What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-06 compared with 2025-05-08 · 307 added, 164 removed, 266 unchanged (64% 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 corporate growth strategy, including our early-stage pipeline and research and development (“R&D”) investment strategy and key value drivers;

our strategic priorities, our corporate growth strategy, including our early-stage pipeline and research and development (“R&D”) investment strategy and key value drivers;

our technology platform;

our COVID-19 program (our “COVID-19 Program”) (which currently includes our Nuvaxovid™ prototype COVID-19 vaccine ("NVX-CoV2373” or “prototype COVID-19 vaccine”), our Nuvaxovid™ COVID-19 vaccine for the 2023-2024 vaccination season (“XBB COVID-19 Vaccine”) and our Nuvaxovid™ updated COVID-19 vaccine for the 2024-2025 vaccination season (“NVX-CoV2705” or “updated COVID-19 vaccine”) collectively, referred to as our (“COVID-19 Vaccine”));

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 March 31, 2025 are issued;

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 June 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;

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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, including the U.S.

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”) approval of the BLA for our COVID-19 Vaccine and alignment with the U.S.

FDA on the post marketing commitment;

our expectation of manufacturing capacity, timing, production, distribution, and delivery for our COVID-19 Vaccine by us and our partners;

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;

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 CIC vaccine candidate and our stand-alone influenza vaccine candidate including 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;

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;

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Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements.

Such risks and uncertainties include, without limitation, our ability to successfully and timely manufacture, market, distribute, or deliver our COVID-19 Vaccine and the impact of our not having received a BLA from the U.S.

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 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;

Such risks and uncertainties include, without limitation, our ability to successfully and timely obtain and maintain full U.S.

FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver our COVID-19 Vaccine;

the impact of delays in obtaining regulatory approval, including regulatory decisions impacting labeling, approval or authorization, including the scope of the indicated population, product dosage, manufacturing processes, shelf life, safety, for our product candidates;

challenges in conducting the PMC study, our ability to obtain adequate additional funding to maintain our current level of operations and fund the further development of our vaccine candidates;

challenges related to our partnership with Sanofi, including collaboration on the PMC, and in pursuing additional partnership opportunities;

challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to

process qualification, assay validation, and stability testing, necessary to satisfy applicable regulatory authorities;

challenges or delays in conducting clinical trials or studies for our product candidates;

challenges or delays in obtaining regulatory authorization for our product candidates, including for future COVID-19 variant strain changes, our CIC vaccine candidate, our stand-alone influenza vaccine candidate or other product candidates;

manufacturing, distribution or export delays

or challenges;

manufacturing, distribution or export delays or challenges;

our substantial dependence on Serum Institute of India Pvt.

(“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;

the impact of potential legislative, regulatory, or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance;

uncertainty with respect to pricing, third-party reimbursement and healthcare reform;

uncertainty in the regulatory pathway for our COVID -19 Vaccine;

the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements;

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Our three strategic priorities are:

focusing on our partnership with Sanofi announced in May 2024, leveraging our technology platform and pipeline to forge additional partnerships, and advancing our proven technology platform and early-stage pipeline.

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 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.

Our proprietary Matrix-M ® adjuvant when added to vaccines, has been shown to help induce a stronger and longer-lasting immune response.

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 to the vaccine and it has demonstrated a favorable tolerability profile in clinical trials.

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 Collaboration and License Agreement with Sanofi, to co-commercialize our COVID-19 vaccine, including future updated versions that address seasonal COVID-19 variants.

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.

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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 consolidated financial statements.

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 December 2024, we initiated the initial cohort of a Phase 3 trial comparing our CIC vaccine and stand-alone influenza vaccine to our updated COVID-19 vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

We intend to partner these vaccine candidates in order to advance to BLA filing and commercialization.

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.

Furthermore, we provide our Matrix-M adjuvant for use in collaborations.

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Additionally, we provide Matrix-M adjuvant for use in various programs in preclinical and clinical stage, as well as preclinical investigations.

Examples include, an agreement with the Gates Foundation, and in a related master transfer agreement with a leading pharmaceutical company for exploration of Matrix-M ® adjuvant used as a potential advancement in their pipeline.

We continue to advance our strategic assessment of our emerging, early-stage pipeline.

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.

Our R&D investment strategy seeks to place smart, lower-cost investments on the programs with the highest potential value, both within infectious disease and beyond, with the intent of partnering these programs at proof of concept.

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 at proof of concept.

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

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We are actively developing an H5N1 avian pandemic influenza vaccine candidate and the toxicology study is underway.

We are actively monitoring the emerging public health situation and are pursuing funding opportunities to join preparedness options.

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.

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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

Our COVID-19 BLA is currently under review with the U.S.

FDA and had originally been assigned a Prescription Drug User Fee Act (“PDUFA”) date of April 1, 2025.

During April 2025, we received formal communication from the U.S.

FDA in the form of an information request for a post marketing commitment (“PMC”) to generate additional clinical data.

We have responded to the U.S.

FDA’s information request with a proposed study design and continue to engage with the U.S.

FDA to address the PMC request and move to approval as soon as possible..

In May 2025, the U.S.

FDA approved the BLA for Nuvaxovid for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g.

asthma, cancer, diabetes, obesity, smoking).

The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19.

The BLA approval triggered a $175 million milestone payment under the Sanofi CLA.

Product Pipeline

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Our COVID-19 Vaccine, partnered with Sanofi, is our most advanced product.

We will continue to commercialize our updated COVID-19 vaccine through the end of the 2024-2025 vaccination season, and beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize our COVID-19 vaccine worldwide in accordance with a commercialization plan agreed by us and Sanofi.

In 2025 and continuing during the term of the Sanofi CLA, Sanofi will lead commercialization efforts for our COVID-19 Vaccine.

Our COVID-19 Vaccine has received authorizations from the U.S.

FDA, the European Commission (“EC”), the WHO and several other countries for both adult and adolescent populations.

We advanced our COVID-19 vaccine to a post-authorization Phase 3 safety and immunogenicity trial.

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 an H5N1 avian pandemic influenza vaccine candidate and monitoring the emerging public health situation while pursuing funding opportunities to join preparedness options.

We are conducting early-stage research in diseases such as, RSV combinations, varicella-zoster virus (shingles) and Clostridium difficile (C.

Diff.) colitis.

We are actively developing an H5N1 avian 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.

We believe our partner-led R21/Matrix™ adjuvant malaria vaccine presents significant potential.

Based on preliminary results from an ongoing Phase 3 trial in infants and toddlers in Africa, showing 72-79% efficacy, the R21/Matrix-M ® adjuvant malaria vaccine has been authorized in Ghana, Nigeria, and Burkina Faso, and in December 2023, was granted prequalification by the WHO.

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 TM and Flublok TM to evaluate immunogenicity and safety in Phase 1/2 combination vaccine trials.

Under our agreement, we have also provided a sole license to Sanofi for the independent development of a COVID-19 and influenza combination product using our COVID-19 Vaccine in combination with two of Sanofi’s separately marketed influenza vaccines, Fluzone High-Dose and Flublok, to evaluate immunogenicity and safety in Phase 1/2 combination vaccine trials.

These two combination vaccine candidates were granted Fast Track designation by the U.S.

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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 season.

Serum samples from this study will continue to be tested against newly emerging strains as we prepare for the 2025-2026 season, and these results are expected to support regulatory submissions in the U.S.

and other jurisdictions for future variant strain formulations.

In July 2024, we locked the database for 338 participants aged 18 and older in Part 2 of the Study 313, which evaluated the immunogenicity of a single dose of the XBB.1.5 subvariant vaccine NVX-CoV2601 in previously unvaccinated individuals.

Data from Study 313 are intended to support the BLA and regulatory submissions in other territories for future variant strain formulations.

Phase 2b/3 Pediatric Hummingbird™ Study

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 study.

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.

We expect to conduct an additional study, Study 318, 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 starting in the fourth quarter of 2025.

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.

In August 2023, we announced topline results from our Phase 2b/3 Hummingbird™ trial that met its primary endpoints in children aged 6 through 11 years demonstrating both tolerability and immunologic responses.

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

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

Safety follow up is expected to be 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

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.

We are working closely with the U.S.

FDA and Sanofi to finalize the trial design, with plans to initiate enrollment in the fourth quarter of 2025.

The Company will be responsible to conduct the PMC trial.

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 Sanofi Transition Services and Sanofi Technology Transfer.

COVID-Influenza Combination and Stand-alone Influenza Program

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Our Phase 3 immunogenicity and safety trial completed enrollment with an initial cohort of approximately 2,000 participants.

We anticipate topline data for this initial patient cohort by mid-2025.

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

Both vaccine candidates were well tolerated with reactogenicity profiles that were comparable to authorized comparators.

After consultation with the U.S.

FDA, we determined that seeking an accelerated approval pathway for either of our CIC or stand-alone influenza candidates would not be feasible.

While not a pivotal study, the data from the Phase 3 immunogenicity and safety trial will be essential to inform the design of a subsequent pivotal trial in older adults for both programs.

We do not intend to advance these vaccine candidates without a partner and we therefore do not intend to make additional investments in these programs and are seeking to partner both vaccine candidates.

The Phase 3 immunogenicity and safety trial builds on Phase 2 data that was previously shared in May 2023, where the vaccine candidates showed preliminary robust immune responses, reassuring safety profiles, and reactogenicity that was comparable to the licensed influenza vaccine comparator arms.

The Phase 2 dose-confirming randomized, observer-blinded trial evaluated the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates, and higher doses of Novavax's COVID-19 vaccine in 1,575 adults aged 50 through 80 years.

The CIC vaccine candidate achieved both anti-SARS-CoV-2 immunoglobulin G (IgG) and neutralizing levels comparable to our prototype COVID-19 vaccine.

In addition, several of the combination formulations achieved responses to both SARS-CoV-2 and to the four homologous influenza strains that were comparable to the reference comparators, supporting their prioritization for advanced development.

FDA, we determined that seeking an accelerated approval pathway for our CIC and stand-alone influenza candidates would not be feasible.

While the Phase 3 immunogenicity and safety trial is not a pivotal study, the data will inform a future registrational Phase 3 program.

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

We continue to invest in development of our pipeline that uses our recombinant nanoparticle technology platform and Matrix-M adjuvant.

We continue to believe these assets are key value drivers and intend to partner these assets towards a BLA filing.

We continue to believe these assets are key value drivers that would enable the generation of additional vaccine candidates.

R21/Matrix-M Adjuvant Malaria Vaccine

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Business Highlights

First Quarter 2025 and Recent Highlights

Second Quarter 2025 and Recent Highlights

Strategic Priority #1:

Sanofi Partnership

• COVID-19 BLA under review by the U.S.

In April 2025, we received an information request for a PMC for a clinical trial.

Discussions with the U.S.

FDA regarding our proposed study design are ongoing and we believe our BLA is approvable upon alignment on the details of the PMC.

◦ Achievement of BLA approval triggers a $175 million milestone payment from Sanofi.

• In May 2025, the U.S.

FDA approved the Nuvaxovid™ BLA for prevention of COVID-19 in adults 65 years and older and individuals aged 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

◦ BLA approval triggered a $175 million milestone payment from Sanofi.

• Completed transition of Nuvaxovid commercial leadership in the U.S.

to Sanofi for the 2025-2026 COVID-19 vaccination season.

• Transfers of marketing authorization to Sanofi for U.S.

and European Union markets, assuming approvals in each jurisdiction, are expected in Q4 2025, and trigger an additional $50 million in combined milestones from Sanofi.

and European Union (EU) markets are expected in the fourth quarter of 2025 which will trigger an additional $50 million in combined milestones from Sanofi.

Strategic Priority #2:

Leverage our technology platform and pipeline to forge additional partnerships

• In April 2025, Novavax and Takeda Pharmaceutical Company Limited (“Takeda”) announced significantly improved terms for their partnership to support ongoing commercialization of Nuvaxovid ® in Japan.

As part of this agreement, we will receive a $20 million upfront payment, a payment related to the 2024-2025 season and are eligible to receive annual milestone payments plus royalties on net sales.

• In March 2025, we signed an additional Material Transfer Agreement (“MTA") for Matrix-M ® with a top tier pharmaceutical company, expanded the scope of the MTA signed in the fall to now include viral pathogens, and entered a preclinical collaboration with a new partner to explore the application and utility of Matrix-M ® with their cancer vaccine candidate.

• Completed enrollment and expect initial cohort data by mid-year for the Phase 3 trial for our COVID-19-Influenza Combination and stand-alone seasonal influenza vaccine candidates to evaluate immunogenicity and safety in adults aged 65 and older.

We intend to partner these programs, and this trial reflects the material completion of our investment.

• Presented data at the April 2025 World Vaccine Congress on the potential of our technology platform and Matrix-M ® adjuvant, which showcases attributes related to efficacy and tolerability.

Highlights included utility of Matrix-M ® across multiple vaccine platforms and disease areas, underscoring breadth of potential partnership opportunities.

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

• In June 2025, we reported initial cohort data for the Phase 3 trial for our CIC and stand-alone seasonal influenza vaccine candidates, showing robust immune responses for both candidates.

This descriptive data set will help inform a potential future registrational Phase 3 program.

Novavax intends to partner these programs and this trial reflects the completion of material investment by Novavax.

Discussions are ongoing with potential partners for these late-stage assets.

◦ New T-cell response data in both CIC and stand-alone influenza vaccine candidates were numerically higher than the Fluzone HD comparator arm indicating the potential for an increased duration of protection.

• In May 2025, Novavax and Takeda Pharmaceuticals announced significantly improved terms for their partnership to support ongoing commercialization of Nuvaxovid in Japan.

Takeda filed for approval of the updated Nuvaxovid vaccine in June and is on track to be on the market for the fall respiratory season in Japan.

• R21/Matrix-M ® , a malaria vaccine developed in partnership with Serum Institute of India and Oxford University, continued to make meaningful progress in addressing the urgent and unmet needs of malaria-endemic regions with 20 million doses sold since launch in mid-2024.

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

These arrangements have led to discussions with potential business partners to develop new vaccines and improve existing vaccines.

Strategic Priority #3:

Advance our Technology Platform and Early-stage Pipeline

• In April 2025, announced preliminary results from the SHIELD-Utah study that showed Novavax’s COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) targeting the JN.1 strain resulted in fewer and less severe reactogenicity symptoms, when compared with the Pfizer-BioNTech mRNA 2024-2025 vaccine.

• Continued advancement of early-stage preclinical research for H5N1 avian pandemic influenza, respiratory syncytial virus combinations, varicella-zoster virus (shingles) and Clostridioides difficile colitis vaccine candidates.

• In July 2025, we announced preclinical data demonstrating that Novavax’s H5N1 avian pandemic influenza vaccine candidate induced robust immune responses by either single or two-dose intranasal or intramuscular administration in primed non-human primates.

The results were published in Nature Communications.

• Continued advancement of early-stage preclinical research for H5N1 avian pandemic influenza, respiratory syncytial virus combinations, shingles and Clostridioides difficile colitis vaccine candidates.

• Generated preliminary positive data using Matrix-M with an oncology vaccine candidate with potential future application across several tumor types.

• Continued work on new potential Matrix formulations intended to improve upon and expand the utility of Matrix-M.

Other Corporate Highlights

• We continued to evolve and strengthen our Board of Directors with the appointment of Margaret McGlynn, RPh, as Chair of the Board and the appointment of John Shiver, PhD, and Charles Newton as directors.

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 months ended March 31, 2025 and 2024, no sales were recorded under the August 2023 Sales Agreement.

As of March 31, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $51 million.

During the three and six months ended June 30, 2025, no sales were recorded under the August 2023 Sales Agreement.

During the three and six months ended June 30, 2024, we sold 12.2 million shares of our common stock resulting in net proceeds of approximately $188 million, under the August 2023 Sales Agreement.

As of June 30, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $51 million.

In May 2024, the Company entered into the Subscription Agreement, pursuant to which the Company sold and issued to Sanofi, in a private placement, 6,880,481 shares of the Company’s common stock, par value $0.01 per share at a price of $10.00 per share for aggregate gross proceeds to the Company of $68.8 million.

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 March 31, 2025 and 2024

Three Months Ended March 31,

Three Months Ended June 30, 2025 and 2024

Three Months Ended June 30,

2025 2024 Change

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Total revenue $ 239,240 $ 415,484 $ (176,244)

Revenue for the three months ended March 31, 2025 was $666.7 million as compared to $93.9 million for the same period in 2024, an increase of $572.8 million.

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.

Revenue for the three months ended March 31, 2024 was primarily comprised of revenue from product sales of COVID-19 Vaccine.

The increase in revenue is primarily due to an increase in product sales from recognition of amounts previously deferred under the Canada and New Zealand APAs and an increase in licensing, royalties, and other revenue from transition services and technology transfer revenue under the Sanofi CLA.

Revenue for the three months ended June 30, 2025 was $239.2 million as compared to $415.5 million for the same period in 2024, a decrease of $176.2 million.

Revenue for the three months ended June 30, 2025 was primarily comprised of licensing revenue from the achievement of milestones and transition services and technology transfer under the Sanofi CLA and licensing and royalty revenue with Takeda.

Revenue for the three months ended June 30, 2024 was primarily comprised of revenue from licensing revenue under the Sanofi CLA.

The decrease in revenue is primarily due to a decrease in licensing revenue under the Sanofi CLA.

Product sales

Product sales for the three months ended March 31, 2025, were $621.7 million as compared to $89.8 million during the three months ended March 31, 2024.

Our product sales related to revenue from Nuvavovid™ sales, which commenced in 2022, commercial supply sales of COVID-19 Vaccine, revenue from supply of Adjuvant and other products, and recognition of amounts previously deferred under the Canada and New Zealand APAs.

Product sales for the three months ended June 30, 2025 were $10.7 million as compared to $22.6 million for the same period in 2024, a decrease of $11.9 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.

The categories of Product sales were as follows:

Three Months Ended March 31,

Three Months Ended June 30,

2025 2024 Change

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Total Product sales

$ 10,724 $ 22,588 $ (11,864)

(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 June 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 $7.5 million of revenue previously reported as License, royalties, and other revenue to product sales revenue for the three months ended March 31, 2024 related to adjuvant supply sales and other supply sales.

We reclassified $2.7 million of revenue previously reported as License, royalties, and other revenue to Product sales revenue for the three months ended June 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 March 31, 2025 was $45.0 million as compared to $4.0 million during the same period in 2024, an increase of $41.0 million.

The increase was primarily due to $40.3 million of revenue from transition services and technology transfer under the Sanofi CLA.

Licensing, royalties, and other revenue during the three months ended June 30, 2025 was $228.5 million as compared to $392.9 million during the same period in 2024, a decrease of $164.4 million.

The decrease was primarily due to a decrease in licensing revenue under the Sanofi CLA.

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

Three Months Ended March 31,

Three Months Ended June 30,

2025 2024 Change

1 unchanged sentence

Sanofi $ 199,412 $ 392,896 $ (193,484)

Takeda 27,212 — 27,212

Other partners (1)

1 unchanged sentence

Total licensing, royalties, and other revenue $ 228,516 $ 392,896 $ (164,380)

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

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

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

Three Months Ended March 31,

Three Months Ended June 30,

2025 2024 Change

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

$ — $ 386,250 $ (386,250)

Milestones 175,000 — 175,000

Transition services and technology transfer:

7 unchanged sentences

$ 199,412 $ 392,896 $ (193,484)

(1) Upfront fee amortization and Milestones amortization represent revenue recognized during the period related to 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.

Three Months Ended March 31,

(1) Upfront fee amortization and Milestones amortization represent revenue recognized during the period related to a portion of the 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.

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

Three Months Ended June 30,

2025 2024 Change

Takeda licensing, royalties, and other revenue

Upfront fee (1)

$ 18,500 $ — $ 18,500

Milestones 3,434 — 3,434

Royalties 5,000 — 5,000

Support services 278 — 278

Tota Total Takeda licensing, royalties, and other revenue $ 27,212 $ — $ 27,212

(1) Upfront fee includes $14.5 million of nonrefundable upfront payments associated with the collaboration and exclusive license agreement, as amended with Takeda (“Amended Takeda CLA”) and $4.0 million of previously unrecognized consideration from the collaboration and exclusive license agreement with Takeda (“Original Takeda CLA”).

Three Months Ended June 30,

2025 2024 Change

Expenses (in thousands):

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Cost of Sales

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 certain firm purchase commitments and $1.8 million related to unutilized manufacturing capacity.

Cost of sales was $59.2 million for the three months ended March 31, 2024, including expense of $8.8 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments and $6.0 million related to unutilized manufacturing capacity.

Cost of sales was $15.3 million for the three months ended June 30, 2025, including expenses of $1.1 million related to excess, obsolete, or expired inventory and $1.7 million related to unutilized manufacturing capacity.

Cost of sales was $46.2 million for the three months ended June 30, 2024, including expense of $11.4 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments and $12.9 million related to unutilized manufacturing capacity.

The decrease in cost of sales of $30.9 million was mainly driven by a decrease in the number of COVID-19 Vaccine doses sold, a decrease in excess, obsolete, and expired inventory charges, and a decrease in unutilized manufacturing capacity charges.

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Research and Development Expenses

Research and development expenses were $88.9 million for the three months ended March 31, 2025 as compared to $92.7 million for the three months ended March 31, 2024, a decrease of $3.7 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, as summarized in the table below (in thousands):

Three Months Ended March 31,

Research and development expenses were $79.2 million for the three months ended June 30, 2025 as compared to $106.9 million for the three months ended June 30, 2024, a decrease of $27.7 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):

Three Months Ended June 30,

Coronavirus vaccines $ 20,194 $ 40,812

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Total research and development expenses $ 79,233 $ 106,946

Research and development expenses for coronavirus vaccines for the three months ended March 31, 2025 and 2024 decreased from $26.1 million to $18.1 million primarily as a result of 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, including embedded lease costs, under manufacturing supply agreements with CMOs and contract manufacturing and development organizations (“CDMOs”).

Research and development expenses for coronavirus vaccines for the three months ended June 30, 2025 and 2024 decreased from $40.8 million to $20.2 million primarily as a result of 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 $48.1 million for the three months ended March 31, 2025 as compared to $86.8 million for the same period in 2024, a decrease of $38.7 million.

The decrease in selling, general, and administrative expenses is primarily due to certain cost containment measures to reduce our operating spend, including reduction in costs as a result of the sale of Novavax CZ in December 2024.

Selling, general, and administrative expenses were $43.6 million for the three months ended June 30, 2025 as compared to $101.3 million for the same period in 2024, a decrease of $57.7 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.

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 March 31,

Three Months Ended June 30,

2025 2024 Change

1 unchanged sentence

Interest expense $ (5,518) $ (4,143) $ (1,375)

Other income, net

Other income (expense), net 11,902 7,731 4,171

Total other income (expense), net

$ 6,384 $ 3,588 $ 2,796

Total other income (expense), net was $6.4 million of income for the three months ended June 30, 2025 as compared to a total other income (expense), net of $3.6 million of income for the same period in 2024.

The increase in other income (expense), net is primarily due to changes in foreign currency transaction gains during the period, offset by a decrease in interest income during the period from lower cash and marketable securities balances.

Income Tax Expense

During the three months ended June 30, 2025, we recognized income tax expense of $0.9 million related to federal, state, and foreign income taxes, and foreign withholding tax expense.

During the three months ended June 30, 2024, we recognized an income tax expense of $2.2 million related to federal, state, and foreign income taxes.

Three Months Ended June 30,

2025 2024 Change

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

Net income $ 106,508 $ 162,381 $ (55,873)

Net income per share, basic $ 0.66 $ 1.09 $ (0.43)

Net income per share, diluted $ 0.62 $ 0.99 $ (0.37)

Weighted average shares outstanding, basic 162,019 148,379 13,640

Weighted average shares outstanding, dilutive 177,215 165,855 11,360

Net income for the three months ended June 30, 2025 was $106.5 million, or $0.66 per share, basic and $0.62 per share, dilutive, as compared to net income of $162.4 million, or $1.09 per share, basic and $0.99 per share dilutive, for the same period in 2024.

The decrease in net income during the three months ended June 30, 2025, was primarily due to a decrease in total revenue partially offset by a decrease in total expenses.

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

Six Months Ended June 30, 2025 and 2024

Six Months Ended June 30,

2025 2024 Change

Revenue (in thousands):

Product sales $ 632,402 $ 112,424 $ 519,978

Licensing, royalties, and other 273,493 396,915 (123,422)

Total revenue $ 905,895 $ 509,339 $ 396,556

Revenue for the six months ended June 30, 2025 was $905.9 million as compared to $509.3 million for the same period in 2024, an increase of $396.6 million.

Revenue for the six months ended June 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, the recognition of previously deferred upfront payments and revenue from transition services and technology transfer under the Sanofi CLA, and licensing and royalty revenue with Takeda.

Revenue for the six months ended June 30, 2024 was primarily comprised of revenue from licensing revenue 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.

Product sales

Product sales for the six months ended June 30, 2025 were $632.4 million as compared to $112.4 million during the six months ended June 30, 2024, an increase of $520.0 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.

The categories of Product sales were as follows:

Six Months Ended June 30,

2025 2024 Change

Product sales (in thousands)

Nuvaxovid sales (1)

$ 605,931 $ 102,228 $ 503,703

Supply sales (2)

26,471 10,196 16,275

Total Product sales

$ 632,402 $ 112,424 $ 519,978

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

We reclassified $10.2 million of revenue previously reported as License, royalties, and other revenue to Product sales revenue for the six months ended June 30, 2024 related to adjuvant supply sales and other supply sales.

Licensing, royalties, and other

Licensing, royalties, and other revenue during the six months ended June 30, 2025 was $273.5 million as compared to $396.9 million during the same period in 2024, a decrease of $123.4 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 the Amended Takeda CLA.

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

Six Months Ended June 30,

2025 2024 Change

Licensing, royalties, and other (in thousands)

Sanofi $ 239,733 $ 392,896 $ (153,163)

Takeda 27,212 — 27,212

Other partners (1)

6,548 4,019 2,529

Total licensing, royalties, and other revenue $ 273,493 $ 396,915 $ (123,422)

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

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

Six Months Ended June 30,

2025 2024 Change

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

$ — $ 386,250 $ (386,250)

Milestones 175,000 — 175,000

Transition services and technology transfer:

Upfront fee amortization (1)

32,180 4,573 27,607

Milestones amortization (1)

14,808 2,073 12,735

Cost reimbursements

17,745 — 17,745

Total Sanofi licensing, royalties, and other revenue

$ 239,733 $ 392,896 $ (153,163)

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

Six Months Ended June 30,

2025 2024 Change

Takeda licensing, royalties, and other revenue

Upfront fee (1)

$ 18,500 $ — $ 18,500

Milestones 3,434 — 3,434

Royalties 5,000 — 5,000

Support services 278 — 278

Tota Total Takeda licensing, royalties, and other revenue $ 27,212 $ — $ 27,212

(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.

Six Months Ended June 30,

2025 2024 Change

Expenses (in thousands):

Cost of sales $ 29,439 $ 105,451 $ (76,012)

Research and development 168,170 199,625 (31,455)

Selling, general, and administrative 91,702 188,096 (96,394)

Total expenses $ 289,311 $ 493,172 $ (203,861)

Cost of Sales

Cost of sales was $29.4 million for the six months ended June 30, 2025, including expenses of $1.4 million related to excess, obsolete, or expired inventory and $3.5 million related to unutilized manufacturing capacity.

Cost of sales was $105.5 million for the six months ended June 30, 2024, including expense of $20.2 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments and $18.8 million related to unutilized manufacturing capacity.

The decrease in cost of sales of $76.0 million was mainly driven by a decrease in the number of COVID-19 Vaccine doses sold, 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 decreased to $168.2 million for the six months ended June 30, 2025 from $199.6 million for the same period in 2024, a decrease of $31.5 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):

Six Months Ended June 30,

Coronavirus vaccines $ 46,722 $ 65,962

Other vaccine development programs 2,720 736

Total direct external research and development expense 49,442 66,698

Employee expenses 68,270 74,191

Stock-based compensation expense 7,790 11,682

Facility expenses 25,812 24,696

Other expenses 16,856 22,358

Total research and development expenses $ 168,170 $ 199,625

Research and development expenses for coronavirus vaccines for the six months ended June 30, 2025 and 2024 decreased from $66.0 million to $46.7 million primarily as a result of a reduction in manufacturing and support costs due, in part, to a reduction in our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, and under manufacturing supply agreements with CMOs and CDMOs.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses decreased to $91.7 million for the six months ended June 30, 2025 from $188.1 million for the same period in 2024, a decrease of $96.4 million.

Other Income (Expense)

Six Months Ended June 30,

2025 2024 Change

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

Interest expense $ (11,241) $ (8,254) $ (2,987)

21,957 11,385 10,572

Total other income (expense), net

$ 10,716 $ 3,131 $ 7,585

Total other income (expense), net was $4.3 million of income for the three months ended March 31, 2025 as compared to a total other income (expense), net of $0.5 million of expense for the same period in 2024.

The increase in other income (expense), net is primarily due to 2025 other income items of $4.8 million from the derivative action settlement proceeds and $3.6 million of state incentives, partially offset by the unfavorable impact in 2025 as compared to 2024 of exchange rates on foreign currency denominated balances.

Total other income (expense), net for the six months ended June 30, 2025 was $10.7 million of income as compared to $3.1 million of income for the same period in 2024, an increase of $7.6 million.

The increase in other income (expense) is primarily due to changes in foreign currency transaction gains during the period, offset by a decrease in interest income during the period from lower cash and marketable securities balances.

Income Tax Expense

During the three months ended March 31, 2025, we recognized income tax expense of $0.7 million related to federal, state, and foreign income taxes, and foreign withholding tax expense of $0.5 million.

During the three months ended March 31, 2024, we recognized an income tax expense of $2.3 million related to federal, state, and foreign income taxes.

Net Income (Loss)

Three Months Ended March 31,

During the six months ended June 30, 2025, we recognized an income tax expense of $2.1 million related to federal, state, and foreign income taxes and foreign withholding taxes.

During the six months ended June 30, 2024, we recognized an income tax expense of $4.5 million related to federal, state, and foreign income taxes.

Six Months Ended June 30,

2025 2024 Change

Net Income (Loss) (in thousands, except per share information):

Net income (loss) $ 518,646 $ (147,550) $ 666,196

Net income (loss) per share, basic $ 3.22 $ (1.05) $ 4.27

Net income (loss) per share, diluted $ 2.93 $ (1.05) $ 3.98

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

Net Income $ 625,154 $ 14,831 $ 610,323

Net Income per share, basic $ 3.87 $ 0.10 $ 3.77

Net income per share, dilutive $ 3.55 $ 0.10 $ 3.45

Weighted average shares outstanding, basic 161,536 144,147 17,389

Weighted average shares outstanding, dilutive 177,410 145,121 32,289

Net loss for the three months ended March 31, 2025 was $518.6 million, or $3.22 per share, basic and $2.93 per share, dilutive, as compared to net loss of $147.6 million, or $1.05 per share, basic and dilutive, for the same period in 2024.

The increase in net income during the three months ended March 31, 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 three months ended March 31, 2025, was primarily a result of sales of our common stock.

Net income for the six months ended June 30, 2025 was $625.2 million, or $3.87 per share, basic and $3.55 per share, dilutive, as compared to net income of $14.8 million, or $0.10 per share, basic and $0.10 per share dilutive, for the same period in 2024.

The increase in net income during the six months ended June 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 six months ended June 30, 2025 is primarily a result of sales of our common stock in 2024 and common stock issued under our incentive programs.

Liquidity Matters and Capital Resources

2 unchanged sentences

the progress of preclinical studies and clinical trials;

the time and costs involved in obtaining regulatory approvals;

the time and costs involved in obtaining and maintaining regulatory approvals;

the costs of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights;

7 unchanged sentences

In May 2024, we entered into the Sanofi CLA pursuant to which we received a non-refundable upfront payment of $500 million.

During the quarter ended March 31, 2025, we received a milestone payment of $50 million for database lock of an existing Phase 2/3 clinical trial in 2024 and are eligible to receive additional development, technology transfer, launch, and sales milestone payments totaling up to $650 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products.

During the quarter ended June 30, 2025, we received a milestone payment of $50 million for database lock of an existing Phase 2/3 clinical trial in 2024, achieved the $175 million milestone upon the approval of the marketing authorization for a COVID-19 Vaccine Product in a pre-filled syringe from the U.S.

We expect to receive the $175.0 million milestone payment in the three months ended September 2025.

We are eligible to receive additional development, technology transfer, launch, and sales milestone payments totaling up to $475 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products.

In addition, we are eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four adjuvant Products and $210 million for each adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products.

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 a $175 million milestone upon the approval of the BLA marketing authorization for our COVID-19 Vaccine Product in a pre-filled syringe from the U.S.

FDA, $25 million upon the transfer of the U.S.

MAH to Sanofi, $25 million upon the transfer of EMA MAH in a pre-filled syringe to Sanofi, and $75 million 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 $125.0 million milestone upon achievement of certain influenza-COVID-19 combination products-related

development milestones, and a $225.0 million in influenza-COVID-19 combination products-related launch milestones.

We believe our BLA is approvable based on conversations with U.S.

FDA, as of our PDUFA date on April 1 and through the date of this Quarterly Report on Form 10-Q.

We recently received formal communication from the U.S.

FDA in the form of an information request for a post marketing commitment (“PMC”) to generate additional clinical data.

We have responded to the FDA’s information request with a proposed study design and continue to engage with the U.S.

FDA to address the PMC request and move to approval as soon as possible.

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

MAH to Sanofi, $25 million upon the transfer of the European Medicines Agency (“EMA”) MAH in a pre-filled syringe to Sanofi, and $75 million 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 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.

Beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi expect 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.

1 unchanged sentence

Takeda Amended and Restated Collaboration and License Agreement

On April 29, 2025, we entered into a collaboration and exclusive license agreement, as amended, (the “Amended Takeda CLA”) with Takeda which amends and supersedes the collaboration and exclusive license agreement, dated February 24, 2021, (the “Original Takeda CLA,” together with the Amended Takeda CLA, the “ Takeda CLA”).

Under the Amended Takeda CLA, we will receive a non-refundable upfront payment of approximately $20 million of which $5.0 million is creditable against royalties owed by Takeda for its fiscal year 2024.

In addition, on an annual basis, (i) we will receive $2.0 million to compensate us for services provided by us under the Takeda CLA, and (ii) 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), commencing on April 1, 2024 and will continue until the latest 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.

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 the 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 three and six months ended June 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 six months ended June 30, 2025 was $0.3 million.

Under the Amended Takeda CLA, we will receive 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 latest 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.

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.

Supply Agreements

As of March 31, 2025, we have remaining obligations under APAs with certain countries globally, excluding the Vaccine Alliance (“Gavi”), of $248.4 million.

As of June 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 March 31, 2025, $31.2 million was classified as current Deferred revenue and $102.6 million was classified as non-current Deferred revenue in our consolidated balance sheet.

With respect to the Australia APA, as of June 30, 2025, $31.2 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.

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 $114.6 million, as of March 31, 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 and $26.4 million remains to be billed upon delivery of doses of COVID-19 Vaccine.

With respect to other obligations under APAs of $88.2 million, as of June 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.

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

In March 2025, we received a communication (the “Notice”) terminating, with immediate effect, our APA with His Majesty the King in Right of Canada as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (the “Canadian government”), for the purchase of doses of COVID-19 Vaccine (the “Canada APA”).

As a result of the termination, we were required under the terms of the Canada APA, to repay $28.0 million in advanced purchase payments

previously received within 30 days of the Notice, which we repaid in March 2025.

We recognized $575.7 million, previously in deferred revenue and other liabilities, as product revenue in the first quarter of 2025.

In March 2025, we and the Pharmaceutical Management Agency (“Pharmac”), a New Zealand Crown entity, executed a Deed of Settlement and Release (“New Zealand Settlement Agreement”) of its APA (the “New Zealand APA”).

As part of the New Zealand Settlement Agreement, we agreed to pay Pharmac a refund of previously received upfront payments of $4.0 million, which was paid in March 2025 .

Under the New Zealand Settlement Agreement, we have no remaining obligation to Pharmac under the New Zealand APA.

We recognized $27.3 million as product revenue in the first quarter of 2025.

In November 2024, we entered into a settlement agreement with the Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), pursuant to which we and the Authority agreed to terminate the Amended and Restated Supply Agreement with the Authority and to fully settle the outstanding amount under dispute related to upfront payments of $112.5 million.

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 March 31, 2025, pursuant to our settlement agreement with the UK, the remaining upfront payment previously received from the authority is classified as $36.9 million of other current liabilities and $49.3 million of Other non-current liabilities on our consolidated balance sheet.

As of June 30, 2025, pursuant to our settlement agreement with the UK, the remaining upfront payment previously received from the authority is classified as $37.5 million of other current liabilities and $39.8 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 the $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 March 31, 2025, the remaining amounts included on our consolidated balance sheet are classified as $225.0 million in non-current Deferred revenue for the additional credit that may be applied against future qualifying sales, $80.0 million in Other current liabilities, and $240.0 million in Other non-current liabilities.

As of June 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 $225.0 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.

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

As of March 31, 2025, we had $746.6 million in cash and cash equivalents, restricted cash and marketable securities as compared to $938.2 million as of December 31, 2024.

We funded our operations for the three months ended March 31, 2025 primarily with cash and cash equivalents, milestone payments under the Sanofi CLA and revenue from product sales.

As of June 30, 2025, we had $627.5 million in cash and cash equivalents, restricted cash and marketable securities as compared to $938.2 million as of December 31, 2024.

We expect to receive $175.0 million in the third quarter of 2025 related to the milestone payment triggered under the Sanofi CLA that is included in Accounts receivable as of June 30, 2025 in the accompanying unaudited financial statements.

We funded our operations for the six months ended June 30, 2025 primarily with cash and cash equivalents, 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 exploring the use of our real estate portfolio in Gaithersburg, Maryland.

We anticipate our future operations to be funded primarily by milestone payments, royalties, transition services and technology transfer 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 three months ended March 31, 2025 and 2024 (in thousands):

Three Months Ended March 31,

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 six months ended June 30, 2025 and 2024 (in thousands):

Six Months Ended June 30,

2025 2024 Change

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Effect on exchange rate on cash, cash equivalents, and restricted cash 6,976 (3,111) 10,087

Net decrease in cash, cash equivalents, and restricted cash

Net increase (decrease) in cash, cash equivalents, and restricted cash

(276,310) 111,748 (388,058)

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Cash, cash equivalents, and restricted cash at end of period $ 268,982 $ 695,558 $ (426,576)

Net cash used in operating activities was $185.5 million for the three months ended March 31, 2025, as compared to $83.6 million for the same period in 2024.

Net cash used in operating activities was $313.0 million for the six months ended June 30, 2025, as compared to $230.7 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 $73.3 million for the three months ended March 31, 2025, as compared to $7.3 million for the same period in 2024.

The increase in cash used in investing activities is primarily due to our investment in marketable securities, partially offset by lower expenditures on equipment and leasehold improvements.

Net cash used in financing activities was $7.1 million for the three months ended March 31, 2025, as compared to net cash provided by financing activities of $5.9 million for the same period in 2024.

Net cash provided by investing activities was $37.8 million for the six months ended June 30, 2025, as compared to $380.0 million of cash used for the same period in 2024.

The increase in cash provided by investing activities is primarily due to our investment in marketable securities, partially offset by lower expenditures on equipment and leasehold improvements.

Net cash used in financing activities was $8.1 million for the six months ended June 30, 2025, as compared to net cash provided by financing activities of $264.1 million for the same period in 2024.

The increase in cash used in financing activities is primarily due to a decrease in net proceeds from sales of common stock, the exercise of stock-based awards, and payment of finance lease liabilities.

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis