What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-06 compared with 2026-05-06 · 229 added, 102 removed, 318 unchanged (51% of the section changed)

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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 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 (“Restructuring Plan”), which includes a more focused investment in our COVID-19 Vaccine;

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);

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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;

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 candidate to advance towards a Biologics License Application (“BLA”) filing and commercialization;

the expected timing, content, and outcomes of regulatory actions;

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(“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;

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;

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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.

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”).

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.

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.

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Our testing shows this results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M ® adjuvant.

Matrix-M TM Adjuvant

Matrix-M ® Adjuvant

Our proprietary Matrix-M ® adjuvant is another key differentiator within our platform.

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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.

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Commercial Products

In 2025 and continuing during the term of the Sanofi CLA, Sanofi will lead commercialization efforts for our COVID-19 Vaccine (Nuvaxovid™).

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.

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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.

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

Partner Pipeline Programs

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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.

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

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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.

Second Quarter 2026 and Recent Highlights

• Our Sanofi partnership continues to advance, supporting significant potential near- and long-term value creation.

◦ Sanofi confirmed with Novavax they intend to be among the first movers in the combination vaccine segment and that they are in advanced discussions with regulators regarding their Phase 3 CIC trial timing.

Initiation of this trial in the U.S.

or European Union will trigger a $125 million milestone to Novavax.

◦ Manufacturing technology transfer to Sanofi for Nuvaxovid™ is expected to be completed in mid-2027, which would trigger a $75 million milestone payment to Novavax.

◦ Sanofi is expanding the commercial reach of Nuvaxovid this season through broader commercial activities in the U.S.

and launches in the United Kingdom, Germany and Canada, with Novavax eligible to receive royalties in the high teens to low twenties as a percentage of Sanofi's global net sales.

◦ Sanofi received Fast Track designation from the U.S.

FDA for its H5 pandemic influenza vaccine candidate (SP0335) utilizing Matrix-M ® .

• A growing body of scientific evidence supports Matrix-M ® ’s utility in oncology and infectious disease.

Multiple scientific evaluations by partners and potential partners are underway, enabling future licensing opportunities.

• We advanced our differentiated C.

difficile vaccine candidate into pre-IND interactions with the U.S.

FDA and initiated GMP manufacturing process, supporting potential clinical entry as early as 2027.

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.

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.

Critical Accounting Policies and Use of Estimates

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

Three Months Ended March 31, 2026 and 2025

Three Months Ended March 31,

Three Months Ended June 30, 2026 and 2025

Three Months Ended June 30,

2026 2025 Change

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Total revenue $ 56,698 $ 239,240 $ (182,542)

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.

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”).

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.

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.

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The categories of Product sales were as follows:

Three Months Ended March 31,

Three Months Ended June 30,

2026 2025 Change

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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 during the three months ended June 30, 2026 was $37.8 million as compared to $228.5 million during the same period in 2025, a decrease of $190.7 million.

The decrease was primarily due to a decrease in licensing revenue under the Sanofi CLA and the collaboration and exclusive license agreement, as amended with Takeda (“Amended Takeda CLA”).

Licensing, royalties, and other revenue were comprised of the following:

Three Months Ended March 31,

Three Months Ended June 30,

2026 2025 Change

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Sanofi $ 35,768 $ 199,412 $ (163,644)

Pfizer 30,000 — 30,000

Takeda 215 27,212 (26,997)

Serum 1,823 1,892 (69)

Other partners (1)

11,049 $ 200 10,849

Total licensing, royalties, and other revenue $ 37,844 $ 228,516 $ (190,672)

(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.

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

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

Three Months Ended March 31,

Three Months Ended June 30,

2026 2025 Change

Sanofi licensing, royalties, and other revenue (in thousands)

Milestones $ — $ 175,000 $ (175,000)

Royalties 676 — 676

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(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.

Three Months Ended March 31,

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.

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

Three Months Ended June 30,

2026 2025 Change

Takeda licensing, royalties, and other revenue

Upfront fee (1)

$ — $ 18,500 $ (18,500)

Milestones — 3,434 (3,434)

(50) 5,000 (5,050)

Support services 265 278 (13)

Total Total Takeda licensing, royalties, and other revenue

$ 215 $ 27,212 $ (26,997)

(1) Upfront fee includes $14.5 million of nonrefundable upfront payments associated with the Amended Takeda CLA and $4.0 million of previously unrecognized consideration from the Original Takeda CLA.

Three Months Ended June 30,

2026 2025 Change

Expenses (in thousands):

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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.

Cost of sales was $14.2 million for the three months ended June 30, 2026, including $2.3 million right of use asset impairment charges for CMO manufacturing capacity of excess quantities;

$1.8 million related to unutilized manufacturing capacity;

and $1.6 million related to excess, obsolete, or expired inventory.

Cost of sales was $15.3 million for the three months ended June 30, 2025, including expenses of $1.1 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments and $1.7 million related to unutilized manufacturing capacity.

The decrease in cost of sales of $1.1 million was mainly driven by cost containment measures to reduce our operating spend, partially offset by higher impairment

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,

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:

Three Months Ended June 30,

Research and Development Expenses (in thousands):

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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.

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.

Other Income, Net

Three Months Ended March 31,

Three Months Ended June 30,

2026 2025 Change

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Total other income, net $ 3,230 $ 6,384 $ (3,154)

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.

Total other income, net was $3.2 million for the three months ended June 30, 2026 as compared to $6.4 million for the same period in 2025.

The decrease in other income, net is primarily due to unfavorable impact in 2026 as compared to 2025 of exchange rates on foreign currency denominated balances and by an increase in interest expense from higher Long-term debt balance.

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.

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.

Net Income (Loss)

Three Months Ended March 31,

Three Months Ended June 30,

2026 2025 Change

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Weighted average shares outstanding, basic 164,574 162,019 2,555

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.

Weighted average shares outstanding, diluted 164,574 177,215 (12,641)

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.

The increase in weighted average shares outstanding for the three months ended June 30, 2026, was primarily a result of common stock issued under our incentive programs.

Six Months Ended June 30, 2026 and 2025

Six Months Ended June 30,

2026 2025 Change

Revenue (in thousands):

Product sales $ 61,054 $ 632,402 $ (571,348)

Licensing, royalties, and other 135,158 273,493 (138,335)

Total revenue $ 196,212 $ 905,895 $ (709,683)

Revenue for the six months ended June 30, 2026 was $196.2 million as compared to $905.9 million for the same period in 2025, a decrease of $709.7 million.

Revenue for the six months ended June 30, 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 six months ended June 30, 2025 was primarily comprised of revenue from the termination of our APAs with Canada (“Canada APA”) and New Zealand (“New Zealand APA”) of $575.7 million and $27.3 million, respectively, licensing revenue from the achievement of milestones under the Sanofi CLA, the recognition of previously deferred upfront payments and revenue from transition services and technology transfer under the Sanofi CLA, and licensing and royalty revenue with Takeda.

The decrease in revenue is primarily due to nonrecurring Product sales from the termination of our Canada and New Zealand APAs and by a decrease in Licensing, royalties, and other revenue from the Sanofi CLA and the Amended Takeda CLA, partially offset by revenue under the Pfizer License Agreement.

Product sales

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.

The categories of Product sales were as follows:

Six Months Ended June 30,

2026 2025 Change

Product sales (in thousands)

Nuvaxovid™ sales (1)

$ 9,558 $ 605,931 $ (596,373)

Supply sales (2)

51,496 26,471 25,025

Total Product sales

$ 61,054 $ 632,402 $ (571,348)

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

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

Licensing, royalties, and other

Licensing, royalties, and other revenue during the six months ended June 30, 2026 was $135.2 million as compared to $273.5 million during the same period in 2024, a decrease of $138.3 million.

The decrease was primarily due to a decrease in revenue under the Sanofi CLA, offset by an increase in revenue from other partners, including under the Amended Takeda CLA.

Licensing, royalties, and other revenue were comprised of the following:

Six Months Ended June 30,

2026 2025 Change

Licensing, royalties, and other (in thousands)

Sanofi $ 84,666 $ 239,733 $ (155,067)

Pfizer 30,000 — 30,000

Takeda 950 27,212 (26,262)

Serum 9,189 6,548 2,641

Other partners (1)

10,353 — 10,353

Total licensing, royalties, and other revenue $ 135,158 $ 273,493 $ (138,335)

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

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

Six Months Ended June 30,

2026 2025 Change

Sanofi licensing, royalties, and other revenue (in thousands)

Milestones $ — $ 175,000 $ (175,000)

4,195 — 4,195

Transition services and technology transfer:

Upfront fee amortization (1)

20,834 32,180 (11,346)

Milestones amortization (1)

9,313 14,808 (5,495)

Cost reimbursements

50,324 17,745 32,579

Total Sanofi licensing, royalties, and other revenue

$ 84,666 $ 239,733 $ (155,067)

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

Six Months Ended June 30,

2026 2025 Change

Takeda licensing, royalties, and other revenue

Upfront fee (1)

$ — $ 18,500 $ (18,500)

Milestones — 3,434 (3,434)

611 5,000 (4,389)

Support services 339 278 61

Tota Total Takeda licensing, royalties, and other revenue $ 950 $ 27,212 $ (26,262)

(1) Upfront fee includes $14.5 million of nonrefundable upfront payments associated with the Amended Takeda CLA and $4.0 million of previously unrecognized consideration from the Original Takeda CLA.

Six Months Ended June 30,

2026 2025 Change

Expenses (in thousands):

Cost of sales $ 44,941 $ 29,439 $ 15,502

Research and development 166,165 168,170 (2,005)

Selling, general, and administrative 55,442 91,702 (36,260)

Total expenses $ 266,548 $ 289,311 $ (22,763)

Cost of Sales

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.

Research and Development Expenses

Research and development expenses decreased to $166.2 million for the six months ended June 30, 2026 from $168.2 million for the same period in 2025, a decrease of $2.0 million.

The decrease was primarily due to cost containment measures to reduce our operating spend, as summarized in the table below (in thousands):

Six Months Ended June 30,

Coronavirus vaccines $ 54,328 $ 28,824

CIC and influenza vaccines 3,556 19,621

Other vaccine development programs 5,393 997

Total direct external research and development expense 63,277 49,442

Employee expenses 63,313 68,270

Stock-based compensation expense 5,562 7,790

Facility expenses 19,690 25,812

Other expenses 14,323 16,856

Total research and development expenses $ 166,165 $ 168,170

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses decreased to $55.4 million for the six months ended June 30, 2026 from $91.7 million for the same period in 2025, a decrease of $36.3 million.

Other Income (Expense)

Six Months Ended June 30,

2026 2025 Change

Other income (expense), net (in thousands):

Interest expense $ (10,590) $ (11,241) $ 651

Other income 20,744 21,957 (1,213)

Total other income (expense), net $ 10,154 $ 10,716 $ (562)

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.

Income Tax Expense

During the six months ended June 30, 2026, we recognized an income tax expense of $2.7 million related to foreign income taxes and foreign withholding taxes.

During the six months ended June 30, 2025, we recognized an income tax expense of $2.1 million related to federal, state, and foreign income taxes and foreign withholding taxes.

Net Income (Loss)

Six Months Ended June 30,

2026 2025 Change

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

Net income (loss) $ (62,878) $ 625,154 $ (688,032)

Net income (loss) per share, basic $ (0.38) $ 3.87 $ (4.25)

Net income (loss) per share, diluted $ (0.38) $ 3.55 $ (3.93)

Weighted average shares outstanding, basic 163,929 161,536 2,393

Weighted average shares outstanding, diluted 163,929 177,410 (13,481)

Net income (loss) for the six months ended June 30, 2026 was net loss of $62.9 million, or $0.38 per share, basic and diluted, as compared to net income of $625.2 million, or $3.87 per share, basic and $3.55 per share, diluted, for the same period in 2025.

The decrease in net income (loss) during the six months ended June 30, 2026, was primarily due to a decrease in total revenue.

The increase in weighted average shares outstanding for the six months ended June 30, 2026 is primarily a result of common stock issued under our incentive programs.

Liquidity Matters and Capital Resources

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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.

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.

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.

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.

As of June 30, 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.

As of June 30, 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.

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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

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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.

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.

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.

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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.

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

$35.2 million was classified as non-current Deferred revenue in our consolidated balance sheet.

Recognition of these amounts are 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.

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.

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.

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.

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The term loans mature in March 2031, at which time all outstanding principal and accrued interest are due and payable in full.

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.

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.

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.

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

Three Months Ended March 31,

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

Six Months Ended June 30,

2026 2025 Change

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Cash, cash equivalents, and restricted cash at end of period $ 196,040 $ 268,982 $ (72,942)

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.

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.

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.

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.

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.

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.

We believe that our cash, cash equivalents, and marketable securities as of June 30, 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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis