NOVAVAX INC
For the period ended Dec 31, 2024. Filed Feb 27, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Feb 27, 2025
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Table of Contents
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | BUSINESS | 4 |
| Item 1A. | RISK FACTORS | 26 |
| Item 1B. | UNRESOLVED STAFF COMMENTS | 64 |
| Item 1C. | CYBERSECURITY | 64 |
| Item 2. | PROPERTIES | 64 |
| Item 3. | LEGAL PROCEEDINGS | 64 |
| Item 4. | MINE SAFETY DISCLOSURES | 67 |
| PART II | ||
| Item 5. | MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES | 67 |
| Item 6. | RESERVED | 68 |
| Item 7. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 68 |
| Item 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 83 |
| Item 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA | 84 |
| Item 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 84 |
| Item 9A. | CONTROLS AND PROCEDURES | 84 |
| Item 9B. | OTHER INFORMATION | 86 |
| Item 9C. | DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS | 86 |
| PART III | ||
| Item 10. | DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE | 86 |
| Item 11. | EXECUTIVE COMPENSATION | 86 |
| Item 12. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | 86 |
| Item 13. | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE | 87 |
| Item 14. | PRINCIPAL ACCOUNTING FEES AND SERVICES | 87 |
| PART IV | ||
| Item 15. | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES | 88 |
CERTAIN DEFINITIONS
All references in this Annual Report on Form 10-K to “Novavax,” the “Company,” “we,” “us,” and “our” refer to Novavax, Inc. including its wholly-owned subsidiaries (unless the context otherwise indicates). All references in this Annual Report on Form 10-K to "NVX-CoV2373” or “prototype COVID-19 vaccine” refer to our Nuvaxovid™ prototype COVID-19 vaccine; all references to "NVX-CoV2601" or "XBB COVID-19 vaccine" refer to our Nuvaxovid TM COVID-19 vaccine for the 2023-2024 vaccination season; and all references to "NVX-CoV2705", "JN.1 COVID-19 vaccine" or “updated COVID-19 vaccine” refer to our Nuvaxovid TM COVID-19 vaccine for the 2024-2025 vaccination season. We refer to our prototype COVID-19 vaccine and updated COVID-19 vaccines, collectively, as our “COVID-19 vaccine”. Local regulatory authorities have also specified nomenclature for our COVID-19 vaccine for labeling within their territories (e.g., “Novavax COVID-19 Vaccine, Adjuvanted”, “Novavax COVID-19, Adjuvanted (2023-2024 or 2024-2025 Formula),” respectively, for the U.S., and “Nuvaxovid™” for ex-U.S. territories). The Company’s partner, Serum Institute of India Pvt. Ltd., markets Novavax’s COVID-19 vaccine as “Covovax™.”
NOTE REGARDING TRADEMARKS
Novavax™, Nuvaxovid™, Matrix-M™, Matrix-A™,Matrix-C™, Matrix-V™, Prepare™, Resolve™, and ResVax™ are trademarks of Novavax. Any other trademarks referred to in this Annual Report on Form 10-K are the property of their owners. All rights reserved. We do not intend our use or display of other companies’ trade names or trademarks to imply an endorsement or sponsorship of us by such companies, or any relationship with any of these companies.
FORWARD-LOOKING INFORMATION
This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K, our actual results may differ materially from those anticipated in these forward-looking statements. Please also see the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS
Our business is subject to numerous risks which are discussed more fully under the heading “Risk Factors” in this Annual Report on Form 10-K. These risks include, but are not limited to, the following:
We have a history of losses and our future profitability is uncertain.
We will continue to require significant funding to maintain our current level of operations and fund the further development of our vaccine candidates.
Our existing collaboration, funding and supply agreements, including our collaboration and license agreement entered into with Sanofi Pasteur Inc. ("Sanofi") in May 2024 (the "Sanofi CLA") and or our advance purchase agreements ("APAs"), do not assure success of our vaccine candidates or vaccines or that we will be able to fully fund our vaccine candidates or vaccines or our operations, and if we are unable to satisfy the performance obligations under such agreements, we may not be eligible to receive milestone payments under such agreements, the agreements may be terminated, the purchase commitments may be reduced or we may be required to refund advance payments.
Because our vaccine product development and commercialization efforts depend on new and rapidly evolving technologies, we cannot be certain that our efforts will be successful.
We are a biotechnology company and face significant risk in developing, manufacturing, and commercializing our products and product candidates.
We must identify vaccines for development with our technologies and establish successful third-party relationships.
The regulatory and commercial success of our COVID-19 Vaccine remains uncertain. While we have received conditional marketing authorization (“CMA”), or emergency use authorization (“EUA”) or full approval for our prototype COVID-19 Vaccine and our updated COVID-19 vaccine in a number of jurisdictions, we may be unable to obtain full regulatory approvals in the United States (“U.S.”) or other jurisdictions for our updated COVID-19 vaccine or new versions in the future, or produce a successful vaccine in a timely manner, if at all.
We are highly dependent on the commercial success of our COVID-19 Vaccine, and even though we have received CMA, EUA or full approval in certain jurisdictions for our COVID-19 Vaccine, and even if we have products licensed in additional markets, our vaccine products may not be initially or ever profitable.
Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products and product candidates.
Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees.
There is significant competition in the development of a vaccine against COVID-19 and a combined vaccine against COVID-19 and influenza, and we may never see returns on the significant resources we are devoting to our vaccine candidates.
We may not succeed in obtaining full U.S. Food and Drug Administration (“U.S. FDA”) licensure or foreign regulatory approvals necessary to sell our vaccine candidates.
Our product candidates might fail to meet their primary endpoints in clinical trials, meaning that we will not have the clinical data required to support full regulatory approvals.
We may fail to obtain regulatory approval for our prototype COVID-19 vaccine and NVX-CoV2601 or for our other current or future product candidates on a timely basis or comply with our continuing regulatory obligations if approval is obtained.
The later discovery of previously unknown problems with a product, manufacturer, or facility may result in restrictions, including withdrawal of a vaccine that had previously received regulatory approval in certain jurisdictions from the market.
Our success depends on our ability to maintain the proprietary nature of our technology.
Our business may be adversely affected if we do not successfully execute our business development initiatives.
Servicing our 5.00% convertible senior unsecured notes due 2027 (the “Notes”) requires a significant amount of cash, and we may not have sufficient cash flow resources to pay our debt.
Because our stock price has been and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected.
Litigation could have a material adverse impact on our results of operation and financial condition.
We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies, such as the COVID-19 pandemic.
PART I
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.