# EDGAR Filing Document

**Accession Number:** 0001000694
**File Stem:** 0001104659-25-097317
**Filing Date:** 2025-10
**Character Count:** 17128
**Document Hash:** ee7ab812d977f0d9f30e7ee79124aee3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-097317.hdr.sgml**: 20251007

**ACCESSION NUMBER**: 0001104659-25-097317

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251001

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251007

**DATE AS OF CHANGE**: 20251007

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** NOVAVAX INC
- **CENTRAL INDEX KEY:** 0001000694
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 222816046
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-26770
- **FILM NUMBER:** 251378233

**BUSINESS ADDRESS:**
- **STREET 1:** 700 QUINCE ORCHARD ROAD
- **CITY:** GAITHERSBURG
- **STATE:** MD
- **ZIP:** 20878
- **BUSINESS PHONE:** 240-268-2000

**MAIL ADDRESS:**
- **STREET 1:** 700 QUINCE ORCHARD ROAD
- **CITY:** GAITHERSBURG
- **STATE:** MD
- **ZIP:** 20878

?xml version='1.0' encoding='ASCII'?

**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549**

**FORM 8-K**

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**CURRENT REPORT** 

**PURSUANT TO SECTION 13 OR 15(d)**

**OF THE SECURITIES EXCHANGE ACT OF 1934** 

**Date of Report (Date of earliest event reported): October 1, 2025**

**NOVAVAX, INC.**

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

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| | | |
|:---|:---|:---|
| **Delaware** | **0-26770** | **22-2816046** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

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**700 Quince Orchard Road**

**Gaithersburg, Maryland 20878**

**(Address of Principal Executive Offices, including Zip Code)** 

**(240) 268-2000**

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

**(Former name or former address, if changed since last report.)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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| |
|:---|
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |

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

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**Title of each class** | &nbsp;&nbsp;**Trading <br> Symbol(s)** | &nbsp;&nbsp;**Name of each exchange on which <br> registered** |
| &nbsp;&nbsp;Common Stock, Par Value $0.01 per share | &nbsp;&nbsp;NVAX | &nbsp;&nbsp;The Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ◻

**Item 7.01. Regulation FD Information.**

On October 7, 2025, Novavax, Inc. ("Novavax" or the "Company") issued a press release announcing the information discussed under Item 8.01 hereof. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Item 7.01 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

**Item 8.01. Other Events.**

On October 1, 2025 the European Commission approved the transfer application to change the holder of the marketing authorization for Nuvaxovid<sup>™</sup> from the Company's wholly owned subsidiary, Novavax CZ, to Sanofi Winthrop Industrie. Completion of the transfer authorization has triggered a $25 million milestone payment from Sanofi Pasteur Inc. under the Company's Collaboration and License Agreement with Sanofi. The Company anticipates receipt of payment in the first quarter of 2026.

**Cautionary Note Regarding Forward-Looking Statements.**

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Any statements in the discussion below and elsewhere in this Current Report about expectations, beliefs, plans, objectives, assumptions, or future events or performance of the Company are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding expected milestone payments under the Sanofi agreement. Generally, forward-looking statements can be identified through the use of words or phrases such as "believe," "may," "could," "will," "would," "possible," "can," "estimate," "continue," "ongoing," "consider," "anticipate," "intend," "seek," "plan," "project," "expect," "should," "would," "aim," or "assume," the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Novavax's current beliefs and expectations about the future of our business, events and trends, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, challenges or delays related to the requested PMC or in obtaining further regulatory authorization for its COVID-19 vaccine; antigenic drift or shift in the SARS-CoV-2 spike protein, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and other risks and uncertainties identified in Part I, Item 1A "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission ("SEC") on February 27, 2025, as updated by the information in Part II, Item 1A "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which may be further detailed and modified or updated in other documents we file with the SEC from time to time, and are available at www.sec.gov and at www.novavax.com. You are encouraged to read these filings as they are made.

Novavax cannot guarantee future results, events, level of activity, performance, or achievement. Any or all of Novavax's forward-looking statements in this Current Report on Form 8-K may turn out to be inaccurate or materially different from actual results. Further, any forward-looking statement speaks only as of the date when it is made, and Novavax undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. New factors emerge from time to time, and it is not possible for Novavax to predict which factors will arise. In addition, Novavax cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

**Item 9.01. Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm2528134d1_ex99-1.htm) | [Press release, Dated October 7, 2025](tm2528134d1_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). |

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**SIGNATURES**

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

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| | | |
|:---|:---|:---|
|  | Novavax, Inc. | Novavax, Inc. |
| Date: October 7, 2025 | By: | /s/ Mark J. Casey |
|  | Name: | Mark J. Casey |
|  | Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary |

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## Exhibit 99.1

**Exhibit 99.1**

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| | |
|:---|:---|
| **Press Release** | ![](tm2528134d1_ex99-1img001.jpg) |

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**Novavax Continues to Deliver on Sanofi Partnership, Completing Nuvaxovid<sup>®</sup> EU Marketing Authorization Transfer and Triggering $25 Million Milestone Payment**

**GAITHERSBURG, Md., October 7, 2025 –** Novavax, Inc. (Nasdaq: NVAX) has completed the transfer of the marketing authorization for its COVID-19 vaccine, Nuvaxovid® to Sanofi, in the European Union (EU) enabling Sanofi to take full responsibility for commercial and regulatory activities in the EU. The transfer triggered a milestone payment of $25 million to Novavax and further progresses the collaboration and license agreement (CLA) between both companies.

"Novavax continues to steadily advance our corporate growth strategy while delivering on our partnership agreement," said John C. Jacobs, President and Chief Executive Officer, Novavax. "The successful transfer of our EU marketing authorization to Sanofi is yet another step forward in ensuring global access to our protein-based, non-mRNA COVID-19 vaccine."

**VACCINE AUTHORIZATION (U.S.)**

Nuvaxovid is a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

**IMPORTANT SAFETY INFORMATION**

**Contraindications**

&nbsp;&nbsp;&nbsp;&nbsp;· Do not administer Nuvaxovid to
individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of Nuvaxovid or to individuals who
had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of Novavax COVID-19 Vaccine, Adjuvanted *.* 

**Warnings and Precautions**

&nbsp;&nbsp;&nbsp;&nbsp;· **Management of Acute Allergic Reactions:** Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration
of Nuvaxovid.

&nbsp;&nbsp;&nbsp;&nbsp;· **Myocarditis and Pericarditis**:
Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Nuvaxovid. There
have been post-marketing reports of myocarditis and pericarditis following administration of Nuvaxovid. The Centers for Disease Control
and Prevention has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals
with a history of myocarditis or pericarditis(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

&nbsp;&nbsp;&nbsp;&nbsp;· **Syncope (fainting):** Syncope
(fainting) may occur in association with administration of injectable vaccines, including Nuvaxovid. Procedures should be in place to
avoid injury from fainting.

&nbsp;&nbsp;&nbsp;&nbsp;· **Altered Immunocompetence:** Immunocompromised
persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to Nuvaxovid.

&nbsp;&nbsp;&nbsp;&nbsp;· **Limitations of Vaccine Effectiveness:** Nuvaxovid may not protect all vaccine recipients.

**Adverse Reactions**

The most commonly reported (>10%) solicited adverse reactions were injection site tenderness, injection site pain, injection site redness, headache, muscle pain, fatigue, malaise, joint pain, fever and nausea/vomiting.

*To report suspected adverse reactions, contact Novavax, Inc. at 1-844-668-2829 or the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or <u>https://vaers.hhs.gov</u>.*

**About Novavax**

Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit <u>novavax.com</u> and <u>LinkedIn</u> for more information.

**Forward-Looking Statements**

Statements herein relating to the future of Novavax, its operating plans and prospects, the possible achievement of additional milestones or receipt of milestone payments or royalties under the CLA, future marketing initiatives and the potential development and commercialization of Sanofi combination products, and efforts to pursue additional partnerships, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at <u>http://www.sec.gov</u> and <u>www.novavax.com</u>, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

**Contacts:**

<u>Investors</u>

Luis Sanay, CFA

240-268-2022

<u>ir@novavax.com</u>

<u>Media</u>

Giovanna Chandler

240-720-7804

<u>media@novavax.com</u>