NOVAVAX INC

Previous wording

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, our ability to successfully and timely obtain and maintain full U.S. FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver our COVID-19 Vaccine; the impact of delays in obtaining regulatory approval, including regulatory decisions impacting labeling, approval or authorization, including the scope of the indicated population, product dosage, manufacturing processes, shelf life, safety, for our product candidates; challenges in conducting the PMC study, our ability to obtain adequate additional funding to maintain our current level of operations and fund the further development of our vaccine candidates; challenges related to our partnership with Sanofi, including collaboration on the PMC, and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation, and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for our product candidates; manufacturing, distribution or export delays or challenges; our substantial dependence on Serum Institute of India Pvt. Ltd. (“SII”) and Serum Life Sciences Limited (“SLS” and together with SII, “Serum”) for co-formulation and filling our COVID-19 Vaccine and the impact of any delays or disruptions in their operations; the impact of potential legislative, regulatory, or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance; uncertainty with respect to pricing, third-party reimbursement and healthcare reform; uncertainty in the regulatory pathway for our COVID -19 Vaccine; the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty obtaining scarce raw materials and supplies, including for our proprietary adjuvant; resource constraints, including human capital and manufacturing capacity, constrain…

Excerpt shortened here; the source contains the full paragraph.

Current wording

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, our ability to successfully and timely obtain and maintain full U.S. FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver our COVID-19 Vaccine; the impact of delays in obtaining regulatory approval, including regulatory decisions impacting labeling, approval or authorization, including the scope of the indicated population, product dosage, manufacturing processes, shelf life, safety, for our product candidates; challenges in conducting the PMC study, our ability to obtain adequate additional funding to maintain our current level of operations and fund the further development of our vaccine candidates; challenges related to our partnership with Sanofi, including collaboration on the PMC, and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation, and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for our product candidates; manufacturing, distribution or export delays or challenges; our substantial dependence on Serum Institute of India Pvt. Ltd. (“SII”) and Serum Life Sciences Limited (“SLS” and together with SII, “Serum”) for co-formulation and filling our COVID-19 Vaccine and the impact of any delays or disruptions in their operations; the impact of potential legislative, regulatory, or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance; uncertainty with respect to pricing, third-party reimbursement and healthcare reform; uncertainty in the regulatory pathway for our COVID -19 Vaccine; the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty obtaining scarce raw materials and supplies, including for our proprietary adjuvant; resource constraints, including human capital and manufacturing capacity, constrain…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

We are a company tackling global health challenges through scientific innovation that seeks to maximize our deep scientific expertise in vaccines and our cutting-edge technology platform. The differentiated platform features our recombinant protein-based nanoparticle technology and unique Matrix-M adjuvant. Our three strategic priorities are: focusing on our partnership with Sanofi announced in May 2024, enhancing existing partnership and leveraging our technology platform and pipeline to forge additional partnerships, and advancing our proven technology platform and early-stage pipeline. Our corporate growth strategy is supported by a lean and focused operating model.

Current wording

We are a company tackling global health challenges through scientific innovation that seeks to maximize our deep scientific expertise in vaccines and our cutting-edge technology platform. The differentiated platform features our recombinant protein-based nanoparticle technology and unique Matrix-M adjuvant. Our three strategic priorities are: focusing on our partnership with Sanofi announced in May 2024, enhancing existing partnership and leveraging our technology platform and pipeline to forge additional partnerships, and advancing our proven technology platform and early-stage pipeline. Our corporate growth strategy is supported by a lean, agile, and focused operating model.

Previous wording

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 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. We are pursuing early-stage research in diseases such as, respiratory syncytial virus (“RSV”) combinations, varicella-zoster virus (shingles) and Clostridioides difficile (C. Diff.) colitis. We are actively working to evaluate several RSV combination candidates to progress forward toward an Investigational New Drug (“IND”). We are actively developing an H5N1 avian pandemic influenza vaccine candidate and the toxicology study is underway. We are pursuing funding opportunities to join preparedness options. Additionally, we are evaluating potential expansion beyond infectious diseases, where we believe our technology could augment and improve upon current therapies.

Current wording

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 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. We are pursuing early-stage research in diseases such as, respiratory syncytial virus (“RSV”) combinations, varicella-zoster virus (“Shingles”) and Clostridioides difficile (“C. Diff.”) colitis. We are actively working to evaluate several RSV combination candidates to progress forward toward an Investigational New Drug (“IND”). We are actively developing a pandemic influenza vaccine candidate and the toxicology study is underway. We are pursuing funding opportunities to join preparedness options. Additionally, we are evaluating potential expansion beyond infectious diseases, where we believe our technology could augment and improve upon current therapies.

Previous wording

•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.

Current wording

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

Previous wording

Additionally, we intend to develop our early-stage pipeline using a disciplined and capital-efficient approach. Our R&D investment strategy seeks to place targeted investments on the programs with the highest potential value, both within infectious disease and beyond, with the intent of partnering these programs at proof of concept. 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 conducting early-stage research in diseases such as, RSV combinations, shingles and C. Diff. 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.

Current wording

Additionally, we intend to develop our early-stage pipeline using a disciplined and capital-efficient approach. Our R&D investment strategy seeks to place targeted investments on the programs with the highest potential value, both within infectious disease and beyond, with the intent of partnering these programs at proof of concept. We would consider advancing a program ourselves where data and commercial landscape indicate a unique high-value opportunity. We are actively developing a pandemic influenza vaccine candidate and pursuing funding opportunities to join preparedness options. We are conducting early-stage research in diseases such as, RSV combinations, Shingles and C. Diff. 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.

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

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

Previous wording

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. 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. The U.S. 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.

Current wording

This trial is evaluating the safety, effectiveness (immunogenicity), and efficacy of two doses of our COVID-19 Vaccine, followed by a booster 6 months after the primary vaccination series. The trial completed enrollment in September 2023 and includes three age de-escalation cohorts of 1,200 children each. Safety follow up was completed in October 2025. The U.S. 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.

Previous wording

In May 2025, we announced that the U.S. FDA, as a part of its BLA approval, requested a PMC to conduct a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. 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.

Current wording

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

Previous wording

Second Quarter 2025 and Recent Highlights

Current wording

Third Quarter 2025 and Recent Highlights

Previous wording

•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.

Current wording

•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.

Previous wording

•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.

Current wording

•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.

Previous wording

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

Current wording

•Continued advancement of early-stage preclinical research for Shingles, C. Diff. and RSV combination vaccine candidates.

Previous wording

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.

Current wording

In August 2023, we entered into an At Market Issuance Sales Agreement (the “August 2023 Sales Agreement”), which allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock, and terminated our then-existing At Market Issuance Sales agreement entered in June 2021. During the three and nine months ended September 30, 2025, no sales were recorded under the August 2023 Sales Agreement. During the nine months ended September 30, 2024, we sold 12.2 million shares of our common stock under the August 2023 Sales Agreement, resulting in net proceeds of approximately $188 million. There were no sales recorded under the August 2023 Sales Agreement during the three months ended September 30, 2024. As of September 30, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $51 million.

Previous wording

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.

Current wording

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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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

Previous wording

(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.

Current wording

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

Previous wording

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.

Current wording

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

Previous wording

(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.

Current wording

(1)Upfront fee amortization and Milestones amortization represent revenue recognized during the period related to a portion of the $500 million upfront payment and the $50 million milestone for database lock of an existing Phase 2/3 clinical trial in 2024 that were deferred upon achievement and are recognized in revenue over time. During the three months ended 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.

Previous wording

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. The cost of sales as a percentage of Product sales may fluctuate in the future as a result of changes to our customer pricing mix or standard costs.

Current wording

Cost of sales was $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.

Previous wording

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):

Current wording

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

Previous wording

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”).

Current wording

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”).

Previous wording

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.

Current wording

Selling, general, and administrative expenses were $31.7 million for the three months ended September 30, 2025 as compared to $70.7 million for the same period in 2024, a decrease of $39.1 million. The decrease in selling, general, and administrative expenses is primarily due to certain cost containment measures to reduce our operating spend, including a reduction in our global commercial footprint and administrative infrastructure and the sale of the Novavax CZ manufacturing facility in December 2024.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

Revenue for the nine months ended September 30, 2025 was $976.3 million as compared to $593.9 million for the same period in 2024, an increase of $382.5 million. Revenue for the nine months ended September 30, 2025 was primarily comprised of revenue from the termination of our APAs with Canada (“Canada APA”) and New Zealand (“New Zealand APA”) of $575.7 million and $27.3 million, respectively, licensing revenue from the achievement of milestones under the Sanofi CLA and revenue from Transition Services and Technology Transfer under the Sanofi CLA, and licensing and royalty revenue with Takeda. Revenue for the nine months ended September 30, 2024 was primarily comprised of revenue from licensing revenue from execution of the Sanofi CLA, revenue from Transition Services and Technology Transfer under the Sanofi CLA, and Product sales of COVID-19 Vaccine. The increase in revenue is primarily due to an increase in Product sales from the termination of our Canada and New Zealand APAs, partially offset by a decrease in Licensing, royalties, and other revenue from the Sanofi CLA.

Previous wording

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.

Current wording

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.

Previous wording

(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.

Current wording

(2) Supply sales include commercial sales of COVID-19 Vaccine, adjuvant sales, and sale of other materials to our partners. We reclassified $13.5 million of revenue previously reported as License, royalties, and other revenue to Product sales revenue for the nine months ended September 30, 2024 related to adjuvant supply sales and other supply sales.

Previous wording

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.

Current wording

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.

Previous wording

(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.

Current wording

(1)Upfront fee amortization and Milestones amortization represent revenue recognized during the period related to a portion of the $500 million upfront payment and the $50 million milestone for database lock of an existing Phase 2/3 clinical trial in 2024 that were deferred upon achievement and are recognized in revenue over time.

Previous wording

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.

Current wording

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.

Previous wording

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):

Current wording

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):

Previous wording

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. The decrease in selling, general, and administrative expenses is primarily due to certain cost containment measures to reduce our operating spend, including a reduction in our global commercial footprint and administrative infrastructure and the sale of the Novavax CZ manufacturing facility in December 2024.

Current wording

Selling, general, and administrative expenses 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. 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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

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.