movements of deferred income tax assets as of December 31, 2025, and December 31, 2024, are as follows:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Intangible assets | 727 | 3289 |
| Lease liabilities | 3492 | 6292 |
| Accruals | 4759 | 4015 |
| Unrealized profit in inventory | 13472 | 10498 |
| Other | 8780 | 5923 |
| Tax losses | 10268 | 11906 |
| **Total deferred tax assets** | **41498** | **41923** |

---

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Intangible assets** | **Lease liabilities** | **Accruals** | **Unrealized profit in inventory** | **Other** | **Tax losses** | **Total** |
| **At January 1, 2024** | **2183** | **7063** | **4151** | **8453** | **3484** | **12529** | **37863** |
| (Charged)/credited |  |  |  |  |  |  |  |
| - to profit or loss | 1107 | (371) | (133) | 1811 | 3076 | (416) | 5074 |
| - other movement |  |  |  |  |  |  |  |
| - to accumulated deficit |  |  |  | 847 | (626) | 540 | 761 |
| - currency translation | (1) | (400) | (3) | (613) | (11) | (747) | (1775) |
| **At December 31, 2024** | **3289** | **6292** | **4015** | **10498** | **5923** | **11906** | **41923** |
| (Charged)/credited |  |  |  |  |  |  |  |
| - to profit or loss | 10724 | (3478) | 743 | 3247 | 1432 | (16396) | (3728) |
| - other movement | (12240) |  | (8) |  | 8 | 12240 |  |
| - to accumulated deficit |  |  |  | (1718) | 1417 |  | (301) |
| - currency translation | (1046) | 678 | 9 | 1445 |  | 2518 | 3604 |
| **At December 31, 2025** | **727** | **3492** | **4759** | **13472** | **8780** | **10268** | **41498** |

---

Deferred tax assets relate primarily to historical net operating losses in the Netherlands and Sweden. Under current tax legislation, tax losses in both jurisdictions may be carried forward indefinitely and do not expire.

Management has assessed the recoverability of these deferred tax assets based on the Group's latest budget for 2026 and its long-range forecasts for the subsequent five-year period. These forecasts indicate that the Group expects to generate sufficient taxable profits within the next three years to utilize the available tax loss carry forwards. Accordingly, management concludes that it remains probable that the deferred tax assets will be realized and that continued recognition is appropriate.

------

Accruals represent deferred tax assets recognized for temporary differences between the carrying amount and tax bases of accrued liabilities in the U.S.

The unused tax losses were incurred by the Dutch fiscal unity and Pharming Healthcare.

The current part of the net deferred tax assets is $17.2 million and $11.9 million for the years ended December 31, 2025 and 2024.

The component and annual movement of deferred income tax liabilities as of December 31, 2025 and December 31, 2024, are as follows:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Tangible fixed assets | (3266) | (2916) |
| Convertible bonds | (4652) | (5067) |
| Other liabilities | (2563) | (3396) |
| **Total deferred tax liabilities** | **(10481)** | **(11379)** |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Tangible fixed assets** | **Convertible bonds** | **Other liabilities** | **Total** |
| **At January 1, 2024** | **(4865)** | **—** | **(3237)** | **(8102)** |
| (Charged)/credited |  |  |  |  |
| - to profit or loss | 1749 | (1038) | (160) | 551 |
| - to other comprehensive income |  | (4251) |  | (4251) |
| - currency translation | 200 | 222 | 1 | 423 |
| **At December 31, 2024** | **(2916)** | **(5067)** | **(3396)** | **(11379)** |
| (Charged)/credited |  |  |  |  |
| - to profit or loss | 4 | 1040 | 835 | 1879 |
| - currency translation | (354) | (625) | (2) | (981) |
| **At December 31, 2025** | **(3266)** | **(4652)** | **(2563)** | **(10481)** |

---

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.INTANGIBLE ASSETS

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **RUCONEST® for HAE (EU)** | **RUCONEST® licenses** | **Joenja® license** | **KL1333 license** | **Goodwill** | **Software** | **Total** |
| At cost | 581 | 69709 | 24447 |  |  | 4772 | 99509 |
| Accumulated amortization | (581) | (24437) | (1326) |  |  | (1898) | (28242) |
| **Carrying value at January 1, 2024** | **—** | **45272** | **23121** | **—** | **—** | **2874** | **71267** |
| Amortization charges |  | (3686) | (1735) |  |  | (852) | (6273) |
| Assets acquired |  |  |  |  |  | 6 | 6 |
| Divestments - cost | (570) |  |  |  |  |  | (570) |
| Divestment - accumulated amortization | 570 |  |  |  |  |  | 570 |
| Currency translation - cost | (11) | (4131) | (1449) |  |  | (283) | (5874) |
| Currency translation - amortization | 11 | 1603 | 151 |  |  | 148 | 1913 |
| **Movement 2024** | **—** | **(6214)** | **(3033)** | **—** | **—** | **(981)** | **(10228)** |
| At cost |  | 65578 | 22998 |  |  | 4495 | 93071 |
| Accumulated amortization |  | (26520) | (2910) |  |  | (2602) | (32032) |
| **Carrying value at December 31, 2024** | **—** | **39058** | **20088** | **—** | **—** | **1893** | **61039** |
| Amortization charges |  | (3839) | (1809) |  |  | (893) | (6541) |
| Assets acquired |  |  |  | 61114 | 2903 | 87 | 64104 |
| Currency translation - cost |  | 8636 | 3029 | 8745 | 416 | 592 | 21418 |
| Currency translation - amortization |  | (3647) | (456) |  |  | (379) | (4482) |
| **Movement 2025** | **—** | **1150** | **764** | **69859** | **3319** | **(593)** | **74499** |
| At cost |  | 74214 | 26027 | 69859 | 3319 | 5174 | 178593 |
| Accumulated amortization |  | (34006) | (5175) |  |  | (3874) | (43055) |
| **Carrying value at December 31, 2025** | **—** | **40208** | **20852** | **69859** | **3319** | **1300** | **135538** |

---

***RUCONEST® for HAE (EU)***

The Company has capitalized development costs in relation to RUCONEST® for HAE in the EU. Following market launch of the product in 2010 the amortization of the asset started, and no further development costs have been capitalized in respect to this item since then. These development costs are fully amortized since the end of 2021.

***RUCONEST® license***

------

The RUCONEST® license relates to RUCONEST® acquisition of all North American commercialization rights from Bausch Health (formerly Valeant Pharmaceuticals) in 2016 and the RUCONEST® acquisition of all European commercialization and distribution rights from Swedish Orphan International AB, or Sobi, in 2020. The remaining useful life and residual value of the RUCONEST® license for HAE (EU) were reassessed after the strategic decision to withdraw the product from the non-US markets.

***Joenja®***

In August 2019, Pharming entered into a development collaboration and license agreement with Novartis to develop and commercialize leniolisib, the P13Kδ inhibitor being developed by Novartis to treat patients with Activated Phosphoinositide 3-kinase Delta Syndrome, or APDS. Following FDA approval on March 24, 2023, the amortization of the Joenja® license commenced. Since 2023, no additional development costs were capitalized.

***Napazimone (KL1333) license***

Following the acquisition of Abliva AB in February 2025, Pharming obtained the exclusive global rights (excluding South Korea and Japan) to develop and commercialize napazimone (KL1333) under a license agreement. Napazimone (KL1333) is a novel oral therapy targeting mitochondrial DNA-driven primary mitochondrial diseases and is currently in a pivotal Phase 2 clinical trial (FALCON), for which the Independent Data Monitoring Committee (IDMC) supported continuation of the FALCON study without and modifications. The product has received Fast Track designation in the U.S. and Orphan Drug Designation in both the U.S. and EU. As napazimone (KL1333) is still in development and not yet approved for sale, the intangible asset is not amortized. The asset is tested for impairment annually or when indicators arise, in accordance with IAS 36. Amortization will commence once the product is available for use, which is expected upon regulatory approval and market launch.

***Goodwill***

Goodwill arose from the acquisition of Abliva AB, as further described in Note 3. Business combinations and acquisitions of non-controlling interests. The goodwill represents the expected future economic benefits arising from assets that are not individually identified and separately recognized. Goodwill is recognized as an intangible asset with an indefinite useful life and is not amortized, but is tested for impairment annually or more frequently if indicators of impairment arise, in accordance with IAS 36.

***Software***

Amortization of software is mainly related to the ERP system SAP S/4HANA.

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.PROPERTY, PLANT AND EQUIPMENT

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Operational facilities** | **Leasehold Improvement** | **Machinery and equipment** | **Other** | **Asset under construction** | **Total** |
| At cost | 4913 | 5546 | 9660 | 5131 | 179 | 25429 |
| Accumulated depreciation | (3388) | (2487) | (6386) | (3479) |  | (15740) |
| **Carrying value at January 1, 2024** | **1525** | **3059** | **3274** | **1652** | **179** | **9689** |
| Investments |  | 197 | 219 | 230 | 144 | 790 |
| Internal transfer - cost |  |  |  | 175 | (175) |  |
| Depreciation charges | (355) | (266) | (756) | (900) |  | (2277) |
| Currency translation - cost | (291) | (311) | (582) | (152) | (3) | (1339) |
| Currency translation - accumulated depreciation | 216 | 148 | 410 | 115 |  | 889 |
| **Movement 2024** | **(430)** | **(232)** | **(709)** | **(532)** | **(34)** | **(1937)** |
| At cost | 4622 | 5432 | 9297 | 5384 | 145 | 24880 |
| Accumulated depreciation | (3527) | (2605) | (6732) | (4264) |  | (17128) |
| **Carrying value at December 31, 2024** | **1095** | **2827** | **2565** | **1120** | **145** | **7752** |
| Investments |  | 173 | 188 | 388 |  | 749 |
| Internal transfer - cost |  | 144 |  |  | (145) | (1) |
| Divestments |  |  | (143) |  |  | (143) |
| Depreciation charges | (360) | (333) | (659) | (706) |  | (2058) |
| Depreciation of disinvestment |  |  | 96 |  |  | 96 |
| Currency translation - cost | 609 | 654 | 1226 | 343 |  | 2832 |
| Currency translation - accumulated depreciation | (479) | (333) | (909) | (273) |  | (1994) |
| **Movement 2025** | **(230)** | **305** | **(201)** | **(248)** | **(145)** | **(519)** |
| At cost | 5231 | 6403 | 10568 | 6115 |  | 28317 |
| Accumulated depreciation | (4366) | (3271) | (8204) | (5243) |  | (21084) |
| **Carrying value at December 31, 2025** | **865** | **3132** | **2364** | **872** | **—** | **7233** |

---

The Company had capital expenditures of $0.7 million and $0.8 million, mainly related to new machinery and equipment for the years ended December 31, 2025 and 2024.

For the years ended December 31, 2025 and 2024, depreciation charges on production related property, plant and equipment of $0.7 million and $0.8 million have been included in the value of inventories and an amount of $1.4 million and $1.5 million of the total depreciation costs for 2025 and 2024 have been charged to the statement of income (other operating costs).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.RIGHT-OF-USE ASSETS

This Note provides information for leases where the Group is a lessee.

**Amounts recognized in the balance sheet**

The balance sheet shows the following amounts relating to lease:

------

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **Buildings** | **Cars** | **Total** |
| At cost | 30959 | 4009 | 34968 |
| Accumulated depreciation | (9311) | (1880) | (11191) |
| **Carrying value at January 1, 2024** | **21648** | **2129** | **23777** |
| Additions |  | 2395 | 2395 |
| Remeasurement | 338 |  | 338 |
| Divestments | (305) | (1694) | (1999) |
| Depreciation charges | (2627) | (1280) | (3907) |
| Depreciation of disinvestment | 186 | 1515 | 1701 |
| Impairment | (5027) |  | (5027) |
| Currency translation - cost | (1431) | (41) | (1472) |
| Currency translation - accumulated depreciation | 557 | 19 | 576 |
| **Movement 2024** | **(8309)** | **914** | **(7395)** |
| At cost | 24534 | 4669 | 29203 |
| Accumulated depreciation | (11195) | (1626) | (12821) |
| **Carrying value at January 1, 2025** | **13339** | **3043** | **16382** |
| Additions |  | 551 | 551 |
| Remeasurement | 2393 |  | 2393 |
| Divestments | (1367) | (1174) | (2541) |
| Depreciation charges | (2345) | (1194) | (3540) |
| Depreciation of disinvestment | 1367 | 1009 | 2376 |
| Impairment | (491) |  | (491) |
| Currency translation - cost | 2877 | 91 | 2968 |
| Currency translation - accumulated depreciation | (1324) | (37) | (1360) |
| **Movement 2025** | **1110** | **(754)** | **356** |
| At cost | 27946 | 4136 | 32082 |
| Accumulated depreciation | (13497) | (1847) | (15344) |
| **Carrying value at December 31, 2025** | **14449** | **2289** | **16738** |

---

During 2022, the lease for the DSP facility at Pivot Park in Oss, the Netherlands commenced and resulted in an investment of $14.6 million. The intention for this facility was primarily to set up our independent production line for a former pipeline product relating to Pompe disease. The pipeline product was cancelled and the building remained empty and unused. Since 2024, Pharming has entered into negotiations to terminate this lease. Consequently, the Company fully impaired the related right-of-use asset. Impairment charges totaled $13.6 million over the period 2022 to 2024. Following an inflation-related increase in lease payments in 2025, the right-of-use asset was remeasured upward by $0.5 million and immediately impaired, given the continued unused status of the facility. At the end of 2025, the Company entered into a termination agreement to cancel the lease related to the respective asset. As the associated right-of-use asset had previously been fully impaired, its carrying amount at the time of termination was nil. The termination agreement resulted in a book gain of $3.9 million, which has been recognized in the consolidated statement of income under "Other income".

The building remeasurement is related to adjustments in the existing right-of-use assets to reflect inflation-related higher lease payments.

The Company applies for the recognition exemption for short-term leases and leases of low-value assets. The respective lease payments are recorded in the consolidated statement of income and are immaterial to the financial statements.

**Amounts recognized in the statement of income**

Depreciation charges on production related right-of-use assets of $0.6 million in 2025, $0.5 million in 2024 and $0.5 million in 2023, have been included in the value of inventories. An amount of $3.0 million of the total 2025 depreciation costs has been charged to the statement of income. In 2024 and 2023, depreciation costs of $3.4 million and $3.7 million, respectively, have been charged to the statement of income.

------

The statement of income shows the following amounts relating to leases:

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Depreciation right-of-use assets |  |  |  |
| Depreciation right-of-use buildings | (1779) | (2094) | (2380) |
| Depreciation right-of-use cars | (1194) | (1280) | (1284) |
| **Total depreciation right-of-use assets** | **(2973)** | **(3374)** | **(3664)** |
| Interest expense (Note 7) | (1034) | (1038) | (1088) |
| Impairment expense | (491) | (5027) | (4663) |
| Gain on termination of lease agreement (Note 6) | 3877 |  |  |
| **Total** | **(621)** | **(9439)** | **(9415)** |

---

**Lease charges**

The non-cancellable leases at December 31, 2025, have remaining terms of between one and 12 years and generally include a clause to enable upward revision of the rental charge on an annual basis according to prevailing market conditions.

The expected lease charges after the end of the reporting year have been disclosed in Note 26. Financial risk management. Allocations of the lease charges to costs or general and administrative expenses have been based on the nature of the asset in use.

&nbsp;&nbsp;&nbsp;&nbsp;13.INVESTMENTS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**13.1 INVESTMENT ACCOUNTED FOR USING THE EQUITY METHOD**

The investment in BioConnection group (BioConnection) provides the Company with significant influence over BioConnection, and as such has been treated as an associate of the Group.

As at December 31, 2025, the asset relates to an investment in the ordinary shares of BioConnection Investments B.V. During the second quarter of 2022, Pharming entered into a share purchase agreement to sell a portion of its investments, following receipt of an offer for all shares in BioConnection by Gimv, a European investment company listed on Euronext Brussels. The existing shareholders (including Pharming) reached agreement with Gimv on the sale of all issued and outstanding shares to a new holding company (BioConnection Investments B.V.) incorporated by Gimv, followed by a partial re-investment by existing shareholders of the purchase price in the share capital of BioConnection Investments B.V. The re-investment relates to the purchase of ordinary shares and a preference share. The transaction diluted Pharming's stake in BioConnection from 43.85% in 2021 to 23.60% in 2022. At December 31, 2025, Pharming's stake in this investment is 23.00%.

The Company made an assessment on the accounting treatment of the agreement and concluded that the sale of the BioConnection ordinary shares and purchase of the BioConnection Investments B.V. ordinary shares shall be considered as a dilution of an existing equity stake in an investment accounted for using the equity method. Hence Pharming recognized the dilution of its equity stake as a reduction of the carrying amount of the investment accounted for using the equity method. The preference share is valued as an investment in debt instruments designated at FVTPL.

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | | **% of ownership interest** | **% of ownership interest** | **% of ownership interest** | | |
| **Name of entity** | **Place of business** | **2025** | **2024** | **2023** | **Nature of relationship** | **Measurement method** |
| BioConnection Investments B.V. | Oss, NL | 23.00% | 23.60% | 23.60% | Associate | Equity |

---

------

---

| | | | |
|:---|:---|:---|:---|
| $'000 | **Carrying amount** | **Carrying amount** | **Carrying amount** |
| Name of entity | **2025** | **2024** | **2023** |
| **BioConnection Investments B.V.** |  |  |  |
| **Balance at January 1** | 466 | 2285 | 2501 |
| **Movement during the year** |  |  |  |
| Share in net profit (loss) | 623 | (1131) | (289) |
| Impairment |  | (629) |  |
| Contributions | 739 |  |  |
| Currency translation | 116 | (59) | 73 |
| **Balance at December 31** | **1944** | **466** | **2285** |

---

In accordance with IAS 36, the Company reviewed the carrying value of the investment in BioConnection for impairment whenever events or changes in circumstances indicate that the carrying value may not be recoverable. In 2024, based on a comprehensive review of the investee's performance, financial position, expected future cash flows and market conditions, the Company determined that an impairment is required. Basis to determine the impairment expense relates to the required fair value calculation for the relating investment in debt instruments designated at FVTPL (the preference share). This calculation relates to a discounted cash flow model for which more details can be found at Note 13.2. Investment in debt instruments designated as at FVTPL. The Company will continue to monitor the performance of this investee and assess whether additional impairments may be necessary in future periods, depending on changes in circumstances or the performance of the investee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**13.2 INVESTMENT IN DEBT INSTRUMENTS DESIGNATED AS AT FVTPL**

The asset relates to the preference share as obtained as part of the agreement referred to above relating to BioConnection Investments B.V. Management made an assessment on the accounting treatment of the preference share obtained. Management concluded that the asset should be recognized as a financial asset (debt instrument) measured at initial recognition at fair value, subsequently measured at fair value through profit and loss. The fair value was calculated based on a commonly accepted valuation method, the option pricing model ("OPM"), which considers the share classes as call options on the total shareholders' equity value according to the rights and preferences of each class of equity. The payoff profile of the share classes was analyzed through a portfolio of call options, with the total equity value of a company as the underlying asset of the options and specific terms for each option calibrated to mirror, in aggregate, the payoff profile of the share classes. Relying on the forward-looking Black-Scholes-Merton ("BSM") financial instrument pricing framework, the OPM effectively captures the full range of potential outcomes for the share classes at exit. The OPM takes into consideration the full spectrum of risks in terms of future potential upside or downside but does not require explicit estimates of the possible future outcomes. The BSM model is commonly used to price assets on financial markets and allows to estimate the theoretical value of a call option, using six key parameters, namely the underlying equity value, strike price, time to maturity, risk free rate, expected volatility of the underlying equity and dividend yield on the underlying equity, which is a Level 3 input in terms of IFRS 13. Significant increases or decreases in equity value, volatility and time to maturity and below assumptions in isolation would result in a significantly lower or higher fair value assessment.

The following assumptions were used in the BSM model to determine the fair value of the asset:

---

| | | |
|:---|:---|:---|
| | **2025** | **2024** |
| Expected time to maturity | 4 years | 4 years |
| Volatility | 50% | 50% |
| Risk-free interest rate | 3.48% | 2.60% |

---

------

The carrying amount of this investment has changed as follows:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| **Balance at Balance at January 1** | **3767** | **6093** |
| Fair value changes | 2345 | (2051) |
| Currency translation | 591 | (275) |
| **Balance at December 31** | **6703** | **3767** |

---

**Sensitivity analysis**

To illustrate the exposure of the carrying value of the investment to further fair value movements as a result of changes in the economic environment, a sensitivity analysis of fair value has been prepared over the key drivers most affected by the current uncertainties. It is possible that there will be movements in these key inputs after December 31, 2025. While it is unlikely that these reported inputs would move in isolation, these sensitivities have been performed independently to illustrate the impact each individual input has on the reported fair value, and they do not represent management's estimate at December 31, 2025.

The main assumptions in determination of the equity value are shown in below table.

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** |
| **Revenue level** | **Fair value** | **Discount rate** | **Fair value** | **EBITDA margin** | **Fair value** |
| -10.0% | 3.4 | -2.0% | 7.6 | -5.0% | 4.8 |
| -5.0% | 5.3 | -1.0% | 7.1 | -2.5% | 5.9 |
| Base case | 6.7 | Base case | 6.7 | Base case | 6.7 |
| +5.0% | 7.8 | +1.0% | 6.3 | +2.5% | 7.5 |
| +10.0% | 8.7 | +2.0% | 6.0 | +5.0% | 8.1 |

---

The impact of the remaining variables on the BSM model are shown in below table:

---

| | | | |
|:---|:---|:---|:---|
| **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** | **Preference share BioConnection (in million $)** |
| **Time to maturity** | **Fair value** | **Volatility** | **Fair value** |
| - 2 years | 7.6 | -10.0% | 7.4 |
| - 1 year | 7.1 | -5.0% | 7.0 |
| Base case | 6.7 | Base Case | 6.7 |
| + 1 year | 6.3 | +5.0% | 6.3 |
| + 2 years | 6.0 | +10.0% | 6.0 |

---

**13.3 INVESTMENT IN EQUITY INSTRUMENTS DESIGNATED AS AT FAIR VALUE THROUGH OTHER COMPREHENSIVE INCOME**

**Orchard Therapeutics Plc**

In 2024, the Company received $0.2 million from the sale of its 0.54% shareholding in Orchard Therapeutics Plc following its acquisition by Kyowa Kirin Co., Ltd. The research collaboration and licensing agreement with Orchard was terminated, and the OTL-105 program discontinued.

------

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | | **% of ownership interest** | **% of ownership interest** | **% of ownership interest** | | |
| **Name of entity** | **Place of business** | **2025** | **2024** | **2023** | **Nature of relationship** | **Measurement method** |
| Orchard Therapeutics Plc. | London, UK | —% | —% | 0.54% | Investment | Fair value |

---

The fair value as at December 31, 2023, was determined on the basis of the trading price as at that date.

---

| | | | |
|:---|:---|:---|:---|
| $'000 | **Carrying amount** | **Carrying amount** | **Carrying amount** |
| Name of entity | **2025** | **2024** | **2023** |
| **Orchard Therapeutics Plc.** |  |  |  |
| **Balance at January 1** |  | 2020 | 403 |
| **Movement during the year** |  |  |  |
| Initial recognition from a business combination | 220 |  |  |
| Fair value adjustments through OCI (pre-tax) |  | 106 | 1573 |
| Disposal of investment designated as at FVOCI | (220) | (2098) |  |
| Currency translation |  | (28) | 44 |
| **Balance at December 31** | **—** | **—** | **2020** |

---

**Isomerase**

As part of the acquisition of Abliva AB in 2025, the Company obtained an interest in Isomerase. This interest was subsequently disposed of in the same year, resulting in a net position of zero.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.MARKETABLE SECURITIES

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Government treasury certificates |  | 50525 |
| Money market funds | 33796 | 62424 |
| **Total marketable securities** | **33796** | **112949** |

---

The decrease in marketable securities reflects a rebalancing to increase immediately available liquidity following the Abliva acquisition, supporting integration activities and the expansion of commercial activities in 2025.

Government treasury certificates, denominated in euros, are readily convertible, carry an S&P AA1 rating, and have a maturity of six months or less from the acquisition date. These certificates are classified as held-to-maturity and measured at amortized costs. We have considered the expected credit loss and recognized no impairment losses, due to the AA1 credit ratings. Reference is made to Note 26. Financial Risk Management showing the difference between the carrying amount and the fair value. Since 2024, the Company has also invested in SEC Rule 2a-7 compliant institutional money market funds, which offer enhanced financial flexibility.

The carrying value of the marketable securities include accrued interest and dividends of $0.1 million in 2025 and $0.4 million in 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.RESTRICTED CASH, CASH AND CASH EQUIVALENTS

------

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Restricted cash (non-current) | 1227 | 1505 |
| Restricted cash (current) | 761 |  |
| Cash and cash equivalents | 145305 | 54944 |
| **Total restricted cash, cash and cash equivalents** | **147293** | **56449** |

---

Cash is free at disposal of the Company, except for restricted cash, which amounts to $2.0 million and $1.5 million in 2025 and 2024, respectively. Restricted cash includes deposits for rent.

For purposes of the cash flow statement restricted cash and marketable securities are not considered as ''cash and cash equivalents''.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.INVENTORIES

Inventories mainly include batches of RUCONEST® and Joenja® and work in progress available for production of RUCONEST® and Joenja®.

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Finished goods | 18214 | 16297 |
| Work in progress | 46688 | 39002 |
| Raw materials |  | 425 |
| **Balance at December 31** | **64902** | **55724** |

---

Changes in the adjustment to net realizable value:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| **Balance at January 1** | (8663) | (4276) |
| Addition to impairment | (6193) | (7608) |
| Release of impairment | 538 | 15 |
| Usage of impairment | 2522 | 2749 |
| Currency translation | (1263) | 457 |
| **Balance at December 31** | **(13060)** | **(8663)** |

---

The inventory valuation at December 31, 2025 and 2024 of $64.9 million and $55.7 million respectively, is stated net of an impairment of $13.1 million and $8.7 million for the years ended December 31, 2025 and 2024. The impairment primarily relates to products no longer eligible for commercial sales.

Inventories are available for use in commercial, preclinical and clinical activities. Estimates have been made with respect to the ultimate use or sale of product, taking into account current and expected sales as well as preclinical and clinical programs. These estimates are reflected in the additions to the impairment. The releases of the impairment relate to amendments to the estimates as a result of actual sales differing from forecasted sales, the fact that vials allocated to preclinical and clinical programs can be returned to inventory, and quality issues in the manufacturing process can be reevaluated once more information is known. The costs of vials used in preclinical and clinical programs are presented under the research and development costs. Usage of impairment relates to the usage of material not sold that had been previously impaired.

Cost of inventories recognized as expenses included in the costs of sales amounted $32.0 million in 2025, $25.6 million in 2024 and $21.4 million in 2023. The main portions of inventories at December 31, 2025, have expiration dates starting beyond 2026 and are generally expected to be sold and/or used before expiration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.TRADE AND OTHER RECEIVABLES

------

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Trade receivables | 41767 | 41531 |
| Prepaid expenses | 6263 | 4651 |
| Value added tax | 2176 | 3638 |
| Other receivables | 1932 | 1596 |
| Taxes and social security | 2566 | 3407 |
| **Balance at December 31** | **54704** | **54823** |

---

Trade receivables are amounts due from customers for goods sold in the ordinary course of business. They are generally due for settlement within 30-60 days and therefore are all classified as current. The Company's outstanding trade receivables are mainly related to the sales in the United States. The trade receivables remained relatively stable compared to 2024, driven by the timing of customer orders and payments around year-end.

The Company did not recognize any expected credit losses. Pharming measures the loss allowance for trade receivables at an amount equal to lifetime ECL. The expected credit losses on trade receivables are estimated using a provision matrix by reference to past default experience of the debtor and an analysis of the debtor's current financial position, adjusted for factors that are specific to the debtors, general economic conditions of the industry in which the debtors operate and an assessment of both the current as well as the forecast direction of conditions at the reporting date. Pharming has a limited number of customers with long term relationships, without a history of shortfalls. As a result no loss allowance for expected credit losses is recognized.

The taxes and social security receivable includes $2.3 million of corporate income tax receivable (2024: $2.8 million).

Due to the short-term nature of the current receivables, their carrying amount is considered to be the same as their fair value.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.CONVERTIBLE BONDS

Recognition and movements of the convertible bonds were as follows:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Bond component (classified as liability) | 98056 | 82399 |
| Option component (classified as equity) | 13835 | 12225 |
| **Balance at December 31** | **111890** | **94624** |

---

Bond component:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| **Balance at January 1** | **82399** | **138422** |
| Repurchase |  | (134924) |
| Carrying value initial recognition |  | 81785 |
| Interest paid (cash flow) | (5067) | (4457) |
| Amortization | 8752 | 5725 |
| Accrued interest | 933 | 1972 |
| Currency translation | 11038 | (6124) |
| **Balance at December 31** | **98056** | **82399** |
| **- Current portion** | **5336** | **4245** |
| **- Non-current portion** | **92719** | **78154** |

---

Option component:

------

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| **Balance at January 1** | **12225** | **—** |
| Carrying value initial recognition derivative liability |  | 23517 |
| Fair value loss (gain) upon reclassification to equity |  | (7040) |
| Income tax recorded in other comprehensive income |  | (4251) |
| Currency translation | 1610 |  |
| **Balance at December 31** | **13835** | **12225** |

---

In April 2024, the Company offered €100.0 million ($103.5 million) of senior unsecured convertible bonds due 2029 (the "New Bonds") convertible into new and/or existing ordinary shares in the capital of the Company. The offer was fully subscribed. The net proceeds of the issue of the bonds were used for the repurchase of the outstanding €125.0 million ($129.4 million) 3.0% senior unsecured convertible bonds due in 2025 issued on January 21, 2020 (ISIN: XS2105716554), which has been launched concurrently to the offering of the New Bonds to strengthen its financial position while enhancing flexibility for the continued execution of its business strategy over the next several years.

The New Bonds have a principal amount of €100,000 each. The New Bonds are issued at par and carry a coupon of 4.5% per annum payable semi-annually in arrears in equal installments on April 25 and October 25 of each year, commenced on October 25, 2024. Unless previously converted, redeemed or purchased and cancelled, the New Bonds will be redeemed at par on 25th April 2029.

The initial conversion price has been set at €1.2271 ($1.2700), representing a premium of 37.5% above the volume weighted average price (VWAP) of a Share on Euronext Amsterdam between opening of trading on the launch date and the pricing of the offering (i.e., €0.8924 ($0.9236)). The initial conversion price of the New Bonds will be subject to customary adjustment provisions as set out in the terms and conditions. The number of ordinary shares initially underlying the New Bonds is 81,492,951, representing 12.0% of the Company's current issued share capital. The New Bonds are listed on the Frankfurt Exchange (ISIN: XS2763018889).

The New Bonds are classified as hybrid financial instruments under IAS 32 and pursuant to it the debt host contract and the embedded derivative for the fair value of the conversion rights into Pharming shares (the "conversion option") are recognized separately.

The conversion option was at initial recognition was measured using a pricing model. As the Company did not have sufficient placement capacity to fulfil conversion of the New Bonds into ordinary shares at the date of issue, the conversion option was recognized as a financial liability derivative. During the shareholder's meeting on May 21, 2024, the Company received shareholder approval to increase share capital to support the potential conversion. At the Physical settlement notice date of June 11, 2024, when the New Bond holders were notified that the cash settlement alternative would no longer be available, the conversion option was reclassified to equity at fair value, which resulted in a fair value gain of $7.0 million immediately prior to the reclassification. Subsequently, the value of this equity component is not remeasured, apart from currency revaluation, and amounts to $13.8 million, net of income tax effects, at December 31, 2025.

---

| | | |
|:---|:---|:---|
| **Parameter** | **At initial recognition** | **Immediately prior to reclassification** |
| Share price | 0.8924 | 0.7690 |
| Conversion price per share | 1.2271 | 1.2271 |
| Dividend yield | —% | —% |
| Expected term in years | 5.00 | 4.85 |
| **Risk-free rate** | 2.90% | 3.01% |
| Volatility | 44.34% | 43.99% |
| Barrier price per share | 1.5952 | 1.5952 |

---

------

The debt host contract component was measured at initial recognition as the difference between the proceeds from the bond and the value of the conversion option at initial recognition. This debt host contract is subsequently measured at amortized cost, which amounts to $98.1 million at December 31, 2025.

Direct costs associated with the issue of the New Bonds were allocated to the debt host contract ($2.2 million) and the conversion option ($0.6 million) in amounts proportional to the above mentioned initial value. They were accounted for respectively in the amortized cost (debt host contract) and in the income statement (conversion option).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.PROVISIONS

---

| | | |
|:---|:---|:---|
| Amounts in US$ '000 | **Restructuring** | **Total** |
| **Balance at At 1 January 2025** | **—** | **—** |
| Arising during the year | 3521 | 3521 |
| Utilized | (2335) | (2335) |
| Unused amounts reversed |  |  |
| Changes in discount rate |  |  |
| **Balance at At 31 December 2025** | **1187** | **1187** |
| **- Current portion** | **1187** | **1187** |
| **- Non-current portion** | **—** | **—** |

---

**Restructuring**

Pharming Group recorded a restructuring provision during the year, of which $1.2 million is unutilized as at December 31, 2025. The provision relates principally to the elimination of certain non-commercial and non-medical staff positions as part of a cost optimization program.

The restructuring plan was agreed upon with the Company's Works Council and announced to employees in October 2025, when the provision was recognized in the financial statements. The restructuring is expected to be substantially completed by 2026.

The provision was measured at the best estimate of the expenditure required to settle the present obligation at the reporting date, based on formal plans and communication to affected employees. No reimbursement is expected.

The expected cash outflows related to the restructuring provision are anticipated to occur primarily in 2026. The provision does not include costs associated with future operating activities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.LEASES

Lease liabilities can be specified as follows:

------

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| **Balance at January 1** | **29914** | **33123** |
| Additions | 551 | 2425 |
| Remeasurement | 2393 | 338 |
| Interest expense accrued | 1130 | 1141 |
| Payments of lease liabilities | (5376) | (5149) |
| Disposals of lease liabilities | (13687) | (309) |
| Currency translation | 2794 | (1655) |
| **Balance at December 31** | **17719** | **29914** |
| **- Current portion** | **3369** | **2946** |
| **- Non-current portion** | **14351** | **26968** |

---

Additions in 2024 and 2025 relate to newly leased cars and remeasurement reflects adjustments due to lease extensions and inflation-related higher lease payments on buildings. The disposal of lease liabilities relates to the early termination of the DSP facility lease at Pivot Park in Oss. Further information is disclosed in note 12. Right-of-use Assets.

Future minimum lease payments as at December 31, 2025 and 2024 are as follows:

---

| | | | | |
|:---|:---|:---|:---|:---|
| | **2025** | **2025** | **2024** | **2024** |
| Amounts in $'000 | **Minimum payments** | **Present value of payments** | **Minimum payments** | **Present value of payments** |
| Within one year | 3860 | 3734 | 4730 | 4650 |
| After one year but not more than five years | 10180 | 9494 | 15267 | 13764 |
| More than five years | 5048 | 4491 | 15322 | 11500 |
| **Balance at December 31** | **19088** | **17719** | **35319** | **29914** |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.TRADE AND OTHER PAYABLE

Trade and other payables as at December 31, 2025 and 2024 are as follows:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Accounts payable | 8545 | 10103 |
| Taxes and social security | 6043 | 3284 |
| Accruals for employees | 21795 | 16117 |
| Accruals for rebates and discounts | 19342 | 14631 |
| Accrual for production | 15819 | 8559 |
| Other accruals | 34356 | 13917 |
| **Balance at December 31** | **105899** | **66611** |

---

The increase in trade and other payables is mainly due to timing of payments. The Other accruals relate to general expenses for which no invoice was received yet and include, at December 31, 2025, the fee payable for the termination of the DSP facility lease and the sales milestone payable to Novartis on Joenja® sales. Accruals for employees mainly relate to bonuses for employees, holiday allowances and non-taken vacation days and increased due to an increase in the number of employees, partly offset by a decrease on bonuses for employees. The accrual for rebates and discounts has increased, mainly due to the increase of revenues and timing of settlements. Finally, accruals for production relate to production activities by our Contracted Manufacturing Organizations (CMOs), for which no invoice is received yet. The increase is mainly related to timing of invoicing by these CMO's.

------

The taxes and social security payable includes $3.9 million of corporate income tax payable (2024: $0.3 million).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.SHARE-BASED COMPENSATION

The remuneration policy for the Board of Directors was adopted by our shareholders on May 24, 2024 and governs the remuneration of both the Executive and the Non-Executive Directors, hereafter referred to as the Remuneration Policy. In accordance with Dutch law, the policy must be submitted to our shareholders for adoption every four years.

The Policy refers to an undefined number of Executive Directors and Non-Executive Directors. The Board of Directors is composed of six Non-Executive Directors (seven until June 11, 2025). In case of future appointments of additional Executive Directors, the Policy shall also be applicable to the remuneration packages for these additional Directors, if any, in accordance with the terms thereof. Therefore, any reference below to Executive Director in the singular also includes the plural, and vice versa, subject to more restrictive deviations in the Policy and except for specific references to the CEO.

The remuneration packages of the individual Directors are determined by the Board of Directors, without the involvement of the Executive Director in the deliberations and decision-making concerning his own remuneration, and each time within the restrictions set by the remuneration policy.

Arrangements in the form of shares or rights to subscribe for shares will each time remain subject to the approval of the shareholders at the General Meeting, notwithstanding the adopted policy.

On June 11, 2025, our shareholders also authorized the Board of Directors, for a period of eighteen months, as the company body authorized to grant and issue the ordinary shares to the Executive Director under the long-term incentive program and the transition arrangement, respectively, and to exclude any preemptive rights of existing shareholders in connection with these issuances.

The total expense recognized for the years ended December 31, 2025 and 2024 for share-based payment plans amounts to $13.8 million and $11.2 million. The total expense recognized in 2023 for share-based payment plans amounts to $9.3 million.

The total expenses for share based payment plans in 2025, 2024 and 2023 is specified as follows:

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 |  |  |  |
| **Share-based compensation (in $'000)** | **2025** | **2024** | **2023** |
| Non-executive directors' remuneration | 229 | 238 | 246 |
| Employee options | 364 | 703 | 1654 |
| Long term incentive plan | 5725 | 4153 | 4006 |
| Restricted stock units | 7449 | 6154 | 3345 |
| **Balance at Share-based compensation expense** | **13767** | **11248** | **9251** |

---

The employee options expense decreased due to a change in the employee share-based compensation plans where since 2022 Restricted Stock Units (RSU's) have been granted instead of employee options. No new employee option grants were applicable for 2025.

The restricted stock units expense increased significantly as the program was introduced in 2022 and is now active for four full years over a 4-year vesting period per grant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;***22.1 Models and assumptions***

***Models and assumptions***

------

IFRS 2 describes a hierarchy of permitted valuation methods for share-based payment transactions. If possible, an entity should use market prices at measurement date to determine the fair value of its equity instruments. If market prices are unavailable, as is the case with Pharming's option plans and long-term incentive plan, the entity shall estimate the fair value of the equity instruments granted.

A valuation technique should be used to estimate the value or price of those equity instruments as it would have been at the measurement date in an arm's length transaction between knowledgeable, willing parties.

The valuation technique shall be consistent with generally accepted valuation methodologies for pricing financial instruments and shall incorporate all factors and assumptions that knowledgeable market participants would consider in setting the price.

Whatever pricing model is selected, it should, as a minimum, take into account the following elements:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The exercise price of the option;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The expected time to maturity of the option;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The current price of the underlying shares;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The expected volatility of the share price;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The dividends expected on the shares;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The risk-free interest rate for the expected time to maturity of the option.

*Models and assumptions option plans*

The costs of option plans are measured by reference to the fair value of the options at the grant date of the option. Note that during 2024 and 2025 no options were granted to employees.

The six elements above are all incorporated in the Black-Scholes model used to determine the fair value of options. The exercise price of the option and the share price are known at grant date. Volatility is based on the historical end-of-month closing share prices over a period prior to the option grant date being equal to the expected option life, with a minimum of three years. It is assumed no dividend payments are expected.

The total number of shares with respect to which options may be granted pursuant to the option plans accumulated, shall be determined by Pharming, but shall not exceed 10% of all issued and outstanding shares of Pharming on a diluted basis. Shares transferred or to be transferred, upon exercise of options shall be applied to reduce the maximum number of shares reserved under the plans. Unexercised options can be re-used for granting of options under the option plans.

Pharming may grant options to a member of the Executive Committee or an employee:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• At the time of a performance review;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Only in relation to an individual: a date within the first month of his or her employment;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In case of an extraordinary achievement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In case of a promotion to a new function within Pharming.

The option exercise price is the price of the Pharming shares on the stock exchange on the trading day prior to the date of grant. Vested options can be exercised at any time within five years following the date of grant. Unexercised options shall be deemed lapsed and shall cease to exist automatically after five years. Exercise of options is subject to compliance with laws and regulations in the Netherlands. Exercise of options is including withholding taxes. Each option is equal to one share unless otherwise stated. Options are not applicable for early retirement.

The following assumptions were used in the Black-Scholes model to determine the fair value of options at grant date:

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| | | | |
|:---|:---|:---|:---|
| | **2025** | **2024** | **2023** |
| Expected time to maturity | n/a | n/a | 1 - 4 years |
| Volatility | n/a | n/a | 38% - 46% |
| Risk-free interest rate | n/a | n/a | 2.20% - 2.68% |

---

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*Option plan employees*

Article 2.1 of the option plan for employees' states: Pharming may grant options to any employee. The criteria for the granting of the options up to December 11, 2020 was determined by the Board of Supervisory Directors of Pharming, at its sole discretion. Up to December 11, 2020, the Board of Management proposed (i) whether the criteria for granting an option have been met by a potential participant and (ii) the number of options to be granted. As from December 11, 2020, the execution of the Company's remuneration policy and other benefits policies and incentive programs, as approved by the Board of Directors (to the extent required), for all staff members of the Company and its subsidiaries, excluding the CEO and the other members of the Executive Committee, is delegated to the CEO.

Article 4.4 of the employee option plan deals with the vesting scheme of employee options and reads as follows: in case of the termination of the employment of a participant, except for retirement and death, Pharming at its sole discretion is entitled to decide that the options of the participant shall lapse. The following schedule shall apply for the cancellation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In the event of termination of employment within one year as of a date of grant, all options shall lapse;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In the event of termination of employment after the first year as of a date of grant, all options, less 1/4 of the number of options shall be lapsed. The number of options to be cancelled decreases for each month that the employment continued for more than one year as of that date of grant by 1/48 of the number of options granted of that date of grant.

*Models and assumption Long Term Incentive Plan*

For the long-term incentive plan, the following elements of Pharming and/or the peer group are included in order to determine the fair value of long-term incentive plan share awards, using Monte Carlo simulation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Start and end date of performance period;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The grant date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The share prices;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Exchange rates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Expected volatilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Expected correlations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Expected dividend yields;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Risk free interest rates.

Volatilities are based on the historical end-of-month closing share prices over the 3 years.

Correlations are based on 3 years of historical correlations based on end-of-month closing quotes, taking into account exchange rates. Expected dividend yields for peers and risk-free interest rates (depending on the currency) are obtained from Bloomberg.

Under the LTIP, restricted shares are granted conditionally each year with shares vesting based on the market condition in which the total shareholder return performance of the Pharming share is compared to the total shareholder return of a peer group of other European biotech companies.

During 2025, there were no LTIP grants other than the grants for the executive directors and members of the executive committee as disclosed below.

Upon a change of control, all remaining LTIP shares will vest automatically.

*Long Term Incentive Plan for the Executive Directors*

As part of the Remuneration Policy, the Long Term Incentive Program is applicable to Executive Directors and has been aligned with prevailing "best practices" and is performance related only. For the Executive Directors, the on-target value of the shares to be awarded under the newly designed LTI Program, as described in the remuneration policy, is set at 300% of the gross annual salary for the CEO (individual level of 425% was approved by EGM for the CEO, Mr. Fabrice Chouraqui) and 200% for the members of the Executive committee (representing around 50th percentile (second quartile) of the U.S. benchmark group and just in the top quartile of the EU benchmark group for the Executive Directors).

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The maximum value of the shares that can vest under the LTI program is set at 450.0% of the gross annual salary for the CEO (individual level of 637.5% was approved for the CEO, Mr. Fabrice Chouraqui, by the EGM) and 300% for other Executive Directors and Officers. Executive Directors are required to retain the shares awarded under the LTI program for a minimum of five years from the date of grant.

The shares granted to the Executive Directors under the LTI program will vest in three years after the grant date, subject to the achievement of the targets set by the Board of Directors, upon proposal of the Remuneration Committee, for the three-year performance period (i.e., double-trigger vesting), their relative weightings and the pay-out limits. All shares awarded will be subject to a retention period of five years from the date of grant (i.e., two years after vesting), in accordance with the best practice provisions of the DCGC.

The performance objectives include the Total Shareholder Return (40% weighing) and the achievement of long-term strategy oriented objectives (60% weighing). The peer group used to determine the Total Shareholder Return is composed of the companies included in the AMX Index (or AScX Index for the period until promotion to the AMX Index in September 2025) and the Nasdaq Biotechnology Index, represented by the IBB ETF, respectively, equally weighted, at the time of the determination.

The thresholds and payout percentages for the LTI program are given by the following table, as to be determined for each of the indices separately (each weighted at 50% of pay-out):

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| | |
|:---|:---|
| TSR equal to index | 80% pay-out |
| TSR 10% above index | 90% pay-out |
| TSR 20% above index | 100% pay-out |
| TSR 40% above index | 110% pay-out |
| TSR 60% above index | 120% pay-out |
| TSR 80% above index | 130% pay-out |
| TSR 100% above index | 150% pay-out |
| TSR below index | 0% pay-out |

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The range of assumptions used in the Monte Carlo simulation to determine the fair value of long-term incentive plan share awards at grant date were:

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| | | | |
|:---|:---|:---|:---|
| | **2025** | **2024** | **2023** |
| Volatilities | 43.3% | 40.5% | 42.0% |
| Risk-free interest rates | 2.04% | 2.53% | 2.34% |
| Dividend yields | —% | —% | —% |

---

*Restricted Stock Units*

This Plan is effective as of October 26, 2022, and shall be executed in compliance with the Articles of Association and applicable law and concerns Pharming's (senior) management. The RSU plans are not applicable for the board of directors, nor the executive committee. For each participant, the RSU's granted to them will vest in four equal tranches of twelve months, provided that at the time of vesting such participant is still an employee. No performance criteria are applicable to this plan. The fair value of the grant is, in line with IFRS 2, the actual share price at date of the grant. The relating expense will be charged to Pharming's results over the vesting for the following tranches:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.a first tranche of 25% of the RSU's granted, vesting twelve months after the Vesting Commencement Date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.a second tranche of 25% of the RSU's granted, vesting two years after the Vesting Commencement Date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c.a third tranche of 25% of the RSU's granted, vesting three years after the Vesting Commencement Date; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d.a fourth tranche of 25% of the RSU's granted, vesting four years after the Vesting Commencement Date.

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***Option plans***

An overview of activity in the number of options for 2025 is as follows (please also refer to Note 27. Earnings per share and fully-diluted shares in respect of movements since the reporting date)(note that the dollar weighted average exercise price is translated using the closing exchange rate for the respective year (2025: 1:1.1713)):

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | **2025** | **2025** | **2024** | **2024** | **2023** | **2023** |
| | **Number** | **Weighted Average Exercise Price ($)** | **Number** | **Weighted Average Exercise Price ($)** | **Number** | **Weighted Average Exercise Price ($)** |
| **Balance at January 1** | 24238937 | 0.932 | 34482312 | 0.952 | 47596801 | 0.897 |
| Granted |  |  |  |  | 270000 | 1.349 |
| Forfeited | (439592) | 1.010 | (634874) | 0.896 | (1423375) | 0.992 |
| Expired | (751001) | 1.358 | (3707334) | 0.840 | (205000) | 0.847 |
| Exercised | (14568436) | 1.074 | (5901167) | 0.784 | (11756114) | 0.857 |
| **Balance at December 31** | **8479908** | **0.998** | **24238937** | **0.932** | **34482312** | **0.952** |
| **- Vested** | 7573658 | 0.990 | 19816437 | 0.942 | 9284834 | 0.856 |
| **- Unvested** | 906250 | 1.065 | 4422500 | 0.889 | 25197478 | 0.987 |

---

For the options outstanding at the end of the year, the range of exercise prices and weighted average remaining contractual life is as follows (note that the range of exercise prices is translated using the closing exchange rate for the respective year (2025: 1:1.1713):

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| | | | |
|:---|:---|:---|:---|
| | **2025** | **2024** | **2023** |
| Range of exercise prices ($) | 0.83 - 1.54 | 0.73 - 1.54 | 0.78 - 1.63 |
| Weighted average remaining contractual life (years) | 1.07 | 1.41 | 1.91 |

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*Exercised options 2025*

In 2025, a total of 14,568,436 options have been exercised with an average exercise price of $1.074. In 2024, a total of 5,901,167 options have been exercised with an average exercise price of $0.784. In 2023, a total of 11,756,114 options have been exercised with an average exercise price of $0.857.

All options outstanding at December 31, 2025, are exercisable with the exception of the unvested options granted to the employees still in service. The share options for the employees vest after one year under the condition the employees are still in service at vesting date.

Exercise prices of options outstanding at December 31, 2025, and the exercise values are in the following ranges (note that the exercise value in $ is translated using the closing exchange rate for the respective year (2025: 1:1.1713)):

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | **2025** | **2025** | **2024** | **2024** | **2023** | **2023** |
| Exercise prices in $ | **Number** | **Exercise value** <br>**in $'000** | **Number** | **Exercise value** <br>**in $'000** | **Number** | **Exercise value** <br>**in $'000** |
| 0.57 – 0.85 | 350000 | 296 | 10460750 | 8555 | 6739000 | 4967 |
| 0.85 – 1.63 | 8129908 | 8168 | 13778187 | 14045 | 27743312 | 24862 |
| **Balance at December 31** | **8479908** | **8465** | **24238937** | **22600** | **34482312** | **29828** |

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*Granted options*

In 2025 and 2024, the Company granted no options to employees. In 2023, the Company granted 270,000 options to employees with a weighted average exercise price of $1.349; fair values for options granted in 2023 were in the range of $0.223 - $0.581.

***Long Term Incentive Plan***

An overview of the number of LTIP shares granted in 2022-2025 and in total as well as the fair value per share award is as follows (note that the fair value per share award in $ is translated using the closing exchange rate for the respective year (2025: 1:1.1713)):

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| **Participant category** | **2025** | **2024** | **2023** | **2022** | **Total** |
| Executive Members of the Board of Directors | 3614572 | 1824602 | 1681570 | 2363455 | 9484199 |
| Executive Committee | 6952793 | 4997299 | 4221870 | 5816083 | 21988045 |
| **Total** | **10567365** | **6821901** | **5903440** | **8179538** | **31472244** |
| Fair value per share award ($) | 0.636 | 0.896 | 0.880 | 0.517 |  |

---

The following table provides an overview of LTIP shares granted, forfeited or issued in 2022-2025 as well as the number of LTIP shares reserved at December 31, 2025:

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Participant category** | **Granted** | **Issued** | **Forfeited / Unvested** | **Reserved at December 31, 2025** |
| Executive Members of the Board of Directors | 9484199 |  | (3621658) | 5862541 |
| Executive Committee | 21988045 | (4193981) | (4019809) | 13774255 |
| **Total** | **31472244** | **(4193981)** | **(7641467)** | **19636796** |

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***Restricted stock units***

An overview of the granted RSU's to the Company's (senior) managers, as well as the number of RSU's reserved at December 31, 2025, is as follows:

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| | | | | |
|:---|:---|:---|:---|:---|
| **Grant year** | **Granted** | **Issued** | **Forfeited / Unvested** | **Reserved at December 31, 2025** |
| 2022 | 4931000 | (3202582) | (808872) | 919546 |
| 2023 | 7979250 | (3339765) | (1631263) | 3008222 |
| 2024 | 12091227 | (2810032) | (1627603) | 7653592 |
| 2025 | 8272308 |  |  | 8272308 |
| **Total** | **33273785** | **(9352379)** | **(4067738)** | **19853668** |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.BOARD OF DIRECTORS

In connection with the listing of our ADSs on Nasdaq, we converted our two-tier board structure into a one-tier board structure, with a single board of directors consisting of the executive director and non-executive directors. The new structure became effective on December 11, 2020. Since that date, the Board of Directors is jointly responsible for the management of the Company. The daily management of the Company and the execution of the strategy are entrusted to the CEO, as the only Executive Director. The CEO is supported by the non-statutory Executive Committee in the execution of his tasks and responsibilities. The Non-Executive Directors share statutory management responsibility, but shall focus on the supervision on the policy and functioning of the performance of the duties by the Executive Director and the Company's general state of affairs. The Non-

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Executive Directors would focus on the supervision on the policy and functioning of the performance of the duties by the Executive Directors and the Company's general state of affairs.

Dr. S. de Vries was the Company's sole Executive member of the Board of Directors during 2024 and continued to be the Chief Executive Officer until March 4, 2025, after which he was succeeded by Mr. F. Chouraqui.

The Board of Directors has the following members:

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| | | |
|:---|:---|:---|
| Dr. R. Peters | Chair of the Board of Directors and Non-Executive Board Member |  |
| Ms. D. Jorn | Vice Chair of the Board of Directors and Non-Executive Board Member | until June 11, 2025 |
| Dr. M. Pykett | Vice Chair of the Board of Directors and Non-Executive Board Member | as of June 11, 2025 |
| Ms. B. Yanni | Non-Executive Board Member |  |
| Ms. J. van der Meijs | Non-Executive Board Member |  |
| Mr. L. Kruimer | Non-Executive Board Member |  |
| Mr. S. Baert | Non-Executive Board Member | until June 11, 2025 |
| Dr. E. Sullivan | Non-Executive Board Member | as of June 11, 2025 |
| Dr. S. de Vries | Executive Board Member and Chief Executive Officer | until March 4, 2025 |
| Mr. F. Chouraqui | Executive Board Member and Chief Executive Officer | as of March 4, 2025 |

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***Non-Executive members Board of Directors***

*Remuneration*

For 2025 the annual compensation of the non-executive members of the Board of Directors was as follows:

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Responsibility** | **Cash in Euros**<br> **(per annum)** | **Ordinary shares in Euros \***<br>**(per annum)** | **Cash in U.S. dollars<br>(per annum)** | **Ordinary shares in U.S. dollars \*<br>(per annum)** |
| Chair of the Board of Directors | 90000 | 40000 | 101331 | 45036 |
| Non-Executive Director | 45000 | 30000 | 50666 | 33777 |
| Chair Audit Committee | 15000 |  | 16889 |  |
| Member Audit Committee | 7500 |  | 8444 |  |
| Chair Remuneration Committee | 12500 |  | 14074 |  |
| Member Remuneration Committee | 6250 |  | 7037 |  |
| Chair of the Transaction Committee | 12500 |  | 14074 |  |
| Member of the Transaction Committee | 6250 |  | 7037 |  |
| Chair Governance Committee | 12500 |  | 14074 |  |
| Member Governance Committee | 6250 |  | 7037 |  |

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*\*All shares to be valued at the 20 day VWAP preceding the Annual General Meeting of Shareholders, without further restrictions or grant.*

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An additional compensation of €1,000 ($1,126) per day in case of extraordinary activities, as determined by the Chair of the Board of Directors. Compensation of the Non-Executive members of the Board of Directors and / or of former members of the Supervisory Board of Directors for 2025, 2024 and 2023 was as follows:

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| | | | | |
|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Year** | **Cash** | **Share-Based Payment** | **Total** |
| Dr. Richard Peters | 2025 | 122 | 45 | **167** |
|  | 2024 | 111 | 43 | **154** |
|  | 2023 | 26 | 20 | **46** |
| Mr. Paul Sekhri | 2025 |  |  | **—** |
|  | 2024 |  |  | **—** |
|  | 2023 | 55 | 32 | **87** |
| Ms. Deborah Jorn | 2025 | 30 | 15 | **45** |
|  | 2024 | 64 | 32 | **96** |
|  | 2023 | 55 | 32 | **87** |
| Ms. Barbara Yanni | 2025 | 80 | 34 | **114** |
|  | 2024 | 77 | 32 | **109** |
|  | 2023 | 62 | 32 | **94** |
| Dr. Mark Pykett | 2025 | 66 | 34 | **100** |
|  | 2024 | 63 | 32 | **95** |
|  | 2023 | 55 | 32 | **87** |
| Ms. Jabine van der Meijs | 2025 | 80 | 34 | **114** |
|  | 2024 | 77 | 32 | **109** |
|  | 2023 | 62 | 32 | **94** |
| Mr. Leonard Kruimer | 2025 | 75 | 34 | **109** |
|  | 2024 | 72 | 32 | **104** |
|  | 2023 | 58 | 32 | **90** |
| Mr. Steven Baert | 2025 | 36 | 15 | **51** |
|  | 2024 | 69 | 32 | **101** |
|  | 2023 | 58 | 32 | **90** |
| Dr. Elaine Sullivan | 2025 | 50 | 23 | **73** |
|  | 2024 |  |  | **—** |
|  | 2023 |  |  | **—** |
| **Total** | **2025** | **539** | **234** | **773** |
|  | **2024** | **533** | **235** | **768** |
|  | **2023** | **431** | **244** | **675** |

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***Shares, options and warrants***

***Shares***

At December 31, 2025, the Non-Executive members of the Board of Directors held the following numbers of shares:

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| | |
|:---|:---|
| | **Ordinary shares** |
| Dr. Richard Peters | 104742 |
| Dr. Mark Pykett | 177469 |
| Ms. Barbara Yanni | 177469 |
| Mr. Leonard Kruimer | 152631 |
| Ms. Jabine van der Meijs | 152631 |
| Dr. Elaine Sullivan | 21163 |
| **Total** | **786105** |

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All shares held by the Non-Executive members of the Board of Directors are unrestricted.

***Loans or guarantees***

During 2025, the Company has not granted loans or guarantees to any member of the Non-Executive members of the Board of Directors. No loans or guarantees to Non-Executive members of the Board of Directors were outstanding at December 31, 2025.

***Executive members Board of Directors***

*Remuneration*

The Executive Board Member is entitled to the following remuneration packages:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Fixed remuneration: annual base salary;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Variable remuneration: the variable remuneration components are (a) an annual bonus in cash as a percentage of the fixed component (short-term incentive) and (b) a (share- based) long-term incentive;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Others: contribution pension premiums, travel allowance and holiday allowance.

Mr. Sijmen de Vries served as Executive Board Member and CEO until March 4, 2025. Thereafter, he continued to provide services to the Company in a consulting capacity from March 4, 2025 to December 31, 2025. The compensation disclosed below reflects his remuneration for the entire year 2025, up to and including December 31, 2025:

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Year** | **Fixed remuneration** | **Short-term variable: annual bonus** | **Share-based payments** | **Post-employment benefits** | **Other** | **Total** |
| Dr Sijmen de Vries, CEO and Executive Director | 2025 | 756 | 132 | 858 | 176 | 36 | 1959 |
| Dr Sijmen de Vries, CEO and Executive Director | 2024 | 694 | 414 | 987 | 116 | 35 | 2246 |
| Dr Sijmen de Vries, CEO and Executive Director | 2023 | 673 | 615 | 1371 | 115 | 35 | 2809 |

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Mr. Fabrice Chouraqui commenced employment on February 1, 2025, and served as Executive Board Member and CEO from March 4, 2025 through December 31, 2025. The compensation disclosed below reflects his remuneration for the full 2025 financial year, up to and including December 31, 2025:

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Year** | **Fixed remuneration** | **Short-term variable: annual bonus** | **Share-based payments** | **Post-employment benefits** | **Other** | **Total** |
| Mr Fabrice Chouraqui, CEO and Executive Director | 2025 | 688 | 760 | 1335 | 8 | 388 | 3179 |

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*Options*

The Executive Board Members did not hold options during 2025.

*Shares*

December 31, 2025, the executive members of the board held the following numbers of unvested restricted shares under the Long term Incentive Plan and Restricted Stock Units Plan:

---

| | |
|:---|:---|
| **Shares held** | **As at 31 December 2025** |
| Mr. Fabrice Chouraqui | 4,637,834 |

---

*Long term Incentive Plan*

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| | **Year** | **Granted** | **Settled** | **Forfeited / Unvested** | **December 31, 2025** |
| Mr. Fabrice Chouraqui | 2025 | 3,614,572 |  |  | 3,614,572 |

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*Restricted Stock Units*

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| | **Year** | **Granted** | **Settled** | **Forfeited / Unvested** | **December 31, 2025** |
| Mr. Fabrice Chouraqui | 2025 | 1,023,302 |  |  | 1,023,302 |

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*Loans or guarantees*

During the year 2025, no loans or guarantees have been granted to the Executive members of the Board of Directors. No loans or guarantees to the Executive member of the Board of Directors were outstanding at December 31, 2025.

The Executive member of the Board of Director is the sole statutory director.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24.RELATED PARTY TRANSACTIONS

Related parties' disclosure relates mainly to key management compensation and to transactions with the associated company of BioConnection Investments B.V. (BioConnection).

Key management includes members of the Board of Directors:

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---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** | **2023** |
| Salaries and other short-term employee benefits | 3300 | 1676 | 1756 |
| Post-employment benefits | 184 | 116 | 115 |
| Share-based compensation | 2427 | 1222 | 1615 |
| **Total** | **5911** | **3014** | **3486** |

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All direct transactions with members of the Board of Directors have been disclosed in Notes 22. Share-based compensation and 23. Board of Directors of these financial statements.

For the years ended December 31, 2025, 2024 and 2023 related party transactions with BioConnection were in the ordinary course of that company's fill and finish business and amounted to $5.4 million, $4.6 million and $4.7 million respectively. At December 31, 2025, the Company owed $1.3 million to BioConnection and was owed by BioConnection $0.0 million for fill and finish services supplied. At December 31, 2024, the Company owed $1.5 million to BioConnection and was owed by BioConnection $0.3 million for fill and finish services supplied. At December 31, 2023, the Company owed $1.7 million to BioConnection and was owed by BioConnection $0.5 million for fill and finish services supplied.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;25.COMMITMENTS AND CONTINGENCIES

***Material agreements***

At the end of 2025, the Company had several agreements with third parties related to the manufacturing of RUCONEST® and Joenja®. In these agreements certain minimum volumes are committed. Total future commitments under these agreements for the year ended December 31, 2025, and December 31, 2024, are approximately $40.1 million and $41.6 million, of which $33.4 million relates to 2026 and $6.7 million relates to 2027 and further. All expenditures relate to the cost of goods.

***License agreements***

The Group is a licensee under agreements with third parties regarding the development and marketing of its pipeline products. Under these agreements, the Group is obligated to make milestone payments whenever specified development, regulatory and commercial milestones are met, and to pay royalties to the licensors based on future sales levels. As both the timing and achievement of milestones and future sales levels are uncertain, the financial effect of these agreements cannot be estimated reliably.

*License agreement for the development and commercialization of leniolisib*

In August 2019, Pharming entered into a development collaboration and license agreement with Novartis to develop and commercialize leniolisib, a small molecule phosphoinositide 3-kinase delta (P13Kδ) inhibitor being developed by Novartis to treat patients with Activated Phosphoinositide 3-kinase Delta Syndrome (APDS). Pharming received FDA approval for the commercialization of leniolisib in the United States of America in March 2023 and received a positive CHMP opinion in March 2026 on the leniolisib regulatory filing submitted to EMA.

The license agreement includes the following milestone and royalty payments:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Phased development and regulatory milestone payments totaling in the low-double digit millions of US dollars, of which $10.4 million has been incurred up through the reporting date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Sales milestone payments totaling in the low-triple digit millions of US dollars, of which $5.0 million has been incurred up through the reporting date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Royalty payments for a term of 10 years on the net sales of licensed products at a rate in the low double-digit range, gradually increasing if net sales reach certain levels. For the years ended December 31, 2025, 2024 and 2023 the Company incurred $10.8 million, $4.9 million and $2.1 million, respectively, of royalty payments to Novartis.

*License agreement for the development and commercialization of napazimone (KL1333)*

------

Following acquisition of Abliva AB in February 2025, Pharming has now become party to a license agreement with Yungjin Pharmaceutical to develop and commercialize napazimone (KL1333), a small molecule treatment candidate for primary mitochondrial diseases.

The license agreement includes the following milestone and royalty payments:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Phased development and regulatory milestone payments totaling in the mid-double digit millions of US dollars.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Sales milestone payments totaling in the low-triple digit millions of US dollars.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Royalty payments for a term of 10 years on the net sales of licensed products at a rate gradually increasing if net sales reach certain levels, from a single-digit to a low double-digit range.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.FINANCIAL RISK MANAGEMENT

Pharming is exposed to several financial risks: market risks (being currency risk and interest rate risk), credit risks and liquidity risks. The Board of Directors and the Executive Committee are responsible for the management of currency, interest, credit and liquidity risks and as such ultimately responsible for decisions taken in this field.

*Capital risk management*

The Company manages its capital to ensure that it will be able to continue as a going concern. This includes a regular review of cash flow forecasts and, if deemed appropriate, subsequent raising of funds through execution of equity and/or debt transactions. In doing so, the Board of Directors' and Executive Committees' strategy is to achieve a capital structure which takes into account the best interests of all stakeholders. Pharming's capital structure includes cash and cash equivalents, marketable securities, debt and equity:

---

| | | |
|:---|:---|:---|
| Amounts in $'000 | **2025** | **2024** |
| Cash and cash equivalents | 145305 | 54944 |
| Restricted cash | 1988 | 1505 |
| Marketable securities | 33796 | 112949 |
| Convertible bond - current | (5336) | (4245) |
| Convertible bond - non-current | (92719) | (78154) |
| **Net cash (debt)** | **83034** | **86999** |
| Cash and cash equivalents | 145305 | 54944 |
| Restricted cash | 1988 | 1505 |
| Marketable securities | 33796 | 112949 |
| Gross debt - fixed interest rates | (98056) | (82399) |
| Gross debt - variable interest rates |  |  |
| **Net cash (debt)** | **83034** | **86999** |

---

Reconciliation of liabilities arising from financing activities:

------

---

| | | | |
|:---|:---|:---|:---|
| Amounts in $'000 | **Convertible Bond (liability)** | **Lease Liabilities** | **Total** |
| **Balance at Carrying value 1 January 2025** | 82399 | 29914 | 112313 |
| *Movements from financing cash flows:* |  |  |  |
| Interest payments | (5067) | (1130) | (6197) |
| Principal repayments |  | (4245) | (4245) |
|  | **(5067)** | **(5376)** | **(10442)** |
| *Other movements:* |  |  |  |
| New leases, remeasurements and disposals |  | (10743) | (10743) |
| Accrued interest | 9685 | 1130 | 10815 |
| Currency translation | 11038 | 2794 | 13833 |
|  | **20723** | **(6819)** | **13904** |
| **Balance at Carrying value 31 December 2025** | **98056** | **17719** | **115775** |

---

*Currency risk*

This is the risk that the fair value of assets, liabilities and especially the future cash flows of financial instruments will fluctuate because of changes in foreign exchange rates. Pharming's policy for the management of foreign currency risks is aimed at protecting the operating profit and positions held or recorded in foreign currencies, in particular of the United States Dollar (USD) for the Group. Certain payments and sales in the United States are being and will be received in USD. Some direct payments of U.S. activities are carried in USD through the Dutch entities. At December 31, 2025, the Group's cash and cash equivalents, including restricted cash, and marketable securities amounted to $181.1 million. This balance consists of cash assets denominated in euros for a total amount of $79.9 million or €68.2 million (applying an exchange rate EUR/USD at December 31, 2025, of 1.1713) and cash assets in USD for a total amount of $96.5 million. The USD cash balance will mainly be used for the commercialization activities of the U.S. organization. The remaining cash balance (equivalent to $4.7 million) is primarily denominated in British pounds, Australian dollars and Swedish krona, and is utilized by the respective local entities.

Cash and cash equivalents (including restricted cash), accounts receivables and inventories denominated in USD amounted in total to $146.4 million (€125.0 million), respectively $32.8 million (€28.0 million) for the trade and other payables denominated in USD. Pharming performed a sensitivity analysis by applying an adjustment to the spot rate at year-end. As the balance of the cash and cash equivalents (including restricted cash), accounts receivables, inventories, trade and other payables, denominated in USD, at year-end is $113.6 million, a 10% weakening of the euro versus U.S. dollar would have an impact of $11.4 million on the Group's gain (weakening of the euro). The balance sheet positions denominated in other foreign currencies are minimal, resulting in a correspondingly low currency risk.

*Interest rate risk*

Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. Pharming's interest rate risk policy is aimed at minimizing the interest rate risks associated with the financing of the Company and thus at the same time optimizing the net interest costs. This policy translates into a certain desired profile of fixed-interest and floating interest positions, including those generated by cash and cash equivalents and marketable securities and those paid on finance lease liabilities. As the interest rate on the convertible bond is a fixed percentage, Pharming concluded that the total risk on interest is not material.

The issue of the Convertible Bonds due 2029 at a fixed interest rate of 4.50% p.a. has rendered this concern obsolescent. The interest on the vast majority of the Company's financial instruments is not variable with market interest rates. More information on the Convertible Bonds due 2029 can be found in Note 18. Convertible bonds.

*Credit risk*

------

Credit risk is defined as the risk that one party to a financial instrument will cause a financial loss for the other party by failing to discharge obligations. Pharming manages credit risk exposure through the selection of financial institutions having a high credit rating, using credit rating reports issued by institutions such as Standard & Poor's and Moody's. The exposure to credit risk at December 31, 2025, is represented by the carrying amounts of cash and cash equivalents, marketable securities and trade and other receivables.

The carrying amounts of the cash and cash equivalents (including restricted cash) as at December 31, 2025, amounted to $147.3 million and was held through financial institutions with a A- to A rating or better from Standard & Poor's, A3 to Aa3 ratings from Moody's and A to AA- ratings from Fitch.

Marketable securities at December 31, 2025, amounted to $33.8 million (2024: $112.9 million). As of December 31, 2025, the Company held no government treasury certificates (2024: $50.5 million). Since 2024, the Company has also invested in SEC Rule 2a-7 compliant institutional money market funds, which offer enhanced financial flexibility. As of December 31, 2025, these investments amounted to $33.8 million. Complying with SEC Rule 2a-7, these funds ensure liquidity and stability through requirements on liquidity, maturity limits, credit quality and diversification.

Trade and other receivables at December 31, 2025, amounted to $54.7 million. As at the date of these financial statements, these amounts have largely been settled, including receipts in cash and receipt of goods and services in exchange of prepaid expense items. Based on the credit ratings of cash and cash equivalents (including restricted cash) as well as the positions taken with respect to marketable securities and trade and other receivables, the Company considers that this risk is adequately managed.

*Liquidity risk*

The liquidity risk refers to the risk that an entity will encounter difficulty in meeting obligations associated with financial liabilities. Pharming's objective is to maintain a minimum level and certain ratio of cash and cash equivalents (including short-term deposits and SEC Rule 2a-7 compliant institutional money market funds). The strategy of the Company is to repay its obligations through generation of cash income from operating activities such as product sales. In case such cash flows are insufficient, the Company relies on financing cash flows as provided through the issuance of shares or incurring financial liabilities. Note 2 of these financial statements more extensively describes the Company's going concern assessment.

The following table provides the maturity profile of financial liabilities, the amounts presented are the gross undiscounted contractual cash flows due:

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Within one year** | **In 2-4 years** | **Beyond 4 years** | **Total** | **Prior year total** |
| Trade and other payables | 105899 |  |  | 105899 | 66611 |
| Lease Liabilities | 3860 | 9086 | 6142 | 19088 | 35319 |
| Convertible Bonds | 5271 | 130307 |  | 135578 | 129118 |
| **Total** | **115030** | **139393** | **6142** | **260565** | **231048** |

---

*Fair value estimation*

The Company uses the following hierarchy for determining the fair value of financial instruments measured at fair value:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Level 2: Inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Level 3: Inputs for the asset or liability that are not based on observable market data or which are based on the probability of future events occurring (that is, unobservable inputs).

The following table presents the assets that are measured at fair value at year-end 2025 and 2024:

------

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | **2025** | **2025** | **2025** | **2024** | **2024** | **2024** |
| Amounts in $'000 | **Level 1** | **Level 3** | **Total** | **Level 1** | **Level 3** | **Total** |
| Marketable securities (money market funds) | 33796 |  | 33796 | 62424 |  | 62424 |
| Investments in debt instruments designated as at FVTPL |  | 6703 | 6703 |  | 3767 | 3767 |
| **Balance at December 31** | **33796** | **6703** | **40499** | **—** | **3767** | **66191** |

---

The following table includes carrying values and the estimated fair values of financial instruments:

---

| | | | | |
|:---|:---|:---|:---|:---|
| | **2025** | **2025** | **2024** | **2024** |
| Amounts in $'000 | **Carrying value** | **Fair value** | **Carrying value** | **Fair value** |
| **Assets:** |  |  |  |  |
| Cash and cash equivalents, including restricted cash | 147293 | 147293 | 56449 | 56449 |
| Trade and other receivables | 54704 | 54704 | 54823 | 54823 |
| **Liabilities:** |  |  |  |  |
| Convertible Bond (incl. equity component) | 111890 | 157481 | 94624 | 107899 |
| Lease Liabilities | 17719 | 17719 | 29914 | 29914 |
| Trade and other payables | 105899 | 105899 | 66611 | 66611 |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.EARNINGS PER SHARE AND FULLY-DILUTED SHARES

Basic earnings per share is calculated based on the weighted average number of ordinary shares outstanding during the year. Diluted earnings per share is normally computed based on the weighted average number of ordinary shares outstanding including the dilutive effect of shares to be issued in the future under certain arrangements such as option plans. However, as the net result represents a loss in 2025, the diluted earnings per share are equal to the basic earnings per share for 2025. For the years ended December 31, 2025, 2024 and 2023, the basic and diluted profit per share are:

---

| | | | |
|:---|:---|:---|:---|
| | **2025** | **2024** | **2023** |
| Net profit (loss) attributable to equity owners of the parent (in $'000) | 2851 | (11841) | (10548) |
| Weighted average shares outstanding | 688773370 | 671347279 | 657020521 |
| Basic profit (loss) per share (in $) | 0.004 | (0.018) | (0.016) |
| Weighted average diluted shares outstanding | 746866045 | 785412134 | 725463948 |
| Diluted profit (loss) per share (in $) | 0.004 | (0.018) | (0.016) |

---

The diluted net profit used in the calculation of dilutive profit per share amounts to $2.9 million. Difference between the weighted average shares outstanding and the weighted average diluted shares outstanding used for basic profits calculations per share relates to restricted stock units (RSU), options and LTIP. The 81,492,951 average shares related to the convertible bonds are anti-dilutive and are therefore excluded from the weighted average number of ordinary shares for the purpose of diluted earnings per share.

*Diluted shares*

The composition of the number of shares and share rights outstanding as well as authorized share capital as per December 31, 2025, and the date of these financial statements is provided in the following table.

------

Movements of shares and other instruments between December 31, 2025, and April 1, 2026, are shown in the table below:

---

| | | | | |
|:---|:---|:---|:---|:---|
| | **December 31, 2025** | **Shares issued** | **Other** | **April 1, 2026** |
| Shares | 701680440 | 4571860 |  | 706252300 |
| RSU | 19853668 | (298494) | (1339365) | 18215809 |
| Convertible bonds | 81492951 |  |  | 81492951 |
| Options | 8479908 | (1968750) | (30000) | 6481158 |
| LTIP | 19636796 | (2304616) | 2960584 | 20292764 |
| **Issued** | **831143763** | **—** | **1591219** | **832734982** |
| Available for issue | 224856237 |  | (1591219) | 223265018 |
| **Authorized share capital** | **1056000000** | **—** | **—** | **1056000000** |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;28.SHAREHOLDERS' EQUITY

The Company's authorized share capital amounts to $12.4 million (€10.6 million), exchange rate (EUR:$) equals 1:1.1713) and is divided into 1,056,000,000 ordinary shares with a nominal value of €0.01 each. The movement in number of ordinary shares outstanding during the year is summarized as follows:

---

| | | |
|:---|:---|:---|
| Number of shares outstanding | **2025** | **2024** |
| **Balance at January 1** | 680308735 | 671073243 |
| Options exercised / LTIP shares issued | 21371705 | 9235492 |
| **Balance at December 31** | **701680440** | **680308735** |

---

All shares outstanding have been fully paid-up.

***Acquisition of remaining interest in Abliva***

In the period from February 14, 2025, to June 18, 2025, Pharming acquired the remaining 11.1% interest in the voting shares of Abliva, thereby increasing its ownership to 100%. A cash consideration of $7.9 million was paid to the non-controlling shareholders. The carrying amount of the acquired non-controlling interest was $7.8 million before the disposal. The difference of $0.2 million, has been recognized directly in accumulated deficit in equity. Following the acquisition of the remaining interest in Abliva, the total consideration in cash amounts to $68.0 million in 2025 based on the price of SEK 0.45 paid per share.

***Non controlling interest***

NCI movements during the year relate solely to the full acquisition of the remaining Abliva shares, reducing the NCI balance to zero.

---

| | |
|:---|:---|
| Amounts in $'000 | **2025** |
| **Balance at January 1** | **—** |
| Acquisition of subsidiary | 7285 |
| Share of loss attributable to NCI | (313) |
| Equity contributions by parent attributed to NCI | 706 |
| Currency translation differences (OCI) attributable to NCI | 83 |
| Acquisition of NCI | (7761) |
| **Balance at December 31** | **—** |

---

***Other reserves***

------

Other reserves include those reserves related to currency translation, fair value revaluation, participating interest and capitalized development costs and the conversion option of the convertible bond for which the movements are shown below:

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| Amounts in $'000 | **Legal Reserve Currency translation reserve (CTA)** | **Legal Reserve Capitalized development cost** | **Legal Reserve participating interest** | **Legal Reserve Fair value revaluation** | **Reserve Convertible bond** | **Total** |
| **Balance at January 1, 2024** | **(342)** | **106** | **—** | **(1821)** | **—** | **(2057)** |
| Reserves | (187) |  |  | 1742 |  | 1555 |
| Other comprehensive income (loss) for the year | (11980) |  |  | 79 |  | (11901) |
| Other reserves | (1) | (30) |  |  |  | (31) |
| Value conversion rights of convertible bonds |  |  |  |  | 12225 | 12225 |
| **Balance at December 31, 2024** | **(12510)** | **76** | **—** | **—** | **12225** | **(209)** |
| Reserves |  |  |  |  |  |  |
| Other comprehensive income (loss) for the year | 27367 |  |  |  | 1610 | 28977 |
| Reclassification of accumulated OCI upon acquisition of NCI | 83 |  |  |  |  | 83 |
| Other reserves |  | (32) |  |  |  | (32) |
| **Balance at December 31, 2025** | **14941** | **44** | **—** | **—** | **13835** | **28819** |

---

Please refer to the consolidated statement of changes in equity and Note 27. Earnings per share and fully-diluted shares.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;29.EVENTS AFTER THE REPORTING YEAR

On January 15, 2026, the Certificate of Dissolution of Abliva Inc., a wholly owned subsidiary of the Group, was filed with the Secretary of State of the State of Delaware. The filing confirms that Abliva Inc. was duly dissolved in accordance with Section 275 of the Delaware General Corporation Law. The subsidiary was non-operational, and its dissolution has no material impact on the Company's financial position, results of operations, cash flows, or internal organization.

The Board of Directors did not identify any other events after the reporting period affecting the 2025 financial statements.

## Exhibit 4.6

**Certain information in this document, marked by [\*\*\*], has been excluded because it is both not material and is the type that the registrant treats as private or confidential.**

**LICENSE & COLLABORATION AGREEMENT**

by and between

YungJin Pharm Co., Ltd

And

NEUROVIVE Pharmaceutical AB (PUBL)

DATE: April 28th, 2017

------

**TABLE OF CONTENTS**

---

| | |
|:---|:---|
| [1.&nbsp;&nbsp;&nbsp;&nbsp;Definitions and Construction](#if64977b8082a42a69665f405341761ea) | [ii](#if64977b8082a42a69665f405341761ea) |
| [2.&nbsp;&nbsp;&nbsp;&nbsp;Development and Regulatory Activities](#i1aeded4c0f3d42d296cac8a3e8e4a388) | [vii](#i1aeded4c0f3d42d296cac8a3e8e4a388) |
| [3.&nbsp;&nbsp;&nbsp;&nbsp;Granted Licenses and Joint Technology](#if6cd3a0de9b54f95b0dcd6e174809928) | [xi](#if6cd3a0de9b54f95b0dcd6e174809928) |
| [4.&nbsp;&nbsp;&nbsp;&nbsp;Upfront Payments, Milestone Payments, Sales Related Payments and Royalties](#i2b8bc37788dc45cea7692dfd13436127) | [xi](#i2b8bc37788dc45cea7692dfd13436127) |
| [5.&nbsp;&nbsp;&nbsp;&nbsp;Payment, Reports, Record Retention and Audit](#i249283e6704245d7894fa82907ff0e41) | [xiii](#i249283e6704245d7894fa82907ff0e41) |
| [6.&nbsp;&nbsp;&nbsp;&nbsp;Intellectual Property Rights](#ia82daad5875d4d5d8d143b3ffd940edb) | [xiv](#ia82daad5875d4d5d8d143b3ffd940edb) |
| [7.&nbsp;&nbsp;&nbsp;&nbsp;Representations and Warranties](#i615f0687123c42b3b7b2f5db425d819a) | [xvi](#i615f0687123c42b3b7b2f5db425d819a) |
| [8.&nbsp;&nbsp;&nbsp;&nbsp;Confidentiality and Non-Disclosure](#i8b10fdb51c32439a9a5d6346d6f52dc8) | [xviii](#i8b10fdb51c32439a9a5d6346d6f52dc8) |
| [9.&nbsp;&nbsp;&nbsp;&nbsp;Term and Termination](#i98e953cfb7144fa88509e83db4e9823e) | [xix](#i98e953cfb7144fa88509e83db4e9823e) |
| [10.&nbsp;&nbsp;&nbsp;&nbsp;Consequences of Termination.](#icb261965fe7a4408a65c2f7a6b30386b) | [xix](#icb261965fe7a4408a65c2f7a6b30386b) |
| [11.&nbsp;&nbsp;&nbsp;&nbsp;Indemnification](#i1f03ea1737764f40b1f5866ca354ae78) | [xxi](#i1f03ea1737764f40b1f5866ca354ae78) |
| [12.&nbsp;&nbsp;&nbsp;&nbsp;Limitation of Liability](#ia5c1e6e996ca433ab0eb0212b7c313d7) | [xxi](#ia5c1e6e996ca433ab0eb0212b7c313d7) |
| [13.&nbsp;&nbsp;&nbsp;&nbsp;Miscellaneous](#i4553991b43914c52bab21d111fb160ed) | [xxi](#i4553991b43914c52bab21d111fb160ed) |

---

i

------

**LICENSE & COLLABORATION AGREEMENT**

This License & Research Collaboration Agreement (the "**Agreement**") is made effective as of April 28th, 2017 (the "Effective Date") by and between

(1)**YungJin Pharm Co., Ltd** ("**YUNGJIN**"), a company incorporated in Korea with an address at 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea; and

(2)**NeuroVive Pharmaceutical AB** (**publ**) ("**NVP**"), a company incorporated in Sweden with offices at Medicon Village, Scheelevägen 2, SE-223 81 Lund, Sweden.

**<u>Recitals</u>**

(A)WHEREAS, YUNGJIN has expertise in mitochondrial drug discovery and has identified the Licensed Compound (as defined below);

(B)WHEREAS, NVP is a specialty pharmaceutical company focused on mitochondrial medicines;

(C)WHEREAS, YUNGJIN and NVP have identified that they have complementary drug research and development expertise regarding the Licensed Compound;

(D)WHEREAS, YUNGJIN is willing to grant NVP an exclusive license in the Territory (as de-fined below) to the Licensed Compound within the Field (as defined below) ; and

(E)WHEREAS, NVP is willing to accept the license mentioned under (D) above on the terms and conditions set forth in this Agreement.

**<u>Agreement</u>**

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

**1. Definitions and Construction**

1.1Unless otherwise specifically provided in this Agreement, the following terms shall have the following meanings:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.1"**Advisory Committee**" is defined in Section 2.2.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.2"**Advisory Committee Term**" is defined in Section 2.2.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.3"**Assets**" is defined in Section 7.2(a).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.4"**Affiliates**" means, with respect to a Person, any other Person that controls, is controlled by or is under common control with such first Person. For purposes of this definition only, "control" means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) to own, directly or indirectly, more than fifty percent (50%) of the outstanding voting securities or other ownership interest of such Person.

- ii

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.5"**CMC**" is defined in Section 2.4.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.6"**Commercialization**" or "**Commercialize**" means engaging in any and all activities directed to distribution, sale and marketing of the Licensed Product in the Territory other than Development or manufacturing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.7"**Commercially Reasonable Efforts**" means those efforts that are consistent with the efforts and resources normally used by a biotechnology company of similar size to NVP in the research and development of a potential product or the commercialization of a product, in each case owned by it or to which it has exclusive rights, with similar product characteristics as a Licensed Product and of similar market potential at a similar stage in its development or product life as a Licensed Product, taking into account all relevant factors, including patent coverage, safety and efficacy, product profile, competitiveness of the marketplace, proprietary position and profitability (including pricing and reimbursement).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.8"**Confidential Information**" means (a) any information regarding the contents of this Agreement, (b) any information or data relating to the Licensed Compound and Licensed Product, as well as (c) any information that otherwise relates to a Party's or its Affiliates' trade secrets, products, promotional material, research and development activities, proprietary rights or business affairs, to the extent such foregoing information is provided by a Party to the other Party or otherwise developed or generated in connection with the discussions and negotiations pertaining to, or in the course of performing, this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.9"**Cover**" means, with respect to a product and a claim of a patent in any country, that such claim would be infringed, absent a license, by the manufacture, use, offer for sale, sale or importation of such product in such country; and "Covering" has the corresponding meaning.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.10"**CTA**" is defined in Section 2.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.11"**CTD**" is defined in Section 2.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.12"**Disclosing Party**" is defined in Section 8.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.13"**Development**" or "**Develop**" means all activities relating to obtaining and maintaining Regulatory Approval for the Licensed Product in the Field in the Territory, including the conduct of clinical trials for approval of the Licensed Product for such Field in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.14"**Development Plan**" means a high-level plan specifying, discovery, non-clinical and clinical development and, as applicable, Commercialization activities for the Licensed Compound and the Licensed Product (including a description of the anticipated timing to start, perform and complete such activities, annual projected development budgets developed with respect to Licensed Compound that have reached the stage in which GLP Toxicology Studies are performed (or are more advanced), and anticipated phases and milestones associated with such activities) to be undertaken with respect to Development, Manufacturing, and Commercialization of Licensed Product in the Territory as updated from time to time in accordance with Section 2.4.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.15"**Effective Date**" is defined in the preamble to this Agreement.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.16"**FDA**" shall mean the United States Food and Drug Administration or any successor agency with comparable responsibilities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.17"**Field**" means all rare indications (with prevalence less than 7 in 10,000) where mitochondrial dysfunction has been implicated in the pathogenesis such as, but not limited to: Mitochondrial Respiratory Chain Diseases (MRCD), Amyotrophic Lateral Sclerosis (ALS), Huntington's disease, Friedreich's Ataxia and Progeria.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.18"**Force Majeure**" means an event which is beyond a non-performing Party's reasonable control, including war, riot, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, natural disaster, labor disputes or compliance with any law or governmental order, rule, regulation or direction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.19"**IB**" shall mean the Investigator's Brochure (IB) and is a compilation of the clinical and non-clinical data on the investigational product that are relevant to the study of the product in human subjects. An overall risk-benefit assessment, reference safety information, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of a proposed clinical study is a part of the IB.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.20"**IMPD**" shall mean Investigational Medicinal Product Dossier and is the summary of information related to the quality, manufacture and control of the Investigational Medicinal Product, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of a proposed clinical study is a part of the IMPD.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.21"**IND**" shall mean an application to the Regulatory Authorities in a country which is equivalent to an Investigational New Drug Application defined in the United States Food, Drug, and Cosmetic Act and applicable regulations promulgated thereunder by FDA, the filing of which is necessary to commence clinical testing of a pharmaceutical product in humans.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.22"**IRB**" is defined in Section 2.4.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.23"**Joint Patent**" is defined in Section 3.5.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.24"**Joint Technology**" is defined in Section 3.5.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.25"**Licensed Compound**" means KL1333 within the Field.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.26"**Licensed Patents**" means (i) those patents and patent applications specified in Schedule 1 and all patents and patent applications Covering Licensed Compound or Licensed Product as well as (ii) all patent applications filed either from such patents or patent applications or from an application claiming priority from any of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (iii) any and all patents that have issued or in the future issue from the foregoing patent applications ((i) and (ii)), including utility models and design patents and certificates of invention, (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((i), (ii) and (iii)), and (v) any similar rights, including so-called pipeline protection, or any importation,

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revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent applications and patents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.27"**Licensed Product**" means products containing only Licensed Compound as its sole active ingredient.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.28"**Licensed Rights**" means the Licensed Patents and the Licensed Know-How.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.29"**Licensed Know-How**" means YUNGJIN's Confidential Information developed prior to or after the Effective Date and exemplified in Schedule 2 such as trade secrets, inventions, data, assays, formulae, processes, results of experimental work and tests, Records and know-how relating to the Licensed Compound and/or Licensed Product necessary or useful for the development, manufacture, use and/or Commercialization of the Licensed Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.30"**MAA**" is defined in Section 2.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.31"**Manufacturing**" means activities involved in manufacturing product for clinical trials and commercial production of Licensed Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.32"**NDA**" shall mean application to the Regulatory Authorities in a country which is equivalent to a new drug application, including all documents, data, and other information concerning Licensed Product necessary therefor, required for Regulatory Approval of a pharmaceutical product by the FDA in the U.S.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.33"**Net Sales**" means, with respect to a Licensed Product, the total amount billed by NVP, its Affiliates and their sub-licensees to third parties after deduction of normal and customary trade, cash, early payment and quantity discounts, price reductions, taxes, custom duties, amounts repaid or credited due to rejections, defects, return goods allowance, recalls or returns, freight, transportation charges, bad debts written off and other similar and customary deductions that are consistent with International Financial Reporting Standards.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.34"**ODD**" is defined in Section 2.4.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.35"**Parties**" means YUNGJIN and NVP and "Party" means either of YUNGJIN or NVP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.36"**Person**" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.37"**Phase I Clinical Trial**" means a human clinical trial of a Licensed Product, the principal purpose of which is to evaluate safety in healthy individuals or patients, to determine pharmacokinetic parameters and other key pharmaceutical properties of the Licensed Product (including absorption, metabolism, and elimination), or to determine the appropriate range of doses to evaluate in further clinical trials, in each case as described in 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding regulations of the relevant jurisdictions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.38"**Phase II Clinical Trial**" means a human clinical trial of a Licensed Product, the principal purpose of which is to evaluate the effectiveness and safety of such Licensed Product in the target patient population, as described in 21 C.F.R. §

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312.21(b), as amended from time to time, or the corresponding regulations of the relevant jurisdictions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.39"**Priority Countries**" means EP countries as listed in Section 6.1.3, U.S., Canada, Mexico, Australia, China, India, Brazil, Turkey, Saudi Arabia, Russia, Taiwan, Singapore, Israel and the Retained Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.40"**Receiving Party**" is defined in Section 8.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.41"**Records**" means all laboratory notebooks and all other records, documents and files (whether in paper, electronic or other form) which contain information or data relating to the Licensed Compound or Licensed Product and which have been generated on, prior to or after the Effective Date, including technical, scientific and other know-how as well as information relating to the prosecution or maintenance of the Licensed Patents, any and all agreements with and assignments from the inventors of the inventions Covered or claimed by the Licensed Patents and any and all agreements with and assignments from any former owners other than the inventors of the Licensed Patents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.42"**Regulatory Approval**" means all approvals necessary for the manufacture, marketing, importation and sale of a Licensed Product for one or more indications within the Field in a country or regulatory jurisdiction, including satisfaction of all applicable regulatory and notification requirements and receipt of all required pricing approvals.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.43"**Regulatory Authority**" means any governmental authority that has responsibility in its applicable jurisdiction over the testing, development, manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of pharmaceutical products in a given jurisdiction, including the FDA, EMA, National Competent Authorities in EU, and MHLW.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.44"**Regulatory Filing**" means all applications, filings, submissions, approvals, licenses, registrations, permits, notifications and authorizations (or waivers) with respect to the testing, development, manufacture or commercialization of the Licensed Compound or Licensed Product made to or received from any Regulatory Authority in a given country, including any INDs and MAAs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.45"**Retained Territory**" means Korea and Japan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.46"**Royalty Term**" is defined in Section 4.4.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.47"**Successful outcome of Phase I Clinical Trials in the EU or US**" means outcome data of the Phase I Clinical Trial enabling the start of a Phase II Clinical Trial in the US or EU.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.48"**Successful outcome of a Phase II program in the EU or US**" means outcome data of a Phase II Clinical Trial enabling a US or EU phase III Clinical Trial first patient in.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.49"**Term**" is defined in Section 9.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.50"**Territory**" means the world except the Retained Territory.

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1.2**Construction**. Except where the context requires otherwise, whenever used, the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word "or" has the inclusive meaning represented by the phrase "and/or." Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The term "including" or "includes" as used in this Agreement means including "without limiting" the generality of any description preceding such term.

**2.<u>Development and Regulatory Activities</u>**

2.1**Development of Licensed Compound and Licensed Product**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.1As between the Parties, NVP shall have sole control, authority and discretion, at its sole expense, over the research and Development of the Licensed Compound and Licensed Product in the Field in the Territory, including all regulatory activities related thereto, as further described in this Article 2. YUNGJIN shall be solely responsible for, at its sole expense, development of the Licensed Compound and Licensed Product in the Field in the Retained Territory. For the purpose of YUNGJIN's development in the Retained Territory, YUNGJIN is allowed to cross-reference and use CMC, documentation and regulatory filings controlled by NVP for the Licensed Product in the Territory without any financial consideration. Likewise, NVP is allowed to cross-reference CMC, documentation and regulatory filings controlled by YUNGJIN for the Licensed Compound and Licensed Product in the Retained Territory without any financial consideration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.2NVP shall, upon reasonable request from YUNGJIN and at YUNGJIN's expense, provide such information as is available to NVP and as may be reasonably necessary or appropriate to support YUNGJIN's efforts to satisfy regulatory requirements specific to the Retained Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.3YUNGJIN shall by June 30, 2017 include the first subject in and conduct its planned Clinical Phase I first in man study with Licensed Compound within the Field in Korea in accordance with the clinical protocol approved by the Korean Regulatory Authority.

2.2**Advisory Committee**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.1**Establishment**. The Parties hereby establish an advisory committee (the "**Advisory Committee**"), to discuss the Development Plan, including amendments thereto, and strategies for research and Development of the Licensed Compound and Licensed Product during the Term of this Agreement until the first Regulatory Approval for a Licensed Product in the Territory (hereinafter, "**Advisory Committee Term**"), at which point the Advisory Committee will disband. The Advisory Committee will be composed of one (I) senior personnel of each Party, each of whom shall have experience in pharmaceutical discovery and development. Within thirty (30) days after the Effective Date, each Party will designate its initial member to serve on the Advisory Committee and notify the other Party of the dates of availability for the first meeting of the Advisory Committee. Each Party may replace its representative on the Advisory Committee with written notice to the other Party.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.2**Authority**. For the duration of Advisory Committee Term, the Advisory Committee will oversee the Parties' activities in furtherance of the Development Plan according to this Agreement as follows:

The Advisory Committee will review and may suggest revisions of the Development Plan, review relevant data, consider and advise on any technical issues that arise, review project milestones, advise on clinical and pre-clinical development, regulatory and manufacturing matters and strategies, and review and advise on financial matters relating to the Licensed Product in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.3**Meetings**. The Advisory Committee shall meet semi-annually. The first meeting of the Advisory Committee shall be held as soon as reasonably practicable, but in no event later than sixty (60) days, following the Effective Date. Meetings shall be held at such place or places as are mutually agreed or by teleconference or videoconference. Each Party may from time to time invite a reasonable number of participants who are under obligations of confidentiality consistent with this Agreement, in addition to its representative, to attend Advisory Committee meetings in a non-voting capacity. At each meeting of the Advisory Committee, NVP will update YUNGJIN on, and the Parties will review and discuss, the Development Plan and the status of NVP's Development activities with respect to Licensed Compound and Licensed Product in the Territory, and NVP will provide YUNGJIN with semi-annual updates summarizing its plans for and progress with respect to Development of Licensed Product in the Territory. Likewise, YUNGJIN will update NVP on its plan and the status of clinical development of the Licensed Compound and Licensed Product in the Retained Territory. Each Party shall solely bear all costs it incurs in connection with its participation at any meetings under this Section 2.2.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.4The Advisory Committee shall be co-chaired by the representative of NVP and the representative of YUNGJIN.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Decisions of the Advisory Committee shall be made by unanimous vote, with each Party's representative on the Advisory Committee having one (1) vote.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)In the event that the Advisory Committee cannot or does not, after good faith efforts, reach agreement on an issue, such issue shall be referred to Chief Executive Officer of NVP and Chief Executive Officer of YUNGJIN. Such officers of the Parties shall meet promptly thereafter and shall negotiate in good faith to resolve such issue. Both Parties shall make a commercially reasonable effort to resolve such issue within sixty (60) days of commencing such negotiation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)In case no resolution is achieved in the process contemplated under Section 2.2.4 (b) the position of the Chief Executive Officer of NVP will prevail.

2.3YUNGJIN will, when requested by NVP, assist NVP in preparation and collection of data to facilitate FDA IND, EMA Clinical Trial Applications ("**CTA**"), and other FDA and EMA regulatory interactions, and with Common Technical Document ("**CTD**") module assembly for NDA and EMA marketing authorization applications ("**MAA**"), at NVP's

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expense. At NVP's request and expense, YUNGJIN will also participate with qualified staff at regulatory agency interactions. YUNGJIN will immediately after the signing of this Agreement provide to NVP copies of all necessary documentation and underlying reports necessary for FDA IND and EMA CTA applications and other regulatory interactions, such as but not limited to: the IMPD, IB, IND, phase I clinical protocol approved by the Korean Regulatory Authority, CMC reports, pharmacology reports, pharmacokinetic reports and toxicology reports. The necessary documents and reports are listed in Schedule 3 and the not yet received reports that are expected to be provided according to this Section 2.3 are marked as pending.

2.4**NVP Development Plan**. Within one hundred eighty (180) days following the Effective Date, NVP shall prepare and provide to the Advisory Committee a draft Development Plan for development of Licensed Product in the Field in the Territory for the subsequent twelve (12)-month period, and shall consider in good faith all reasonable comments provided by YUNGJIN and the Advisory Committee before preparing a final version of such plan for review by the Advisory Committee. The Development Plan may be supplemented, modified and updated by NVP from time to time, and NVP shall provide each such updated Development Plan (including the above final version of such plan incorporating comments provided by the Advisory Committee) to the Advisory Committee for review.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.1NVP will provide necessary scientific, clinical, Chemistry, Manufacturing and Control ("**CMC**") expertise, resources, as well as finance for these development activities for the Licensed Compound in the Territory. NVP will validate the mitochondrial physiological effects of the Licensed Compound and study the in vivo effects of the Licensed Compound. NVP will provide medicinal chemistry, as well as formulation and other CMC aspects input as appropriate for the Licensed Compound in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.2NVP will prepare and complement pre-clinical documentation, prepare clinical program, and develop a regulatory strategy for the Licensed Compound for the treatment of mitochondrial disorders within the Field in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.3NVP will seek clinical trial approvals with Ethics Committees / investigational review boards ("**IRB**"), the National Competent Authorities within EU, FDA and other Regulatory Authorities in other regions where NVP believes there are commercial opportunities. The regulatory interactions may include seeking scientific advice and applications for Orphan Drug Designation ("ODD") in the EU and the US for the treatment of mitochondrial disorders within the Field.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.4Subject to CTA and IND approvals in EU and US respectively, NVP will run the clinical development program for EU and US. For other regions of the world in the Territory the clinical development program will be subject to NVP's view from clinical development and commercial opportunity and considerations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.5NVP will be responsible for pharmaceutical development and CMC for the Licensed Compound including documenting and producing drug product for clinical development, as well as commercial production, in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.6**Conduct of Development Activities; Diligence**. NVP shall conduct all Development of the Licensed Compound and Licensed Product in the Field in the Territory in accordance with the then-current Development Plan and in compliance with all applicable laws. NVP shall use Commercially Reasonable Efforts to Develop the Licensed Product in the Territory, alone or with or through

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one (1) or more Affiliates or sub-licensees; provided, however, if NVP fails to conduct any meaningful development activities for the Licensed Compound and Licensed Product over a period of twelve (12) continuous months, then such failure shall be deemed to be a failure to meet the diligence obligations set forth in this Section 2.4.6 and a material breach of a material provision of this Agreement, and YUNGJIN shall have the right to terminate this Agreement in accordance with Article 9. Meaningful development activities include, without limitation, (a) planning, preparing for the conduct of (including drafting protocols and negotiating with clinical research organization and clinical trial sites) and writing study reports for clinical trials and (b) conducting regulatory affairs, including planning for and attending regulatory meetings, preparing Regulatory Filings and addressing issues raised by Regulatory Authorities; provided, however, if NVP has failed to submit to or discuss with a Regulatory Authority a Regulatory Filing that includes NVP's proposed protocol for the then subsequent clinical trial within twelve (12) months after the last patient out of each Phase I Clinical Trial and Phase II Clinical Trial conducted by NVP, then NVP shall be deemed to be in a material breach of its diligence obligations hereunder, and YUNGJIN shall have the right to terminate this Agreement in accordance with Article 9; provided that such twelve (12)-month period will be extended by the amount of any delay resulting from (i) clinical or regulatory delays that are outside of NVP's reasonable control, including requests or requirements of a Regulatory Authority beyond what would be reasonably anticipated, or (ii) delays in manufacturing needed quantities of Licensed Compound or Licensed Product that are outside of NVP's reasonable control.

2.5Each of YUNGJIN and NVP will fund their own activities under this Agreement.

2.6**Collaboration and Information Exchange**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6.1YUNGJIN and NVP expressly state their intentions to create an open and constructive collaboration. In addition to the Advisory Committee meetings, the Parties shall meet in person and through virtual means on a regular basis with the objective of driving the collaboration to a fruitful and successful venture. The Parties will exchange information, share Records and make written progress reports as necessary or useful related to pre-clinical, clinical, CMC and all other dossier-related materials, data and information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6.2Upon the Effective Date and on an ongoing basis thereafter, YUNGJIN and NVP shall each make available to the other Party and its Affiliates as soon as practicable the relevant information relating to the Licensed Compound or Licensed Product which is in their or their Affiliates' possession as of the Effective Date or which comes into their or their Affiliates' possession through the performance of its obligations hereunder, in order to develop and commercialize the Licensed Product in their respective territories.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6.3NVP shall promptly notify YUNGJIN in writing of material changes of regulatory status, including but not limited to, filing NDA and Regulatory Approval, with respect to the Licensed Product in the Territory.

2.7No later than the date on which marketing approval is given in any country in the world, YUNGJIN and NVP will enter into a safety agreement dealing with responsibilities for a world-wide safety database and other matters required to meet the safety and adverse event reporting requirements. Prior to such agreement, clinical safety will be handled in the Territory by NVP and in the Retained Territory by YUNGJIN, and the Parties will

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exchange safety information promptly in order for each Party to comply with safety reportin re• uiremen

2.8**Non-Compete**. [\*\*\*]

**3.<u>Granted Licenses and Joint Technology</u>**

3.1YUNGJIN hereby grants to NVP an exclusive royalty-bearing license under the Licensed Rights with the right to sub-license to Develop, use, manufacture and Commercialize Licensed Product within the Field in the Territory, which license includes the rights to (a) incorporate the Licensed Rights in Regulatory Filings with Regulatory Authorities in the Territory or in Commercialization materials for the Licensed Product and (b) cross-reference and use CMC, documentation and regulatory filings controlled by YUNGJIN for the Licensed Product in the Retained Territory. NVP shall not Commercialize the Licensed Product to any customers located in the Retained Territory, nor shall NVP Commercialize the Licensed Product to any customer who purchases from NVP for purposes of use or sale in the Retained Territory. NVP will select trademarks at its discretion and own any and all trademarks used in exploiting this license. YUNGJIN shall not commercialize the Licensed Product in the Territory, nor shall YUNGJIN provide or commercialize the Licensed Product to any customer who purchases from YUNGJIN for the purposes of use or sale in the Territory.

3.2YUNGJIN specifically agrees and accepts that the Licensed Compound and Licensed Product may not be developed, used, distributed or sold for indications outside the Field anywhere in the world without NVP's prior written approval.

3.4**Sublicenses**. NVP may grant sublicenses to its Affiliates or third parties under the license granted in Section 3.1. The sublicense granted by NVP subject to the rights granted in Article 3 shall be consistent with the terms and conditions of this Agreement. At YUNGJIN's request, NVP will promptly provide YUNGJIN with the name and address of any of its sub-licensees. Any sublicense will not relieve NVP of its obligations to YUNGJIN under this Agreement. NVP will be responsible for all obligations under this Agreement applicable to any such sub-licensee, and will remain fully responsible for performance of this Agreement notwithstanding any sublicenses granted.

3.5**Joint Technology**. The Parties shall own jointly any and all information, including data, discovered, generated, created or made jointly by two or more individual inventors with at least one individual inventor being an employee or consultant to each of the Parties and/or its respective Affiliates and/or their respective subcontractors in the course of performing or exercising the Parties' rights under this Agreement (hereinafter, "**Joint Technology**"), together with all patents and other intellectual property rights in any Joint Technology ("**Joint Patent**"). Each Party may exercise its ownership rights in and to such Joint Technology and Joint Patents, including the right to license or otherwise to exploit, transfer, or encumber its ownership interest, without an accounting or obligation to, or consent required from, the other Party, but subject to the confidentiality obligation under Article 8.

**4.<u>Upfront Payments, Milestone Payments, Sales Related Payments and Royalties</u>**

4.1NVP shall pay to YUNGJLN the following non-refundable **Upfront Payments**:

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)a payment of USD [\*\*\*] within thirty (30) days after the Effective Date of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)a payment of USD [\*\*\*]within one year after the Effective Date of this Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)a payment of USD [\*\*\*] within thirty (30) days after the successful outcome of the Phase I Clinical Trial in Korea by YUNGJIN referred to in Section 2.1.3, meaning outcome data enabling a Korean Phase II Clinical Trial.

4.2NVP shall pay to YUNGJIN the following non-refundable Milestone Payments for the Licensed Compound passes the defined event milestone within thirty (30) days after such event has occurred as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Successful outcome of a Phase I Clinical Trial in the US or EU – USD [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Successful outcome of a Phase II Clinical Trial in the US or EU – USD [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)NDA Approval in the US – USD [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Reimbursement Approval in the UK, France, Germany and USD – [\*\*\*] each of said Approvals which in total will amount to a payment of USD [\*\*\*].

NVP agrees to notify YUNGJIN promptly of the occurrence of each of the above events.

4.3NVP shall pay to YUNGJIN the following non-refundable **Sales Related Payments** when Licensed Product achieves the following defined total Net Sales in one calendar year (payment is due only once) within sixty (60) days after the expiration of the year triggering the payment:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Total Net Sales in one calendar year exceeds USD [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Total Net Sales in one calendar year exceeds USD [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Total Net Sales in one calendar year exceeds USD [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Total Net Sales in one calendar year exceeds USD [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)Total Net Sales in one calendar year exceeds USD [\*\*\*]

For the avoidance of doubt, even in case of the achievement of more than one milestone event in one calendar year, NVP shall pay YUNGJIN the Sales Related Payments for each achievement.

4.4NVP shall pay to YUNGJIN royalties based on Net Sales of Licensed Product in the Field in the Territory during the applicable Royalty Term.

**Royalty Term**. Royalties shall be paid under this Section 4.4, on a country-by-country basis, on Net Sales during the period of time beginning on the first commercial sale of Licensed Product in such country and continuing until the later of: (i) the expiration of the last-to-expire Licensed Patents in such country Covering such Licensed Product; (ii)

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[\*\*\*] in such country; provided however that no royalties will [\*\*\*] the ("**Royalty Term**")

Royalties are non-refundable and payable within sixty (60) days after the end of each calendar quarter. **Royalties** will be calculated as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)[\*\*\*] on the portion of aggregate Net Sales for the Licensed Product in countries which are subject to royalties in each calendar year that are less [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)[\*\*\*] on the portion of aggregate Net Sales for the Licensed Product in countries which are subject to royalties in each calendar year that exceed USD [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)[\*\*\*] on the portion of aggregate Net Sales for the Licensed Product in countries which are subject to royalties in each calendar year that exceed USD [\*\*\*] but are less than USD [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)[\*\*\*] on the portion of aggregate Net Sales for the Licensed Product in countries which are subject to royalties in each calendar year that exceed USD [\*\*\*].

**5.<u>Payment, Reports, Record Retention and Audit</u>**

5.1Royalties shall be calculated on a calendar quarter basis and royalties and other payments shall be made to such bank account of YUNGJIN as is designated by YUNGJIN to NVP in writing.

5.2All payments shall be made in USD. If any currency conversion shall be required in connection with any payment due hereunder, such conversion shall be made using the currency exchange rate published in the Wall Street Journal (internet edition) or, if no longer available, another qualified source that is mutually acceptable to the Parties on the last business day of the calendar quarter to which such payment relates. All payments shall be made without withholding or any reductions on account of taxes unless required by applicable laws.

5.3**Withholding Taxes**. NVP shall be entitled to deduct from any payment due to YUNGJIN under this Agreement the amount of any withholding taxes payable by NVP, or any taxes required to be withheld by NVP, to the extent NVP pay to the appropriate governmental authority on behalf of YUNGJIN such taxes, levies or charges. NVP shall use reasonable efforts to minimize any such taxes, levies or charges required to be withheld on behalf of YUNGJIN by NVP. NVP promptly shall deliver to YUNGJIN a proof of payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental authority with respect thereto. YUNGJIN shall provide NVP with all forms or documentation required by any applicable taxation laws, treaties or agreements to such withholding or as necessary to claim a benefit. If withholding of taxes is not required by applicable laws in the Territory, NVP shall comply with such applicable laws in the Territory.

5.4**Interest Due**. Without limiting any other rights or remedies available to YUNGJIN, NVP shall pay YUNGJIN [\*\*\*] annum interest on any payments that are not paid on or before the date such payments are due under this Agreement, or the maximum rate permitted by law, if less.

5.5NVP shall deliver a written final report to YUNGJIN within thirty (30) days after the expiration of each calendar quarter that shows with respect to each country of the

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Territory the sales volume of Licensed Product and the Net Sales by NVP, its Affiliates and their sub-licensees during such calendar quarter and how the royalties under Section 4.4 have been calculated. To the extent any Sales Related Payments under Section 4.3 would become due, Net Sales by NVP, its Affiliates and their sub-licensees shall be reported in the same manner.

5.6NVP shall, and shall cause its Affiliates and their sub-licensees to keep complete and accurate records and books of account in accordance with generally accepted accounting standards showing the information that is necessary for determination of the royalties and Sales Related Payments due hereunder. Such books and records shall be retained for five (5) years after the end of the period to which such books and records pertain.

5.7Upon the written request by YUNGJIN, NVP shall, and shall cause its Affiliates to, permit YUNGJIN or a certified public accountant or independent accounting firm, in each case, acceptable to the Parties to inspect during regular business hours going back no more than five (5) years preceding the current year, all or any part of NVP's, its Affiliates' books and records necessary to check the accuracy of the royalties and Sales Related Payments due hereunder. YUNGJIN shall provide NVP with a copy of any report prepared by such accountant. The charges of the accountant shall be paid by YUNGJLN, provided, however, that if royalties for a given calendar year has been underpaid by more than five percent (5%), the charges will be paid by NVP.

**6.<u>Intellectual Property Rights</u>**

6.1YUNGJIN shall retain all rights, title and interest in and to any and all Licensed Patents in the Territory and Retained Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.1YUNGJIN shall have the right, using legal counsel of its choosing, to file, prosecute (including any interferences, reissue proceedings and re-examinations and opposition proceedings), maintain, withdraw, abandon, and defend the Licensed Patents and Joint Patents in the Territory and Retained Territory, and YUNGJIN shall bear all costs and expenses of obtaining and maintaining such Licensed Patents and Joint Patents, including fees and expenses paid to outside legal counsel and experts, direct costs of in-house counsel and filing, prosecution and maintenance expenses associated therewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.2YUNGJIN shall inform NVP of material activities related to patent prosecution (including any interferences, reissue proceedings and re-examinations and opposition proceedings), maintenance, withdrawals, abandoning or defence of the Licensed Patents and Joint Patents in the Territory and Retained Territory and provide NVP with copies of all relevant communications and underlying documentation. Such information shall be provided in a timely manner to allow NVP reasonable time to provide comments and suggestions with respect to any material actions to be taken by YUNGJIN, and YUNGJIN shall reasonably consider all comments, suggestions and prosecution actions recommended by NVP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.3With respect to non-Priority Countries, YUNGJIN may elect not to pursue or continue the filing, prosecution or maintenance of a Licensed Patent or Joint Patent in such country (countries) in the Territory or take any other action with respect to a Licensed Patent or Joint Patent in such particular country (countries) in the Territory that is necessary to establish, preserve or extend rights thereto, then in each such case YUNGJIN shall notify NVP thereof in writing in such timely manner as may be necessary due to deadlines imposed by the relevant

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patent authority (authorities) by which action must be taken to establish, preserve or maintain such Licensed Patent or Joint Patent in such country (countries). Upon NVP's receipt of such notice, NVP may request to pursue or continue the filing, registration, continued prosecution (including any interference, reissue proceedings and re-examinations) or maintenance, of such Licensed Patents or Joint Patents. NVP shall then have the right through counsel of its choosing, to pursue the filing or registration, or support the continued prosecution (including any interference, reissue proceedings and re-examinations) or maintenance, of such Licensed Patents or Joint Patents in the name of YUNGJIN at NVP's expense in each such country (countries). For the avoidance of doubt, YUNGJIN has as of the Effective Date made its election to pursue or continue the filing, prosecution or maintenance of the patent applications No. 1 of Schedule 1 in KR (WIPO Country Code), and No. 2 of Schedule 1 in the following countries only (listed using WIPO Country Codes): US, EP (i.e., AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM and TR), JP, CN, AU, CA, EA (i.e., AM, AZ, BY, KG, KZ, RU, TJ and TM), MX, BR, CL, CO, IN, ID, HK and ZA. To be clear, YUNGJIN was under no contractual obligation prior to the Effective Date to pursue or continue the filing, prosecution or maintenance of the patent applications in Priority Countries, and as the deadlines for the filing, prosecution or maintenance filing of the above patent applications have already passed for the countries not listed above, YUNGJIN shall not be liable or otherwise held responsible for its decision to forgo the filing, prosecution or maintenance filing of the above patent applications.

6.2**Infringement and Action**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.1Each Party shall promptly notify the other Party when such Party becomes aware of or reasonably believes that any of Licensed Patents, Licensed Know-How, Joint Patents or Joint Technology is being infringed or is under a threat of being infringed by a third party, or is subject to a declaratory judgment action arising from such infringement. After receipt of such notice, YUNGJIN has the right to, but is not obliged to, take such action to stop such infringement or act as YUNGJIN may deem necessary. In connection therewith, NVP shall cooperate fully with YUNGJIN to stop such infringement or act and, if so requested by YUNGJIN, may join YUNGJIN as a party to any action brought by YUNGJIN for such purpose. If YUNGJIN decides not to take such action to stop such infringement YUNGJIN shall promptly notify NVP thereof (in any event in a timely manner in order not to jeopardize any deadline for taking such action), and NVP may take appropriate actions to stop such infringement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.2The Party taking the action contemplated under Section 6.2.1 shall have full control over any action taken, including the right to select counsel and appeal any adverse decision rendered in any court. The Party taking the action may not settle or discontinue the action without the other Party's prior approval, which approval shall not be unreasonably withheld or delayed. In case where NVP initiates the action to stop a third party's infringement as contemplated under Section 6.2.1, any costs incurred by such action and any awards gained from such action shall be evenly shared between the Parties.

6.3**Infringement of Third Party Patents**.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.1After the Effective Date, either Party shall promptly notify the other Party of its knowledge of any claim made against it or its Affiliate by any third party for infringement of a patent of such third party in connection with the development, manufacture, or sale of Licensed Compound or Licensed Product and/or its use. The notified Party agrees to render such reasonable assistance (excluding financial assistance) as the notifying Party may reasonably request in defending such claim at no expense to the requesting Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.2The Party which is subject to any third party claim shall defend such action against it at its sole expense. If such Party seeks to settle such third party claim, either by license or otherwise, then such Party may only do so with the consent of the other Party (which consent shall not unreasonably be withheld or delayed).

**7.<u>Representations and Warranties</u>**

7.1Each Party represents and warrants to the other Party (i) that it has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; (ii) that it has taken all necessary action on its part required to authorize the execution and delivery of this Agreement; (iii) that the execution, delivery and performance of this Agreement will not result in a violation of, be in material conflict with, or constitute a material default under, any agreement in existence as of the Effective Date or subsequently entered into between it and any other Person; and (iv) that it has not withheld any information from the other Party which it reasonably believes would influence a reasonable party's decision to enter into this Agreement.

7.2YUNGJIN represents, warrants and covenants to NV? that as of the Effective Date (or as of such other dates or time periods as may be explicitly specified below):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)YUNGJIN is entitled to grant the rights to NVP specified herein and none of the Licensed Compound, Licensed Patents and Licensed Know-How existing today (collectively the "Assets") are subject to any encumbrance, lien or claim of ownership by any third party and no third party, including any employee or consultant of YUNGJPS or its Affiliates, has any right in relation to any of the Assets which conflicts with NVP's use or exploitation of the Assets according to this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Other than examination by the relevant patent office in the course of patent applications, none of the Licensed Patents are or have been the subject of any court, tribunal, arbitration or patent office proceedings regarding its validity or enforcement nor have any such proceedings been threatened or are any such proceedings pending.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)To YUNGJIN's actual knowledge, no third party infringes or violates, or has infringed or violated, any of the Licensed Patents or misuses or has misused any of the Records or Licensed Know-How pertaining to the Licensed Compound. No third party has claimed that, or, to YUNGJIN's actual knowledge, has reason to claim that, exercise under any of the Licensed Patents infringes or has infringed any intellectual property rights of such third party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Neither YUNGJIN nor any of its Affiliates is or has been a party to any opposition or interference proceedings or any litigation relating to third party intellectual property rights which may be relevant to the exploitation of any of the Assets.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)All Licensed Patents have been diligently prosecuted and all time limits in the prosecution process have been complied with. All payments due in respect of the prosecution, maintenance and renewal of the Licensed Patents have been paid in full.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)To YUNGJIN's actual knowledge, no third party has been given access to YUNGJIN's Confidential Information other than pursuant to customary agreements on confidentiality and restricted use and no third party has breached or threatened to breach any such agreements or undertakings.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)Neither YUNGJIN nor any of its Affiliates is a party to any contract, agreement, obligation or arrangement with a third party of material importance to the Assets.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)YUNGJIN has in all material respects complied with all applicable laws, regulatory rules and regulations as well as any requests or notifications from any governmental organization or regulatory body in connection with its conduct of the research program with the Licensed Compound and is not subject to or in violation of any outstanding judgment, injunction, order, decree or other requirement from any such organization or body in connection therewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)The transactions contemplated by this Agreement will not result in any employee of YUNGJIN or its Affiliates being entitled to employment by or any payment or other compensation from NVP or its Affiliates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j)YUNGJIN has received no notice of any claims, suits, arbitration or administrative or other legal proceedings (including but not limited to tax or employment matters) relating to the Assets or the research program with the Licensed Compound and, to the best of YUNGJIN's knowledge, no facts or circumstances are likely to lead to such proceedings being threatened.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(k)YUNGJIN has not been debarred and is not subject to debarment pursuant to Section 306 of the United States Federal Food, Drug and Cosmetics Act or equivalent laws or regulations in other jurisdictions.

7.3**NVP Covenants**. Without limiting any other obligation hereunder, NVP covenants that it will use Commercially Reasonable Efforts to perform all of its obligations hereunder, including the conduct of the Development and Commercialization of the Licensed Compound and Licensed Product, in accordance with this Agreement and in compliance with all applicable legal requirements, and that it will take reasonable measures to cure any noncompliance as soon as reasonably practicable after becoming aware of the same. For the avoidance of doubt, NVP's taking such measures to cure does not relieve or exempt NVP's obligation due to the noncompliance.

7.4**No Warranties**. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED HEREIN, THE PARTIES AGREE THAT NEITHER PARTY MAKES, EXPECTS OR ACKNOWLEDGES ANY WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY, NON-INFRINGEMENT, PATENTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER INCLUDED WITHIN THE CLAIMS OF LICENSED PATENTS, INCLUDING LICENSED PRODUCT. THE PARTIES UNDERSTAND AND AGREE THAT DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCT WILL INVOLVE APPROVAL BY REGULATORY AUTHORITIES, AND THAT NO PARTY IS GUARANTEEING THE SAFETY OR EFFICACY OF PRODUCT, OR THAT LICENSED PRODUCT WILL RECEIVE THE REQUIRED APPROVALS.

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**8.<u>Confidentiality and Non-Disclosure</u>**

8.1During the term of this Agreement and for a period of five (5) years following the termination or expiration thereof, each Party (the "**Receiving Party**") shall keep confidential and not use, publish or otherwise disclose any Confidential Information of the other Party (the "**Disclosing Party**"), except to the extent permitted by the terms of this Agreement or to the extent such use is necessary for the fulfilment of the Receiving Party's obligations under this Agreement.

8.2The Receiving Party's obligations of confidentiality in Section 8.1 above shall not extend to any Confidential Information of the Disclosing Party that (i) is or comes into the public domain without breach of this Agreement; (ii) the Receiving Party can demonstrate by competent evidence is received by the Receiving Party from a third party without any obligation of confidentiality and without breach of any confidentiality obligation; (iii) the Receiving Party can demonstrate by competent evidence is already known by the Receiving Party at the time of disclosure; or (iv) the Receiving Party can demonstrate by competent evidence was independently developed by the Receiving Party following the Effective Date without use of or reference to any such Confidential Information.

8.3Notwithstanding Section 8.1 above,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.1Each Party shall be entitled to use and disclose Confidential Information of the other Party to the extent reasonably required for its exploitation of the rights granted to it under this Agreement or to the extent reasonably required for its proper performance under the license granted hereunder on a need-to-know basis on condition that such recipients agree to keep the Confidential Information confidential for the same extent as the Receiving Party is required to keep the Confidential Information confidential under this Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.2The Parties acknowledge that they each may engage in fundraising activities with private investors. In such event, the Parties may disclose the terms and subject matter of this Agreement, under terms of confidentiality no less strict than those contained in this Agreement, to such investors or potential investors conducting due diligence.

8.4This Agreement shall not restrict the Receiving Party from complying with a lawfully issued governmental order, legal requirement or the requirement of a national securities exchange or another similar regulatory body to produce or disclose the Disclosing Party's Confidential Information; provided, however, that the Receiving Party shall promptly notify the Disclosing Party of such order or requirement to enable the Disclosing Party to oppose the order or obtain a protective order. If the Receiving Party is thereafter required to disclose such Confidential Information, both Parties will endeavour to agree to a mutually satisfactory means to disclose such information.

8.5All press releases, public announcements or public relations activities and the timing for such activities by the Parties with regard to this Agreement or the transactions contemplated by it shall be mutually approved by the Parties in advance of such release, announcement or activity. Each Party shall keep the terms of and the transactions covered by this Agreement confidential and shall not — unless to the extent otherwise agreed between the Parties in writing — disclose such information to any other Person, or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other Party or its Affiliates in any manner without the prior written consent of the other Party in each instance (which shall not be unreasonably withheld). The restrictions imposed by this Section 8.5 will not prohibit either Party from making any disclosure that is required

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by applicable law, rule or regulation or the requirements of a national securities exchange or another similar regulatory body, in which event such Party may disclose such information as it deems necessary in order to comply with such requirements and such Party shall make reasonable efforts to notify the other Party prior to making such disclosure.

**9. Term and Termination**

9.1The term of this Agreement (the "**Term**") shall commence upon the Effective Date and, unless terminated earlier pursuant to this Article 9, shall remain in effect until the earlier of: (i) 31 December 2039; or (ii) on a country-by-country basis, the expiration of the Royalty Term with respect to the Licensed Product in such country. Upon the expiration of this Agreement with respect to the Licensed Product and country, the licenses granted to NVP under this Agreement with respect to the Licensed Product and country shall become fully-paid, perpetual and irrevocable.

9.2**Termination by Either Party for Material Breach**. Each of YUNGJIN and NVP may terminate this Agreement effective immediately at any time upon written notice to the other Party if the other Party is in material breach of this Agreement and, where such breach is capable of being cured, fails to remedy such breach within sixty (60) days after having been given a written request for such remedy including notice that the Agreement may otherwise be terminated.

9.3**Termination by NVP**. NVP may at its sole discretion terminate this Agreement at any time after the Effective Date by giving YUNGJIN one (1) month prior written notice of termination.

9.4**Termination due to Insolvency**. A Party may terminate this Agreement in the event any of the following occurs with respect to the other Party: (i) the other Party becomes bankrupt or insolvent, files a petition in bankruptcy, makes a general assignment for the benefit of creditors, otherwise acknowledges in writing insolvency, or is adjudged bankrupt, and the other Party (A) fails to assume this Agreement in any such bankruptcy proceeding within thirty (30) days after filing or (B) assumes and assigns this Agreement to a third party; (ii) the other Party goes into or is placed in a process of complete liquidation; (iii) a trustee or receiver is appointed for any substantial portion of the other Party's business and such trustee or receiver is not discharged within sixty (60) days after appointment; (iv) any case or proceeding shall have been commenced or other action taken against the other Party in bankruptcy or seeking liquidation, reorganization, dissolution, a winding-up arrangement, composition or readjustment of its debts or any other relief under any applicable bankruptcy, insolvency, reorganization or similar law now or hereafter in effect and is not dismissed or converted into a voluntary proceeding governed by clause (i) above within sixty (60) days after filing; or (v) there shall have been issued a warrant of attachment, execution, distraint or similar process against any substantial part of the property of the other Party and such event shall have continued for a period of sixty (60) days and none of the following has occurred: (A) it is dismissed, (B) it is bonded in a manner reasonably satisfactory to the terminating Party, or (C) it is discharged.

**10.<u>Consequences of Termination</u>.**

10.1Upon the early termination (i.e., not upon expiration) of this Agreement by YUNGJIN pursuant to Section 9.2 (termination by YUNGJIN for NVP's material breach) notified by YUNGJIN to NVP prior to the first successful outcome of a Phase I Clinical Trial for the Licensed Product referred to under Section 4.2 (a), by NVP pursuant to Section 9.3

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(termination by NVP at its sole discretion) or by YUNGJIN pursuant to Section 9.4 (termination by YUNGJIN due to NVP's insolvency):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.1all licenses granted to NVP under this Agreement will terminate, including the license granted by YUNGJIN to NVP under Article 3 (Granted Licenses) above;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.2NVP shall diligently wind down, in accordance with applicable laws, all Development activities it is conducting for Licensed Product in the Territory at the time of notice of such termination;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3NVP shall transfer and assign to YUNGJIN all Regulatory Filings and Regulatory Approvals for Licensed Product in the Territory;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.4NVP shall assign to YUNGJIN all of its right, title and interest in and to any and all trademarks for the Licensed Product, including all goodwill therein;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.5NVP shall transfer the patent files for all Licensed Patents in the Territory to YUNGJIN; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.6NVP shall transfer and assign to YUNGJIN all of its right, title and interest in and to the Licensed Rights including the rights to the Licensed Patent under Section 6.1.3. In the event the foregoing transfer or assignment is not legally feasible, NVP shall grant to YUNGJIN, an exclusive, royalty-free and fully-paid license, with the right to grant sublicenses through multiple tiers, under all such Licensed Rights, to develop, make, have made, use, import, export, offer for sale and sell Licensed Compound and Licensed Product in the Field in the Territory.

10.2Upon the early termination (i.e. not upon expiration) of this Agreement by YUNGJIN pursuant to Section 9.2 notified by YUNGJIN to NVP after the first successful outcome of a Phase I Clinical Trial for the Licensed Product as referred to in Section 4.2(a) what is stated in Sections 10.1.1-6 shall apply and YUNGJIN shall pay royalties based on the net sales of YUNGJIN. its Affiliates and their sub-licensees [\*\*\*] in Section 4.4 (a)-(d) during Royalty Term to NVP. The Sections of this Agreement relating to calculation, payment, audits, etc. of royalties shall apply mutatis mutandis with respect o YUNGJIN.

10.3Upon the early termination (i.e. not upon expiration) of this Agreement by NVP pursuant to Section 9.2 or Section 9.4 what is stated this Agreement will remain in full force and effect with the change that any and all unpaid Upfront Payment under Section 4.1, all unpaid Milestone Payments under Section 4.2 and all unpaid Sales Related Payments under Section 4.3 will be reduced by [\*\*\*] and the royalty rates stated in Section 4.4 (a)-(d) will be reduced by [\*\*\*].

10.4**Return of Confidential Information**. Upon termination of this Agreement as stated in Section 10.1 or 10.2, the Receiving Party shall return to the Disclosing Party or, at the Disclosing Party's option, destroy all Confidential Information received from the Disclosing Party, provided that for a period of five (5) years following the termination the Receiving Party shall be permitted to retain (i) one copy thereof for archival purposes and for the purpose of determining its obligations under this Agreement and (ii) such additional copies of any computer records or files containing such Confidential Information that have been created solely by the Receiving Party's automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with the Receiving Party's standard archiving and back-up procedures, but not for any other use or purpose.

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10.5The expiration or termination of this Agreement shall be without prejudice to any rights or obligations of the Parties that may have accrued prior to the termination and, except as otherwise expressly provided herein, shall not limit any rights or remedies which may be available by law or otherwise.

**11.<u>Indemnification</u>**

11.1In addition to any other remedy available to the Parties, but subject to the limitation of liability set forth in Article 12, each Party (the "**Indemnifying Party**") shall defend, indemnify and hold harmless the other Party, its Affiliates and its and their respective officers, directors, partners, shareholders, employees and agents (the "**Indemnified Party**") from and against any and all loss, damages, costs and expenses incurred by the Indemnified Party to the extent resulting from, arising out of, or in connection with, (a) any breach of any covenant or obligation in this Agreement by the Indemnifying Party, (b) the inaccuracy or breach of any representation or warranty made by the Indemnifying Party in this Agreement, (c) any activities for research, development, manufacturing, use or commercialization of the Licensed Product by the Indemnifying Party, its Affiliates or their licensees in its own territory without any involvement of the Indemnified Party or (d) the enforcement of the Indemnified Party's rights under this Article 11.

11.2If either Party expects to seek indemnification under this Agreement, it shall promptly give notice to the Indemnifying Party of the basis for such claim of indemnification. If indemnification is sought as a result of any third party claim or suit, such notice to the Indemnifying Party shall be given within fifteen (15) working days after receipt by the other Party of such claim or suit; provided, however, that the failure to give notice within such time period shall not relieve the Indemnifying Party of its obligation to indemnify unless it shall be materially prejudiced by the failure, even in which cases Indemnifying Party's obligation is relieved only to the extent that its obligation is prejudiced by such failure. Each Party shall fully cooperate with the other Party in the defense of all such claims or suits, and each Party shall be obligated to use commercially reasonable efforts to mitigate any damages for which it seeks indemnification hereunder. No offer of settlement or compromise shall be binding on a Party hereto without its prior written consent (which consent shall not be unreasonably withheld) unless such settlement fully releases such Party without any liability, loss, cost or obligation to such Party.

**12.<u>Limitation of Liability</u>**

12.1To the maximum extent permitted by applicable law but subject to the exceptions set out in Section 12.2 below, the Parties' liability to pay damages in connection with this Agreement shall be limited to direct loss, excluding liability for loss of profits or other indirect losses or damages arising out of or relating to this Agreement.

12.2None of the limitations in Section 12.1 above shall apply in respect of liability due to gross negligence or willful misconduct by a Party or its Affiliates.

**13.<u>Miscellaneous</u>**

13.1**Assignment**. This Agreement may not be assigned by either Party in whole or in part without the prior written consent of the other Party, except that each Party without the other Party's consent may assign this Agreement and its rights and obligations hereunder to any of its Affiliates or any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of the business to which this Agreement relates.

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13.2**Governing Law**. The interpretation and construction of this Agreement shall be governed by the laws of Switzerland, without giving effect to any conflicts of laws principles that would require the application of other law.

13.3**Arbitration**. Any dispute, controversy or claim arising out of or in connection with this Agreement, shall be finally settled by an arbitration before three (3) arbitrators pursuant to the Rules of Arbitration of the International Chamber of Commerce then in effect. The seat of the arbitration shall be Singapore. The proceedings shall be in English. All decisions of the arbitration tribunal shall be final and binding on the Parties and shall be enforceable in any court of competent jurisdiction in accordance with their terms.

13.4**Notices**. Any notice, request, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement, and shall be deemed given only if hand delivered or sent by an internationally recognized overnight delivery service, costs prepaid, or by e-mail (with transmission confirmed), to the Party to whom notice is to be given at the following address (or at such other address such Party may have provided to the other Party in accordance with this Section 13.4:

If to YUNGJIN:

Address: Korea Advanced Nano Fab Center (KANC) 9F, 109, Gwanggyo-ro,

Gyeonggi-do, 16229, Korea

e-mail: kolee@yungjin.co.kr

For the attention of: Kwang-ok Lee, Head of Research Center

If to NVP:

Address: Medicon Village, Scheelevagen 2, SE-223 81 Lund, Sweden

e-mail: <u>erik.kinnman@neurovive.com</u>

For the attention of: Erik Kimunan, CEO

Such notice, shall be deemed to have been given as of the date delivered by hand or transmitted by e-mail (with transmission confirmed), or on the second business day (at the place of delivery) after deposit with an internationally recognized overnight delivery service, whichever is the earlier.

13.5**Relationship of the Parties**. The status of a Party under this Agreement shall be that of an independent contractor. Nothing contained in this Agreement shall be construed as creating a partnership, joint venture or agency relationship between the Parties or, except as otherwise expressly provided in this Agreement, as granting either Party the authority to bind or contract any obligation in the name of or on the account of the other Party or to make any statements, representations, warranties or commitments on behalf of the other Party.

13.6**Waiver**. A Party's failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy shall not constitute a waiver of that provision, right or remedy or prevent such Party from enforcing any or all provisions of this Agreement and exercising any rights or remedies. To be effective any waiver must be in writing. All rights and remedies are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.

- xxii

------

13.7**Severability**. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then, to the fullest extent permitted by applicable law and if the rights and obligations of any Party will not be materially and adversely affected: (a) such provision will be given no effect by the Parties and shall not form part of this Agreement, (b) all other provisions of this Agreement shall remain in full force and effect, and (c) the Parties shall use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with applicable law and achieves, as nearly as possible, the original intention of the Parties. To the fullest extent permitted by applicable law, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect.

13.8**Force Majeure**. If a Party is prevented, hindered or delayed in or from performing any of its obligations under this Agreement by a Force Majeure event, such Party shall within ten (10) working days of the occurrence of such Force Majeure event give notice in writing to the other Party specifying the nature and extent of such event, its anticipated duration and any action taken to minimize its effect. Subject to providing such notice the affected Party shall not be liable for delay in performance or for non-performance of its obligations under this Agreement nor shall the other Party have the right to terminate this Agreement. The suspension of performance allowed hereunder shall be no greater in scope and no longer in duration than is reasonably required.

13.9**Entire Agreement**. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter of the Agreement. Each Party confirms that it is not relying on any representations, warranties or covenants of the other Party except as specifically set out in this Agreement. Nothing in this Agreement is intended to limit or exclude any liability for fraud. All Schedules referred to in this Agreement are intended to be and are hereby specifically incorporated into and made a part of this Agreement. No modification will be effective unless in writing and signed by authorized representatives of both Parties.

THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above.

---

| | |
|:---|:---|
| SIGNED for and on behalf of <br>YungJin Pharm Co., Ltd. | SIGNED for and on behalf of <br>NeuroVive Pharmaceutical AB (PUBL) |
| <u>/s/ Sujun Park</u><br>Signature | /s/ <u>Greg Batcheller</u><u>_____________</u><br>Signature |
| Name: <u>Sujun Park</u><br>Title: <u>CEO / President</u> | Name: <u>Greg Batcheller</u><u>_____________</u><br>Title: <u>Chairman</u><u>_</u> |

---

- xxiii

------

**Schedule 1 – Licensed Patents**

---

| | | | |
|:---|:---|:---|:---|
| | **Application No.** | **Publication No.** | **Publication<br>Date** |
| 1 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
|  | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 2 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
|  | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

- xxiv

------

**Schedule 2– Licensed Know-How**

1.[\*\*\*]

2.[\*\*\*]

3.[\*\*\*]

4.[\*\*\*]

5.[\*\*\*]

6.[\*\*\*]

- xxv

------

**Schedule 3– Regulatory documents and study reports**

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| **No.** | **Category** | **Data** | **Specific Information** | **Document** | &nbsp;&nbsp;&nbsp;**Language** | &nbsp;&nbsp;&nbsp;**Received** | &nbsp;&nbsp;&nbsp;**Pending** |
| 1.1 | CMC | Chemical synthetic route | [\*\*\*] | [\*\*\*] |  |  | ✔ |
| 1.2 | CMC | Process development | [\*\*\*] | [\*\*\*] |  |  | ✔ |
| 1.2 | CMC | Process development | [\*\*\*] | [\*\*\*] | Korean |  | ✔ |
| 1.2 | CMC | Process development | [\*\*\*] | [\*\*\*] | Korean | ✔ |  |
| 1.3 | CMC | Manufacturing | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 1.3 | CMC | Manufacturing | [\*\*\*] | [\*\*\*] | Korean | ✔ |  |
| 1.3 | CMC | Manufacturing | [\*\*\*] | [\*\*\*] | Korean |  | ✔ |
| 1.4 | CMC | Drug substance specification | [\*\*\*] | [\*\*\*] | Korean | ✔ |  |
| 1.5 | CMC | ICH stability data Drug substance |  | [\*\*\*] | Korean | ✔ |  |
| 1.5 | CMC | ICH stability data Drug substance |  | [\*\*\*] | Korean | ✔ |  |
| 1.5 | CMC | ICH stability data Drug substance |  | [\*\*\*] | Korean | ✔ |  |
| 1.5 | CMC | ICH stability data Drug substance |  | [\*\*\*] | Korean | ✔ |  |

---

- xxvi

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| **No.** | **Category** | **Data** | **Specific Information** | **Document** | &nbsp;&nbsp;&nbsp;**Language** | &nbsp;&nbsp;&nbsp;**Received** | &nbsp;&nbsp;&nbsp;**Pending** |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.6 | CMC | [\*\*\*] |  | [\*\*\*] | Korean |  | ✔ |

---

- xxvii

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| **No.** | **Category** | **Data** | **Specific Information** | **Document** | &nbsp;&nbsp;&nbsp;**Language** | &nbsp;&nbsp;&nbsp;**Received** | &nbsp;&nbsp;&nbsp;**Pending** |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.7 | CMC | [\*\*\*] |  | [\*\*\*] | Korean | ✔ |  |
| 1.8 | CMC | Drug product specification |  | [\*\*\*] | Korean | ✔ |  |
| 1.8 | CMC | Drug product specification |  | [\*\*\*] | Korean | ✔ |  |

---

- xxviii

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| **No.** | **Category** | **Data** | **Specific Information** | **Document** | &nbsp;&nbsp;&nbsp;**Language** | &nbsp;&nbsp;&nbsp;**Received** | &nbsp;&nbsp;&nbsp;**Pending** |
| 1.8.1 | CMC | Drug product specification |  |  |  | ✔ |  |
| 1.9 | CMC | Estimated COGS |  | [\*\*\*] | Korean | ✔ |  |
| 1.10 | CMC | Preclinical formulation | [\*\*\*] |  | Korean | ✔ |  |
| 2.1 | Commercial | Estimation of number of patients |  |  |  |  | ✔ |
| 2.2 | Other | Back up series program | [\*\*\*] |  |  |  | ✔ |
| 3.1 | Pharmacology | Safety pharmacology | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 3.2 | Pharmacology | Safety pharmacology | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 3.3 | Pharmacology | Safety pharmacology | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 3.4 | Pharmacology | Efficacy in vivo | [\*\*\*] | [\*\*\*] | English |  | ✔ |
| 3.5 | Pharmacology | Efficacy in vivo | [\*\*\*] | [\*\*\*] | English |  | ✔ |
| 3.6 | Pharmacology | Mode of action in vitro | [\*\*\*] |  |  |  | ✔ |
| 3.7 | Pharmacology | Mode of action in vivo | [\*\*\*] |  |  |  | ✔ |
| 4.1 | Regulatory | Scientific advice | [\*\*\*] |  |  |  | ✔ |
| 4.2 | Regulatory | Clinical development plan |  |  |  |  | ✔ |
| 4.3 | Regulatory | GLP status | [\*\*\*] |  |  |  | ✔ |
| 4.4 | Regulatory | Target Product Profile |  |  |  |  | ✔ |
| 4.5 | Regulatory | Investigator's Brochure (IB) |  | [\*\*\*] | Korean | ✔ |  |

---

- xxix

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| **No.** | **Category** | **Data** | **Specific Information** | **Document** | &nbsp;&nbsp;&nbsp;**Language** | &nbsp;&nbsp;&nbsp;**Received** | &nbsp;&nbsp;&nbsp;**Pending** |
| 4.6 | Regulatory | Documents to and correspondence with regulatory<br>authority | [\*\*\*] |  |  |  | ✔ |
| 5.1 | Toxicokinetic/<br>pharmacokinetic | In vitro metabolism | [\*\*\*] |  |  |  | ✔ |
| 5.2 | Toxicokinetic/<br>pharmacokinetic |  | [\*\*\*] |  |  |  | ✔ |
| 5.5 | Toxicokinetic/<br>pharmacokinetic | ADME | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.1 | Toxicology/Safety | Acute toxicity/MTD | [\*\*\*] | [\*\*\*] | Korean | ✔ |  |
| 6.1 | Toxicology/Safety | Acute toxicity/MTD | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.1 | Toxicology/Safety | Acute toxicity/MTD | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.2 | Toxicology/Safety | Acute toxicity/MTD | [\*\*\*] | [\*\*\*] | English | ✔ |  |
|  |  |  |  |  |  | ✔ |  |
| 6.3 | Toxicology/Safety | [\*\*\*] | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.3 | Toxicology/Safety | [\*\*\*] | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.3 | Toxicology/Safety | [\*\*\*] | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.3 | Toxicology/Safety | [\*\*\*] | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.4 | Toxicology/Safety | Phototoxicity | [\*\*\*] |  |  |  | ✔ |
| 6.5 | Toxicology/Safety | Local tolerance |  |  |  | N/A | N/A |

---

- xxx

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| **No.** | **Category** | **Data** | **Specific Information** | **Document** | &nbsp;&nbsp;&nbsp;**Language** | &nbsp;&nbsp;&nbsp;**Received** | &nbsp;&nbsp;&nbsp;**Pending** |
| 6.6 | Toxicology/Safety | Repeated dose, rodent | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.6 | Toxicology/Safety | Repeated dose, rodent | [\*\*\*] | [\*\*\*] | English | ✔ |  |
| 6.7 | Toxicology/Safety | Repeated dose, rodent | [\*\*\*] |  | English | ✔ |  |
| 6.8 | Toxicology/Safety | Special studies | [\*\*\*] |  |  | N/A | N/A |
| 6.9 | Toxicology/Safety | Estimation of first does in humans |  | [\*\*\*] | English | ✔ |  |
| 6.10 | Toxicology/Safety | hERG activity |  |  |  |  | ✔ |
| 6.1.1 | Toxicology/Safety | Receptor binding profile |  |  |  |  | ✔ |
| 7.1 | IPR | Patens and search reports |  | [\*\*\*] | Korean | ✔ |  |
| 7.1 | IPR | Patens and search reports |  | [\*\*\*] | Korean | ✔ |  |
| 7.1 | IPR | Patens and search reports |  | [\*\*\*] | Korean | ✔ |  |
| 7.1 | IPR | Patens and search reports |  | [\*\*\*] | English | ✔ |  |
| 7.1 | IPR | Patens and search reports |  | [\*\*\*] | English | ✔ |  |
| 7.1 | IPR | Patens and search reports |  | [\*\*\*] | English | ✔ |  |
| 7.1 | IPR | Patens and search reports |  | [\*\*\*] | English | ✔ |  |

---

- xxxi

## Exhibit 8.1

Exhibit 8.1

**Subsidiaries of Pharming Group B.V.**

---

| | |
|:---|:---|
| **Name of Subsidiary** | **State or Other Jurisdiction of Incorporation** |
| Pharming Americas B.V. | The Netherlands |
| Pharming Intellectual Property B.V. | The Netherlands |
| Broekman Instituut B.V. | The Netherlands |
| Pharming Healthcare, Inc. | Delaware |
| ProBio, Inc. | Delaware |
| Pharming Technologies B.V. | The Netherlands |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming Research & Development B.V. | The Netherlands |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming Australia Pty Ltd | Australia |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming UK Ltd | The United Kingdom |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming Germany GmbH\* | Germany |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pharming France SAS\* | France |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Abliva AB\*\* | Sweden |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Abliva, Inc.\*\*\* | Delaware |

---

\* This entity was established in November 2025<br>\*\* This entity was acquired in February 2025<br>\*\*\* This entity is dissolved in January 2026

## Exhibit 12.1

Exhibit 12.1

**Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a)**

**as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002**

I, Fabrice Chouraqui, certify that:

&nbsp;&nbsp;&nbsp;&nbsp;1.I have reviewed this annual report on Form 20-F/A of Pharming Group N.V. (the "Company");

&nbsp;&nbsp;&nbsp;&nbsp;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

&nbsp;&nbsp;&nbsp;&nbsp;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;

&nbsp;&nbsp;&nbsp;&nbsp;4.The Company's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d- 15(f)) for the Company and have:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Evaluated the effectiveness of the Company's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Disclosed in this report any change in the Company's internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting; and

&nbsp;&nbsp;&nbsp;&nbsp;5.The Company's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company's auditors and the audit committee of the Company's board of directors (or persons performing the equivalent functions):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company's ability to record, process, summarize and report financial information; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company's internal control over financial reporting.

Date: April 13, 2026

By: /s/ Fabrice Chouraqui

<br>Fabrice Chouraqui, PharmD, MBA

Chief Executive Officer

*(Principal Executive Officer)*

## Exhibit 12.2

Exhibit 12.2

**Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a)**

**as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002**

I, Kenneth Lynard, certify that:

&nbsp;&nbsp;&nbsp;&nbsp;1.I have reviewed this annual report on Form 20-F/A of Pharming Group N.V. (the "Company");

&nbsp;&nbsp;&nbsp;&nbsp;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

&nbsp;&nbsp;&nbsp;&nbsp;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;

&nbsp;&nbsp;&nbsp;&nbsp;4.The Company's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d- 15(f)) for the Company and have:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Evaluated the effectiveness of the Company's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Disclosed in this report any change in the Company's internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting; and

&nbsp;&nbsp;&nbsp;&nbsp;5.The Company's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company's auditors and the audit committee of the Company's board of directors (or persons performing the equivalent functions):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company's ability to record, process, summarize and report financial information; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company's internal control over financial reporting.

Date: April 13, 2026

By: /s/ Kenneth Lynard

<br>Kenneth Lynard

Chief Financial Officer

*(Principal Financial Officer)*

## Exhibit 13.1

Exhibit 13.1

**Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**

In connection with the Annual Report on Form 20-F/A of Pharming Group N.V. (the "Company") for the fiscal year ended December 31, 2025 as filed with the Securities and Exchange Commission on the date hereof (the "Annual Report"), Fabrice Chouraqui, Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)The Annual Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: April 13, 2026

By: /s/ Fabrice Chouraqui

<br>Fabrice Chouraqui, PharmD, MBA

Chief Executive Officer

*(Principal Executive Officer)*

## Exhibit 13.2

Exhibit 13.2

**Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**

In connection with the Annual Report on Form 20-F/A of Pharming Group N.V. (the "Company") for the fiscal year ended December 31, 2025 as filed with the Securities and Exchange Commission on the date hereof (the "Annual Report"), Kenneth Lynard, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)The Annual Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: April 13, 2026

By: /s/ Kenneth Lynard

Kenneth Lynard

Chief Financial Officer

*(Principal Financial Officer)*

## Exhibit 15.1

<br> <br>

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in Registration Statement No. 333-260557 on Form S-8 of our reports dated April 1, 2026, relating to the financial statements of Pharming Group N.V. and the effectiveness of Pharming Group N.V.'s internal control over financial reporting, appearing in this Annual Report on Form 20-F/A for the year ended December 31, 2025.

/s/ Deloitte Accountants B.V.

Eindhoven, The Netherlands

April 13, 2026

<br>