NOVAVAX INC

Previous wording

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements in the discussion below and elsewhere in this Quarterly Report about expectations, beliefs, plans, objectives, assumptions, or future events or performance of Novavax, Inc. (“Novavax,” together with its wholly owned subsidiaries, the “Company,” “we,” or “us”) are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements about our capabilities, goals, expectations regarding future revenue and expense levels, and capital raising activities; our strategic priorities, our corporate growth strategy, including our early-stage pipeline and research and development (“R&D”) investment strategy and key value drivers; our technology platform; our COVID-19 program (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 (“NVX-CoV2601”) 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”; our operating plans and prospects, including our ability to continue as a going concern through one year from the date of our unaudited financial statements for the period ended September 30, 2025 are issued; the implementation and anticipated impact of our global restructuring and cost reduction plan (“Restructuring Plan”), which includes a more focused investment in our COVID-19 Program; our cash flow forecast and projected revenue, including potential royalties and milestones pursuant to our collaboration and license agreement (the “Sanofi CLA”) with Sanofi Pasteur Inc. (“Sanofi”) and our other license agreements; potential market sizes and demand for our products and product candidates; the efficacy, safety, and intended utilization of our products and product candidates; the development of our clinical-stage product candidates and our recombinant vaccine and adjuvant technologies; the development of our preclinical product candidates; our expectations related to enrollment in our clinical trials; the conduct, timing, and potential results from clinical trials and other preclinical studies; plans for and potential timing of future and pending regulatory filings and actions; our ability to successfully conduct our postmarketing commitment (“PMC”) study requested by the U.S. Food and Drug Administration (“U.S. FDA”) following the U.S. FDA’s approval of the…

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Current wording

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements in the discussion below and elsewhere in this Quarterly Report about expectations, beliefs, plans, objectives, assumptions, or future events or performance of Novavax, Inc. (“Novavax,” together with its wholly owned subsidiaries, the “Company,” “we,” or “us”) are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements about our capabilities, goals, expectations regarding future revenue and expense levels, and capital raising activities; our corporate growth strategy and key value drivers; our technology platform; 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 the next 12 months from the issuance of the financial statements included in this Quarterly Report on Form 10-Q; our global restructuring and cost reduction plan (“Restructuring Plan”), which includes a more focused investment in our COVID-19 Vaccine; our cash flow forecast and projected revenue, including potential royalties and milestones pursuant to the Sanofi CLA (as defined below) and Pfizer License Agreement (as defined below); potential market sizes and demand for our products and product candidates; the efficacy, safety, and intended utilization of our products and product candidates; the development of our clinical-stage product candidates and our recombinant vaccine and adjuvant technologies; the development of our preclinical product candidates; our research and development investment strategy; the potential expansion of our pipeline beyond infectious diseases into other therapeutic areas; our expectations related to enrollment in our clinical trials; the conduct, timing, and potential results from clinical trials and other preclinical studies; plans for and potential timing of regulatory filings; our expectation of manufacturing capacity, timing, production, distribution, and delivery for our COVID-19 Vaccine by us and our partners; our expectations with respect to the anticipated ongoing development and commercialization or licensure of the COVID-19 Vaccine; our expectations with respect to the anticipated ongoing development of COVID-19 variant strain-containing formulations, including the Phase 2b/3 Hummingbird™ trial, our CIC vaccine candidate and our stand-alone influenza vaccine candidate; our partnership efforts for our COVID-19-In…

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Previous wording

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, our ability to successfully and timely obtain and maintain full U.S. FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver our COVID-19 Vaccine; 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; challenges in conducting the 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; 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; manufacturing, distribution or export delays or challenges; our substantial dependence on Serum Institute of India Pvt. Ltd. (“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; 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; uncertainty with respect to pricing, third-party reimbursement and healthcare reform; uncertainty in the regulatory pathway for our COVID -19 Vaccine; 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; resource constraints, including human capital and manufacturing capacity, constrain…

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Current wording

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, our ability to successfully and timely obtain and maintain full U.S. FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver our COVID-19 Vaccine; 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; 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; 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; manufacturing, distribution or export delays or challenges; our substantial dependence on Serum Institute of India Pvt. Ltd. (“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; 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; uncertainty with respect to pricing, third-party reimbursement and healthcare reform; uncertainty in the regulatory pathway for our COVID -19 Vaccine; 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; resource constraints, including human capital and manu…

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Previous wording

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. Our proprietary Matrix-M adjuvant, when added to vaccines, has been shown to help induce a strong and long-lasting immune response. Our recombinant protein-based nanoparticle technology has been shown to be highly immunogenetic. Together, we believe that our technology platform can induce potent, durable and broad immune responses, with the potential to be antigen-sparing. Our Matrix-M adjuvant can increase both antibody and cell-mediated immune responses in vaccines and it has demonstrated a favorable tolerability profile in clinical trials. Our technology platform is used in our authorized COVID-19 Vaccine and the R21/Matrix-M adjuvant malaria vaccine.

Current wording

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 near- and long-term value. Our proprietary Matrix-M™ adjuvant, when added to vaccines, has been shown to help induce a strong and long-lasting immune response. Our recombinant protein-based nanoparticle technology has been shown to be highly immunogenic. When combined, we believe that our technology platform can induce potent, durable and broad immune responses, with the potential to be antigen-sparing. Our Matrix-M™ adjuvant can increase both antibody and cell-mediated immune responses to a vaccine and it has demonstrated a favorable tolerability profile in clinical trials. Our technology platform is used in our COVID-19 Vaccine and the R21/Matrix-M™ malaria vaccine.

Previous wording

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.

Current wording

Additionally, we are advancing our early-stage pipeline with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale, and strong commercial opportunity and R&D to expand the utility of our Matrix technology platform.

Previous wording

Furthermore, we provide our Matrix-M adjuvant for use in collaborations. These include the R21/Matrix-M adjuvant malaria vaccine, a malaria vaccine developed by our partner, the Jenner Institute, University of Oxford (“R21/Matrix-M adjuvant malaria vaccine”) and manufactured by SII. R21/Matrix-M adjuvant malaria vaccine is authorized in several countries. Additionally, we provide Matrix-M adjuvant for use in various programs in preclinical and clinical stage, as well as preclinical investigations. Examples include, an agreement with the Gates Foundation, two material transfer agreements with leading pharmaceutical companies for exploration of Matrix-M adjuvant used as a potential advancement in their pipeline, and a third material transfer agreement to explore Matrix M in a pre-clinical collaboration in oncology.

Current wording

Furthermore, we provide our Matrix-M™ adjuvant for use in collaborations. These include the R21/Matrix-M™ malaria vaccine, a malaria vaccine developed by our partners, SII and the Jenner Institute, University of Oxford (“R21/Matrix-M™ malaria vaccine”). Additionally, we provide Matrix-M™ adjuvant for use in various programs in preclinical and clinical stage, as well as preclinical investigations. Matrix-M™ adjuvant is being explored under our Collaboration and License Agreement Sanofi Pasteur Inc. (“Sanofi”) (“Sanofi CLA”) and our License and Option Agreement with Pfizer Inc. (“Pfizer”) (“Pfizer License Agreement”), as well as under multiple material transfer agreements with both global pharmaceutical companies and biotechs for exploration of Matrix-M™ adjuvant used as a potential advancement in their pipelines, including preclinical collaborations in oncology.

Previous wording

We believe our recombinant nanoparticle vaccine technology and our proprietary Matrix-M adjuvant are well suited for the development and commercialization of vaccine candidates targeting areas both within and beyond the infectious disease space.

Current wording

We believe our recombinant nanoparticle vaccine technology and our proprietary Matrix-M™ adjuvant are well suited for the development and commercialization of vaccine candidates targeting areas both within and beyond the infectious disease space, including in hard-to-treat infectious diseases and oncology.

Previous wording

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. The differentiated platform features our recombinant protein-based nanoparticle technology and unique Matrix-M adjuvant. Our three strategic priorities are: focusing on our partnership with Sanofi announced in May 2024, enhancing existing partnership and leveraging our technology platform and pipeline to forge additional partnerships, and advancing our proven technology platform and early-stage pipeline. Our corporate growth strategy is supported by a lean, agile, and focused operating model.

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Recombinant Protein-Based Nanoparticle Vaccine Technology

Previous wording

Once a target of interest has been identified, the genetic sequence encoding an antigen is selected for developing the vaccine construct. The genetic sequence may be optimized to enhance protein stability or confer resistance to degradation. This genetic construct is inserted into the baculovirus Spodoptera frugiperda (“Sf-/BV”) insect cell-expression system, which enables efficient, large-scale expression of the optimized protein. The Sf-/BV system produces protein-based antigens that are properly folded and modified, which can be critical for functional, protective immunity. Our testing shows this results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M adjuvant.

Current wording

Once a target of interest has been identified, the genetic sequence encoding an antigen is selected for developing the vaccine construct. The genetic sequence may be optimized to enhance protein stability or confer resistance to degradation. This genetic construct is generally inserted into the baculovirus Spodoptera frugiperda (“Sf-/BV”) insect cell-expression system, which enables efficient, large-scale expression of the optimized protein. The Sf-/BV system produces protein-based antigens that are properly folded and modified, which can be critical for functional, protective immunity. Our testing shows this results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M™ adjuvant.

Previous wording

Our proprietary Matrix-M adjuvant is a key differentiator within our platform. This adjuvant has enabled potent, well tolerated, and durable efficacy by stimulating the entry of antigen presenting cells (“APCs”) into the injection site and enhancing antigen presentation in local lymph nodes. This in turn activates APCs, T-cell and B-cell populations, and plasma cells, which promote the production of high affinity antibodies, an immune boosting response. This potent mechanism of action enables a lower dose of antigen to achieve the desired immune response, thereby contributing to increased vaccine supply and manufacturing capacity. These immune-boosting and dose-sparing capabilities contribute to the adjuvant’s highly unique profile.

Current wording

Our proprietary Matrix-M™ adjuvant is another key differentiator within our platform. This adjuvant has enabled potent, well tolerated, and durable efficacy by stimulating the entry of antigen presenting cells (“APCs”) into the injection site and enhancing antigen presentation in local lymph nodes with an acceptable safety and tolerability profile. This in turn activates APCs, T-cell and B-cell populations, and plasma cells, which promote the production of high affinity antibodies, an immune boosting response. This potent mechanism of action enables a lower dose of antigen to achieve the desired immune response, thereby contributing to increased vaccine supply and manufacturing capacity. These immune-boosting and dose-sparing capabilities contribute to the adjuvant’s highly unique profile.

Previous wording

In August 2025, the U.S. FDA approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Current wording

In August 2025, the U.S. FDA approved the JN.1 COVID-19 Vaccine for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

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Our pipeline encompasses vaccine candidates for infectious diseases. Our COVID-19 Vaccine, partnered with Sanofi, is our most advanced product. In 2025 and continuing during the term of the Sanofi CLA, Sanofi will lead commercialization efforts for our COVID-19 Vaccine. Our COVID-19 Vaccine has received authorizations from the U.S. FDA, the European Commission (“EC”), the World Health Organization (“WHO”) and several other countries for both adult and adolescent populations. Beyond our COVID-19 Vaccine, our late-stage pipeline includes a CIC vaccine candidate, and our stand-alone influenza vaccine candidate.

Current wording

In 2025 and continuing during the term of the Sanofi CLA, Sanofi will lead commercialization efforts for our COVID-19 Vaccine (Nuvaxovid™). Our COVID-19 Vaccine has received authorizations from the U.S. FDA, the European Commission, and several other countries for both adult and adolescent populations.

Previous wording

We are advancing our pipeline of 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. Development and advancement of our in-house pipeline leverages our core expertise and our experience in respiratory and infectious diseases and vaccines, and we intend to explore new opportunities with the potential to expand beyond infectious diseases. Our partnered pipeline includes our COVID-19 Vaccine and our Matrix-M adjuvant used in collaboration for development of new and existing vaccines.

Current wording

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. Development and advancement of our in-house pipeline leverages our core expertise and our experience in respiratory and infectious diseases and vaccines, and we intend to explore new opportunities with the potential to expand beyond infectious diseases.

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In addition to our own pipeline, we have several partnership opportunities. For example, our Matrix-M adjuvant is being used for collaboration in R21/Matrix-M adjuvant malaria vaccine.

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In addition to our own pipeline programs, we have several ongoing partnerships.

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Under our agreement, we have also provided a sole license to Sanofi for the independent development of a COVID-19 and influenza combination product using our COVID-19 Vaccine in combination with two of Sanofi’s separately marketed influenza vaccines, Fluzone High-Dose and Flublok, to evaluate immunogenicity and safety in Phase 1/2 combination vaccine trials. These two combination vaccine candidates were granted Fast Track designation by the U.S. FDA in December 2024 to prevent influenza and COVID-19 infections in individuals aged 50 and older. In October 2025, Sanofi reported preliminary positive immunogenicity and safety Phase 1/2 data for Nuvaxovid in combination with both Fluzone High-Dose and Flublok. Sanofi also has a non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines, and a non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M adjuvant.

Current wording

Under our Sanofi CLA, we have provided a sole license to Sanofi for the independent development of a COVID-19 and influenza combination product using our COVID-19 Vaccine in combination with two of Sanofi’s separately marketed influenza vaccines, Fluzone High-Dose and Flublok. These two combination vaccine candidates were granted Fast Track designation by the U.S. FDA in December 2024 to prevent influenza and COVID-19 infections in individuals aged 50 and older. In October 2025, Sanofi reported positive Phase 1/2 results with their combination vaccine candidates and will engage with regulatory authorities on next steps. Sanofi also has a non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines, and a non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M™ adjuvant.

Previous wording

In September 2025, we amended the Sanofi CLA to expand Sanofi's license to include use of Novavax's Matrix-M adjuvant in Sanofi's pandemic influenza vaccine candidate program. Sanofi recently received funding from the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response, part of the U.S. Department of Health and Human Services, for early-stage work on this vaccine candidate including the Matrix-M adjuvant.

Current wording

In September 2025, we amended the Sanofi CLA to expand Sanofi's license to include use of Novavax's Matrix-M™ adjuvant in Sanofi's pandemic influenza vaccine candidate program. Sanofi received funding from the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response, part of the U.S. Department of Health and Human Services, for early-stage work on this vaccine candidate including the Matrix-M™ adjuvant.

Previous wording

In May 2025, we announced that the U.S. FDA, as a part of its BLA approval, requested a PMC to conduct a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. The Company will be responsible to conduct the PMC trial, which was initiated in the fourth quarter of 2025. Sanofi will reimburse the Company for 70% of the PMC costs, capped at the currently agreed upon cost estimates. The Company will recognize cost reimbursements from Sanofi related to the PMC in Licensing, royalties, and other revenue over time using an input method, consistent with research and development transition services that support further regulatory approval and development of the COVID-19 Vaccine (“Sanofi Transition Services”) and services related to the technology transfer of the existing manufacturing process for the COVID-19 Vaccine Products and Matrix-M™ adjuvant (the “Sanofi Technology Transfer”).

Current wording

In May 2025, we announced that the U.S. FDA, as a part of its BLA approval of Nuvaxovid™, requested that we conduct as one of our postmarketing commitments (“PMCs”) a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. Although the BLA has since been transferred to Sanofi, we are currently conducting the PMC trial on behalf of Sanofi which will reimburse us for 70% of the PMC costs, capped at the currently agreed upon cost estimates. We updated our total expected costs and the amounts of variable consideration for research and development transition services that support further regulatory approval and development of the COVID-19 Vaccine (“Sanofi Transition Services”) for costs and reimbursements from the PMC. Revenue related to the PMC will be recognized in Licensing, royalties, and other revenue over time using an input method, consistent with Sanofi Transition Services.

Previous wording

In October 2025, we initiated an additional study, Study 318, as a post-marketing commitment for the U.S. FDA. The study is evaluating the safety and immunogenicity of the JN.1 vaccine in the US-approved population of individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID‑19 and in adults ≥ 65 years of age.

Current wording

In addition, in October 2025, we initiated an additional PMC study evaluating the safety and immunogenicity of Nuvaxovid™ in the population of individuals for which Nuvaxovid™ is approved in the U.S., i.e., individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID‑19 and in adults ≥ 65 years of age. Following the transfer of the U.S. marketing authorization, Sanofi is now responsible for the conduct of this study.

Previous wording

In December 2024, we initiated a Phase 3 immunogenicity and safety trial for our CIC and stand-alone influenza vaccine candidates to evaluate the immunogenicity and safety compared to our updated COVID-19 Vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older. Our Phase 3 immunogenicity and safety trial completed enrollment with an initial cohort of approximately 2,000 participants. In June 2025, we reported data from this initial cohort, which showed both vaccine candidates induced robust immune responses across all antigens tested. Both vaccine candidates were well tolerated with reactogenicity profiles that were comparable to authorized comparators. After consultation with the U.S. FDA, we determined that seeking an accelerated approval pathway for our CIC and stand-alone influenza candidates would not be feasible. While the Phase 3 immunogenicity and safety trial is not a pivotal study, the data will inform a future registrational Phase 3 program. We do not intend to make additional investments in these programs and are seeking a partner to advance both vaccine candidates.

Current wording

In December 2024, we initiated a Phase 3 immunogenicity and safety trial for our CIC and stand-alone influenza vaccine candidates to evaluate the immunogenicity and safety compared to our COVID-19 Vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older. Our Phase 3 immunogenicity and safety trial completed enrollment with an initial cohort of approximately 2,000 participants. In June 2025, we reported data from this initial cohort, which showed both vaccine candidates induced robust immune responses across all antigens tested. Both vaccine candidates were well tolerated with reactogenicity profiles that were comparable to authorized comparators. After consultation with the U.S. FDA, we determined that seeking an accelerated approval pathway for our CIC and stand-alone influenza candidates would not be feasible. While the Phase 3 immunogenicity and safety trial is not a pivotal study, the data will inform a future registrational Phase 3 program. We do not intend to make additional investments in these programs and are seeking a partner to advance both vaccine candidates.

Previous wording

R21/Matrix-M adjuvant malaria vaccine, formulated with our Matrix-M adjuvant, is developed by our partner, the Jenner Institute, University of Oxford, and manufactured by SII. We have an agreement with SII related to its manufacture of R21/Matrix-M adjuvant malaria vaccine under which SII purchases our Matrix-M adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single- to low-double digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.

Current wording

R21/Matrix-M™ malaria vaccine, formulated with our Matrix-M™ adjuvant is developed by our partners, SII and the Jenner Institute, University of Oxford. We have an agreement with SII related to its manufacture of R21/Matrix-M™ malaria vaccine under which SII purchases our Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single- to low-double digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.

Previous wording

In July 2024, first commercial doses of R21/Matrix-M adjuvant malaria vaccine have been administered to children in Cote d’Ivoire and South Sudan. As part of the WHO malaria program, at their discretion, the vaccine is expected to be included in countries such as Central African Republic, Chad, Democratic Republic of Congo, Mozambique, Nigeria and Uganda.

Current wording

In July 2024, first commercial doses of R21/Matrix-M™ malaria vaccine were administered to children in Cote d’Ivoire and South Sudan. As of May 2026, over 30 million doses of R21/Matrix-M™ malaria vaccine have been distributed and are available in 25 countries.

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COVID-19 Vaccine Regulatory and Licensure

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R21/Matrix-M™ Malaria Vaccine Regulatory and Licensure

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In December 2023, the WHO announced it prequalified the R21/Matrix-M adjuvant malaria vaccine to prevent malaria disease in children caused by the P. falciparum parasite in endemic areas. Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and enabled rollout of the vaccine in mid-2024. The WHO recommended that the R21/Matrix-M adjuvant malaria vaccine be administered in a four-dose schedule beginning at five months of age.

Current wording

In December 2023, the WHO announced it prequalified the R21/Matrix-M™ malaria vaccine to prevent malaria disease in children caused by the P. falciparum parasite in endemic areas. Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and enabled rollout of the vaccine in mid-2024. The WHO recommended that the R21/Matrix-M™ malaria vaccine be administered in a four-dose schedule beginning at five months of age.

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Third Quarter 2025 and Recent Highlights

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First Quarter 2026 and Recent Highlights

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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 three and nine months ended September 30, 2025, no sales were recorded under the August 2023 Sales Agreement. During the nine months ended September 30, 2024, we sold 12.2 million shares of our common stock under the August 2023 Sales Agreement, resulting in net proceeds of approximately $188 million. There were no sales recorded under the August 2023 Sales Agreement during the three months ended September 30, 2024. As of September 30, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $51 million.

Current wording

In August 2023, we entered into an At Market Issuance Sales Agreement (the “August 2023 Sales Agreement”), which allowed us to issue and sell up to $500 million in gross proceeds of shares of our common stock pursuant to a registration statement on Form S-3 (the “Shelf Registration Statement”), and terminated our then-existing At Market Issuance Sales Agreement entered in June 2021. No sales were recorded under the August 2023 Sales Agreement during the three months ended March 31, 2026, and 2025. The Shelf Registration Statement expired in February 2026, and no future sales will be made under the August 2023 Sales Agreement.

Previous wording

Revenue for the nine months ended September 30, 2025 was $976.3 million as compared to $593.9 million for the same period in 2024, an increase of $382.5 million. Revenue for the nine months ended September 30, 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, 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. Revenue for the nine months ended September 30, 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. 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.

Current wording

Revenue for the three months ended March 31, 2026 was $139.5 million as compared to $666.7 million for the same period in 2025, a decrease of $527.1 million. Revenue for the three months ended March 31, 2026 was primarily comprised of commercial product sales of COVID-19 Vaccine and adjuvant sales; licensing revenue under the Pfizer License Agreement; revenue from transition services and technology transfer under the Sanofi CLA; and royalty revenue with Sanofi and Serum. Revenue for the three months ended March 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, and the recognition of previously deferred upfront payments and revenue from transition services and technology transfer under the Sanofi CLA.

Previous wording

Product sales for the three months ended September 30, 2025 were $13.4 million as compared to $41.5 million for the same period in 2024, a decrease of $28.1 million. Our Product sales related to revenue from Nuvaxovid sales, which commenced in 2022, commercial supply sales of COVID-19 Vaccine, and revenue from supply of adjuvant and other products. We have transitioned the commercial lead for sales and distribution to Sanofi resulting in a decrease in Nuvaxovid sales and an increase in supply sales.

Current wording

Product sales for the three months ended March 31, 2026 were $42.2 million as compared to $621.7 million for the same period in 2025, a decrease of $579.5 million. Our Product sales related to revenue from Nuvaxovid TM sales, which commenced in 2022, commercial supply sales of COVID-19 Vaccine, and revenue from supply of adjuvant and other materials.

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(1) Nuvaxovid sales are sales of our COVID-19 Vaccine associated with APAs with various governments globally and commercial markets, where we are the commercial lead for sales and distribution, made through pharmaceutical wholesale distributors.

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(1)Nuvaxovid TM 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.

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(2)Supply sales include commercial sales of COVID-19 Vaccine, adjuvant sales, and sale of other materials to our partners. We reclassified $3.3 million of revenue previously reported as License, royalties, and other revenue to Product sales revenue for the three months ended September 30, 2024 related to adjuvant supply sales and other supply sales.

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(2)Supply sales include commercial sales of COVID-19 Vaccine, adjuvant sales, and other material sales to our partners.

Previous wording

Licensing, royalties, and other revenue during the three months ended September 30, 2025 was $57.0 million as compared to $43.0 million during the same period in 2024, an increase of $14.0 million. The increase was primarily due to an increase in revenue from transition services and technology transfer in licensing revenue under the Sanofi CLA resulting from continued progress on the Transition Services and Technology Transfer, as well as the impact of changes in total costs and consideration estimates.

Current wording

Licensing, royalties, and other revenue during the three months ended March 31, 2026 was $97.3 million as compared to $45.0 million during the same period in 2025, an increase of $52.3 million. The increase was primarily due to recognition of the upfront payment under the Pfizer License Agreement.

Previous wording

(1)Other partners revenue includes royalties and license fees associated with agreements with other partners such as Serum and SK bioscience, Co., Ltd.

Current wording

(1)Other partners revenue includes royalties, license fees, and other revenue associated with agreements with other partners such as Takeda and SK bioscience, Co., Ltd.

Previous wording

(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. During the three months ended September 30, 2025, recognized a change in estimate to cumulative revenue recognized for the Sanofi Transition Services performance obligation of $12.5 million as further described in Note 6, which also resulted in a reduction in upfront fee and milestone amortization revenue during the third quarter of 2025, and an increase in cost reimbursement revenue.

Current wording

(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. During the three months ended March 31, 2026, we recognized a change in estimate to cumulative revenue recognized for the Sanofi Transition Services performance obligation of $6.1 million as a result of changes in total expected costs and changes to estimates of variable consideration from expected cost reimbursements.

Previous wording

Cost of sales was $21.5 million for the three months ended September 30, 2025, including expenses of $0.5 million related to excess, obsolete, or expired inventory, $1.8 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, and $3.5 million related to unutilized manufacturing capacity. Cost of sales was $60.6 million for the three months ended September 30, 2024, including expense of $6.2 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, $18.2 million related to unutilized manufacturing capacity, and a credit of $0.7 million related to certain negotiated reductions to previously recognized firm purchase commitments. The decrease in cost of sales of $39.1 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. 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.

Current wording

Cost of sales was $30.7 million for the three months ended March 31, 2026, including expenses of $4.2 million related to losses on firm purchase commitments and $1.4 million related to unutilized manufacturing capacity. Cost of sales was $14.1 million for the three months ended March 31, 2025, including expenses of $0.3 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments and $1.8 million related to unutilized manufacturing capacity. The increase in cost of sales of $16.6 million was mainly driven by an increase in supply sales of COVID-19 Vaccine, adjuvant sales, and other material sales to our partners. 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.

Previous wording

Research and development expenses were $98.3 million for the three months ended September 30, 2025 as compared to $87.2 million for the three months ended September 30, 2024, a increase of $11.1 million. The increase was primarily due to an increase in in overall expenditures relating to development activities on coronavirus vaccines, including our COVID-19

Current wording

Research and development expenses were $95.5 million for the three months ended March 31, 2026 as compared to $88.9 million for the three months ended March 31, 2025, a increase of $6.5 million. The increase was primarily due to additional transition services performed under the Sanofi CLA, partially offset by cost containment measures to reduce our operating spend, as summarized in the table below:

Previous wording

Selling, general, and administrative expenses were $31.7 million for the three months ended September 30, 2025 as compared to $70.7 million for the same period in 2024, a decrease of $39.1 million. 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.

Current wording

Selling, general, and administrative expenses were $28.8 million for the three months ended March 31, 2026 as compared to $48.1 million for the same period in 2025, a decrease of $19.3 million. 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.

Previous wording

During the three months ended September 30, 2025, we recognized an income tax benefit of $0.7 million related to federal, state, and foreign income taxes, and foreign withholding tax expense. During the three months ended September 30, 2024, we recognized an income tax benefit of $1.0 million related to federal, state, and foreign income taxes, and foreign withholding taxes.

Current wording

During the three months ended March 31, 2026, we recognized income tax expense of $1.0 million related to foreign income taxes and foreign withholding tax expense. During the three months ended March 31, 2025, we recognized income tax expense of $1.2 million related to federal, state, and foreign income taxes, and foreign withholding taxes.

Previous wording

Net income (loss) for the nine months ended September 30, 2025 was net income of $422.8 million, or $2.61 per share, basic and $2.53 per share, dilutive, as compared to net loss of $106.5 million, or $(0.71) per share, basic and dilutive, for the same period in 2024. The increase in net income during the nine months ended September 30, 2025, was primarily due to an increase in total revenue and a decrease in total expenses.

Current wording

Net loss for the three months ended March 31, 2026 was $9.5 million, or $0.06 per share, basic and dilutive, as compared to net income of $518.6 million, or $3.22 per share, basic and $2.93 per share, dilutive, for the same period in 2025. The increase in net loss during the three months ended March 31, 2026, was primarily due to a decrease in total revenue.

Previous wording

The increase in weighted average shares outstanding for the three months ended September 30, 2025, was primarily a result of sales of our common stock in 2024 and common stock issued under our incentive programs.

Current wording

The increase in weighted average shares outstanding for the three months ended March 31, 2026, was primarily a result of common stock issued under our incentive programs.

Previous wording

Our future capital requirements depend on numerous factors including, but not limited to, revenue from our Product sales, milestone payments, royalties, and reimbursements under licensing arrangements with our strategic partners; our projected activities related to the development and commercial support of our COVID-19 Vaccine and our CIC and stand-alone influenza vaccine candidates, including significant commitments under various clinical research organizations, CMO, and CDMO agreements; the progress of preclinical studies and clinical trials; 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. We plan to continue developing other vaccines and product candidates, such as our potential combination vaccine candidates, which are in various stages of development. 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. Additionally, our plans include our ongoing restructuring and cost reduction measures as a part of our Restructuring Plan (see Note 16 to our accompanying unaudited 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.

Current wording

Our future capital requirements depend on numerous factors including, but not limited to, revenue from our Product sales, milestone payments, royalties, and reimbursements under licensing arrangements with our strategic partners; our projected activities related to the development and commercial support of our COVID-19 Vaccine and our CIC and stand-alone influenza vaccine candidates, including significant commitments under various contract research organization, contract manufacturing organization and contract development and manufacturing organization agreements; the progress of preclinical studies and clinical trials; 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. We plan to continue developing other vaccines and product candidates, such as our potential combination vaccine candidates, which are in various stages of development. 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. Additionally, our plans include our ongoing restructuring and cost reduction measures as a part of our Restructuring Plan (see Note 16 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, and results of operations.

Previous wording

In May 2024, we entered into the Sanofi CLA pursuant to which we received a non-refundable upfront payment of $500 million. During the nine months ended September 30, 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. FDA. As of September 30, 2025, we are eligible to receive additional development, technology transfer, launch, and sales milestone payments totaling up to $475 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products. 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.

Current wording

In May 2024, we entered into the Sanofi CLA pursuant to which we received a non-refundable upfront payment of $500 million. As of March 31, 2026, we are eligible to receive additional development, technology transfer, launch, and sales milestone payments totaling up to $425 million and royalty payments on Sanofi’s sales of such licensed products. 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.

Previous wording

On April 29, 2025, we entered into the Amended Takeda CLA which amends and supersedes the Original Takeda CLA.

Current wording

In April 2025, we entered into the Amended Takeda CLA which amends and supersedes the Original Takeda CLA.