SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

Total revenue of $70 million in the third quarter of 2025 Continued successful execution of Sanofi partnership with $225 million in milestones achieved year-to-date including $50 million earned on marketing authorization transfers Sanofi reported preliminary positive immunogenicity and safety Phase 1/2 data for Nuvaxovid ™ in combination with both Fluzone High-Dose and Flublok Sanofi received BARDA grant for pandemic influenza vaccine candidate using Novavax's Matrix-M® adjuvant Maryland site consolidation transactions resulted in $60 million cash proceeds and approximately $230 million in expected future cost savings Raises Full Year 2025 Revenue Framework and Affirms Financial Guidance C ompany to host conference call today at 8:30 a.m. ET GAITHERSBURG, Md., Nov. 6, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the third quarter ended September 30, 2025. "We have continued the steady transformation of Novavax and are proud of our progress this quarter," said John C. Jacobs, President and Chief Executive Officer, Novavax. "This year we have relaunched the Company with a focus on R&D and partnerships intended to position us well for long-term growth and profitability." Third Quarter 2025 and Recent Highlights Key Highlights Strategic Priority #1: Optimize our Sanofi Partnership Continued successful execution of Sanofi partnership with $225 million in milestones earned year-to-date, including $50 million earned in the fourth quarter of 2025, upon marketing authorization transfers for E.U. and U.S. markets. 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. Food and Drug Administration (FDA). 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, Novavax expanded Sanofi's license to include use of Novavax's Matrix-M® adjuvant in Sanofi's pandemic influenza vaccine candidate program. Sanofi received funding from the Biomedical Advanced Research and Development Authority (BARDA) for early-stage clinical work on this vaccine candidate. Strategic Priority #2: Enhance Existing Partnerships and Leverage our Technology Platform and Pipeline to Forge Additional Partnerships In September 2025, our partner Takeda received approval of Nuvaxovid in Japan which triggered a milestone payment to Novavax. R21/Matrix-M, a malaria vaccine developed in partnership with Serum Institute of India 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, Novavax announced material transfer agreements with three pharmaceutical companies to explore the utility of Matrix-M in their portfolios; discussions continue with these companies for the potential use of Matrix-M in the development of new vaccines and/or improve existing vaccines. Strategic Priority #3: Advance our Technology Platform and Early-Stage Pipeline Continued advancement of early-stage preclinical research for varicella-zoster virus (shingles), Clostridioides difficile colitis and respiratory syncytial virus combinations 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, Novavax 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, Novavax 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. Third Quarter 2025 Revenue Third Quarter 2025 Financial Results Total revenue for the third quarter of 2025 was $70 million, compared to $85 million in the same period in 2024. Cost of sales for the third quarter of 2025 was $21 million, compared to $61 million in the same period in 2024. Research and development (R&D) expenses for the third quarter of 2025 were $98 million, compared to $87 million in the same period in 2024. R&D transition services expenses reimbursed by Sanofi in the third quarter of 2025 were $46 million or approximately 47% of total R&D expenses in the period. Selling, general, and administrative (SG &A) expenses for the third quarter of 2025 were $32 million, compared to $71 million for the same period in 2024. The 55% decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus ongoing general administrative cost reduction efforts. Non-cash charges for the third quarter of 2025 were $126 million. The $97 million asset impairment related to the Maryland site consolidation transactions announced in October 2025, which includes the write off of the right-of-use asset, property and equipment, and intangibles, partially offset by a gain recognized on the sale of adjacent land. The $29 million loss on debt extinguishment related to the August 2025 convertible debt refinancing. Net loss for the third quarter of 2025 was $202 million, compared to net loss of $121 million in the same period in 2024. Cash, cash equivalents, marketable securities and restricted cash (Cash) were $778 million as of September 30, 2025, compared to $938 million as of December 31, 2024. Financial Framework Full Year 2025 Financial Guidance Novavax provides Full Year 2025 Financial Guidance for Combined R&D and SG&A Expenses and Non-GAAP Combined R&D and SG&A Expenses and currently expects to achieve the following results: Non-GAAP Combined R&D and SG&A Expenses exclude R&D Reimbursements, which are amounts reimbursed by Novavax's license partners. See "Non-GAAP Financial Measures" below. R&D Reimbursements are recorded as revenue under Licensing, Royalties and Other Revenue. Full Year 2025 Revenue Framework Novavax transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 COVID-19 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi's sales forecasts for certain revenue components, these are not included in the Full Year 2025 Revenue Framework. For 2025, Novavax currently expects to achieve Adjusted Total Revenue1 of between $1,040 million and $1,060 million. Components of Revenue excluded from the Full Year 2025 Revenue Framework are described below. Sanofi Supply Sales Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2025-2026 COVID-19 vaccination season and the reimbursement for this supply will be recorded as product sales. Sanofi Royalties Sanofi will initiate lead commercial responsibility for the 2025-2026 COVID-19 vaccination season in select markets, including the U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi sales. Sanofi Influenza-COVID-19 Combination and Matrix-M Related Milestones Novavax is eligible to receive up to $350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi Influenza-COVID-19 combination products. For each new vaccine using Matrix-M, Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single digit sales royalties for 20 years. Conference Call Novavax will host its quarterly conference call today at 8:30 a.m. ET. To join the call without operator assistance, you may register and enter your phone number at to receive an instant automated call back. You may also dial direct to be entered to the call by an operator. The dial-in numbers for the conference call are (888) 880-3330 (Domestic) or (+1) (646) 357-8766 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 11:30 a.m. ET on November 6, 2025, until 11:59 p.m. ET on November 13, 2025. To access the replay by telephone, dial (800) 770-2030 (Domestic) or (+1) (609) 800-9909 (International) and use passcode 3585070#. A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events. A replay of the webcast will be available on the Novavax website until December 5, 2025. About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via R&D innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information. Non-GAAP Financial Measures The Company presents the following non-GAAP financial measures in this press release: Non-GAAP Combined R&D and SG&A Expenses, Adjusted Total Revenue and Adjusted Licensing, Royalties and Other Revenue. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP). The Company believes that the presentation of these adjusted financial measures is useful to investors as they provide additional information on comparisons between periods by including certain items that affect overall comparability. The Company uses these non-GAAP financial measures for business planning purposes and to consider underlying trends of its business. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP. Our use of non-GAAP financial measures may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. The Company is unable to reconcile these revenue forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable effort because the Company is reliant on Sanofi sales forecasts for certain revenue categories, which are not available. Forward-Looking Statements This press release contains forward-looking statements relating to the future of Novavax , its mission; its corporate strategy and operating plans, objectives and prospects; its value drivers and strategic priorities, its partnerships, including expectations with respect to potential royalties, milestones, and cost reimbursement, and plans for additional potential partnering activities; its expectations regarding manufacturing capacity, timing, production and delivery for its COVID-19 vaccine; the development of Novavax's clinical and preclinical product candidates and pipeline advancement opportunities, including with respect to new Matrix formulations; the conduct, timing and potential results from clinical trials, conducted by Novavax or its partners, and other preclinical and postmarketing studies; expectations as to the timing and outcome of future and pending regulatory filings and actions; expected savings from Maryland site consolidation transactions; full year 2025 financial guidance and revenue framework; and Novavax's future financial or business performance. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges or delays in obtaining regulatory authorization or approval for its COVID-19 vaccine, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its COVID-19 vaccine; challenges related to Novavax's partnership with Sanofi, including collaboration on the Nuvaxovid 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 its product candidates, including the Nuvaxovid PMC; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on SII and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of its COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in negotiating, amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19 or influenza; challenges and uncertainty related to regulatory development; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities, including with respect to Novavax's Matrix-M adjuvant; Novavax's expectations 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 its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: Investors Luis Sanay, CFA 240-268-2022 [email protected] Media Yvonne Sprow 844-264-8571 [email protected] SOURCE Novavax, Inc. 21% more press release views with Request a Demo

Novavax has successfully achieved U.S. BLA approval and completed both EU and U.S. marketing authorization transfers for Nuvaxovid™ to Sanofi in line with its CLA and its corporate strategy, securing a total of $225 million in non-dilutive capital year-to-date 2025 GAITHERSBURG, Md., Nov. 4, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) has completed the transfer of the U.S. marketing authorization for its COVID-19 vaccine, Nuvaxovid™ to Sanofi, enabling Sanofi to take full responsibility for commercial and regulatory activities in the U.S. and fulfilling part of its collaboration and license agreement (CLA). The transfer triggered the second of two $25 million marketing authorization transfer milestone payments to Novavax, following the European Union (EU) transfer completed in October 2025. "With the successful achievement of our BLA approval and completion of both U.S. and EU marketing authorization transfers for Nuvaxovid™ to Sanofi, we have delivered on our partnership agreement and secured $225 million in additional milestone revenue to date," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We look forward to Sanofi's success in globally marketing our protein-based, non-mRNA COVID-19 vaccine in the years to come." Novavax is eligible to receive additional future milestones and royalties under the CLA related to Nuvaxovid, combination products developed by Sanofi using Nuvaxovid and new vaccines created by Sanofi utilizing Novavax's Matrix-M® adjuvant. VACCINE AUTHORIZATION (U.S.) Nuvaxovid is a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 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. IMPORTANT SAFETY INFORMATION Contraindications Do not administer Nuvaxovid to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of Nuvaxovid or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of Novavax COVID-19 Vaccine, Adjuvanted. Warnings and Precautions Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of Nuvaxovid. Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Nuvaxovid. There have been post-marketing reports of myocarditis and pericarditis following administration of Nuvaxovid. The Centers for Disease Control and Prevention has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis(). Syncope (fainting): Syncope (fainting) may occur in association with administration of injectable vaccines, including Nuvaxovid. Procedures should be in place to avoid injury from fainting. Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to Nuvaxovid. Limitations of Vaccine Effectiveness: Nuvaxovid may not protect all vaccine recipients. Adverse Reactions The most commonly reported (>10%) solicited adverse reactions were injection site tenderness, injection site pain, injection site redness, headache, muscle pain, fatigue, malaise, joint pain, fever and nausea/vomiting. To report suspected adverse reactions, contact Novavax, Inc. at 1-844-668-2829 or the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or . About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information. Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, the possible achievement of additional milestones or receipt of milestone payments or royalties under the CLA, future marketing initiatives and the potential development and commercialization of Sanofi combination products, and efforts to pursue additional partnerships, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: Investors Luis Sanay, CFA 240-268-2022 [email protected] Media Yvonne Sprow 240-720-7804 [email protected] SOURCE Novavax, Inc. 21% more press release views with Request a Demo