What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-06 compared with 2025-11-06 · 222 added, 405 removed, 198 unchanged (76% of the section changed)

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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 corporate growth 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;

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;

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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 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 Biologics License Application ("BLA”) for our COVID-19 Vaccine;

our expectation of manufacturing capacity, timing, production, distribution, and delivery for our COVID-19 Vaccine by us and our partners, including our anticipated timing of the U.S.

FDA’s approval of our BLA supplement to extend the shelf life of our COVID-19 vaccine;

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 monovalent or bivalent formulations, including the Phase 2b/3 Hummingbird™ trial, and our COVID-19-Influenza (“CIC”) vaccine candidate and our stand-alone influenza vaccine candidate including partnership efforts for our CIC vaccine candidate and stand-alone influenza vaccine candidate to advance towards a BLA filing and commercialization;

efforts to expand the COVID-19 Vaccine label worldwide as a booster, and to various age groups and geographic locations;

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-Influenza (“CIC”) vaccine candidate and stand-alone influenza vaccine candidate to advance towards a Biologics License Application (“BLA”) filing and commercialization;

efforts to expand our COVID-19 Vaccine label worldwide as a booster, and to various age groups and geographic locations;

the expected timing, content, and outcomes of regulatory actions;

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plans regarding partnering activities and business development initiatives;

our plans regarding APA amendments;

plans regarding APA amendments;

and other matters referenced herein.

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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 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 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;

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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;

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;

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;

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challenges in identifying and successfully pursuing innovation expansion opportunities;

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 our Annual Report on Form 10-K for the year ended December 31, 2024, and this Quarterly Report on Form 10-Q, which may be detailed and modified or updated in other documents filed with the Securities and Exchange Commission (“SEC”) from time to time, and are available at www.sec.gov and at www.novavax.com.

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 our Annual Report on Form 10-K for the year ended December 31, 2025, and this Quarterly Report on Form 10-Q, which may be detailed and modified or updated in other documents filed with the Securities and Exchange Commission (“SEC”) from time to time, and are available at www.sec.gov and at www.novavax.com.

You are encouraged to read these filings as they are made.

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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.

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.

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.

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.

Our growth strategy focuses on maximizing the impact of our cutting-edge technology by forging strategic partnerships for our Matrix-M™ adjuvant and research and development (“R&D”) assets.

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 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.

In May 2024, we entered into a CLA with Sanofi, to co-commercialize our COVID-19 Vaccine, including future updated versions that address seasonal COVID-19 variants.

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.

In December 2024, Sanofi announced that the U.S.

FDA granted Fast Track designation to two Sanofi combination vaccine candidates:

the first combination consists of Fluzone High-Dose TM combined with our COVID-19 Vaccine, and the second combination consists of Flublok TM with our COVID-19 Vaccine.

Sanofi is evaluating the safety and immunogenicity of both combination vaccine candidates in two separate Phase 1/2 trials.

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.

We discuss this agreement in further detail in Note 6 to our accompanying unaudited consolidated financial statements.

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.

Our late-stage programs include a CIC vaccine candidate, as well as a stand-alone influenza vaccine candidate.

In June 2025, we reported data from 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, which showed both vaccine candidates induced robust immune responses across all antigens tested.

Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators.

We intend to partner these vaccine candidates to advance further development.

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.

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.

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.

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.

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.

We continue to advance our early-stage pipeline.

We intend to develop our early-stage pipeline using a disciplined and capital-efficient approach.

We would consider advancing a program ourselves where data and commercial landscape indicate a unique high-value opportunity.

We are pursuing early-stage research in diseases such as, respiratory syncytial virus (“RSV”) combinations, varicella-zoster virus (“Shingles”) and Clostridioides difficile (“C.

Diff.”) colitis.

We are actively working to evaluate several RSV combination candidates to progress forward toward an Investigational New Drug (“IND”).

We are actively developing a pandemic influenza vaccine candidate and the toxicology study is underway.

We are pursuing funding opportunities to join preparedness options.

Additionally, we are evaluating potential expansion beyond infectious diseases, where we believe our technology could augment and improve upon current therapies.

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.

We were incorporated in 1987 under the laws of the State of Delaware.

Our principal executive offices are located at 21 Firstfield Road, Gaithersburg, Maryland, 20878, and our telephone number is (240) 268-2000.

Our common stock is listed on the Nasdaq Global Select Market under the symbol “NVAX.”

Technology Overview

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.

Recombinant Nanoparticle Vaccine Technology

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.

Recombinant Protein-Based Nanoparticle Vaccine Technology

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.

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.

Matrix-M Adjuvant ®

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.

Matrix-M TM Adjuvant

Our proprietary Matrix-M™ adjuvant is another key differentiator within our platform.

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.

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These immune-boosting and dose-sparing capabilities contribute to the adjuvant’s highly unique profile.

We continue to evaluate commercial opportunities for the use of our Matrix-M adjuvant alongside vaccine antigens produced by other manufacturers.

Matrix-M adjuvant is being evaluated in combination with several partner-led malaria vaccine candidates, including for R21/Matrix-M adjuvant malaria vaccine.

The R21/Matrix-M adjuvant malaria vaccine has been licensed to SII for commercialization.

We continue to evaluate partnership opportunities for use of our Matrix-M™ adjuvant in other manufacturers’ pipelines.

We currently have multiple partnerships and material transfer agreements in place for Matrix-M™ adjuvant.

In May 2024, pursuant to the Sanofi CLA, Sanofi received a non-exclusive license to develop and commercialize other vaccine products that include our Matrix-M™ adjuvant.

In September 2024, we signed a Matrix-M adjuvant related agreement with a leading pharmaceutical company to enable exploration of our technology for the potential advancement of their pipeline candidates.

In the first quarter of 2025, we signed two additional material transfer agreements to explore the use of Matrix-M adjuvant.

COVID-19 Vaccine Regulatory and Licensure

In 2025, we signed three material transfer agreements with other pharmaceutical companies to explore the use of our Matrix-M™ adjuvant for the potential advancement of their pipeline candidates, with the latest material transfer agreement signed in the fourth quarter of 2025.

In January 2026, we entered into the Pfizer License Agreement for use of Matrix-M™ adjuvant in up to two infectious disease areas.

In April 2026, we signed a new material transfer agreement (MTA) with a top 10 leading pharmaceutical company and leader in oncology to explore Matrix-M™ in multiple oncology targets, as well as antibiotic resistant bacterial infections and other infectious diseases.

Also in April, we signed a new MTA with an existing pharmaceutical partner for evaluation of Matrix-M™ in up to nine additional identified infectious disease areas.

In February, Novavax expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an innovative oncology company.

In total, Novavax now has MTA collaborations and/or license agreements partnerships with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the rights to explore Matrix-M™ in over 30 unique fields of experimentation across both infectious diseases and oncology.

Commercial Products

In May 2025, the U.S.

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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.

Product Pipeline

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.

Pipeline Overview

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.

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.

In October and November 2025, respectively, we announced that we completed the transfer of the Nuvaxovid™ BLA and the European Medicines Agency approval to Sanofi, who remains responsible for further development and commercialization of this product.

Commercial Products and Product Pipeline

The graphic represents all disclosed partnerships.

In total, we now have MTA collaborations and/or license agreements providing access to explore Matrix-M™ in over 30 unique fields of experimentation across both infectious diseases and oncology.

Commercial Products

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 (“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.

Additionally, we intend to develop our early-stage pipeline using a disciplined and capital-efficient approach.

We would consider advancing a program ourselves where data and commercial landscape indicate a unique high-value opportunity.

We are actively developing a pandemic influenza vaccine candidate and pursuing funding opportunities to join preparedness options.

We are conducting early-stage research in diseases such as, RSV combinations, Shingles and C.

Lastly, we are evaluating potential expansion beyond infectious diseases, where we believe our technology has the potential to augment and improve upon current therapies.

In the first quarter of 2025, we entered into a preclinical collaboration with a partner to explore the application and utility of Matrix-M adjuvant with their cancer vaccine candidate.

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.

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.

FDA, the European Commission, and several other countries for both adult and adolescent populations.

Novavax Pipeline Programs

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.

Additionally, we intend to continue developing our early-stage pipeline programs using a disciplined and capital-efficient approach.

Our R&D investment strategy seeks to place targeted investments on the programs with the highest potential value, both within infectious disease and beyond, with the intent of partnering these programs earlier in the development process, while maintaining the flexibility to internalize assets when strategically advantageous.

In 2026, our Clostridioides difficile colitis vaccine candidate was prioritized as the potential next asset to enter the clinic as early as 2027 from our early-stage pipeline.

In addition, the preliminary preclinical data generated on our varicella-zoster virus (shingles) and respiratory syncytial virus early-stage assets were positive and will inform our future antigen design and adjuvant work.

We are also continuing to progress our adjuvant research which is intended to expand the utility of our adjuvant offering by creating new adjuvants based on our Matrix technology.

Partner Pipeline Programs

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

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 preliminary positive immunogenicity and safety Phase 1/2 data for Nuvaxovid in combination with both Fluzone High-Dose and Flublok.

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.

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.

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.

In January 2026, we entered the Pfizer License Agreement for use of our Matrix-M™ adjuvant.

Under the terms of the agreement, Pfizer will obtain a non-exclusive license for Matrix-M™ adjuvant for use with Pfizer's products in two infectious disease areas.

The agreement provides for an upfront payment of $30 million, with the potential for up to $500 million in development and sales milestone payments.

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™ adjuvant.

In total, Novavax now has MTA collaborations and/or license agreements partnerships with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the rights to explore Matrix-M in over 30 unique fields and indications across both infectious diseases and oncology.

Coronavirus Vaccine Clinical Development

We continue to evaluate vaccine safety, immunogenicity, and effectiveness through ongoing clinical trials and collaborative evidence-generating real-world studies.

Phase 3 Strain-Change and Re-vaccination Studies

In October 2024, we initiated and fully enrolled Study 315 to evaluate safety and immunogenicity of a single dose of the JN.1 subvariant vaccine NVX-CoV2705 in previously vaccinated adults.

Topline data from this study was submitted to the U.S.

FDA in February 2025 and showed that our JN.1 vaccine induced robust cross-reactive neutralizing activity to the JN.1 variant and to a panel of JN.1 lineage strains representing virtually all of those that circulated in the U.S.

during the 2024-2025 respiratory virus se ason.

We conduct testing against newly emerging strains as we prepare for the annual vaccination season, and this testing informs future strain formulations.

In October 2025, we initiated an additional study, Study 318, as a post-marketing commitment for the U.S.

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.

Phase 2b/3 Pediatric Hummingbird™ Trial

In December 2024, we achieved the $50 million milestone under our agreement with Sanofi, associated with the database lock for one of the three cohorts in this trial.

This trial is evaluating the safety, effectiveness (immunogenicity), and efficacy of two doses of our COVID-19 Vaccine, followed by a booster 6 months after the primary vaccination series.

The trial completed enrollment in September 2023 and includes three age de-escalation cohorts of 1,200 children each.

Safety follow up was completed in October 2025.

FDA has informed us that, due to changes in pediatric sero-epidemiology that have occurred since trial initiation, an additional immunogenicity study will be needed to support a supplemental BLA to expand the pediatric indication.

We continue to engage with Sanofi to assess the feasibility of achieving an expanded indication in the U.S.

given recent policy changes impacting the indicated pediatric population for COVID-19 vaccines.

Phase 4 Postmarketing Commitment Clinical Efficacy and Safety Trial

Phase 4 Postmarketing Commitments

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”).

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.

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.

COVID-Influenza Combination and Stand-alone Influenza Program

Phase 3 Clinical Trial of CIC and Stand-alone Influenza Vaccine Candidates

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.

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.

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We do not intend to make additional investments in these programs and are seeking a partner to advance both vaccine candidates.

R21/Matrix-M Adjuvant Malaria Vaccine

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.

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.

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.

Malaria is a life-threatening disease caused by a parasite that infects mosquitoes and is subsequently transmitted to humans.

According to the 2024 WHO World Malaria Report, in 2023, there were an estimated 263 million malaria cases and 597,000 malaria-related deaths worldwide.

We believe malaria has the potential to be preventable through our partner-led R21/Matrix-M™ malaria vaccine, with the first doses distributed and administered across the African region in 2024 after having received authorization in 2023 in several countries and prequalification by the WHO.

R21/Matrix-M™ Malaria Vaccine

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.

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.

R21/Matrix-M™ Malaria Vaccine Regulatory and Licensure

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 adjuvant malaria vaccine be administered in a four-dose schedule beginning at five months of age.

The WHO recommended that the R21/Matrix-M™ malaria vaccine be administered in a four-dose schedule beginning at five months of age.

Business Highlights

Third Quarter 2025 and Recent Highlights

Strategic Priority #1:

Optimize our Sanofi Partnership

• Continued successful execution of Sanofi partnership with $225 million in milestones earned year-to-date, including $50 million earned in the fourth quarter of 2025, upon marketing authorization transfers for E.U.

• 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.

Both programs have received Fast Track designation from the U.S.

• In August 2025, the 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.

Nuvaxovid was approved with an extended shelf life of six months in a pre-filled syringe formulation.

• Beginning in the third quarter of 2025, Sanofi assumed the lead commercial role for Nuvaxovid in the U.S.

and select ex-U.S.

markets for the 2025-2026 COVID-19 vaccination season.

• In September 2025, we expanded 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 (BARDA) for early-stage clinical work on this vaccine candidate.

Strategic Priority #2:

Enhance Existing Partnerships and Leverage our Technology Platform and Pipeline to Forge Additional Partnerships

• In September 2025, our partner Takeda received approval of Nuvaxovid in Japan which triggered a milestone payment to Novavax.

• R21/Matrix-M, a malaria vaccine developed in partnership with SII and Oxford University, continued to make meaningful progress in addressing the urgent and unmet needs of malaria-endemic regions with 25 million doses sold since launch in mid-2024.

• In the first quarter of 2025, we announced material transfer agreements with three pharmaceutical companies to explore the utility of Matrix-M in their portfolios;

discussions continue with these companies for the potential use of Matrix-M in the development of new vaccines and/or improve existing vaccines.

Strategic Priority #3:

Advance our Technology Platform and Early-Stage Pipeline

• Continued advancement of early-stage preclinical research for Shingles, C.

and RSV combination vaccine candidates.

• Pursuing government funding for pandemic influenza vaccine candidate.

• Continued exploration of our Matrix-M platform technology in oncology.

Other Corporate Highlights

• In August 2025, we completed a convertible debt refinancing;

extending the maturity of the majority of the Company’s existing 2027 Notes to 2031, with improved terms, and providing additional proceeds through the issuance of new 2031 Notes.

This transaction further supports the financial strength of the company and its ability to execute on its long-term growth strategy.

• In October 2025, we announced transactions to enable the planned consolidation of its Maryland based facilities in line with its corporate strategy.

These transactions will result in $60 million in payments to Novavax and are expected to result in future cost savings of approximately $230 million over 11 years.

First Quarter 2026 and Recent Highlights

• In January 2026, we entered into the Pfizer License Agreement for use of Novavax's Matrix-M™ adjuvant in vaccine development.

Under the terms of the agreement, Pfizer was granted a non-exclusive license for Matrix-M™ use in two infectious disease areas.

• 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.

In addition, we are eligible to receive high-mid-single digit percentage royalties on sales from products incorporating Matrix-M™.

• Pfizer will be solely responsible for the development and commercialization of its products utilizing Matrix-M™ and we will be responsible for the supply of Matrix-M™.

• This partnership has the potential to generate billions of dollars of revenue for us over the life of the agreement.

• In 2026, we continued to expand our Matrix-M™ partnering efforts with global pharmaceutical companies and innovative biopharma companies.

• In April, we signed a new MTA with a top ten global pharmaceutical company who is also a global leader in oncology to explore Matrix-M™ in a broad array of oncology targets, as well as antibiotic resistant bacterial infections and other infectious diseases.

• In April, we signed a new MTA with an existing pharmaceutical partner for evaluation of Matrix-M™ in nine additional, identified disease areas.

• In February, we expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an innovative oncology company.

• In total, we now have MTA collaborations and/or license agreements with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the rights to explore Matrix-M™ in over 30 unique fields of experimentation across both infectious diseases and oncology.

• The goal of our MTA collaborations is to enable exploration of Matrix-M™ with the intent of entering into a deeper partnership via formal license agreements, that in turn results in the advancement of a partner’s R&D clinical work toward commercialization of innovative vaccines.

• The broad utility of our technology has resulted in several companies exploring Matrix-M for application in the same high-potential markets, including infectious disease areas such as cytomegalovirus, Epstein-Barr Virus, pneumococcal, and RSV;

and also includes overlap in oncology areas such as colorectal cancer, head and neck cancer and pancreatic cancer.

• Existing partners under license and MTA agreements, have the rights to address fields and indications that cover over 50% of the global market opportunity for infectious disease and oncology vaccines and immunotherapeutics, which is projected to grow to over $100 billion by the early 2030s.

• In April, Sanofi announced positive Phase 4 data from COMPARE, a head-to-head study showing that Nuvaxovid demonstrated statistically significant lower side effects compared to Moderna’s mNEXSPIKE across all pre-specified endpoints, reinforcing Nuvaxovid’s well-established and differentiated reactogenicity profile ahead of the fall season.

• Continued to progress Novavax R&D innovation in support of our growth strategy.

• Clostridioides difficile colitis vaccine candidate prioritized as potential next asset to enter the clinic as early as 2027.

• Preliminary preclinical data generated by us on our varicella-zoster virus (shingles) and respiratory syncytial virus early-stage assets were positive and provide path forward for informing our future antigen design and adjuvant work.

• Ongoing adjuvant research is intended to expand the utility of our technology by creating new adjuvants tailored to foster specific differentiated immune properties certain diseases that may require unique immune responses.

Sales of Common Stock

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.

In May 2024, we entered into the securities subscription agreement, pursuant to which we sold and issued to Sanofi, in a private placement, 6.9 million shares of our common stock, par value $0.01 per share at a price of $10.00 per share for aggregate gross proceeds to us of $68.8 million.

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.

Critical Accounting Policies and Use of Estimates

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Our historical results are not necessarily indicative of the results for any periods in the future.

Three Months Ended September 30, 2025 and 2024

Three Months Ended September 30,

2025 2024 Change

Revenue (in thousands):

Product sales $ 13,442 $ 41,528 $ (28,086)

Licensing, royalties, and other 57,003 42,984 14,019

Total revenue $ 70,445 $ 84,512 $ (14,067)

Revenue for the three months ended September 30, 2025 was $70.4 million as compared to $84.5 million for the same period in 2024, a decrease of $14.1 million.

Revenue for the three months ended September 30, 2025 was primarily comprised of licensing revenue from Transition Services and Technology Transfer and product supply sales of COVID-19 Vaccine under the Sanofi CLA and milestone and royalty revenue with Takeda.

Revenue for the three months ended September 30, 2024 was primarily comprised of revenue from Product sales of COVID-19 Vaccine and revenue from Transition Services and Technology Transfer under the Sanofi CLA.

The decrease in revenue is primarily due to a decrease in Product sales of COVID-19 Vaccine partially offset by product supply sales of COVID-19 Vaccine and an increase in revenue from Transition Services and Technology Transfer in licensing revenue under the Sanofi CLA.

Product sales

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.

The categories of Product sales were as follows:

Three Months Ended September 30,

2025 2024 Change

Product sales (in thousands)

Nuvaxovid sales (1)

$ (332) $ 38,210 $ (38,542)

Supply sales (2)

13,774 3,318 10,456

Total Product sales

$ 13,442 $ 41,528 $ (28,086)

(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.

During the three months ended September 30, 2025, Nuvaxovid sales include excess gross-to-net deductions primarily due to updates to estimated product returns.

(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.

Licensing, royalties, and other

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.

Licensing, royalties, and other revenue were comprised of the following:

Three Months Ended September 30,

2025 2024 Change

Licensing, royalties, and other (in thousands)

Sanofi $ 48,294 $ 36,115 $ 12,179

Takeda 6,445 4,918 1,527

Other partners (1)

2,264 1,951 313

Total licensing, royalties, and other revenue $ 57,003 $ 42,984 $ 14,019

(1) Other partners revenue includes royalties and license fees associated with agreements with other partners such as Serum.

Sanofi licensing, royalties, and other revenue were comprised of the following:

Three Months Ended September 30,

2025 2024 Change

Sanofi licensing, royalties, and other revenue (in thousands)

$ — $ 3,392 $ (3,392)

4,196 — 4,196

Transition services and technology transfer:

Upfront fee amortization (1)

(1,083) 14,973 (16,056)

Milestones amortization (1)

(645) 7,032 (7,677)

Cost reimbursements

45,826 10,718 35,108

Total Sanofi licensing, royalties, and other revenue

$ 48,294 $ 36,115 $ 12,179

(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.

Takeda licensing, royalties, and other revenue were comprised of the following (in thousands):

Three Months Ended September 30,

2025 2024 Change

Takeda licensing, royalties, and other revenue

Milestones $ 4,717 $ — $ 4,717

1,456 4,564 (3,108)

Support services 272 354 (82)

Tota Total Takeda licensing, royalties, and other revenue $ 6,445 $ 4,918 $ 1,527

Three Months Ended September 30,

2025 2024 Change

Expenses (in thousands):

Cost of sales $ 21,496 $ 60,619 $ (39,123)

Research and development 98,274 87,164 11,110

Selling, general, and administrative 31,655 70,747 (39,092)

Impairment of assets held for sale

97,038 — 97,038

Total expenses $ 248,463 $ 218,530 $ 29,933

Cost of Sales

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.

Research and Development Expenses

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

Program, in support of Sanofi Transition Services, offset by certain cost containment measures to reduce our operating spend, as summarized in the table below (in thousands):

Three Months Ended September 30,

Coronavirus vaccines $ 39,439 $ 21,798

Other vaccine development programs

Total direct external research and development expense 40,735 24,458

Employee expenses 31,779 33,504

Stock-based compensation expense 3,491 5,166

Facility expenses 14,568 13,855

Other expenses 7,701 10,181

Total research and development expenses $ 98,274 $ 87,164

Research and development expenses for coronavirus vaccines for the three months ended September 30, 2025 and 2024 increase from $21.8 million to $39.4 million primarily as a result of increased costs in support of Sanofi Transition Services, offset by our global restructuring and cost reduction efforts and 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, under manufacturing supply agreements with CMOs and contract manufacturing and development organizations (“CDMOs”).

Selling, General, and Administrative Expenses

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.

Impairment of assets held for sale

During the three months ended September 30, 2025, we classified our corporate headquarters facility at 700 Quince Orchard, Gaithersburg, Maryland (“700QO”), together with certain related property and equipment and land parcel adjacent to the facility (collectively referred to as the "Disposal Group"), as held for sale.

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 million was recognized during the three months ended September 30, 2025, and recorded in Impairment of assets held for sale in the Consolidated Statements of Operations.

In October 2025, the Company entered into a definitive agreement to sell the Disposal Group (see Note 18 to our unaudited consolidated financial statements).

For the remainder of 2025, we expect a reduction in our annual combined research and development, and selling, general, and administrative spend as a result of our Restructuring Plan as discussed in Note 16 to our accompanying unaudited consolidated financial statements.

Other Income (Expense)

Three Months Ended September 30,

2025 2024 Change

Other income (expense), net (in thousands):

Interest expense $ (5,482) $ (4,236) $ (1,246)

Loss on debt extinguishment

(28,714) — (28,714)

Other income (expense), net 9,178 15,922 (6,744)

Total other income (expense), net

$ (25,018) $ 11,686 $ (36,704)

Total other income (expense), net was $25.0 million of expense for the three months ended September 30, 2025 as compared to a total other income (expense), net of $11.7 million of income for the same period in 2024.

The decrease in other

income (expense), net is primarily due to a $28.7 million loss on debt extinguishment recorded in the three months ended September 30, 2025 and a reduction in interest income on investments in marketable securities during the period.

Income Tax Expense

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.

Three Months Ended September 30,

2025 2024 Change

Net loss (in thousands, except per share information):

$ (202,379) $ (121,300) $ (81,079)

Net loss per share, basic and diluted

$ (1.25) $ (0.76) $ (0.49)

Weighted average shares outstanding, basic and dilutive

162,353 160,049 2,304

Net loss for the three months ended September 30, 2025 was $202.4 million, or $1.25 per share, basic and dilutive, as compared to net loss of $121.3 million, or $0.76 per share, basic and dilutive, for the same period in 2024.

The increase in net loss during the three months ended September 30, 2025, was primarily due to the impairment of assets held for sale and loss on debt extinguishment, partially offset by a decrease in total operating expenses.

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.

Nine Months Ended September 30, 2025 and 2024

Nine Months Ended September 30,

Three Months Ended March 31, 2026 and 2025

Three Months Ended March 31,

2026 2025 Change

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Total revenue $ 139,514 $ 666,655 $ (527,141)

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.

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.

Product sales

Product sales for the nine months ended September 30, 2025 were $645.8 million as compared to $154.0 million during the nine months ended September 30, 2024, an increase of $491.9 million.

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 products, and the termination of our Canada and New Zealand APAs.

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.

We have transitioned the commercial lead for sales and distribution to Sanofi resulting in a decrease in Nuvaxovid TM sales and an increase in supply sales.

The categories of Product sales were as follows:

Nine Months Ended September 30,

Three Months Ended March 31,

2026 2025 Change

Product sales (in thousands)

Nuvaxovid sales (1)

Nuvaxovid TM sales (1)

$ 9,558 $ 608,025 $ (598,467)

3 unchanged sentences

$ 42,200 $ 621,678 $ (579,478)

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

We reclassified $13.5 million of revenue previously reported as License, royalties, and other revenue to Product sales revenue for the nine months ended September 30, 2024 related to adjuvant supply sales and other supply sales.

(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.

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

Licensing, royalties, and other

Licensing, royalties, and other revenue during the nine months ended September 30, 2025 was $330.5 million as compared to $439.9 million during the same period in 2024, a decrease of $109.4 million.

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.

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.

Licensing, royalties, and other revenue were comprised of the following:

Nine Months Ended September 30,

Three Months Ended March 31,

2026 2025 Change

1 unchanged sentence

Sanofi $ 48,899 $ 40,321 $ 8,578

Takeda 33,657 4,918 28,739

Pfizer 30,000 — 30,000

Serum 7,366 4,456 2,910

Other partners (1)

1 unchanged sentence

Total licensing, royalties, and other revenue $ 97,314 $ 44,977 $ 52,337

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

(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.

Sanofi licensing, royalties, and other revenue were comprised of the following:

Nine Months Ended September 30,

Three Months Ended March 31,

2026 2025 Change

Sanofi licensing, royalties, and other revenue (in thousands)

$ — $ 389,642 $ (389,642)

Milestones 175,000 — 175,000

4,196 — 4,196

Royalties $ 3,521 $ — $ 3,521

Transition services and technology transfer:

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Takeda licensing, royalties, and other revenue were comprised of the following (in thousands):

Nine Months Ended September 30,

2025 2024 Change

Takeda licensing, royalties, and other revenue

Upfront fee (1)

$ 18,500 $ — $ 18,500

Milestones 8,151 — 8,151

6,456 4,564 1,892

Support services 550 354 196

Tota Total Takeda licensing, royalties, and other revenue

$ 33,657 $ 4,918 $ 28,739

(1) Upfront fee includes $14.5 million of nonrefundable upfront payments associated with the Amended Takeda CLA and $4.0 million of previously unrecognized consideration from the Original Takeda CLA.

Nine Months Ended September 30,

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.

Three Months Ended March 31,

2026 2025 Change

3 unchanged sentences

Selling, general, and administrative 28,777 48,090 (19,313)

Impairment of assets held for sale

97,038 — 97,038

Total expenses $ 154,944 $ 151,142 $ 3,802

Cost of Sales

Cost of sales was $50.9 million for the nine months ended September 30, 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 $7.0 million related to unutilized manufacturing capacity.

Cost of sales was $166.1 million for the nine months ended September 30, 2024, including expense of $26.4 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, $37.1 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 $115.1 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.

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.

Research and Development Expenses

Research and development expenses decreased to $266.4 million for the nine months ended September 30, 2025 from $286.8 million for the same period in 2024, a decrease of $20.3 million.

The decrease was primarily due to a reduction in overall expenditures relating to development activities on coronavirus vaccines, including our COVID-19 Program, and CIC, and due to certain cost containment measures to reduce our operating spend, as summarized in the table below (in thousands):

Nine Months Ended September 30,

Coronavirus vaccines $ 86,161 $ 87,759

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:

Three Months Ended March 31,

Research and Development Expenses (in thousands):

COVID-19 Vaccine $ 34,255 $ 7,277

CIC and influenza vaccines 2,853 12,504

Other vaccine development programs

6 unchanged sentences

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses decreased to $123.4 million for the nine months ended September 30, 2025 from $258.8 million for the same period in 2024, a decrease of $135.5 million.

Impairment of assets held for sale

During the nine months ended September 30, 2025, we classified the Disposal Group as held for sale.

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 million was recognized during the nine months ended September 30, 2025, and recorded in Impairment of assets held for sale in the Consolidated Statements of Operations.

In October 2025, the Company entered into a definitive agreement to sell the Disposal Group (see Note 18 to our unaudited consolidated financial statements).

Other Income (Expense)

Nine Months Ended September 30,

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.

Other Income, Net

Three Months Ended March 31,

2026 2025 Change

Other income (expense), net (in thousands):

Other income, net (in thousands):

Interest expense $ (4,901) $ (5,723) $ 822

Loss on debt extinguishment (28,714) — (28,714)

Other income 31,136 27,307 3,829

Total other income (expense), net $ (14,301) $ 14,817 $ (29,118)

Total other income (expense), net for the nine months ended September 30, 2025 was $14.3 million of expense as compared to $14.8 million of income for the same period in 2024, a decrease of $29.1 million.

The decrease in other income (expense) is primarily due to a $28.7 million loss on debt extinguishment.

Other income, net 11,825 10,056 1,769

Total other income, net $ 6,924 $ 4,333 $ 2,591

Total other income, net was $6.9 million for the three months ended March 31, 2026 as compared to $4.3 million for the same period in 2025.

The increase in other income, net is primarily due favorable impact in 2026 as compared to 2025 of exchange rates on foreign currency denominated balances, partially offset by 2025 nonrecurring other income items of $4.8 million from the derivative action settlement proceeds and $3.6 million of state incentives.

Income Tax Expense

During the nine months ended September 30, 2025, we recognized an income tax expense of $1.5 million related to federal, state, and foreign income taxes and foreign withholding taxes.

During the nine months ended September 30, 2024, we recognized an income tax expense of $3.4 million related to federal, state, and foreign income taxes.

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.

Net Income (Loss)

Nine Months Ended September 30,

Three Months Ended March 31,

2026 2025 Change

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Net income (loss) per share, basic $ (0.06) $ 3.22 $ (3.28)

Net income (loss) per share, dilutive $ 2.53 $ (0.71) $ 3.24

Net income (loss) per share, diluted $ (0.06) $ 2.93 $ (2.99)

Weighted average shares outstanding, basic 163,276 161,049 2,227

Weighted average shares outstanding, dilutive 163,276 177,625 (14,349)

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.

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

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.

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.

Liquidity Matters and Capital Resources

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;

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;

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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.

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.

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.

Sanofi Collaboration and License Agreement

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.

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.

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.

As of September 30, 2025, remaining Sanofi sales milestone payments of $475 million include $125 million related to COVID-19 Vaccine Products and $350 million related to influenza-COVID-19 combination products.

The COVID-19 Vaccine Products milestones remaining include $25 million receivable upon the transfer of the U.S.

marketing authorization holder (“MAH”) to Sanofi, $25 million receivable upon the transfer of the European Medicines Agency (“EMA”) MAH in a pre-filled syringe to Sanofi, and $75 million receivable upon the completion of the technology transfer of our manufacturing process for the COVID-19 Vaccine Products to Sanofi.

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.

In October 2025, we completed the transfer of the EMA MAH in a pre-filled syringe to Sanofi which triggered a $25 million milestone.

In November 2025, we completed the transfer of the U.S.

FDA MAH in a pre-filled syringe to Sanofi which triggered a $25 million milestone.

We expect to receive these milestones in the first quarter of 2026

As of March 31, 2026, remaining Sanofi milestone payments of $425 million include $75 million related to COVID-19 Vaccine products receivable upon the completion of the technology transfer of our manufacturing process for the COVID-19 Vaccine products to Sanofi.

We are eligible to receive milestone payments totaling up to $350 million in the aggregate with respect to the CIC Products and this total amount is outstanding.

We are eligible to receive a $125 million milestone payment upon achievement of initiation of a Sanofi CIC Product Phase 3 trial and a $225 million CIC Product-related launch milestone.

We are eligible to receive royalty payments in the high teens to low twenties percent on Sanofi’s sales of such licensed products.

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.

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Takeda Amended and Restated Collaboration and License Agreement

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

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.

We allocated $26.9 million of fixed consideration to the Updated Takeda License performance obligations and $0.6 million to Takeda Support Services.

We recognized revenue of $26.9 million related to the Updated Takeda License on the transfer of the rights and control of the license to Takeda during the nine months ended September 30, 2025.

The Takeda Support Services are recognized in revenue over time using an input method to measure progress by utilizing costs incurred to-date relative to total expected costs.

Revenue recognized related to Takeda support Services for the three and nine months ended September 30, 2025 was $0.3 million and $0.6 million, respectively.

Under the Amended Takeda CLA, we received a non-refundable upfront payment of $19.5 million of which $5.0 million is creditable against royalties owed by Takeda for its fiscal year 2024.

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.

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.

During the three months ended September 30, 2025, we recognized $4.7 million of milestone revenue for additional milestones earned under the Amended Takeda CLA.

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.

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

Under the Amended Takeda CLA, on an annual basis, we will receive $2.0 million to compensate us for services provided by us under the Amended Takeda CLA.

If Takeda receives marketing approval of the COVID-19 Vaccine in that year or such approval is not necessary for such year, 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.

We are eligible to receive 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), commencing 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.

During the three months ended March 31, 2026, we recognized $0.7 million of royalty revenue earned under the Amended Takeda CLA and $0.1 million for Takeda Support Services.

Pfizer License Agreement

In January 2026, we entered into the Pfizer License Agreement for use of our Matrix-M™ adjuvant.

Under the terms of the agreement, Pfizer will obtain a non-exclusive license for Matrix-M™ adjuvant for use with Pfizer's products in up to two disease areas.

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.

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™ adjuvant.

Supply Agreements

As of September 30, 2025, we have $222.1 million of remaining obligations under APAs with certain countries globally, excluding the Vaccine Alliance (“Gavi”).

These obligation include $133.9 million related to an APA with the Commonwealth of Australia for the purchase of doses of COVID-19 Vaccine (the “Australia APA”) and $88.2 million related to various other countries.

With respect to the Australia APA, as of September 30, 2025, $31.3 million was classified as current Deferred revenue and $102.6 million was classified as non-current Deferred revenue in our consolidated balance sheet.

Following the withdrawal of our application at the request of the Therapeutic Goods Administration (“TGA”) for authorization of our updated COVID-19 Vaccine, we are in discussions with the TGA regarding potential regulatory paths for approval, including the submission of a new application.

We may seek to further amend the Australian APA in light of this development, which amendment may not be achievable on acceptable terms or at all.

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 if the Australian APA were to be terminated, of which $10.8 million may become refundable if 2025 dose deliveries are cancelled.

Specifically, Australia may cancel doses that are due to be delivered in 2025 if we do not receive regulatory approval for, and deliver, the updated COVID-19 Vaccine on or before December 31, 2025, and may terminate the Australia APA, as amended, if we do not receive regulatory approval for, and deliver, the updated COVID-19 Vaccine on or before March 31, 2026.

With respect to other obligations under APAs of $88.2 million, as of September 30, 2025, $38.4 million was classified as current Deferred revenue, $49.8 million was classified as non-current Deferred revenue in our consolidated balance sheet.

As of March 31, 2026, we have $207.2 million of remaining obligations under APAs with certain countries globally, excluding the Vaccine Alliance (“Gavi”).

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.

With respect to the Australia APA, as of March 31, 2026, $48.4 million was classified as current Deferred revenue and $85.4 million was classified as non-current Deferred revenue in our consolidated balance sheet.

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.

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.

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.

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.

In the third quarter of 2025, we withdrew our application for our COVID-19 Vaccine based on recommendations made by the Therapeutic Goods Administration.

The parties are in ongoing discussions regarding outstanding issues and obligations under the APA.

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.

With respect to other obligations under APAs of $73.3 million, as of March 31, 2026, $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.

Recognition of these amounts is dependent on delivery of doses or expiry of optional dose order quantities.

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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.

As of September 30, 2025, pursuant to our settlement agreement with the UK, the remaining upfront payment previously received from the authority is classified as $38.0 million of other current liabilities and $30.0 million of Other non-current liabilities on our consolidated balance sheet.

As of March 31, 2026, pursuant to our settlement agreement with the UK, the remaining upfront payment previously received from the authority is classified as $39.2 million of other current liabilities and $10.2 million of Other non-current liabilities on our consolidated balance sheet.

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”).

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 September 30, 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 $210.0 million in Other non-current liabilities.

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 6 to our accompanying unaudited consolidated financial statements), which will

continue for the deferred payment term of the Gavi Settlement Agreement.

As of March 31, 2026, 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 $160.0 million in Other non-current liabilities.

On February 22, 2024, the claims and counterclaims were dismissed with prejudice.

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For additional information on the 2031 Notes, see Note 11 to our accompanying unaudited consolidated financial statements.

As of September 30, 2025, we had $778.2 million in cash and cash equivalents, restricted cash and marketable securities as compared to $938.2 million as of December 31, 2024.

We received $175 million related to the milestone payment triggered under the Sanofi CLA in 2025.

We funded our operations for the nine months ended September 30, 2025 primarily with cash and cash equivalents, proceeds from the 2031 Notes, milestone payments under the Sanofi CLA and revenue from Product sales.

Credit Agreement

In February 2026, we entered into the Credit Agreement with MidCap Financial Trust, as administrative agent.

The Credit Agreement provides for a senior secured term loan facility of up to $330 million, available in four tranches.

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.

Borrowings under the Credit Agreement bear interest, payable monthly in arrears, at a rate per annum equal to the one-month Secured Overnight Financing Rate (“Term SOFR”) plus 5.00%, subject to a Term SOFR floor of 2.00%.

The term loans mature in March 2031, at which time all outstanding principal and accrued interest are due and payable in full.

As of March 31, 2026, we had $794.9 million in cash and cash equivalents, restricted cash and marketable securities as compared to $750.5 million as of December 31, 2025.

We funded our operations for the three months ended March 31, 2026, primarily with cash and cash equivalents, proceeds from the 2031 Notes and the Credit Agreement, milestone payments under the Sanofi CLA, and revenue from Product sales.

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.

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, 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 the nine months ended September 30, 2025 and 2024 (in thousands):

Nine Months Ended September 30,

The following table summarizes cash flows for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

2026 2025 Change

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Cash, cash equivalents, and restricted cash at end of period $ 232,925 $ 278,480 $ (45,555)

Net cash used in operating activities was $205.2 million for the nine months ended September 30, 2025, as compared to $85.9 million of cash provided for the same period in 2024.

The increase in cash used in operating activities is primarily due to a reduction in cash received from receivables on APA agreements in 2025 as compared to the same period in 2024.

Net cash used in investing activities was $98.8 million for the nine months ended September 30, 2025, as compared to $348.0 million of cash used for the same period in 2024.

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 $34.3 million for the nine months ended September 30, 2025, as compared to net cash provided by financing activities of $264.0 million for the same period in 2024.

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.

Net cash used in operating activities was $32.4 million for the three months ended March 31, 2026, as compared to $185.5 million of cash used in operating activities for the same period in 2025.

The decrease in cash used in operating activities is primarily due to certain cost containment measures to reduce our operating spend, including a reduction in our global commercial footprint and administrative infrastructure.

Net cash used in investing activities was $28.4 million for the three months ended March 31, 2026, as compared to $73.3 million of cash used for the same period in 2025.

The decrease in cash used in investing activities is primarily due to the completion of the sale of held for sale assets.

Net cash provided by financing activities was $37.7 million for the three months ended March 31, 2026, as compared to net cash used in financing activities of $7.1 million for the same period in 2025.

The increase in cash provided by financing activities is primarily due to net proceeds from our Credit Agreement.

Going Concern

As described in Note 2 to our accompanying unaudited consolidated financial statements, we evaluated our ability to continue as a going concern and concluded that we will have sufficient capital available to fund our operations for at least one-year from the date that the financial statements were issued.

We believe that our cash, cash equivalents, and marketable securities as of March 31, 2026, 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 Quarterly Report on Form 10-Q.

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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis