NOVAVAX INC

Previous wording

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-In…

Excerpt shortened here; the source contains the full paragraph.

Current wording

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™”); 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 as defined in Note 16 to our consolidated financial statements (“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 our COVID-19-Influenza (“CIC”) vaccine candidate and our stand-alone influenza vaccine candidate; our partnership efforts for our CIC vaccine candidate and stand-alone influenza vaccine ca…

Excerpt shortened here; the source contains the full paragraph.

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 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 manu…

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 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;

Previous wording

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.

Current wording

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, a malaria vaccine developed by our partners, SII and the Jenner Institute, University of Oxford (“R21/Matrix-M™ malaria vaccine”).

Previous wording

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.

Current wording

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 with 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.

Previous wording

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.

Current wording

In May 2025, the U.S. Food and Drug Administration (“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.

Previous wording

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.

Current wording

Continuing during the term of the Sanofi CLA, Sanofi leads 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.

Previous wording

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.

Current wording

We are also continuing to progress our adjuvant research to expand its utility by creating new adjuvants based on our Matrix technology.

Previous wording

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.

Current wording

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.

Previous wording

First Quarter 2026 and Recent Highlights

Current wording

Second Quarter 2026 and Recent Highlights

Previous wording

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.

Current wording

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 and six months ended June 30, 2026, and 2025. The Shelf Registration Statement expired in February 2026, terminating the August 2023 At-the-Market Sales Agreement. No sales were recorded under the August 2023 Sales Agreement during the six months ended June 30, 2026, prior to its expiration.

Previous wording

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.

Current wording

Revenue for the three months ended June 30, 2026 was $56.7 million as compared to $239.2 million for the same period in 2025, a decrease of $182.5 million. Revenue for the three months ended June 30, 2026 was primarily comprised of revenue from transition services and technology transfer under the Sanofi CLA, revenue from supply of adjuvant and other materials, and royalty revenue with Sanofi and Serum. 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 Pharmaceutical Company Limited (“Takeda”).

Previous wording

We have transitioned the commercial lead for sales and distribution to Sanofi resulting in a decrease in Nuvaxovid TM sales and an increase in supply sales.

Current wording

Product sales for the three months ended June 30, 2026 were $18.9 million as compared to $10.7 million for the same period in 2025, an increase of $8.1 million. Our Product sales related to revenue from Nuvaxovid TM 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 Nuvaxovid TM sales and an increase in supply sales.

Previous wording

(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.

Current wording

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

Previous 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 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.

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 June 30, 2026, we recognized a change in estimate to cumulative revenue recognized for the Sanofi Transition Services performance obligation of $10.8 million as a result of changes in total expected costs and changes to estimates of variable consideration from expected cost reimbursements.

Previous wording

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:

Current wording

Research and development expenses were $70.7 million for the three months ended June 30, 2026 as compared to $79.2 million for the three months ended June 30, 2025, a decrease of $8.5 million. The decrease was primarily due to cost containment measures to reduce our operating spend, as summarized in the table below:

Previous wording

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.

Current wording

Selling, general, and administrative expenses were $26.7 million for the three months ended June 30, 2026 as compared to $43.6 million for the same period in 2025, a decrease of $16.9 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.

Previous wording

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.

Current wording

During the three months ended June 30, 2026, we recognized income tax expense of $1.7 million related to foreign income taxes and foreign withholding tax expense. During the three months ended June 30, 2025, we recognized income tax expense of $0.9 million related to federal, state, and foreign income taxes, and foreign withholding taxes.

Previous wording

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.

Current wording

Net loss for the three months ended June 30, 2026 was $53.4 million, or $0.32 per share, basic and diluted, as compared to net income of $106.5 million, or $0.66 per share, basic and $0.62 per share, diluted, for the same period in 2025. The decrease in net income (loss) during the three months ended June 30, 2026, was primarily due to a decrease in total revenue.

Previous wording

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 Nuvaxovid TM sales, which commenced in 2022, commercial supply sales of COVID-19 Vaccine, and revenue from supply of adjuvant and other materials.

Current wording

Product sales for the six months ended June 30, 2026 were $61.1 million as compared to $632.4 million for the same period in 2025, a decrease of $571.3 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.

Previous wording

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.

Current wording

Cost of sales was $44.9 million for the six months ended June 30, 2026, including expenses of $4.2 million related to losses on firm purchase commitments; $3.2 million related to unutilized manufacturing capacity; $2.3 million right of use asset impairment charges for CMO manufacturing capacity of excess quantities; and $1.6 million related to excess, obsolete, or expired inventory. 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. The increase in cost of sales of $15.5 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.

Previous wording

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.

Current wording

Total other income (expense), net for the six months ended June 30, 2026 was $10.2 million of income as compared to $10.7 million of income for the same period in 2025, a decrease of $0.6 million. The decrease in other income (expense) is primarily due to 2025 nonrecurring other income items of $4.8 million from the derivative action settlement proceeds and $3.6 million of state incentives, partially offset by the favorable impact in 2026 as compared to 2025 of exchange rates on foreign currency denominated balances.

Previous wording

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.

Current wording

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 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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

As of June 30, 2026, we have $207.2 million of remaining obligations under APAs with certain countries globally, excluding the Vaccine Alliance (“Gavi”). These obligations 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 June 30, 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. 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. Under the terms of the Australia APA, regulatory approval, which we can be achieved through multiple regulatory pathways, is required on or before certain deadlines. We believe such requirements can be satisfied by either (i) TGA approval of Nuvaxovid, or (ii) by TGA approval of a special access importation into the Australian market. We have been pursuing a special access importation from the TGA to help ensure our supply is available for Australia. We are awaiting a final decision on the outcome of its application for special importation. In light of these developments, if we are unable to receive regulatory approval by either means, we may seek alternatives to continued performance under the agreement. With respect to other obligations under APAs of $73.3 million, as of June 30, 2026, $38.1 million was classified as current Deferred revenue and

Previous wording

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.

Current wording

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 June 30, 2026, pursuant to our settlement agreement with the UK, the remaining upfront payment previously received from the authority is classified as $39.8 million of other current liabilities on our consolidated balance sheet.

Previous wording

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.

Current wording

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 June 30, 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 $145.0 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.

Previous wording

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.

Current wording

As of June 30, 2026, we had $723.9 million in cash and cash equivalents, restricted cash and marketable securities as compared to $750.5 million as of December 31, 2025.

Previous wording

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.

Current wording

We funded our operations for the six months ended June 30, 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. 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.

Previous wording

The following table summarizes cash flows for the three months ended March 31, 2026 and 2025 (in thousands):

Current wording

The following table summarizes cash flows for the six months ended June 30, 2026 and 2025 (in thousands):

Previous wording

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.

Current wording

Net cash used in operating activities was $105.2 million for the six months ended June 30, 2026, as compared to $313.0 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.

Previous wording

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.

Current wording

Net cash provided by investing activities was $6.5 million for the six months ended June 30, 2026, as compared to $37.8 million of cash provided 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 in 2026.

Previous wording

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.

Current wording

Net cash provided by financing activities was $38.9 million for the six months ended June 30, 2026, as compared to net cash used in financing activities of $8.1 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.