MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our audited consolidated financial statements and the related notes included elsewhere in this filing.
+Added: The following discussion and analysis does not include certain items related to the year ended December 31, 2023, including year-to-year comparisons between the year ended December 31, 2024 and the year ended December 31, 2023.
+Added: For a comparison of our results of operations for the fiscal years ended December 31, 2024 and December 31, 2023, see Item 7.
+Added: Management's Discussion and Analysis of Financial Condition and Results of Operations of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 27, 2025.
Any statements in the discussion below and elsewhere in this Annual Report on Form 10-K about expectations, beliefs, plans, objectives, assumptions, or future events or performance of Novavax, Inc.
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our technology platform;
−Removed: our COVID-19 program (which currently includes our Nuvaxovid™ prototype COVID-19 vaccine ("NVX-CoV2373” or “prototype COVID-19 vaccine”), our Nuvaxovid™ COVID-19 vaccine for the 2023-2024 vaccination season (“XBB COVID-19 Vaccine”) and our Nuvaxovid™ updated COVID-19 vaccine for the 2024-2025 vaccination season (“NVX-CoV2705” or “updated COVID-19 vaccine”) collectively referred to as our (“COVID-19 Vaccine”));
+Added: our COVID-19 Vaccine (which includes “Nuvaxovid™” and “JN.1 COVID-19 Vaccine”, our Nuvaxovid™ COVID-19 Vaccine for the 2025-2026 vaccination season);
our operating plans and prospects, including our ability to continue as a going concern through one year from the date of Novavax’ audited financial statements for the year ended December 31, 2025;
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our research and development investment strategy;
−Removed: the potential expansion of our pipeline beyond infections diseases into other therapeutic areas;
+Added: the potential expansion of our pipeline beyond infectious diseases into other therapeutic areas;
our expectations related to enrollment in our clinical trials;
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and other matters referenced herein.
−Removed: 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.
−Removed: Table o f Contents
+Added: 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,”
+Added: “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.
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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.
−Removed: Such risks and uncertainties include, without limitation, our ability to successfully and timely manufacture, market, distribute, or deliver our updated COVID-19 vaccine and the impact of our not having received a BLA from the U.S.
−Removed: Food and Drug Administration (U.S.
−Removed: FDA”) for the 2024-2025 vaccination season;
−Removed: challenges related to our partnership with Sanofi and in pursuing additional partnership opportunities;
+Added: Such risks and uncertainties include, without limitation, our ability to successfully and timely obtain and maintain full U.S.
+Added: FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver our COVID-19 Vaccine;
+Added: the impact of delays in obtaining regulatory approval, including regulatory decisions impacting labeling, approval or authorization, including the scope of the indicated population, product dosage, manufacturing processes, shelf life, safety, for our product candidates;
+Added: challenges in conducting the postmarketing commitment (“PMC”) study, our ability to obtain adequate additional funding to maintain our current level of operations and fund the further development of our vaccine candidates;
+Added: challenges related to our partnership with Sanofi, including collaboration on the PMC, 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, assay validation, and stability testing, necessary to satisfy applicable regulatory authorities;
challenges or delays in conducting clinical trials or studies for our product candidates;
−Removed: challenges or delays in obtaining regulatory authorization for our product candidates, including for future COVID-19 variant strain changes, our CIC vaccine candidate, our stand-alone influenza vaccine candidate or other product candidates, including as a result of resource constraints at regulatory authorities including the U.S.
−Removed: FDA and the WHO;
manufacturing, distribution or export delays or challenges;
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(“SII”) and Serum Life Sciences Limited (“SLS” and together with SII, “Serum”) for co-formulation and filling our COVID-19 Vaccine and the impact of any delays or disruptions in their operations;
+Added: the impact of potential legislative, regulatory, or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance;
+Added: uncertainty with respect to pricing, third-party reimbursement and healthcare reform;
+Added: uncertainty in the regulatory pathway for our COVID -19 Vaccine;
+Added: the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements;
difficulty obtaining scarce raw materials and supplies, including for our proprietary adjuvant;
−Removed: resource constraints, including human capital and manufacturing capacity, constraints on our ability to pursue planned regulatory pathways, alone or with partners;
−Removed: challenges in implementing the Restructuring Plan;
+Added: resource constraints, including human capital and manufacturing capacity, constraints on our ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions;
our ability to timely deliver doses;
−Removed: challenges in obtaining commercial adoption and market acceptance of our COVID-19 vaccine, any COVID-19 variant strain-containing formulation, our CIC vaccine candidate, our stand-alone influenza vaccine candidate or our other product candidates;
+Added: challenges in obtaining commercial adoption and market acceptance of our COVID-19 Vaccine or any COVID-19 variant strain containing formulation, or our CIC vaccine candidates, stand-alone influenza vaccine candidates or other candidates;
challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities including requirements to deliver doses that may require us to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements;
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challenges in identifying and successfully pursuing innovation expansion opportunities;
−Removed: our expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than our assumptions;
+Added: our expectation as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than our assumptions;
and other risks and uncertainties identified in Part I, Item 1A “Risk Factors” of this Annual Report on Form 10-K, which may be detailed and modified or updated in other documents filed with the SEC from time to time, and are available at www.sec.gov and at www.novavax.com.
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In addition, we 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.
−Removed: Information in this Annual Report on Form 10-K, includes a financial measure that was not prepared in accordance with U.S.
−Removed: generally accepted accounting principles (“GAAP”), which we refer to as adjusted cost of sales.
−Removed: We are presenting this non-GAAP financial measure to assist an understanding of our business and its performance.
−Removed: Adjusted cost of sales includes an estimate of standard manufacturing costs that were previously expensed to research and development prior to regulatory approvals for our COVID-19 Vaccine that would otherwise have been capitalized to inventory.
−Removed: Any non-GAAP financial measures presented are not, and should not be viewed as, substitutes for financial measures required by GAAP, have no standardized meaning prescribed by GAAP, and may not be comparable to the calculation of similar measures of other companies.
−Removed: We are a company tackling global health challenges through scientific innovation that seeks to maximize our deep scientific expertise in vaccines and our cutting-edge technology platform.
−Removed: The differentiated platform features our recombinant protein-based nanoparticle technology and unique Matrix-M ™ adjuvant.
−Removed: Our three strategic priorities are:
−Removed: focusing on our partnership with Sanofi announced in May 2024, leveraging our technology platform and pipeline to forge additional partnerships, and advancing our proven technology platform and early-stage pipeline.
−Removed: Our corporate growth strategy is supported by a lean and focused operating model.
−Removed: Table o f Contents
+Added: Novavax tackles some of the world’s most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including its Matrix-M ™ adjuvant and protein-based nanoparticles.
+Added: Our corporate growth strategy focuses on maximizing the impact of our cutting-edge technology by forging partnerships for our Matrix-M adjuvant and research and development (“R&D”) assets while maintaining a lean and focused operating model.
Our technology platform combined with our deep vaccine expertise, is the fuel for innovation and partnerships and we believe it has the potential to create significant value.
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Our Matrix-M™ adjuvant can increase both antibody and cell-mediated immune responses to the vaccine and it has demonstrated a favorable tolerability profile in clinical trials.
−Removed: Our technology platform is used in our authorized COVID-19 vaccine and the R21/Matrix-M ™ adjuvant malaria vaccine.
−Removed: We have developed and manufactured our updated COVID-19 vaccine for the 2024-2025 vaccination season for use in individuals aged 12 and older.
−Removed: Our updated vaccine received Emergency Use Authorization (“EUA”) from the U.S.
−Removed: FDA in August 2024, along with several additional global regulatory authorizations for use in the 2024-2025 vaccination season.
−Removed: In the U.S., our BLA for our prototype COVID-19 vaccine and for our XBB COVID-19 vaccine is currently under U.S.
−Removed: FDA review with a Prescription Drug User Fee Act (“PDUFA”) date of April 2025.
−Removed: In May 2024, we entered into a Collaboration and License Agreement with Sanofi, to co-commercialize our COVID-19 vaccine, including future updated versions that address seasonal COVID-19 variants.
−Removed: Under the terms of the agreement, we will continue to commercialize our updated COVID-19 vaccine through the end of the 2024-2025 vaccination season and beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize the COVID-19 vaccine worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply certain of our existing APA customers and strategic partners, including Takeda Pharmaceutical Company Limited (“Takeda”) and SII.
−Removed: Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.
−Removed: Additionally, Sanofi has the right to develop novel influenza-COVID-19 combination vaccines utilizing our COVID-19 vaccine and Sanofi’s seasonal influenza vaccine, combination products containing our COVID-19 vaccine and one or more non-influenza vaccines, and multiple new vaccines utilizing our Matrix-M ™ adjuvant.
−Removed: In December 2024, Sanofi announced that the U.S.
−Removed: FDA granted Fast Track designation to two Sanofi combination vaccine candidates:
−Removed: the first combination consists of Fluzone High-Dose combined with our COVID-19 vaccine, and the second combination consists of Flublok with our COVID-19 vaccine.
−Removed: Sanofi is evaluating the safety and immunogenicity of both combination vaccine candidates in two separate Phase 1/2 trials.
−Removed: We are eligible to receive royalties and milestones associated with the ongoing sales of our COVID-19 vaccine and Sanofi’s influenza-COVID-19 combination vaccines and any other combination vaccines Sanofi may develop, as well as ongoing product royalties for vaccines developed with our Matrix-M ™ adjuvant.
−Removed: We discuss this agreement in further detail in Note 4 to our accompanying consolidated financial statements.
−Removed: Additionally, we are advancing our pipeline of both late- and early-stage programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale and strong commercial opportunity.
−Removed: Our late-stage programs include a CIC vaccine candidate, as well as a stand-alone influenza vaccine candidate.
−Removed: In December 2024, we initiated the initial cohort of a Phase 3 trial comparing our CIC vaccine and stand-alone influenza vaccine to our updated COVID-19 vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.
−Removed: We intend to partner these vaccine candidates in order to advance to BLA filing and commercialization.
+Added: Our technology platform is used in our authorized COVID-19 Vaccine (“Nuvaxovid”) and the R21/Matrix-M™ adjuvant malaria vaccine.
+Added: Additionally, we are advancing our pipeline programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale and strong commercial opportunity.
Furthermore, we provide our Matrix-M™ adjuvant for use in collaborations.
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Additionally, we provide Matrix-M™ adjuvant for use in various programs in preclinical and clinical stage, as well as preclinical investigations.
−Removed: Examples include, an agreement with the Gates Foundation, and in a related master transfer agreement with a leading pharmaceutical company for exploration of Matrix-M™ adjuvant used as a potential advancement in their pipeline.
−Removed: We continue to advance our strategic assessment of our emerging, early-stage pipeline.
−Removed: We intend to develop our early-stage pipeline using a disciplined and capital-efficient approach.
−Removed: Our R&D investment strategy seeks to place smart, lower-cost investments on the programs with the highest potential value, both within infectious disease and beyond, with the
−Removed: Table o f Contents
−Removed: intent of partnering these assets at proof of concept and shifting late-stage development costs to our partners to finalize clinical development.
−Removed: We are pursuing early-stage research in diseases such as, respiratory syncytial virus (“RSV”) combinations, varicella-zoster virus (shingles) and Clostridioides difficile (C.
−Removed: Diff.) colitis.
−Removed: We are actively working to evaluate several RSV combination candidates to progress forward toward an Investigational New Drug (“IND”).
−Removed: We are actively developing an H5N1 avian pandemic influenza vaccine candidate and the toxicology study is underway.
−Removed: We are actively monitoring the emerging public health situation and are pursuing funding opportunities to join preparedness options.
−Removed: Additionally, we are evaluating potential expansion beyond infectious diseases including therapeutic areas such as oncology, where we believe our technology could augment and improve upon current therapies.
+Added: Examples include, several material transfer agreements with global pharmaceutical companies for exploration of Matrix-M™ adjuvant used as a potential advancement in their pipeline, including a pre-clinical collaboration in oncology.
Business Highlights
−Removed: Fourth Quarter 2024 and Recent Highlights
−Removed: Strategic Priority #1:
−Removed: Sanofi Partnership
−Removed: • Transitioned lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine beginning with the 2025-2026 vaccination season for the U.S.
−Removed: and other select major markets.
−Removed: • Achieved $50 million milestone associated with the first pediatric database lock in the fourth quarter of 2024.
−Removed: • Prescription Drug User Fee Act target action date of April 2025 for our COVID-19 vaccine BLA.
−Removed: ◦ Achievement of BLA approval triggers a $175 million milestone payment from Sanofi.
−Removed: • Marketing authorization transfers to Sanofi for U.S.
−Removed: and European Union markets are expected in late 2025.
−Removed: ◦ Achievement triggers an additional $50 million in combined milestone payments from Sanofi.
−Removed: • Sanofi announced it received U.S.
−Removed: FDA Fast Track designation for two combination vaccine candidates progressing to Phase 1/2 clinical trials, combining Novavax’s proven COVID-19 vaccine with Sanofi’s market-leading influenza vaccines.
−Removed: ◦ Potential for future $350 million development and launch milestone payments associated with Sanofi influenza-COVID-19 combination products.
−Removed: Strategic Priority #2:
−Removed: Leverage our technology platform and pipeline to forge additional partnerships
−Removed: • In December 2024, initiated an initial cohort of 2,000 participants for the Phase 3 trial for our CIC and stand-alone seasonal influenza vaccine candidates to evaluate immunogenicity and safety in adults aged 65 and older.
−Removed: ◦ Initial cohort data expected by mid-2025.
−Removed: ◦ Intend to partner both vaccine programs to advance all future clinical development, regulatory filing and commercialization activities.
−Removed: • R21/Matrix-M™ adjuvant malaria vaccine launched in additional countries in Africa by SII.
−Removed: Strategic Priority #3:
−Removed: Advance our technology platform and early-stage pipeline
−Removed: • Continued preclinical development of H5N1 avian pandemic influenza program evaluating multiple highly pathogenic avian influenza strains.
−Removed: • Continued advancement of early-stage preclinical research for RSV combinations, varicella-zoster virus (shingles) and C.
−Removed: colitis vaccine candidates.
−Removed: • Initiated exploratory preclinical work in areas outside of infectious disease, such as oncology.
−Removed: • Advancing artificial intelligence capabilities to significantly accelerate predictive modeling, optimize discovery and enhance the precision of vaccine design.
−Removed: • Initiated work on new potential Matrix formulations intended to enable different regimens and dosing schedules, improve vaccines and enable targeted approaches and advancements in therapeutic areas beyond infectious diseases.
−Removed: Table o f Contents
+Added: • In January 2026, we entered into a license agreement with Pfizer for use of our Matrix-M TM adjuvant in vaccine development.
+Added: Under the terms of the agreement, Pfizer was granted a non-exclusive license for Matrix-M TM use in two infectious disease areas.
+Added: ◦ We received an upfront payment of $30 million in the first quarter of 2026 and have the potential for up to $500 million in additional development and sales milestones.
+Added: In addition, we are eligible to receive high-mid-single digit percentage royalties on sales products incorporating Matrix-M TM .
+Added: ◦ Pfizer will be solely responsible for the development and commercialization of its products utilizing Matrix-M TM and we will be responsible for the supply of Matrix-M TM .
+Added: ◦ This partnership has the potential to generate billions of dollars of revenue for us over the life of the agreement.
+Added: • We continued the successful execution of the Sanofi partnership with $225 million in milestones earned in full year 2025, including $50 million earned in the fourth quarter of 2025, upon marketing authorization transfers for European Union and U.S.
+Added: ◦ In December 2025, Sanofi shared positive Phase 1/2 data from their influenza-COVID-19 combination programs and their belief that these data support the high probability of demonstrating non-inferiority in Phase 3 trials that would compare the new vaccine against the widely used regimen where both the influenza and COVID-19 vaccines are co-administered.
+Added: ◦ Sanofi has stated they are working with regulators on next steps for these combination programs.
+Added: • We have multiple material transfer agreements (“MTA”) with pharmaceutical companies, including major global pharmaceutical companies, who are evaluating the potential of Matrix-M TM in their portfolio of vaccine products.
+Added: ◦ In the fourth quarter of 2025, we signed a new MTA with a large pharmaceutical company to explore the utility of Matrix-M TM in its portfolio.
+Added: ◦ In February 2026, we expanded an existing MTA with a major global pharmaceutical company to explore an additional field.
+Added: ◦ In February 2026, we signed a new MTA with an oncology company.
+Added: • Other partners continue to demonstrate the value of our technology with Takeda achieving 12% market share with Nuvaxovid in Japan and the R21/Matrix-M TM , malaria vaccine, marketed by Serum Institute of India, continues its successful launch with 30 million doses sold since its launch in mid-2024, achieving over 80% market share.
+Added: • We continued advancement of early-stage candidates and Matrix-M TM technology.
+Added: ◦ Preclinical research ongoing for Clostridioides difficile colitis (C.
+Added: diff), varicella-zoster virus (shingles), and respiratory syncytial virus combinations vaccine candidates.
+Added: ◦ Significant progress made on preclinical candidates, for example the newest preclinical data from C.
+Added: diff vaccine candidate provided encouraging results.
+Added: ◦ We intend to enter the clinic with at least one program as early as 2027.
+Added: ◦ We continued exploration of our adjuvant technology to expand its utility both within infectious disease and potentially beyond, such as oncology.
Financing Transactions
−Removed: In August 2023, we entered into an At Market Issuance Sales Agreement (the “August 2023 Sales Agreement”), which allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock, and terminated our then-existing At Market Issuance Sales Agreement entered in June 2021 (the “June 2021 Sales Agreement”).
+Added: In August 2025, we issued $225.0 million aggregate principal amount of our 4.625% Convertible Senior Notes due 2031 (the “2031 Notes”) consisting of (a) $175.3 million principal amount of 2031 Notes issued in exchange for $148.8 million principal amount of our 5.00% Convertible Senior Notes due 2027 (the “2027 Notes”), and (b) approximately $49.7 million principal amount of 2031 Notes issued for cash, in each case, pursuant to exemptions from registration under the Securities Act of 1933, as amended (the “Securities Act”), and the rules and regulations thereunder.
+Added: In August 2023, we entered into an At Market Issuance Sales Agreement (the “August 2023 Sales Agreement”), which allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock, and terminated our then-existing At Market Issuance Sales Agreement entered in June 2021.
During the year ended December 31, 2024, we sold 12.2 million shares of our common stock under our August 2023 Sales Agreement, resulting in net proceeds of approximately $188 million.
+Added: During the year ended December 31, 2025, we did not sell any shares under the August 2023 Sales Agreement.
As of December 31, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $51 million.
−Removed: In May 2024, we also entered into a securities subscription agreement (the "Sanofi Subscription Agreement") with Sanofi, pursuant to which we sold and issued to Sanofi, in a private placement, 6.9 million shares of our common stock, at a price of $10.00 per share, for aggregate gross proceeds to us of $68.8 million.
−Removed: During the year ended December 31, 2023, we sold 38.3 million shares of our common stock under our August 2023 Sales Agreement and 7.9 million shares of our common stock under our June 2021 Sales Agreement, resulting in net proceeds of approximately $321 million, of which $6.9 million was included in Prepaid expenses and other current assets as of December 31, 2023 and received in cash in January 2024.
−Removed: In August 2023, we also entered into a Securities Subscription Agreement (the "SK Subscription Agreement") with SK bioscience Co., Ltd.
−Removed: ("SK"), pursuant to which we agreed to sell and issue to SK, in a private placement (the "Private Placement"), 6.5 million shares of our common stock at a price of $13.00 per share (the “SK Shares”) for aggregate gross proceeds to us of approximately $84.5 million.
−Removed: The closing of the Private Placement occurred on August 10, 2023.
+Added: In May 2024, we also entered into a securities subscription agreement with Sanofi, pursuant to which we sold and issued to Sanofi, in a private placement, 6.9 million shares of our common stock, at a price of $10.00 per share, for aggregate gross proceeds to us of $68.8 million.
+Added: In February 2026, we entered into the Credit Agreement with MidCap Financial Trust, as administrative agent.
+Added: The Credit Agreement provides for a senior secured term loan facility of up to $330 million, available in four tranches.
+Added: The first tranche of $130 million, of which $50 million was funded at closing, is available to be drawn, subject to customary conditions, through February 2028.
+Added: Borrowings under the Credit Agreement bear interest, payable monthly in arrears, at a rate per annum equal to the secured overnight financing rate (“Term SOFR”) plus 5.00%, subject to a Term SOFR floor of 2.00%.
+Added: The term loans mature in March 2031, at which time all outstanding principal and accrued interest are due and payable in full.
Critical Accounting Policies and Use of Estimates
−Removed: The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with GAAP.
+Added: The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles (“GAAP”).
The preparation of our consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, and equity and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.
−Removed: These estimates, particularly estimates relating to accounting for product sales revenue, licensing and transition services revenue, inventory realizability, and research and development expenses have a material impact on our consolidated financial statements and are discussed in detail throughout our analysis of the results of operations discussed below.
+Added: These estimates, particularly estimates relating to accounting for licensing and transition services revenue and research and development expenses have a material impact on our consolidated financial statements and are discussed in detail throughout our analysis of the results of operations discussed below.
We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities, and equity that are not readily apparent from other sources.
Actual results and outcomes could differ from these estimates and assumptions.
−Removed: For an in-depth discussion of each of our significant accounting policies, including our critical accounting policies and further information regarding estimates and assumptions involved in their application, see Note 2 to the accompanying consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Annual Report on Form 10-K.
−Removed: Revenue Recognition, Product Sales - Advance Purchase Agreements (“APAs”)
−Removed: Product sales include sales associated with COVID-19 Vaccine supply agreements, sometimes referred to as APAs, with various international governments.
−Removed: We recognize revenue from product sales related to these APA’s based on the transaction price per dose calculated in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), at the point in time when control of the product transfers to the customer and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory.
−Removed: The APAs typically contain terms that include upfront payments, which are reflected in Deferred revenue.
−Removed: We constrain the transaction price for APA’s until it is probable that a significant reversal in revenue recognized will not occur.
−Removed: Specifically, if an APA includes a provision whereby the customer may request a discount, return, or refund, or includes a term that may have the effect of decreasing the price per
−Removed: Table o f Contents
−Removed: dose of previously delivered shipments, revenue is constrained based on an estimate of the impact of the transaction price until it is probable that a significant reversal in revenue recognized will not occur.
−Removed: Revenue Recognition, Product Sales - U.S.
−Removed: Product sales in the U.S.
−Removed: are primarily made through large pharmaceutical wholesale distributors at the wholesale acquisition cost (“WAC”).
−Removed: We recognize revenue upon title transfer (which is typically at time of delivery), provided all other revenue recognition criteria have been met.
−Removed: The transaction price includes estimates of variable consideration for which reserves are established that primarily result from invoice discounts for prompt payment, wholesale distributor fees, chargebacks, and product returns (collectively, “gross-to-net deductions”).
−Removed: These estimates are based on the amounts earned or to be claimed for related sales and are classified as either reductions of gross accounts receivable or a current liability based on the nature of the estimate, the expected settlement method, and net position by individual customer.
−Removed: Where appropriate, these estimates are based on factors such as industry data and forecasted customer buying and payment patterns, our experience, current contractual and statutory requirements, specific known market events, and trends.
−Removed: Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
−Removed: If actual results vary from estimates, we will adjust the estimates, which would affect product sales in the period such variances become known.
−Removed: Gross-to-net deductions include the following :
−Removed: • Wholesale distributor fees, discounts, and chargebacks:
−Removed: We have arrangements under which our indirect customers such as retailers and healthcare providers receive discounts to the WAC.
−Removed: The chargeback represents the difference between the WAC and this negotiated discounted price.
−Removed: For distribution and related services, we pay service fees to our wholesale distributors.
−Removed: In addition, we typically offer wholesale distributor customers invoice discounts on product sales for prompt payments.
−Removed: We estimate chargebacks, discounts, and fees we will owe and deduct these amounts from gross product sales at the time the revenue is recognized based on the contractual terms and our expectations regarding future customer behaviors.
−Removed: • Product returns:
−Removed: We offer wholesale distributors and indirect customers the right to return expired doses.
−Removed: Estimated returns for COVID-19 Vaccine are determined considering levels of inventory in the distribution channel, projected market demand, utilization data, returns claims received, and product shelf life.
−Removed: Our estimates of product returns are subject to significant uncertainty.
−Removed: Actual customer product returns could vary significantly from our estimates, resulting in changes to the estimates in subsequent periods.
−Removed: The estimated amount for product returns is deducted from gross product sales in the period the related product sales are recognized.
−Removed: Fees payable to retailers, healthcare providers, and buying groups, including certain patient assistance programs, are deducted from gross product sales in the period the related product sales are recognized.
−Removed: During the year ended December 31, 2024, we recognized gross-to-net deductions against U.S.
−Removed: commercial product sales of $120.3 million for product returns and $105.8 million for wholesale distributor fees, discounts and chargebacks.
−Removed: As of December 31, 2024, $77.1 million and $10.1 million related to product returns, wholesale distributor fees, discounts, and chargebacks were included in Accrued expenses and Accounts payable, respectively, and $50.6 million was included in and reduced Accounts receivable on our consolidated balance sheet.
−Removed: During the year ended December 31, 2023, we recognized gross-to-net deductions against U.S.
−Removed: commercial product sales of $84.7 million for product returns and $47.0 million for wholesale distributor fees, discounts and chargebacks.
−Removed: As of December 31, 2023, $82.5 million related to product returns and $20.6 million related to wholesale distributor fees, discounts, and chargebacks were included in Accrued expenses and $2.6 million was included in and reduced Accounts receivable on our consolidated balance sheet.
−Removed: Revenue Recognition, Licensing, Royalties, and Other - Licensing and Transition Services
−Removed: The terms of licensing agreements may contain multiple performance obligations, which may include licenses and transition services.
−Removed: We evaluate licensing agreements under ASC 606, to determine the distinct performance obligations.
+Added: For an in-depth discussion of each of our significant accounting policies, including our critical accounting policies and further information regarding estimates and assumptions involved in their application, see Note 2 to the consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Annual Report on Form 10-K.
+Added: Revenue Recognition, Licensing, Royalties, and Other - Licensing, Transition Services, and Technology Transfer
+Added: The terms of licensing agreements may contain multiple performance obligations, which may include licenses, transition services, and technology transfer.
+Added: We evaluate licensing agreements under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), to determine the distinct performance obligations.
Prior to recognizing revenue, we estimate the transaction price, including variable consideration that is subject to a constraint.
Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved.
−Removed: Total consideration may include nonrefundable upfront license fees, transition service fees, other
−Removed: Table o f Contents
−Removed: payments based upon the achievement of specified milestones, and royalty payments based on product sales from licensed products.
+Added: Total consideration may include nonrefundable upfront license fees, transition service fees, technology transfer fees, and other payments based upon the achievement of specified milestones, and royalty payments based on product sales from licensed products.
For multiple performance obligation arrangements, we allocate the transaction price to each distinct performance obligation based on its relative stand-alone selling price.
9 unchanged sentences
Changes in estimates related to the process are recognized in the period when such changes are made on a cumulative catch-up basis.
−Removed: We have not experienced any material adjustments as a result of changes in estimates arising from this process.
−Removed: Inventory Realizability
−Removed: We periodically analyze our inventories for excess amounts or obsolescence and write down obsolete or otherwise unmarketable inventory to its estimated net realizable value.
−Removed: We estimate excess or obsolete inventory and losses on firm purchase commitments of inventory quarterly based on multiple factors, including assumptions about expected future demand and market conditions, current sales orders, and product expiry dates.
−Removed: Our assumptions about expected future demand are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory write down that we report in a particular period.
−Removed: For the year ended December 31, 2024, we recorded inventory write-downs of $21.0 million and losses on firm purchase commitments of inventory of $7.4 million.
−Removed: In addition, for the year ended December 31, 2024, we recorded recoveries on firm purchase commitments of $0.7 million related primarily to negotiated reductions to previously recognized firm purchase commitments.
−Removed: For the year ended December 31, 2023, we recorded inventory write-downs of $72.4 million and losses on firm purchase commitments of inventory of $73.5 million.
−Removed: In addition, for the year ended December 31, 2023, we recorded recoveries on firm purchase commitments of $40.2 million related primarily to negotiated reductions to previously recognized firm purchase commitments.
+Added: During the year ended December 31, 2025, we recorded adjustments of $21.7 million as a result of changes in estimates arising from this process.
Accounting for Research and Development Expenses
5 unchanged sentences
The financial terms of these agreements are based on negotiated terms, vary from contract to contract, and may result in an uneven level of activity over time.
−Removed: There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense.
+Added: There may be instances in which payments made to our third-party service providers will exceed the level of services provided and result in a prepayment of the expense.
Additionally, invoicing from third-party service providers may not coincide with actual work performed and can result in a prepaid or an accrual position at the end of the period.
−Removed: The estimation process requires us to make
−Removed: Table o f Contents
−Removed: significant judgments and estimates in determining the services incurred as of the balance sheet date, which may result in either a prepaid or an accrual balance.
+Added: The estimation process requires us to make significant judgments and estimates in determining the services incurred as of the balance sheet date, which may result in either a prepaid or an accrual balance.
As actual costs become known, we adjust our estimates.
10 unchanged sentences
Management's Discussion and Analysis of Financial Condition and Results of Operations located in Annual Report on Form 10-K for the year ended December 31, 2024.
+Added: Year Ended December 31,
2025 2024 Change
3 unchanged sentences
438,438 468,960 (30,522)
−Removed: Grants — 427,323 (427,323)
Total revenue $ 1,123,479 $ 682,162 $ 441,317
−Removed: Revenue for the year ended December 31, 2024 was $682.2 million as compared to $983.7 million for the year ended December 31, 2023, a decrease of $301.5 million.
−Removed: Revenue for the year ended December 31, 2024, was primarily comprised of revenue from licensing and product sales of COVID-19 Vaccine.
−Removed: Revenue for the year ended December 31, 2023, was primarily comprised of revenue from product sales of COVID-19 Vaccine and services performed under our USG Agreement.
−Removed: The decrease in revenue is due to a decrease in revenue under the USG Agreement and in the quantity of dose sales of COVID-19 Vaccine, partially offset by licensing, royalties, and other revenue from the Sanofi CLA.
+Added: Revenue for the year ended December 31, 2025 was $1.1 billion as compared to $682.2 million for the year ended December 31, 2024, an increase of $441.3 million.
+Added: Revenue for the year ended December 31, 2025 was primarily comprised of revenue from the termination of our APAs with Canada (“Canada APA”) and New Zealand (“New Zealand APA”) of $575.7 million and $27.3 million, respectively;
+Added: commercial product sales of COVID-19 Vaccine, adjuvant sales, and sale of other materials to the our partners;
+Added: licensing revenue from the achievement of milestones under the Sanofi CLA and revenue from transition services and technology transfer under the Sanofi CLA and licensing and royalty revenue with Takeda.
+Added: Revenue for the year ended December 31, 2024 was primarily comprised of revenue from licensing revenue from execution of the Sanofi CLA, revenue from Transition Services and Technology Transfer under the Sanofi CLA, and Product sales of COVID-19 Vaccine.
+Added: The increase in revenue is primarily due to an increase in Product sales from the termination of our Canada and New Zealand APAs, partially offset by a decrease in Licensing, royalties, and other revenue from the Sanofi CLA.
Product sales
−Removed: Product sales for 2024 were $190.2 million as compared to $531.4 million for 2023, a decrease of $341.2 million.
−Removed: The decrease in product sales is primarily due to a decreased quantity of dose sales of COVID-19 Vaccine under our APA agreements during the year ended December 31, 2024 as compared to 2023.
−Removed: The geographic distribution of product sales was as follows:
+Added: Product sales for 2025 were $685.0 million as compared to $213.2 million for 2024, an increase of $471.8 million.
+Added: Our Product sales related to revenue from Nuvaxovid sales, which commenced in 2022, commercial supply sales of COVID-19 Vaccine, revenue from supply of adjuvant and other materials, and the termination of our Canada and New Zealand APAs.
+Added: The categories of Product sales were as follows:
+Added: Year Ended December 31,
2025 2024 Change
Product sales (in thousands):
−Removed: North America
+Added: Nuvaxovid sales (1)
$ 625,182 $ 190,212 $ 434,970
−Removed: Europe 93,270 268,361 (175,091)
−Removed: Rest of the world
+Added: Supply sales (2)
59,859 22,990 36,869
−Removed: Total product sales revenue
+Added: Total Product sales
$ 685,041 $ 213,202 $ 471,839
−Removed: Table o f Contents
+Added: (1) Nuvaxovid sales are sales of our COVID-19 Vaccine associated with APAs with governments and commercial markets, where we are the commercial lead for sales and distribution, made through pharmaceutical wholesale distributors.
+Added: (2) Supply sales include commercial sales of COVID-19 Vaccine, adjuvant sales, and other material sales to our partners.
Licensing, royalties, and other
−Removed: Licensing, royalties, and other revenues for 2024 were $492.0 million as compared to $25.0 million for 2023, an increase of $467.0 million.
−Removed: The increase was primarily due to revenue from the Sanofi CLA.
+Added: Licensing, royalties, and other revenue for 2025 was $438.4 million as compared to $469.0 million for 2024, a decrease of $30.5 million.
+Added: The decrease was primarily due to a decrease in revenue under the Sanofi CLA, offset by an increase in revenue from other partners, including under the Amended Takeda CLA.
+Added: Licensing, royalties, and other revenue by license partner for the year ended December 31, 2025 and 2024 were as follows:
+Added: Year Ended December 31,
2025 2024 Change
Licensing, royalties, and other (in thousands):
+Added: Sanofi $ 386,319 $ 459,375 $ (73,056)
+Added: Takeda 41,697 937 40,760
+Added: Other partners (1)
10,422 8,648 1,774
−Removed: Sales-based royalties
+Added: Total licensing, royalties, and other revenue $ 438,438 $ 468,960 $ (30,522)
+Added: (1) Other partners revenue includes royalties and license fees associated with agreements with other partners such as Serum and SK bioscience, Co., Ltd.
+Added: Sanofi licensing, royalties, and other revenue were comprised of the following:
+Added: Year Ended December 31,
+Added: 2025 2024 Change
+Added: Sanofi licensing, royalties, and other revenue (in thousands):
$ — $ 389,642 $ (389,642)
+Added: 225,000 — 225,000
+Added: 5,750 — 5,750
Transition services and technology transfer:
+Added: Upfront fee amortization (1)
43,915 34,343 9,572
−Removed: Matrix-M™ adjuvant
+Added: Milestones amortization (1)
20,032 15,965 4,067
+Added: Cost reimbursements
91,622 19,425 72,197
−Removed: Total licensing, royalties, and other revenue
+Added: Total Sanofi licensing, royalties, and other revenue
$ 386,319 $ 459,375 $ (73,056)
−Removed: We did not have any Grants revenue during the year ended December 31, 2024, as compared to $427.3 million during the year ended December 31, 2023, a decrease of $427.3 million.
−Removed: Grant revenue for the year ended December 31, 2023 was comprised of revenue for services performed under our USG Agreement.
−Removed: As of December 31, 2023, we had recognized the full contract funding under the USG Agreement in revenue.
+Added: (1) Upfront fee amortization and Milestones amortization represent revenue recognized during the period related to a portion of the $500 million upfront payment and the $50 million milestone for database lock of an existing Phase 2/3 clinical trial in 2024 that were deferred upon achievement and are recognized in revenue over time.
+Added: During the year ended December 31, 2025, we recognized a change in estimate to cumulative revenue recognized for the Sanofi transition services and technology transfer performance obligation of $21.7 million as further described in Note 4 to our consolidated financial statements.
+Added: Takeda licensing, royalties, and other revenue were comprised of the following:
+Added: Year Ended December 31,
2025 2024 Change
+Added: Takeda licensing, royalties, and other revenue (in thousands):
+Added: Upfront fee (1)
+Added: $ 18,500 $ — $ 18,500
+Added: 8,151 — 8,151
+Added: 14,258 — 14,258
+Added: Support services 788 937 (149)
+Added: Total Takeda licensing, royalties, and other revenue
+Added: $ 41,697 $ 937 $ 40,760
+Added: (1) Upfront fee includes $14.5 million of nonrefundable upfront payments associated with the Amended Takeda CLA (as defined in Note 4 to our consolidated financial statements) and $4.0 million of previously unrecognized consideration from the Original Takeda CLA.
+Added: Year Ended December 31,
+Added: 2025 2024 Change
Expenses (in thousands):
2 unchanged sentences
Selling, general, and administrative 157,479 337,185 (179,706)
+Added: Impairment of assets held for sale
+Added: 97,845 — 97,845
Total expenses $ 670,684 $ 931,093 $ (260,409)
Cost of Sales
−Removed: Cost of sales decreased to $202.7 million for 2024 as compared to $343.8 million for 2023, a decrease of $141.0 million.
−Removed: The decrease was primarily due to a decrease in the quantity of dose sales of COVID-19 Vaccine and a decrease in excess, obsolete, or expired inventory and losses on certain firm purchase commitments.
−Removed: Cost of sales for 2024 included expense of $28.4 million related to excess, obsolete, or expired inventory and losses on certain firm purchase commitments, $3.8 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, $44.9 million related to unutilized manufacturing capacity, and a credit of $0.7 million related to negotiated reductions to certain previously recognized firm purchase commitments.
−Removed: Cost of sales for 2023 included expense of $145.9 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments, $6.1 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, $64.0 million related to unutilized manufacturing capacity, and a credit of $40.2 million related to negotiated reductions to certain previously recognized firm purchase commitments.
−Removed: The cost of sales as a percentage of product sales may fluctuate in the future as a result of changes to our customer mix, quantity of dose sales, or standard costs.
+Added: Cost of sales was $73.0 million for the year ended December 31, 2025, including expenses of $1.9 million related to excess, obsolete, or expired inventory, $1.8 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, and $8.1 million related to unutilized manufacturing capacity.
+Added: Cost of sales was $202.7 million for the year ended December 31, 2024, including expense of $27.7 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments, $3.8 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, and $44.9 million related to unutilized manufacturing capacity.
+Added: The decrease in cost of sales of $129.7 million was mainly driven by a decrease in the number of COVID-19 Vaccine doses sold, the sale of the Novavax CZ manufacturing facility in December 2024, a decrease in excess, obsolete, and expired inventory charges, and a decrease in unutilized manufacturing capacity charges.
+Added: The cost of sales as a percentage of Product sales may fluctuate in the future as a result of changes to our customer pricing mix or standard costs.
Research and Development Expenses
Research and development expenses decreased to $342.3 million for 2025 as compared to $391.2 million for 2024, a decrease of $48.8 million.
−Removed: The decrease was primarily due to a reduction in overall expenditures relating to development
−Removed: Table o f Contents
−Removed: activities on coronavirus vaccines, including our COVID-19 Vaccine and CIC, as summarized in the table below (in thousands):
+Added: The decrease was primarily due to certain cost containment measures to reduce our operating spend and due to a reduction in overall expenditures relating to development activities on our CIC vaccine, standalone influenza
+Added: vaccine, and COVID-19 Vaccine and the sale of the Novavax CZ manufacturing facility in December 2024, as summarized in the table below:
+Added: Year Ended December 31,
+Added: 2025 2024 Change
Research and Development Expenses (in thousands):
−Removed: Coronavirus vaccines $ 122,445 $ 413,448
+Added: COVID-19 Vaccine
+Added: $ 80,444 $ 81,736 $ (1,292)
+Added: CIC and influenza vaccines
+Added: 30,019 44,831 (14,812)
Other vaccine development programs 4,634 510 4,124
5 unchanged sentences
Total research and development expenses $ 342,320 $ 391,169 $ (48,849)
−Removed: Research and development expenses for coronavirus vaccines for the year ended December 31, 2024 and 2023 decreased to $122.4 million from $413.4 million primarily as a result of a reduction in coronavirus vaccines clinical and support costs.
−Removed: The decrease was also the result of a reduction in manufacturing and support costs due, in part, to a reduction in our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, including embedded lease costs, under manufacturing supply agreements with CMOs and CDMOs.
−Removed: We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with vaccine development.
−Removed: As we obtain data from preclinical studies and clinical trials, we may elect to discontinue or delay clinical trials in order to focus our resources on more promising vaccine candidates.
−Removed: Completion of clinical trials may take several years or more, but the length of time can vary substantially depending upon the phase, size of clinical trial, primary and secondary endpoints, and the intended use of the vaccine candidate.
−Removed: The cost of clinical trials may vary significantly over the life of a project as a result of a variety of factors, including:
−Removed: • the number of participants who participate in the clinical trials;
−Removed: • the number of sites included in the clinical trials;
−Removed: • if clinical trial locations are domestic, international, or both;
−Removed: • the time to enroll participants;
−Removed: • the duration of treatment and follow-up;
−Removed: • the safety and efficacy profile of the vaccine candidate;
−Removed: • the cost and timing of, and the ability to secure, regulatory approvals.
−Removed: As a result of these uncertainties, we are unable to determine the duration and completion costs of our research and development projects or when, and to what extent, we will generate future cash flows from our research projects.
−Removed: For 2025, we expect research and development expenses to decrease as compared to 2024 as we continue to right-size our operating expenses as part of our cost reduction initiative.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses decreased to $157.5 million for 2025 from $337.2 million for 2024, a decrease of $179.7 million.
−Removed: The decrease in selling, general, and administrative expenses is primarily due to cost containment measures to reduce our operating spend, including a decrease in advertising and promotion costs in support of our COVID-19 commercial program, employee expenses, and professional fees, partially offset by restructuring expenses.
−Removed: Table o f Contents
+Added: The decrease in selling, general, and administrative expenses is primarily due to certain cost containment measures to reduce our operating spend, including a reduction in our global commercial footprint and administrative infrastructure, and the sale of the Novavax CZ manufacturing facility in December 2024.
+Added: Impairment of Assets Held for Sale
+Added: During the year ended December 31, 2025, we classified our corporate headquarters facility at 700 Quince Orchard, Gaithersburg, Maryland (“700QO”), together with its related finance lease obligation, certain related property and equipment and land parcel adjacent to the facility (collectively referred to as the "Disposal Group"), as held for sale.
+Added: The carrying value of the Disposal Group was determined to be greater than its fair value less costs to sell and, consequently, an impairment loss of $97.8 million was recognized during the year ended December 31, 2025, and recorded in Impairment of assets held for sale in the consolidated statement of operations.
+Added: In October 2025, we entered into a definitive agreement to sell the Disposal Group and received the initial net payment of $19.7 million related to the parcel purchase (land sale) in November 2025 (see Note 19 to our consolidated financial statements).
+Added: The remaining approximately $39.8 million payment was scheduled to occur upon the closing of the remaining components of the transaction in the first quarter of 2026, which was received in January 2026 (see Note 22 to our consolidated financial statements).
Other Income (Expense), Net:
+Added: Year Ended December 31,
2025 2024 Change
1 unchanged sentence
Interest expense $ (22,547) $ (20,075) $ (2,472)
+Added: Loss on debt extinguishment (28,714) — (28,714)
Gain on disposition of Novavax CZ assets
— 51,949 (51,949)
+Added: Other income, net
40,633 40,442 191
1 unchanged sentence
$ (10,628) $ 72,316 $ (82,944)
−Removed: We had total net other income of $72.3 million for 2024 compared to total net other income of $23.5 million for 2023, an increase of $48.8 million.
−Removed: The increase in other income (expense), net is primarily due to the gain on the disposition of Novavax CZ assets, the favorable impact in 2024 as compared to 2023, of exchange rates on foreign currency denominated balances, including an intercompany loan with Novavax CZ, and additional interest income on Cash and cash equivalents and Marketable securities balances, partially offset by additional interest expense.
+Added: We had total net other expense of $10.6 million for 2025 compared to total net other income of $72.3 million for 2024, a decrease of $82.9 million.
+Added: The decrease in other income (expense), net is primarily due to a $28.7 million Loss on debt extinguishment in 2025 and the $51.9 million Gain on the disposition of Novavax CZ assets in 2024.
Income Tax Expense:
During the years ended December 31, 2025 and 2024, we recognized $1.9 million and $10.9 million of income tax expense, respectively, related to federal, state, and foreign income taxes.
+Added: Net Income (Loss):
+Added: Year Ended December 31,
2025 2024 Change
−Removed: Net Loss (in thousands, except per share information):
−Removed: Net loss $ (187,499) $ (545,062) $ 357,563
−Removed: Net loss per share, basic and diluted $ (1.23) $ (5.41) $ 4.18
−Removed: Weighted average shares outstanding, basic and diluted 152,190 100,768 51,422
−Removed: Net loss for 2024 was $187.5 million, or $1.23 per share, as compared to $545.1 million, or $5.41 per share, for 2023, a decrease of $357.6 million, or $4.18 per share.
−Removed: The decrease in net loss during the years ended December 31, 2024, was primarily due to a decrease in total expenses, partially offset by a decrease in total revenue.
−Removed: The increase in weighted average shares outstanding for 2024 is primarily a result of sales of our common stock.
+Added: Net Income (Loss) (in thousands, except per share information):
+Added: Net income (loss)
+Added: $ 440,302 $ (187,499) $ 627,801
+Added: Net income (loss) per share, basic
+Added: $ 2.72 $ (1.23) $ 3.95
+Added: Net income (loss) per share, diluted
+Added: 2.58 $ (1.23) $ 3.81
+Added: Weighted average shares outstanding, basic
+Added: 161,991 152,190 9,801
+Added: Weighted average shares outstanding, diluted
+Added: 173,103 152,190 20,913
+Added: Net income for 2025 was $440.3 million, or $2.72 per share, basic, and $2.58 per share, diluted, as compared to a net loss of $187.5 million, or $1.23 per share, basic and diluted, for 2024, an increase of $627.8 million, or $3.95 per share, basic, and $3.81 per share, diluted.
+Added: The increase in net income during the years ended December 31, 2025, was primarily due to an increase in total revenue from the termination of our Canada and New Zealand APAs and a decrease in total expenses.
+Added: The increase in weighted average shares outstanding for 2025 is primarily a result of common stock issued under our incentive programs and sales of our common stock in 2024.
Liquidity Matters and Capital Resources
2 unchanged sentences
the progress of preclinical studies and clinical trials;
−Removed: the time and costs involved in obtaining regulatory approvals;
+Added: the time and costs involved in obtaining and maintaining regulatory approvals;
the costs of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights;
and other manufacturing, sales, and distribution costs.
−Removed: We plan to continue developing other vaccines and product candidates, such as our potential combination vaccine and stand-alone influenza vaccine candidates, which are in various stages of development.
−Removed: Our ability to generate revenue from product sales is subject to uncertainty specifically as it relates to our ability to successfully develop, manufacture, distribute, and market our updated vaccine and to successfully execute on our APAs, as discussed below.
−Removed: Additionally, our plans include our ongoing restructuring and cost reduction measures (see Note 18 to our accompanying consolidated financial statements), and may also include raising additional capital through a combination of additional equity and debt financing, collaborations, strategic alliances, asset sales, and marketing, distribution, or licensing arrangements.
+Added: We plan to continue developing other vaccines and product candidates, such as our potential combination vaccine candidates, which are in various stages of development.
+Added: Our ability to generate revenue from Product sales is subject to uncertainty specifically as it relates to our ability to successfully develop, manufacture, distribute, and market our updated vaccine and to successfully execute on our licensing arrangements with our strategic partners and our APAs, as discussed below.
+Added: Additionally, our plans include our ongoing restructuring and cost reduction measures as a part of our Restructuring Plan (see Note 19 to our consolidated financial statements), and may also include raising additional capital through a combination of additional equity and debt financing, collaborations, strategic alliances, asset sales, and marketing, distribution, or licensing arrangements.
New financings may not be available to us on commercially acceptable terms, or at all.
If we are unable to obtain additional capital, we will assess our capital resources and may be required to delay, reduce the scope of, or eliminate some or all of our operations, or further downsize our organization, any of which may have a material adverse effect on our business, financial condition, results of operations.
−Removed: In May 2024, we entered into the Sanofi CLA pursuant to which Sanofi received:
−Removed: Table o f Contents
−Removed: i) A co-exclusive license to commercialize our current stand-alone COVID-19 Vaccine, including our prototype vaccine and updated vaccines, that address seasonal variants throughout the world (the “COVID-19 Vaccine Products”);
−Removed: ii) A sole license to develop and commercialize combination products containing a potential combination of our COVID-19 Vaccine and Sanofi’s seasonal influenza vaccine (“COVID-19 and influenza Combination Products” or “CIC Products”);
−Removed: iii) A non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines (“Other Combination Products” and together with the COVID-19 Vaccine Products, CIC Products, and Other Combination Products, “Licensed COVID-19 Products”) and
−Removed: iv) A non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M™ adjuvant.
−Removed: Under the Sanofi CLA, we received a non-refundable upfront payment of $500 million.
−Removed: We also achieved a $50.0 million milestone, which is included in Accounts receivable on the Consolidated balance sheet as of December 31, 2024.
−Removed: We are eligible to receive development, technology transfer, launch, and sales milestone payments totaling up to an additional $650.0 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products.
−Removed: In addition, we are also eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four Adjuvant Products and $210 million for each Adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products.
−Removed: Commencing shortly after the effective date of the Sanofi CLA, we commenced activities related to the technology transfer of our manufacturing process for the COVID-19 Vaccine Products and Matrix-M™ components to Sanofi.
−Removed: Until the successful completion of such transfer, we will supply Sanofi with both COVID-19 Vaccine Products and Matrix-M™ intermediary components for Sanofi’s use and are eligible for reimbursement of such costs from Sanofi.
−Removed: Additionally, Sanofi will reimburse us for our research and development and medical affairs costs related to the COVID-19 Vaccine Products in accordance with agreed upon plans and budgets.
−Removed: Under the Sanofi CLA, we will continue to commercialize the updated vaccine through the end of the 2024-2025 vaccination season.
−Removed: Beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize the COVID-19 Vaccine Products worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply our existing APA customers and strategic partners, including Takeda and SII.
+Added: Sanofi Collaboration and License Agreement
+Added: In May 2024, we entered into the Sanofi CLA pursuant to which we received a non-refundable upfront payment of $500 million.
+Added: During the year ended December 31, 2025, we received milestone payments of $50 million for the database lock of an existing Phase 2/3 clinical trial in 2024 and $175 million earned upon the approval of the marketing authorization for a COVID-19 Vaccine product in a pre-filled syringe from the U.S.
+Added: We achieved the $25 million milestone for the transfer of the European Medicines Agency approval to Sanofi and the $25 million milestone for the transfer of the U.S.
+Added: marketing authorization to Sanofi in October and November 2025, respectively.
+Added: We received these milestone payments in December 2025 and January 2026, respectively.
+Added: As of December 31, 2025, we are eligible to receive additional development, technology transfer, launch, and sales milestone payments totaling up to $425 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products.
+Added: In addition, we are eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four adjuvant Products and $210 million for each adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products.
+Added: As of December 31, 2025, remaining Sanofi sales milestone payments of $425 million include $75 million related to COVID-19 Vaccine products and $350 million related to influenza-COVID-19 combination products.
+Added: The COVID-19 Vaccine products milestones remaining are a $75 million receivable upon the completion of the technology transfer of our manufacturing process for the COVID-19 Vaccine products to Sanofi.
+Added: The influenza-COVID-19 combination product milestones include a $125 million milestone receivable upon achievement of certain influenza-COVID-19 combination products-related development milestones, and a $225 million in influenza-COVID-19 combination products-related launch milestones.
+Added: Beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi began to commercialize the COVID-19 Vaccine products worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply our existing APA customers and strategic partners, including Takeda and SII.
Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.
−Removed: In May 2024, we also entered into the Sanofi Subscription Agreement, pursuant to which we sold and issued to Sanofi, in a private placement, 6.9 million shares of our common stock at a price of $10.00 per share for aggregate gross proceeds to us of $68.8 million.
−Removed: We have also entered into supply agreements, sometimes referred to as APAs, with various countries globally.
−Removed: As of December 31, 2024, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties under the licensing agreements, was approximately $1.3 billion, of which $1.1 billion is included in Deferred revenue on our consolidated balance sheet.
−Removed: Failure to timely meet regulatory milestones, obtain timely supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under our APAs may require us to refund portions of upfront or other payments or result in reduced future payments, which could adversely impact our ability to realize revenue from our unsatisfied performance obligations or result in the reversal of previously recognized revenue.
−Removed: In the first quarter of 2025, we received written notice of a $23 million claim related to certain performance obligations under an APA agreement with a customer.
−Removed: We believe we have fulfilled the requirements related to this matter and are evaluating the merits of the claim.
−Removed: The timing to fulfill performance obligations related to APAs will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine under certain of our APAs.
−Removed: The APAs typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment, and are applied to billings upon delivery of COVID-19 Vaccine.
−Removed: Such upfront payments generally become non-refundable upon our achievement of certain development, regulatory, and commercial milestones.
−Removed: Additionally, for the remaining APA agreements, our intent is to deliver doses or when appropriate, amicably negotiate and exit
−Removed: Table o f Contents
−Removed: The timing to fulfill performance obligations related to the Sanofi CLA will depend on the timing of costs incurred relative to total expected costs.
−Removed: In August 2024, our updated COVID-19 vaccine received EUA from the U.S.
−Removed: FDA for active immunization to prevent COVID-19 in individuals aged 12 and older.
−Removed: Doses became available within the U.S.
−Removed: at many major pharmacy retailers, following the Center for Biologics Evaluation and Research release of vaccine batches.
−Removed: We have established reserves for gross-to-net deductions for amounts that we expect to return to our customers.
−Removed: As of December 31, 2024, gross-to-net deduction balances were $116.7 million related to product returns and $21.1 million related to wholesale distributor fees, discounts, and chargebacks.
−Removed: As of December 31, 2024, $77.1 million of gross-to-net deductions were included in Accrued expenses, $10.1 million were included Accounts payable, and $50.6 million were included in and reduced Accounts receivable on the consolidated balance sheet.
−Removed: Pursuant to the Settlement Agreement with Fujifilm (see Note 4 to our accompanying consolidated financial statements), in March 2024, we paid $42.0 million to Fujifilm, the parties agreed to a mutual release of claims arising from, under or otherwise in connection with the prior confidential settlement agreement and release effective September 30, 2022, and Fujifilm agreed to dismiss its demand for arbitration with the Judicial Arbitration and Mediation Services (“JAMS”).
−Removed: This payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expenses from Fujifilm manufacturing activity and accordingly, during the year ended December 31, 2024, we recorded a benefit of $26.6 million as Research and development expenses.
−Removed: We have an APA with the Commonwealth of Australia (“Australia”) for the purchase of doses of COVID-19 Vaccine (the “Australia APA”).
−Removed: In December 2024, we entered into an amendment to the Australia APA with Australia.
−Removed: Pursuant to the amendment, we acknowledged the cancellation by Australia of the delivery of certain doses of our COVID-19 Vaccine scheduled for delivery between the fourth quarter of 2023 and the fourth quarter of 2025 and we agreed to credit approximately $31 million of the advanced payment paid by Australia to us against outstanding invoices and invoices for the future delivery of approximately 3 million doses of COVID-19 Vaccine without requiring additional cash payments.
−Removed: We also agreed to an updated delivery schedule providing for the potential delivery of COVID-19 Vaccine or future variant COVID-19 Vaccine through the end of 2029.
−Removed: The amendment further provides for certain remedies for Australia, including return of unused credit, cancellation of doses, or termination of the Australia APA, in the event we miss or under deliver doses to Australia or fail to receive regulatory approval of a variant COVID-19 vaccine.
+Added: Takeda Amended and Restated Collaboration and License Agreement
+Added: In April, we entered into the Amended Takeda CLA which amends and supersedes the Original Takeda CLA.
+Added: We determined the initial transaction price at inception of the Amended Takeda CLA to be $27.5 million, consisting of (i) $19.5 million of a non-refundable upfront payment, (ii) $4.0 million of non-cancelable annual support payments within the 18 month notice period for contract termination, and (iii) $4.0 million of previously unrecognized consideration from the Original Takeda CLA.
+Added: We allocated $26.9 million of fixed consideration to the Updated Takeda License performance obligations and $0.6 million to Takeda Support Services.
+Added: We recognized revenue of $40.9 million related to the Updated Takeda License in 2025.
+Added: The Takeda Support Services are recognized as revenue over time using an input method to measure progress by utilizing costs incurred to-date relative to total expected costs.
+Added: Revenue recognized related to Takeda Support Services for the year ended December 31, 2025 was $0.8 million.
+Added: Under the Amended Takeda CLA, we received a non-refundable upfront payment of $19.5 million of which $5.0 million was creditable against royalties owed by Takeda for its fiscal year 2024.
+Added: In addition, on an annual basis, we will receive $2.0 million to compensate us for services provided by us under the Takeda CLA, and we will receive an additional $8.0 million annual milestone payment, of which $5.0 million is creditable against royalties owed by Takeda in its fiscal year 2025 or thereafter, if Takeda receives marketing approval of the COVID-19 Vaccine in that year or such approval is not necessary for such year.
+Added: The parties have also updated the financial terms to replace the share of operating profits and, instead, provide us with a tiered royalty as a percentage of Takeda’s, its affiliates’ and sublicensees’ total net sales in the mid to high-teen percentages (subject to certain capped royalty reductions), which commenced on April 1, 2024 and will continue until the later of (a) twenty years after April 29, 2025, (b) all our know-how licensed under the Amended Takeda CLA has become publicly available through no fault of Takeda, and (c) the expiration of the last valid claim in the intellectual property rights licensed by us to Takeda under the Amended Takeda CLA covering COVID-19 Vaccine in Japan.
+Added: In connection with the Amended Takeda CLA, on April 29, 2025, we entered into a release agreement with Takeda under which we released Takeda and Takeda released us from all claims that were asserted or could have been asserted by either party against the other party that related to the Original Takeda CLA and the activities thereunder.
+Added: Pfizer License and Option Agreement
+Added: In January 2026, we entered into a License and Option Agreement with Pfizer Inc.
+Added: (“Pfizer”) for use of our Matrix-M™.
+Added: Under the terms of the agreement, Pfizer will obtain a non-exclusive license for Matrix-M™ for use with Pfizer's products in up to two disease areas.
+Added: The agreement provides for an upfront payment of $30 million and we have the potential to receive up to $500 million in development and sales milestone payments.
+Added: In addition to milestone payments, we are eligible to receive tiered high mid-single digit percentage royalty payments on sales of any product by Pfizer that includes Matrix-M™.
+Added: Supply Agreements
+Added: As of December 31, 2025, we have $207.2 million of remaining obligations under APAs with certain countries globally, excluding the Vaccine Alliance (“Gavi”).
+Added: These obligation include $133.9 million related to an APA with the Commonwealth of Australia (“Australia”) for the purchase of doses of COVID-19 Vaccine (the “Australia APA”) and $73.3 million related to various other countries.
+Added: With respect to the Australia APA, as of December 31, 2025, $48.4 million was classified as current Deferred revenue and $85.4 million was classified as non-current Deferred revenue in our consolidated
+Added: balance sheet.
+Added: In December 2024, we entered into an amendment to the Australia APA pursuant to which, among other things, we acknowledged the cancellation by Australia of the delivery of certain doses of our COVID-19 Vaccine scheduled for delivery between the fourth quarter of 2023 and the fourth quarter of 2025 and we agreed to credit approximately $31 million of the advanced payment paid by Australia to us against outstanding invoices and invoices for the future delivery of approximately three million doses of COVID-19 Vaccine without requiring additional cash payments.
+Added: In addition, the amendment provides for certain remedies for Australia, including return of unused credit, cancellation of doses, or termination of the Australia APA, in the event we are unable to gain regulatory approval of a variant COVID-19 vaccine or supply doses per the terms of the agreement.
+Added: Specifically, Australia did not take delivery of doses that were due to be delivered in 2025 and may seek to cancel the future delivery of the 2025 as well as 2026 doses.
+Added: If we are unable to provide doses per the supply schedule as amended, after six months, Australia may seek to terminate the APA.
The amendment also provides Australia with the right to cancel doses if we fail to timely notify Australia of changes to our commercialization plans.
−Removed: As of December 31, 2024, $15.6 million was classified as current Deferred revenue and $118.2 million was classified as non-current Deferred revenue with respect to the Australia APA in our consolidated balance sheet, which will be recognized in product revenue as doses are delivered to Australia.
−Removed: We have an APA with the Pharmaceutical Management Agency (“Pharmac”), a New Zealand Crown entity, for the purchase of doses of COVID-19 Vaccine (the “New Zealand APA”).
−Removed: In July 2024, Pharmac provided notice of its termination of the New Zealand APA.
−Removed: Pharmac has requested a refund of certain advanced payments, and we are in discussion with Pharmac regarding whether a refund of the advanced payments is appropriate under the New Zealand APA.
−Removed: As of December 31, 2024 , $31.3 million was classified as Other current liabilities with respect to the New Zealand APA in our consolidated balance sheet.
−Removed: Approximately $125 million of the contract value related to future deliverables may no longer be available if the New Zealand APA is terminated.
−Removed: We responded to Pharmac in September 2024 indicating we do not believe Pharmac has the right to unilaterally terminate the contract or receive a refund of any part of the remaining upfront payment.
−Removed: We are in ongoing discussions with Pharmac to resolve this matter, which may not be achievable on acceptable terms or at all.
−Removed: We have an APA with His Majesty the King in Right of Canada as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (the “Canadian government”), for the purchase of doses of COVID-19 Vaccine (the “Canada APA”).
−Removed: The Canadian government may terminate the Canada APA, as amended, as we failed to receive regulatory approval for our COVID-19 Vaccine using bulk antigen produced at Biologics Manufacturing Centre Inc.
−Removed: (“BMC”) on or before December 31, 2024.
−Removed: Therefore, we are in discussions with Canada regarding a potential amendment to the Canada APA to address possible alternatives, which may not be achievable on acceptable terms or at all.
−Removed: As of December 31, 2024, $555.7 million was classified as current Deferred revenue with respect to the Canada APA in our consolidated balance sheet.
−Removed: If the Canadian government terminates the Canada APA, $28.0 million of advanced payments previously received would become refundable, which was classified as Other current liabilities in our consolidated balance sheet, and approximately $224 million of the contract value related to future deliverables would no longer be available.
−Removed: Table o f Contents
−Removed: In November 2024, we and The Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”) entered into a Termination and Settlement Agreement (the “Settlement Agreement”) and a Letter of Amendment to the Settlement Agreement (the “Settlement Agreement Amendment”), relating to the Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) and the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020 (the “Original UK Supply Agreement”).
−Removed: The Settlement Agreement resolved the disputes regarding the Amended and Restated Supply Agreement and released both parties of all claims arising out of or connected with the Amended and Restated Supply Agreement.
−Removed: Under the terms of the Settlement Agreement and Settlement Agreement Amendment, we and the Authority agreed to terminate the Amended and Restated Supply Agreement and to fully settle the outstanding amount under dispute related to upfront payments of $112.5 million previously received by us from the Authority under the Amended and Restated Supply Agreement.
−Removed: Pursuant to the Settlement Agreement, we agreed to pay a refund of $123.8 million (the “Settlement Payment”) to the Authority in equal quarterly installments of $10.3 million over a three year period, ending in June 2027.
−Removed: The Settlement Payment amount includes an $11.3 million provision for interest over the period and may be avoided if we choose to accelerate payments.
−Removed: As of December 31, 2024, the remaining upfront payment previously received from the authority is classified as $36.4 million of other current liabilities and $58.8 million of Other non-current liabilities on our consolidated balance sheet.
−Removed: We entered into an APA with the Vaccine Alliance (“Gavi”) in May 2021 (the “Gavi APA”), pursuant to which we received upfront payments of $700 million from Gavi (the “Advance Payment Amount”) to be applied against purchases of our prototype vaccine by certain countries participating in the COVAX Facility.
−Removed: As of December 31, 2023, the remaining Gavi Advance Payment Amount was $696.4 million.
−Removed: In February 2024, we and Gavi entered into a Termination and Settlement Agreement (the “Gavi Settlement Agreement”) terminating the Gavi APA, settling the arbitration proceedings, and releasing both parties of all claims arising from, under, or otherwise in connection with the Gavi APA.
−Removed: Pursuant to the Gavi Settlement Agreement, we are responsible for payment to Gavi of (i) an initial settlement payment of $75 million, which we paid in February 2024, and (ii) deferred payments, in equal annual amounts of $80 million payable each calendar year through a deferred payment term ending December 31, 2028.
−Removed: The deferred payments are due in variable quarterly installments beginning in the second quarter of 2024 and total $400 million during the deferred payment term.
−Removed: Such deferred payments may be reduced through Gavi’s use of an annual vaccine credit equivalent to the unpaid balance of such deferred payments each year, which may be applied to qualifying sales of any of our vaccines funded by Gavi for supply to certain low-income and lower-middle income countries.
−Removed: We have the right to price the vaccines offered to such low-income and lower-middle income countries in our discretion, and, when utilized by Gavi, we will credit the actual price per vaccine paid against the applicable credit.
−Removed: We intend to price vaccines offered via the tender process, consistent with our shared goal with Gavi to provide equitable access to those countries.
−Removed: Also, pursuant to the Gavi Settlement Agreement, we granted Gavi an additional credit of up to $225 million that may be applied against qualifying sales of any of our vaccines for supply to such low-income and lower-middle income countries that exceed the $80 million deferred payment amount in any calendar year during the deferred payment term.
−Removed: In total, the Gavi settlement agreement is comprised of $700 million of potential consideration, consisting of the $75 million initial settlement payment, deferred payments of up to $400 million that may be reduced through annual vaccine credits, and the additional credit of up to $225 million that may be applied for certain qualifying sales.
−Removed: We recorded the $3.6 million difference between the refund liability recorded as of December 31, 2023 of $696.4 million and the $700 million of total consideration under the arrangement as a revenue adjustment during the year ended December 31, 2024.
+Added: In the event that we do not, on or before the relevant contractual deadlines, receive regulatory approval for, and deliver, the seasonally updated COVID-19 Vaccine, up to $92.5 million of deferred revenue may become refundable.
+Added: In the third quarter of 2025 we withdrew our application for our COVID-19 Vaccine based on recommendations made by the TGA.
+Added: The parties are in ongoing discussions and have agreed to a meeting to discuss outstanding issues and obligations under the APA.
+Added: In light of these developments, we may seek to further amend the Australian APA, which amendment may not be achievable on acceptable terms or at all.
+Added: With respect to other obligations under APAs of $73.3 million, as of December 31, 2025, $38.1 million was classified as current Deferred revenue and $35.2 million was classified as non-current Deferred revenue in our consolidated balance sheet.
+Added: Recognition of these amounts is dependent on delivery of doses or expiry of optional dose order quantities.
+Added: In November 2024, we entered into a settlement agreement with the Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), pursuant to which we and the Authority agreed to terminate the Amended and Restated Supply Agreement with the Authority and to fully settle the outstanding amount under dispute related to upfront payments of $112.5 million.
+Added: We agreed to pay a refund of $123.8 million, including interest of $11.3 million to the Authority, in equal quarterly installments of $10.3 million over a three year period, ending in June 2027.
+Added: As of December 31, 2025, pursuant to our settlement agreement with the UK, the remaining upfront payment previously received from the authority is classified as $38.6 million of other current liabilities and $20.2 million of Other non-current liabilities on our consolidated balance sheet.
+Added: In February 2024, we and Gavi entered into a Termination and Settlement Agreement (the “Gavi Settlement Agreement”) terminating our APA with Gavi (the “Gavi APA”).
+Added: In total, the Gavi settlement agreement is comprised of $700 million of potential consideration, consisting of $75 million initial settlement payment, deferred payments of up to $400 million that may be reduced through annual vaccine credits, and an additional credit of up to $225 million that may be applied against certain qualifying sales.
As of December 31, 2025, the remaining amounts included on our consolidated balance sheet are classified as $225.0 million in non-current Deferred revenue for the additional credit that may be applied against future qualifying sales, $80.0 million in Other current liabilities, and $195.0 million in Other non-current liabilities.
−Removed: In addition, we and Gavi entered into a security agreement pursuant to which we granted Gavi a security interest in accounts receivable from SII under the SII R21 Agreement (see Note 3 to our accompanying consolidated financial statements), which will continue for the deferred payment term of the Gavi Settlement Agreement.
+Added: In addition, we and Gavi entered into a security agreement pursuant to which we granted Gavi a security interest in accounts receivable from SII under the SII R21 Agreement (see Note 4 to our consolidated financial statements), which will continue for the deferred payment term of the Gavi Settlement Agreement.
On February 22, 2024, the claims and counterclaims were dismissed with prejudice.
−Removed: We continue to assess our manufacturing needs and modify our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, and in doing so recognize that significant costs may be incurred.
−Removed: For the 2023-2024 vaccination season, we depended exclusively on Serum for co-formulation and filling and finishing.
−Removed: For the 2024-2025 vaccination season, we expanded our supply chain network and introduced new single-dose vial and pre-filled syringe product presentations in certain markets.
−Removed: In May 2024, we and SLS entered into a supply agreement (the “SLS Supply Agreement”) under which SLS will supply us antigen drug substance and finished COVID-19 Vaccine doses.
−Removed: The SLS Supply Agreement includes the general terms and conditions of supply orders between us and SLS.
−Removed: Table o f Contents
−Removed: execute firm purchase orders to include specific quantities to be delivered under the SLS Supply Agreement.
−Removed: Pursuant to the SLS Supply Agreement, SLS or its authorized manufacturer is responsible for obtaining and maintaining all necessary permits or other regulatory approvals to manufacture drug substance and drug product.
−Removed: Unless otherwise earlier terminated, the SLS Supply Agreement will expire on the later of June 30, 2028 or two years after the expiration or termination of the last firm purchase order under the SLS Supply Agreement.
−Removed: Either party may terminate the SLS Supply Agreement if the other party commits a material breach of the SLS Supply Agreement that is not timely cured or is not curable.
−Removed: The SLS Supply Agreement contains certain customary representations and warranties of the parties along with certain customary covenants, including confidentiality and indemnity provisions.
−Removed: Any delays or disruptions in these suppliers’ operations could prevent or delay the delivery of customer orders.
−Removed: As of December 31, 2024, we had $545.3 million in cash and cash equivalents and restricted cash and $392.9 million in marketable securities as compared to $583.8 million in cash and cash equivalents and restricted cash as of December 31, 2023.
−Removed: We funded our operations in 2024 primarily with cash and cash equivalents, marketable securities, non-refundable upfront payment under the Sanofi CLA and Sanofi Subscription Agreement, proceeds from the sale of securities under our August 2023 Sales Agreement, upfront payments under APAs, and revenue from product sales.
−Removed: In May 2023, we announced our plan to restructure our global footprint to reduce our planned expenditures and in January 2024, we announced further reductions in our global workforce.
−Removed: We anticipate our future operations to be funded primarily by milestone payments, royalties, transition services and technology transfer under the Sanofi CLA, revenue and/or royalties from product sales, our cash and cash equivalents and investments in marketable securities, and other potential funding sources including equity financings, which may include at the market offerings, debt financings, collaborations, strategic alliances, asset sales, and marketing, distribution or licensing arrangements.
+Added: 2031 Convertible Notes
+Added: In August 2025, we issued $225.0 million aggregate principal amount of our 4.625% Convertible Senior Notes due 2031 (the “2031 Notes”) consisting of (a) $175.3 million principal amount of 2031 Notes issued in exchange for $148.8 million principal amount of our 5.00% Convertible Senior Notes due 2027, and (b) approximately $49.7 million principal amount of 2031 Notes issued for cash, in each case, pursuant to exemptions from registration under the Securities Act and the rules and regulations thereunder.
+Added: The 2031 Notes were issued pursuant to, and are governed by, an indenture, dated as of August 27, 2025, between the Company and The Bank of New York Mellon Trust Company, N.A.
+Added: For additional information on the 2031 Notes, see Note 12 to our consolidated financial statements.
+Added: Credit Agreement
+Added: In February 2026, we entered into the Credit Agreement with MidCap Financial Trust, as administrative agent.
+Added: The Credit Agreement provides for a senior secured term loan facility of up to $330 million, available in four tranches.
+Added: The first tranche of $130 million, of which $50 million was funded at closing, is available to be drawn, subject to customary conditions, through February 2028.
+Added: Borrowings under the Credit Agreement bear interest, payable monthly in arrears, at a rate per annum
+Added: equal to Term SOFR plus 5.00%, subject to a Term SOFR floor of 2.00%.
+Added: The term loans mature in March 2031, at which time all outstanding principal and accrued interest are due and payable in full.
+Added: As of December 31, 2025, we had $750.5 million in cash and cash equivalents, restricted cash and, marketable securities as compared to $938.2 million as of December 31, 2024.
+Added: We funded our operations in 2025 primarily with cash and cash equivalents, milestone payments under the Sanofi CLA, proceeds from the 2031 Notes, and revenue from Product sales.
+Added: In accordance with our ongoing Restructuring Plan, we continue to restructure our global footprint including further reductions in our global workforce and facilitating the disposal of real estate assets in Gaithersburg, Maryland.
+Added: We anticipate our future operations to be funded primarily by milestone payments, royalties, transition services and technology transfer and cost reimbursements under our Sanofi CLA, revenue from Product sales, our cash and cash equivalents and investments in marketable securities, borrowing under the Credit Agreement and other potential funding sources including equity financings, which may include at the market offerings, debt financings, collaborations, strategic alliances, asset sales, and marketing, distribution or licensing arrangements.
The following table summarizes cash flows for 2025 and 2024:
+Added: Year Ended December 31,
Net cash (used in) provided by:
7 unchanged sentences
Cash, cash equivalents, and restricted cash at end of year $ 256,052 $ 545,292 $ (289,240)
−Removed: Net cash used in operating activities was $87.3 million for 2024, as compared to cash used in operating activities of $714.0 million in 2023.
−Removed: The decrease in cash used in operating activities is primarily due to the non-refundable upfront payment under the Sanofi CLA and an overall decrease in operating expenses period-over-period, partially offset by the timing of payments to vendors.
+Added: Net cash used in operating activities was $244.6 million for 2025, as compared to $87.3 million in 2024.
+Added: The increase in cash used in operating activities is primarily due to a reduction in cash received from receivables on APAs and cash received from the Sanofi CLA in 2025 as compared to the same period in 2024, partially offset by an overall decrease in operating expenses period-over-period.
Net cash used in investing activities was $78.3 million for 2025, as compared to $204.0 million in 2024.
−Removed: The increase in cash used in investing activities is primarily due to our investment in marketable securities, partially offset by proceeds on the disposition of Novavax CZ assets of 192.6 million and lower expenditures on equipment and leasehold improvements.
−Removed: Capital expenditures for the years ended December 31, 2024 and 2023 were $13.1 million and $53.8 million, respectively.
+Added: The decrease in cash used in investing activities is primarily due to our lower investment in marketable securities in 2025 as compared to 2024.
Net cash provided by financing activities was $27.7 million for 2025, as compared to $260.6 million in 2024.
−Removed: The increase in cash provided by financing activities is primarily as a result of the 2023 repayment of $325.0 million of our 3.75% Convertible notes in 2023, partially offset by lower proceeds from the sale of shares under our August 2023 Sales Agreement and Sanofi Subscription Agreement, totaling $263.3 million in 2024, as compared with proceeds from the sale of shares under our June 2021 Sales Agreement and August 2023 Sales Agreement and the sale of SK Shares, totaling $360.2 million in 2023.
−Removed: Table o f Contents
+Added: The decrease in cash provided by financing activities is primarily due to a decrease in net proceeds from sales of common stock, partially offset by proceeds from the issuance of our 2031 Notes.
Going Concern
−Removed: The accompanying consolidated financial statements in Part II, Item 8, “Financial Statements and Supplementary Data,” of this Annual Report on Form 10-K have been prepared assuming that we will continue as a going concern within one year after the date that the financial statements are issued and contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business.
−Removed: At December 31, 2024, we had $530.2 million in cash and cash equivalents, $392.9 million in marketable securities, and had negative working capital of $25.5 million.
−Removed: During 2024, we incurred a net loss of $187.5 million and had net cash flows used in operating activities of $87.3 million.
−Removed: In accordance with Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements - Going Concern , we evaluated our ability to continue as a going concern within one year after the date that the accompanying consolidated financial statements are issued.
−Removed: Based on our current cash, cash equivalents and marketable securities balances and our current cash flow forecast for the one-year going concern look forward period, we concluded that we expect to have sufficient capital available to fund our operations for the one-year period from the date that these financial statements are issued.
−Removed: As of December 31, 2023, we had concluded that there was substantial doubt about our ability to continue as a going concern primarily due to significant uncertainty related to our ability to successfully develop, manufacture, distribute, and market our COVID-19 Vaccine and execute on certain cost-reduction initiatives.
−Removed: The Sanofi CLA, combined with proceeds from the disposition of assets held by Novavax CZ, cost reductions and the settlement of certain liabilities, alleviated the substantial doubt.
+Added: We believe that our cash, cash equivalents, and marketable securities as of December 31, 2025, together with cash expected to be generated from product sales and licensing, royalties and other revenue, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of the financial statements included in this Annual Report on Form 10-K.
Contractual Obligations
6 unchanged sentences
Finance leases obligation (1)
+Added: 5,238 2,823 1,932 483 —
Convertible notes payable (2)
5 unchanged sentences
Total contractual obligations $ 338,797 $ 60,009 $ 47,603 $ 6,185 $ 225,000
−Removed: (1) In 2022, we issued $175.3 million of 5.00% convertible senior unsecured notes due in 2027.
+Added: (1) In 2025, we classified our corporate headquarters facility at 700 Quince Orchard, Gaithersburg, Maryland (“700QO”), together with its related finance lease obligation, certain related property and equipment and land parcel adjacent to the facility (collectively referred to as the "Disposal Group"), as held for sale.
+Added: As a result, the assets and liabilities of the Disposal Group were presented separately within Current assets and Current liabilities in our consolidated balance sheet.
+Added: The held‑for‑sale finance lease obligation, totaling $47.9 million, is excluded from our Finance lease obligation in the table above and will be derecognized upon the assignment of the lease agreement, which occurred in January 2026.
+Added: For additional information regarding the Disposal Group, refer to Note 19 to our consolidated financial statements.
+Added: (2) In 2025, we issued $225.0 million aggregate principal amount of our 4.625% Convertible Senior Notes due 2031 (the “2031 Notes”) consisting of (a) $175.3 million principal amount of 2031 Notes issued in exchange for $148.8 million principal amount of our 5.00% Convertible Senior Notes due 2027, and (b) approximately $49.7 million principal amount of 2031 Notes issued for cash, in each case, pursuant to exemptions from registration under the Securities Act and the rules and regulations thereunder.
+Added: For additional information on the 2031 Notes, see Note 12 to our consolidated financial statements.
(3) Purchase commitments primarily represent our non-cancelable fixed payment obligations under certain CMO, CDMO, and laboratory supply agreements that we are not contractually able to terminate for convenience.
8 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.