What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-06 · 198 added, 168 removed, 405 unchanged (47% of the section changed)

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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;

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;

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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 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, 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.

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

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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 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.

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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 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.

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

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

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

We are pursuing funding opportunities to join preparedness options.

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

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

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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 pursuing funding opportunities to join preparedness options.

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.

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FDA in December 2024 to prevent influenza and COVID-19 infections in individuals aged 50 and older.

In October 2025, Sanofi reported preliminary positive immunogenicity and safety Phase 1/2 data for Nuvaxovid in combination with both Fluzone High-Dose and Flublok.

Sanofi also has a non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines, and a non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M adjuvant.

In September 2025, we amended the Sanofi CLA to expand Sanofi's license to include use of Novavax's Matrix-M adjuvant in Sanofi's pandemic influenza vaccine candidate program.

Sanofi recently received funding from the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response, part of the U.S.

Department of Health and Human Services, for early-stage work on this vaccine candidate including the Matrix-M adjuvant.

Coronavirus Vaccine Clinical Development

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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.

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.

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.

This ongoing trial is evaluating the safety, effectiveness (immunogenicity), and efficacy of two doses of our prototype COVID-19 Vaccine (NVX-CoV2373), followed by a booster 6 months after the primary vaccination series.

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 is expected to be completed in October 2025.

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.

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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.

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 Sanofi Transition Services and Sanofi Technology Transfer.

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”).

COVID-Influenza Combination and Stand-alone Influenza Program

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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.

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 that would enable the generation of additional vaccine candidates.

R21/Matrix-M Adjuvant Malaria Vaccine

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Business Highlights

Second Quarter 2025 and Recent Highlights

Third Quarter 2025 and Recent Highlights

Strategic Priority #1:

Sanofi Partnership

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

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 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.

• 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

• 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.

• 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.

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 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.

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.

Critical Accounting Policies and Use of Estimates

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Recent Accounting Pronouncements Not Yet Adopted

See “Note 2―Summary of Significant Accounting Policies” included in our Notes to Consolidated Financial Statements (Unaudited) (under the caption “ Recent Accounting Pronouncements ”).

See “Note 2―Summary of Significant Accounting Policies” included in our unaudited consolidated financial statements (under the caption “ Recent Accounting Pronouncements ”).

Results of Operations

The following is a discussion of the historical financial condition and results of our operations that should be read in conjunction with the unaudited consolidated financial statements and notes set forth in this Quarterly Report.

The following is a discussion of the historical financial condition and results of our operations that should be read in conjunction with our unaudited consolidated financial statements and notes set forth in this Quarterly Report.

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

Three Months Ended June 30, 2025 and 2024

Three Months Ended June 30,

Three Months Ended September 30, 2025 and 2024

Three Months Ended September 30,

2025 2024 Change

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

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.

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 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.

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 June 30,

Three Months Ended September 30,

2025 2024 Change

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

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

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 $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.

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 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 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 June 30,

Three Months Ended September 30,

2025 2024 Change

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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 and SK bioscience, Co., Ltd.

(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 June 30,

Three Months Ended September 30,

2025 2024 Change

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$ — $ 3,392 $ (3,392)

Milestones 175,000 — 175,000

4,196 — 4,196

Transition services and technology transfer:

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$ 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 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.

(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 June 30,

Three Months Ended September 30,

2025 2024 Change

Takeda licensing, royalties, and other revenue

Upfront fee (1)

$ 18,500 $ — $ 18,500

Milestones $ 4,717 $ — $ 4,717

Royalties 5,000 — 5,000

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

(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,

Three Months Ended September 30,

2025 2024 Change

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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 $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.

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 $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,

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

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

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”).

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 $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.

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 June 30,

Three Months Ended September 30,

2025 2024 Change

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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)

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

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.

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 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,

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 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,

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,

2025 2024 Change

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Total revenue $ 976,340 $ 593,851 $ 382,489

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.

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.

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.

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.

The categories of Product sales were as follows:

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Change

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

We reclassified $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.

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.

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 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 were comprised of the following:

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Change

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

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Change

2 unchanged sentences

Milestones 175,000 — 175,000

4,196 — 4,196

Transition services and technology transfer:

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$ 288,027 $ 429,012 $ (140,985)

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

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Change

3 unchanged sentences

Milestones 8,151 — 8,151

Royalties 5,000 — 5,000

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.

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Change

3 unchanged sentences

Selling, general, and administrative 123,357 258,843 (135,486)

Impairment of assets held for sale

97,038 — 97,038

Total expenses $ 537,775 $ 711,702 $ (173,927)

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.

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.

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.

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):

Six Months Ended June 30,

Nine Months Ended September 30,

Coronavirus vaccines $ 86,161 $ 87,759

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Total research and development expenses $ 266,444 $ 286,789

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.

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)

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Change

1 unchanged sentence

Interest expense $ (16,723) $ (12,490) $ (4,233)

21,957 11,385 10,572

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)

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

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.

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.

Income Tax Expense

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,

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.

Net Income (Loss)

Nine Months Ended September 30,

2025 2024 Change

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

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

Net income (loss) $ 422,775 $ (106,469) $ 529,244

Net income (loss) per share, basic $ 2.61 $ (0.71) $ 3.32

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

Weighted average shares outstanding, basic 161,811 149,486 12,325

Weighted average shares outstanding, dilutive 168,195 149,486 18,709

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.

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.

Liquidity Matters and Capital Resources

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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.

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.

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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 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.

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.

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 $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.

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

Beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi began to commercialize the COVID-19 Vaccine Products worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply our existing APA customers and strategic partners, including Takeda and SII.

Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.

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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 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 three and six months ended June 30, 2025.

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 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.

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 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.

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.

Supply Agreements

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

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 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.

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 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.

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.

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 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.

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.

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 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.

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.

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 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.

2031 Convertible Notes

In August 2025, we issued $225.0 million aggregate principal amount of our 4.625% Convertible Senior Notes due 2031 (the “2031 Notes”) consisting of (a) $175.3 million principal amount of 2031 Notes issued in exchange for $148.8 million principal amount of our 5.00% Convertible Senior Notes due 2027, and (b) approximately $49.7 million principal amount of 2031 Notes issued for cash, in each case, pursuant to exemptions from registration under the Securities Act and the rules and regulations thereunder.

The 2031 Notes were issued pursuant to, and are governed by, an indenture, dated as of August 27, 2025, between the Company and The Bank of New York Mellon Trust Company, N.A.

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.

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

Six Months Ended June 30,

The following table summarizes cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):

Nine Months Ended September 30,

2025 2024 Change

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Cash, cash equivalents, and restricted cash at end of period $ 283,357 $ 588,587 $ (305,230)

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.

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 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.

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.

Going Concern

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What changed 10-Q

Item 2. Management’s Discussion and Analysis