# EDGAR Filing Document

**Accession Number:** 0000899460
**File Stem:** 0001193125-26-208916
**Filing Date:** 2026-5
**Character Count:** 405750
**Document Hash:** d68f42fd0510143f238460d348f00180
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-208916.hdr.sgml**: 20260506

**ACCESSION NUMBER**: 0001193125-26-208916

**CONFORMED SUBMISSION TYPE**: 10-Q

**PUBLIC DOCUMENT COUNT**: 105

**CONFORMED PERIOD OF REPORT**: 20260331

**FILED AS OF DATE**: 20260506

**DATE AS OF CHANGE**: 20260506

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** MANNKIND CORP
- **CENTRAL INDEX KEY:** 0000899460
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 133607736
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 10-Q
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-50865
- **FILM NUMBER:** 26948280

**BUSINESS ADDRESS:**
- **STREET 1:** 1 CASPER STREET
- **CITY:** DANBURY
- **STATE:** CT
- **ZIP:** 06810
- **BUSINESS PHONE:** 818-661-5000

**MAIL ADDRESS:**
- **STREET 1:** 1 CASPER STREET
- **CITY:** DANBURY
- **STATE:** CT
- **ZIP:** 06810

?xml version='1.0' encoding='ASCII'? 10-Q

**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549** 

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**Form** 10-Q

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

**For the quarterly period ended** **March 31,** 2026

**Or** 

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

**For the transition period from to .** 

**Commission file number:** 000-50865

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MannKind Corporation

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

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| | |
|:---|:---|
| Delaware | 13-3607736 |
| **(State or other jurisdiction of**<br>**incorporation or organization)** | **(I.R.S. Employer**<br>**Identification No.)** |
| 1 Casper Street <br>Danbury**,** Connecticut | 06810 |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

**(**818**)** 661-5000

**(Registrant's telephone number, including area code)** 

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N/A

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

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| | |
|:---|:---|
| **Title of each class** | **Name of each exchange on which registered** |
| Common Stock, par value $0.01 per share<br> MNKD | The Nasdaq Stock Market LLC |

---

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). Yes ☒ No ☐

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

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| | | | |
|:---|:---|:---|:---|
| Large accelerated filer | ☒ | Accelerated filer | ☐ |
| Non-accelerated filer | ☐ | Smaller reporting company | ☐  |
|  |  | &nbsp;&nbsp;&nbsp;&nbsp;Emerging growth company | ☐ |

---

If an emerging growth company, 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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of April 24, 2026, there were 308,950,166 shares of the registrant's common stock, $0.01 par value per share, outstanding.

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**MANNKIND CORPORATION**

**Form 10-Q** 

**For the Quarterly Period Ended March 31, 2026** 

**TABLE OF CONTENTS**

---

| | |
|:---|:---|
|  | **Page** |
| [<u>PART I: FINANCIAL INFORMATION</u>](#part_1_financial_information) | 2 |
| [<u>Item 1. Financial Statements (Unaudited)</u>](#item_1_financial_statements) | 2 |
| [<u>Condensed Consolidated Statements of Operations: Three months ended March 31, 2026 and 2025</u>](#condensed_consol_stmt_of_operations) | 2 |
| [<u>Condensed Consolidated Statements of Comprehensive Income: Three months ended March 31, 2026 and 2025</u>](#cond_cons_statements_of_comp_inc_loss) | 3 |
| [<u>Condensed Consolidated Balance Sheets: March 31, 2026 and December 31, 2025</u>](#condensed_consol_balance_sheets) | 4 |
| [<u>Condensed Consolidated Statements of Stockholders' Deficit:</u>](#consolidated_statements_stockholders)[<u>Three months ended March 31, 2026 and 2025</u>](#consolidated_statements_stockholders) | 5 |
| [<u>Condensed Consolidated Statements of Cash Flows: Three months ended March 31, 2026 and 2025</u>](#condensed_consolidated_statements_cash_f) | 6 |
| [<u>Notes to Condensed Consolidated Financial Statements</u>](#notes_to_condensed_consolidated_financia) | 7 |
| [<u>Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations</u>](#item_2_managements_discussion_analysis_f) | 35 |
| [<u>Item 3. Quantitative and Qualitative Disclosures About Market Risk</u>](#item_3_quantitative_qualitative_disclosu) | 42 |
| [<u>Item 4. Controls and Procedures</u>](#item_4_controls_procedures) | 42 |
| [<u>PART II: OTHER INFORMATION</u>](#part_2_other_information) | 43 |
| [<u>Item 1. Legal Proceedings</u>](#item_1_legal_proceedings) | 43 |
| [<u>Item 1A. Risk Factors</u>](#item_1a_risk_factors) | 43 |
| [<u>Item 2. Unregistered Sales of Equity Securities and Use of Proceeds</u>](#item_2_unregistered_sales_equity_securit) | 74 |
| [<u>Item 3. Defaults Upon Senior Securities</u>](#item_3_defaults_upon_senior_securities) | 74 |
| [<u>Item 4. Mine Safety Disclosures</u>](#item_4_mine_safety_disclosures) | 74 |
| [<u>Item 5. Other Information</u>](#item_5_or_information) | 74 |
| [<u>Item 6. Exhibits</u>](#item_6_exhibits) | 75 |
| [<u>SIGNATURES</u>](#signature) | 76 |

---

------

**PART 1: FINANCIAL INFORMATION** 

**ITEM 1. FINANCIAL STATEMENTS** 

**MANNKIND CORPORATION AND SUBSIDIARIES** 

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** 

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
|  | **(In thousands except per share data)** | **(In thousands except per share data)** |
| Revenues: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Commercial product sales | $33907 | $18973 |
| &nbsp;&nbsp;&nbsp;&nbsp;Collaborations and services | 23515 | 29376 |
| &nbsp;&nbsp;&nbsp;&nbsp;Royalties | 32749 | 30005 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total revenues | 90171 | 78354 |
| Expenses: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cost of goods sold – commercial, excluding amortization of acquired intangible assets | 7509 | 3768 |
| &nbsp;&nbsp;&nbsp;&nbsp;Cost of revenue – collaborations and services | 9964 | 13748 |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 17231 | 11022 |
| &nbsp;&nbsp;&nbsp;&nbsp;Selling, general and administrative | 54085 | 25014 |
| &nbsp;&nbsp;&nbsp;&nbsp;Amortization of acquired intangible assets | 4367 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(Gain) loss on foreign currency transaction | (1318) | 2509 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total expenses | 91838 | 56061 |
| (Loss) income from operations | (1667) | 22293 |
| Other income (expense): |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest income, net | 1429 | 1956 |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense | (7478) | (4645) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense on liability for sale of future royalties | (2563) | (3577) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense on financing liability | (2393) | (2410) |
| &nbsp;&nbsp;&nbsp;&nbsp;Loss on settlement of debt | (917) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Other expense | (2777) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other expense | (14699) | (8676) |
| (Loss) income before income tax expense | (16366) | 13617 |
| Income tax expense | 253 | 459 |
| Net (loss) income | $(16619) | $13158 |
| Net (loss) income per share – basic | $(0.05) | $0.04 |
| Weighted average shares used to compute net (loss) income<br> per share – basic | 308267 | 303481 |
| Net (loss) income per share – diluted | $(0.05) | $0.04 |
| Weighted average shares used to compute net (loss) income<br> per share – diluted | 308267 | 320897 |

---

See notes to condensed consolidated financial statements.

------

**MANNKIND CORPORATION AND SUBSIDIARIES** 

**CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME** 

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
|  | **(In thousands)** | **(In thousands)** |
| Net (loss) income | $(16619) | $13158 |
| Other comprehensive (loss) income: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized (loss) gain on available-for-sale securities | (119) | 65 |
| Comprehensive (loss) income | $(16738) | $13223 |

---

See notes to condensed consolidated financial statements.

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**MANNKIND CORPORATION AND SUBSIDIARIES**

**CONDENSED CONSOLIDATED BALANCE SHEETS**

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **December 31, 2025** |
|  | **(In thousands except share <br>and per share data)** | **(In thousands except share <br>and per share data)** |
| **ASSETS** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $52834 | $74882 |
| &nbsp;&nbsp;&nbsp;&nbsp;Short-term investments | 81027 | 96464 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable, net | 28137 | 38367 |
| &nbsp;&nbsp;&nbsp;&nbsp;Inventory | 49166 | 35313 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 39996 | 46553 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 251160 | 291579 |
| Restricted cash | 747 | 745 |
| Long-term investments |  | 5012 |
| Property and equipment, net | 82554 | 82423 |
| Goodwill | 67595 | 67595 |
| Developed technology - on-body infusor | 185708 | 190027 |
| IPR&D - ReadyFlow Formulation | 129600 | 129600 |
| Other intangible assets | 5024 | 5072 |
| Other assets | 22015 | 20129 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $744403 | $792182 |
| **LIABILITIES AND STOCKHOLDERS' DEFICIT** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $16144 | $9034 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | 58598 | 64628 |
| &nbsp;&nbsp;&nbsp;&nbsp;Senior convertible notes – current |  | 36280 |
| &nbsp;&nbsp;&nbsp;&nbsp;Liability for sale of future royalties – current | 14010 | 14298 |
| &nbsp;&nbsp;&nbsp;&nbsp;Contingent consideration - current | 23877 | 21132 |
| &nbsp;&nbsp;&nbsp;&nbsp;Financing liability – current | 10407 | 10328 |
| &nbsp;&nbsp;&nbsp;&nbsp;Deferred revenue – current | 11525 | 15331 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 134561 | 171031 |
| Liability for sale of future royalties – long term | 136561 | 136985 |
| Financing liability – long term | 92784 | 93092 |
| Deferred revenue – long term | 38905 | 39977 |
| Recognized loss on purchase commitments – long term | 64635 | 65952 |
| Operating lease liability | 10281 | 10689 |
| Contingent consideration – long term | 5146 | 5114 |
| Milestone liabilities | 2003 | 2003 |
| Term loan | 318722 | 318361 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 803598 | 843204 |
| Commitments and contingencies (Note 15) |  |  |
| Stockholders' deficit: |  |  |
| Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; <br> no shares issued or outstanding as of March 31, 2026 or December 31, 2025 |  |  |
| Common stock, $0.01 par value – 800,000,000 shares authorized;<br> 308,907,331 and 307,832,587 shares issued and outstanding as of<br> March 31, 2026 and December 31, 2025, respectively | 3089 | 3078 |
| Additional paid-in capital | 3150295 | 3141741 |
| Accumulated other comprehensive (loss) income | (4) | 115 |
| Accumulated deficit | (3212575) | (3195956) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' deficit | (59195) | (51022) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' deficit | $744403 | $792182 |

---

See notes to condensed consolidated financial statements.

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**MANNKIND CORPORATION AND SUBSIDIARIES**

**CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT**

**(Unaudited)** 

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
|  | **Common Stock** | **Common Stock** |  |  |  |  |
|  | **Shares** | **Amount** | **Additional<br>Paid-in Capital** | **Accumulated Other Comprehensive Income (Loss)** | **Accumulated Deficit** | **Total** |
|  | **(In thousands)** | **(In thousands)** | **(In thousands)** | **(In thousands)** | **(In thousands)** | **(In thousands)** |
| BALANCE, JANUARY 1, 2026 | 307833 | $3078 | $3141741 | $115 | $(3195956) | $(51022) |
| &nbsp;&nbsp;&nbsp;&nbsp;Issuance of common stock pursuant to<br>&nbsp;&nbsp;&nbsp;&nbsp; conversion of senior convertible note principal | 569 | 6 | 1729 |  |  | 1735 |
| &nbsp;&nbsp;&nbsp;&nbsp;Net issuance of common stock associated<br> with stock options and restricted stock units | 402 | 4 | 101 |  |  | 105 |
| &nbsp;&nbsp;&nbsp;&nbsp;Issuance of common stock from market<br>&nbsp;&nbsp;&nbsp;&nbsp;price stock purchase plan | 103 | 1 | 269 |  |  | 270 |
| &nbsp;&nbsp;&nbsp;&nbsp;Stock-based compensation expense |  |  | 6455 |  |  | 6455 |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized loss on available-for-sale<br> securities |  |  |  | (119) |  | (119) |
| &nbsp;&nbsp;&nbsp;&nbsp;Net loss |  |  |  |  | (16619) | (16619) |
| BALANCE, MARCH 31, 2026 | 308907 | $3089 | $3150295 | $(4) | $(3212575) | $(59195) |

---

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
|  | **Common Stock** | **Common Stock** |  |  |  |  |
|  | **Shares** | **Amount** | **Additional<br>Paid-in Capital** | **Accumulated Other Comprehensive Income** | **Accumulated Deficit** | **Total** |
|  | **(In thousands)** | **(In thousands)** | **(In thousands)** | **(In thousands)** | **(In thousands)** | **(In thousands)** |
| BALANCE, JANUARY 1, 2025 | 302960 | $3029 | $3118865 | $1109 | $(3201819) | $(78816) |
| &nbsp;&nbsp;&nbsp;&nbsp;Net issuance of common stock associated<br> with stock options and restricted stock <br> units | 959 | 10 | 1580 |  |  | 1590 |
| &nbsp;&nbsp;&nbsp;&nbsp;Stock-based compensation expense |  |  | 5385 |  |  | 5385 |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized gain on available-for-sale<br> securities |  |  |  | 65 |  | 65 |
| &nbsp;&nbsp;&nbsp;&nbsp;Net income |  |  |  |  | 13158 | 13158 |
| BALANCE, MARCH 31, 2025 | 303919 | $3039 | $3125830 | $1174 | $(3188661) | $(58618) |

---

See notes to condensed consolidated financial statements.

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**MANNKIND CORPORATION AND SUBSIDIARIES**

**CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS** 

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **Three months ended March 31,** | **Three months ended March 31,** |
|  | **2026** | **2025** |
|  | **(In thousands)** | **(In thousands)** |
| CASH FLOWS FROM OPERATING ACTIVITIES: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Net (loss) income | $(16619) | $13158 |
| &nbsp;&nbsp;&nbsp;&nbsp;Adjustments to reconcile net (loss) income to net cash used in<br> operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Stock-based compensation | 6455 | 5385 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest on liability for sale of future royalties | 2565 | 3577 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Sold portion of royalty revenue | (3275) | (3000) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Write-off of inventory | 1075 | 466 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Noncash lease expense of right-of-use assets | 532 | 544 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation and amortization | 6382 | 2106 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(Gain) loss on foreign currency transactions | (1318) | 2509 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net accretion of investments | (271) | (919) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Change in fair value of contingent liability | 2777 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Amortization of debt discount and issuance costs | 452 | 109 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Loss on settlement of debt | 917 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other, net | (62) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Change in deferred tax liability |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Changes in operating assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable, net | 10290 | (17096) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Inventory | (14928) | (1472) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 6557 | (3044) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other assets | (2416) | (1661) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | 7110 | (1751) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | (5771) | 134 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Deferred revenue | (4878) | (4450) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities | (939) | (972) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash used in operating activities | (5365) | (6377) |
| CASH FLOWS FROM INVESTING ACTIVITIES: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Purchase of available-for-sale securities | (10301) | (44104) |
| &nbsp;&nbsp;&nbsp;&nbsp;Proceeds from maturities of available-for-sale securities | 30906 | 50396 |
| &nbsp;&nbsp;&nbsp;&nbsp;Purchase of property and equipment | (1880) | (330) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash provided by investing activities | 18725 | 5962 |
| CASH FLOWS FROM FINANCING ACTIVITIES: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Principal payments on senior convertible notes | (35502) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Net proceeds related to issuance of common stock associated with<br> restricted stock units and stock options | 105 | 1590 |
| &nbsp;&nbsp;&nbsp;&nbsp;Principal payments on financing liability | (279) | (200) |
| &nbsp;&nbsp;&nbsp;&nbsp;Proceeds from market price stock purchase plan | 270 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash (used in) provided by financing activities | (35406) | 1390 |
| **NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH** | (22046) | 975 |
| **CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD** | 75627 | 47076 |
| **CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD** | $53581 | $48051 |

---

---

| | | |
|:---|:---|:---|
|  | **Three months ended March 31,** | **Three months ended March 31,** |
|  | **2026** | **2025** |
|  | **(In thousands)** | **(In thousands)** |
| **SUPPLEMENTAL CASH FLOWS DISCLOSURES:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest paid in cash | 9746 | $3012 |
| &nbsp;&nbsp;&nbsp;&nbsp;Income taxes paid in cash | 63 | 207 |
| **NON-CASH INVESTING AND FINANCING ACTIVITIES:** |  |  |
| &nbsp;&nbsp;Issuance of common stock upon settlement of senior convertible notes | 1735 |  |
| &nbsp;&nbsp;Purchases of property and equipment included in accounts payable and accrued expenses | 267 | 144 |

---

See notes to condensed consolidated financial statements.

------

**MANNKIND CORPORATION AND SUBSIDIARIES**

**NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS** 

**(Unaudited)** 

**1. Description of Business and Significant Accounting Policies** 

The unaudited condensed consolidated financial statements of MannKind Corporation and its subsidiaries ("MannKind," the "Company," "we" or "us"), have been prepared in accordance with generally accepted accounting principles in the United States of America ("GAAP") for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the "SEC"). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The information included in this quarterly report on Form 10-Q should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026 (the "Annual Report").

In the opinion of management, all adjustments, consisting only of normal, recurring adjustments, considered necessary for a fair presentation of the results of these interim periods have been included. The results of operations for the three months ended March 31, 2026 may not be indicative of the results that may be expected for the full year.

*Financial Statement Estimates* — The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and notes. Actual results could differ from those estimates or assumptions. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. These effects could have a material impact on the estimates and assumptions used in the preparation of the condensed consolidated financial statements. The more significant estimates include revenue recognition, including gross-to-net adjustments, stand-alone selling price considerations for recognition of collaboration revenue and measurement of progress related to recognition of deferred revenue for collaboration revenue, the fair value of developed technology and in process research and development ("IPR&D"), assessing long-lived assets for impairment, the fair value of the contingent consideration liability, clinical trial expenses, inventory costing, interest expense on liability for sale of future royalties, stock-based compensation, the determination of the provision for income taxes and corresponding deferred tax assets and liabilities, the valuation allowance recorded against net deferred tax assets, and expected cash flows from royalties received in connection with United Therapeutics' ("UT's") net revenue for the sale of Tyvaso DPI.

*Business* — MannKind is a biopharmaceutical company focused on the development and commercialization of patient-centric therapies that address serious unmet medical needs for those living with cardiometabolic and orphan lung diseases. The Company is currently commercializing three products: Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes; Furoscix (furosemide injection), to treat fluid buildup in patients with chronic heart failure or chronic kidney disease; and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. The Company also developed Tyvaso DPI (treprostinil) inhalation powder, which is approved for the treatment of pulmonary arterial hypertension ("PAH") and for the treatment of pulmonary hypertension associated with interstitial lung disease ("PH-ILD"). The Company receives a royalty on net sales and revenue from supplies of Tyvaso DPI that it manufactures for its development and marketing partner, United Therapeutics.

*Basis of Presentation* — The condensed consolidated financial statements have been prepared in accordance with GAAP.

*Principles of Consolidation* — The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated.

*Reclassifications* — Certain immaterial amounts reported in prior year's accrued expenses footnote have been reclassified to conform with the current year presentation.

*Segment Information* — Operating segments are identified as components of an enterprise which engage in business activities that result in revenue and expenses for which separate discrete financial information is available for evaluation by the chief operating decision-maker (the "CODM") in making decisions regarding resource allocation and assessing performance on a regular basis. The CODM is comprised of the Company's CEO and CFO. To date, the Company has viewed its operations and manages its business as a single reportable segment operating in the United States of America. The business and accounting policies of the Company's single reportable segment are further explained below. The measure of segment assets is reported as total assets in the consolidated balance sheets. No intra-entity sales or transfers are transacted within the Company.

The key metric utilized by the CODM to assess resource allocation and performance is the Company's segment net income, which is the same as the consolidated net income reported in the condensed consolidated statements of operations. The CODM also analyzes

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the Company's consolidated net income to evaluate its return on segment assets and to establish budgets and forecasts. The table below shows the details of the Company's segment revenues and significant expense categories regularly provided to and reviewed by the CODM as well as other significant segment items included in consolidated net income in the condensed consolidated statements of operations:

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
| Revenues | **2026** | **2025** |
| &nbsp;&nbsp;&nbsp;&nbsp;Afrezza | $15273 | $14887 |
| &nbsp;&nbsp;&nbsp;&nbsp;Furoscix | 15493 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;V-Go | 3141 | 4086 |
| &nbsp;&nbsp;&nbsp;&nbsp;Collaborations and services | 23515 | 29376 |
| &nbsp;&nbsp;&nbsp;&nbsp;Royalties | 32749 | 30005 |
| Total revenues | 90171 | 78354 |
| Less significant segment expenses (income): |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cost of goods sold – commercial, excluding amortization of acquired intangible assets | 7509 | 3768 |
| &nbsp;&nbsp;&nbsp;&nbsp;Cost of revenue – collaborations and services | 9964 | 13748 |
| &nbsp;&nbsp;&nbsp;&nbsp;Amortization of intangible assets | 4367 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 17231 | 11022 |
| &nbsp;&nbsp;&nbsp;&nbsp;Selling | 38571 | 13762 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 15514 | 11252 |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest income, net | (1429) | (1956) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense, net | 12434 | 10632 |
| &nbsp;&nbsp;&nbsp;&nbsp;Loss on settlement of debt | 917 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Other<sup>(1)</sup> | 1712 | 2968 |
| Consolidated net (loss) income | $(16619) | $13158 |

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(1) Includes (gain) loss on foreign currency transaction, expense related to the fair value adjustment of the contingent consideration and income tax expense.

*Revenue Recognition* — The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services.

To determine revenue recognition for arrangements that are within the scope of Accounting Standards Codification ("ASC") Topic 606, *Revenue from Contracts with Customers* ("ASC 606"), the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.

At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company has two types of contracts with customers: (i) contracts for commercial product sales with wholesale distributors, specialty and retail pharmacies, and durable medical equipment suppliers ("DMEs") and (ii) collaboration arrangements.

*Revenue Recognition — Net Revenue — Commercial Product Sales —* The Company sells its products to a limited number of wholesale distributors, specialty and retail pharmacies, DMEs, specialty distributors and direct purchasers in the U.S. and India (collectively, its "Customers"). Wholesale distributors subsequently resell the Company's products to retail pharmacies and certain medical centers or hospitals. Specialty and retail pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company's products.

The Company transfers control and recognizes revenue upon delivery of product to wholesale distributors, specialty and retail pharmacies, DMEs, specialty distributors and direct purchasers. Product revenues are recorded net of applicable reserves, including discounts, allowances, rebates, returns and other incentives. See *Reserves for Variable Consideration* below.

*Reserves for Variable Consideration* — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade

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discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payers, and other indirect customers relating to the Company's sale of its products. These reserves, as further detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Significant judgment is required in estimating gross-to-net adjustments, including historical experience, payer channel mix, current contract prices under applicable programs, unbilled claims, claim submission time lags and inventory levels in the distribution channel.

Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reduce recognized revenue to the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.

The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company's analysis also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the current period estimates of gross-to-net adjustments and, therefore, the transaction price was not reduced further during the current period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from the Company's estimates, the Company will adjust these estimates, which would affect net revenue from commercial product sales and earnings in the period such variances become known.

*Trade Discounts and Allowances* — The Company generally provides Customers with discounts which include incentives, such as prompt pay discounts, that are explicitly stated in the Company's contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company's sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and as a reduction to accounts receivable, net.

*Product Returns* — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending 12 months after its expiration date, which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company's current return reserve percentage is estimated to be in the low single digits. Adjustments to the returns reserve are made when changes in the Company's assumptions result in revised estimates to the Company's assumptions.

*Provider Chargebacks and Discounts* — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase products from the Company. Customers charge the Company for the difference between what they pay for products and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is recorded in accrued expenses and other current liabilities. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer's notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit.

*Government Rebates* — The Company is subject to discount obligations under Medicare and state Medicaid programs. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities. Estimates around Medicaid have historically required significant judgment due to timing lags in receiving invoices for claims from states. For Afrezza and Furoscix, the Company also estimates the number of patients in the initial and catastrophic phases of the Part D benefit for whom the Company will owe an additional liability under the Medicare Part D Manufacturer Discount Program. The Company's liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for products that have been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. The Company's estimates include

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consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel.

*Payer Rebates* — The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates, including estimates for product that has been recognized as revenue, but which remains in the distribution channel, and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. The Company's estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel.

*Other Incentives* — Other incentives which the Company offers include voluntary patient support programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with the products that have been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities.

*Revenue Recognition — Collaborations and Services* — The Company enters into licensing, research or other agreements under which the Company licenses certain rights to its product candidates to third parties, conducts research or provides other services to third parties. The terms of these arrangements may include but are not limited to payment to the Company of one or more of the following: up-front license fees; development, regulatory, and commercial milestone payments; payments for commercial manufacturing and clinical supply services the Company provides; and royalties on net sales of licensed products and sublicenses of the rights. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment such as determining the performance obligation in the contract and determining the stand-alone selling price for each performance obligation identified in the contract.

If an arrangement has multiple performance obligations, the allocation of the transaction price is determined from observable market inputs, if available, and the Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue. Current deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. However, the timing of recognition is based on the Company's current estimates and, if the estimates should change in the future, the Company may recognize a different amount of deferred revenue over the next 12-month period. For further information, see Note 10 – *Collaborations, Licensing and Other Arrangements*.

The Company recognizes upfront license payments as revenue upon delivery of the license only if the license is determined to be a separate unit of accounting from the other undelivered performance obligations. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the license is not considered as a distinct performance obligation, then the license and other undelivered performance obligations would be evaluated to determine if such should be accounted for as a single unit of accounting. If concluded to be a single performance obligation, the transaction price for the single performance obligation is recognized as revenue over the estimated period of when the performance obligation is satisfied. If the license is considered to be a distinct performance obligation, then the estimated revenue is included in the transaction price for the contract, which is then allocated to each performance obligation based on the respective standalone selling prices.

Whenever the Company determines that an arrangement should be accounted for over time, the Company determines the period over which the performance obligations will be performed, and revenue will be recognized over the period the Company is expected to complete its performance obligations. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement, including estimating future revenue to be earned over the contract term.

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The Company's collaboration agreements typically entitle the Company to additional payments upon the achievement of development, regulatory and sales milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as upfront fees and research funding, in the Company's revenue calculation. If these milestones are not considered probable at the inception of the collaboration, the milestones will typically be recognized in one of two ways depending on the timing of when the milestone is achieved. If the milestone is improbable at inception and subsequently deemed probable of achievement, such will be added to the transaction price, resulting in a cumulative adjustment to revenue, based on measurement of progress.

The Company's collaboration agreements, for accounting purposes, represent contracts with customers and therefore are not subject to accounting literature on collaboration agreements. The Company grants licenses to its intellectual property, supplies raw materials, semi-finished goods or finished goods, provides research and development services and offers sales support for the co-promotion of products, all of which are outputs of the Company's ongoing activities, in exchange for consideration. Accordingly, the Company concluded that its collaboration agreements must generally be accounted for pursuant to ASC 606.

For collaboration agreements that allow collaboration partners to select additional optioned products or services, the Company evaluates whether such options contain material rights (i.e., have exercise prices that are discounted compared to what the Company would charge for a similar product or service to a new collaboration partner). The exercise price of these options includes a combination of licensing fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, the Company concludes the option does not contain a material right, and therefore is not included in the transaction price at contract inception.

The Company also evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts. Any change in transaction price is assessed by management as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•To the extent the change in estimated variable consideration relates to performance obligations that have been partially or fully satisfied, the effect of the change is recognized as an adjustment to revenue in the period of the change. This adjustment is recorded on a cumulative catch-up basis, reflecting the amount of revenue that would have been recognized if the revised estimate had been used since contract inception.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•To the extent the change in estimated variable consideration relates to performance obligations that have not yet been satisfied, or when the Company elects to use the practical expedient described above, the effect of the change is recognized prospectively over the remaining performance period.

With respect to the Company's significant collaboration and service agreement with UT that includes a long-term commercial supply agreement (as amended, the "CSA"), the Company initially identified three distinct performance obligations: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI ("R&D Services and License"); (2) development activities for the next generation of the product ("Next-Gen R&D Services"); and (3) a material right associated with the manufacturing and supply of product ("Manufacturing Services"). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were recorded to deferred revenue and are recognized over the Manufacturing Services performance obligation as required by ASC 606. Under the CSA, UT issued purchase orders for the supply of Tyvaso DPI with revenue recognized at the point in time in which control of the product is transferred to UT, and deferred revenue is recognized as product is delivered over the CSA term using an output method based on the estimate of the measurement of progress. In January 2026, the Company and UT executed the Seventh Amendment to the CSA (the "Seventh Amendment") which modified the CSA by establishing minimum annual purchase obligations for commercial supply as well as tiered pricing dependent on the volume of units purchased beginning in 2026 through the end of the CSA term. The Seventh Amendment is accounted for as a termination of the existing contract and the creation of a new contract. The outstanding balance of deferred revenue from the prior contract was carried forward into the new contract and included with the consideration expected to be received under the modified pricing terms. Upon the execution of the Seventh Amendment, the Company assessed the CSA with UT and determined that a material right existed for the optional manufacturing services and elected to account for it using the practical alternative allowed for under ASC 606 (i.e., allocate the transaction price to the optional services by reference to the services expected to be provided and the corresponding expected consideration). Under this practical alternative, the Company has made a policy election to recognize changes in estimated consideration attributable to the contract prospectively, such that the amount of revenue to be recognized per unit for future deliveries is adjusted, without recording a cumulative catch-up to amounts recognized in prior periods. Revenue is then recognized at the point in time in which control of the product is transferred to UT. See Note 10 – *Collaborations, Licensing and Other Arrangements*.

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*Revenue Recognition — Royalties —* The Company recognizes royalty revenue for a sales-based or usage-based royalty if it is promised in exchange for an intellectual property license. The royalty revenue is recognized as the subsequent sale of the product occurs or, if later and applicable, the satisfaction or partial satisfaction of the performance obligation to which the royalty has been allocated. The Company's UT License Agreement (as defined in Note 10 *– Collaborations, Licensing and Other Arrangements*) entitles it to receive a 10% royalty on net sales of Tyvaso DPI for the license of the Company's IP that was considered to be interdependent with the development activities that supported the approval of Tyvaso DPI. Although the Company recognizes a 10% royalty on net revenue from the sale of Tyvaso DPI as revenue, it only collects 9% of future royalties due to its sale in December 2023 of 1% of future royalties as detailed in Note 15 *– Commitments and Contingencies*.

*Milestone Payments* — At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis.

The Company's net revenue as shown on the condensed consolidated statement of operations is comprised of the following (in thousands):

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| **Net revenue:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Product revenue <sup>(1)</sup> | $55922 | $47791 |
| &nbsp;&nbsp;&nbsp;&nbsp;Services <sup>(2)</sup> | 1500 | 558 |
| &nbsp;&nbsp;&nbsp;&nbsp;Royalties <sup>(3)</sup> | 32749 | 30005 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total net revenue | $90171 | $78354 |

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(1)Amounts represent the revenue from Afrezza, Furoscix and V-Go sales to wholesale distributors, specialty and retail pharmacies, DMEs, specialty distributors and direct purchasers and from the manufacture of Tyvaso DPI delivered to UT.

(2)Amounts represent revenue generated from the Company's collaboration arrangements, including services related to the development agreement with UT as well as arrangements with other collaboration partners. See Note 10 – *Collaborations, Licensing and Other Arrangements*.

(3)Amounts represent royalties earned based on UT's net revenue from Tyvaso DPI sales.

**Cost of goods sold and cost of revenue**

The cost of goods sold – commercial, excluding amortization of acquired intangibles, of $7.5 million and $3.8 million for the three months ended March 31, 2026 and 2025, respectively, is associated with product revenue for Afrezza, Furoscix and V-Go. The cost of revenue – collaborations and services of $10.0 million and $13.7 million for the three months ended March 31, 2026 and 2025, respectively, is primarily associated with manufacturing activities for Tyvaso DPI.

*Cost of Goods Sold — Commercial* — Cost of goods sold - commercial is associated with the product revenue for Afrezza, Furoscix and V-Go and includes material, labor costs and manufacturing overhead. Write-offs of inventory and certain other period costs are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of goods sold excludes the cost of insulin purchased under the Company's Insulin Supply Agreement (the "Insulin Supply Agreement") with Amphastar Pharmaceuticals, Inc. ("Amphastar"). The Company incurs a quarterly capacity fee through its agreement with Amphastar which is included in cost of goods sold. See Note 15 – *Commitments and Contingencies* for additional information on this agreement. All insulin inventory on hand was written off and the full purchase commitment contract to purchase future insulin was accrued as a recognized loss on purchase commitments in prior years.

*Cost of Revenues* — *Collaborations and Services* — Cost of revenues for collaborations and services is primarily associated with product revenue for Tyvaso DPI and includes material, labor costs and manufacturing overhead. Write-offs of inventory and certain other period costs are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of revenues for collaborations and services also includes the cost of product development.

*Research and Development ("R&D") —* Clinical trial expenses result from obligations under contracts with vendors, consultants and clinical site agreements in addition to internal costs associated with conducting clinical trials. R&D costs are expensed as incurred. Clinical study and certain research costs are recognized over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Nonrefundable advance payments for services to be

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received in the future for use in R&D activities are recorded as prepaid assets and expensed in the period when the services are performed.

*Cash, Cash Equivalents and Restricted Cash* — The Company considers all highly liquid investments with original maturities of 90 days or less at the time of purchase, that are readily convertible into cash to be cash equivalents. As of March 31, 2026 and December 31, 2025, cash equivalents were comprised of interest-bearing money market funds, U.S. Treasury securities, corporate bonds and commercial paper with original maturities of 90 days or less from the date of purchase.

The Company records restricted cash when cash and cash equivalents are restricted as to withdrawal or usage. Restricted cash under a letter of credit issued in connection with a facility lease assumed by the Company that will not be available for use in the Company's operations within 12 months of the reporting date is presented in non-current assets.

*Available-for-Sale Investments* — The Company's available-for-sale investments consist primarily of highly liquid money market funds, commercial bonds and paper, and U.S. Treasury securities that are intended to facilitate liquidity and capital preservation. Available-for-sale investments are measured at fair value with realized gains and losses and unrealized losses related to credit risk reported in other income (expense) in the consolidated statements of operations. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income until realized. These investments with maturities less than 12 months are included in short-term investments and investments with maturities in excess of 12 months are included in long-term investments in the condensed consolidated balance sheets. The accretion of these investments, net of amortization, is recognized as interest income in the condensed consolidated statements of operations. See Note 3 *– Investments*.

*Concentration of Credit Risk* — Financial instruments that potentially subject the Company to concentration of credit risk consisted of cash and cash equivalents and investments. Cash and cash equivalents are held in high credit quality institutions. Cash equivalents consisted of interest-bearing money market funds and U.S. Treasury securities with original or remaining maturities of 90 days or less at the time of purchase. Investments generally consisted of commercial paper, corporate notes or bonds and U.S. Treasury securities. Cash equivalents and investments are regularly monitored by management.

*Accounts Receivable and Allowance for Credit Losses* — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for credit losses if there are estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for credit losses. The allowance for expected credit losses is based primarily on past collections experience relative to the length of time receivables are past due. However, when available evidence reasonably supports an assumption that future economic conditions will differ from current and historical payment collections, an adjustment is reflected in the allowance for expected credit losses. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company's customers have the right of setoff for these amounts against the related accounts receivable.

*Pre-Launch Inventory* — The Company periodically evaluates whether costs incurred to manufacture inventory prior to regulatory approval or commercial validation should be capitalized as inventory or expensed as research and development. Such costs are capitalized only when management determines that the inventory is expected to provide probable future economic benefit and is likely to be used in commercial production. If management is aware of any specific material risks or contingencies other than the normal regulatory reporting process, or if the criteria for capitalizing inventory produced prior to regulatory approval are otherwise not met, the Company would not capitalize such inventory costs, and would instead recognize such costs as R&D expense in the period incurred. See Note 5 – *Inventories.*

*Inventories* — Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company's products based on management's judgment that future economic benefits are expected to be realized; otherwise, such costs are expensed as incurred as cost of goods sold. The Company uses contract manufacturing organizations ("CMOs") in the U.S. and outside of the U.S. to produce its Furoscix inventory and a CMO outside of the U.S. for certain stages of V-Go inventory.

The Company periodically analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value and writes down such inventories, as appropriate. In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or may become obsolete or are forecasted to become obsolete due to expiration, the Company will record a charge to write down such unmarketable inventory to its estimated net realizable value.

The Company analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. The Company performs an assessment of projected sales and evaluates the lower of cost or net realizable value and the potential excess inventory on hand at the end of each reporting period. Excess and obsolete inventory identified, if any, are recorded as an inventory write-off within the condensed consolidated statements of operations and comprehensive loss.

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*Property and Equipment* — Property and equipment is recorded at historical cost, net of accumulated depreciation. Depreciation expense is recorded over the assets' useful lives on a straight-line basis and included in cost of goods sold, research and development, and selling, general and administrative expense in the condensed consolidated statements of operations. See Note 6 – *Property and Equipment*.

*Impairment of Long-Lived Assets* — Long-lived assets include property and equipment, operating lease right-of-use assets and other intangible assets. The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Assets are considered to be impaired if the carrying value is considered to be unrecoverable.

If the Company believes an asset to be impaired, the impairment recognized is the amount by which the carrying value of the asset exceeds the fair value of the asset. Fair value is determined using market, income or cost approaches as appropriate for the asset. Any write-downs are treated as permanent reductions in the carrying amount of the asset and recognized as an operating loss.

*Acquisitions —* The Company first determines whether a set of assets acquired constitute a business and should be accounted for as a business combination. If the assets acquired do not constitute a business, the Company accounts for the transaction as an asset acquisition. Business combinations are accounted for by means of the acquisition method of accounting. Under the acquisition method, assets acquired, including developed technology and in-process R&D ("IPR&D"), and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company's condensed consolidated financial statements. Leases are recorded at the net present value of the remaining lease payments. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. A gain on bargain purchase is recorded if the fair value of the net assets acquired exceeds the fair value of the consideration transferred. Contingent consideration obligations incurred in connection with a business combination (including the assumption of an acquiree's liability arising from an acquisition it consummated prior to the Company's acquisition) are recorded at their fair values on the acquisition date and remeasured at their fair values each subsequent reporting period until the related contingencies have been resolved. The resulting changes in fair values are recorded in earnings. Measurement period adjustments related to acquired assets and liabilities may be recorded within one year of the acquisition date and are recognized in earnings in the period in which the adjustments are identified. The accompanying consolidated balance sheet as of March 31, 2026 includes certain assets acquired and liabilities assumed based on management's preliminary estimates of their respective fair values such as valuation of acquired intangible assets, contingent liabilities and deferred tax assets and liabilities. The Company expects to finalize these fair value measurements as additional information becomes available, including completion of its review of acquired contractual arrangements and other relevant facts and circumstances. See Note 2 *– Business Combinations*.

In contrast, asset acquisitions are accounted for by using a cost accumulation and allocation model. Under this model, the cost of the acquisition is allocated to the assets acquired and liabilities assumed. IPR&D projects with no alternative future use are recorded in R&D expense upon acquisition, and contingent consideration obligations incurred in connection with an asset acquisition are recorded when it is probable that they will occur and they can be reasonably estimated.

*Goodwill and Other Intangible Assets —* The fair value of acquired intangible assets is determined using either a cost approach or an income approach. The cost approach establishes fair value based on the cost of reproducing or replacing the asset, less depreciation for functional or economic obsolescence. The income approach, referred to as the excess earnings method, utilizes Level 3 fair value inputs to determine the present value of future economic benefits to be derived from ownership of the intangible asset. Market participant valuations assume a global view considering all potential jurisdictions and indications based on discounted after-tax cash flow projections, risk adjusted for estimated probability of technical and regulatory success.

The Company tests for impairment annually on a reporting unit basis, at the beginning of the Company's fourth fiscal quarter and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying amount. To the extent the carrying amount of a reporting unit is less than its estimated fair value, an impairment charge will be recorded.

Finite-lived intangible assets are amortized on a straight-line basis over the estimated useful life. Estimated useful lives are determined considering the period assets are expected to contribute to future cash flows. Finite-lived intangible assets are tested for impairment when facts or circumstances suggest that the carrying value of the asset may not be recoverable. If the carrying value exceeds the projected undiscounted pretax cash flows of the intangible asset, an impairment loss equal to the excess of the carrying value over the estimated fair value (discounted after-tax cash flows) is recognized.

IPR&D acquired in a business combination is considered an indefinite-lived intangible asset until the completion or abandonment of the associated R&D efforts. During the R&D period, the asset is not amortized but rather is tested for impairment annually, or when facts or circumstances suggest that the carrying value of the asset may not be recoverable. Once the R&D efforts are completed, the Company accounts for the resulting asset as a finite-lived intangible asset. If the R&D efforts are abandoned, the asset balance is written off to R&D expense.

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*Recognized Loss on Purchase Commitments* — The Company reviews the terms of the long-term supply agreements and assesses the need for any accrual for estimated losses, such as lower of cost or net realizable value, that will not be recovered by future product sales. The recognized loss on purchase commitments is reduced as inventory items are received or as the liability is extinguished. See Note 15 – *Commitments and Contingencies*.

*Milestone Rights Liability* — In July 2013, in conjunction with the execution of a (now repaid) loan agreement with Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, "Deerfield"), the Company entered into a Milestone Rights Purchase Agreement (the "Milestone Rights Agreement") pursuant to which the Company issued certain milestone rights to Deerfield Private Design Fund II, L.P. and Horizon Santé FLML SÀRL (the "Original Milestone Purchasers"). The foregoing milestone rights provided the Original Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and Afrezza sales milestones, $45.0 million of which remains payable as of March 31, 2026 upon achievement of such milestones (collectively, the "Milestone Rights"). In December 2021, the Milestone Rights were purchased by Barings Global Special Situations Credit Fund 4 (Delaware), L.P. and Barings Global Special Situations Credit 4 (LUX) S.ar.l. (together, the "Milestone Purchasers"). As a result, the Milestone Purchasers have assumed the rights and obligations of the Original Milestone Purchasers and are now entitled to all rights under the Milestone Rights Agreement. The Milestone Rights liability is reported at fair value at the date of the agreement which is periodically offset against payments. See Note 11 – *Fair Value of Financial Instruments*.

The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones and discounted to present value using a selected market discount rate. The expected timing and probability of achieving the milestones was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The Milestone Rights liability is remeasured as the specified milestone events are achieved. Specifically, as each milestone event is achieved, the portion of the initially recorded Milestone Rights liability that pertains to the milestone event being achieved, is remeasured to the amount of the specified related milestone payment. The resulting change in the balance of the Milestone Rights liability due to remeasurement is recorded in the Company's condensed consolidated statements of operations as interest expense. Furthermore, the Milestone Rights liability is reduced upon the settlement of each milestone payment. As a result, each milestone payment would be effectively allocated between a reduction of the recorded Milestone Rights liability and an expense representing a return on a portion of the Milestone Rights liability paid to the investor for the achievement of the related milestone event. See Note 8 – *Accrued Expenses and Other Current Liabilities* and Note 15 – *Commitments and Contingencies*.

*Fair Value of Financial Instruments* — The Company applies various valuation approaches in determining the fair value of its financial assets and liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

Level 1 — Quoted prices for identical instruments in active markets.

Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.

Level 3 — Significant inputs to the valuation model are unobservable.

*Income Taxes* — The provisions for federal, foreign, state and local income taxes are calculated on pre-tax income based on current tax law and include the cumulative effect of any changes in tax rates from those used previously in determining deferred tax assets and liabilities. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which the temporary differences are expected to be recovered or settled. A valuation allowance is recorded to reduce net deferred income tax assets to amounts that are more likely than not to be realized.

For uncertain tax positions, the Company determines whether it is "more likely than not" that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit can be recorded in the financial statements. For those tax positions where it is "not more likely than not" that a tax benefit will be sustained, no tax benefit is recognized. Penalties, if probable and reasonably estimable, are recognized as a component of income tax expense. The Company has reduced its deferred tax assets for uncertain tax positions but has not recorded liabilities for income tax expense, penalties, or interest.

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*Contingencies* — The Company records a loss contingency for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These accruals represent management's best estimate of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation and may revise its estimates.

*Stock-Based Compensation* — Share-based payments to employees, including grants of restricted stock units ("RSUs"), performance-based restricted stock units ("Performance RSUs"), performance-based non-qualified stock options awards ("PNQs"), restricted stock units with market conditions ("Market RSUs"), options and the compensatory elements of employee stock purchase plans, are recognized in the condensed consolidated statements of operations based upon the fair value of the awards at the grant date. RSUs are valued based on the market price on the grant date. Market RSUs are valued using a Monte Carlo valuation model and RSUs with performance conditions are evaluated for the probability that the performance conditions will be met and estimates the date at which the performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. The Company uses the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options and the compensatory elements of employee stock purchase plans. See Note 14 – *Stock-Based Compensation Expense*.

*Net Income or Loss Per Share of Common Stock* — Basic net income or loss per share ("EPS") is computed by dividing net income or loss by the weighted average number of common shares outstanding for the period. Diluted EPS reflects the effect of potential common stock issuances resulting from assumed stock option exercises and vesting of RSUs, unless the effect is anti-dilutive, when applying the treasury stock method, as well as potential dilution under the if-converted method for convertible debt securities. For periods where the Company has presented a net loss, potentially dilutive securities are excluded from the computation of diluted EPS as they would be anti-dilutive.

*Recently Issued Accounting Standards*

In November 2024, the FASB issued ASU No. 2024-03, *Disaggregation of Income Statement Expenses*, which amends ASC 220-40, *Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40)*, to require disaggregated disclosure of income statement expenses for public entities. This ASU does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. The objective of this ASU is to address requests from investors for more detailed information about the types of expenses included in commonly presented expense captions. This ASU is effective for all public entities for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. While the Company does not anticipate a material impact on its financial position, results of operations, or cash flows, adoption of this ASU will result in additional disclosures related to the disaggregation of income statement expenses.

In September 2025, the FASB issued ASU No. 2025-06, *Targeted Improvements to the Accounting for Internal-Use Software*, which modifies the accounting for software costs under Subtopic 350-40, *Intangibles - Goodwill and Other - Internal-Use Software*. The objective of this ASU is to better align the accounting with how software is being developed by removing all references to prescriptive and sequential software development. Instead, an entity is required to start capitalizing software costs when both management has authorized and committed to funding the software project and it is probable that the project will be completed and the software will be used for its intended purpose. This ASU is effective for all entities subject to the internal-use software guidance in Subtopic 350-40 for annual reporting periods beginning after December 15, 2027. Early adoption is permitted at the start of an annual period. The Company is currently evaluating the potential impact of this ASU on its financial position, results of operations or cash flows.

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company's condensed consolidated financial position or results of operations upon adoption.

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**2. Business Combinations**

On October 7, 2025 (the "Merger Date"), the Company completed its merger with scPharmaceuticals Inc. ("scPharma") at a price of $5.35 per share in cash plus one non-tradable contingent value right ("CVR") per share, which represents the right to receive up to an aggregate amount of $1.00 per CVR in cash upon the achievement of certain regulatory and net sales milestones on or prior to the applicable milestone outside dates, for total consideration of up to $6.35 per share in cash, representing a total equity value of approximately $303.8 million and representing a total deal value of up to approximately $363.5 million if the CVR milestones are achieved at the maximum payment amount.

*Accounting Treatment*

The merger with scPharma was accounted for as a business combination using the acquisition method of accounting, which requires the assets acquired and liabilities assumed to be recognized at their respective fair values as of the Merger Date and resulted in the recognition of a developed technology intangible asset of $194.0 million and an IPR&D intangible asset of $129.6 million. The excess of purchase price over the fair value of the net assets acquired in this transaction was recorded as $65.7 million in goodwill. See Note 7 – *Goodwill and Other Intangible Assets*.

The fair value of the acquired developed technology related to the on-body infusor and the IPR&D were derived using an income approach, specifically a projected discounted cash flow method, adjusted for the probability of regulatory and commercial success. The projected discounted cash flow models used to estimate the Company's Developed technology and IPR&D reflect significant assumptions regarding the estimates a market participant would make in order to evaluate a commercial drug and a drug development asset, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The extent, character and utility of the intangible assets

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The cost-savings attributes of the intangible assets

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The nature of the functional or economic obsolescence of each intangible asset, and,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The relative risk and uncertainty associated with an investment in intangible assets

The determination of the fair value of the developed technology and IPR&D intangible assets as such, required management to make significant estimates and assumptions related to future cash flows and the discount rate. The discount rates used in the determination of fair value for developed technology and IPR&D were both 23% and both used a royalty rate of 10%. The developed technology and IPR&D are both level 3 in the fair value hierarchy described above in Note 1 – *Description of Business and Significant Accounting Policies*.

*Contingent Value Right ("CVR")*

The contingent consideration for the CVR is included in Contingent consideration - short term and Contingent consideration - long term in the table above and in the consolidated balance sheets and is achieved through the following milestones:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*1. Milestone 1:* Receipt of FDA approval of a drug-device combination product comprising high concentration furosemide (the "ReadyFlow Formulation") delivered either in an autoinjector or a self-dose injection delivery system (such milestone, "Milestone 1") with (a) $0.75 per CVR if Milestone 1 is achieved by September 30, 2026, (b) $0.50 per CVR if Milestone 1 is achieved by December 31, 2026 and (c) $0.25 per CVR if Milestone 1 is achieved by June 30, 2027.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2. Milestone 2:* Achievement in any trailing consecutive 12-month period ending prior to and including December 31, 2026 of at least $110.0 million of worldwide net sales of Furoscix and, if any, the ReadyFlow Formulation (collectively, the "Products") in such 12-month period ("Milestone 2") with (a) $0.25 per CVR upon the achievement of $120.0 million of worldwide net sales in such period and (b) between $0.10 and $0.25 per CVR if, as of December 31, 2026, the highest worldwide net sales in any trailing 12-month period were between $110.0 million and $120.0 million, which payment will be calculated on a straight-line basis such that the payment per CVR increases proportionally as worldwide net sales increase from $110.0 million to $120.0 million. Milestone 2 will not be achieved if trailing worldwide net sales are less than $110.0 million during this period. No payment shall be made if the highest worldwide net sales in any trailing twelve-month period are less than $110.0 million.

The CVR was valued using both a Scenario-Based Method for Milestone 1 and a Monte Carlo Simulation Method for Milestone 2 to estimate the probability of success. The probability adjusted cash flow included significant estimates and assumptions pertaining to commercialization events and net sales received by the Company during the term of the CVR Agreement (as discussed above). See Note 11 – *Fair Value of Financial Instruments* for the key assumptions used in determining fair value.

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The contingent consideration liability is remeasured each subsequent reporting period until the related contingencies have been resolved. For the three months ended March 31, 2026, the Company recorded $2.8 million to other expense as a result of the remeasurement of the fair value of the contingent consideration liability obtained from the acquisition of scPharma. The following table summarizes the activities within the account balance as of March 31, 2026 (in thousands):

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| | |
|:---|:---|
| Beginning balance as of January 1, 2026 | $26246 |
| Fair value changes | 2777 |
| Balance as of March 31, 2026 | $29023 |

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*Measurement period adjustments*

During the three months ended March 31, 2026, the Company did not record any measurement period adjustments to its acquired assets and liabilities. The Company expects to finalize the purchase price allocation within the one year measurement period, ending October 7, 2026.

**3. Investments**

*Cash Equivalents* — Cash equivalents consist of highly liquid investments with original maturities of 90 days or less at the time of purchase that are readily convertible into cash.

*Available-for-Sale Investments Portfolio* —The Company's investments portfolio consists of highly liquid money market funds, commercial bonds and paper, and U.S. Treasury securities (collectively, the "Investments") for which the Company accounts for as available-for-sale. Unrealized gains and losses are recorded in other comprehensive income.

The contractual maturities of the Investments are summarized below (in thousands):

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **March 31, 2026** | **March 31, 2026** | **December 31, 2025** | **December 31, 2025** |
|  | **Available-for-Sale Investments** | **Available-for-Sale Investments** | **Available-for-Sale Investments** | **Available-for-Sale Investments** |
|  | **Amortized<br>Cost Basis** | **Aggregate<br>Fair Value** | **Amortized<br>Cost Basis** | **Aggregate<br>Fair Value** |
| Due in one year or less<sup>(1)</sup> | $109083 | $109079 | $132732 | $132836 |
| Due after one year through five years |  |  | 5001 | 5012 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total | $109083 | $109079 | $137733 | $137848 |

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(1)The investments due in one year or less include cash equivalents of $28.1 million as of March 31, 2026 and $36.4 million as of December 31, 2025.

The fair values of the Investments are disclosed below (dollars in thousands):

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
|  | **March 31, 2026** | **March 31, 2026** | **March 31, 2026** | **March 31, 2026** | **March 31, 2026** |
| **Available-for-Sale Investments** | **Investment Level** | **Amortized Cost<br>(Carrying Value)** | **Gross Unrealized Holding Gains** | **Gross Unrealized<br>Holding Losses** | **Estimated<br>Fair Value** |
| Money market funds | Level 1 | $15354 | $— | $— | $15354 |
| Commercial bonds and paper | Level 2 | 33178 | 5 | (12) | 33171 |
| U.S. Treasury securities | Level 2 | 60551 | 16 | (13) | 60554 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total cash equivalents and investments |  | 109083 | 21 | (25) | 109079 |
| Less: cash equivalents |  | (28052) |  |  | (28052) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total Investments |  | $81031 | $21 | $(25) | $81027 |

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
|  | **December 31, 2025** | **December 31, 2025** | **December 31, 2025** | **December 31, 2025** | **December 31, 2025** |
| **Available-for-Sale Investments** | **Investment Level** | **Amortized Cost<br>(Carrying Value)** | **Gross Unrealized Holding Gains** | **Gross Unrealized<br>Holding Losses** | **Estimated<br>Fair Value** |
| Money market funds | Level 1 | $28303 | $— | $— | $28303 |
| Commercial bonds and paper | Level 2 | 21230 | 28 |  | 21258 |
| U.S. Treasury securities | Level 2 | 88200 | 99 | (12) | 88287 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total cash equivalents and investments |  | 137733 | 127 | (12) | 137848 |
| Less: cash equivalents |  | (36372) |  |  | (36372) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total Investments |  | $101361 | $127 | $(12) | $101476 |

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As of March 31, 2026 and December 31, 2025, there was $0.6 million and $0.7 million, respectively, of accrued interest receivable on investments which is included in prepaid expense and other current assets in our condensed consolidated balance sheets.

*Available-for-Sale Investment — Thirona —* In June 2021 and January 2022, the Company purchased $3.0 million and $5.0 million, respectively, of convertible promissory notes issued by Thirona Bio, Inc. ("Thirona"). Following Thirona's cessation of operations in September 2025 after recent clinical trial results, the Company determined the investment was other-than-temporarily impaired and recorded a $6.6 million impairment loss, inclusive of the write-off of $1.3 million of previously recognized unrealized gains, representing the fair value at that time. The Company also wrote off approximately $1.1 million of interest receivable, with the impairment recorded in other income (expense) in the consolidated statements of operations for the year ended December 31, 2025.

**4. Accounts Receivable** 

Accounts receivable, net consists of the following (in thousands):

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| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **December 31, 2025** |
| Accounts receivable – commercial |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable, gross | $28120 | $44274 |
| &nbsp;&nbsp;&nbsp;&nbsp;Wholesaler distribution fees and prompt pay discounts | (3208) | (3332) |
| &nbsp;&nbsp;&nbsp;&nbsp;Reserve for returns | (9806) | (10208) |
| &nbsp;&nbsp;&nbsp;&nbsp;Allowance for credit losses |  | (61) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total accounts receivable – commercial, net | 15106 | 30673 |
| Accounts receivable – collaborations and services | 13031 | 7694 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total accounts receivable, net | $28137 | $38367 |

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As of March 31, 2026, there was no allowance for credit losses and doubtful accounts for commercial accounts receivable or credit losses for collaborations and services accounts receivable. As of March 31, 2026 and December 31, 2025, the Company's three customers representing the largest individual accounts receivable balances accounted for approximately 54% and 68% of commercial accounts receivable, respectively. As of March 31, 2026 and December 31, 2025, the Company's collaboration partner, UT, comprised 96% and 94%, respectively, of the collaborations and services accounts receivable.

UT comprised of approximately 62% and 75% of consolidated revenues for the three months ended March 31, 2026 and 2025, respectively. For the three months ended March 31, 2026, no single commercial customer accounted for 10% or more of the Company's consolidated revenues. For the three months ended March 31, 2025, one other commercial customer accounted for approximately 11% of the Company's consolidated revenues.

**5. Inventories**

Inventories consist of the following (in thousands):

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| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **December 31, 2025** |
| Raw materials | $9518 | $14757 |
| Work-in-process | 32391 | 11087 |
| Finished goods | 7257 | 9469 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total inventory | $49166 | $35313 |

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Work-in-process and finished goods as of March 31, 2026 and December 31, 2025 include conversion costs and exclude the cost of insulin. All insulin inventory on hand was written off in prior years and the projected loss on the purchase commitment contract to

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purchase future insulin was accrued in prior years. See Note 15 – *Commitments and Contingencies* under *Contingencies — Commitments.* Raw materials inventory included $1.7 million and $0.8 million of pre-launch inventory as of March 31, 2026 and December 31, 2025, respectively, which consisted of fumaryl diketopiperazine and autoinjector components.

The Company analyzed its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. The Company also performed an assessment of projected sales and evaluated the lower of cost or net realizable value and the potential excess inventory on hand as of March 31, 2026 and December 31, 2025. Inventory that did not meet acceptable standards, or was forecasted to become obsolete due to expiration, is reserved for inventory obsolescence in the condensed consolidated balance sheets and recorded as costs of goods sold in the condensed consolidated statements of operations.

**6. Property and Equipment** 

Property and equipment consisted of the following (dollars in thousands):

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| | | | |
|:---|:---|:---|:---|
|  | **Estimated Useful<br>Life (Years)** | **March 31, 2026** | **December 31, 2025** |
| Land |  | $875 | $875 |
| Buildings | 39-40 | 17389 | 17389 |
| Building improvements | 5-40 | 90915 | 90988 |
| Machinery and equipment | 3-15 | 69550 | 68785 |
| Furniture, fixtures and office equipment | 5-10 | 3166 | 3122 |
| Computer equipment and software | 3 | 8780 | 8780 |
| Construction in progress |  | 7670 | 6397 |
|  |  | 198345 | 196336 |
| Less accumulated depreciation |  | (115791) | (113913) |
| &nbsp;&nbsp;&nbsp;&nbsp;Total property and equipment, net |  | $82554 | $82423 |

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Depreciation expense related to property and equipment was as follows (in thousands):

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| Depreciation expense | $2015 | $2058 |

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During each of the three months ended March 31, 2026 and 2025, the Company retired $0.1 million of manufacturing equipment, computer hardware and software, computer equipment, lab equipment, and building improvements, as it was no longer in service. The net book value for the disposed assets in both periods was *de minimis*.

**7. Goodwill and Other Intangible Assets**

*Goodwill* — Goodwill represents the excess of the purchase price over the identifiable tangible and intangible assets acquired plus liabilities assumed arising from business combinations. Goodwill is tested at least annually for impairment by assessing qualitative factors in determining whether it is more likely than not that the fair value of net assets is below their carrying amounts. See Note 1 – *Description of Business and Significant Accounting Policies*.

In 2022, the Company recorded additions of $1.9 million to Goodwill related to its acquisition of V-Go. In 2025, the Company recorded additions of $65.7 million to Goodwill related to its merger with scPharma.

*Intangible Assets* — Intangible assets consisted of the following (dollars in thousands):

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **Estimated** | **March 31, 2026** | **March 31, 2026** | **March 31, 2026** | **December 31, 2025** | **December 31, 2025** | **December 31, 2025** |
|  | **Useful<br>Life (Years)** | **Cost** | **Accumulated<br>Amortization** | **Net Book Value** | **Cost** | **Accumulated<br>Amortization** | **Net Book Value** |
| Developed technology - on-body infusor | 11.25 | 194000 | (8292) | 185708 | 194000 | (3973) | 190027 |
| ReadyFlow Formulation – IPR&D |  | 129600 |  | 129600 | 129600 |  | 129600 |
| iSPERSE License – IPR&D<sup>(1)</sup> |  | 4300 |  | 4300 | 4300 |  | 4300 |
| Developed technology - V-Go<sup>(1)</sup> | 7.5 | 1200 | (476) | 724 | 1200 | (428) | 772 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total |  | $329100 | $(8768) | $320332 | $329100 | $(4401) | $324699 |

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(1)Included within Other intangible assets on the consolidated balance sheets.

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Amortization expense related to the Developed technology - on-body infusor ("on-body infusor") was $4.3 million for the three months ended March 31, 2026. The on-body infusor was acquired from scPharma in October 2025. See Note 2 – *Business Combinations*. The estimated annual amortization expense for the on-body infusor will be approximately $17.3 million per year for the years ended December 31, 2026 through 2036. Amortization expense related to the Developed technology - V-Go was *de minimis* for the three months ended March 31, 2026 and 2025. The estimated annual amortization expense for the Developed technology - V-Go will be approximately $0.2 million per year for the years ended December 31, 2026 through 2029.

The ReadyFlow Formulation is an indefinite-lived intangible asset, and as such is not amortized but rather is tested for impairment annually, or when facts or circumstances indicate the carrying value of the asset may not be recoverable. Once available for use, the intangible asset will be accounted for as a finite-lived intangible asset. If the R&D efforts are abandoned, the IPR&D asset balance will be written off to R&D expense. The ReadyFlow Formulation was acquired from scPharma in October 2025 and was determined to be a Level 3 asset. See Note 11 – *Fair Value of Financial Instruments* for a description of the fair value hierarchy.

The iSPERSE License – IPR&D is an indefinite-lived intangible asset, and as such is not amortized but rather is tested for impairment annually, or when facts or circumstances indicate the carrying value of the asset may not be recoverable. Upon completion of the underlying R&D efforts, the intangible asset will be accounted for as a finite-lived intangible asset. If the R&D efforts are abandoned, the IPR&D asset balance will be written off to R&D expense. The iSPERSE License IPR&D was acquired from Pulmatrix in July 2024.

The Company evaluates its other intangible assets for potential impairment when events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. See Note 1 – *Description of Business and Significant Accounting Policies*.

**8. Accrued Expenses and Other Current Liabilities** 

Accrued expenses and other current liabilities were comprised of the following (in thousands):

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| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **December 31, 2025** |
| Salary and related expenses | $29025 | $27645 |
| Discounts and allowances for commercial product sales | 12766 | 18202 |
| Commercial accruals | 4288 | 3502 |
| Accrued contract research organization | 2510 | 4863 |
| Accrued contract manufacturing organization | 1253 | 747 |
| Accrued royalty | 396 | 591 |
| Accrued interest | 1824 | 2152 |
| Operating lease liability - current | 1957 | 2110 |
| Current portion of milestone rights liability<sup>(1)</sup> | 520 | 520 |
| Professional fees | 1041 | 1015 |
| Returns reserve for acquired product<sup>(2)</sup> | 240 | 291 |
| Other | 2778 | 2990 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | $58598 | $64628 |

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(1)See Note 15 – *Commitments and Contingencies* under *Contingencies — Milestone Rights.*

(2)See Note 15 – *Commitments and Contingencies* under *Loss Contingencies — Returns Reserve for Acquired Product.*

**9. Borrowings** 

The Company's borrowings as of March 31, 2026 are as follows (in thousands):

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| | |
|:---|:---|
|  | **Amounts** |
| Blackstone term loan, due 2030 | 325000 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total principal payments | 325000 |
| Debt issuance costs | (6278) |
| &nbsp;&nbsp;&nbsp;&nbsp;Total debt | $318722 |

---

------

*<u>Blackstone Credit Facility</u>*

On August 6, 2025 (the "Closing Date"), the Company entered into a senior secured term loan agreement, which was subsequently amended on August 24, 2025 (as amended, the "Credit Agreement"), with Blackstone Alternative Credit Advisors LP, as Blackstone Representative and Lead Arranger (in such capacity, "Blackstone"), the lenders party thereto from time to time, the subsidiary guarantors party thereto from time to time, and Wilmington Trust, National Association, as administrative agent and collateral agent for the lenders (in such capacity, the "Agent").

Pursuant to the credit facility provided for by the Credit Agreement (the "Blackstone Credit Facility"), the lenders (i) funded a $75 million initial term loan on the Closing Date; (ii) provided $250.0 million in delayed draw term loans on October 7, 2025 in connection with the transactions contemplated by the merger agreement with scPharma, with an additional $50.0 million in delayed draw term loan commitments remaining available under the Credit Agreement subject to certain customary draw down conditions, and (iii) made available up to $300.0 million in the form of uncommitted delayed draw term loans, which the Company may borrow in the future subject to mutual agreement with Blackstone and the lenders under the Credit Agreement. After deducting debt issuance costs payable by the Company, the net proceeds from the Blackstone Credit Facility were approximately $317.7 million. Amortization of debt issuance costs related to the Blackstone Credit Facility for the three months ended March 31, 2026 were approximately $0.4 million. As of March 31, 2026, the unamortized debt issuance costs were $6.3 million.

The Blackstone Credit Facility will mature on August 6, 2030 (the "Maturity Date"). The Company elected to borrow the existing term loans as SOFR Loans, which bear interest at a rate per annum equal to one, three or six month term SOFR (at the Company's election), subject to a 2.00% floor (the "Adjusted Term SOFR"), plus a margin of 4.75%. Upon the occurrence and continuation of an event of default under the Credit Agreement, interest on the term loans accrues at the applicable rate plus 2.00% per annum. Interest is paid quarterly or, if the Company elects 1-month SOFR, monthly. The interest rate margin for a SOFR loan increases to 5.00% at any time the Company's ratio of indebtedness to adjusted EBITDA (measured on a trailing four quarter basis) is greater than or equal to 5.00:1.00 as of the most recent fiscal quarter for which the Company has delivered financial statements. As of March 31, 2026, the effective interest rate is 9.09% per annum. Term loans under the Credit Agreement are funded net of an upfront fee payable by the Company. The Company shall pay the delayed draw term loan lenders a ticking fee at a rate per annum equal to 1.00% of the daily unused portion of the delayed draw term loan commitments beginning on the one year anniversary of the agreement through the end of the delayed draw commitment period, payable quarterly in arrears.

All term loans under the Blackstone Credit Facility, as well as any accrued and unpaid interest and fees, are repayable on the Maturity Date. The Company has the option to prepay the loans under the Blackstone Credit Facility in whole or in part, subject to early prepayment fees in an amount equal to (a) the greater of (i) the present value of the sum of (x) 3.00% of the principal amount to be prepaid as if that amount would otherwise be prepaid on the first anniversary of the Closing Date, and (y) the amount of all interest which would otherwise have accrued under the Credit Agreement for the period from the date of such prepayment to the first anniversary of the Closing Date, assuming an interest rate for such period equal to the sum of the applicable margin for SOFR Loans plus Adjusted Term SOFR as of the date of determination, computed using a discount rate equal to the treasury rate as of such date plus 50 basis points (the "Make Whole Premium") and (ii) 3.00% of the principal amount to be prepaid if prepayment occurs on or prior to the first anniversary of the Closing Date, (b) 3.00% of principal prepaid if prepayment occurs after the first anniversary of the Closing Date but on or prior to the second anniversary of the Closing Date, (c) 1.00% of principal prepaid if prepayment occurs after the second anniversary of the Closing Date and prior to or on the third anniversary of the Closing Date and (d) 0.00% after the third anniversary of the Closing Date. In addition, subject to the terms and conditions of the Credit Agreement, the Company is required to make a mandatory prepayment of the term loans upon occurrence of certain events such as upon certain assets sales, events of loss, incurrence of debt not permitted to be incurred under the Credit Agreement, or a change of control.

The Company's obligations under the Blackstone Credit Facility are guaranteed by each of the Company's subsidiaries and any future subsidiaries, subject to limited exceptions set forth in the Credit Agreement, and are secured by a first-priority perfected security interest (subject to permitted liens), on substantially all of the assets of the Company and the subsidiary guarantors, including intellectual property.

The Credit Agreement includes representations and warranties, affirmative covenants (including reporting obligations), negative covenants and events of default that are usual and customary for facilities of this type, in each case, subject to certain permitted exceptions as set forth therein. The Credit Agreement also contains a financial covenant for the benefit of the lenders, which requires the Company to have liquidity of at least $40.0 million as of the last business day of each fiscal quarter ending after the Closing Date, with liquidity defined as our unrestricted cash and cash equivalents which are subject to a control agreement, in favor of the Agent, for the benefit of the lenders.

As of March 31, 2026, there were no events of default and the Company was in compliance with all covenants under the Credit Agreement.

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*<u>Senior convertible notes</u>*

In March 2021, the Company issued $230.0 million aggregate principal amount of senior convertible notes (the "senior convertible notes") in a private offering. The Company's net proceeds from the March 2021 offering were approximately $222.7 million, after deducting the initial purchasers' discounts and commissions and the estimated offering expenses payable by the Company. The senior convertible notes were issued pursuant to an indenture, dated March 4, 2021 (the "Indenture"), between the Company and U.S. Bank National Association, as trustee. The senior convertible notes were general unsecured obligations of the Company and matured on March 1, 2026. The senior convertible notes bore cash interest from March 4, 2021 at an annual rate of 2.50% payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2021.

On December 17, 2024, the Company entered into separate, privately negotiated exchange agreements (the "Exchange Agreements") with certain holders (the "Holders") of the senior convertible notes. Under the terms of the Exchange Agreements, the Holders agreed to exchange an aggregate principal amount of approximately $193.7 million of the senior convertible notes in exchange for an aggregate of 26,749,559 shares of the Company's common stock. In addition, pursuant to the exchange agreements, the Company made an aggregate cash payment of approximately $89.2 million to the Holders for additional exchange consideration. Immediately following the exchange, approximately $36.3 million in aggregate principal amount of the senior convertible notes remained outstanding.

On March 4, 2026, the Company settled the remaining $36.3 million aggregate principal amount of the senior convertible notes, all of which were tendered for conversion prior to the maturity date of March 1, 2026. The settlement was made on March 4, 2026 with $35.5 million in cash and 569,023 shares of the Company's common stock. The issuance of shares in connection with the repayment resulted in a loss on settlement of debt of approximately $0.9 million which was recorded in the condensed consolidated statements of operations for the three months ended March 31, 2026.

**10. Collaborations, Licensing and Other Arrangements**

Revenue from collaborations and services were as follows (in thousands):

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| UT CSA<sup>(1)</sup> | $22015 | $28818 |
| UT License Agreement | 1000 |  |
| Amphastar co-promotion agreement | 500 | 500 |
| Cipla License and Distribution Agreement |  | 36 |
| Other |  | 22 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total revenue from collaborations and services | $23515 | $29376 |

---

(1)Amounts consist of revenue recognized for Manufacturing Services to UT for the periods presented.

*United Therapeutics License Agreement* — In September 2018, the Company and UT entered into an exclusive global license and collaboration agreement (the "UT License Agreement"), pursuant to which UT is responsible for global development, regulatory and commercial activities with respect to Tyvaso DPI.

Total revenue from UT was as follows (in thousands):

---

| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| **Revenue from UT** |  |  |
| Royalties<sup>(1)</sup> | $32749 | $30005 |
| UT CSA | 22015 | 28818 |
| UT License Agreement | 1000 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Total revenue from UT | $55764 | $58823 |

---

(1)Amounts consist of royalties associated with the UT License Agreement. The contract asset related to the royalties receivable of $29.5 million and $27.0 million as of March 31, 2026 and 2025, respectively, was included in prepaid expense and other current assets in the condensed consolidated balance sheets and collected in the following quarter.

Pursuant to the UT License Agreement, the Company receives a 10% royalty on net sales of Tyvaso DPI. In December 2023, the Company sold a 1% royalty on future net sales of Tyvaso DPI to a royalty purchaser, with the Company retaining a 9% royalty. In

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August 2021, the Company and UT entered into the CSA pursuant to which the Company is responsible for manufacturing and supplying to UT, and UT is responsible for purchasing from the Company in accordance with the contractual terms. In addition, UT is responsible for supplying treprostinil at its expense in quantities necessary to enable the Company to manufacture Tyvaso DPI as required by the CSA.

The remaining performance obligation under the CSA, including the material right related to the tiered pricing within the contract, as amended and discussed below, is for manufacturing services to deliver product throughout the contract term. The revenue recognized under the CSA for manufacturing services is comprised of the sale of product to UT, recognition of previously deferred revenue, and reimbursements from other agreements for individual performance obligations. The portion of revenue related to each deliverable included in UT CSA revenue (in thousands) is as follows:

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| **UT CSA Revenue** |  |  |
| Sale of product | $17930 | 25114 |
| Recognition of previously deferred revenue | 1713 | 3412 |
| Other agreements | 2372 | 292 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total UT CSA revenue | $22015 | $28818 |

---

There have been various amendments to the CSA since inception. Under the Seventh Amendment, the term of the CSA continues until December 31, 2031 (unless earlier terminated) and is thereafter renewed automatically for additional, successive two-year terms unless (i) UT provides notice to the Company at least 24 months in advance of such renewal that UT does not wish to renew the CSA or (ii) the Company provides notice to UT at least 48 months in advance of such renewal that the Company does not wish to renew the CSA. The Company and UT each have normal and customary termination rights, including termination for material breach that is not cured within a specific timeframe or in the event of liquidation, bankruptcy or insolvency of the other party.

Under the Seventh Amendment, UT will provide notice of their purchase quantity on or prior to October 15th of each year. Additionally, the Seventh Amendment defines a tiered pricing structure based on annual purchase volume. Under the practical alternative for measuring material rights, revenue is recognized on a per unit basis based on the allocation of expected consideration to the manufacturing services performance obligation over the remaining contract term. The Company recognizes changes in estimated consideration resulting from changes in future estimated purchase quantities prospectively, such that the amount of revenue to be recognized per unit for future deliveries is adjusted, without recording a cumulative catch-up to amounts recognized in prior periods. Revenue is then recognized at the point in time in which control of the product is transferred to UT.

During 2024, the Company entered into additional agreements for individual performance obligations which are accounted for separately as they are distinct from Manufacturing Services and offered at a standalone selling price, for which we recognized revenue of $2.4 million and $0.3 million for the three months ended March 31, 2026 and 2025, respectively. Revenue for these arrangements is recognized at the point in time that the related service is delivered.

Under the terms of the UT License Agreement, UT has an option to develop additional dry powder inhalation therapies. In August 2025, UT exercised its option, which was memorialized in an amendment to the UT License Agreement (the "First Amendment"), and is treated as a separate contract for revenue recognition purposes under ASC 606. Under the First Amendment, the Company will formulate a dry powder formulation of ralinepag, an investigational molecule, using its proprietary Technosphere platform, and United Therapeutics will conduct preclinical and clinical development. This development program has been designated MNKD-1501. Per the First Amendment, the Company received an upfront payment of $5.0 million in 2025 and is eligible to receive up to $35.0 million in development milestones. The $35.0 million in development milestones is considered constrained due to the inherent uncertainty in the timing and likelihood of achieving the associated milestones. The Company is also eligible to receive 10% royalties on net sales of any resulting product. As of March 31, 2026, $2.0 million of the initial upfront payment has been recognized as revenue, based on the input measure of progress, and the remaining $3.0 million is included within deferred revenue - short term on the Company's consolidated balance sheets.

As of March 31, 2026, deferred revenue from UT consisted of $50.4 million, of which $11.5 million was classified as current and $38.9 million was classified as long-term on the condensed consolidated balance sheet. As of December 31, 2025, deferred revenue consisted of $55.3 million, of which $15.3 million was classified as current and $40.0 million was classified as long-term on the condensed consolidated balance sheet.

*Cipla License and Distribution Agreement* — In May 2018, the Company and Cipla Ltd. ("Cipla") entered into an exclusive agreement for the marketing and distribution of Afrezza in India and the Company received a $2.2 million nonrefundable license fee which was fully recognized as revenue from collaborations and services as of December 31, 2025. Under the terms of the agreement,

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Cipla is responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla, and began recording commercial product sales from this agreement in the fourth quarter of 2025. The Company is entitled to minimum purchase commitment revenue and royalties on Afrezza sales in India once cumulative gross sales have reached a specified threshold. In December 2024, the Central Drugs Standard Control Organisation ("CDSCO") in India approved Afrezza for adults and, accordingly, the Company was entitled to the regulatory milestone payment from Cipla totaling $1.1 million, which was recognized as revenue from collaborations and services in the year ended December 31, 2024.

The Company recorded $0.1 million of revenue from commercial product sales to Cipla in India for the three months ended March 31, 2026. There were no commercial product sales to India for the three months ended March 31, 2025.

*Amphastar* — In November 2024, the Company entered into a co-promotion agreement which provides the terms and conditions upon which the Company's sales force shall promote Baqsimi (glucagon) nasal powder to designated health care professionals in territories where the Company currently promotes Afrezza. Per the terms of the co-promotion agreement, as amended in December 2025, Amphastar is obligated to pay fixed quarterly payments to the Company through December 31, 2026. The Company identified a single performance obligation satisfied over time. Revenue is recognized based on the measurement of progress. The Company recognized $0.5 million in collaborations and services revenue from this agreement on its condensed consolidated statements of operations for both of the three months ended March 31, 2026 and 2025.

**11. Fair Value of Financial Instruments**

The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level input that is significant to the overall fair value measurement. The Company uses the exit price method for estimating the fair value of loans for disclosure purposes. Inputs used in the valuation techniques to derive fair values are classified based on a three-level hierarchy are described in Note 1 – *Description of Business and Significant Accounting Policies*.

The carrying amounts reported in the condensed consolidated financial statements for cash, accounts receivable, accounts payable, and accrued expenses and other current liabilities (excluding the Milestone Rights liability) approximate their fair value due to their relatively short maturities. The fair value of the senior convertible notes, Milestone Rights liability, Financing liability, Liability for sale of future royalties and Contingent consideration liability are disclosed below.

*Financial Liabilities* — The following tables set forth the fair value of the Company's financial instruments (Level 3 in the fair value hierarchy) (in millions):

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| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **March 31, 2026** |
|  |  | **Fair Value** |
|  | **Carrying Value** | **Significant<br>Unobservable<br>Inputs (Level 3)** |
| Financial liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Milestone rights<sup>(1)</sup> | $2.5 | $22.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;Financing liability<sup>(2)</sup> | 103.2 | 107.9 |
| &nbsp;&nbsp;&nbsp;&nbsp;Liability for sale of future royalties<sup>(3)</sup> | 150.6 | 96.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;Contingent consideration liability<sup>(4)</sup> | 29.0 | 29.0 |

---

(1)Fair value was determined by applying a Monte Carlo simulation method for the calculation of the potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other Level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 4.09%, dividend yield of 0%, volatility of 43.0%, period of 7 years and credit risk of 12.0%.

(2)Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 9.0%. A change in yield of + or – 2% would result in a fair value of $95.8 million and $122.6 million, respectively.

(3)Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 10.0%. A change in yield of + or – 2% would result in a fair value of $87.9 million and $105.4 million, respectively.

(4)Fair value was determined to be $24.0 million for Milestone 1 using a probability weighted expected return methodology based on the Company's estimate of probability of achievement of regulatory approval which was 85% across various timepoints and a discount rate of 11.4%. A change in estimate of probability and discount rate for Milestone 1 of + or – 2% would result in a fair value of $24.9 million and $23.1 million, respectively. Fair value was determined to be $5.0 million for Milestone 2 using a Monte Carlo simulation method based on a 51.9% volatility and 11.4% discount rate. Market based inputs and other Level 3 inputs were used to forecast future revenue. A change in discount rate on Milestone 2 of + or – 2% would result in a fair value of $5.0 million and $5.1 million, respectively.

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| | | |
|:---|:---|:---|
|  | **December 31, 2025** | **December 31, 2025** |
|  |  | **Fair Value** |
|  | **Carrying Value** | **Significant<br>Unobservable<br>Inputs (Level 3)** |
| Financial liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Senior convertible notes<sup>(1)</sup> | $36.3 | $39.3 |
| &nbsp;&nbsp;&nbsp;&nbsp;Milestone rights<sup>(2)</sup> | 2.5 | 22.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;Financing liability<sup>(3)</sup> | 103.4 | 121.9 |
| &nbsp;&nbsp;&nbsp;&nbsp;Liability for sale of future royalties<sup>(4)</sup> | 151.3 | 168.1 |
| &nbsp;&nbsp;&nbsp;&nbsp;Contingent consideration liability<sup>(5)</sup> | 26.2 | 26.2 |

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(1)Fair value was determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 5.0%, volatility of 40.3% and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2% would result in a fair value of $39.0 million and $39.5 million, respectively.

(2)Fair value was determined by applying a Monte Carlo simulation method for the calculation of the potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other Level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 3.94%, dividend yield of 0%, volatility of 43.0%, period of 7 years and credit risk of 10%.

(3)Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 7.0%. A change in yield of + or – 2% would result in a fair value of $106.7 million and $140.6 million, respectively.

(4)Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 8%. A change in yield of + or – 2% would result in a fair value of $148.3 million and $192.3 million, respectively.

(5)Fair value was determined to be $23.7 million for Milestone 1 using a probability weighted expected return methodology based on the Company's estimate of probability of achievement of regulatory approval which was 85% across various timepoints and a discount rate of 10%. A change in estimate of probability and discount rate for Milestone 1 of + or – 2% would result in a fair value of $24.7 million and $22.7 million, respectively. Fair value was determined to be $2.6 million for Milestone 2 using a Monte Carlo simulation method based on a 25.2% volatility and 10% discount rate. Market based inputs and other Level 3 inputs were used to forecast future revenue. A change in discount rate on Milestone 2 of + or – 2% would result in a fair value of $2.6 million and $2.7 million, respectively.

*Milestone Rights Liability* — The fair value measurement of the Milestone Rights liability is sensitive to the discount rate and the timing of achievement of milestones. The Company utilized a Monte-Carlo Simulation Method to simulate the Afrezza net sales under a neutral framework to estimate the potential payments and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. The Company then discounted the future expected payments at cost of debt with a term equal to the simulated time to payout based on cumulative sales. See Note 15 – *Commitments and Contingencies*.

*Financing Liability* — The Sale-Leaseback Transaction in November 2021 resulted in a financing liability. See Note 15 – *Commitments and Contingencies*.

*Liability for Sale of Future Royalties* — The sale of a portion of our royalty rights in December 2023 resulted in a liability for sale of future royalties. See Note 15 – *Commitments and Contingencies*.

*Contingent Consideration Liability* — The acquisition of scPharma in October 2025 resulted in a contingent consideration liability. See Note 2 – *Business Combinations*.

**12. Common and Preferred Stock**

The Company is authorized to issue 800,000,000 shares of common stock, par value $0.01 per share, and 10,000,000 shares of undesignated preferred stock, par value $0.01 per share, issuable in one or more series as designated by the Company's board of directors. No other class of capital stock is authorized. As of March 31, 2026 and December 31, 2025, 308,907,331 and 307,832,587 shares of common stock, respectively, were issued and outstanding and no shares of preferred stock were outstanding.

In February 2018, the Company entered into a controlled equity offering sales agreement with Cantor Fitzgerald & Co. ("Cantor Fitzgerald"), as sales agent, which was amended and restated in February 2025 (as amended, the "CF Sales Agreement"). Pursuant to the CF Sales Agreement, the Company may offer and sell, from time to time, through Cantor Fitzgerald, shares of the Company's common stock. Cantor Fitzgerald may sell shares by any method deemed to be an "at-the-market offering" as defined in Rule 415 under the Securities Act of 1933, as amended. On February 26, 2025, the Company filed a sales agreement prospectus under a registration statement on Form S-3, which became effective upon filing, covering the sale of up to $200.0 million of our common stock through Cantor Fitzgerald under the CF Sales Agreement. There have been no sales under the CF Sales Agreement since 2023.

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During the three months ended March 31, 2026, the Company received $0.3 million from the market price stock purchase plan ("MPSPP") for 102,580 shares of common stock. There were no shares of common stock issued under the MPSPP for the three months ended March 31, 2025.

For shares of common stock issued pursuant to the Company's 2004 employee stock purchase plan ("ESPP"), see Note 14 – *Stock-Based Compensation Expense.*

**13. Earnings per Common Share**

The following tables summarize the components of the basic and diluted EPS computations (in thousands, except per share amounts):

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| **EPS – basic:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Net (loss) income (numerator) | $(16619) | $13158 |
| &nbsp;&nbsp;&nbsp;&nbsp;Weighted average common shares (denominator) | 308267 | 303481 |
| &nbsp;&nbsp;&nbsp;&nbsp;Net (loss) income per share | $(0.05) | $0.04 |
| **EPS – diluted:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Net (loss) income (numerator) | $(16619) | $13158 |
| &nbsp;&nbsp;&nbsp;&nbsp;Effect of interest and amortization expense on convertible notes |  | 284 |
| &nbsp;&nbsp;&nbsp;&nbsp;Adjusted net (loss) income (numerator) | $(16619) | $13442 |
| &nbsp;&nbsp;&nbsp;&nbsp;Weighted average common shares | 308267 | 303481 |
| &nbsp;&nbsp;&nbsp;&nbsp;Effect of dilutive securities – common shares issuable |  | 17416 |
| &nbsp;&nbsp;&nbsp;&nbsp;Adjusted weighted average common shares (denominator) | 308267 | 320897 |
| &nbsp;&nbsp;&nbsp;&nbsp;Net (loss) income per share | $(0.05) | $0.04 |

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For the three months ended March 31, 2026, diluted net loss per share was the same as basic net loss per share because the inclusion of potential common shares would have been antidilutive. Potentially dilutive securities outstanding for the three months ended March 31, 2026 were 3.0 million shares of common stock underlying RSUs and Market RSUs and 3.5 million shares underlying options and PNQs.

For the three months ended March 31, 2025, diluted net income per share excluded the weighted average effect of 4.9 million shares of common stock underlying RSUs and Market RSUs and 0.3 million shares underlying options and PNQs as they were antidilutive.

**14. Stock-Based Compensation Expense** 

Total stock-based compensation expense recognized in the condensed consolidated statements of operations is included in the following categories (in thousands):

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| Cost of goods sold | 244 | 117 |
| Cost of revenue – collaborations and services | 851 | 895 |
| Research and development | 516 | 699 |
| Selling, general and administrative | 4844 | 3674 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total | $6455 | $5385 |

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Total stock-based compensation expense recognized in the condensed consolidated statements of operations was as follows (in thousands):

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| RSUs and options | 6162 | 5212 |
| Employee stock purchase plan | 293 | 173 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total | $6455 | $5385 |

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The following table summarizes information pertaining to RSUs:

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| | | |
|:---|:---|:---|
|  | **Number of<br>Shares** | **Weighted<br>Average<br>Grant Date<br>Fair Value<br>per Share** |
| Outstanding as of January 1, 2026 | 16485829 | $5.82 |
| &nbsp;&nbsp;&nbsp;&nbsp;Granted | 2307140 | 5.08 |
| &nbsp;&nbsp;&nbsp;&nbsp;Vested | (246822) | 4.40 |
| &nbsp;&nbsp;&nbsp;&nbsp;Forfeited | (471991) | 5.33 |
| Outstanding as of March 31, 2026 | 18074156 | 5.75 |

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As of March 31, 2026, there was $58.4 million of unrecognized stock-based compensation expense related to RSUs, Market RSUs and Performance RSUs, which is expected to be recognized over a weighted average period of approximately 2.0 years.

The following table summarizes information pertaining to options:

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Number of<br>Shares** | **Weighted<br>Average Exercise<br>Price per Share** | **Weighted<br>Average<br>Remaining <br>Contractual<br>Term<br>(Years)** | **Aggregate<br>Intrinsic<br>Value ($000)** |
| Outstanding as of January 1, 2026 | 5365220 | $1.66 | 2.36 | $21522 |
| Granted | 7778380 | 2.44 |  |  |
| Exercised | (242270) | 1.78 |  |  |
| Forfeited |  |  |  |  |
| Expired |  |  |  |  |
| Outstanding as of March 31, 2026 | 12901330 | $2.13 | 6.79 | $4463 |
| Exercisable as of March 31, 2026 | 5122950 | $1.65 | 2.14 | $4385 |

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The following table summarizes the key assumptions used by the Company to value the stock option awards granted during the three months ended March 31, 2026. The Company did not grant options during the three months ended three months ended March 31, 2025.

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| | |
|:---|:---|
|  | **Three Months Ended March 31,** |
| Fair value of common stock | 2.44 |
| Expected term (years) | 6.50 |
| Volatility | 58.51% |
| Interest rate | 3.88% |

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As of March 31, 2026, there was $11.3 million of unrecognized stock-based compensation expense related to stock options, which is expected to be recognized over a weighted average period of approximately 3.9 years.

*Employee Stock Purchase Plan*

The Company provides all employees, including executive officers, the ability to purchase common stock at a discount under the ESPP. The ESPP is designed to comply with Section 423 of the Internal Revenue Code and provides all employees with the opportunity to purchase up to $25,000 worth of common stock (based on the undiscounted fair market value at the commencement of the offering period) each year at a purchase price that is the lower of 85% of the fair market value of the common stock on either the date of purchase or the commencement of the offering period. An employee may not purchase more than 5,000 shares of common stock on any purchase date. The executives' rights under the ESPP are the same as those of all other employees.

There were approximately 1.9 million shares of common stock available for issuance under the ESPP as of March 31, 2026.

**15. Commitments and Contingencies** 

*Guarantees and Indemnifications* — In the ordinary course of its business, the Company makes certain indemnities, commitments and guarantees under which it may be required to make payments in relation to certain transactions. The Company, as permitted under Delaware law and in accordance with its Bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company's request in such capacity. The term of the

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indemnification period is for the officer's or director's lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer insurance policy that may enable it to recover a portion of any future amounts paid. The Company believes the fair value of these indemnification agreements is minimal and therefore has not recorded any liability for these indemnities in the condensed consolidated balance sheets. The Company accrues for losses for any known contingent liability, including those that may arise from indemnification provisions, when future payment is probable and the amount can be reasonably estimated. No such losses have been recorded to date.

*Litigation* — The Company is subject to legal proceedings and claims which arise in the ordinary course of its business. The Company does not anticipate the final disposition of any matters will have a material adverse effect on the results of operations, financial position, or cash flows of the Company. The Company maintains liability insurance coverage to protect the Company's assets from losses arising out of or involving activities associated with ongoing and normal business operations. The Company records a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company's policy is to accrue for legal expenses in connection with legal proceedings and claims as they are incurred.

*Contingencies — Milestone Rights* — In July 2013, the Company entered into the Milestone Rights Agreement with the Original Milestone Purchasers, pursuant to which the Company granted the Milestone Rights to receive payments up to $90.0 million upon the occurrence of specified strategic and sales milestones, of which $45.0 million remains payable to the Milestone Purchasers as of March 31, 2026.

The Milestone Rights Agreement includes customary representations and warranties and covenants by the Company, including restrictions on transfers of intellectual property related to Afrezza. The Milestone Rights are subject to acceleration in the event the Company transfers its intellectual property related to Afrezza in violation of the terms of such agreement.

As of March 31, 2026, the remaining Milestone Rights liability balance was $2.5 million and consisted of $0.5 million of current liability, which was presented as accrued expenses and other current liabilities, and $2.0 million of long-term liability, which was presented as milestone liabilities in the condensed consolidated balance sheets. The value of the Milestone Rights liability was based on initial fair value estimates calculated using the income approach and is reduced by milestone achievement payments made.

*Liability for Sale of Future Royalties* — In December 2023, the Company executed a Purchase and Sale Agreement (the "PSA") with Sagard Healthcare Partners Funding Borrower SPE 2, LP ("Sagard"). Pursuant to the PSA, Sagard paid the Company $150.0 million (the "Upfront Proceeds"), net of $0.4 million in reimbursements of Sagard's fees and expenses (the "Reimbursements"), for the purchase of a 1% royalty on future net sales of Tyvaso DPI by UT under the terms of the UT License Agreement (the "Sagard Royalty"). Sagard will also pay the Company a milestone of $50.0 million if net sales of Tyvaso DPI meet or exceed $1.9 billion for any 12 consecutive months on or prior to December 31, 2026 ("Net Sales Threshold A"), or a milestone of $45.0 million if net Sales Threshold A is not met and net sales of Tyvaso DPI meet or exceed $2.3 billion for any 12 consecutive months on or prior to September 30, 2027 ("Net Sales Threshold B"), resulting in a purchase price not to exceed $200.0 million (the "Purchase Price"). If Net Sales Thresholds A and B are not met and net sales of Tyvaso DPI meet or exceed $3.5 billion for any calendar year after September 30, 2027, no royalties will be payable to Sagard for the remainder of that year. The PSA applies to net sales of Tyvaso DPI generated during October 1, 2023 through December 31, 2042 (the "Termination Date") and will automatically terminate upon payment of the final royalty owed to Sagard thereafter. Upon the Termination Date, ownership of the Sagard Royalty will revert to the Company.

Given the Company's continuing involvement with the generation of Tyvaso DPI revenue under the UT License Agreement and CSA, which includes the Company's supply and manufacture of Tyvaso DPI, and the Company's retention and associated defense and maintenance obligations of the intellectual property required in the manufacture of Tyvaso DPI, the Upfront Proceeds were recorded as a liability for sale of future royalties (the "Royalty Liability") on the condensed consolidated balance sheets, and any proceeds from future milestones will be added to the Royalty Liability balance upon receipt. Although the Company is not obligated to repay any portion of the Purchase Price to Sagard, the Royalty Liability under the PSA is secured by a security interest granted to Sagard in the underlying 1% royalty rights and any proceeds therefrom. As a result of the PSA, transaction costs totaling $4.4 million (including the Reimbursements) are reported net of the Royalty Liability balance and amortized to interest expense in the condensed consolidated statements of operations over the life of the PSA using the effective interest method. Unamortized transaction costs were approximately $3.9 million as of both March 31, 2026 and December 31, 2025.

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The Company will continue to recognize the full 10% of future royalty revenues in its condensed consolidated statements of operations, with the Sagard Royalty being non-cash revenue for the Company. As royalty payments are earned by and remitted to Sagard, the balance of the Royalty Liability will be effectively repaid as it is amortized over the life of the PSA. To amortize the Royalty Liability, the Company estimated the total amount of future royalty payments to be made to Sagard over the life of the PSA. The excess of those future estimated royalty payments over the Purchase Price proceeds received is recognized in the condensed consolidated statements of operations as non-cash interest expense over the life of the PSA utilizing an imputed effective interest rate. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate may vary during the term of the agreement depending on a number of factors, including the amount and timing of forecasted royalty payments which affects the timing and ultimate amount of reductions to the liability. The Company will evaluate the effective interest rate periodically based on its forecasted royalty payments utilizing the prospective method.

The Company periodically assesses the forecasted royalty payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments, or the timing of such payments, are materially different than original estimates, the Company will prospectively adjust the effective interest rate and amortization of the Royalty Liability.

The following table shows the activity within the Royalty Liability account as well as the effective interest rate (dollars in thousands):

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| | |
|:---|:---|
|  | **Amount** |
| Balance, January 1, 2026 | $151283 |
| &nbsp;&nbsp;&nbsp;&nbsp;Amortization of deferred transaction costs | 57 |
| &nbsp;&nbsp;&nbsp;&nbsp;Non-cash interest expense on liability for sale of future royalties | 2506 |
| &nbsp;&nbsp;&nbsp;&nbsp;Royalty revenue earned by or payable to Sagard | (3275) |
| Balance, March 31, 2026 | $150571 |

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*Sale-Leaseback Transaction*— In November 2021, the Company sold certain land, building and improvements located in Danbury, CT (the "Property") to an affiliate of Creative Manufacturing Properties (the "Purchaser") for a sales price of $102.3 million, subject to the terms and conditions contained in a purchase and sale agreement.

Effective with the closing of the Sale-Leaseback Transaction, the Company and the Purchaser entered into a lease agreement (the "Lease"), pursuant to which the Company leased the Property from the Purchaser for an initial term of 20 years, with four renewal options of five years each. The total annual rent under the Lease starts at approximately $9.5 million per year, subject to a 50% rent abatement during the first year of the Lease, and will increase annually by (i) 2.5% in the second through fifth year of the Lease and (ii) 3% in the sixth and each subsequent year of the Lease, including any renewal term, utilizing a weighted average discount rate of 9.0%. The Company is responsible for payment of operating expenses, property taxes and insurance for the Property. The Purchaser will hold a security deposit of $2.0 million during the Lease term. Pursuant to the terms of the Lease, the Company has four options to repurchase the Property, in 2026, 2031, 2036 and 2041, for the greater of (i) $102.3 million or (ii) the fair market value of the Property.

Effective with the closing of the Sale-Leaseback Transaction, the Company and the Purchaser also entered into a right of first refusal agreement (the "ROFR"), pursuant to which the Company has a right to re-purchase the Property from the Purchaser in accordance with terms and conditions set forth in the ROFR. Specifically, if the Purchaser receives, and is willing to accept, a bona fide purchase offer for the Property from a third-party purchaser, the Company has certain rights of first refusal to purchase the Property on the same material terms as proposed in such bona fide purchase offer.

As of March 31, 2026, the related financing liability was $103.2 million, which was recognized in the condensed consolidated balance sheet and of which $92.8 million was long-term and $10.4 million was current. As of December 31, 2025, the related financing liability was $103.4 million, of which $93.1 million was long-term and $10.3 million was current.

Financing liability information was as follows (dollars in thousands):

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| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **December 31, 2025** |
| Weighted average remaining lease term (in years) | 15.6 | 15.8 |
| Weighted average discount rate | 9.0% | 9.0% |

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| Interest expense | $2342 | $2359 |
| Amortization of debt issuance costs | 51 | 51 |
| Interest expense on financing liability | $2393 | $2410 |

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The Company's remaining financing liability payments were as follows (in thousands):

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| | |
|:---|:---|
|  | **March 31, 2026** |
| 2026 | 7911 |
| 2027 | 10849 |
| 2028 | 11174 |
| 2029 | 11510 |
| 2030 | 11855 |
| Thereafter | 153913 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total | 207212 |
| Interest payments | (101813) |
| Debt issuance costs | (2208) |
| Total financing liability | $103191 |

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*Commitments* — In July 2014, the Company entered into the Insulin Supply Agreement pursuant to which Amphastar manufactures for and supplies to the Company certain quantities of recombinant human insulin for use in Afrezza. Under the terms of the Insulin Supply Agreement, Amphastar is responsible for manufacturing the insulin in accordance with the Company's specifications and agreed-upon quality standards.

In December 2023, the Company and Amphastar amended the Insulin Supply Agreement to extend the term, restructure the annual purchase commitments and include a capacity fee for certain future periods. The Company's remaining purchase commitments and estimated capacity fee liability as of March 31, 2026 were as follows (€ in millions):

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| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **March 31, 2026** |
|  | **Remaining Purchase Commitments <br>(€ in millions)** | **Estimated Capacity Fees**<sup>(1)</sup>**<br>(€ in millions)** |
| 2026 (Remaining)<sup>(1)</sup> |  | 2.3 |
| 2027 | 3.2 | 2.3 |
| 2028 | 5.6 | 1.3 |
| 2029 | 5.8 | 1.0 |
| 2030 | 5.8 | 1.0 |
| 2031 | 5.8 | 1.0 |
| 2032 | 7.3 | 0.6 |
| 2033 | 7.8 | 0.5 |
| 2034 | 7.8 | 0.5 |
| 2035 | 5.1 | 0.4 |
| 2036 | 1.0 | 0.1 |
| Total | 55.2 | 11.0 |

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(1)During the three months ended March 31, 2026, the Company incurred a capacity fee of €0.8 million, or $0.9 million, which was recognized as cost of goods sold for commercial sales in our condensed consolidated statement of operations.

Pursuant to the amendment, the term of the Insulin Supply Agreement expires on the later of December 31, 2034 and the completion of the total remaining purchase commitment quantities, unless terminated earlier, and can be renewed for additional, successive two-year terms upon 12 months' written notice given prior to the end of the initial term or any additional two-year term. The Company and Amphastar each have normal and customary termination rights, including termination for a material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, the Company may terminate the Insulin Supply Agreement upon two years' prior written notice to Amphastar without cause or upon 30 days' prior written notice to Amphastar if a controlling regulatory authority withdraws approval for Afrezza, provided, however, in the event of a termination pursuant to either of the latter two scenarios, the provisions of the Insulin Supply Agreement require the Company to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination.

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The Company periodically reviews the terms of the long-term Insulin Supply Agreement and assesses the need for any accrual for estimated losses, such as lower-of-cost or net-realizable-value that will not be recovered by future product sales. The recognized loss on purchase commitments of $64.6 million and $66.0 million is included in our condensed consolidated balance sheets as of March 31, 2026 and December 31, 2025, respectively, and is reduced as inventory items are received or such liability is extinguished.

As a result of the increase in future cash flows for the excess capacity fees and extended term included in the amendment of the Insulin Supply Agreement, the Company analyzed the need for additional estimated losses and concluded that an increase in the recognized loss on purchase commitments was not required as the net realizable value of inventory resulting from the purchase commitment was in excess of the carrying value. Increases in costs associated with the amendment will be recognized through inventory as incurred.

*Office Leases* — In May 2017, the Company executed an office lease with Russell Ranch Road II LLC for the Company's corporate offices in Westlake Village, California, which was renewed in April 2022. Pursuant to the renewal, the monthly lease payments of $79,543 began in February 2023 and are subject to 3% annual increases, plus the estimated cost of maintaining the property and common areas by the landlord, and are further subject to a six-month base rent concession beginning February 2023. The Company was also entitled to a one-time allowance up to $0.9 million as reimbursement for tenant improvements or the purchase of furniture, fixtures or equipment. Of the $0.9 million allowance, an amount up to $0.7 million may be applied as an additional base rent concession. The Company has no further right to extend the lease term beyond July 31, 2028.

In July 2024, the Company assumed certain leased real property (the "Bedford Lease") in connection with the Pulmatrix transaction. The Bedford Lease pertains to certain premises in a building located in Bedford, Massachusetts. The monthly base rent payments of $101,282 are subject to 3% annual increases, plus the estimated cost of maintaining the property and common areas by the landlord. The Company also assumed from Pulmatrix a $0.7 million obligation to repay landlord-funded tenant improvements at a rate of $6,000 per month through the end of the lease term in November 2033. The Company has the right to extend the lease term for an additional five-year term.

In October 2025, the Company assumed a 9,342 square foot facility in Burlington, Massachusetts in connection with the acquisition of scPharma which was previously entered into as a sublease in August 2023 and extends through August 2029. The monthly lease payments are $28,805 and are subject to fixed annual increases of $779.

Lease information was as follows (dollars in thousands):

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| | | |
|:---|:---|:---|
|  | **March 31, 2026** | **December 31, 2025** |
| Operating lease right-of-use assets<sup>(1)</sup> | $11291 | $11822 |
| Operating lease liability-current<sup>(2)</sup> | $1957 | $2110 |
| Operating lease liability-long-term | 10281 | 10689 |
| &nbsp;&nbsp;Total | $12238 | $12799 |
| Weighted average remaining lease term (in years) | 6.2 | 6.4 |
| Weighted average discount rate | 7.7% | 7.6% |

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(1)Operating right-of-use assets related to offices and the manufacturing facility for V-Go are included in other assets in the condensed consolidated balance sheets.

(2)Operating lease liability – current is included in accrued expenses and other current liabilities in the condensed consolidated balance sheets.

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| | | |
|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2025** |
| Operating lease costs | 792 | 728 |
| Variable lease costs | 147 | 244 |
| Cash paid | 939 | 972 |

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The Company's future minimum office lease payments were as follows (in thousands):

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| | |
|:---|:---|
|  | **March 31, 2026** |
| 2026 | 2086 |
| 2027 | 2834 |
| 2028 | 2455 |
| 2029 | 1735 |
| 2030 | 1528 |
| Thereafter | 4708 |
| Total | 15346 |
| Less: imputed interest | (3108) |
| Total operating lease liability | $12238 |

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**16. Income Taxes**

During the three months ended March 31, 2026 and 2025, the Company recorded income tax expense of $0.3 million and $0.5 million, respectively, related to state taxes, which was calculated using the discrete year-to-date method. The effective tax rate differs from the federal statutory tax rate of 21% primarily due to the existence of valuation allowances against net deferred tax assets and current liabilities resulting from the estimated state income tax liabilities.

Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and concluded, in accordance with the applicable accounting standards, that net deferred tax assets should be fully reserved.

The Company has assessed its position with regards to uncertainty in tax positions and has not recognized a liability for unrecognized tax benefits. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months. The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. During the three months ended March 31, 2026, the Company recognized a *de minimis* amount of interest and penalties. The Company's tax years since 2022 remain subject to examination by tax authorities.

In June 2024, California enacted Senate Bills 167 and 175 ("SB 167" and "SB 175"). SB 167 suspends the use of net operating losses ("NOLs") and limits the use of business credits to $5.0 million for the 2024-2026 tax years. Under SB 175, the NOL suspension and credit limitations will not apply for the 2025 and 2026 tax years if certain budget goals are met. Although the Company does not expect this legislation to have a material effect on its results of operations or cash flows, management continues to evaluate any potential impact.

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**ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS** 

*Statements in this report that are not strictly historical in nature are "forward-looking statements" within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would," and similar expressions intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below in Part II, Item 1A Risk Factors and elsewhere in this Quarterly Report on Form 10-Q. The preceding interim condensed consolidated financial statements and this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and related notes for the year ended December 31, 2025 and Management's Discussion and Analysis of Financial Condition and Results of Operations contained in the Annual Report. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made.* 

**OVERVIEW** 

We are a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, we aim to deliver therapies designed to fit seamlessly into daily life.

Our cardiometabolic business is currently comprised of three commercial products: Afrezza (insulin human) Inhalation Powder; Furoscix (furosemide injection); and the V-Go wearable insulin delivery device:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Afrezza is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes. Afrezza was developed by us and consists of a dry powder formulation of human insulin delivered from a small portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and delivers insulin quickly to the bloodstream.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Furoscix is a novel formulation of furosemide that delivers an 80 mg dose via an on-body infusor over a five-hour period. Furoscix is approved by the U.S. Food and Drug Administration (or FDA) for the treatment of edema in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease. Furoscix is the first FDA-approved subcutaneous loop diuretic that delivers intravenous-equivalent diuresis at home as opposed to a hospital setting. Furoscix was developed by scPharma, which we acquired in October 2025. See Note 2 – *Business Combinations* in the Consolidated Financial Statements included in Part II, Item 8 – Financial Statements and Supplementary Data.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•V-Go is a mechanical basal-bolus insulin delivery system that is worn like a patch and can eliminate the need for taking multiple daily injections. V-Go administers a continuous preset basal rate of insulin over 24 hours and provides discreet on-demand bolus dosing at mealtimes. V-Go received 510(k) clearance by the FDA in 2010 and has been available commercially since 2012. In May 2022, we acquired V-Go from Zealand Pharma US, Inc. and Zealand Pharma A/S.

We anticipate two potential milestones for our cardiometabolic business in 2026 based on regulatory submissions that we made in 2025. The FDA is currently reviewing a supplemental biologics license application (or sBLA) pursuant to which we are seeking approval for Afrezza in children and adolescents living with type 1 or type 2 diabetes. The sBLA has been assigned a PDUFA target action date of May 29, 2026. The FDA is also reviewing a supplemental new drug application (or sNDA) pursuant to which we are seeking approval for Furoscix ReadyFlow Autoinjector, a high-concentration formulation of furosemide that is delivered subcutaneously in under ten seconds. The sNDA has been assigned a PDUFA target action date of July 26, 2026.

In the United States, we are solely responsible for the commercialization of Afrezza, Furoscix and V-Go. Outside of the U.S., our strategy has been to establish regional partnerships in foreign jurisdictions where there are commercial opportunities, subject to the receipt of necessary foreign regulatory approvals. In December 2025, we supplied our partner in India, Cipla, with an initial shipment of Afrezza to support their launch of Afrezza in India. We expect to supply Cipla with additional product in accordance with the annual purchase commitments in our supply agreement.

The proprietary formulation and inhaler technologies used in Afrezza have also been deployed in our efforts to develop products to treat orphan lung diseases. Our first product to address an orphan lung disease, Tyvaso DPI (treprostinil) inhalation powder, received FDA approval in May 2022 for the treatment of pulmonary arterial hypertension (or PAH) and pulmonary hypertension associated with interstitial lung disease (or PH-ILD). Our development and marketing partner, United Therapeutics, began commercializing Tyvaso DPI in June 2022 and is obligated to pay us a royalty on net sales of the product. We also receive revenue for the supply of Tyvaso DPI that we manufacture for UT. In August 2025, we announced the expansion of our collaboration, pursuant to which we

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will formulate ralinepag (MNKD-1501) as a dry powder using our proprietary technologies. United Therapeutics will conduct preclinical and clinical development activities of MNKD-1501. Per the agreement, we received an upfront payment and are eligible to receive milestone payments upon achievement of specified development milestones as well as royalties on net sales of MNKD-1501, if approved.

The other major program in our pipeline that will potentially address an orphan lung disease is MNKD-201, a dry-powder formulation of nintedanib for the treatment of idiopathic pulmonary fibrosis (or IPF). An oral dosage form of nintedanib has been available for more than a decade. However, a fairly large oral dose is required in order to achieve sufficient drug levels in lung tissue. High systemic levels of nintedanib are often associated with undesirable side effects. Our goal with an inhaled formulation is to deliver a therapeutic amount of nintedanib to the lungs while avoiding high levels of the drug in other tissues. In 2024, we conducted a Phase 1 clinical study of MNKD-201, which met its primary objective of demonstrating positive safety results and good tolerability in healthy volunteers. We are currently conducting a Phase 1b study of MNKD-201 in the United States, with top line data expected in the third quarter of 2026, as well as a global Phase 2 study to assess the potential safety and efficacy of this investigational product in patients with IPF, in which we expect the first patient to be enrolled in the second quarter of 2026.

MNKD-701 is another pipeline opportunity that we are exploring. This program is focused on bumetanide, a more potent loop diuretic than furosemide. We are currently evaluating the feasibility of formulating bumetanide as a dry-powder that can be administered via oral inhalation.

Our business is subject to significant risks, including but not limited to our ability to manufacture sufficient quantities of our products and Tyvaso DPI. Other significant risks also include the risk that our products may only achieve a limited degree of commercial success and the risks inherent in drug development, clinical trials and the regulatory approval process for our product candidates, which in some cases depends upon the efforts of our partners. Ongoing changes in tariff policy by the U.S. government may potentially raise the future cost to source the raw materials and components needed to manufacture our products. We are actively monitoring this situation and exploring strategies to mitigate the risks.

**CRITICAL ACCOUNTING POLICIES AND ESTIMATES**

Our critical accounting policies and estimates can be found in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report. See Note 1 – *Description of Business and Significant Accounting Policies* in the condensed consolidated financial statements included in Part I – Financial Statements (Unaudited) for descriptions of the new accounting policies and impact of adoption.

**RESULTS OF OPERATIONS** 

**Trends and Uncertainties**

Our collaboration agreement with UT entitles us to receive a 10% royalty on net sales of Tyvaso DPI, subject to our sale of a 1% royalty on future net sales to a royalty purchaser (leaving us with a 9% royalty). Our royalty revenue reflects trends in demand for Tyvaso DPI in the marketplace. See Note 15 – *Commitments and Contingencies* in the condensed consolidated financial statements.

Our future success is dependent on our, and our current and future collaboration partners', ability to effectively commercialize approved products. Our future success is also dependent on our pipeline of new products and expansion opportunities for existing products, such as new formulations or expanded indications. There is a high rate of failure inherent in the R&D process for new drugs. As a result, there is a high risk that the funds we invest in research programs will not generate sufficient financial returns. Products may appear promising in development but fail to reach market within the expected or optimal timeframe, or at all.

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**Three months ended March 31, 2026 and 2025**

**Revenues** 

The following table provides a comparison of the revenue categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended March 31,** | **Three Months Ended March 31,** |  |  |
|  | **2026** | **2025** | **$ Change** | **% Change** |
| &nbsp;&nbsp;Revenues |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Commercial product sales: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Gross revenue from product sales | $47928 | $29576 | $18352 | 62% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Less: Wholesaler distribution fees, rebates and<br> chargebacks, product returns and other<br> discounts | 14021 | 10603 | 3418 | 32% |
| &nbsp;&nbsp;Net revenue from commercial product sales | $33907 | $18973 | 14934 | 79% |
| &nbsp;&nbsp;Gross-to-net revenue adjustment percentage | 29% | 36% |  |  |
| &nbsp;&nbsp;Collaborations and services | 23515 | 29376 | (5861) | (20%) |
| &nbsp;&nbsp;Royalties | 32749 | 30005 | 2744 | 9% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total revenues | $90171 | $78354 | 11817 | 15% |

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*Afrezza* — Gross revenue from sales of Afrezza decreased by $1.1 million, or 5%, for the three months ended March 31, 2026 compared to the same period in the prior year. The decrease was driven primarily by lower demand. The gross-to-net adjustment was 31% of gross revenue, or $6.8 million, for the three months ended March 31, 2026 compared to 36% of gross revenue, or $8.3 million, for the same period in the prior year. The decreased gross-to-net percentage was primarily attributable to a decrease in government and commercial rebates in accordance with contractual arrangements. As a result, net revenue from sales of Afrezza increased by $0.4 million, or 3%, for the three months ended March 31, 2026 compared to the same period in the prior year.

*Furoscix* — Gross revenue from sales of Furoscix was $20.9 million for the three months ended March 31, 2026. The gross-to-net adjustment was 26% of gross revenue, or $5.4 million, resulting in net revenue of $15.5 million for the three months ended March 31, 2026. There was no Furoscix revenue in the prior-year period as we did not own or commercialize Furoscix until our acquisition of scPharma in October 2025.

*V-Go* — Gross revenue from sales of V-Go decreased by $1.5 million, or 23%, for the three months ended March 31, 2026 compared to the same period in the prior year and was primarily a result of lower demand. The gross-to-net adjustment was 36% of gross revenue, or $1.8 million, for the three months ended March 31, 2026 compared to 36% of gross revenue, or $2.3 million, for the same period in the prior year. As a result, net revenue from sales of V-Go decreased by $0.9 million, or 23%, for the three months ended March 31, 2026 compared to the same period in the prior year.

*Collaborations and Services and Royalties* — Net revenue from collaborations and services decreased by $5.9 million, or 20%, for the three months ended March 31, 2026 compared to the same period in the prior year. The decrease in revenue in the current quarter was primarily attributable to decreased product sold to UT due to timing of manufacturing activities and recognition of the related deferred revenue. Royalty revenue from UT increased by $2.7 million, or 9%, for the three months ended March 31, 2026 due to UT's increase in net revenue from sales of Tyvaso DPI.

**Commercial product gross profit** 

The following table provides a comparison of the commercial product gross profit categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended March 31,** | **Three Months Ended March 31,** |  |  |
|  | **2026** | **2025** | **$ Change** | **% Change** |
| Commercial product gross profit: |  |  |  |  |
| &nbsp;&nbsp;Commercial product sales | $33907 | $18973 | $14934 | 79% |
| &nbsp;&nbsp;Less: Cost of goods sold | 7509 | 3768 | 3741 | 99% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Commercial product gross profit: | $26398 | $15205 | 11193 | 74% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Gross margin | 78% | 80% |  |  |

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Commercial product gross profit increased by $11.2 million, or 74%, for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily attributable to the increase in total product revenues after adding Furoscix to our product portfolio following the acquisition of scPharma in October 2025.

**Expenses**

The following table provides a comparison of the expense categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |  |  |
|  | **2026** | **2025** | **$ Change** | **% Change** |
| Expenses: |  |  |  |  |
| Cost of goods sold – commercial, excluding amortization of acquired intangible assets | $7509 | $3768 | $3741 | 99% |
| Cost of revenue – collaborations and services | 9964 | 13748 | (3784) | (28%) |
| Research and development | 17231 | 11022 | 6209 | 56% |
| Selling, general and administrative | 54085 | 25014 | 29071 | 116% |
| Amortization of acquired intangible assets | 4367 |  | 4367 | 100% |
| (Gain) loss on foreign currency transaction | (1318) | 2509 | (3827) | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total expenses | $91838 | $56061 | 35777 | 64% |

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Cost of revenue – collaborations and services decreased by $3.8 million, or 28%, for the three months ended March 31, 2026 compared to the same period in the prior year. The decrease was primarily a result of decreased product sold to UT.

Research and development expenses increased by $6.2 million, or 56%, for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily attributable to higher personnel costs following the acquisition of scPharma and higher costs from development of MNKD-201 as studies advanced.

Selling, general and administrative expenses increased by $29.1 million, or 116%, for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily related to costs associated with the promotion and support of Furoscix, as well as higher Afrezza-related expenses including expanding the field based teams and preparing for a potential pediatric launch of Afrezza in 2026.

Amortization of acquired intangible assets was $4.4 million for the three months ended March 31, 2026 and was related to the amortization of the developed technology related to the Furoscix on-body infuser acquired from scPharma.

Gain on foreign currency transaction was $1.3 million for the three months ended March 31, 2026 compared to a loss of $2.5 million for the same period in the prior year due to fluctuations in Euro to U.S. dollar exchange rates. Under the Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. We are required to record the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the recognized gain or loss on purchase commitments.

**Other Income (Expense)** 

The following table provides a comparison of the other income (expense) categories for the three months ended March 31, 2026 and 2025 (dollars in thousands):

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |  |  |
|  | **2026** | **2025** | **$ Change** | **% Change** |
| Interest income, net | $1429 | $1956 | $(527) | (27%) |
| Interest expense | (7478) | (4645) | (2833) | (61%) |
| Interest expense on liability for sale of future royalties | (2563) | (3577) | 1014 | 28% |
| Interest expense on financing liability | (2393) | (2410) | 17 | 1% |
| Loss on settlement of debt | (917) |  | (917) | \* |
| Other expense | (2777) |  | (2777) | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other expense | $(14699) | $(8676) | 6023 | (69%) |

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Interest income, net, consisting of interest and accretion on investments net of amortization, decreased by $0.5 million for the three months ended March 31, 2026 compared to the same period in the prior year primarily due to a lower average balance on our securities portfolio and lower yields.

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Interest expense increased by $2.8 million for the three months ended March 31, 2026 compared to the same period in the prior year. The increase was primarily due to new term loans with an aggregate principal amount of $325.0 million, which were drawn in August and October 2025.

Interest expense on liability for sale of future royalties decreased by $1.0 million for the three months ended March 31, 2026 compared to the same period in the prior year. Interest consists of imputed interest and the amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023. Imputed interest is based on third-party estimates of future royalties to be generated from Tyvaso DPI. See Note 15 – *Commitments and Contingencies.* 

Interest expense on financing liability was $2.4 million for the three months ended March 31, 2026 and 2025, and represents interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, Connecticut.

Loss on settlement of debt of $0.9 million for the three months ended March 31, 2026 was incurred in connection with the settlement of the senior convertible notes in March 2026.

Other expense of $2.8 million for the three months ended March 31, 2026 was the result of the remeasurement of the fair value of the contingent consideration liability obtained from the acquisition of scPharma. The contingent consideration will be remeasured each subsequent reporting period until the related contingencies have been resolved.

N**on-GAAP Measures** To supplement our condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP financial measures for net (loss) income and net (loss) income per share – basic. We are providing these non-GAAP financial measures, which are among the indicators management uses as a basis for evaluating our financial performance, to disclose additional information to facilitate the comparison of past and present operations. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this Quarterly Report on Form 10-Q have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

The following table reconciles our financial measures for net (loss) income and net (loss) income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation as adjusted by certain non-cash items identified below.

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** | **Three Months<br>Ended March 31,** |
|  | **2026** | **2026** | **2025** | **2025** |
|  | **Net Income** | **Basic EPS** | **Net Income** | **Basic EPS** |
| GAAP reported net (loss) income | $(16619) | $(0.05) | $13158 | 0.04 |
| Non-GAAP adjustments: |  |  |  |  |
| Stock compensation | 6455 | 0.02 | 5385 | 0.02 |
| Interest expense on liability for sale of future royalties | 2563 | 0.01 | 3577 | 0.01 |
| Sold portion of royalty revenue <sup>(1)</sup> | (3275) | (0.01) | (3000) | (0.01) |
| (Gain) loss on foreign currency transaction | (1318) | 0.00 | 2509 | 0.01 |
| Amortization of intangible assets acquired | 4367 | 0.01 |  |  |
| Loss on settlement of debt | 917 | 0.00 |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Non-GAAP adjusted net (loss) income | $(6910) | $(0.02) | $21629 | $0.07 |
| Weighted average shares used to compute net (loss) income per share – basic | 308267 |  | 303481 |  |

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(1)Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three months ended March 31, 2026 and 2025, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of

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operations. Our royalties from collaborations during the three months ended March 31, 2026 and 2025 totaled $32.7 million and $30.0 million, respectively, of which $3.3 million and $3.0 million, respectively were remitted to the royalty purchaser.

**LIQUIDITY AND CAPITAL RESOURCES**

Our principal sources of liquidity are our cash, cash equivalents, and investments. Our primary uses of cash include development of our product pipeline, manufacturing and marketing of Afrezza, Furoscix and V-Go, manufacturing Tyvaso DPI, selling, general and administrative expenses, and principal and interest payments on our financing liability and debt.

We fund our operations primarily through sales of Afrezza, Furoscix and V-Go, and royalties, development and manufacturing revenue from UT. Historically, we have funded our operations primarily through the sale of equity and convertible debt securities, from the receipt of upfront and milestone payments from collaborations, from borrowings, from the sale of certain assets and from the sale of a portion of our future royalties that we receive from UT. In combination with our cash, cash equivalents and investments on hand, we believe that these sources of revenue will allow us to meet our liquidity needs over the next 12 months and in the longer term.

As of March 31, 2026, we had $64.6 million in insulin purchase commitments and $325.0 million aggregate principal amount under the Blackstone Credit Facility. The Blackstone Credit Facility will mature on August 6, 2030. As of March 31, 2026, the effective interest rate is 9.09% per annum. The SOFR Loans borrowed under the Blackstone Credit Facility are subject to the Adjusted Term SOFR plus margin of 5.00%. We have the option to prepay the loans under the Blackstone Credit Facility in whole or in part, subject to early prepayment fees on or prior to the third anniversary of the Closing Date. See Note 9 – *Borrowings* for further information related to the Blackstone Credit Facility.

In July 2013, we granted Milestone Rights to the original purchasers under the Milestone Rights Agreement. The original purchasers later assigned those rights to new holders. As of March 31, 2026, $45.0 million remains payable upon the occurrence of specified strategic and sales milestones under the Milestone Rights Agreement. See Note 15 – *Commitments and Contingencies* for further information related to the Milestone Rights.

In October 2025, we entered into the CVR Agreement with the rights agent party thereto, which governs the terms of the CVRs issued to the former stockholders of scPharma in the acquisition transaction. The maximum aggregate amount payable with respect to the CVRs issued at the closing of the acquisition is $59.7 million, subject to the achievement of certain regulatory and net sales milestones on or prior to the applicable milestone outside dates in accordance with the CVR Agreement.

In addition to the above, we also expect to have material cash requirements relating to paying our employees and consultants, professional services fees, marketing expenses, manufacturing expenditures, and clinical trial expenses. In addition, we make substantial and often long-term investments in our supply chain in order to ensure we have enough inventory and drug product to meet current and future revenue forecasts, as well as clinical trial needs.

Pursuant to the CF Sales Agreement with Cantor Fitzgerald, we may offer and sell, from time to time, through Cantor Fitzgerald, shares of our common stock. Under the CF Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an "at-the-market offering" as defined in Rule 415 under the Securities Act of 1933, as amended. On February 26, 2025, we filed a sales agreement prospectus under a registration statement on Form S-3, which became effective upon filing, covering the sale of up to $200.0 million of our common stock through Cantor Fitzgerald under the CF Sales Agreement, of which $200.0 million remained available as of March 31, 2026.

During the three months ended March 31, 2026, we used a net $5.4 million of cash for our operating activities. Cash used in operating activities consisted of net loss of $16.6 million offset by non-cash adjustments of $16.2 million and a net decrease in cash flow from operating assets and liabilities of $5.0 million. Non-cash items primarily included stock-based compensation of $6.5 million, depreciation and amortization of $6.4 million and change in fair value of contingent consideration of $2.8 million. These charges were partially offset by the sold portion of royalty revenue of $3.3 million and gain on foreign currency transactions of $1.3 million. The net decrease in cash flows from operating assets and liabilities was primarily due to an increase of $14.9 million in inventory, decrease of $5.8 million in accrued expenses and other current liabilities and decrease of $4.9 million in deferred revenue. The net decrease in cash flows from operating assets and liabilities was partially offset by a decrease of $10.3 million in accounts receivable.

During the three months ended March 31, 2025, we used a net $6.4 million of cash for our operating activities. Cash used in operating activities consisted of net income of $13.2 million offset by non-cash adjustments of $10.8 million and a net decrease in cash flows from operating assets and liabilities of $30.3 million. Non-cash items primarily included stock-based compensation of $5.4 million, depreciation and amortization of $2.1 million, and interest on liability for sale of future royalties of $3.6 million. These charges were partially offset by the sold portion of royalty revenue of $3.0 million. The net decrease in cash flows from operating assets and

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liabilities was primarily due to an increase of $17.1 million in accounts receivable, decrease of $4.5 million in deferred revenue and increase of $3.0 million in prepaid expenses and other current assets.

Cash provided by investing activities of $18.7 million for the three months ended March 31, 2026 was primarily due to $30.9 million of proceeds from maturities of available-for-sale securities. Cash provided was partially offset by the purchase of $10.3 million of available-for-sale securities as well as $1.9 million of property and equipment.

Cash provided by investing activities of $6.0 million for the three months ended March 31, 2025 was primarily due to the maturity of $50.4 million of debt securities, partially offset by the purchase of $44.1 million of debt securities.

Cash used in financing activities of $35.4 million for the three months ended March 31, 2026 was primarily due to payments made to settle our remaining senior convertible notes.

Cash used in financing activities of $1.4 million for the three months ended March 31, 2025 was primarily due to $1.6 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options.

**Future Liquidity Needs**

We believe that we will be able to meet our near-term liquidity needs based on our cash, cash equivalents and investments on hand, sales of Afrezza, Furoscix and V-Go, royalties and manufacturing revenue from the production and sale of Tyvaso DPI and, if necessary, borrowings under the Blackstone Credit Facility, as well as through debt or equity financing, for our long-term liquidity needs. We expect to continue to incur expenditures for the foreseeable future in support of our manufacturing operations, sales and marketing costs for our products and development costs for other product candidates in our pipeline. As of March 31, 2026, we had capital resources comprised of cash, cash equivalents and investments totaling $133.9 million, and total principal amount of outstanding borrowings of $325.0 million.

To date, we have been able to timely make required interest payments under our outstanding indebtedness, but we cannot guarantee that we will be able to do so in the future. If we fail to repay our outstanding indebtedness when required, we will be in default under the applicable instrument for such indebtedness and may also suffer an event of default under the terms of other borrowing arrangements that we may enter into from time to time. Any of these events could have a material adverse effect on our business, results of operations and financial condition, up to and including the noteholders initiating bankruptcy proceedings or causing us to cease operations altogether.

We believe our resources will be sufficient to fund our operations for at least the next 12 months from the date of issuance of our condensed consolidated financial statements included in Part I – Financial Statements (Unaudited).

**Contractual Obligations**

There were no material changes outside of the ordinary course of business in our contractual obligations from those disclosed within "Management's Discussion and Analysis of Financial Condition and Results of Operations," as contained in our Annual Report on Form 10-K for the year ended December 31, 2025.

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**ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK** 

**Interest Rate Risk** 

Interest on borrowings under the Blackstone Credit Facility accrues at a rate per annum equal to (i) in the case of a Base Rate Loan, the greatest of (a) the prime rate in effect on such day, (b) the federal funds rate in effect on such day plus 0.5%, (c) Adjusted Term SOFR for a one-month's tenor in effect on such day plus 1%, and (d) 3.0% plus a margin of 3.75%, or (ii) in the case of a SOFR Loan, one, three or six month Adjusted Term SOFR (at our election), subject to a 2% floor, plus a margin of 4.75%. The interest rate margin increases to 4.00% in the case of a Base Rate Loan and 5.00% in the case of a SOFR Loan at any time the Company's ratio of indebtedness to adjusted EBITDA (measured on a trailing four quarter basis) is greater than or equal to 5.00:1.00 as of the most recent fiscal quarter for which the Company has delivered financial statements. Accordingly, our interest expense under the Blackstone Credit Facility is subject to changes in the various market interest rates. If a hypothetical 10% change in the SOFR interest rates on March 31, 2026 were to have occurred, this change would not have had a material effect on our annual interest payment obligation on the borrowings under the Blackstone Credit Facility, which as of March 31, 2026, are SOFR Loans with an effective interest rate of 9.09% per annum. See Note 9 – *Borrowings* for information about the principal amount of outstanding debt.

**Foreign Currency Exchange Risk** 

We incur and will continue to incur significant expenditures for insulin supply obligations under our Insulin Supply Agreement. Such obligations are denominated in Euros. At the end of each reporting period, the recognized gain or loss on purchase commitment is converted to U.S. dollars at the then-applicable foreign exchange rate. As a result, our business is affected by fluctuations in exchange rates between the U.S. dollar and the Euro. For the three months ended March 31, 2026, we realized a $1.3 million currency gain, which was reflected as gain on foreign currency transaction in the accompanying condensed consolidated statements of operations.

Exchange rate fluctuations may adversely affect our expenses, results of operations, financial position and cash flows. If a change in the U.S. dollar to Euro exchange rate equal to 10% of the U.S. dollar to Euro exchange rate on March 31, 2026 were to have occurred, this change would have resulted in a foreign currency impact to our pre-tax income of approximately $6.5 million.

**ITEM 4. CONTROLS AND PROCEDURES** 

**Disclosure Controls and Procedures** 

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), as of March 31, 2026. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our Chief Executive Officer and our Chief Financial Officer have concluded, as of such date, that our disclosure controls and procedures were effective at the reasonable assurance level.

**Changes in Internal Control over Financial Reporting** 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rule 13a-15(f) of the Exchange Act. An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of any change in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation did not identify any change in our internal control over financial reporting that occurred during our latest fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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**PART II. OTHER INFORMATION** 

**ITEM 1. LEGAL PROCEEDINGS**

We are subject to legal proceedings and claims that arise in the ordinary course of our business. As of the date hereof, we believe that the final disposition of such matters will not have a material adverse effect on our financial position, results of operations or cash flows. We maintain liability insurance coverage to protect our assets from losses arising out of or involving activities associated with ongoing and normal business operations. See Note 15 – *Commitments and Contingencies* in the condensed consolidated financial statements.

**Item 1A. *Risk Factors***

*Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found immediately following the below summary, and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC before making investment decisions regarding our common stock.*

**Summary Risk Factors**

**RISKS RELATED TO OUR BUSINESS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The products that we or our collaboration partner are commercializing may only achieve a limited degree of commercial success.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, our revenues could decline materially.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Manufacturing risks may adversely affect our ability to manufacture our products and Tyvaso DPI, which could reduce our gross margin and profitability.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If our suppliers fail to deliver materials and services needed for commercial manufacturing in a timely and sufficient manner or fail to comply with applicable regulations, and if we fail to timely identify and qualify alternative suppliers, our business, financial condition and results of operations would be harmed and the market price of our common stock and other securities could decline.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If third-party payers do not cover our approved products, such products might not be prescribed, used or purchased, which would adversely affect our revenues.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We may need to raise additional capital to fund our operations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If our data or our information technology systems, or those of third parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We expect that our results of operations will fluctuate for the foreseeable future, which may make it difficult to predict our future performance from period to period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We may incur losses and may not generate positive or sufficient cash flow from operations in the future which may have an adverse impact on our working capital, total assets and stockholders' equity and our ability to service all of our indebtedness and commitments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Continued testing of our products and product candidates may not yield successful results, and even if it does, we may still be unable to successfully commercialize our current or future products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If we do not achieve our projected development goals in the timeframes we expect, our business, financial condition and results of operations will be harmed and the market price of our common stock and other securities could decline.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The long-term safety and efficacy of approved products may differ from clinical studies, which could negatively impact sales and could lead to reputational harm or other negative effects.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Our products, product candidates and technology may not be able to compete effectively or may be rendered obsolete.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We may undertake internal restructuring activities in the future that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Changes in funding or staffing for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The Blackstone Credit Facility contains restrictive covenants that may materially limit our operating flexibility. A default under the instruments governing our indebtedness, including the Blackstone Credit Facility, could materially and adversely affect our financial position.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We may not realize the anticipated benefits of the scPharma acquisition or any future acquisition or strategic transaction; we may be unable to successfully integrate new products, technologies or businesses we acquire.

**RISKS RELATED TO GOVERNMENT REGULATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Our product candidates must undergo costly and time-consuming rigorous nonclinical and clinical testing and we must obtain regulatory approval prior to the sale and marketing of any product in each jurisdiction. The results of this testing or issues that develop in the review and approval by a regulatory agency may subject us to unanticipated delays or prevent us from marketing any products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If we do not comply with regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be fined or forced to remove a product from the market, subject to criminal prosecution, or experience other adverse consequences, including restrictions or delays in obtaining regulatory marketing approval.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Healthcare legislation may impact the net sales of commercial products sold by us or any partner.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If we or any partner fails to comply with federal and state healthcare laws, including fraud and abuse and health information laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure, or that of the third parties with whom we work, to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.

**RISKS RELATED TO OUR COMMON STOCK**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Our stock price is volatile.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Future sales of shares of our common stock in the public market, or the perception that such sales may occur, may depress our stock price and adversely impact the market price of our common stock and other securities.

**GENERAL RISK FACTORS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Unstable market, economic and geopolitical conditions may have serious adverse consequences on our business, financial condition and stock price.

*You should consider carefully the following information about the risks described below, together with the other information contained in this Quarterly Report on Form 10-Q before you decide to buy or maintain an investment in our common stock. We believe the risks described below are the risks that are material to us as of the date of this Quarterly Report. Additional risks and uncertainties that we are unaware of may also become important factors that affect us. The risk factors set forth below marked with an asterisk (\*) did not appear as separate risk factors in, or contains changes to the similarly titled risk factors included in, Item 1A of the Annual Report. If any of the following risks actually occur, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock could decline, and you may lose all or part of the money you paid to buy our common stock.*

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**RISKS RELATED TO OUR BUSINESS** 

***The products that we or our collaboration partner are commercializing may only achieve a limited degree of commercial success.***

Successful commercialization of therapeutic products is subject to many risks, including some that are outside our control. There are numerous examples of failures to fully exploit the market potential of therapeutic products, including by biopharmaceutical and device companies with more experience and resources than us. Products that we commercialize ourselves (including Afrezza, Furoscix and any products that we may develop or acquire in the future) and the product that is commercialized by our current collaboration partner (including future products that may be commercialized by a collaboration partner) may not gain market acceptance among physicians, patients, third-party payers and the healthcare community. The degree of market acceptance of our or a collaboration partner's products depends on many factors, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•approved labeling claims;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•effectiveness of efforts by us and/or any current or future collaboration or marketing partner to support and educate patients and physicians about the benefits and proper administration of our products, and the perceived advantages of our products and the disadvantages of competitive products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•willingness of the healthcare community and patients to adopt new technologies or therapies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•ability to manufacture the product in sufficient quantities with acceptable quality and cost;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•perception of patients and the healthcare community, including third-party payers, regarding the safety, efficacy and benefits compared to competing products or therapies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•convenience and ease of administration relative to existing treatment methods;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•coverage and reimbursement, as well as pricing relative to other treatment therapeutics and methods; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•marketing and distribution support.

Because of these and other factors, the products described above may not gain market acceptance or otherwise be commercially successful. Failure to achieve market acceptance would limit our ability to generate revenue and would adversely affect our results of operations. We and our current or any future collaboration partner may need to enhance our/their commercialization capabilities in order to successfully commercialize such products in the United States or any other jurisdiction in which such product is approved for commercial sale, and we or the collaboration partner may not have sufficient resources to do so.

***If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, our revenues could decline materially.\**** 

Treprostinil, the active ingredient in Tyvaso DPI, is a prostacyclin analog that has been available as a generic injectable since late 2017. In more recent years, other dosage forms of treprostinil have become available, including in June 2025, when Yutrepia, a dry-powder formulation of treprostinil, was launched by Liquidia Corporation. Yutrepia and Tyvaso DPI now compete against each other for market share. On its February 2026 earnings call, United Therapeutics highlighted the development of Tresmi, a treprostinil solution for use in a soft mist inhaler with plans to file for approval of Tresmi in PAH and PH-ILD within the year and launch commercially in the following year. Such public statements regarding Tresmi's potential advantages and United Therapeutics' future commercial plans indicate that United Therapeutics may choose to prioritize Tresmi or other pipeline products over Tyvaso DPI.

One such potential pipeline product is ralinepag, a novel, highly selective prostacyclin receptor agonist for which United Therapeutics intends to submit an NDA in the second half of 2026. Although we are also collaborating with United Therapeutics on the development of a dry powder formulation of ralinepag (MNKD-1501), a significant portion of our current revenue is derived from royalties and collaboration and services revenue associated with United Therapeutics' commercialization of Tyvaso DPI. Because United Therapeutics is solely responsible for the development, marketing, promotion, and sale of Tyvaso DPI, our ability to maintain and grow this revenue is highly dependent on the commercial performance of Tyvaso DPI and on United Therapeutics' strategic priorities, resource allocation decisions, and overall commitment to undertake development activities that could potentially expand the therapeutic indications for Tyvaso DPI. Moreover, we have limited control over United Therapeutics' commercialization activities, including decisions related to marketing strategy, salesforce deployment, pricing, market access, physician outreach, patient support programs, and the prioritization of Tyvaso DPI relative to other products in its portfolio.

If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, diverts resources toward Tresmi or other therapies, or if Tresmi, if and when launched, displaces Tyvaso DPI in the market, our revenues from Tyvaso DPI could decline materially and may not be offset by revenues from ralinepag DPI (MNKD-1501) or any other product in our collaboration. United Therapeutics' strategic priorities are outside our control, and we cannot predict how evolving market dynamics, product differentiation claims, or United Therapeutics' internal assessments will influence its promotional and development strategies.

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Any reduction in Tyvaso DPI sales—including due to competitive products introduced by United Therapeutics itself, shifting promotional strategies, or physician or patient preference trends influenced by United Therapeutics' messaging or otherwise—would adversely affect our results of operations. Our business and results of operations remain significantly exposed to United Therapeutics' strategic and commercial decisions.

***In order to increase adoption and sales of our products, we need to continue to develop our commercial organization, including maintaining and growing a highly experienced and skilled workforce with qualified sales representatives.***

Our sales forces promote our products to different target groups of physicians. In order to successfully commercialize our approved products, we must continue to build our sales, marketing, distribution, managerial and other commercial capabilities. The market for skilled commercial personnel is highly competitive, and we may not be able to hire all of the personnel we need on a timely basis or retain them for a sufficient period. Factors that may hinder our ability to successfully market and commercially distribute our products include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•inability to recruit, retain and effectively manage adequate numbers of effective sales personnel;

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•unforeseen delays, costs and expenses associated with maintaining our sales organization.

If we are unable to maintain effective sales forces for our products, including potential future products, we may not be able to generate sufficient product revenue in the United States. We are required to expend significant time and resources to train our sales forces to educate physicians about our products. In addition, we must continually train our sales forces and equip them with effective marketing materials to ensure that a consistent and appropriate message about our products is being delivered to our potential customers. We currently have limited resources compared to some of our competitors, and the continued development of our own commercial organization to market our products and any additional products we may develop or acquire will be expensive and time-consuming. We also cannot be certain that we will be able to continue to successfully develop this capability.

Similarly, if UT does not effectively engage or maintain its sales force for Tyvaso DPI, our ability to recognize royalties and manufacturing revenue from this collaboration will be adversely affected.

***Manufacturing risks may adversely affect our ability to manufacture our products and Tyvaso DPI, which could reduce our gross margin and profitability.***

Afrezza and Tyvaso DPI are manufactured by us in our Danbury, Connecticut facility, where we assemble the inhalers from their individual molded parts, formulate the inhalation powders, fill plastic cartridges with the powders, package the cartridges into secondary packaging and assemble the final kits. If and when needed, we also utilize a contract packager to assemble final kits for commercial sale.

The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, especially in scaling up production to commercial batch sizes. These problems include difficulties with production costs, capacity utilization and yields. We may also experience shortages of qualified personnel, which could impact our ability to meet manufacturing requirements. In addition, there is a need to comply with strictly enforced federal, state and foreign regulations, including inspections. Our facility is inspected on a regular basis by the FDA. If the FDA makes any major observations during future inspections, the corrective actions required could be onerous and time-consuming.

Any of these factors could cause us to delay or suspend production, could entail higher costs and may result in our being unable to obtain sufficient quantities for the commercialization of drug products at the costs that we currently anticipate. If we fail to deliver the required commercial quantities of the product on a timely basis, at commercially reasonable prices and at acceptable quality, and we were unable to promptly find on a timely basis one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volume and quality, we would likely be unable to meet demand for such drug products and we would lose potential revenues.

As demand for our products increases, we may have to invest additional resources to purchase components, hire and train employees, and enhance or expand our manufacturing capabilities. If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins could fluctuate or decline. In addition, we may be unable to support commercialization of Tyvaso DPI.

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Unlike Afrezza and Tyvaso DPI, which are assembled and formulated domestically, V-Go is wholly manufactured on our behalf by contract manufacturers located in China. Our contract manufacturer uses MannKind-owned, custom-designed, semi-automated manufacturing equipment and production lines to meet our quality requirements. Separate contract manufacturers in China perform release testing, sterilization, inspection and packaging functions. As a result, our V-Go business is subject to risks associated with doing business in China, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•adverse political and economic conditions, particularly those potentially negatively affecting the trade relationship between the United States and China;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•trade protection measures and import and export licensing and control requirements, although in July 2025, we received a ruling from U.S. Customs and Border Protection that V-Go qualifies for duty-free treatment under subheading 9817.00.96 of the Harmonized Tariff Schedule of the United States ("HTSUS");

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•potentially negative consequences from changes in tax laws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•difficulties associated with the Chinese legal system, including increased costs and uncertainties associated with enforcing contractual obligations in China;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•historically lower protection of intellectual property rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•unexpected or unfavorable changes in regulatory requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes and volatility in currency exchange rates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•possible patient or physician preferences for more established pharmaceutical products and medical devices manufactured in the United States; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•difficulties in managing foreign relationships and operations generally.

These risks may be exacerbated by our limited experience with V-Go and its manufacturing processes. If V-Go does not continue to qualify for duty-free treatment, any tariffs that apply to imported goods from China could materially and adversely affect our margins on V-Go sales.

Similarly, the drug formulation and device components of Furoscix are manufactured for us by third parties, some of which are outside the United States. In addition to the risks identified above, any future curtailment in the availability of materials could result in production or other delays with consequent adverse effects on us. In addition, because regulatory authorities must generally approve raw material sources for pharmaceutical products, changes in raw material suppliers may result in production delays or higher raw material costs.

***If our suppliers fail to deliver materials and services needed for commercial manufacturing in a timely and sufficient manner or fail to comply with applicable regulations, and if we fail to timely identify and qualify alternative suppliers, our business, financial condition and results of operations would be harmed and the market price of our common stock and other securities could decline.***

For the commercial manufacture of inhaled drug products, we need access to sufficient, reliable and affordable supplies of raw materials for formulating powders, such as fumaryl diketopiperazine (or FDKP), as well as other components, such as the inhaler and the related cartridges. For Afrezza, we also require a supply of insulin. Currently, the only source of insulin that we have qualified for Afrezza is manufactured by Amphastar. We must rely on all of our suppliers to comply with relevant regulatory and other legal requirements, including the production of insulin and FDKP in accordance with current good manufacturing practices (or cGMP) for drug products, and the molding of the inhaler and cartridges components in accordance with the quality management system regulations for medical devices (or QMSRs).

For certain other components, such as packaging materials, we obtain materials from a limited number of suppliers, including some parts and components that are purchased from single-source vendors. For outsourced products such as Furoscix and V-Go, this is also true for some of the components required by our contract manufacturers. Depending on a limited number of suppliers exposes us to risks, including limited control over pricing, availability, quality and delivery schedules. In addition, we do not have long-term supply agreements for such components and, in many cases, purchases are made on a purchase order basis. As a result, our suppliers have no obligation to manufacture for us or sell to us any given quantity of components. Because we do not have long-standing relationships with all of the suppliers in our supply chain, we may not be able to convince them to continue to make components available to us unless there is demand for such components from their other customers. If any one or more of our suppliers cease to provide us with sufficient quantities of components in a timely manner or on pricing and quality terms acceptable to us, we would have to seek alternative sources of supply. Because of factors such as the proprietary nature of our products, our quality control standards and regulatory requirements, we cannot quickly engage additional or replacement suppliers for some of our critical components.

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In addition, materials sourced from suppliers located outside the United States have or may become subject to tariffs under U.S. trade policies. Although our current inventories of such materials are sufficient to meet our projected production levels for at least the next six months, our manufacturing costs may be impacted by any prevailing tariffs on imports at the time such materials enter the United States. Components made domestically from imported materials that are or become subject to tariffs would be expected to become more expensive in the future. These and any future tariffs will increase our cost of goods and decrease our operating margins.

We may also have difficulty obtaining similar components from other suppliers that meet the requirements of the FDA or other regulatory agencies. Although we conduct our own inspections and review and/or approve investigations of each supplier, there can be no assurance that the FDA, upon inspection, would find that the supplier substantially complies with the QMSR or cGMP requirements, where applicable. If a supplier fails to comply with these requirements or the comparable requirements in foreign countries, regulatory authorities may subject us to regulatory action, including criminal prosecutions, fines and suspension of the manufacture of our products. If we are required to find a new or additional supplier, we will need to evaluate that supplier's ability to provide material that meets regulatory requirements, including cGMP or QMSR requirements, as well as our specifications and quality requirements, which would require significant time and expense and could delay production.

As a result, our ability to purchase adequate quantities of the components for our products may be limited. Additionally, our suppliers may encounter problems that limit their ability to manufacture components for us, including financial difficulties or damage to their manufacturing equipment or facilities. In general, if any of our suppliers is unwilling or unable to meet its supply obligations or if we encounter delays or difficulties in our relationships with manufacturers or suppliers, and we are unable to secure an alternative supply source in a timely manner and on favorable terms, our business, financial condition, and results of operations may be harmed and the market price of our common stock and other securities may decline.

***International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.*** 

We operate in a global economy, and our business depends on a global supply chain for the development, manufacturing, and distribution of our products, and for the advancement of our preclinical and clinical development programs. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty.

Recent and potential future changes in international trade policies, particularly regarding U.S.-China trade relations and pharmaceutical-specific tariffs, present material risks to our operations and financial performance. While we manufacture Afrezza and Tyvaso DPI in our Danbury, Connecticut facility and our Furoscix contract manufacturers have domestic operations, we and our suppliers must obtain raw materials, chemicals, device components, and specialized equipment from international sources. In addition, V-Go is manufactured for us by contract manufacturers in China, although this product is currently eligible for duty-free treatment under a specific exemption in the HTSUS.

Unlike many industries, our ability to pass increased costs to customers is limited by the structure of pharmaceutical and medical device pricing and reimbursement systems. Pricing for our products is established through annual or multi-year contracts with commercial, third-party payers and pharmacy benefit managers, customers, and group purchasing organizations, and reimbursement methodologies established by government programs, such as Medicare. These arrangements typically include fixed pricing terms that were negotiated prior to the implementation of the recently announced tariffs. As a result, and depending on the timing and scope of the implementation of these tariffs, cost increases due to tariffs may be difficult or impossible to pass through to customers until the next negotiation cycle, which could be up to 36 months away.

Current or future tariffs will also result in increased manufacturing expense, as well as research and development expenses, including with respect to increased costs associated with active pharmaceutical ingredients, raw materials, laboratory equipment and research materials and components. Trade restrictions affecting the import of materials necessary for clinical trials could result in delays to our development timelines. Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence and negatively impact our business, results of operations, financial condition and growth prospects.

Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially

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and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects.

Our royalty revenue and results of operations may also be adversely impacted if our marketing and collaboration partner, United Therapeutics, is adversely impacted by any of the factors described above.

In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this report.

***If third-party payers do not cover our approved products, such products might not be prescribed, used or purchased, which would adversely affect our revenues.***

In the United States and elsewhere, sales of prescription pharmaceuticals depend in large part on the availability of coverage and adequate reimbursement to the consumer from third-party payers, such as government health administration authorities and private insurance plans. In general, patients are less likely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products. Third-party payers are increasingly challenging the prices charged for medical products and services. The market for our approved products depends significantly on access to third-party payers' formularies, which are the lists of medications and devices for which third-party payers provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical and device companies. Also, third-party payers may refuse to include a particular branded product in their formularies or otherwise restrict patient access to a branded product when a less costly generic equivalent or other alternative is available. Because each third-party payer individually approves coverage and reimbursement levels, obtaining coverage and adequate reimbursement is a time-consuming and costly process. We may be required to provide scientific and clinical support for the use of any product to each third-party payer separately with no assurance that approval would be obtained. Even if favorable coverage and reimbursement status is attained from some payers for our products, less favorable coverage policies and reimbursement rates may be implemented in the future. Such less favorable coverage could impact the market acceptance of any product and could have a negative effect on our revenues and operating results. Even if we succeed in bringing more products to market, we cannot be certain that any such products would be considered cost-effective or that coverage and adequate reimbursement to the consumer would be available.

Our future revenues and ability to generate positive cash flow from operations may be affected by the continuing efforts of government and other third-party payers to contain or reduce the costs of healthcare through various means. In the United States, there have been several congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. For example, the Inflation Reduction Act of 2022 ("IRA") limited insulin copays to $35 per month for Medicare Part D beneficiaries starting in 2023. Further, the U.S. Department of Health and Human Services ("HHS") imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. In addition, HHS has been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to 20 products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our current and any future product candidates that we develop, which could have an adverse effect on our operating results and our overall financial condition. In certain foreign markets, the pricing of prescription pharmaceuticals is subject to direct governmental control. The European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

If we or any collaboration partner is unable to obtain and maintain coverage of, and adequate third-party reimbursement for, our approved products, physicians may limit how much or under what circumstances they will prescribe or administer them and patients may decline to purchase them. This in turn could affect our or any collaboration partner's ability to successfully commercialize such products and would impact our profitability, results of operations, financial condition, and prospects.

***We may not realize the anticipated benefits of the scPharma acquisition or any future acquisition or strategic transaction; we may be unable to successfully integrate new products, technologies or businesses we acquire.***

In October 2025, we acquired scPharma as part of a strategy of assessing potential strategic acquisitions, dispositions, partnerships and other strategic transactions. We expect to continue this strategy by periodically evaluating and pursuing acquisition of companies, therapeutic products, product candidates and technologies. The integration of any acquired business, product, technology or other assets into our company may be complex and time-consuming and, if such businesses, products, technologies or assets are not

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successfully integrated, we may not achieve the anticipated benefits, cost-savings or growth opportunities. Potential difficulties that may be encountered in the integration process include the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•unanticipated liabilities related to acquired assets, companies or joint ventures;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•integrating personnel, operations and systems, while maintaining focus on producing and delivering consistent, high quality products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•coordinating geographically dispersed organizations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•diversion of management time and focus from operating our business to management of strategic alliances or joint ventures or acquisition integration challenges;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•retention of key employees;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•increases in our expenses and reductions in our cash available for operations and other uses;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•retaining existing customers and attracting new customers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•managing inefficiencies associated with integrating the operations of our company; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•possible write-offs or impairment charges relating to acquired assets, businesses or joint ventures.

Furthermore, these acquisitions and other arrangements, even if successfully integrated, may fail to further our business strategy as anticipated, expose us to increased competition or challenges with respect to our products or geographic markets, and expose us to additional liabilities or restructuring costs associated with an acquired business, product, technology or other asset or arrangement. In particular, the scPharma acquisition may have a potentially adverse effect on our net debt and liquidity position as a result of the acquisition purchase price being paid in cash. Because we incurred debt to pay for the acquisition, our interest expense, leverage and debt service requirements have increased significantly. Any one of these challenges or risks could impair our ability to realize any benefit from our acquisitions or arrangements after we have expended resources on them. Future acquisitions or dispositions could also result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities or amortization expenses or write-offs of goodwill, developed technologies and in-process research and development, any of which could harm our financial condition.

***We may need to raise additional capital to fund our operations.\****

We may need to raise additional capital, whether through the sale of equity or debt securities, additional strategic business collaborations, the establishment of other funding facilities, licensing arrangements, asset sales or other means, in order to support our ongoing activities, including the commercialization of our products and the development of our product candidates. It may be difficult for us to raise additional funds on favorable terms, or at all. The extent of our additional funding requirements will depend on a number of factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the degree to which we are able to generate revenue from products that we or a collaboration partner commercialize;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the occurrence of milestone(s) that trigger one or more CVR payments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of developing and commercializing our products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to repay or refinance existing indebtedness;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the rate of progress and costs of our clinical studies and R&D activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of procuring raw materials and operating our manufacturing facility;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our success in establishing additional strategic business collaborations or other sales or licensing of assets, and the timing and amount of any payments we might receive from any such transactions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•actions taken by the FDA and other regulatory authorities affecting Afrezza, Furoscix, V-Go, Tyvaso DPI, our product candidates or competitive products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the emergence of competing technologies and products and other market developments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other intellectual property rights or defending against claims of infringement by others;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the level of our legal and litigation expenses; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of discontinuing projects and technologies, and/or decommissioning existing facilities, if we undertake any such activities.

We have raised capital in the past through borrowings and the sale of equity and debt securities and the sale of certain assets. In the future, we may pursue the sale of additional equity, debt securities and/or assets, or the establishment of other funding facilities including asset-based borrowings. There can be no assurances, however, that we will be able to raise additional capital in the future on acceptable terms, or at all. Volatility and disruptions of the global supply chain and financial markets, if sustained or recurrent, could prevent us or make it more difficult for us to access capital.

Issuances of additional debt or equity securities or the issuance of common stock upon conversion of outstanding convertible debt securities for shares of our common stock could impact the rights of the holders of our common stock and will dilute their ownership percentage. Moreover, the establishment of other funding facilities may impose restrictions on our operations. These restrictions could include limitations on additional borrowing and specific restrictions on the use of our assets, as well as prohibitions on our ability to create liens, pay dividends, redeem our stock or make investments. We may also raise additional capital by pursuing opportunities for the licensing or sale of certain intellectual property and other assets. We cannot offer assurances, however, that any strategic collaboration, sales of securities or sales or licenses of assets will be available to us on a timely basis or on acceptable terms, if at all. We may be required to enter into relationships with third parties to develop or commercialize products or technologies that we otherwise would have sought to develop independently, and any such relationships may not be on terms as commercially favorable to us as might otherwise be the case.

In the event that sufficient additional funds are not obtained through strategic collaboration opportunities, sales of securities, funding facilities, licensing arrangements, borrowing arrangements and/or asset sales on a timely basis, we may be required to reduce expenses through the delay, reduction or curtailment of our projects, or further reduction of costs for facilities and administration.

We cannot provide assurances that changed or unexpected circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate. There can be no assurances that we will be able to raise additional capital in sufficient amounts or on favorable terms, or at all. If we are unable to raise adequate additional capital when required or in sufficient amounts or on terms acceptable to us, we may have to delay, scale back or discontinue one or more product development programs, curtail our commercialization activities, significantly reduce expenses, sell assets (potentially at a loss), enter into relationships with third parties to develop or commercialize products or technologies that we otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue an acquisition of our company at a price that may result in up to a total loss on investment for our stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all of our assets.

***If our data or information technology systems, or those of third parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.***

We, and third parties with whom we work, employ and are increasingly dependent upon information technology systems, infrastructure, applications, websites and other resources. Our business, and that of the third parties with whom we work, requires collecting, receiving, manipulating, analyzing, storing, processing, generating, using, disclosing, protecting, securing, transmitting, sharing, disposing of, and making accessible (collectively "processing") large amounts of data, including proprietary, confidential and sensitive data (such as personal or health-related data), intellectual property, and trade secrets (collectively, "sensitive information"). As a result, we and the third parties with whom we work face a variety of evolving threats that could cause security incidents.

Cyber-attacks, malicious internet-based activity, online and offline fraud and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties with whom we work. Such threats are prevalent and continue to increase, are increasingly difficult to detect, and come from a variety of sources, including traditional computer "hackers," threat actors "hacktivists," organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation-states, and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors, for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services. We and the third parties with whom we work may be subject to physical threats, such as telecommunications failures, earthquakes, fires or floods, as well as a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks (such as credential stuffing), credentials harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by artificial intelligence, and other similar threats. Ransomware attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are

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becoming increasingly prevalent and severe and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments. Some of our workforce works remotely, which also poses increased risks to our information technology systems and data, as employees working from home, in transit or in public locations, utilize network connections, computers and devices outside our premises or network. Future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities' systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.

We rely on third parties and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email and productivity software, and other functions. We also rely on third-party service providers to provide other products or services, or otherwise to operate our business. Our business, including our ability to manufacture drug products and conduct clinical trials, therefore depends on the continuous, effective, reliable and secure operation of our information technology resources and those of third parties with whom we work, including computer hardware, software, networks, Internet servers and related infrastructure. Our ability to monitor these third parties' information security practices is limited, and these third parties may not have adequate information security measures in place. If our third-party service providers experience a security incident or other interruption, we could experience adverse consequences. In particular, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners' supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems (including our products) or the third-party information technology systems that support us and our services. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award.

While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. We take steps designed to detect, mitigate and remediate vulnerabilities in our information technology systems (such as our hardware and/or software, including that of third parties with whom we work), but we may not be able to detect, mitigate, and remediate all such vulnerabilities on a timely basis. It may also be difficult and/or costly to detect, investigate, mitigate, contain, and remediate a security incident. Further, we may experience delays in developing and deploying remedial measures and patches designed to address identified vulnerabilities, which could be exploited and result in a security incident. Actions taken by us or the third parties with whom we work to detect, investigate, mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of our business. Threat actors may also gain access to other networks and systems after a compromise of our networks and systems. A security incident or other interruption could disrupt our ability (and that of third parties with whom we work) to provide our products. We may expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against security incidents. Certain data privacy and security obligations have required us to implement and maintain specific security measures, industry-standards or reasonable security measures to protect our information technology systems and sensitive information.

Any of the previously identified or similar threats could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive information or our information technology systems, or those of the third parties with whom we work. For example, although we have not directly experienced a cyberattack, third parties with whom we work have experienced security incidents, such as the SolarWinds attack in December 2020, the ransomware attack on Kronos Private Cloud in December 2021 and the Change Healthcare data breach in February 2024. In all of these cases, we were able to apply software patches or move operations to a new provider in order to avoid any negative impact on our operations or the sensitive information we may process. Nonetheless, these incidents illustrate that despite our efforts to identify and remediate vulnerabilities, if any, in our information technology systems and those of third parties with whom we work, our efforts may not be successful.

Applicable data privacy and security obligations may require us, or we may voluntarily choose, to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents, or to take other actions, such as providing credit monitoring and identify theft protection services. Such disclosures and related actions can be costly, and the disclosures or the failure to comply with such applicable requirements could lead to adverse consequences. If we (or a third party with whom we work) experience a security incident or are perceived to have experienced a security incident, we may experience material adverse consequences. These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; diversion of management attention; interruptions in our operations (including availability of data); financial loss; and other similar harms. Security incidents and material attendant consequences may cause customers to stop using our products, deter new customers from using our products, and negatively impact our ability to grow and operate our business. Additionally, our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts

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are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. We cannot be sure that our cybersecurity insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position. Sensitive information of the Company or our customers could also be leaked, disclosed, or revealed as a result of or in connection with the use of generative artificial intelligence ("AI") technologies by our employees, personnel or vendors.

***We expect that our results of operations will fluctuate for the foreseeable future, which may make it difficult to predict our future performance from period to period.***

Our operating results have fluctuated in the past and are likely to do so in future periods. Some of the factors that could cause our operating results to fluctuate from period to period include the factors that will affect our funding requirements described above under "Risk Factors – We may need to raise additional capital to fund our operations." In addition, the current inflationary environment related to increased aggregate demand and supply chain constraints has the potential to adversely affect our operating expenses.

We believe that comparisons from period to period of our financial results are not necessarily meaningful and should not be relied upon as indications of our future performance.

***The Blackstone Credit Facility contains restrictive covenants that may materially limit our operating flexibility. A default under the instruments governing our indebtedness, including the Blackstone Credit Facility, could materially and adversely affect our financial position.\****

The Blackstone Credit Facility requires us, and any debt arrangements we may enter into in the future may require us, to comply with various covenants that limit our ability to, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•dispose of assets;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•complete mergers or acquisitions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•incur indebtedness or modify existing debt agreements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•sell royalties or revenue interests;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•amend or modify certain material agreements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•engage in additional lines of business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•encumber assets;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•pay dividends or make other distributions to holders of our capital stock;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•make specified investments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•change certain organizational documents; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•engage in transactions with our affiliates.

In addition, the Blackstone Credit Facility requires us to maintain at least $40.0 million of liquidity, tested quarterly, with liquidity defined as our unrestricted cash and cash equivalents held in collateral accounts of the lenders. The covenants in the Blackstone Credit Facility could prevent us from pursuing business opportunities that we or our stockholders may consider beneficial.

Our obligations under the Blackstone Credit Facility are guaranteed by each of our subsidiaries and any future subsidiaries, subject to limited exceptions, and are secured by a security interest in substantially all of our and the subsidiary guarantors' assets, including intellectual property. A breach of any of these covenants could result in an event of default under the Blackstone Credit Facility. If we default under our obligations under the Blackstone Credit Facility, the lenders could proceed against the collateral granted to them to secure our indebtedness or declare all obligations under the Blackstone Credit Facility to be due and payable. In certain circumstances, procedures by the lenders could result in a loss by us of all of our equipment and inventory, which are included in the collateral granted to the lenders. In addition, upon any distribution of assets pursuant to any liquidation, insolvency, dissolution, reorganization or similar proceeding, the holders of secured indebtedness will be entitled to receive payment in full from the proceeds of the

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collateral securing our secured indebtedness before the holders of other indebtedness or our common stock will be entitled to receive any distribution with respect thereto.

There can be no assurance that we will have sufficient resources to make any required repayments of principal and interest under the terms of our indebtedness when required. If we fail to pay interest on the Blackstone Credit Facility when required or principal at maturity, we will be in default and may also suffer an event of default under the terms of other borrowing arrangements that we may enter into from time to time. In addition, a default under other indebtedness of ours in an aggregate principal amount of $10.0 million or more would constitute an event of default under the Blackstone Credit Facility. Any of these events could have a material adverse effect on our business, results of operations and financial condition, up to and including lenders initiating bankruptcy proceedings or causing us to cease operations altogether.

***We may incur losses and may not generate positive or sufficient cash flow from operations in the future which may have an adverse impact on our working capital, total assets and stockholders' equity and our ability to service all of our indebtedness and commitments.\****

Our ability to sustain positive cash flow from operations and profitability depends heavily upon successfully commercializing our products, and although we had positive cash flows from operations and net income in the year ended December 31, 2025, we may not continue to generate positive cash flow from operations or be profitable in the future. In addition, we cannot assure you that we will maintain a level of cash flows from operating activities sufficient to permit us to make scheduled payments on our insulin purchase commitments and debt obligations. If our cash flows and capital resources are insufficient to fund our obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital or restructure or refinance our obligations. In the past, we have had losses that have had, and we may in the future have losses that have, an adverse impact on our working capital, total assets and stockholders' equity.

As of March 31, 2026, we had an accumulated deficit of $3.2 billion. The accumulated deficit has resulted principally from costs incurred in our R&D programs, the write-off of assets (including goodwill, inventory and property, plant and equipment) and general operating expenses. We expect to make substantial expenditures and may incur operating losses in the future in order to continue commercializing our products and to advance development of product candidates in our pipeline.

In addition, we may from time to time seek to retire or purchase our outstanding debt through cash purchases and/or exchanges for equity securities, in open market purchases, privately negotiated transactions or otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity requirements, contractual restrictions, and other factors. The amounts involved in any such transactions, individually or in the aggregate, may be material. Further, any such purchases or exchanges may result in us acquiring and retiring a substantial amount of such indebtedness, which could impact the trading liquidity of such indebtedness.

***Our business, product sales, results of operations and ability to access capital could be adversely affected by the effects of health pandemics or epidemics, in regions where we or third parties distribute our products or where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.***

Our business could be adversely affected by the effects of health pandemics or epidemics in regions where we have business operations, and we could experience significant disruptions in the operations of third-party manufacturers and distributors upon whom we rely. For example, sales and demand for Afrezza were adversely affected by the global COVID-19 pandemic, and future pandemics or epidemics could adversely affect the demand for and sales of our products in the future. Quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to infectious diseases, could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain. In addition, our contract manufacturers in China could be impacted by that country's policy of strict lockdowns in order to reduce the spread of disease. Disruptions in sales and demand for our products would be expected to occur:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•if patients are physically quarantined or are unable or unwilling to visit healthcare providers,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•if physicians restrict access to their facilities for a material period of time,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•if healthcare providers prioritize treatment of acute or communicable illnesses over chronic disease management,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•if pharmacies are closed or suffering supply chain disruptions,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•if patients lose access to employer-sponsored health insurance due to periods of high unemployment, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•as a result of general disruptions in the operations of payers, distributors, logistics providers and other third parties that are necessary for our products to be prescribed and reimbursed.

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Clinical trials of our products were delayed as a result of the COVID-19 pandemic and may be affected by a future health pandemic or epidemic. Clinical site initiation and patient enrollment may be delayed due to prioritization of hospital resources toward the health pandemic or epidemic. Some patients may not be able or willing to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, our ability to recruit and retain patients and principal investigators and site staff would adversely impact our clinical trial operations.

A pandemic or epidemic also has the potential for disruption of global financial markets. This disruption, if sustained or recurrent, could make it more difficult for us to access capital, which could negatively affect our liquidity. In addition, a recession or market correction as a result of a health pandemic or epidemic could materially affect our business and the value of our common stock.

***If we do not obtain regulatory approval of our products in foreign jurisdictions, we will not be able to market in such jurisdictions, which could limit our commercial revenues. We may not be able to establish additional regional partnerships or other arrangements with third parties for the commercialization of our products outside of the United States.***

Afrezza has been approved in the United States, Brazil and India, but we have not yet obtained approval in any other jurisdiction. V-Go has received 510(k) clearance from the FDA, but has not received a comparable approval in any other country. Similarly, Furoscix is approved only in the United States. In order to market our products in a foreign jurisdiction, we must obtain regulatory approval in each such foreign jurisdiction, and we may never be able to obtain such approvals. The research, testing, manufacturing, labeling, sale, import, export, marketing, and distribution of therapeutic products outside the United States are subject to extensive regulation by foreign regulatory authorities, whose regulations differ from country to country. We will be required to comply with the different regulations and policies of the jurisdictions where we seek approval for our products, and we have not yet identified all of the requirements that we will need to satisfy to submit our products for approval for other jurisdictions. This will require additional time, expertise and expense, including the potential need to conduct additional studies or development work for other jurisdictions beyond the work that we have conducted to support the approval of our products in the United States.

Our current strategy for the future commercialization of our products outside of the United States, subject to receipt of the necessary regulatory approvals, is to seek, establish and maintain regional partnerships in foreign jurisdictions where there are commercial opportunities. It may be difficult to find or maintain collaboration partners that are able and willing to devote the time and resources necessary to successfully commercialize our products. Collaborations with third parties may require us to relinquish material rights, including revenue from commercialization, agree to unfavorable terms or assume material ongoing development obligations that we would have to fund. These collaboration arrangements are complex and time-consuming to negotiate, and if we are unable to reach agreements with third-party collaborators, we may fail to meet our business objectives and our financial condition may be adversely affected. We may also face significant competition in seeking collaboration partners, and may not be able to find a suitable collaboration partner in a timely manner on acceptable terms, or at all. Any of these factors could cause delay or prevent the successful commercialization of our products in foreign jurisdictions and could have a material and adverse impact on our business, financial condition and results of operations and the market price of our common stock and other securities could decline.

***Continued testing of our products and product candidates may not yield successful results, and even if it does, we may still be unable to successfully commercialize our current or future products.***

We have generally sought to develop product candidates through our internal research programs. All product candidates require preclinical, clinical and other testing prior to seeking regulatory approval to market them. Accordingly, the development timelines for product candidates can stretch over many years. Further research and development on these programs requires significant financial resources. Given our limited financial resources, we may not be able to complete the full clinical development of our product candidates unless we are able to obtain specific funding for these programs or enter into collaborations with third parties.

Our research and development programs are designed to test the safety and efficacy of our product candidates through extensive nonclinical and clinical testing. We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or impact commercialization of any of our product candidates, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•safety and efficacy results obtained in our nonclinical and early clinical testing may be inconclusive or may not be predictive of results that we may obtain in our future clinical studies or following long-term use, and we may as a result be forced to stop developing a product candidate or alter the marketing of an approved product;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the analysis of data collected from clinical studies of our products and product candidates may not reach the statistical significance necessary, or otherwise be sufficient to support FDA or other regulatory approval for the claimed indications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•after reviewing clinical data, we or any collaborators may abandon projects that we previously believed were promising;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our product candidates may not produce the desired effects or may result in adverse health effects or other characteristics that preclude regulatory approval or limit their commercial use once approved; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•disruptions caused by geopolitical conflicts, man-made or natural disasters or public health pandemics or epidemics or other business interruptions.

As a result of any of these events, we, any collaborator, the FDA, or any other regulatory authorities may suspend or terminate clinical studies or marketing of any of our products or product candidates at any time. Any suspension or termination of our clinical studies or marketing activities may harm our business, financial condition and results of operations and the market price of our common stock and other securities may decline.

***If we do not achieve our projected development goals in the timeframes we expect, our business, financial condition and results of operations will be harmed and the market price of our common stock and other securities could decline.***

For planning purposes, we estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical studies and the submission of regulatory filings. From time to time, we publicly announce the expected timing of some of these milestones. All of these milestones are based on a variety of assumptions. The actual timing of the achievement of these milestones can vary dramatically from our estimates, in many cases for reasons beyond our control, depending on numerous factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the rate of progress, costs and results of our clinical studies and preclinical research and development activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to identify and enroll patients who meet clinical study eligibility criteria;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to access sufficient, reliable and affordable supplies of components used in the manufacture of our product candidates or to source clinical supplies from contract manufacturers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of expanding and maintaining manufacturing operations, as necessary;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the extent to which our clinical studies compete for clinical sites and eligible subjects with clinical studies sponsored by other companies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•actions by regulators; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•disruptions caused by geopolitical conflicts, man-made or natural disasters or public health pandemics or epidemics or other business interruptions.

If we fail to commence or complete, or experience delays in or are forced to curtail, our proposed development programs or otherwise fail to adhere to our projected development goals in the timeframes we expect (or within the timeframes expected by analysts or investors), our business, financial condition and results of operations may be harmed and the market price of our common stock and other securities may decline. In addition, we may be delayed or prevented from generating revenues from milestone or other payments that depend on our ability to achieve any milestone obligations specified in an out-licensing arrangement.

***The long-term safety and efficacy of approved products may differ from clinical studies, which could negatively impact sales and could lead to reputational harm or other negative effects.***

The effects of approved therapeutic products over terms longer than the clinical studies or in much larger populations may not be consistent with earlier clinical results. If long-term use of an approved therapeutic product results in adverse health effects or reduced efficacy or both, the FDA or other regulatory agencies may terminate our or any collaboration partner's ability to market and sell the product, may narrow the approved indications for use or otherwise require restrictive product labeling or marketing, or may require further clinical studies, which may be time-consuming and expensive and may not produce favorable results.

V-Go received pre-market clearance in 2010 under Section 510(k) of the U.S. Federal Food, Drug, and Cosmetic Act. This process typically requires the submission of less supporting documentation than other FDA approval processes and does not always require long-term clinical studies. As a result, we currently lack significant published long-term clinical data supporting the safety and efficacy of V-Go and the benefits it offers that might have been generated in connection with other approval processes. For these reasons, adults who require insulin and their healthcare providers may be slower to adopt or recommend V-Go, we may not have comparative data that our competitors have or are generating, and third-party payers may not be willing to provide coverage or reimbursement for V-Go. Further, future studies or clinical experience may indicate that treatment with V-Go is not superior to treatment with competitive products. Such results could slow the adoption of V-Go and significantly reduce our sales, which could prevent us from achieving our forecasted sales targets or achieving or sustaining profitability. Moreover, if future results and experience indicate that V-Go causes unexpected or serious complications or other unforeseen negative effects, we could be subject to mandatory product recalls, suspension or withdrawal of FDA clearance or approval, significant legal liability or harm to our business reputation.

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***Our products, product candidates and technology may not be able to compete effectively or may be rendered obsolete.\****

The rapid rate of scientific discoveries and technological changes could result in our approved products, technologies or one or more of our product candidates becoming obsolete or noncompetitive. Third parties may develop or introduce new products that render our technology or products less competitive, uneconomical or obsolete. For example, on its February 2026 earnings call, United Therapeutics described Tresmi, a treprostinil solution for use in a soft mist inhaler, as a "category killer" in reference to dry-powder inhalers. If any of our Technosphere powders used in Afrezza, Tyvaso DPI, MNKD-1501, MNKD-201 and MNKD-701, which are based on our proprietary excipient, FDKP, are viewed to be inferior to alternative drug delivery technologies, our product portfolio and pipeline could be materially and adversely affected. Our future success may depend not only on our ability to develop our product candidates, but also our ability to improve them in order to keep pace with emerging industry developments. We cannot assure you that we will be able to do so.

We also expect to face competition from universities and other non-profit research organizations. These institutions carry out a significant amount of research and development in various areas of unmet medical need. These institutions are becoming increasingly aware of the commercial value of their findings and are more active in seeking patent and other proprietary rights as well as licensing revenues.

***Reports of side effects or safety concerns in related technology fields or in other companies' clinical studies could delay or prevent us from obtaining regulatory approval for our product candidates or negatively impact public perception of our approved products.***

There are a number of clinical studies being conducted by other pharmaceutical companies involving compounds similar to, or potentially competitive with, our product candidates. Adverse results reported by these other companies in their clinical studies or by companies that use our proprietary formulation and inhaler technologies could delay or prevent us from obtaining regulatory approval, may subject our products to class warnings in their labels or negatively impact public perception of our product candidates, which could harm our business, financial condition and results of operations and cause the market price of our common stock and other securities to decline.

***If product liability claims are brought against us, we may incur significant liabilities and suffer damage to our reputation.***

The testing, manufacturing, marketing and sales of our products and any clinical testing of our product candidates expose us to potential product liability claims. A product liability claim may result in substantial judgments as well as consume significant financial and management resources and result in adverse publicity, decreased demand for a product, injury to our reputation, withdrawal of clinical studies volunteers and loss of revenues. We currently carry worldwide product liability insurance in the amount of $10.0 million as well as other liability policies. Our insurance coverage may not be adequate to satisfy any liability that may arise, and because insurance coverage in our industry can be very expensive and difficult to obtain, we cannot assure you that we will seek to obtain, or be able to obtain if desired, sufficient additional coverage. If losses from such claims exceed our liability insurance coverage, we may incur substantial liabilities that we may not have the resources to pay. If we are required to pay a product liability claim our business, financial condition and results of operations would be harmed and the market price of our common stock and other securities may decline.

***If we lose any key employees, our operations and our ability to execute our business strategy could be materially harmed.***

We face intense competition for qualified employees among companies in the biotechnology and biopharmaceutical industries. Our success depends upon our ability to attract, retain and motivate highly skilled employees. We may be unable to attract and retain these individuals on acceptable terms, if at all. In addition, we may be required to expand our workforce. These activities will require the addition of new personnel, including management, and the development of additional expertise by existing personnel, and we cannot assure you that we will be able to attract or retain any such new personnel on acceptable terms, if at all.

The loss of the services of any principal member of our management, commercial and scientific staff could significantly delay or prevent the achievement of our scientific and business objectives. All of our employees are "at will" and we currently do not have employment agreements with any of the principal members of our management, commercial or scientific staff, and we do not have key person life insurance to cover the loss of any of these individuals. Replacing key employees may be difficult and time-consuming because of the limited number of individuals in our industry with the skills and experience required to develop, gain regulatory approval of and commercialize products successfully.

***If our internal controls over financial reporting are not considered effective, our business, financial condition and market price of our common stock and other securities could be adversely affected.***

Section 404 of the Sarbanes-Oxley Act of 2002 requires us to evaluate the effectiveness of our internal controls over financial reporting as of the end of each fiscal year, and to include a management report assessing the effectiveness of our internal controls over financial reporting in our annual report on Form 10-K for that fiscal year.

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Our management, including our Chief Executive Officer and our Chief Financial Officer, does not expect that our internal controls over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system's objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud involving a company have been, or will be, detected. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and we cannot assure you that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. A material weakness in our internal controls has been identified in the past, and we cannot assure you that we or our independent registered public accounting firm will not identify a material weakness in our internal controls in the future. A material weakness in our internal controls over financial reporting would require management and our independent registered public accounting firm to evaluate our internal controls as ineffective. If our internal controls over financial reporting are not considered effective, we may experience a loss of public confidence, which could have an adverse effect on our business, financial condition and the market price of our common stock and other securities.

***Changes or modifications in financial accounting standards may harm our results of operations.***

From time to time, the Financial Accounting Standards Board, either alone or jointly with other organizations, promulgates new accounting principles that could have an adverse impact on our reporting of financial position, results of operations and presentation or classification of cash flows. New pronouncements and varying interpretations of pronouncements have occurred with frequency in the past and are expected to occur again in the future and as a result we may be required to make changes in our accounting policies. Any difficulties in adopting or implementing new accounting standards, and updating or modifying our internal controls as needed on a timely basis, could result in our failure to meet our financial reporting obligations, which could result in regulatory discipline and harm investors' confidence in us. Finally, if we were to change our critical accounting estimates, including those related to the recognition of collaboration revenue and other revenue sources, our operating results could be significantly affected.

***Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.***

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could adversely affect our business operations and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. The One Big Beautiful Bill Act ("OBBBA"), the IRA, the Coronavirus Aid, Relief, and Economic Security Act and legislation informally titled the Tax Cuts and Jobs Act enacted made significant changes to the U.S. tax laws. For example, the Tax Cuts and Jobs Act required taxpayers to capitalize and amortize U.S.-based and non-U.S.-based research and experimental, or R&E, expenditures over five and fifteen years, respectively. The OBBBA restored the deductibility of domestic R&E expenditures in the year incurred for tax years beginning after December 31, 2024, but retained the capitalization and amortization requirement for foreign R&E expenditures. Further guidance from the Internal Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects of any legislation could be repealed, modified or sunset in future years. In addition, it is uncertain if and to what extent various states will conform to federal tax laws. Future tax reform legislation could have a material impact on the value of our deferred tax assets and could increase our future U.S. tax expense.

***Our ability to use net operating loss carryforwards to offset future taxable income may be subject to limitations.\****

As of December 31, 2025, the Company had federal and state net operating loss carryforwards of approximately $2.2 billion and $1.5 billion available, respectively, to reduce future taxable income. $520.5 million of the federal net operating loss carryforwards do not expire and the remaining federal net operating loss carryforwards will begin expiring in 2026 through various future dates.

Pursuant to Internal Revenue Code Sections 382 and 383, annual use of the Company's federal and California net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. As a result of the Company's initial public offering, an ownership change within the meaning of Section 382 occurred in August 2004. As a result, federal net operating loss and credit carryforwards of approximately $105.8 million are subject to an annual use limitation of approximately $13.0 million. The annual limitation is cumulative and therefore, if not fully utilized in a year, can be utilized in future years in addition to the Section 382 limitation for those years. The Company is in the process of completing a Section 382 analysis beginning from the date of our initial public offering through December 31, 2025, to determine whether additional limitations may be placed on the net operating loss carryforwards and other tax attributes and does not anticipate any additional changes in ownership that meet Section 382 study ownership change threshold. There is a risk that changes in ownership may occur in tax years after December 31, 2025. If a change in ownership were to occur, our net operating loss carryforwards and other tax attributes could be further limited or restricted. If limited, the related asset would be removed from the

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In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. For example, California imposed limits on the usability of California state net operating losses to offset taxable income in tax years 2024 through 2026. As a result, if we earn net taxable income, we may be unable to use all or a material portion of our net operating loss carryforwards and other tax attributes, which could potentially result in increased future tax liability to us and adversely affect our future cash flows.

***Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.*** 

A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities. For example, the U.S. Internal Revenue Service or another tax authority could challenge our allocation of income by tax jurisdiction and the amounts paid between our affiliated companies pursuant to our intercompany arrangements and transfer pricing policies, including amounts paid with respect to our intellectual property development. Similarly, a tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable nexus, often referred to as a "permanent establishment" under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions. A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, we expect that we might contest such assessment. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment, the implications could increase our anticipated effective tax rate, where applicable.

***We may undertake internal restructuring activities in the future that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.***

From time to time, we may undertake internal restructuring activities as we continue to evaluate and attempt to optimize our cost and operating structure in light of developments in our business strategy and long-term operating plans. These activities may result in write-offs or other restructuring charges. There can be no assurance that any restructuring activities that we undertake will achieve the cost savings, operating efficiencies or other benefits that we may initially expect. Restructuring activities may also result in a loss of continuity, accumulated knowledge and inefficiency during transitional periods and thereafter. In addition, internal restructurings can require a significant amount of time and focus from management and other employees, which may divert attention from commercial operations. If we undertake any internal restructuring activities and fail to achieve some or all of the expected benefits therefrom, our business, results of operations and financial condition could be materially and adversely affected.

***We deal with hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business.***

Our research and development work involves the controlled storage and use of hazardous materials, including chemical and biological materials. Our operations also produce hazardous waste products. We are subject to federal, state and local laws and regulations (i) governing how we use, manufacture, store, handle and dispose of these materials (ii) imposing liability for costs of cleaning up, and damages to natural resources from past spills, waste disposals on and off-site, or other releases of hazardous materials or regulated substances, and (iii) regulating workplace safety. Moreover, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated, and in the event of an accident, we could be held liable for any damages that may result, and any liability could fall outside the coverage or exceed the limits of our insurance. Currently, our general liability policy provides coverage up to $1.0 million per occurrence and $2.0 million in the aggregate and is supplemented by an umbrella policy that provides a further $20.0 million of coverage; however, our insurance policy excludes pollution liability coverage and we do not carry a separate hazardous materials policy. In addition, we could be required to incur significant costs to comply with environmental laws and regulations in the future. Finally, current or future environmental laws and regulations may impair our research, development or production efforts or have an adverse impact on our business, results of operations and financial condition.

When we purchased our facility in Connecticut in 2001, a soil and groundwater investigation and remediation was being conducted by a former site operator (a "responsible party") under the oversight of the Connecticut Department of Energy & Environmental Protection (formerly the Connecticut Department of Environmental Protection), which investigation and remediation is ongoing. The former site operator and responsible party will make further filings necessary to achieve closure for the environmental investigation and remediation it has conducted at the site, and has agreed to indemnify us for any future costs and expenses we may incur that are directly related to its prior operations at the facility. If we are unable to collect these future costs and expenses, if any, from the responsible party, our business, financial condition and results of operations may be harmed. When we sold a portion of the property upon which our facility is located to the entity that is now our landlord, we became an additional responsible party for any environmental investigation and remediation on that portion of the property, including with respect to investigation or remediation that

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may be required as a result of our activities since 2001. To date, we have not identified any material environmental investigation or remediation activities that we are required to perform.

***Changes in funding or staffing for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.***

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions or significant changes in staffing levels at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last decade, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

***We maintain our cash at financial institutions, often in balances that exceed federally insured limits.***

We maintain the majority of our cash and cash equivalents in accounts at banking institutions in the United States that we believe are of high quality. Cash held in these accounts often exceed the Federal Deposit Insurance Corporation ("FDIC") insurance limits. If such banking institutions were to fail, we could lose all or a portion of amounts held in excess of such insurance limitations. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position.

**RISKS RELATED TO GOVERNMENT REGULATION**

***Our product candidates must undergo costly and time-consuming rigorous nonclinical and clinical testing and we must obtain regulatory approval prior to the sale and marketing of any product in each jurisdiction. The results of this testing or issues that develop in the review and approval by a regulatory agency may subject us to unanticipated delays or prevent us from marketing any products.***

Our research and development activities for product candidates, as well as the manufacturing and marketing of approved products, are subject to regulation, including regulation for safety, efficacy and quality, by the FDA in the United States and comparable authorities in other countries. FDA regulations and the regulations of comparable foreign regulatory authorities are wide-ranging and govern, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product design, development, manufacture and testing;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product labeling;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product storage and shipping;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•pre-market clearance or approval;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•advertising and promotion; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product sales and distribution.

The requirements governing the conduct of clinical studies as well as the manufacturing and marketing of drug products outside the United States vary widely from country to country. Foreign approvals may take longer to obtain than FDA approvals and can require, among other things, additional testing and different clinical study designs. Foreign regulatory approval processes include essentially all of the risks associated with the FDA approval processes. Some of those agencies also must approve prices of the products. Approval of a product by the FDA does not ensure approval of the same product by the health authorities of other countries. In addition, changes in regulatory policy in the United States or in foreign countries for product approval during the period of product development and regulatory agency review of each submitted new application may cause delays or rejections.

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Clinical testing can be costly and take many years, and the outcome is uncertain and susceptible to varying interpretations. We cannot be certain if or when regulatory agencies might request additional studies, under what conditions such studies might be requested, or what the size or length of any such studies might be. The clinical studies of our product candidates may not be completed on schedule, regulatory agencies may order us to stop or modify our research, or these agencies may not ultimately approve any of our product candidates for commercial sale. The data collected from our clinical studies may not be sufficient to support regulatory approval of our product candidates. Even if we believe the data collected from our clinical studies are sufficient, regulatory agencies have substantial discretion in the approval process and may disagree with our interpretation of the data. Our failure to adequately demonstrate the safety and efficacy of any of our product candidates would delay or prevent regulatory approval of our product candidates, which could prevent us from achieving profitability.

Questions that have been raised about the safety of marketed drugs generally, including pertaining to the lack of adequate labeling, may result in increased cautiousness by regulatory agencies in reviewing new drugs based on safety, efficacy, or other regulatory considerations and may result in significant delays in obtaining regulatory approvals. Such regulatory considerations may also result in the imposition of more restrictive drug labeling or marketing requirements as conditions of approval, which may significantly affect the marketability of our drug products.

Further, if there are any modifications to an approved product, including changes in indications, labeling, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new or supplemental NDA and/or supplemental biologics license application ("sBLA"), which may require us to develop additional data or conduct additional preclinical studies and clinical trials. Failure to comply with these requirements can result in regulatory enforcement actions and adverse publicity. If future clinical trials are unsuccessful, significantly delayed or not completed, we may not be able to market products for other indications.

In addition, the submission of an NDA or BLA including any sNDA or sBLA, to the FDA with supporting clinical safety and efficacy data does not guarantee that the FDA will accept the submission for filing, or that the marketing approval application submissions to any other regulatory authorities will be accepted for filing and review by those authorities. We cannot be certain that we will be able to respond to any regulatory requests during the review period in a timely manner, or at all, without delaying potential regulatory action. We also cannot be certain that any of our product candidates will receive favorable recommendations from any FDA advisory committee or foreign regulatory bodies or be approved for marketing by the FDA or foreign regulatory authorities. In addition, delays in approvals or rejections of marketing applications may be based upon many factors, including regulatory requests for additional analyses, reports, data and studies, regulatory questions regarding data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our drug candidates. This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business, results of operations and prospects.

***If we do not comply with regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be fined or forced to remove a product from the market, subject to criminal prosecution, or experience other adverse consequences, including restrictions or delays in obtaining regulatory marketing approval.***

Even if we comply with regulatory requirements, we may not be able to obtain the labeling claims necessary or desirable for product promotion. We may also be required to undertake post-marketing studies.

In addition, if we or other parties identify adverse effects after any of our products are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn and a reformulation of our products, additional clinical studies, changes in labeling of, or indications of use for, our products and/or additional marketing applications may be required. If we encounter any of the foregoing problems, our business, financial condition and results of operations will be harmed and the market price of our common stock and other securities may decline.

***We are subject to stringent, ongoing government regulation.***

The FDA and comparable foreign regulatory authorities subject any approved therapeutic product to extensive and ongoing regulatory requirements concerning the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and good clinical practice guidelines for any clinical trials that we conduct post-approval. Later discovery of previously unknown problems, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•revisions to the approved labeling to add new safety information;

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals;

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

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

We also are required to register our establishments and list our products with the FDA and certain state agencies. We and any third-party manufacturers or suppliers must continually adhere to federal regulations setting forth cGMP (for drugs) and QMSR (for medical devices), and their foreign equivalents, which are enforced by the FDA and other national regulatory bodies through their facilities inspection programs. In complying with cGMP and foreign regulatory requirements, we and any of our third-party manufacturers or suppliers will be obligated to expend time, money and effort in production, record-keeping and quality control to ensure that our products meet applicable specifications and other requirements. QMSR requirements also impose extensive testing, control and documentation requirements. State regulatory agencies and the regulatory agencies of other countries have similar requirements. In addition, we will be required to comply with regulatory requirements of the FDA, state regulatory agencies and the regulatory agencies of other countries concerning the reporting of adverse events and device malfunctions, corrections and removals (e.g., recalls), promotion and advertising and general prohibitions against the manufacture and distribution of adulterated and misbranded devices. Failure to comply with these regulatory requirements could result in significant civil fines, product seizures, injunctions and/or criminal prosecution of responsible individuals and us. Any such actions would have a material adverse effect on our business, financial condition and results of operations.

As part of the approval of Afrezza, the FDA required us to conduct certain additional clinical studies of Afrezza, including a long-term safety study that was originally intended to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in a standard of care control group. We have an ongoing dialogue with the FDA regarding the agency's current interest in the long-term safety of Afrezza and an appropriate study design or registry to address any concerns. To date, we have not commenced a long-term safety study or budgeted any amount for it, but such a study in its original design would be anticipated to require substantial capital resources that we may not be able to obtain.

The FDA and other regulatory authorities impose significant restrictions on approved products through regulations on advertising, promotional and distribution activities. This oversight encompasses, but is not limited to, direct-to-consumer advertising, healthcare provider-directed advertising and promotion, sales representative communications to healthcare professionals, promotional programming and promotional activities involving the Internet. Regulatory authorities may also review industry-sponsored scientific and educational activities that make representations regarding product safety or efficacy in a promotional context. Prescription drugs may be promoted only for the approved indications in accordance with the approved label. The FDA and other regulatory authorities may take enforcement action against a company for promoting unapproved uses of a product or for other violations of its advertising and labeling laws and regulations. However, physicians may, in their independent medical judgment, prescribe legally available products for off-label uses. The FDA does not regulate the behavior of physicians in their choice of treatments, but the FDA does restrict manufacturer's communications on the subject of off-label use of their products. Enforcement action may include product seizures, injunctions, significant civil or criminal penalties or regulatory letters, which may require corrective advertising or other corrective communications to healthcare professionals. Failure to comply with such regulations also can result in adverse publicity or increased scrutiny of company activities by the U.S. Congress or other legislators. Certain states have also adopted regulations and reporting requirements surrounding the promotion of pharmaceuticals. Failure to comply with state requirements may affect our ability to promote or sell our products in certain states.

The FDA's and other regulatory authorities' policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates, delay the submission or review of an application or require additional expenditures by us. In addition, interested parties (such as individuals, advocacy groups and competing pharmaceutical companies) can file a citizen petition with the FDA to request policy change or some form of administrative action on the FDA's part, including with respect to an NDA. If successful, a citizen petition can significantly delay, or even prevent, the approval of a drug product.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. We also cannot be sure that actions by foreign regulatory bodies pertaining to the safety of drugs or medical devices will not adversely affect our operations. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be denied marketing approval or lose any marketing approval that we have already obtained. There can be no assurance that we will be able to obtain necessary regulatory clearances or approvals on a timely basis, if at all, for any of our product candidates under development, and delays in receipt or failure to receive such clearances or approvals, the loss of previously received clearances or

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approvals, or failure to comply with existing or future regulatory requirements could have a material adverse effect on our business and results of operations.

***Healthcare legislation may impact the net sales of commercial products sold by us or any partner.\****

In both the United States and certain foreign jurisdictions, there has been a number of legislative and regulatory proposals in recent years to change the healthcare system in ways that could impact our ability to sell our products profitably. For example, on July 4, 2025, the OBBBA was signed into law, which narrowed access to the Patient Protection and Affordable Care Act ("PPACA") marketplace exchange enrollment and declined to extend the PPACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired PPACA subsidies. It is possible that the PPACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges, other litigation, and the healthcare reform measures of the current administration will impact the PPACA.

Recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. Specifically, there have been several recent U.S. Presidential executive orders, Congressional inquiries and proposed and enacted legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. These new laws and initiatives may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and accordingly, our financial operations.

Our future revenues and ability to generate positive cash flow from operations may be affected by the continuing efforts of government and other third-party payers to contain or reduce the costs of healthcare through various means. In the United States, there have been several congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products.

We expect that there will continue to be a number of federal and state proposals to implement similar and/or additional governmental controls. We cannot be certain what legislative proposals will be adopted or what actions federal, state or private third-party payers may take in response to any drug pricing and reimbursement reform proposals or legislation. Further, to the extent that such reforms have a material adverse effect on our ability to commercialize our products and product candidates under development, our business, financial condition and profitability may be adversely affected.

We expect that the IRA, as well as other healthcare reform measures that may be adopted in the future, are likely to have a significant effect on the pharmaceutical industry, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product, and could seriously harm our future revenues. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private third-party payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

The current administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, the Centers for Medicare and Medicaid Services ("CMS") and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for MannKind's business. For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, U.S. patients and Medicaid programs prescription drug Most-Favored-Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Other recent actions and proposals include (1) reducing agency workforce; (2) directing HHS and other agencies to lower prescription drug costs for Medicare through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products; (3) imposing tariffs on certain imported pharmaceutical products; and (4) as part of the Make America Healthy Again Commission's recent Strategy Report, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored-Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager payment methodologies, among other things. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers' global pricing strategies and profitability, while increasing their operational costs and compliance risks. If Most-Favored-Nation pricing for pharmaceutical products is implemented and applicable to Afrezza, our revenue opportunities for Afrezza may be adversely affected, as our U.S. pricing for Afrezza would have to be reduced to the lowest price paid

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for Afrezza outside of the United States. In such event and subject to the terms of our agreements with our ex-U.S. partners, we may choose to forgo the ex-U.S. market. Likewise, our royalty revenue from Tyvaso DPI could suffer for the same reason. In June 2024, the U.S. Supreme Court's Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. Finally, Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program. We cannot predict which additional measures may be adopted or the impact of current and additional measures on the marketing, pricing and demand for our products, which could have a material adverse effect on our business, financial condition and results of operations.

***If we or any partner fails to comply with federal and state healthcare laws, including fraud and abuse and health information laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.\****

As a biopharmaceutical company, even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payers, certain federal and state healthcare laws and regulations, including those pertaining to fraud and abuse and patients' rights, are and will be applicable to our business. The number and scope of these laws, regulations and industry standards are changing, subject to differing applications and interpretations, and may be inconsistent between jurisdictions or in conflict with each other, making compliance difficult. The key laws that may affect our ability to operate include, among others:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The federal Anti-Kickback Statute (as amended by PPACA, which modified the intent requirement of the federal Anti-Kickback Statute so that a person or entity no longer needs to have actual knowledge of the Statute or specific intent to violate it to have committed a violation), which constrains our business activities, including our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities by prohibiting, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Federal civil and criminal false claims laws, including without limitation the False Claims Act, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other federal healthcare programs that are false or fraudulent, and knowingly making, or causing to be made, a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government, and under PPACA, 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 false claims laws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The federal Physician Payments Sunshine Act under PPACA, which requires certain manufacturers of drugs, devices, biologics, and medical supplies to report annually to the CMS information related to payments and other transfers of value to physicians (defined to include defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), which created new federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program or falsifying, concealing, or covering up a material fact in connection with the delivery of or payment for health care benefits.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH"), and their respective implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information on entities subject to the law, such as certain healthcare providers, health plans, and healthcare clearinghouses and their respective business associates that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable health information as well as their covered subcontractors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Other state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state and foreign laws governing the privacy and security and other processing of personal data (including 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; state laws that require certain regulatory licenses to manufacture or distribute products commercially and/or the registration of pharmaceutical sales representatives in the jurisdiction; state laws that require pharmaceutical companies to comply with the industry's voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government that otherwise restricts certain payments that may be made to healthcare providers and entities; and state laws that require drug manufacturers to report information related to

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payments and other transfer of value to physicians and other healthcare providers and entities; marketing expenditures or drug pricing.

Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws. We cannot ensure that all our employees, agents, contractors, vendors, licensees, partners or collaborators will comply with all applicable laws and regulations. If we or our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, or any contractual obligations related to the same, we may be subject to governmental enforcement actions, investigations, litigation (including class action lawsuits) and other penalties, including significant civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, defense costs, exclusion from U.S. federal or state healthcare programs, additional reporting requirements and/or oversight (including if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws), bans or restrictions on our processing of personal data, indemnity obligations and the curtailment or restructuring of our operations. Any such event or consequence, including penalties, damages, fines, and curtailment or restructuring of our operations, could materially adversely affect our ability to operate our business, including our ability to run clinical trials, and our financial results and harm our reputation. Although compliance programs can help mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be eliminated. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management's attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state fraud laws may prove costly.

***We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure, or that of the third parties with whom we work, to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.***

In the ordinary course of business, we process sensitive information (as those terms are defined above). Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information. Numerous U.S. states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact our business and ability to provide our products and services. Certain states also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments. These state laws allow for statutory fines for noncompliance. For example, the California Consumer Privacy Act of 2018 ("CCPA") applies to personal data of consumers, business representatives, and employees who are California residents, and requires businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights. The CCPA provides for fines and allows private litigants affected by certain data breaches to recover significant statutory damages. Although the CCPA (like other U.S. comprehensive privacy laws) exempts some data processed in the context of clinical trials, the CCPA may increase compliance costs and potential liability with respect to other personal data we maintain about California residents. Similar laws have passed and are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. These developments further complicate compliance efforts and increase legal risk and compliance costs for us and the third parties with whom we work.

Outside the United States, an increasing number of laws, regulations, and industry standards apply to data privacy and security. For example, the European Union's General Data Protection Regulation ("EU GDPR") and the United Kingdom's GDPR ("UK GDPR") (collectively "GDPR"), Brazil's General Data Protection Law (Lei Geral de Proteção de Dados Pessoais) (Law No. 13,709/2018), and Australia's Privacy Act impose strict requirements for processing personal data. For example, under the GDPR, companies may face temporary or definitive bans on data processing and other corrective actions; fines of up to 20 million euros under the EU GDPR, 17.5 million pounds sterling under the UK GDPR or, in each case, 4% of annual global revenue, whichever is greater; or private litigation related to the processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. We may also be subject to new and emerging data privacy regimes in Asia, including Japan's Act on the Protection of Personal Information and South Korea's Personal Information Protection Act.

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Our employees and personnel use generative AI technologies to perform their work, and the disclosure and use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligations. Governments have passed and are likely to pass additional laws and regulations regulating generative AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits. If we are unable to use generative AI, it could make our business less efficient and result in competitive disadvantages.

In the ordinary course of business, we may transfer personal data from Europe and other jurisdictions to the United States or other countries. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries. In particular, the European Economic Area ("EEA") and the United Kingdom ("UK") have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes are inadequate. Other jurisdictions may adopt or have already adopted similarly stringent data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, such as the EEA standard contractual clauses, the UK's International Data Transfer Agreement / Addendum, and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework) these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. If there is no lawful manner for us to transfer personal data from the EEA, the UK or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions (such as Europe) at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Some European regulators have prevented companies from transferring personal data out of Europe for allegedly violating the GDPR's cross-border data transfer limitations. Regulators in the United States, such as the Department of Justice, are also increasingly scrutinizing certain personal data transfers. For example, the Department of Justice issued a rule titled Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restriction on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered persons that may impact certain business activities such as vendor engagements, sale or sharing of data, employment of certain individuals and investor agreements. Violations of the rule could lead to significant civil and criminal fines and penalties. This rule applies regardless of whether data is anonymized, key-coded, pseudonymized, de-identified or encrypted, which presents particular challenges for companies like ours and may impact our ability to transfer data in connection with certain transactions or agreements.

We are also bound by contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. We publish privacy policies, marketing materials and other statements, such as statements related to compliance with certain certifications or self-regulatory principles concerning data privacy and security. Regulators in the United States are increasingly scrutinizing these statements, and if these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, misleading or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences. In addition, privacy advocates and industry groups have proposed, and may propose, standards with which we are legally or contractually bound to comply, or may become subject to in the future.

Our obligations related to data privacy and security are quickly changing, becoming increasingly stringent and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our information technologies, systems, and practices and to those of any third parties that process personal data on our behalf. Although we endeavor to comply with all applicable data privacy and security obligations, we may at times fail (or be perceived to have failed) to do so. Moreover, despite our efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our business operations and compliance posture. If we or the third parties with whom we work fail, or are perceived to have failed, to address or comply with data privacy and security obligations, we could face significant consequences. These consequences may include, but are not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-related claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans or restrictions on processing personal data; orders to destroy or not use personal data; and imprisonment of company officials. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions or stoppages in our business operations (including, as relevant, clinical trials); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or revision or restructuring of our operations.

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

We participate in the Medicaid Drug Rebate Program, as administered by CMS, and other federal and state government pricing programs in the United States, and we may participate in additional government pricing programs in the future. These programs generally require us to pay rebates or otherwise provide discounts to government payers in connection with drugs that are dispensed to beneficiaries/recipients of these programs. In some cases, such as with the Medicaid Drug Rebate Program, the rebates are based on pricing that we report on a monthly and quarterly basis to the government agencies that administer the programs. Pricing requirements and rebate/discount calculations are complex, vary among products and programs, and are often subject to interpretation by governmental or regulatory agencies and the courts. The requirements of these programs, including, by way of example, their respective terms and scope, change frequently. Responding to current and future changes may increase our costs, and the complexity of compliance will be time consuming. Invoicing for rebates is provided in arrears, and there is frequently a time lag of up to several months between the sales to which rebate notices relate and our receipt of those notices, which further complicates our ability to accurately estimate and accrue for rebates related to the Medicaid program as implemented by individual states. Thus, there can be no assurance that we will be able to identify all factors that may cause our discount and rebate payment obligations to vary from period to period, and our actual results may differ significantly from our estimated allowances for discounts and rebates. Changes in estimates and assumptions may have a material adverse effect on our business, results of operations and financial condition.

In addition, the Office of Inspector General of the HHS and other Congressional, enforcement and administrative bodies have recently increased their focus on pricing requirements for products, including, but not limited to the methodologies used by manufacturers to calculate average manufacturer price ("AMP") and best price ("BP") for compliance with reporting requirements under the Medicaid Drug Rebate Program. We are liable for errors associated with our submission of pricing data and for any overcharging of government payers. For example, failure to submit monthly/quarterly AMP and BP data on a timely basis could result in a civil monetary penalty. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the 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. In addition, in the event that the CMS were to terminate our rebate agreement, no federal payments would be available under Medicaid or Medicare for our covered outpatient drugs.

**RISKS RELATED TO INTELLECTUAL PROPERTY**

***If we are unable to protect our proprietary rights, we may not be able to compete effectively, or operate profitably.***

Our commercial success depends, in large part, on our ability to obtain and maintain intellectual property protection for our technology. Our ability to do so will depend on, among other things, complex legal and factual questions, and it should be noted that the standards regarding intellectual property rights in our fields are still evolving. We attempt to protect our proprietary technology through a combination of patents, trade secrets and confidentiality agreements. We own a number of domestic and international patents, have a number of domestic and international patent applications pending and have licenses to additional patents. We cannot assure you that our patents and licenses will successfully preclude others from using our technologies, and we could incur substantial costs in seeking enforcement of our proprietary rights against infringement. Even if issued, the patents may not give us an advantage over competitors with alternative technologies.

For example, the coverage claimed in a patent application can be significantly reduced before a patent is issued, either in the United States or abroad. Statutory differences in patentable subject matter may limit the protection we can obtain on some of our inventions outside of the United States. For example, methods of treating patients are not patentable in many countries outside of the United States. These and other issues may limit the patent protection we are able to secure internationally. Consequently, we do not know whether any of our pending or future patent applications will result in the issuance of patents or, to the extent patents have been issued or will be issued, whether these patents will be subjected to further proceedings limiting their scope, will provide significant proprietary protection or competitive advantage, or will be circumvented or invalidated.

Furthermore, patents already issued to us or our pending applications may become subject to disputes that could be resolved against us. In the United States and certain other countries, applications are generally published 18 months after the application's priority date. Because publication of discoveries in scientific or patent literature often trails behind actual discoveries, we cannot be certain that we were the first inventor of the subject matter covered by our pending patent applications or that we were the first to file patent applications on such inventions. Assuming the other requirements for patentability are met, in the United States prior to March 15, 2013, the first to make the claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent. After March 15, 2013, under the Leahy-Smith America Invents Act ("AIA"), the United States moved to a first inventor to file system. In general, the AIA and its implementation could increase the uncertainties and costs

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surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

Moreover, the term of a patent is limited and, as a result, the patents protecting our products expire at various dates. As and when these different patents expire, our products could become subject to increased competition. As a consequence, we may not be able to recover our development costs.

An issued patent is presumed valid unless it is declared otherwise by a court of competent jurisdiction. However, the issuance of a patent is not conclusive as to its validity or enforceability and it is uncertain how much protection, if any, will be afforded by our patents. A third party may challenge the validity or enforceability of a patent after its issuance by various proceedings such as oppositions in foreign jurisdictions, or post grant proceedings, including, oppositions, re-examinations or other review in the United States. In some instances, we may seek re-examination or reissuance of our own patents. If we attempt to enforce our patents, they may be challenged in court where they could be held invalid, unenforceable, or have their breadth narrowed to an extent that would destroy their value.

We also rely on unpatented technology, trade secrets, know-how and confidentiality agreements. We require our officers, employees, consultants and advisors to execute proprietary information and invention and assignment agreements upon commencement of their relationships with us. These agreements provide that all inventions developed by the individual on behalf of us must be assigned to us and that the individual will cooperate with us in connection with securing patent protection on the invention if we wish to pursue such protection. We also execute confidentiality agreements with outside collaborators. However, disputes may arise as to the ownership of proprietary rights to the extent that outside collaborators apply technological information to our projects that are developed independently by them or others, or apply our technology to outside projects, and there can be no assurance that any such disputes would be resolved in our favor. In addition, any of these parties may breach the agreements and disclose our confidential information or our competitors might learn of the information in some other way. Thus, there can be no assurance, however, that our inventions and assignment agreements and our confidentiality agreements will provide meaningful protection for our inventions, trade secrets, know-how or other proprietary information in the event of unauthorized use or disclosure of such information. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business, results of operations and financial condition could be adversely affected.

***If we become involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, we would be required to devote substantial time and resources to prosecute or defend such proceedings.***

Competitors may infringe our patents or the patents of our collaborators or licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover its technology. A court may also decide to award us a royalty from an infringing party instead of issuing an injunction against the infringing activity. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

Interference proceedings brought by the United States Patent and Trademark Office ("USPTO"), may be necessary to determine the priority of inventions with respect to our pre-AIA patent applications or those of our collaborators or licensors. Additionally, the AIA has greatly expanded the options for post-grant review of patents that can be brought by third parties. In particular, Inter Partes Review ("IPR"), available against any issued United States patent (pre-and post-AIA), has resulted in a higher rate of claim invalidation, due in part to the much reduced opportunity to repair claims by amendment as compared to re-examination, as well as the lower standard of proof used at the USPTO as compared to the federal courts. With the passage of time an increasing number of patents related to successful pharmaceutical products are being subjected to IPR. Moreover, the filing of IPR petitions has been used by short-sellers as a tool to help drive down stock prices. We may not prevail in any litigation, post-grant review, or interference proceedings in which we are involved and, even if we are successful, these proceedings may result in substantial costs and be a distraction to our management. Further, we may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States.

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 this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, the market price of our common stock and other securities may decline.

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***If our technologies conflict with the proprietary rights of others, we may incur substantial costs as a result of litigation or other proceedings and we could face substantial monetary damages and be precluded from commercializing our products, which would materially harm our business and financial condition.***

Biotechnology patents are numerous and may, at times, conflict with one another. As a result, it is not always clear to industry participants, including us, which patents cover the multitude of biotechnology product types. Ultimately, the courts must determine the scope of coverage afforded by a patent and the courts do not always arrive at uniform conclusions.

A patent owner may claim that we are making, using, selling or offering for sale an invention covered by the owner's patents and may go to court to stop us from engaging in such activities. Such litigation is not uncommon in our industry.

Patent lawsuits can be expensive and would consume time and other resources. There is a risk that a court would decide that we are infringing a third party's patents and would order us to stop the activities covered by the patents, including the commercialization of our products. In addition, there is a risk that we would have to pay the other party damages for having violated the other party's patents (which damages may be increased, as well as attorneys' fees ordered paid, if infringement is found to be willful), or that we will be required to obtain a license from the other party in order to continue to commercialize the affected products, or to design our products in a manner that does not infringe a valid patent. We may not prevail in any legal action, and a required license under the patent may not be available on acceptable terms or at all, requiring cessation of activities that were found to infringe a valid patent. We also may not be able to develop a non-infringing product design on commercially reasonable terms, or at all.

Moreover, certain components of our products may be manufactured outside the United States and imported into the United States. As such, third parties could file complaints under 19 U.S.C. Section 337(a)(1)(B) (a "337 action") with the International Trade Commission (the "ITC"). A 337 action can be expensive and would consume time and other resources. There is a risk that the ITC would decide that we are infringing a third party's patents and either enjoin us from importing the infringing products or parts thereof into the United States or set a bond in an amount that the ITC considers would offset our competitive advantage from the continued importation during the statutory review period. The bond could be up to 100% of the value of the patented products. We may not prevail in any legal action, and a required license under the patent may not be available on acceptable terms, or at all, resulting in a permanent injunction preventing any further importation of the infringing products or parts thereof into the United States. We also may not be able to develop a non-infringing product design on commercially reasonable terms, or at all.

Although we do not believe that our products or product candidates infringe any third-party patents, if a plaintiff was to allege infringement of their patent rights, we would have to establish with the court that their patents are invalid or unenforceable in order to avoid legal liability for infringement of these patents. However, proving patent invalidity or unenforceability can be difficult because issued patents are presumed valid. Therefore, in the event that we are unable to prevail in a non-infringement or invalidity action we will have to either acquire the third-party patents outright or seek a royalty-bearing license. Royalty-bearing licenses effectively increase production costs and therefore may materially affect product profitability. Furthermore, should the patent holder refuse to either assign or license us the infringed patents, it may be necessary to cease manufacturing the product entirely and/or design around the patents, if possible. In either event, our business, financial condition and results of operations would be harmed and our profitability could be materially and adversely impacted.

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 this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, the market price of our common stock and other securities may decline.

In addition, patent litigation may divert the attention of key personnel and we may not have sufficient resources to bring these actions to a successful conclusion. At the same time, some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. An adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling our products or result in substantial monetary damages, which would adversely affect our business, financial condition and results of operations and cause the market price of our common stock and other securities to decline.

***We may not obtain trademark registrations for our potential trade names.***

We have not selected trade names for some of our product candidates in our pipeline; therefore, we have not filed trademark registrations for such potential trade names for our product candidates, nor can we assure that we will be granted registration of any potential trade names for which we do file. No assurance can be given that any of our trademarks will be registered in the United States or elsewhere, or once registered that, prior to our being able to enter a particular market, they will not be cancelled for non-use. Nor can we give assurances, that the use of any of our trademarks will confer a competitive advantage in the marketplace.

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Furthermore, even if we are successful in our trademark registrations, the FDA has its own process for drug nomenclature and its own views concerning appropriate proprietary names. It also has the power, even after granting market approval, to request a company to reconsider the name for a product because of evidence of confusion in the marketplace. We cannot assure you that the FDA or any other regulatory authority will approve of any of our trademarks or will not request reconsideration of one of our trademarks at some time in the future.

**RISKS RELATED TO OUR COMMON STOCK**

***Our stock price is volatile.***

The trading price of our common stock has been and is likely to continue to be volatile. The volatility of pharmaceutical and biotechnology stocks often does not relate to the operating performance of the companies represented by the stock. Our business and the market price of our common stock may be influenced by a large variety of factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•announcements by us, our collaborators (including United Therapeutics), or our competitors concerning clinical study results, acquisitions, strategic alliances, technological innovations, strategic priorities, resource allocation, commercial emphasis, product side effects, product candidates or newly approved commercial products, the relative benefits of product candidates or approved products versus the product candidates or products marketed by us or our collaborators, product discontinuations, or other developments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to obtain marketing approval for our products outside of the United States and to find collaboration partners for the commercialization of our products in foreign jurisdictions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•future estimates of product sales, royalties, prescriptions or other operating metrics;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to successfully commercialize other products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the progress and results of preclinical and clinical studies of our product candidates and of post-approval studies of approved products that are required by the FDA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•general economic, political or stock market conditions, such as inflation, tariffs, and other fiscal and trade policy changes, especially for emerging growth and pharmaceutical market sectors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•geopolitical events;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•legislative developments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•disruptions caused by man-made or natural disasters or public health pandemics or epidemics or other business interruptions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes in the structure of the healthcare payment systems;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the availability of critical materials used in developing and manufacturing our products and product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•developments or disputes concerning our relationship with any of our current or future collaborators or third party manufacturers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•developments or disputes concerning our patents or proprietary rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the expense and time associated with, and the extent of our ultimate success in, securing regulatory approvals;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•announcements by us concerning our financial condition or operating performance;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes in securities analysts' estimates of our financial condition or operating performance;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the trades of short sellers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability, or the perception of investors of our ability, to continue to meet all applicable requirements for continued listing of our common stock on The Nasdaq Global Market, and the possible delisting of our common stock if we are unable to do so;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the status of any legal proceedings or regulatory matters against or involving us or any of our executive officers and directors; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•discussion of our products, competitors' products, or our stock price by the financial and scientific press, the healthcare community and online investor communities such as chat rooms. In particular, it may be difficult to verify statements about us that appear on interactive websites that permit users to generate content anonymously or under a pseudonym. Statements attributed to company officials may, in fact, have originated elsewhere.

Any of these risks, as well as other factors, could cause the market value of our common stock and other securities to decline.

***Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.***

We are incorporated in Delaware. Certain anti-takeover provisions under Delaware law and in our certificate of incorporation and amended and restated bylaws, as currently in effect, may make a change of control of our company more difficult, even if a change in control would be beneficial to our stockholders or the holders of our other securities. Our anti-takeover provisions include provisions such as a prohibition on stockholder actions by written consent, the authority of our board of directors to issue preferred stock without stockholder approval, and supermajority voting requirements for specified actions. In addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which generally prohibits stockholders owning 15% or more of our outstanding voting stock from merging or combining with us in certain circumstances. These provisions may delay or prevent an acquisition of us, even if the acquisition may be considered beneficial by some of our stockholders. In addition, they may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.

***Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America are the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.***

Our amended and restated bylaws provide that, to the fullest extent permitted by law and subject to the court's having personal jurisdiction over the indispensable parties named as defendants, the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any derivative action or proceeding brought on our behalf;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any action or proceeding asserting a breach of fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees arising out of or pursuant to any provision of the Delaware General Corporation Law, our amended and certificate of incorporation or amended and restated bylaws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any action or proceeding to interpret, apply, enforce or determine the validity of our amended and restated certificate of incorporation or our amended and restated bylaws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any action asserting a claim against us or any of our directors, officers or other employees that is governed by the internal affairs doctrine.

These exclusive forum provisions may limit a stockholder's ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers

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and other employees. If a court were to find either exclusive forum provision in our amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.

***Because we do not expect to pay dividends in the foreseeable future, you must rely on stock appreciation for any return on any investment in our common stock.***

We have paid no cash dividends on any of our capital stock to date, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, we are restricted from paying dividends on our capital stock pursuant to the terms of the Blackstone Credit Facility. As a result, we do not expect to pay any cash dividends in the foreseeable future, and payment of cash dividends, if any, will also depend on our financial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors. There is no guarantee that our common stock will appreciate or maintain its current price. You could lose the entire value of any investment in our common stock.

***Future sales of shares of our common stock in the public market, or the perception that such sales may occur, may depress our stock price and adversely impact the market price of our common stock and other securities.\****

We may need to raise substantial additional capital in the future to fund our operations. If we raise additional funds by issuing equity securities or additional convertible debt, the market price of our common stock and other securities may decline. Similarly, if our existing stockholders sell substantial amounts of our common stock in the public market, the market price of our common stock and other securities could decrease. The perception in the public market that we or our existing stockholders might sell shares of common stock could also depress the market price of our common stock and the market price of our other securities.

In addition, a substantial number of shares of our common stock is reserved for issuance upon the exercise of stock options, the vesting of restricted stock unit awards and purchases under our employee stock purchase plan. The issuance or sale of substantial amounts of common stock, or the perception that such issuances or sales may occur, could adversely affect the market price of our common stock and other securities.

***If other biotechnology and biopharmaceutical companies or the securities markets in general encounter problems, the market price of our common stock and other securities could be adversely affected.***

Public companies in general, including companies listed on The Nasdaq Stock Market, have experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. There has been particular volatility in the market prices of securities of biotechnology and other life sciences companies, and the market prices of these companies have often fluctuated because of problems or successes in a given market segment or because investor interest has shifted to other segments. These broad market and industry factors may cause the market price of our common stock and other securities to decline, regardless of our operating performance. We have no control over this volatility and can only focus our efforts on our own operations, and even these may be affected due to the state of the capital markets.

In the past, following periods of large price declines in the public market price of a company's securities, securities class action litigation has often been initiated against that company. Litigation of this type could result in substantial costs and diversion of management's attention and resources, which would hurt our business. Any adverse determination in litigation could also subject us to significant liabilities.

**GENERAL RISK FACTORS**

***Unstable market, economic and geopolitical conditions may have serious adverse consequences on our business, financial condition and stock price.\****

The global credit and financial markets have recently experienced extreme volatility and disruptions. These disruptions can result in severely diminished liquidity and credit availability, increase in inflation, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. There can be no assurance that deterioration in credit and financial markets and confidence in economic conditions will not occur. Our general business strategy may be adversely affected by any such economic downturn, volatile business environment, currency fluctuations, actual or anticipated bank failures, tariffs and trade wars, higher inflation, or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. Our portfolio of corporate and government bonds could also be adversely impacted. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our operations, growth strategy, financial performance and stock price and could require us to delay or abandon clinical development plans. In addition, there is a risk that one or more of our current service

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providers, manufacturers and other partners may not survive an economic downturn or rising inflation, which could directly affect our ability to attain our operating goals on schedule and on budget.

Other international and geopolitical events, including military conflicts, threatened hostilities, conflicts or heighted tension among alliance countries, and other geopolitical conflicts could also have a serious adverse impact on our business. For example, our drug-device combination products are manufactured using plastic materials (including resins and polymer-based parts) and packaging that are derived, directly or indirectly, from petroleum-based feedstocks. Accordingly, the recent increases in crude oil and other energy prices, as well as volatility in those prices, could potentially lead to higher costs for plastic resins, polymer components, adhesives and packaging materials, and other petroleum-related inputs. Rising oil prices may also increase freight and logistics costs and, depending on market conditions, may contribute to broader inflationary pressures that affect labor, utilities and other manufacturing expenses. While we cannot predict the broader consequences, these conflicts and retaliatory and counter-retaliatory actions could materially adversely affect global trade, energy costs, currency exchange rates, inflation, regional economies, and the global economy, which in turn may increase our costs, disrupt our supply chain, impair our ability to raise or access additional capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

***Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.*** 

Currently, our manufacturing facility in Connecticut is the sole location for the manufacturing of Afrezza and Tyvaso DPI. Similarly, we have exclusive supply arrangements with the contract manufacturers that produce V-Go and Furoscix. The facilities and the specialized manufacturing equipment used to manufacture these products would be costly to replace and could require substantial lead-time to repair or replace. We depend on our facilities and on collaborators, contractors and vendors for the continued operation of our business. Natural disasters, such as interruptions in the supply of natural resources, public health pandemics or epidemics, earthquakes and extreme weather conditions, including, but not limited to, hurricanes, floods, tornados, wildfires, and winter storms, or other catastrophic events, including political and governmental changes, conflicts, explosions, actions of animal rights activists, terrorist attacks and wars, could disrupt our operations or those of our collaborators, contractors and vendors. Such conditions may be further exacerbated by the effects of climate change. We might suffer losses as a result of business interruptions that exceed the coverage available under our and our contractors' insurance policies or for which we or our contractors do not have coverage. For example, we are not insured against a terrorist attack. Any natural disaster or catastrophic event could have a significant negative impact on our operations and financial results. Moreover, any such event could delay our research and development programs or cause interruptions in our commercialization of our products.

***Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.*** 

Adverse developments that affect financial institutions, such as events involving liquidity that are rumored or actual, have in the past and may in the future lead to bank failures and market-wide liquidity problems. Additionally, it is uncertain whether the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion.

Although we assess our banking relationships as we believe necessary or appropriate, our access to cash in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect the financial institutions with which we have banking relationships. These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry. These factors could also include factors involving financial markets or the financial services industry generally. The results of events or concerns that involve one or more of these factors could include a variety of material and adverse impacts on our current and projected business operations and our financial condition and results of operations. These could include, but may not be limited to, delayed access to deposits or other financial assets or the uninsured loss of deposits or other financial assets; or termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.

In addition, widespread investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. Any decline in available funding or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our financial and/or contractual obligations or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and results of operations.

------

**ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS** 

None.

**ITEM 3. DEFAULTS UPON SENIOR SECURITIES** 

None.

**ITEM 4. MINE SAFETY DISCLOSURES** 

Not applicable.

**ITEM 5. OTHER INFORMATION**

During the three months ended March 31, 2026, one of our officers (as defined in Rule 16a-1(f) under the Exchange Act) terminated a written trading plan for the orderly disposition of the Company's securities as set forth in the table below:

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
|  |  |  | **Type of Trading Arrangement** | **Type of Trading Arrangement** |  |  |  |
| **Name and Position** | **Action** | **Date of Action** | **Rule <br>10b5-1**<sup>(1)</sup> | **Non-Rule <br>10b5-1**<sup>(2)</sup> | **Total Shares of Common Stock to be Sold** | **Total Shares of Common Stock <br>to be Purchased** | **Expiration Date** |
| Michael Castagna<br>Chief Executive Officer | Termination | March 11, 2026 | X |  | 692665 |  | March 11, 2026 |

---

(1)Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

(2)"Non-Rule 10b5-1 trading arrangement" as defined in Item 408(c) of Regulation S-K under the Exchange Act.

------

**ITEM 6. EXHIBITS**

---

| | |
|:---|:---|
| **Exhibit**<br>**Number** | **Description of Document**  |
| &nbsp;&nbsp;&nbsp;&nbsp;2.1# | [<u>Agreement and Plan of Merger, dated August 24, 2025, by and among MannKind Corporation, Seacoast Merger Sub, Inc. and scPharmaceuticals Inc. (incorporated by reference to Exhibit 2.1 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on August 25, 2025).</u>](https://www.sec.gov/Archives/edgar/data/0000899460/000119312525186994/d931701dex21.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;3.1 | [<u>Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to MannKind's Quarterly Report on Form 10-Q (File No. 000-50865), filed with the SEC on August 9, 2016).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312516676980/d225552dex31.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;3.2 | [<u>Certificate of Amendment of Amended and Restated Certificate of Incorporation of MannKind Corporation (incorporated by reference to Exhibit 3.1 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on March 2, 2017).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312517066630/d313758dex31.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;3.3 | [<u>Certificate of Amendment of Amended and Restated Certificate of Incorporation of MannKind Corporation (incorporated by reference to Exhibit 3.1 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on December 13, 2017).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312517368329/d511527dex31.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;3.4 | [<u>Certificate of Amendment of Amended and Restated Certificate of Incorporation of MannKind Corporation (incorporated by reference to Exhibit 3.1 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on May 27, 2020).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312520153051/d936164dex31.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;3.5 | [<u>Certificate of Amendment of Amended and Restated Certificate of Incorporation of MannKind Corporation (incorporated by reference to Exhibit 3.1 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on May 30, 2023).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312523156575/d473553dex31.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;3.6 | [<u>Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on May 27, 2020).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312520153051/d936164dex32.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;4.1 | Reference is made to Exhibits [<u>3.1</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312516676980/d225552dex31.htm), [<u>3.2</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312517066630/d313758dex31.htm), [<u>3.3</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312517368329/d511527dex31.htm), [<u>3.4</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312520153051/d936164dex31.htm), [<u>3.5</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312523156575/d473553dex31.htm) and [<u>3.6</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312520153051/d936164dex32.htm). |
| &nbsp;&nbsp;&nbsp;&nbsp;4.2 | [<u>Form of common stock certificate (incorporated by reference to Exhibit 4.2 to MannKind's Annual Report on Form 10-K (File No. 000-50865), filed with the SEC on March 16, 2017).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312517085519/d305327dex42.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;4.3 | [<u>Milestone Rights Purchase Agreement, dated as of July 1, 2013, by and among MannKind, Deerfield Private Design Fund II, L.P. and Horizon Santé FLML SÁRL (incorporated by reference to Exhibit 99.3 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on July 1, 2013).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312513279522/d562665dex993.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;4.4 | [<u>Form of Warrant to Purchase Stock issued to MidCap Financial Trust on August 6, 2019 (incorporated by reference to Exhibit 4.1 to MannKind's Current Report on Form 8-K (File No. 000-50865), filed with the SEC on August 7, 2019).</u>](https://www.sec.gov/Archives/edgar/data/899460/000119312519215305/d757696dex41.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;10.1\*\*# | [<u>Seventh Amendment to Commercial Supply Agreement, dated January 7, 2026, by and between MannKind Corporation and United Therapeutics Corporation (incorporated by reference to Exhibit 10.37 to MannKind Corporation's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 26, 2026).</u>](https://www.sec.gov/Archives/edgar/data/0000899460/000119312526073516/mnkd-ex10_37.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;31.1 | [<u>Certification of the Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.</u>](mnkd-ex31_1.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;31.2 | [<u>Certification of the Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.</u>](mnkd-ex31_2.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;32.1 | [<u>Certification of the Chief Executive Officer pursuant to Rules 13a-14(b) and 15d-14(b) of the Securities Exchange Act of 1934, as amended and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350).</u>](mnkd-ex32_1.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;32.2 | [<u>Certification of the Chief Financial Officer pursuant to Rules 13a-14(b) and 15d-14(b) of the Securities Exchange Act of 1934, as amended and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350).</u>](mnkd-ex32_2.htm) |
| &nbsp;&nbsp;&nbsp;&nbsp;101 | Inline Interactive Data Files pursuant to Rule 405 of Regulation S-T. |
| &nbsp;&nbsp;&nbsp;&nbsp;104 | The cover page has been formatted in Inline XBRL. |

---

\*\* Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

# Certain annexes, exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K.

------

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

---

| | | |
|:---|:---|:---|
| Dated: May 6, 2026 | MANNKIND CORPORATION | MANNKIND CORPORATION |
|  | By: | /s/ MICHAEL E. CASTAGNA |
|  |  | Michael E. Castagna |
|  |  | Chief Executive Officer<br>(on behalf of the registrant and as the registrant's Principal Executive Officer) |
|  | By: | /s/ CHRISTOPHER B. PRENTISS |
|  |  | Christopher B. Prentiss |
|  |  | Chief Financial Officer |
|  |  | (Principal Financial and Accounting Officer) |

---

------

## Exhibit 10.1

**Exhibit 10.1**

**Non-employee Director Compensation**

**Adopted November 17, 2017**

**Modified November 14, 2018**

**Modified August 2, 2024**

---

| | |
|:---|:---|
| &nbsp;&nbsp;**Element** | &nbsp;&nbsp;**Amount** |
| &nbsp;&nbsp;**Annual Cash Retainer** | &nbsp;&nbsp;$50,000 (cash)<br>In lieu of cash, a director can elect to receive a RSU valued at $50,000 on the basis of the 20-day trailing average closing price as of the trading day immediately preceding the date of the annual meeting |
| &nbsp;&nbsp;**Annual Equity Grant** | &nbsp;&nbsp;Intended equity value: $250,000<br>(The number of shares for this equity award will be determined using the then-current guideline price for employee equity awards.) |
| &nbsp;&nbsp;**Equity Vehicles** | &nbsp;&nbsp;100% RSU<br>(RSUs vest immediately, but shares will not be distributed until the director leaves the board.) |
| &nbsp;&nbsp;**Initial Equity Grant** |  |
| &nbsp;&nbsp;**Independent Chairman Premium**  | &nbsp;&nbsp;$50,000 (cash) |
| &nbsp;&nbsp;**Committee Member Compensation** | &nbsp;&nbsp;Audit: $10,000<br>Compensation: $7,500<br>Nominating/Governance: $5,000 <br>(cash) |
| &nbsp;&nbsp;**Committee Chair Premiums** | &nbsp;&nbsp;Audit: $15,000<br>Comp: $12,500<br>Nominating/Governance: $5,000<br>(cash) |

---

------

## Exhibit 10.2

**Exhibit 10.2**

**FIFTH AMENDMENT**

**TO**

**COMMERCIAL SUPPLY AGREEMENT**

This amendment is effective the last date signed by a party, between **MannKind Corporation**, a Delaware corporation ("**MannKind**"), having a principal place of business at One Casper Street, Danbury, Connecticut 06810, and **United Therapeutics Corporation**, a Delaware public benefit corporation ("**United Therapeutics**"), having a principal place of business at 1040 Spring Street, Silver Spring, Maryland 20910.

**WHEREAS**, the parties to this amendment entered into a Commercial Supply Agreement effective as of August 12, 2021 (such agreement, as amended in a First Amendment effective October 16, 2021, a Second Amendment effective June 15, 2022, a Third Amendment effective August 31, 2022, and a Fourth Amendment effective December 22, 2022, the "**Agreement**"), and the parties now wish to amend the Agreement as set forth below.

**NOW, THEREFORE**, in consideration of the terms and conditions specified herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.** **AMENDMENTS**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.Effective January 1, 2024, Appendices A, B and E of the Agreement are deleted in their entirety and replaced with the versions of such appendices attached hereto, and all references to such appendices in the Agreement shall be construed as references to the updated versions of each such appendices attached hereto as of such date. Until such date, the existing version of Appendices A, B and E shall remain in effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.Effective immediately, Appendix F of the Agreement is deleted in its entirety and replaced with the version of Appendix F attached hereto. All references to Appendix F in the Agreement shall be construed as a reference to the updated version of Appendix F attached hereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.** **GENERAL.** All terms of the Agreement that are not specifically modified by this amendment remain in full force and effect. The parties may execute this amendment in counterparts, each of which is deemed an original for all purposes, and which together will constitute the same instrument. The parties may execute this amendment by electronic means (electronic signature through generally recognized e-signature vendors), by scanned pdfs of wet-ink signed documents, or by return of originals.

*\* \* \**

*Signature page follows*

Confidential

------

IN WITNESS WHEREOF, the parties have caused this amendment to be signed by their duly authorized representatives as of the date indicated below.

---

| | |
|:---|:---|
| &nbsp;&nbsp;**United Therapeutics Corporation** <br>By: /s/ Patrick Poisson<br>Name: Patrick Poisson <br>Title: EVP, Technical Operations <br>Date: 10-Jan-2024 | &nbsp;&nbsp;**MannKind Corporation** <br>By: /s/ Sanjay Singh <br>Name: Sanjay Singh<br>Title: EVP, Technical Operations<br>Date: 10-Jan-2024 |

---

Confidential

------

## Exhibit 10.3

**Exhibit 10.3**

**SIXTH AMENDMENT**

**TO**

**COMMERCIAL SUPPLY AGREEMENT**

This amendment is effective the last date signed by a party, between **MannKind Corporation**, a Delaware corporation ("**MannKind**"), having a principal place of business at One Casper Street, Danbury, Connecticut 06810, and **United Therapeutics Corporation**, a Delaware public benefit corporation ("**United Therapeutics**"), having a principal place of business at 1000 Spring Street, Silver Spring, Maryland 20910.

**WHEREAS**, the parties to this amendment entered into a Commercial Supply Agreement effective as of August 12, 2021 (such agreement, as amended in a First Amendment effective October 16, 2021, a Second Amendment effective June 15, 2022, a Third Amendment effective August 31, 2022, a Fourth Amendment effective December 22, 2022 and a Fifth Amendment effective January 10, 2024, the "**Agreement**"), and the parties now wish to amend the Agreement as set forth below.

**NOW, THEREFORE**, in consideration of the terms and conditions specified herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.** **AMENDMENTS**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.Effective January 1, 2025, Appendices A and B of the Agreement are deleted in their entirety and replaced with the versions of such appendices attached hereto, and all references to such appendices in the Agreement shall be construed as references to the updated version of each such updated appendix as of such date. Until such date, the existing version of Appendices A and B shall remain in effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.Effective January 1, 2025, Appendix E of the Agreement (Staffing Payments) shall be deleted in its entirety and replaced by the version attached hereto to reflect that Staffing Payments will be included in Cost of Goods Sold (COGS) and not separately reimbursable as of such date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.** **GENERAL.** All terms of the Agreement that are not specifically modified by this amendment remain in full force and effect. The parties may execute this amendment in counterparts, each of which is deemed an original for all purposes, and which together will constitute the same instrument. The parties may execute this amendment by electronic means (electronic signature through generally recognized e-signature vendors), by scanned pdfs of wet-ink signed documents, or by return of originals.

*\* \* \**

*Signature page follows*

Page 1 of 2

Confidential

------

IN WITNESS WHEREOF, the parties have caused this amendment to be signed by their duly authorized representatives as of the date indicated below.

---

| | |
|:---|:---|
| &nbsp;&nbsp;**United Therapeutics Corporation** <br>By: /s/ Patrick Poisson<br>Name: Patrick Poisson <br>Title: EVP, Technical Operations <br>Date: December 2, 2024 | &nbsp;&nbsp;**MannKind Corporation** <br>By: /s/ Sanjay Singh<br>Name: Sanjay Singh<br>Title: EVP, Technical Operations<br>Date: December 2, 2024 |

---

Page 2 of 2

Confidential

------

## Exhibit 31.1

**Exhibit 31.1** 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO RULE 13a-14(a) OR 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Michael E. Castagna, certify that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.I have reviewed this Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026 of MannKind Corporation;

&nbsp;&nbsp;&nbsp;&nbsp;&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;&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 registrant as of, and for, the periods presented in this report;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.The registrant's other certifying officer 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 registrant and have:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&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 registrant, 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;&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;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Evaluated the effectiveness of the registrant'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;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&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 registrant's ability to record, process, summarize and report financial information; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&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 registrant's internal control over financial reporting.

---

| |
|:---|
| /s/ Michael E. Castagna |
| Michael E. Castagna<br>Chief Executive Officer and Director <br>|

---

Date: May 6, 2026

------

## Exhibit 31.2

**Exhibit 31.2** 

CERTIFICATION OF CHIEF FINANCIAL OFFICER

PURSUANT TO RULE 13a-14(a) OR 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Christopher B. Prentiss, certify that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.I have reviewed this Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026 of MannKind Corporation;

&nbsp;&nbsp;&nbsp;&nbsp;&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;&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 registrant as of, and for, the periods presented in this report;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.The registrant's other certifying officer 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 registrant and have:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&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 registrant, 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;&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;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Evaluated the effectiveness of the registrant'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;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&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 registrant's ability to record, process, summarize and report financial information; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&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 registrant's internal control over financial reporting.

---

| |
|:---|
| /s/ Christopher B. Prentiss |
| Christopher B. Prentiss<br>Chief Financial Officer <br>|

---

Date: May 6, 2026

------

## Exhibit 32.1

**Exhibit 32.1** 

CERTIFICATION OF

CHIEF EXECUTIVE OFFICER

PURSUANT TO

RULE 13a-14(b) OR 15d-14(b) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND SECTION 1350 OF

CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE (18 U.S.C. § 1350)<sup>1</sup>

In connection with the filing of the quarterly report of MannKind Corporation (the "Company") on Form 10-Q for the quarterly period ended March 31, 2026, as filed with the Securities and Exchange Commission on or about the date hereof, to which this certification is attached as Exhibit 32.1 (the "Report") and pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Michael E. Castagna, Chief Executive Officer of MannKind Corporation (the "Company"), hereby certifies that, to the best of his knowledge:

1. The Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

In Witness Whereof, the undersigned has set his hand hereto as of the 6th day of May, 2026.

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| /s/ Michael E. Castagna |
| Michael E. Castagna |
| Chief Executive Officer |

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<sup>1</sup> This certification is being furnished solely to accompany this quarterly report on Form 10-Q pursuant to 18 U.S.C. Section 1350, and is not deemed filed for purposes of Section 18 of the Exchange Act or the Securities Act of 1933, as amended, and is not incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language contained in such filing. 

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## Exhibit 32.2

**Exhibit 32.2** 

CERTIFICATION OF

CHIEF FINANCIAL OFFICER

PURSUANT TO

RULE 13a-14(b) OR 15d-14(b) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND SECTION 1350 OF

CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE (18 U.S.C. § 1350)<sup>1</sup>

In connection with the filing of the quarterly report of MannKind Corporation (the "Company") on Form 10-Q for the quarterly period ended March 31, 2026, as filed with the Securities and Exchange Commission on or about the date hereof, to which this certification is attached as Exhibit 32.2 (the "Report") and pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Christopher B. Prentiss, Chief Financial Officer of MannKind Corporation (the "Company"), hereby certifies that, to the best of his knowledge:

1. The Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

In Witness Whereof, the undersigned has set his hand hereto as of the 6th day of May, 2026.

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|:---|
| /s/ Christopher B. Prentiss |
| Christopher B. Prentiss |
| Chief Financial Officer |

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<sup>1</sup> This certification is being furnished solely to accompany this quarterly report on Form 10-Q pursuant to 18 U.S.C. Section 1350, and is not deemed filed for purposes of Section 18 of the Exchange Act or the Securities Act of 1933, as amended, and is not incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language contained in such filing. 

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