Novavax Inc.

05/06/2026 | Press release | Distributed by Public on 05/06/2026 05:51

Quarterly Report for Quarter Ending March 31, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q (this "Quarterly Report") contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Any statements in the discussion below and elsewhere in this Quarterly Report about expectations, beliefs, plans, objectives, assumptions, or future events or performance of Novavax, Inc. ("Novavax," together with its wholly owned subsidiaries, the "Company," "we," or "us") are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements about our capabilities, goals, expectations regarding future revenue and expense levels, and capital raising activities; our corporate growth strategy and key value drivers; our technology platform; our COVID-19 Vaccine (which includes "Nuvaxovid™" and "JN.1 COVID-19 Vaccine", our Nuvaxovid™ COVID-19 Vaccine for the 2025-2026 vaccination season); our operating plans and prospects, including our ability to continue as a going concern through the next 12 months from the issuance of the financial statements included in this Quarterly Report on Form 10-Q; our global restructuring and cost reduction plan ("Restructuring Plan"), which includes a more focused investment in our COVID-19 Vaccine; our cash flow forecast and projected revenue, including potential royalties and milestones pursuant to the Sanofi CLA (as defined below) and Pfizer License Agreement (as defined below); potential market sizes and demand for our products and product candidates; the efficacy, safety, and intended utilization of our products and product candidates; the development of our clinical-stage product candidates and our recombinant vaccine and adjuvant technologies; the development of our preclinical product candidates; our research and development investment strategy; the potential expansion of our pipeline beyond infectious diseases into other therapeutic areas; our expectations related to enrollment in our clinical trials; the conduct, timing, and potential results from clinical trials and other preclinical studies; plans for and potential timing of regulatory filings; our expectation of manufacturing capacity, timing, production, distribution, and delivery for our COVID-19 Vaccine by us and our partners; our expectations with respect to the anticipated ongoing development and commercialization or licensure of the COVID-19 Vaccine; our expectations with respect to the anticipated ongoing development of COVID-19 variant strain-containing formulations, including the Phase 2b/3 Hummingbird™ trial, our CIC vaccine candidate and our stand-alone influenza vaccine candidate; our partnership efforts for our COVID-19-Influenza ("CIC") vaccine candidate and stand-alone influenza vaccine candidate to advance towards a Biologics License Application ("BLA") filing and commercialization; efforts to expand our COVID-19 Vaccine label worldwide as a booster, and to various age groups and geographic locations; the expected timing, content, and outcomes of regulatory actions; funding under our advance purchase agreements ("APAs") and supply agreements and amendments to, termination of, discussion regarding, or legal disputes relating to any such agreement; our available cash resources and usage and the availability of financing generally; plans regarding partnering activities and business development initiatives; plans regarding APA amendments; and other matters referenced herein. Generally, forward-looking statements can be identified through the use of words or phrases such as "believe," "may," "could," "will," "would," "possible," "can," "estimate," "continue," "ongoing," "consider," "anticipate," "intend," "seek," "plan," "project," "expect," "should," "would," "aim," or "assume," the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words.
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 postmarketing commitment ("PMC") study, our ability to obtain adequate additional funding to maintain our current level of operations and fund the further development of our vaccine candidates; challenges related to our partnership with Sanofi, including collaboration on the PMC, and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation, and stability testing, necessary to satisfy applicable regulatory authorities; challenges 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, constraints on our ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; our ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of our COVID-19 Vaccine or any COVID-19 variant strain containing formulation, or our CIC vaccine candidates, stand-alone influenza vaccine candidates or other candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities including requirements to deliver doses that may require us to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for vaccinations against COVID-19 or influenza; 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, 2025, and this Quarterly Report on Form 10-Q, which may be detailed and modified or updated in other documents filed with the Securities and Exchange Commission ("SEC") from time to time, and are available at www.sec.gov and at www.novavax.com. You are encouraged to read these filings as they are made.
We cannot guarantee future results, events, level of activity, performance, or achievement. Any or all of our forward-looking statements in this Quarterly Report may turn out to be inaccurate or materially different from actual results. Further, any forward-looking statement speaks only as of the date when it is made, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Overview
Novavax tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including its Matrix-M™ adjuvant and protein-based nanoparticles. Our growth strategy focuses on maximizing the impact of our cutting-edge technology by forging strategic partnerships for our Matrix-M™ adjuvant and research and development ("R&D") assets.
Our technology platform combined with our deep vaccine expertise, is the fuel for innovation and partnerships and we believe it has the potential to create significant near- and long-term value. Our proprietary Matrix-M™ adjuvant, when added to vaccines, has been shown to help induce a strong and long-lasting immune response. Our recombinant protein-based nanoparticle technology has been shown to be highly immunogenic. When combined, we believe that our technology platform can induce potent, durable and broad immune responses, with the potential to be antigen-sparing. Our Matrix-M™ adjuvant can increase both antibody and cell-mediated immune responses to a vaccine and it has demonstrated a favorable tolerability profile in clinical trials. Our technology platform is used in our COVID-19 Vaccine and the R21/Matrix-M™ malaria vaccine.
Additionally, we are advancing our early-stage pipeline with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale, and strong commercial opportunity and R&D to expand the utility of our Matrix technology platform.
Furthermore, we provide our Matrix-M™ adjuvant for use in collaborations. These include the R21/Matrix-M™ malaria vaccine, a malaria vaccine developed by our partners, SII and the Jenner Institute, University of Oxford ("R21/Matrix-M™ malaria vaccine"). Additionally, we provide Matrix-M™ adjuvant for use in various programs in preclinical and clinical stage, as well as preclinical investigations. Matrix-M™ adjuvant is being explored under our Collaboration and License Agreement Sanofi Pasteur Inc. ("Sanofi") ("Sanofi CLA") and our License and Option Agreement with Pfizer Inc. ("Pfizer") ("Pfizer License Agreement"), as well as under multiple material transfer agreements with both global pharmaceutical companies and biotechs for exploration of Matrix-M™ adjuvant used as a potential advancement in their pipelines, including preclinical collaborations in oncology.
We were incorporated in 1987 under the laws of the State of Delaware. Our principal executive offices are located at 21 Firstfield Road, Gaithersburg, Maryland, 20878, and our telephone number is (240) 268-2000. Our common stock is listed on the Nasdaq Global Select Market under the symbol "NVAX."
Technology Overview
We believe our recombinant nanoparticle vaccine technology and our proprietary Matrix-M™ adjuvant are well suited for the development and commercialization of vaccine candidates targeting areas both within and beyond the infectious disease space, including in hard-to-treat infectious diseases and oncology.
Recombinant Protein-Based Nanoparticle Vaccine Technology
Once a target of interest has been identified, the genetic sequence encoding an antigen is selected for developing the vaccine construct. The genetic sequence may be optimized to enhance protein stability or confer resistance to degradation. This genetic construct is generally inserted into the baculovirus Spodoptera frugiperda ("Sf-/BV") insect cell-expression system, which enables efficient, large-scale expression of the optimized protein. The Sf-/BV system produces protein-based antigens that are properly folded and modified, which can be critical for functional, protective immunity. Our testing shows this results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M™ adjuvant.
Matrix-MTM Adjuvant
Our proprietary Matrix-M™ adjuvant is another key differentiator within our platform. This adjuvant has enabled potent, well tolerated, and durable efficacy by stimulating the entry of antigen presenting cells ("APCs") into the injection site and enhancing antigen presentation in local lymph nodes with an acceptable safety and tolerability profile. This in turn activates APCs, T-cell and B-cell populations, and plasma cells, which promote the production of high affinity antibodies, an immune boosting response. This potent mechanism of action enables a lower dose of antigen to achieve the desired immune response, thereby contributing to increased vaccine supply and manufacturing capacity. These immune-boosting and dose-sparing capabilities contribute to the adjuvant's highly unique profile.
We continue to evaluate partnership opportunities for use of our Matrix-M™ adjuvant in other manufacturers' pipelines. We currently have multiple partnerships and material transfer agreements in place for Matrix-M™ adjuvant. In May 2024, pursuant to the Sanofi CLA, Sanofi received a non-exclusive license to develop and commercialize other vaccine products that include our Matrix-M™ adjuvant. In 2025, we signed three material transfer agreements with other pharmaceutical companies to explore the use of our Matrix-M™ adjuvant for the potential advancement of their pipeline candidates, with the latest material transfer agreement signed in the fourth quarter of 2025. In January 2026, we entered into the Pfizer License Agreement for use of Matrix-M™ adjuvant in up to two infectious disease areas. In April 2026, we signed a new material transfer agreement (MTA) with a top 10 leading pharmaceutical company and leader in oncology to explore Matrix-M™ in multiple oncology targets, as well as antibiotic resistant bacterial infections and other infectious diseases. Also in April, we signed a new MTA with an existing pharmaceutical partner for evaluation of Matrix-M™ in up to nine additional identified infectious disease areas. In February, Novavax expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an innovative oncology company. In total, Novavax now has MTA collaborations and/or license agreements partnerships with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the rights to explore Matrix-M™ in over 30 unique fields of experimentation across both infectious diseases and oncology.
Commercial Products
In May 2025, the U.S. FDA approved the BLA for Nuvaxovid™ for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking). The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid™ was safe and effective for the prevention of COVID-19. The BLA approval triggered a $175 million milestone payment under the Sanofi CLA.
In August 2025, the U.S. FDA approved the JN.1 COVID-19 Vaccine for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
In October and November 2025, respectively, we announced that we completed the transfer of the Nuvaxovid™ BLA and the European Medicines Agency approval to Sanofi, who remains responsible for further development and commercialization of this product.
Commercial Products and Product Pipeline
The graphic represents all disclosed partnerships. In total, we now have MTA collaborations and/or license agreements providing access to explore Matrix-M™ in over 30 unique fields of experimentation across both infectious diseases and oncology.
Commercial Products
In 2025 and continuing during the term of the Sanofi CLA, Sanofi will lead commercialization efforts for our COVID-19 Vaccine (Nuvaxovid™). Our COVID-19 Vaccine has received authorizations from the U.S. FDA, the European Commission, and several other countries for both adult and adolescent populations.
Novavax Pipeline Programs
We are advancing our pipeline programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale, and strong commercial opportunity. Development and advancement of our in-house pipeline leverages our core expertise and our experience in respiratory and infectious diseases and vaccines, and we intend to explore new opportunities with the potential to expand beyond infectious diseases.
Additionally, we intend to continue developing our early-stage pipeline programs using a disciplined and capital-efficient approach. Our R&D investment strategy seeks to place targeted investments on the programs with the highest potential value, both within infectious disease and beyond, with the intent of partnering these programs earlier in the development process, while maintaining the flexibility to internalize assets when strategically advantageous. In 2026, our Clostridioides difficile colitis vaccine candidate was prioritized as the potential next asset to enter the clinic as early as 2027 from our early-stage pipeline. In addition, the preliminary preclinical data generated on our varicella-zoster virus (shingles) and respiratory syncytial virus early-stage assets were positive and will inform our future antigen design and adjuvant work.
We are also continuing to progress our adjuvant research which is intended to expand the utility of our adjuvant offering by creating new adjuvants based on our Matrix technology.
Partner Pipeline Programs
In addition to our own pipeline programs, we have several ongoing partnerships.
Under our Sanofi CLA, we have provided a sole license to Sanofi for the independent development of a COVID-19 and influenza combination product using our COVID-19 Vaccine in combination with two of Sanofi's separately marketed influenza vaccines, Fluzone High-Dose and Flublok. These two combination vaccine candidates were granted Fast Track designation by the U.S. FDA in December 2024 to prevent influenza and COVID-19 infections in individuals aged 50 and older. In October 2025, Sanofi reported positive Phase 1/2 results with their combination vaccine candidates and will engage with regulatory authorities on next steps. Sanofi also has a non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines, and a non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M™ adjuvant.
In September 2025, we amended the Sanofi CLA to expand Sanofi's license to include use of Novavax's Matrix-M™ adjuvant in Sanofi's pandemic influenza vaccine candidate program. Sanofi received funding from the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response, part of the U.S. Department of Health and Human Services, for early-stage work on this vaccine candidate including the Matrix-M™ adjuvant.
In January 2026, we entered the Pfizer License Agreement for use of our Matrix-M™ adjuvant. Under the terms of the agreement, Pfizer will obtain a non-exclusive license for Matrix-M™ adjuvant for use with Pfizer's products in two infectious disease areas. The agreement provides for an upfront payment of $30 million, with the potential for up to $500 million in development and sales milestone payments. In addition to milestone payments, we are eligible to receive tiered high mid-single digit percentage royalty payments on sales of any product by Pfizer that includes Matrix-M™ adjuvant.
In total, Novavax now has MTA collaborations and/or license agreements partnerships with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the rights to explore Matrix-M in over 30 unique fields and indications across both infectious diseases and oncology.
Coronavirus Vaccine Clinical Development
We continue to evaluate vaccine safety, immunogenicity, and effectiveness through ongoing clinical trials and collaborative evidence-generating real-world studies.
Phase 4 Postmarketing Commitments
In May 2025, we announced that the U.S. FDA, as a part of its BLA approval of Nuvaxovid™, requested that we conduct as one of our postmarketing commitments ("PMCs") a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. Although the BLA has since been transferred to Sanofi, we are currently conducting the PMC trial on behalf of Sanofi which will reimburse us for 70% of the PMC costs, capped at the currently agreed upon cost estimates. We updated our total expected costs and the amounts of variable consideration for research and development transition services that support further regulatory approval and development of the COVID-19 Vaccine ("Sanofi Transition Services") for costs and reimbursements from the PMC. Revenue related to the PMC will be recognized in Licensing, royalties, and other revenue over time using an input method, consistent with Sanofi Transition Services.
In addition, in October 2025, we initiated an additional PMC study evaluating the safety and immunogenicity of Nuvaxovid™ in the population of individuals for which Nuvaxovid™ is approved in the U.S., i.e., individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 and in adults ≥ 65 years of age. Following the transfer of the U.S. marketing authorization, Sanofi is now responsible for the conduct of this study.
COVID-Influenza Combination and Stand-alone Influenza Program
Phase 3 Clinical Trial of CIC and Stand-alone Influenza Vaccine Candidates
In December 2024, we initiated a Phase 3 immunogenicity and safety trial for our CIC and stand-alone influenza vaccine candidates to evaluate the immunogenicity and safety compared to our COVID-19 Vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older. Our Phase 3 immunogenicity and safety trial completed enrollment with an initial cohort of approximately 2,000 participants. In June 2025, we reported data from this initial cohort, which showed both vaccine candidates induced robust immune responses across all antigens tested. Both vaccine candidates were well tolerated with reactogenicity profiles that were comparable to authorized comparators. After consultation with the U.S. FDA, we determined that seeking an accelerated approval pathway for our CIC and stand-alone influenza candidates would not be feasible. While the Phase 3 immunogenicity and safety trial is not a pivotal study, the data will inform a future registrational Phase 3 program. We do not intend to make additional investments in these programs and are seeking a partner to advance both vaccine candidates.
Malaria
Malaria is a life-threatening disease caused by a parasite that infects mosquitoes and is subsequently transmitted to humans. According to the 2024 WHO World Malaria Report, in 2023, there were an estimated 263 million malaria cases and 597,000 malaria-related deaths worldwide. We believe malaria has the potential to be preventable through our partner-led R21/Matrix-M™ malaria vaccine, with the first doses distributed and administered across the African region in 2024 after having received authorization in 2023 in several countries and prequalification by the WHO.
R21/Matrix-M™ Malaria Vaccine
R21/Matrix-M™ malaria vaccine, formulated with our Matrix-M™ adjuvant is developed by our partners, SII and the Jenner Institute, University of Oxford. We have an agreement with SII related to its manufacture of R21/Matrix-M™ malaria vaccine under which SII purchases our Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single- to low-double digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.
In July 2024, first commercial doses of R21/Matrix-M™ malaria vaccine were administered to children in Cote d'Ivoire and South Sudan. As of May 2026, over 30 million doses of R21/Matrix-M™ malaria vaccine have been distributed and are available in 25 countries.
R21/Matrix-M™ Malaria Vaccine Regulatory and Licensure
In December 2023, the WHO announced it prequalified the R21/Matrix-M™ malaria vaccine to prevent malaria disease in children caused by the P. falciparum parasite in endemic areas. Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and enabled rollout of the vaccine in mid-2024. The WHO recommended that the R21/Matrix-M™ malaria vaccine be administered in a four-dose schedule beginning at five months of age.
Business Highlights
First Quarter 2026 and Recent Highlights
In January 2026, we entered into the Pfizer License Agreement for use of Novavax's Matrix-M™ adjuvant in vaccine development. Under the terms of the agreement, Pfizer was granted a non-exclusive license for Matrix-M™ use in two infectious disease areas.
We received an upfront payment of $30 million in the first quarter of 2026 and have the potential for up to $500 million in additional development and sales milestones. In addition, we are eligible to receive high-mid-single digit percentage royalties on sales from products incorporating Matrix-M™.
Pfizer will be solely responsible for the development and commercialization of its products utilizing Matrix-M™ and we will be responsible for the supply of Matrix-M™.
This partnership has the potential to generate billions of dollars of revenue for us over the life of the agreement.
In 2026, we continued to expand our Matrix-M™ partnering efforts with global pharmaceutical companies and innovative biopharma companies.
In April, we signed a new MTA with a top ten global pharmaceutical company who is also a global leader in oncology to explore Matrix-M™ in a broad array of oncology targets, as well as antibiotic resistant bacterial infections and other infectious diseases.
In April, we signed a new MTA with an existing pharmaceutical partner for evaluation of Matrix-M™ in nine additional, identified disease areas.
In February, we expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an innovative oncology company.
In total, we now have MTA collaborations and/or license agreements with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the rights to explore Matrix-M™ in over 30 unique fields of experimentation across both infectious diseases and oncology.
The goal of our MTA collaborations is to enable exploration of Matrix-M™ with the intent of entering into a deeper partnership via formal license agreements, that in turn results in the advancement of a partner's R&D clinical work toward commercialization of innovative vaccines.
The broad utility of our technology has resulted in several companies exploring Matrix-M for application in the same high-potential markets, including infectious disease areas such as cytomegalovirus, Epstein-Barr Virus, pneumococcal, and RSV; and also includes overlap in oncology areas such as colorectal cancer, head and neck cancer and pancreatic cancer.
Existing partners under license and MTA agreements, have the rights to address fields and indications that cover over 50% of the global market opportunity for infectious disease and oncology vaccines and immunotherapeutics, which is projected to grow to over $100 billion by the early 2030s.
In April, Sanofi announced positive Phase 4 data from COMPARE, a head-to-head study showing that Nuvaxovid demonstrated statistically significant lower side effects compared to Moderna's mNEXSPIKE across all pre-specified endpoints, reinforcing Nuvaxovid's well-established and differentiated reactogenicity profile ahead of the fall season.
Continued to progress Novavax R&D innovation in support of our growth strategy.
Clostridioides difficile colitis vaccine candidate prioritized as potential next asset to enter the clinic as early as 2027.
Preliminary preclinical data generated by us on our varicella-zoster virus (shingles) and respiratory syncytial virus early-stage assets were positive and provide path forward for informing our future antigen design and adjuvant work.
Ongoing adjuvant research is intended to expand the utility of our technology by creating new adjuvants tailored to foster specific differentiated immune properties certain diseases that may require unique immune responses.
Sales of Common Stock
In August 2023, we entered into an At Market Issuance Sales Agreement (the "August 2023 Sales Agreement"), which allowed us to issue and sell up to $500 million in gross proceeds of shares of our common stock pursuant to a registration statement on Form S-3 (the "Shelf Registration Statement"), and terminated our then-existing At Market Issuance Sales Agreement entered in June 2021. No sales were recorded under the August 2023 Sales Agreement during the three months ended March 31, 2026, and 2025. The Shelf Registration Statement expired in February 2026, and no future sales will be made under the August 2023 Sales Agreement.
Critical Accounting Policies and Use of Estimates
The discussion and analysis of our financial condition and results of operations are based upon our accompanying unaudited financial statements and the unaudited accompanying notes, which have been prepared in accordance with generally accepted accounting principles in the United States.
The preparation of our consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Our critical accounting policies and estimates are included under Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC.
Recent Accounting Pronouncements Not Yet Adopted
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 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 March 31, 2026 and 2025
Revenue
Three Months Ended March 31,
2026 2025 Change
Revenue (in thousands):
Product sales $ 42,200 $ 621,678 $ (579,478)
Licensing, royalties, and other 97,314 44,977 52,337
Total revenue $ 139,514 $ 666,655 $ (527,141)
Revenue for the three months ended March 31, 2026 was $139.5 million as compared to $666.7 million for the same period in 2025, a decrease of $527.1 million. Revenue for the three months ended March 31, 2026 was primarily comprised of commercial product sales of COVID-19 Vaccine and adjuvant sales; licensing revenue under the Pfizer License Agreement; revenue from transition services and technology transfer under the Sanofi CLA; and royalty revenue with Sanofi and Serum. Revenue for the three months ended March 31, 2025 was primarily comprised of revenue from the termination of our APAs with Canada ("Canada APA") and New Zealand ("New Zealand APA") of $575.7 million and $27.3 million, respectively, and the recognition of previously deferred upfront payments and revenue from transition services and technology transfer under the Sanofi CLA.
Product sales
Product sales for the three months ended March 31, 2026 were $42.2 million as compared to $621.7 million for the same period in 2025, a decrease of $579.5 million. Our Product sales related to revenue from NuvaxovidTM sales, which commenced in 2022, commercial supply sales of COVID-19 Vaccine, and revenue from supply of adjuvant and other materials.
We have transitioned the commercial lead for sales and distribution to Sanofi resulting in a decrease in NuvaxovidTM sales and an increase in supply sales.
The categories of Product sales were as follows:
Three Months Ended March 31,
2026 2025 Change
Product sales (in thousands)
NuvaxovidTM sales(1)
$ 9,558 $ 608,025 $ (598,467)
Supply sales(2)
32,642 13,653 18,989
Total Product sales
$ 42,200 $ 621,678 $ (579,478)
(1)NuvaxovidTM sales are sales of our COVID-19 Vaccine associated with APAs with governments and commercial markets, where we are the commercial lead for sales and distribution, made through pharmaceutical wholesale distributors.
(2)Supply sales include commercial sales of COVID-19 Vaccine, adjuvant sales, and other material sales to our partners.
Licensing, royalties, and other
Licensing, royalties, and other revenue during the three months ended March 31, 2026 was $97.3 million as compared to $45.0 million during the same period in 2025, an increase of $52.3 million. The increase was primarily due to recognition of the upfront payment under the Pfizer License Agreement.
Licensing, royalties, and other revenue were comprised of the following:
Three Months Ended March 31,
2026 2025 Change
Licensing, royalties, and other (in thousands)
Sanofi $ 48,899 $ 40,321 $ 8,578
Pfizer 30,000 - 30,000
Serum 7,366 4,456 2,910
Other partners(1)
11,049 $ 200 10,849
Total licensing, royalties, and other revenue $ 97,314 $ 44,977 $ 52,337
(1)Other partners revenue includes royalties, license fees, and other revenue associated with agreements with other partners such as Takeda and SK bioscience, Co., Ltd.
Sanofi licensing, royalties, and other revenue were comprised of the following:
Three Months Ended March 31,
2026 2025 Change
Sanofi licensing, royalties, and other revenue (in thousands)
Licensing:
Royalties $ 3,521 $ - $ 3,521
Transition services and technology transfer:
Upfront fee amortization(1)
12,106 19,912 (7,806)
Milestones amortization(1)
5,551 9,143 (3,592)
Cost reimbursements
27,721 11,266 16,455
Total Sanofi licensing, royalties, and other revenue
$ 48,899 $ 40,321 $ 8,578
(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 March 31, 2026, we recognized a change in estimate to cumulative revenue recognized for the Sanofi Transition Services performance obligation of $6.1 million as a result of changes in total expected costs and changes to estimates of variable consideration from expected cost reimbursements.
Expenses
Three Months Ended March 31,
2026 2025 Change
Expenses (in thousands):
Cost of sales $ 30,695 $ 14,115 $ 16,580
Research and development 95,472 88,937 6,535
Selling, general, and administrative 28,777 48,090 (19,313)
Total expenses $ 154,944 $ 151,142 $ 3,802
Cost of Sales
Cost of sales was $30.7 million for the three months ended March 31, 2026, including expenses of $4.2 million related to losses on firm purchase commitments and $1.4 million related to unutilized manufacturing capacity. Cost of sales was $14.1 million for the three months ended March 31, 2025, including expenses of $0.3 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments and $1.8 million related to unutilized manufacturing capacity. The increase in cost of sales of $16.6 million was mainly driven by an increase in supply sales of COVID-19 Vaccine, adjuvant sales, and other material sales to our partners. The cost of sales as a percentage of Product sales may fluctuate in the future as a result of changes to our customer pricing mix or standard costs.
Research and Development Expenses
Research and development expenses were $95.5 million for the three months ended March 31, 2026 as compared to $88.9 million for the three months ended March 31, 2025, a increase of $6.5 million. The increase was primarily due to additional transition services performed under the Sanofi CLA, partially offset by cost containment measures to reduce our operating spend, as summarized in the table below:
Three Months Ended March 31,
2026 2025
Research and Development Expenses (in thousands):
COVID-19 Vaccine $ 34,255 $ 7,277
CIC and influenza vaccines 2,853 12,504
Other vaccine development programs
2,264 157
Total direct external research and development expense 39,372 19,938
Employee expenses 35,122 35,621
Stock-based compensation expense 2,934 4,289
Facility expenses 9,940 13,147
Other expenses 8,104 15,942
Total research and development expenses $ 95,472 $ 88,937
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses were $28.8 million for the three months ended March 31, 2026 as compared to $48.1 million for the same period in 2025, a decrease of $19.3 million. 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.
Other Income, Net
Three Months Ended March 31,
2026 2025 Change
Other income, net (in thousands):
Interest expense $ (4,901) $ (5,723) $ 822
Other income, net 11,825 10,056 1,769
Total other income, net $ 6,924 $ 4,333 $ 2,591
Total other income, net was $6.9 million for the three months ended March 31, 2026 as compared to $4.3 million for the same period in 2025. The increase in other income, net is primarily due favorable impact in 2026 as compared to 2025 of exchange rates on foreign currency denominated balances, partially offset by 2025 nonrecurring other income items of $4.8 million from the derivative action settlement proceeds and $3.6 million of state incentives.
Income Tax Expense
During the three months ended March 31, 2026, we recognized income tax expense of $1.0 million related to foreign income taxes and foreign withholding tax expense. During the three months ended March 31, 2025, we recognized income tax expense of $1.2 million related to federal, state, and foreign income taxes, and foreign withholding taxes.
Net Income (Loss)
Three Months Ended March 31,
2026 2025 Change
Net Income (Loss) (in thousands, except per share information):
Net income (loss) $ (9,491) $ 518,646 $ (528,137)
Net income (loss) per share, basic $ (0.06) $ 3.22 $ (3.28)
Net income (loss) per share, diluted $ (0.06) $ 2.93 $ (2.99)
Weighted average shares outstanding, basic 163,276 161,049 2,227
Weighted average shares outstanding, dilutive 163,276 177,625 (14,349)
Net loss for the three months ended March 31, 2026 was $9.5 million, or $0.06 per share, basic and dilutive, as compared to net income of $518.6 million, or $3.22 per share, basic and $2.93 per share, dilutive, for the same period in 2025. The increase in net loss during the three months ended March 31, 2026, was primarily due to a decrease in total revenue.
The increase in weighted average shares outstanding for the three months ended March 31, 2026, was primarily a result of common stock issued under our incentive programs.
Liquidity Matters and Capital Resources
Our future capital requirements depend on numerous factors including, but not limited to, revenue from our Product sales, milestone payments, royalties, and reimbursements under licensing arrangements with our strategic partners; our projected activities related to the development and commercial support of our COVID-19 Vaccine and our CIC and stand-alone influenza vaccine candidates, including significant commitments under various contract research organization, contract manufacturing organization and contract development and manufacturing organization agreements; the progress of preclinical studies and clinical trials; the time and costs involved in obtaining and maintaining regulatory approvals; the costs of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights; and other manufacturing, sales, and distribution costs. We plan to continue developing other vaccines and product candidates, such as our potential combination vaccine candidates, which are in various stages of development. Our ability to generate revenue from Product sales is subject to uncertainty specifically as it relates to our ability to successfully develop, manufacture, distribute, and market our updated vaccine and to successfully execute on our licensing arrangements with our strategic partners and our APAs, as discussed below. Additionally, our plans include our ongoing restructuring and cost reduction measures as a part of our Restructuring Plan (see Note 16 to our consolidated financial statements), and may also include raising additional capital through a combination of additional equity and debt financing, collaborations, strategic alliances, asset sales, and marketing, distribution, or licensing arrangements. New financings may not be available to us on commercially acceptable terms, or at all. If we are
unable to obtain additional capital, we will assess our capital resources and may be required to delay, reduce the scope of, or eliminate some or all of our operations, or further downsize our organization, any of which may have a material adverse effect on our business, financial condition, and results of operations.
Sanofi Collaboration and License Agreement
In May 2024, we entered into the Sanofi CLA pursuant to which we received a non-refundable upfront payment of $500 million. As of March 31, 2026, we are eligible to receive additional development, technology transfer, launch, and sales milestone payments totaling up to $425 million and royalty payments on Sanofi's sales of such licensed products. In addition, we are eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four Adjuvant Products and $210 million for each Adjuvant Product thereafter, and royalty payments on Sanofi's sales of all such licensed products.
As of March 31, 2026, remaining Sanofi milestone payments of $425 million include $75 million related to COVID-19 Vaccine products receivable upon the completion of the technology transfer of our manufacturing process for the COVID-19 Vaccine products to Sanofi. We are eligible to receive milestone payments totaling up to $350 million in the aggregate with respect to the CIC Products and this total amount is outstanding. We are eligible to receive a $125 million milestone payment upon achievement of initiation of a Sanofi CIC Product Phase 3 trial and a $225 million CIC Product-related launch milestone. We are eligible to receive royalty payments in the high teens to low twenties percent on Sanofi's sales of such licensed products.
Beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi began to commercialize the COVID-19 Vaccine products worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply our existing APA customers and strategic partners, including Takeda and SII. Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.
Takeda Amended and Restated Collaboration and License Agreement
In April 2025, we entered into the Amended Takeda CLA which amends and supersedes the Original Takeda CLA.
Under the Amended Takeda CLA, on an annual basis, we will receive $2.0 million to compensate us for services provided by us under the Amended Takeda CLA. If Takeda receives marketing approval of the COVID-19 Vaccine in that year or such approval is not necessary for such year, we will receive an additional $8.0 million annual milestone payment, of which $5.0 million is creditable against royalties owed by Takeda in its fiscal year 2025 or thereafter. We are eligible to receive a tiered royalty as a percentage of Takeda's, its affiliates', and sublicensees' total net sales in the mid to high-teen percentages (subject to certain capped royalty reductions), commencing on April 1, 2024 and will continue until the later of (a) twenty years after April 29, 2025, (b) all our know-how licensed under the Amended Takeda CLA has become publicly available through no fault of Takeda, and (c) the expiration of the last valid claim in the intellectual property rights licensed by us to Takeda under the Amended Takeda CLA covering COVID-19 Vaccine in Japan. During the three months ended March 31, 2026, we recognized $0.7 million of royalty revenue earned under the Amended Takeda CLA and $0.1 million for Takeda Support Services.
Pfizer License Agreement
In January 2026, we entered into the Pfizer License Agreement for use of our Matrix-M™ adjuvant. Under the terms of the agreement, Pfizer will obtain a non-exclusive license for Matrix-M™ adjuvant for use with Pfizer's products in up to two disease areas. The agreement provides for an upfront payment of $30 million and we have the potential to receive up to $500 million in development and sales milestone payments. In addition to milestone payments, we are eligible to receive tiered high mid-single digit percentage royalty payments on sales of any product by Pfizer that includes Matrix-M™ adjuvant.
Supply Agreements
As of March 31, 2026, we have $207.2 million of remaining obligations under APAs with certain countries globally, excluding the Vaccine Alliance ("Gavi"). These obligation include $133.9 million related to an APA with the Commonwealth of Australia ("Australia") for the purchase of doses of COVID-19 Vaccine (the "Australia APA") and $73.3 million related to various other countries. With respect to the Australia APA, as of March 31, 2026, $48.4 million was classified as current Deferred revenue and $85.4 million was classified as non-current Deferred revenue in our consolidated balance sheet. In December 2024, we entered into an amendment to the Australia APA pursuant to which, among other things, we acknowledged
the cancellation by Australia of the delivery of certain doses of our COVID-19 Vaccine scheduled for delivery between the fourth quarter of 2023 and the fourth quarter of 2025 and we agreed to credit approximately $31 million of the advanced payment paid by Australia to us against outstanding invoices and invoices for the future delivery of approximately three million doses of COVID-19 Vaccine without requiring additional cash payments. In addition, the amendment provides for certain remedies for Australia, including return of unused credit, cancellation of doses, or termination of the Australia APA, in the event we are unable to gain regulatory approval of a variant COVID-19 vaccine or supply doses per the terms of the agreement. Specifically, Australia did not take delivery of doses that were due to be delivered in 2025 and may seek to cancel the future delivery of the 2025 as well as 2026 doses. If we are unable to provide doses per the supply schedule as amended, after six months, Australia may seek to terminate the APA. The amendment also provides Australia with the right to cancel doses if we fail to timely notify Australia of changes to our commercialization plans. In the 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. In the third quarter of 2025, we withdrew our application for our COVID-19 Vaccine based on recommendations made by the Therapeutic Goods Administration. The parties are in ongoing discussions regarding outstanding issues and obligations under the APA. In light of these developments, we may seek to further amend the Australian APA, which amendment may not be achievable on acceptable terms or at all. With respect to other obligations under APAs of $73.3 million, as of March 31, 2026, $38.1 million was classified as current Deferred revenue and $35.2 million was classified as non-current Deferred revenue in our consolidated balance sheet. Recognition of these amounts is dependent on delivery of doses or expiry of optional dose order quantities.
In November 2024, we entered into a settlement agreement with the Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the "Authority"), pursuant to which we and the Authority agreed to terminate the Amended and Restated Supply Agreement with the Authority and to fully settle the outstanding amount under dispute related to upfront payments of $112.5 million. We agreed to pay a refund of $123.8 million, including interest of $11.3 million to the Authority, in equal quarterly installments of $10.3 million over a three year period, ending in June 2027. As of March 31, 2026, pursuant to our settlement agreement with the UK, the remaining upfront payment previously received from the authority is classified as $39.2 million of other current liabilities and $10.2 million of Other non-current liabilities on our consolidated balance sheet.
In February 2024, we and Gavi entered into a Termination and Settlement Agreement (the "Gavi Settlement Agreement") terminating our APA with Gavi (the "Gavi APA"). In total, the Gavi settlement agreement is comprised of $700 million of potential consideration, consisting of $75 million initial settlement payment, deferred payments of up to $400 million that may be reduced through annual vaccine credits, and an additional credit of up to $225 million that may be applied against certain qualifying sales. As of March 31, 2026, the remaining amounts included on our consolidated balance sheet are classified as $225.0 million in non-current Deferred revenue for the additional credit that may be applied against future qualifying sales, $80.0 million in Other current liabilities, and $160.0 million in Other non-current liabilities. In addition, we and Gavi entered into a security agreement pursuant to which we granted Gavi a security interest in accounts receivable from SII under the SII R21 Agreement (see Note 6 to our accompanying unaudited consolidated financial statements), which will continue for the deferred payment term of the Gavi Settlement Agreement. On February 22, 2024, the claims and counterclaims were dismissed with prejudice.
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. as trustee. For additional information on the 2031 Notes, see Note 11 to our accompanying unaudited consolidated financial statements.
Credit Agreement
In February 2026, we entered into the Credit Agreement with MidCap Financial Trust, as administrative agent. The Credit Agreement provides for a senior secured term loan facility of up to $330 million, available in four tranches. The first tranche of $130 million, of which $50 million was funded at closing, is available to be drawn, subject to customary conditions, through February 2028. Borrowings under the Credit Agreement bear interest, payable monthly in arrears, at a rate per annum equal to the one-month Secured Overnight Financing Rate ("Term SOFR") plus 5.00%, subject to a Term SOFR floor of 2.00%. The term loans mature in March 2031, at which time all outstanding principal and accrued interest are due and payable in full.
Cash Flows
As of March 31, 2026, we had $794.9 million in cash and cash equivalents, restricted cash and marketable securities as compared to $750.5 million as of December 31, 2025.
We funded our operations for the three months ended March 31, 2026, primarily with cash and cash equivalents, proceeds from the 2031 Notes and the Credit Agreement, milestone payments under the Sanofi CLA, and revenue from Product sales. In accordance with our ongoing Restructuring Plan, we continue to restructure our global footprint including further reductions in our global workforce and facilitating the disposal of real estate assets in Gaithersburg, Maryland. We anticipate our future operations to be funded primarily by milestone payments, royalties, transition services and technology transfer and cost reimbursements under our Sanofi CLA, revenue from Product sales, our cash and cash equivalents and investments in marketable securities, and other potential funding sources including equity financings, which may include at the market offerings, debt financings, collaborations, strategic alliances, asset sales, and marketing, distribution or licensing arrangements.
The following table summarizes cash flows for the three months ended March 31, 2026 and 2025 (in thousands):
Three Months Ended March 31,
2026 2025 Change
Net cash provided by (used in):
Operating activities $ (32,423) $ (185,502) $ 153,079
Investing activities (28,361) (73,319) 44,958
Financing activities 37,675 (7,061) 44,736
Effect on exchange rate on cash, cash equivalents, and restricted cash (18) (930) 912
Net increase (decrease) in cash, cash equivalents, and restricted cash
(23,127) (266,812) 243,685
Cash, cash equivalents, and restricted cash at beginning of period 256,052 545,292 (289,240)
Cash, cash equivalents, and restricted cash at end of period $ 232,925 $ 278,480 $ (45,555)
Net cash used in operating activities was $32.4 million for the three months ended March 31, 2026, as compared to $185.5 million of cash used in operating activities for the same period in 2025. The decrease in cash used in operating activities is primarily due to certain cost containment measures to reduce our operating spend, including a reduction in our global commercial footprint and administrative infrastructure.
Net cash used in investing activities was $28.4 million for the three months ended March 31, 2026, as compared to $73.3 million of cash used for the same period in 2025. The decrease in cash used in investing activities is primarily due to the completion of the sale of held for sale assets.
Net cash provided by financing activities was $37.7 million for the three months ended March 31, 2026, as compared to net cash used in financing activities of $7.1 million for the same period in 2025. The increase in cash provided by financing activities is primarily due to net proceeds from our Credit Agreement.
Going Concern
We believe that our cash, cash equivalents, and marketable securities as of March 31, 2026, together with cash expected to be generated from product sales and licensing, royalties and other revenue, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of the financial statements included in this Quarterly Report on Form 10-Q.
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