What changed in this filing

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Item 1. Business

2026-02-26 compared with 2025-02-27 · 412 added, 463 removed, 185 unchanged (83% of the section changed)

Novavax, Inc., together with our wholly owned subsidiaries, is tackling global health challenges through scientific innovation that seeks to maximize our deep scientific expertise in vaccines and our cutting-edge technology platform.

The differentiated platform features our recombinant protein-based nanoparticle technology and unique Matrix-M ™ adjuvant.

Our corporate growth strategy is focused on delivering value through in-house early-stage research and development (“R&D”) to build a pipeline of high-value assets using our proven technology along with seeking to enter into partnerships to drive value creation for our R&D assets early in the development process and for our Matrix-M™ adjuvant alone.

Our three strategic priorities are:

focusing on our partnership with Sanofi announced in May 2024, leveraging our technology platform

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and pipeline to forge additional partnerships, and advancing our proven technology platform and early-stage pipeline.

Our corporate growth strategy is supported by a lean and focused operating model.

Novavax, Inc., together with our wholly owned subsidiaries, tackles some of the world’s most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including its Matrix-M ™ adjuvant and protein-based nanoparticles.

Our corporate growth strategy focuses on maximizing the impact of our cutting-edge technology by forging partnerships for our Matrix-M adjuvant and research and development (R&D) assets while maintaining a lean and focused operating model.

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 value.

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Our Matrix-M™ adjuvant can increase both antibody and cell-mediated immune responses to the vaccine and it has demonstrated a favorable tolerability profile in clinical trials.

Our technology platform is used in our authorized COVID-19 vaccine and the R21/Matrix-M ™ adjuvant malaria vaccine (as defined below).

We have developed and manufactured our updated COVID-19 vaccine for the 2024-2025 vaccination season for use in individuals aged 12 and older.

Our updated COVID-19 vaccine received Emergency Use Authorization (“EUA”) from the U.S.

Food and Drug Administration (“FDA”) in August 2024, along with several additional global regulatory authorizations for use in the 2024-2025 vaccination season.

In the U.S., our Biologics License Application (“BLA”) for our prototype COVID-19 vaccine and for our XBB COVID-19 vaccine is currently under U.S.

FDA review with a Prescription Drug User Fee Act (“PDUFA”) date of April 2025.

In May 2024, we entered into a Collaboration and License Agreement with Sanofi (the “Sanofi CLA”), to co-commercialize our COVID-19 vaccine, including future updated versions that address seasonal COVID-19 variants.

Under the terms of the agreement, we will continue to commercialize our updated COVID-19 vaccine through the end of the 2024-2025 vaccination season, and beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize the COVID-19 vaccine worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply certain of our existing advance purchase agreement (“APA”) customers and strategic partners, including Takeda Pharmaceutical Company Limited (“Takeda”) and Serum Institute of India Pvt.

Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.

Additionally, Sanofi has the right to develop novel influenza-COVID-19 combination vaccines utilizing our COVID-19 vaccine and Sanofi’s seasonal influenza vaccine, combination products containing our COVID-19 vaccine and one or more non-influenza vaccines, and multiple new vaccines utilizing our Matrix-M ™ adjuvant.

In December 2024, Sanofi announced that the U.S.

Food and Drug Administration (“U.S.FDA”) granted Fast Track designation to two Sanofi combination vaccine candidates:

the first combination consists of Fluzone High-Dose combined with our COVID-19 vaccine, and the second combination consists of Flublok with our COVID-19 vaccine.

Sanofi is evaluating the safety and immunogenicity of both combination vaccine candidates in two separate Phase 1/2 trials.

We are eligible to receive royalties and milestones associated with the ongoing sales of our COVID-19 vaccine and Sanofi’s influenza-COVID-19 combination vaccines and any other combination vaccines Sanofi may develop, as well as ongoing product royalties for vaccines developed with our Matrix-M ™ adjuvant.

We discuss this agreement in further detail in Note 4 to our accompanying consolidated financial statements.

Additionally, we are advancing our pipeline of both late- and early-stage programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale and strong commercial opportunity.

Our late-stage programs include a COVID-19-Influenza (“CIC”) vaccine candidate, as well as a stand-alone influenza vaccine candidate.

In December 2024, we initiated the initial cohort of a Phase 3 trial comparing our CIC vaccine and stand-alone influenza vaccine to our updated COVID-19 vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

We intend to partner these vaccine candidates in order to advance to BLA filing and commercialization.

Our technology platform is used in our authorized COVID-19 Vaccine (Nuvaxovid) and the R21/Matrix-M™ adjuvant malaria vaccine (as defined below).

Additionally, we are advancing our pipeline programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale and strong commercial opportunity.

Furthermore, we provide our Matrix-M™ adjuvant for use in collaborations.

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

R21/Matrix-M™ adjuvant malaria vaccine is authorized in several countries.

Additionally, we provide Matrix-M™ adjuvant for use in various programs in preclinical and clinical stage, as well as preclinical investigations.

Examples include an agreement with the Gates Foundation, and in a related master transfer agreement with a leading pharmaceutical company for exploration of Matrix-M™ adjuvant used as a potential advancement in their pipeline.

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We continue to advance our strategic assessment of our emerging, early-stage pipeline.

We intend to develop our early-stage pipeline using a disciplined and capital-efficient approach.

Our R&D investment strategy seeks to place smart, lower-cost investments on the programs with the highest potential value, both within infectious disease and beyond, with the intent of partnering these assets at proof of concept and shifting late-stage development costs to our partners to finalize clinical development.

We are pursuing early-stage research in diseases such as, respiratory syncytial virus (“RSV”) combinations, varicella-zoster virus (shingles) and Clostridioides difficile (C.

Diff.) colitis.

We are actively working to evaluate several RSV combination candidates to progress forward toward an Investigational New Drug (“IND”).

We are actively developing an H5N1 avian pandemic influenza vaccine candidate and the toxicology study is underway.

We are actively monitoring the emerging public health situation and are pursuing funding opportunities to join preparedness efforts.

Additionally, we are evaluating potential expansion beyond infectious diseases including therapeutic areas such as oncology, where we believe our technology could augment and improve upon current therapies.

Examples include, several material transfer agreements with global pharmaceutical companies for exploration of Matrix-M™ adjuvant used as a potential advancement in their pipeline, including a pre-clinical collaboration in oncology.

We were incorporated in 1987 under the laws of the State of Delaware.

Our principal executive offices are located at 700 Quince Orchard Road, Gaithersburg, Maryland, 20878, and our telephone number is (240) 268-2000.

Our principal executive offices are located at 21 Firstfield Road, Gaithersburg, Maryland, 20878, and our telephone number is (240) 268-2000.

Our common stock is listed on the Nasdaq Global Select Market under the symbol “NVAX.”

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In May 2024, pursuant to the Sanofi CLA, Sanofi received a non-exclusive license to develop and commercialize other vaccine products that include our Matrix-M™ adjuvant.

In September 2024, we signed a Matrix-M™ adjuvant related agreement with a leading pharmaceutical company to enable exploration of our technology for the potential advancement of their pipeline candidates.

COVID-19 Vaccine Regulatory and Licensure

For our updated COVID-19 vaccine for the 2024-2025 vaccination season, in August 2024, we received EUA from the U.S.

FDA for active immunization to prevent COVID-19 in individuals aged 12 and older.

Our updated COVID-19 vaccine is included in the recommendations issued by the U.S.

Centers for Disease Control and Prevention in June 2024.

This follows the recommendation in April 2024, from the World Health Organization (“WHO”) for the recommended use of a monovalent JN.1 lineage COVID-19 vaccine.

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In the U.S., our updated COVID-19 vaccine for the 2024-2025 vaccination season is available in pre-filled syringe product presentation and available in independent pharmacies and major retailers.

In October 2024, the European Commission issued a decision approving our updated COVID-19 vaccine for use in individuals aged 12 and older for the prevention of COVID-19 in the EU.

This decision followed the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (“EMA”).

Additionally, in October 2024, we received BLA approval by the Taiwan Food and Drug Administration for our COVID-19 vaccine for use in individuals aged 12 and older.

In November 2024, we received approval from the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) for our updated COVID-19 vaccine for use in individuals aged 12 and older.

In December 2024, we received approval from Singapore Health Sciences Authority for our updated COVID-19 vaccine for use in individuals aged 12 and older.

We are working to continue to expand our label for primary and re-vaccination in younger children, and to achieve supportive policy recommendations enabling broad market access and to support Sanofi’s commercial efforts, pursuant to our agreement, that have begun in 2025.

We continue to work closely with governments, regulatory authorities, and non-governmental organizations in our commitment to facilitate access to our COVID-19 vaccine.

In 2025, we signed three material transfer agreements with other pharmaceutical companies to explore the use of our Matrix-M™ adjuvant for the potential advancement of their pipeline candidates, with the latest material transfer agreement signed in the fourth quarter of 2025.

In January 2026, we entered into a non-exclusive license agreement with Pfizer for use of Matrix-M adjuvant in up to two infectious disease areas.

We have entered into APAs (also referred to as “supply agreements” throughout this Annual Report on Form 10-K) with various countries globally.

The APAs typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment.

Such upfront payments generally become non-refundable upon our achievement of certain development milestones.

We currently have $1.0 billion in committed APAs anticipated for future delivery under existing agreements, comprised of $225 million under our APA with the Vaccine Alliance (“Gavi”), $556 million under our APA with His Majesty the King in Right of Canada as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (the “Canadian government”), and $258 million under all other APAs.

We have an APA with the Commonwealth of Australia (“Australia”) for the purchase of doses of COVID-19 Vaccine (the “Australia APA”).

In December 2024, we entered into an amendment to the Australia APA with Australia.

Pursuant to the amendment, 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 3 million doses of COVID-19 Vaccine without requiring additional cash payments.

We also agreed to an updated delivery schedule providing for the potential delivery of COVID-19 Vaccine or future variant COVID-19 Vaccine through the end of 2029.

The amendment further provides for certain remedies for Australia, including return of unused credit, cancellation of doses, or termination of the Australia APA, in the event we miss or under deliver doses to Australia or fail to receive regulatory approval of a variant COVID-19 Vaccine.

As of December 31, 2025, we have $0.4 billion of remaining obligations under APAs with certain countries globally.

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”), $225.0 million under our APA with the Vaccine Alliance (“Gavi”), and $73.3 million related to various other countries.

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.

As of December 31, 2024, $15.6 million was classified as current Deferred revenue and $118.2 million was classified as non-current Deferred revenue with respect to the Australia APA in our consolidated balance sheet, which will be recognized in product revenue as doses are delivered to Australia.

We have an APA with the Pharmaceutical Management Agency (“Pharmac”), a New Zealand Crown entity, for the purchase of doses of COVID-19 Vaccine (the “New Zealand APA”).

In July 2024, Pharmac provided notice of its termination of the New Zealand APA.

Pharmac has requested a refund of certain advanced payments, and we are in discussion with Pharmac regarding whether a refund of the advanced payments is appropriate under the New Zealand APA.

As of December 31, 2024 , $31.3 million was classified as Other current liabilities with respect to the New Zealand APA in our consolidated balance sheet.

Approximately $125 million of the contract value related to future deliverables may no longer be available if the New Zealand APA is terminated.

We responded to Pharmac in September 2024 indicating we do not believe

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Pharmac has the right to unilaterally terminate the contract or receive a refund of any part of the remaining upfront payment.

We are in ongoing discussions with Pharmac to resolve this matter, which may not be achievable on acceptable terms or at all.

We have an APA with the Canadian government, for the purchase of doses of COVID-19 Vaccine (the “Canada APA”).

The Canadian government may terminate the Canada APA, as amended, as we failed to receive regulatory approval for our COVID-19 Vaccine using bulk antigen produced at Biologics Manufacturing Centre Inc.

(“BMC”) on or before December 31, 2024.

Therefore, we are in discussions with Canada regarding a potential amendment to the Canada APA to address possible alternatives, which may not be achievable on acceptable terms or at all.

As of December 31, 2024, $555.7 million was classified as current Deferred revenue with respect to the Canada APA in our consolidated balance sheet.

If the Canadian government terminates the Canada APA, $28.0 million of advanced payments previously received would become refundable, which was classified as Other current liabilities in our consolidated balance sheet, and approximately $224 million of the contract value related to future deliverables would no longer be available.

In November 2024, we and 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”) entered into a Termination and Settlement Agreement (the “Settlement Agreement”) and a Letter of Amendment to the Settlement Agreement (the “Settlement Agreement Amendment”), relating to the Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) and the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020 (the “Original UK Supply Agreement”) by and between us and the Authority.

The Settlement Agreement resolved the disputes regarding the Amended and Restated Supply Agreement and released both parties of all claims arising out of or connected with the Amended and Restated Supply Agreement.

Under the terms of the Settlement Agreement and Settlement Agreement Amendment, we and the Authority agreed to terminate the Amended and Restated Supply Agreement and to fully settle the outstanding amount under dispute related to upfront payments of $112.5 million previously received by us from the Authority under the Amended and Restated Supply Agreement.

Pursuant to the Settlement Agreement, we agreed to pay a refund of $123.8 million (the “Settlement Payment”) to the Authority in equal quarterly installments of $10.3 million over a three year period, ending in June 2027.

The Settlement Payment amount includes an $11.3 million provision for interest over the period and may be avoided if we choose to accelerate payments.

As of December 31, 2024, the remaining upfront payment previously received from the authority is classified as $36.4 million of other current liabilities and $58.8 million of Other non-current liabilities on our consolidated balance sheet.

We entered into an APA with Gavi in May 2021 (the “Gavi APA”), pursuant to which we received upfront payments of $700 million from Gavi (the “Advance Payment Amount”) to be applied against purchases of our prototype COVID-19 vaccine by certain countries participating in the COVAX Facility.

As of December 31, 2023, the remaining Gavi Advance Payment Amount was $696.4 million.

In February 2024, we and Gavi entered into a Termination and Settlement Agreement (the “Gavi Settlement Agreement”) terminating the Gavi APA, settling the arbitration proceedings, and releasing both parties of all claims arising from, under, or otherwise in connection with the Gavi APA.

Pursuant to the Gavi Settlement Agreement, we are responsible for payment to Gavi of (i) an initial settlement payment of $75 million, which we paid in February 2024, and (ii) deferred payments, in equal annual amounts of $80 million payable each calendar year through a deferred payment term ending December 31, 2028.

The deferred payments are due in variable quarterly installments beginning in the second quarter of 2024 and total $400 million during the deferred payment term.

Such deferred payments may be reduced through Gavi’s use of an annual vaccine credit equivalent to the unpaid balance of such deferred payments each year, which may be applied to qualifying sales of any of our vaccines funded by Gavi for supply to certain low-income and lower-middle income countries.

We have the right to price the vaccines offered to such low-income and lower-middle income countries in our discretion, and, when utilized by Gavi, we will credit the actual price per vaccine paid against the applicable credit.

We intend to price vaccines offered via the tender process, consistent with our shared goal with Gavi to provide equitable access to those countries.

Also, pursuant to the Gavi Settlement Agreement, we granted Gavi an additional credit of up to $225 million that may be applied against qualifying sales of any of our vaccines for supply to such low-income and lower-middle income countries that exceed the $80 million deferred payment amount in any calendar year during the deferred payment term.

In total, the Gavi settlement agreement is comprised of $700 million of potential consideration, consisting of the $75 million initial settlement payment, deferred payments of up to $400 million that may be reduced through annual vaccine credits, and the additional credit of up to $225 million that may be applied for certain qualifying sales.

We recorded the $3.6 million difference between the refund liability recorded as of December 31, 2023 of $696.4 million and the $700 million of total consideration under the arrangement as a revenue adjustment during the year ended December 31, 2024.

As of December 31, 2024, 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,

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$85.0 million in Other current liabilities, and $275.0 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 3 to our accompanying 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.

Product Pipeline

We are advancing our pipeline of late- and early-stage programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale and strong commercial opportunity.

Development and advancement of our in-house pipeline leverages our core expertise and our experience in respiratory and infectious diseases and vaccines, and we intend to explore new opportunities with the potential to expand beyond infectious diseases.

Our partnered pipeline includes our COVID-19 vaccine and our Matrix-M™ adjuvant used in collaboration for development of new and existing vaccines.

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Pipeline Overview

Our pipeline encompasses vaccine candidates for infectious diseases.

Our COVID-19 vaccine, partnered with Sanofi, is our most advanced product.

We will continue to commercialize our updated COVID-19 vaccine through the end of the 2024-2025 vaccination season, and beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize our COVID-19 vaccine worldwide in accordance with a commercialization plan agreed by us and Sanofi.

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.

As of December 31, 2025, $48.4 million was classified as current Deferred revenue and $85.4 million was classified as non-current Deferred revenue with respect to the Australia APA on our consolidated balance sheet, which will be recognized in product revenue as doses are delivered to Australia.

In the third quarter of 2025 we withdrew our application for our COVID-19 Vaccine based on recommendations made by the TGA.

The parties are in ongoing discussions and have agreed to a meeting to discuss 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.

We had an APA with His Majesty the King in Right of Canada as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (the “Canadian government”), for the purchase of doses of COVID-19 Vaccine (as amended, the “Canada APA”).

As of December 31, 2024, we had $555.7 million of current deferred revenue and $48.0 million of other current liabilities related to advanced payments and other commitments previously made under the Canada APA on our consolidated balance sheet.

In March 2025, we received a communication (the “Notice”) terminating, with immediate effect, the Canada APA on the basis of us not receiving regulatory approval for our COVID-19 Vaccine using bulk antigen produced at Biologics Manufacturing Centre Inc.

on or before December 31, 2024, pursuant to the terms of the Canada APA.

As a result of the Notice, we have no remaining obligations to the Canadian government under the Canada APA.

Therefore, during the year ended December 31, 2025, we recognized $575.7 million, previously recorded in deferred revenue and other current liabilities, as Product sales.

Under the terms of the Canada APA, $28.0 million in advanced purchase payments previously received by us were refundable to the Canadian government within 30 days of receipt of the Notice.

We repaid the $28.0 million in March 2025.

The Canada APA also contemplated we and the Canadian government would endeavor to enter into a memorandum of understanding (the “MOU”) related to certain in-country commitments, including a $20.0 million escrow funding.

The Notice also acknowledged that such MOU is no longer feasible and that the related funds may be released to us.

In March 2025, the Pharmaceutical Management Agency (“Pharmac”), a New Zealand Crown entity, and we executed a Deed of Settlement and Release (“New Zealand Settlement Agreement”) of our APA with New Zealand (the “New Zealand APA”).

As part of the New Zealand Settlement Agreement, we paid Pharmac a refund of previously received upfront payments of $4.0 million.

Under the New Zealand Settlement Agreement, we have no remaining obligation to Pharmac under the New Zealand APA.

Therefore, during the year ended December 31, 2025, we recognized $27.3 million, previously in other current liabilities, as Product sales.

As of December 31, 2024, we had $31.3 million included in Other current liabilities in our consolidated balance sheet related to the New Zealand APA.

Commercial Products and Product Pipeline

Commercial Products

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

Our COVID-19 Vaccine has received authorizations from the U.S.

FDA, the European Commission (“EC”), the WHO and several other countries for both adult and adolescent populations.

We advanced our COVID-19 vaccine to a post-authorization Phase 3 safety and immunogenicity trial.

Beyond our COVID-19 vaccine, our late-stage pipeline includes a CIC vaccine candidate, and our stand-alone influenza vaccine candidate.

FDA, the European Commission (“EC”), and several other countries for both adult and adolescent populations.

COVID-19 Vaccine Regulatory and Licensure

In May 2025, the U.S.

FDA approved the BLA for Nuvaxovid™ for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g.

asthma, cancer, diabetes, obesity, smoking).

The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid™ was safe and effective for the prevention of COVID-19.

The BLA approval triggered a $175 million milestone payment under the Sanofi CLA.

In August 2025, the U.S.

FDA approved the JN.1 COVID-19 Vaccine for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

In November 2025, we announced that we completed the transfer of the Nuvaxovid™ BLA to Sanofi, who remains responsible for further development and commercialization of this product.

Novavax Pipeline

We are advancing our pipeline programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale and strong commercial opportunity.

Development and advancement of our in-house

pipeline leverages our core expertise and our experience in respiratory and infectious diseases and vaccines, and we intend to explore new opportunities with the potential to expand beyond infectious diseases.

Additionally, we intend to develop our early-stage pipeline using a disciplined and capital-efficient approach.

We are actively developing an H5N1 avian pandemic influenza vaccine candidate.

We are conducting early-stage research in diseases such as, RSV combinations, varicella-zoster virus (shingles) and Clostridium difficile (C.

Diff.) colitis.

Lastly, we are evaluating potential expansion beyond infectious diseases, including therapeutic areas such as oncology, where we believe our technology has the potential to augment and improve upon current therapies.

In addition to our own pipeline, we have several partnership opportunities.

For example, our Matrix-M™ adjuvant is being used for collaboration in R21/Matrix-M™ adjuvant malaria vaccine.

We believe our partner-led R21/Matrix™ adjuvant malaria vaccine presents significant potential.

Based on preliminary results from an ongoing Phase 3 trial in infants and toddlers in Africa, showing 72-79% efficacy, the R21/Matrix™ adjuvant malaria vaccine has been authorized in Ghana, Nigeria, and Burkina Faso, and in December 2023, was granted prequalification by the WHO.

Under our agreement, we have also provided a sole license to Sanofi for the independent development of a COVID-19 and influenza combination product using our COVID-19 vaccine in combination with two of Sanofi’s separately marketed influenza vaccines, Fluzone High-Dose and Flublok to evaluate immunogenicity and safety in Phase 1/2 combination vaccine trials.

Our R&D investment strategy seeks to place targeted investments on the programs with the highest potential value, both within infectious disease and beyond, with the intent of partnering these programs at proof of concept.

We would consider advancing a program ourselves where data and commercial landscape indicate a unique high-value opportunity.

We are conducting early-stage research in diseases such as, C.

Diff, shingles and RSV combinations.

In addition, we are developing a pandemic influenza vaccine candidate and pursuing funding opportunities to join preparedness options.

Lastly, we are evaluating potential expansion beyond infectious diseases, where we believe our technology has the potential to augment and improve upon current therapies.

In the first quarter of 2025, we entered into a preclinical collaboration with a partner to explore the application and utility of Matrix-M™ adjuvant with their cancer vaccine candidate.

Partner Pipeline

In addition to our own pipeline, we have several ongoing partnerships.

Under our Sanofi agreement, we have also provided a sole license to Sanofi for the independent development of a COVID-19 and influenza combination product using our COVID-19 Vaccine in combination with two of Sanofi’s separately marketed influenza vaccines, Fluzone High-Dose and Flublok.

These two combination vaccine candidates were granted Fast Track designation by the U.S.

FDA in December 2024 to prevent influenza and COVID-19 infections in individuals aged 50 and older.

Sanofi also has a non-exclusive license to develop and commercialize combination products containing both our COVID-19 vaccine and one or more non-influenza vaccines, and

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a non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M™ adjuvant.

In October 2025, Sanofi reported positive Phase 1/2 results with their combination vaccine candidates and will engage with regulatory authorities on next steps.

Sanofi also has a non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines, and a non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M™ adjuvant.

In September 2025, we amended the Sanofi CLA to expand Sanofi's license to include use of Novavax's Matrix-M™ adjuvant in Sanofi's pandemic influenza vaccine candidate program.

Sanofi received funding from the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response, part of the U.S.

Department of Health and Human Services, for early-stage work on this vaccine candidate including the Matrix-M™ adjuvant.

In January 2026, we entered into a License and Option Agreement with Pfizer Inc.

(“Pfizer”) for use of our Matrix-M™.

Under the terms of the agreement, Pfizer will obtain a non-exclusive license for Matrix-M™ for use with Pfizer's products in two infectious disease areas.

The agreement provides for an upfront payment of $30 million and we have the potential to receive up to $500 million in development and sales milestone payments.

In addition to milestone payments, we are eligible to receive tiered high mid-single digit percentage royalty payments on sales of any product by Pfizer that includes Matrix-M™.

Coronavirus Vaccine Clinical Development

We continue efforts to expand our COVID-19 vaccine label within the adolescent and pediatric indications.

Additionally, we continue to evaluate vaccine safety, immunogenicity, and effectiveness through ongoing clinical trials and collaborative evidence-generating real-world studies.

Phase 3 Strain-Change and Re-vaccination Studies

In October 2024, we initiated and fully enrolled Study 315 to evaluate safety and immunogenicity of a single dose of the JN.1 subvariant vaccine NVX-CoV2705 in previously vaccinated adults.

Topline data is expected in the first quarter of 2025 and is expected to support regulatory submissions in the U.S.

and other jurisdictions for this and future variant strain formulations.

In July 2024, we locked the database for 338 participants aged 18 and older in Part 2 of the Study 313, which will evaluate the immunogenicity of a single dose of the XBB.1.5 subvariant vaccine NVX-CoV2601 in previously unvaccinated individuals.

Data from Study 313 are intended to support BLA supplements and similar regulatory submissions in other territories for future variant strain formulations.

Phase 2b/3 Pediatric Hummingbird™ Study

In December 2024, we achieved the $50 million milestone under our agreement with Sanofi, associated with the database lock for one of the three cohorts in this study.

In August 2023, we announced topline results from our Phase 2b/3 Hummingbird™ trial that met its primary endpoints in children aged 6 through 11 years demonstrating both tolerability and immunologic responses.

This ongoing trial is evaluating the safety, effectiveness (immunogenicity), and efficacy of two doses of our prototype COVID-19 vaccine (NVX-CoV2373), followed by a booster 6 months after the primary vaccination series.

The trial completed enrollment in September 2023 and includes three age de-escalation cohorts of 1,200 children each.

In previous consultations with the U.S.

FDA, the filing strategy included filing a supplemental BLA for children in these age cohorts once the initial BLA is approved.

We are in discussion with the U.S.

FDA regarding additional immunogenicity studies that will be needed to support a supplemental BLA to expand the pediatric indication in light of the progressive increase in the number of children with baseline COVID-19 natural immunity during the Phase 2b/3 Hummingbird™ trial enrollment period, which began in August 2022.

We continue to evaluate vaccine safety, immunogenicity, and effectiveness through ongoing clinical trials and collaborative evidence-generating real-world studies.

Phase 4 Postmarketing Commitments

In May 2025, we announced that the U.S.

FDA, as a part of its BLA approval of Nuvaxovid, requested that we conduct as one of our post-marketing commitments (“PMCs”) a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19.

Although the BLA has since been transferred to Sanofi, we are currently conducting the PMC trial on behalf of Sanofi which will reimburse us for 70% of the PMC costs, capped at the currently agreed upon cost estimates.

We updated our total expected costs and the amounts of variable consideration for research and development transition services that support further regulatory approval and development of the COVID-19 Vaccine (“Sanofi Transition Services”) for costs and reimbursements from the PMC.

Revenue related to the PMC will be recognized in Licensing, royalties, and other revenue over time using an input method, consistent with Sanofi Transition Services.

In addition, in October 2025, we initiated an additional PMC study evaluating the safety and immunogenicity of Nuvaxovid in the population of individuals for which Nuvaxovid is approved in the U.S., i.e., individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID‑19 and in adults ≥ 65 years of age.

Following the transfer of the U.S.

marketing authorization, Sanofi is now responsible for the conduct of this study.

COVID-Influenza Combination and Stand-alone Influenza Program

Phase 3 Clinical Trial of CIC and Stand-alone Influenza Vaccine Candidates

In December 2024, we initiated a Phase 3 trial for our CIC and stand-alone influenza vaccine candidates to evaluate the immunogenicity and safety compared to our updated COVID-19 vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

Our Phase 3 trial has been initiated with an initial cohort of approximately 2,000 participants.

We are working with the U.S.

FDA to assess the potential feasibility of the accelerated approval pathway for our CIC vaccine candidate.

We are not seeking an accelerated approval for our stand-alone influenza vaccine candidate.

We do not intend to launch these vaccine candidates without a partner and we therefore will not be making any additional investments in this program until a partner is in place.

In October 2024, the U.S.

FDA placed a clinical hold on the IND from a spontaneous report of a serious adverse event in a participant who received the CIC vaccine candidate in a Phase 2 trial that completed in 2023.

After providing the U.S.

FDA with the requested additional information on this event, the event term was updated from motor neuropathy to amyotrophic lateral sclerosis, a condition that is not known to be immune-mediated or associated with vaccination, which in this event was assessed as not related to vaccination.

The information provided to the FDA supported our assessment that the serious adverse event was not related to our CIC vaccine candidate and the U.S.

FDA lifted the clinical hold on the IND in November 2024.

The Phase 3 trial builds on Phase 2 data that was previously shared in May 2023, where the vaccine candidates showed preliminary robust immune responses, reassuring safety profiles, and reactogenicity that was comparable to the licensed influenza vaccine comparator arms.

The Phase 2 dose-confirming randomized, observer-blinded trial evaluated the safety and

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effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates, and higher doses of Novavax's COVID-19 vaccine in 1,575 adults aged 50 through 80 years.

The CIC vaccine candidate achieved both anti-SARS-CoV-2 immunoglobulin G (IgG) and neutralizing levels comparable to our prototype COVID-19 vaccine.

In addition, several of the combination formulations achieved responses to both SARS-CoV-2 and to the four homologous influenza strains that were comparable to the reference comparators, supporting their prioritization for advanced development.

We continue to invest in development of our pipeline that uses our recombinant nanoparticle technology platform and Matrix-M ™ adjuvant.

We continue to believe these assets are key value drivers and intend to partner these assets towards a BLA filing.

Phase 3 Clinical Trial of COVID-19 Influenza (“CIC”) and Stand-alone Influenza Vaccine Candidates

In December 2024, we initiated a Phase 3 immunogenicity and safety trial for our CIC and stand-alone influenza vaccine candidates to evaluate the immunogenicity and safety compared to our COVID-19 Vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

Our Phase 3 immunogenicity and safety trial completed enrollment with an initial cohort of approximately 2,000 participants.

In June 2025, we reported data from this initial cohort, which showed both vaccine candidates induced robust immune responses across all antigens tested.

Both vaccine candidates were well tolerated with reactogenicity profiles that were comparable to authorized comparators.

After consultation with the U.S.

FDA, we determined that seeking an accelerated approval pathway for our CIC and stand-alone influenza candidates would not be feasible.

While the Phase 3 immunogenicity and safety trial is not a pivotal study, the data will inform a future registrational Phase 3 program.

We do not intend to make additional investments in these programs and are seeking a partner to advance both vaccine candidates.

Malaria is a life-threatening disease caused by a parasite that infects mosquitos and is subsequently transmitted to humans.

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We have an agreement with SII related to its manufacture of R21/Matrix-M™ adjuvant malaria vaccine under which SII purchases our Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single- to low-double digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.

In July 2024, first commercial doses of R21/Matrix-M™ adjuvant malaria vaccine have been administered to children in Cote d’Ivoire and South Sudan.

As part of the WHO malaria program, at their discretion, the vaccine is expected to be included in countries such as Central African Republic, Chad, Democratic Republic of Congo, Mozambique, Nigeria and Uganda.

Phase 3 Clinical Trial of R21/Matrix-M™ Adjuvant Malaria Vaccine

R21/Matrix-M™ adjuvant malaria vaccine is being evaluated in an ongoing Phase 3 trial conducted by our partner, the Jenner Institute, University of Oxford.

In February 2024, peer-reviewed results from the Phase 3 efficacy trial were published in The Lancet reporting R21/Matrix-M™ adjuvant malaria vaccine has a well-tolerated safety profile and offers high-level efficacy against clinical malaria in African children at sites of both seasonal and perennial transmission.

This Phase 3 trial enrolled 4,800 children aged 5 to 36 months across five sites in four African countries with differing malaria transmission intensities and seasonality.

The trial demonstrated efficacy of 75% when administered prior to the high transmission season during the 12 months following a three-dose series and efficacy of 68% when administered in an age-based schedule in regions where malaria is present perennially during the 12 months following the first three doses.

This R21/Matrix-M™ adjuvant malaria vaccine is a low-cost vaccine and has the potential to make a substantial contribution to reducing the burden of malaria disease and deaths in sub-Saharan Africa.

In July 2024, first commercial doses of R21/Matrix-M™ adjuvant malaria vaccine were administered to children in Cote d’Ivoire and South Sudan.

As of February 2026, R21/Matrix-M™ adjuvant malaria vaccine is available in 24 countries.

R21/Matrix-M™ Adjuvant Malaria Vaccine Regulatory and Licensure

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The WHO recommended that the R21/Matrix-M™ adjuvant malaria vaccine be administered in a four-dose schedule beginning at five months of age.

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License and Collaboration

A summary of our license and collaboration agreements follows:

In May 2024, we entered into the Sanofi CLA, to co-commercialize our COVID-19 Vaccine, including future updated versions that address seasonal COVID-19 variants.

Under the terms of the agreement, we continued to commercialize our COVID-19 Vaccine through the end of the 2024-2025 vaccination season.

Beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize the COVID-19 Vaccine worldwide in accordance with a commercialization plan agreed by the parties, under which we will continue to supply certain of our existing APA customers and strategic partners, including Takeda and SII.

Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.

Sanofi has the right to develop novel influenza-COVID-19 combination vaccines utilizing our COVID-19 Vaccine and Sanofi’s seasonal influenza vaccine, combination products containing our COVID-19 Vaccine and one or more non-influenza vaccines, and multiple new vaccines utilizing our Matrix-M™ adjuvant.

responsible for performing services related to Sanofi Technology Transfer.

Until the successful completion of such transfer, we will supply Sanofi with both COVID-19 Vaccine products and Matrix-M™ intermediary components for Sanofi’s use and we are eligible for reimbursement of such costs from Sanofi.

In addition, we are responsible for Sanofi Transition Services and, in certain cases, are eligible for reimbursement of such costs from Sanofi.

Pursuant to the Sanofi CLA, we are eligible to receive development, technology transfer, launch, and sales milestone payments for COVID-19 Vaccine products, CIC products, and Adjuvant products.

We are also eligible to receive royalty payments on Sanofi’s sales of such licensed products.

We are eligible to receive milestone payments totaling up to $350 million in the aggregate with respect to the COVID-19 Vaccine products, of which $75 million remains outstanding, and royalty payments in the high teens to low twenties percent on Sanofi’s sales of such licensed products.

As of December 31, 2025, the remaining milestone payment is $75 million upon the completion of the technology transfer of the Company’s manufacturing process for the COVID-19 Vaccine products to Sanofi.

We are eligible to receive milestone payments totaling up to $125 million with respect to CIC products upon achievement of certain CIC Product-related development milestones and $225 million in CIC Product-related launch milestones.

We are eligible to receive royalty payments in the high teens to low twenties percent on Sanofi’s sales of such licensed products.

We are also 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 mid-single digit sales royalties for 20 years on Sanofi’s sales of all such licensed products.

In addition, a portion of the technology transfer costs and R&D costs incurred by us will be reimbursed by Sanofi in accordance with agreed upon plans and budgets.

On January 15, 2026, we entered into a License and Option Agreement with Pfizer Inc.

(“Pfizer”) for use of our Matrix-M™.

Under the terms of the agreement, Pfizer will obtain a non-exclusive license for Matrix-M™ for use with Pfizer's products in up to two disease areas.

The agreement provides for an upfront payment of $30 million and we have the potential to receive up to $500 million in development and sales milestone payments.

In addition to milestone payments, we are eligible to receive tiered high mid-single digit percentage royalty payments on sales of any product by Pfizer that includes Matrix-M™.

On April 29, 2025, we entered into a collaboration and exclusive license agreement, as amended (“Amended Takeda CLA”), with Takeda "Pharmaceutical Company Limited (“Takeda”) which amended and superseded our collaboration and exclusive license agreement with Takeda, dated February 24, 2021 (“Original Takeda CLA”).

The Original Takeda CLA, which granted Takeda an exclusive license to develop, manufacture, and commercialize the COVID-19 Vaccine in Japan, was amended so that Takeda may develop and commercialize a strain for the COVID-19 Vaccine that is different from the strain that we select for the year, provided such Takeda selected strain must be procured from us.

Under the Amended Takeda CLA, Takeda will continue to purchase our Matrix-M™ adjuvant to manufacture doses of finished COVID-19 Vaccine with updated adjuvant forecast and other supply terms.

We determined the initial transaction price at inception of the Amended Takeda CLA to be $27.5 million, consisting of (i) $19.5 million of a non-refundable upfront payment, (ii) $4.0 million of non-cancelable annual support payments within the 18 month notice period for contract termination, and (iii) $4.0 million of previously unrecognized consideration from the Original Takeda CLA.

We allocated $26.9 million of fixed consideration to the Updated Takeda License performance obligations and $0.6 million to Takeda Support Services.

We recognized revenue of $40.9 million related to the Updated Takeda License in 2025.

The Takeda Support Services are recognized as revenue over time using an input method to measure progress by utilizing costs incurred to-date relative to total expected costs.

Revenue recognized related to Takeda Support Services for the year ended December 31, 2025 was $0.8 million.

Under the Amended Takeda CLA, we received a non-refundable upfront payment of $19.5 million of which $5.0 million is creditable against royalties owed by Takeda for its fiscal year 2024.

In addition, on an annual basis, we will receive $2.0 million to compensate us for services provided by us under the Takeda CLA, and 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, if Takeda receives marketing approval of the COVID-19 Vaccine in that year or such approval is not necessary for such year.

The parties have also updated the financial terms to replace the share of operating profits and, instead, provide us with 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), which commenced 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.

In connection with the Amended Takeda CLA, on April 29, 2025, we entered into a release agreement with Takeda under which we released Takeda and Takeda released us from all claims that were asserted or could have been asserted by either party against the other party that related to the Original Takeda CLA and the activities thereunder.

We previously granted SII exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of our COVID-19 Vaccine and our CIC vaccine candidate.

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We and SII equally split the revenue from SII’s sale of COVID-19 Vaccine in its licensed territory, net of agreed costs.

In May 2024, we and Serum Life Sciences Limited, a subsidiary of SII ("SLS”), entered into a supply agreement (the “SLS Supply Agreement”) under which SLS agreed to supply us with antigen drug substance and finished COVID-19 Vaccine doses.

In March 2020, we entered into an agreement with SII that granted SII a non-exclusive license for the use of Matrix-M™ adjuvant supplied by us to develop, manufacture, and commercialize R21/Matrix-M™ adjuvant (“SII R21 Agreement”), a malaria vaccine created by the Jenner Institute, University of Oxford (“R21/Matrix-M”).

In December 2023, R21/Matrix-M™ received prequalification by the World Health Organization (“WHO”).

In August 2022, we and SII entered into an influenza license agreement under which we granted SII licenses to develop, manufacture, and commercialize certain vaccine products including influenza vaccine products and influenza and coronavirus combination vaccine products (“CIC”) and are obligated to purchase up to approximately $34 million of certain raw materials under related agreements with SII.

In May 2024, we and SLS entered into a supply agreement (the “SLS Supply Agreement”) under which SLS agreed to supply us with antigen drug substance and finished COVID-19 Vaccine doses.

The SLS Supply Agreement includes the general terms and conditions of supply orders between us and SLS.

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We agreed to supply SLS with all Matrix-M™ adjuvant needed to manufacture finished COVID-19 Vaccine doses.

In March 2020, we entered into an agreement with SLS that granted SII a non-exclusive license for the use of Matrix-M™ adjuvant supplied by us to develop, manufacture, and commercialize R21/Matrix-M™ adjuvant malaria vaccine (the "SII R21 Agreement").

In December 2023, R21/Matrix-M™ adjuvant malaria vaccine received prequalification by the WHO.

In June 2025, we announced results of the initial cohort of our clinical study for its influenza and CIC vaccine candidates with the intent of partnering these programs.

Under the SII R21 Agreement, SII purchases our Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single-to low- double-digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.

We have a collaboration and license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) under which we granted Takeda an exclusive license to develop, manufacture, and commercialize our COVID-19 Vaccine in Japan.

Under the agreement, Takeda purchases Matrix-M™ adjuvant from us to manufacture doses of COVID-19 Vaccine, and we are entitled to receive milestone and sales-based royalty payments from Takeda based on the achievement of certain development and commercial milestones, as well as a portion of net profits from the sale of COVID-19 Vaccine.

In May 2024, we entered into the Sanofi CLA under which we granted and Sanofi received the following:

i) A co-exclusive license to commercialize our current stand-alone COVID-19 Vaccine, including our prototype COVID-19 vaccine and updated COVID-19 vaccines, that address seasonal variants throughout the world (the “COVID-19 Vaccine Products”);

ii) A sole license to develop and commercialize combination products containing a potential combination of our COVID-19 Vaccine and Sanofi’s seasonal influenza vaccine (“COVID-19 and influenza Combination Products” or “CIC Products”);

iii) A non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines (“Other Combination Products” and together with the COVID-19 Vaccine Products, CIC Products, and Other Combination Products, “Licensed COVID-19 Products”);

iv) A non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M™ adjuvant (as described below, the “Adjuvant Products”).

We are also responsible for performing services related to the technology transfer of our manufacturing process for the COVID-19 Vaccine Products and Matrix-M™ components to Sanofi.

Until the successful completion of such transfer, we will supply Sanofi with both COVID-19 Vaccine Products and Matrix-M™ intermediary components for Sanofi’s use and we are eligible for reimbursement of such costs from Sanofi.

In addition, we are responsible for certain research and development and medical affairs services related to the COVID-19 Vaccine.

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Under the Sanofi CLA, we will continue to commercialize our updated COVID-19 vaccine through the end of the 2024-2025 vaccination season.

Beginning in 2025 and continuing during the term of the Sanofi CLA, Sanofi and we will commercialize the COVID-19 Vaccine Products worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply our existing APA customers and strategic partners, including Takeda and SII.

Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.

Pursuant to the Sanofi CLA, we received a non-refundable upfront payment of $500 million in the second quarter of 2024.

In addition, we are eligible to receive development, technology transfer, launch, and sales milestone payments totaling up to $700 million in the aggregate with respect to the COVID-19 Vaccine Products and royalty payments on Sanofi’s sales of such licensed products.

Milestone payments are comprised of a payment of $175 million upon the approval of the marketing authorization for a COVID-19 Vaccine Product in a pre-filled syringe from the U.S.

FDA, $25 million upon the transfer of such approval to Sanofi, $25 million upon the transfer of EMA approval of a COVID-19 Vaccine Product in a pre-filled syringe to Sanofi, $50 million upon database lock of an existing Phase 2/3 clinical trial (identifier 2019nCoV-503), $75 million upon the completion of the technology transfer of our manufacturing process for the COVID-19 Vaccine Products to Sanofi, $125 million upon achievement of certain CIC Product-related development milestones, and $225 million in CIC Product-related launch milestones.

We achieved the $50 million milestone for database lock of an existing Phase 2/3 clinical trial in 2024 and the amount is included in accounts receivable on our consolidated balance sheet.

We are also 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.

In addition, a portion of the technology transfer costs and research and development costs incurred by us will be reimbursed by Sanofi in accordance with agreed upon plans and budgets.

Manufacturing and Supply

We are committed to discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases directly and by leveraging our strategic global partnerships.

In 2024, we modified and continued to assess our manufacturing needs and our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for COVID-19 Vaccine and Matrix-M™ adjuvant, and expected supply needs of Sanofi for both COVID-19 Vaccine Products and Matrix-M™ intermediary components for use under the Sanofi CLA.

In 2025, our global manufacturing footprint was consistent with our contractual obligations to supply, and anticipated demand for COVID-19 Vaccine and Matrix-M™ adjuvant, and expected supply needs of Sanofi for both COVID-19 Vaccine products and Matrix-M™ intermediary components for use under the Sanofi CLA.

A summary of our key manufacturing and supply arrangements follows:

Matrix-M TM Adjuvant

Matrix-M™ Adjuvant

We manufacture our proprietary saponin-based Matrix-M™ adjuvant at our Novavax AB facility in Uppsala, Sweden.

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In May 2024, we entered into the SLS Supply Agreement under which SLS agreed to supply us with antigen drug substance and finished COVID-19 Vaccine doses.

The SLS Supply Agreement includes the general terms and conditions of supply orders between us and SLS.

Supply Agreement includes the general terms and conditions of supply orders between us and SLS.

We and SLS execute firm purchase orders, which include specific quantities to be delivered under the SLS Supply Agreement.

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Our Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

We believe this baculovirus expression system with our nanoparticle configuration formulated with our Matrix-M™ adjuvant offers many advantages compared to

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other technologies, such as enabling dose-sparing effects and refrigerator temperature storage.

We believe this baculovirus expression system with our nanoparticle configuration formulated with our Matrix-M™ adjuvant offers many advantages compared to other technologies, such as enabling dose-sparing effects and refrigerator temperature storage.

We believe our technology platform is well suited for developing COVID-19 and combination vaccines, as well as vaccines against a number of other infectious diseases and potentially beyond the infectious disease area into other therapeutic areas where we believe our technology has the capability to augment and improve on current approaches.

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A variety of different vaccine technologies are being studied, including nucleic acid (RNA/DNA), viral vectors, live attenuated or inactivated, and protein-based vaccines.

Novavax is the first protein-based COVID-19 vaccine that received EUA by the U.S.

FDA and a CMA by the European Commission based on EMA in the European Union.

As of February 2025, Novavax is one of three manufacturers that have a COVID-19 vaccine that has received authorization by the U.S.

FDA for the 2024-2025 vaccination season, with the other manufacturers being Pfizer and Moderna.

As of February 2025, the U.S.

FDA has granted Pfizer and Moderna BLA approval for their updated vaccines in individuals 12 years and older and EUA for their updated vaccines in individuals 6 months to 11 years, while Novavax received EUA by the U.S.

FDA for our updated COVID-19 vaccine in individuals 12 years and older.

Based on our COVID-19 vaccine and its high efficacy against both the original and variant strains and its well-tolerated profile demonstrated in clinical trials, including two pivotal Phase 3 trials in the UK and U.S., we believe our COVID-19 vaccine will continue to play an important role in addressing this global public health need.

Nuvaxovid is the first protein-based COVID-19 Vaccine that was approved by the U.S.

FDA and by the European Commission based on European Medicines Agency (“EMA”) in the European Un ion.

As of February 2026, Nuvaxovid is one of three COVID-19 vaccines that have been approved by the U.S.

FDA for the 2025-2026 vaccination season, with the other vaccines being marketed by Pfizer and Moderna.

Furthermore, a number of companies are selling vaccines for seasonal influenza employing a number of vaccine technologies including inactivated, recombinant and live attenuated technologies.

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Many of our competitors are working on new products and new generations of current products, some by adding an adjuvant that is used to increase the immunogenicity of that product, each of which is intended to be more efficacious than currently marketed products.

Several competitors are working on developing seasonal influenza vaccines using different technologies than those in existing marketed vaccines, the most notable being mRNA from companies including Sanofi, Moderna, and Pfizer.

Despite the significant competition and advancing technologies, based on our completed Phase 2 trial results, we believe that our stand-alone influenza vaccine, our adjuvanted nanoparticle seasonal influenza product, has the potential to be at least as efficacious as current products or products being developed by our competitors.

In December 2024, we initiated our Phase 3 trial for our stand-alone influenza vaccine candidate to evaluate the immunogenicity and safety in adults aged 65 and older with an initial cohort of 2,000 participants.

Additionally, we believe that our platform is well suited for combination vaccines, for example influenza and COVID-19.

In December 2024, we initiated our Phase 3 trial for our CIC vaccine candidate to evaluate the immunogenicity and safety in adults aged 65 and older with an initial cohort of 2,000 participants.

We are working with the U.S.

FDA to determine the potential of our current CIC trial to support accelerated approval.

Our Phase 3 immunogenicity and safety trial completed enrollment with an initial cohort of approximately 2,000 participants.

In June 2025, we reported data from this initial cohort, which showed both vaccine candidates induced robust immune responses across all antigens tested.

Both vaccine candidates were well tolerated with reactogenicity profiles that were comparable to authorized comparators.

Additionally, under the Sanofi CLA, our COVID-19 Vaccine is being used in combination with two Sanofi vaccines that are separately marketed influenza vaccines, Fluzone High-Dose and Flublok, to evaluate immunogenicity and safety in Phase 1/2 combination trials.

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FDA to prevent influenza and COVID-19 infections in individuals aged 50 and older.

Other manufacturers who are actively developing a COVID-19-influenza combination vaccine candidate in Phase 3 trials and are working with the U.S FDA for regulatory approval and commercialization, include Moderna and Pfizer.

In October 2025, Sanofi reported positive Phase 1/2 results with the ir combination vaccine candidates and will engage with regulatory authorities on next steps.

manufacturer who is actively developing a COVID-19-influenza combination vaccine candidate is Moderna and are working with the U.S FDA for regulatory approval and commercialization.

In general, competition among pharmaceutical products is based in part on product efficacy, safety, reliability, availability, price, and patent position.

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Our competitive position also may depend upon our ability to show differentiation with a product that is more efficacious and/or less expensive and quicker to manufacture.

Other factors affecting our competitive position include our ability to attract and

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retain qualified personnel, obtain patent protection or otherwise develop proprietary products or processes, and secure sufficient capital resources for the lengthy period between technological conception and commercial sale.

Patents and Proprietary Rights

Other factors affecting our competitive position include our ability to attract and retain qualified personnel, obtain and maintain patent protection or otherwise develop proprietary products or processes, and secure sufficient capital resources for the lengthy period between technological conception and commercial sale.

Intellectual Property Rights

We generally seek patent protection in the US and in select international countries to protect inventions that we or our partners consider important for our business interests.

Patent protection in biotechnology and pharmaceuticals is uncertain and involved complex legal and factual questions.

Patent protection in biotechnology and pharmaceuticals is uncertain and involved complex legal and factual questions, and we may be unable to protect and/or enforce our intellectual property.

Our success will depend, in part, on whether we can:

• obtain patents to protect our own technologies and product candidates;

• obtain licenses to use the technologies of third-parties, which may be protected by patents;

• protect our trade secrets and know-how.

• obtain and maintain patents to protect our own technologies, products, and product candidates;

• obtain and maintain licenses to use the technologies of third-parties, which may be protected by patents;

• protect and maintain our trade secrets and know-how.

Patent Rights;

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We currently have more than 50 combined patents and pending applications directed to our COVID vaccine technology that are anticipated to expire beyond 2040.

In addition to protecting our vaccine programs, we are pursuing protection for our Matrix-M® Adjuvant program, with expiration dates extending to 2044 and beyond.

In addition to protecting our vaccine programs, we are pursuing further protections for our Matrix-M™ Adjuvant program, with expiration dates potentially extending to 2044 and beyond.

We continue to prepare, file, and prosecute patent applications to provide broad and strong protection of our proprietary rights related to our vaccine products and our adjuvant program.

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While our expired contract with the U.S.

Department of Health and Human Services (“DHHS”), Biomedical Advanced Research and Development Authority provided us with the right to retain ownership in our inventions that may have arisen during performance of that contract, with respect to certain other collaborative research efforts with the U.S.

Department of Health and Human Services (“DHHS”),

Biomedical Advanced Research and Development Authority provided us with the right to retain ownership in our inventions that may have arisen during performance of that contract, with respect to certain other collaborative research efforts with the U.S.

government, certain developments and results that may have commercial potential are to be freely published, not treated as confidential, and we may be required to negotiate a license to developments and results in order to commercialize products.

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It is our policy to require employees, consultants, contractors, manufacturers, collaborators, and other advisors to execute confidentiality agreements upon the commencement of employment, consulting, or collaborative relationships with us.

We also require

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confidentiality agreements from any entity that is to receive confidential information from us.

We also require confidentiality agreements from any entity that is to receive confidential information from us.

With respect to employees, consultants, and contractors, the agreements generally provide that all inventions made by the individual while rendering services to us shall be assigned to us as our property.

In any of the above mentioned scenarios, we require trade secrets be protected in perpetuity, or until certain exceptions arise.

Human Capital

As of February 18, 2025, we have 952 full-time employees, of whom approximately 8% hold MD or PhD degrees, and approximately 20% hold other advanced degrees.

Of our total workforce, approximately 71% of employees are engaged primarily in research, development, and manufacturing activities, and approximately 29% of employees are mainly engaged in executive, business development, commercial, finance and accounting, legal, and administrative functions.

Except for certain employees located in Europe, who are covered by collective agreements with trade unions pursuant to local law, none of our employees are represented by a labor union or works council, and none of our employees have entered into a collective bargaining agreement with us.

We have a team of approximately 749 employees as of December 31, 2025.

Our highly qualified and experienced team, which includes scientists, physicians, and professionals across research, development, manufacturing activities, executive, business development, commercial, finance and accounting, legal, and administrative functions and other essential functions is critical to our success.

We also leverage temporary workers to provide flexibility for our business needs.

We continually evaluate our business needs and opportunities and balance in-house with external expertise and capacity.

Compensation and Benefits;

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We utilize a variety of recruitment vehicles to source top talent, including strategic partnerships with search firms, leveraging social media channels, and a robust employee referral program.

In 2023, we launched the Leading@Novavax competency model to define great leadership.

At Novavax, everyone is a leader, and this model and associated tools, resources, and programs are designed to develop leadership skills at all levels of the organization.

To support the growth and advancement of our employees, we offer tuition and continuing education reimbursement and an array of training and professional development opportunities, including on-the-spot coaching with executive coaches and access to the LinkedIn Learning library of over 16,000 on-demand video tutorials that address skills, knowledge and behaviors related to business, leadership, technology, and innovation.

Our Leading@Novavax competency model defines great leadership.

At Novavax, everyone is leader, and this model and associated tools, resources, and programs are designed to develop leadership skills at all levels of the organization.

To support the growth and advancement of our employees, we offer tuition and continuing education reimbursement as well as a wide range of training and professional development opportunities, including executive coaching engagements and access to the LinkedIn Learning library of over 16,000 on‑demand video tutorials covering skills, knowledge, and behaviors related to business, leadership, technology, and innovation.

In the last 12 months, our employees have viewed and completed videos over 20,000 times.

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Professional development learning series are available to all employees and focus on self-awareness, collaboration, hybrid working, leadership and business acumen.

We also offer a company‑wide mentoring program that enables employees to connect with colleagues across functions, build professional networks, and support their development through mentoring relationships.

We provide an Executive Development Program for employees identified as having high potential and for employees who have been identified as potential successors to leadership positions through our talent review and succession planning process.

Our Executive Development Program includes executive coaching engagements and leadership development programs designed to strengthen our leadership bench and accelerate and prepare our top talent for future growth.

The Executive

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Development Program includes a diverse and global group of 20 employees annually.

The Executive Development Program includes a diverse and global group of 20 employees annually.

Professional development learning series are available to all employees and focus on self-awareness, collaboration, hybrid working, leadership, and business acumen.

Internal Communications

We employ a variety of channels to facilitate open and direct communication, including global forums with executives and employee surveys.

In 2024, we began small group meetings for employees to engage directly with members of the executive leadership team.

Our executive leadership team recognizes the importance of increased employee engagement to the success of each individual’s career and to our success as a whole.

Our culture of inclusivity helps us to create, develop and leverage the strengths of our workforce to meet our growth objectives.

We acknowledge the merits of a diverse workforce and teach our leaders to access different perspectives when generating ideas and decision making.

In 2024, we also made progress in increasing representation of women at the Executive level.

We commenced and completed the reviews of three people processes:

Talent Acquisition, Promotion, and Performance Management.

We also have intentionally incorporated inclusivity principles into our Novavax Leadership Model.

Empowering our Employees

In 2024, Novavax sought to motivate and empower employees by providing tuition and education reimbursement and access to professional coaching and Executive Development programming for high-potential employees.

Sustainability

In addition to the human capital initiatives described above, a range of other initiatives related to sustainability are underway.

These include efforts related to vaccine access and affordability, governing responsibly and sustainability.

We believe that our multi-stakeholder approach through these focus areas is critical to our long-term success and enhances value for our shareholders.

Examples of initiatives supportive of these focus areas include the following:

Access and Affordability

• Focused on seeking to foster an environment with no barriers to use of our vaccines due to either physical availability or pricing of the product.

• In 2024 in the U.S., participated in the Vaccines for Children (VFC) Program, which serves as a critical safety net for children under 19 who are Medicaid-eligible, uninsured, underinsured or American Indian/Alaskan Native.

• Also participated in the 317 Program, which serves uninsured and underinsured adults.

• Participated in the “Bridge Access Program For COVID Vaccines and Treatments” to provide access to COVID-19 vaccine option for adults without other sources of coverage.

• R21/Matrix-M™ adjuvant malaria vaccine, developed by the University of Oxford and its Jenner Institute and the Serum Institute of India, and formulated with our Matrix-M adjuvant is expected to be offered in 15+ countries across Africa by 2025.

• Efforts focused on clinical trial diversity (economic, race, age).

Governing Responsibly

• Policy remains in place to comply with all government and regulatory agency requirements and industry standards with good laboratory practices (“GLP”), current good manufacturing practices (“cGMP”) and good distribution practices (“GDP”).

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• Practice responsible animal welfare practices including searching for non-animal alternatives whenever possible, abiding by the 3R-principle (Reduce, Refine, Replace), working with accredited animal facilities with regional independent animal experimentation ethical review boards approving all experiments.

• “The NovaCode,” a robust handbook of written standards and business ethics policies remains in place.

• Maintain a global hotline for reporting compliance concerns with established internal investigating protocols.

• Maintain a Strategic Compliance Governance Committee to help our partners comply with U.S.

• Hold company-wide business ethics training, guidance, and raw materials review.

• Keep an anti-bribery and anti-corruption policy in place to ensure a transparent and ethical business model.

• Standard operating procedures guide decision-making.

• Abide by robust cybersecurity standards, meeting elevated government contracting requirements.

• Chief Safety Officer continues to build out a robust epidemiology benefit / risk group to better understand the safety profiles of different vaccines.

• Ongoing employee training on our updated Safety Policy.

Sustainability

• Resource management and greenhouse gas reduction strategy, which includes tracking emissions.

• An approach to Procurement that incorporates sustainability metrics into vendor evaluation and selection rubrics.

• Conserving water and monitoring energy use across multi-use leased and owned facilities.

• Sustainable saponin sourcing from our partner Desert King, the key supplier of the Quillaja saponaria (Soapbark), a tree native to central Chile.

Saponin is used to produce the Matrix-M™ adjuvant.

Our Commitment to Sustainability

We focus our sustainability impact on four strategic pillars, which guide our efforts to make a positive impact on global health and operate in a sustainable and inclusive manner.

• GOVERNANCE | Meeting our high standards of governance.

• ENVIRONMENT | Mitigating our environmental impact.

• SOCIAL | Creating a culture that can hire and retain the best employees.

• ACCESS | Maximizing access to our products to improve global health.

We are committed to operating with integrity, transparency and accountability in all that we do.

• Our policies remain in place so that we may comply with all government and regulatory agency requirements and industry standards with good laboratory practices, current good manufacturing practices and good distribution practices.

• Our pharmacovigilance system supports comprehensive safety monitoring and signal detection for products and clinical programs.

• Our Quality Management System supports compliance with national and international reporting requirements and special reporting obligations.

• Our employees and contractors must complete adverse event (“AE”) training and understand how to report AEs.

• We collect, evaluate and report AEs in line with mandates from worldwide health authorities (e.g., the U.S.

FDA, European Medicines Agency).

• We practice responsible animal welfare practices including searching for non-animal alternatives whenever possible, abiding by the 3R-principle (Reduce, Refine, Replace), and working with accredited animal facilities with regional independent animal experimentation ethical review boards approving all experiments.

• We maintain “The NovaCode,” a robust handbook of written standards and business ethics policies.

• We maintain a global hotline for reporting compliance concerns with established internal investigation protocols.

• We maintain a Strategic Compliance Governance Committee to help our partners comply with U.S.

• We hold company-wide business ethics training, guidance and raw materials review.

• We maintain an anti-bribery and anti-corruption policy to foster a transparent and ethical business model.

• We abide by robust cybersecurity standards.

• We maintain an ongoing employee training on our Safety Policy.

We aim to operate in a sustainable manner that reduces our environmental impact.

• We are committed to engaging with material sustainability topics to drive long-term value creation and positive societal impact.

• We align our efforts with the Sustainability Accounting Standards Board (“SASB”), Global Reporting Initiative (“GRI”) and Sweden Non-Financial Reporting Directive (“NFRD”) frameworks to provide that our sustainability reporting accurately reflects the most pertinent topics within the biotechnology industry.

• We disclose greenhouse gas emissions globally.

• We abide by and require our suppliers to abide by our Novavax Environmental Sustainability Policy and Novavax Human Rights Policy.

We seek to build a company and culture that attracts and retains the best talent.

• We offer a number of employee training opportunities.

• We maintain employee health and safety measures, including U.S.

Environmental Health and Safety (“EHS”) management system as well as Occupational Safety and Health Administration (“OSHA”)-required assessments and immunizations.

• We offer a number of employee well-being, satisfaction, charitable and financial benefit programs.

We innovate through R&D and seek to increase access to our products and technology through strategic collaborations.

• R21/Matrix-M™ malaria vaccine offered by Oxford University and Serum Institute of India.

• Nuvaxovid® COVID-19 Vaccine offered by Sanofi.

• We also work to ensure that the products we develop are safe and effective for people of all races, ethnicities and genders.

We have adopt the principles of the Declaration of Helsinki and abide by our Clinical Research Policy.

Government Regulations

The development, production, and marketing of biological products, which include the vaccine candidates being developed by Novavax or our collaborators, are subject to regulation for safety, efficacy, and quality by numerous governmental authorities in the U.S.

and other countries.

We focus on the U.S.

regulatory process and the standards imposed by the U.S.

FDA, the International Council for Harmonisation (“ICH”), and other agencies because we believe meeting U.S.

and ICH standards generally allows us to also satisfy regulatory agencies’ standards in other countries where we intend to do business.

However, we are mindful that expectations in some venues, notably in the European Union and the United Kingdom (in relation to Great Britain), differ to some degree and we take proactive steps to address such differences by maintaining regular filings and correspondence and attending regular meetings with many other non-U.S.

regulatory agencies.

In the U.S., the development, manufacturing, and marketing of human pharmaceuticals and vaccines are subject to extensive regulation under the Federal Food, Drug, and Cosmetic Act, and biological products are subject to regulation under provisions of that act and the Public Health Service Act.

FDA not only assesses the safety and efficacy of these products, but it also regulates, among other things, the testing, manufacture, labeling, storage, record-keeping, advertising, and promotion of such products.

The process of obtaining U.S.

FDA licensure for a new vaccine is costly and time-consuming.

Vaccine clinical development in most countries follows the same general regulatory pathway as drugs and other biologics.

Before applying for U.S.

FDA licensure to market any new vaccine candidate, we expect to first submit an IND that explains to the U.S.

FDA, among other things, the results of preclinical toxicology testing conducted in laboratory animals, the method of manufacture, quality control tests for release, the stability of the investigational product, and our proposed plans for human testing.

At this stage, the U.S.

FDA decides whether it is reasonably safe to move forward with testing the vaccine candidate in humans.

We must then conduct Phase 1 clinical trials and larger-scale Phase 2 and 3 clinical trials that demonstrate the safety, immunogenicity, and efficacy of our vaccine candidate to the satisfaction of the U.S.

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before a clinical trial is initiated or at any time while a clinical trial is ongoing, impose a partial or complete clinical hold based on concerns for patient safety or noncompliance with regulatory requirements.

Following successful completion of all three phases of clinical development, a BLA can be submitted to the U.S.

FDA requesting licensure of the vaccine for marketing based on the vaccine’s safety and efficacy.

Similar pathways exist in Europe and other geographies.

FDA will only approve a BLA if the vaccine is demonstrated to be safe, pure, and potent.

During the U.S.

FDA’s review of a BLA, the proposed manufacturing facility undergoes a pre-approval inspection during which the U.S.

FDA examines in detail the production of the vaccine, the manufacturing facility, and the quality documentation related to the vaccine.

Vaccine licensure also requires the provision of adequate product labeling to allow health care providers to understand the vaccine’s proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public.

Until a vaccine is given to the general population, all potential adverse events cannot be anticipated.

Thus, the U.S.

FDA typically requires Phase 4 post-marketing clinical trials for vaccines after licensure to continue gathering safety, and sometimes effectiveness/efficacy data in the indicated and additional populations.

The Commissioner of the U.S.

FDA may, following the issuance of an appropriate declaration by the Secretary of the DHHS, issue an EUA that would permit the use of an unapproved medical product or unapproved use of an approved medical product to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.

When issuing an EUA, the U.S.

FDA imposes conditions of authorization, with which the EUA holder must comply.

Such conditions include, but may not be limited to, compliance with labeling, distribution of materials designed to ensure proper use, reporting obligations, and restrictions on advertising and promotion.

The EUA is only effective for the duration of the declaration issued by the Secretary of the DHHS that EUAs are appropriate.

FDA may also revise or revoke the EUA sooner if the criteria for issuance are no longer met or other circumstances make a revision or revocation appropriate to protect the public health or safety.

For example, an EUA may be revoked when the U.S.

FDA determines that the underlying public health threat no longer exists or warrants such authorization, or for reasons such as significant adverse inspectional findings, reports of adverse events linked to or suspected of being caused by the EUA product, or newly emerging data that may demonstrate the product may not be effective.

An EUA is separate from and not dependent on the issuance of a public health emergency (“PHE”) by the Secretary of the DHHS.

Therefore, although the COVID-19 PHE expired on May 11, 2023, that expiration will not terminate EUAs issued by the U.S.

In order to ensure continuing safety, the U.S.

FDA and most other non-U.S.

based regulatory agencies continue to oversee the production of vaccines even after the vaccine and manufacturing processes are approved.

For example, monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product.

Manufacturers may also be required to submit the results of their own tests for potency, safety, and purity for each vaccine lot, if requested by the relevant regulatory agency.

They may also be required to submit samples of each vaccine lot to the agency for testing.

In addition to obtaining U.S.

FDA licensure for each product, each domestic manufacturing establishment must be registered with the U.S.

FDA, is subject to U.S.

FDA inspection, and must comply with current Good Manufacturing Practices (“GMP”) regulations.

To supply products for use either in the U.S.

or outside the U.S., including clinical trials, U.S.

and foreign manufacturing establishments, including third-party facilities, must comply with GMP regulations and are subject to periodic inspection by the U.S.

FDA or by corresponding regulatory agencies in their home country.

The EU and the UK similarly provide a faster means to achieve approval by offering CMA to fulfil unmet medical needs.

CMAs are granted with the proviso of obtaining additional comprehensive data to confirm the benefit/risk so that the MA will eventually become unconditional standard MA.

For the purpose of granting a CMA, the benefit to public health of the immediate availability on the market of the medicinal product concerned should outweigh the risk inherent in the fact that additional data are still required.

FDA has several programs designed to expedite the development and approval of drugs and biological products intended to treat serious or life-threatening diseases or conditions, including fast track designation, breakthrough therapy designation, priority review designation, and accelerated approval.

First, the U.S.

FDA may designate a product for Fast Track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for such a disease or condition.

For Fast Track products, sponsors may have more frequent interactions with the U.S.

FDA and the U.S.

FDA may initiate review of sections of a Fast Track product’s application before the application is complete.

FDA granted Fast Track Designation for our prototype COVID-19 vaccine in November 2020 and for our recombinant quadrivalent seasonal influenza vaccine candidate, in January 2020.

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Second, a product may be designated as a Breakthrough Therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

FDA may hold meetings with the sponsor throughout the development process, provide timely advice to the product sponsor regarding development and approval, involve more senior staff in the review process, assign a cross-disciplinary project lead for the review team, and take other steps to design the clinical trials in an efficient manner.

Third, the U.S.

FDA may designate a product for priority review if it is a product that treats a serious disease or life-threatening condition and, if approved, would provide a significant improvement in safety or effectiveness over available therapies.

Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation.

A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and, for a drug product (including a vaccine), to shorten the U.S.

FDA’s goal for taking action on a marketing application from ten months to six months.

Fourth, a product may be eligible for accelerated approval, if it treats a serious or life-threatening condition and generally provides a meaningful advantage over available therapies.

In addition, it must demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (“IMM”) that is reasonably likely to predict an effect on IMM or other clinical benefit.

As a condition of approval, the U.S.

FDA may require that a sponsor of a drug or biologic receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials to confirm efficacy using a clinically meaningful endpoint, thereby confirming efficacy observed pre-approval using a surrogate endpoint.

In addition to regulatory approvals that must be obtained in the U.S., an investigational product is also subject to regulatory approval in other countries in which it is intended to be marketed.

No such product can be marketed in a country until the regulatory authorities of that country have approved an appropriate marketing application.

U.S.FDA licensure does not guarantee approval by other regulatory authorities.

In addition, in many countries, the government is involved in the pricing of the product.

In such cases, the pricing review period often begins after market approval is granted.

We are also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other present and potential federal, state, or local regulations, including national and local regulations that govern our facilities in Sweden and Switzerland.

These and other laws govern our use, handling, and disposal of various biological and chemical substances used in, and waste generated by, our operations.

Our research and development involves the controlled use of hazardous materials, chemicals, and viruses.

Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated.

In the event of such an accident, we could be held liable for any damages that result and any such liability could exceed our resources.

Additionally, for formulations containing controlled substances, we are subject to Drug Enforcement Act regulations.

The FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting of vaccines such as those we are developing.

We, along with third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our vaccine candidates.

The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

Biologics Regulation

In the United States, biological products, or biologics, such as vaccines are subject to regulation under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other federal, state, local and foreign statutes and regulations.

The process required by the FDA before biologics may be marketed in the United States generally involves the following:

• completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s Good Laboratory Practice requirements (“GLPs”);

• submission to the FDA of an investigational new drug application (“IND”), which must become effective before clinical trials may begin;

• approval by an institutional review board (“IRB”) or ethics committee at each clinical site before the trial is commenced;

• performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic candidate for its intended use;

• preparation of and submission to the FDA of a biologics license application (BLA), after completion of all pivotal clinical trials and other necessary studies;

• satisfactory completion of an FDA Advisory Committee review, if applicable;

• a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

• satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with Good Clinical Practice requirements (GCPs);

• FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States.

The preclinical developmental stage generally involves laboratory evaluations of chemistry, formulation and stability, as well as studies to evaluate the candidate’s toxicity in animals, in an effort to support subsequent clinical testing.

The conduct of preclinical studies is subject to federal regulations and requirements, including GLP regulations.

Prior to beginning the first clinical trial with a vaccine candidate in the United States, the trial sponsor must submit an IND to the FDA.

An IND is a request for allowance from the FDA to administer an investigational drug to humans.

The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies.

The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the vaccine candidate, chemistry, manufacturing, and controls information, and any available human data or literature to support the use of the vaccine candidate.

An IND must become effective before human clinical trials may begin.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial.

In such a case, the IND may be placed on full or partial clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin or begin as planned.

Submission of an IND therefore may or may not result in FDA allowance to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCPs, which include, among other things, the requirement that all research subjects provide their informed consent for their participation in any clinical study.

Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring subject safety and the effectiveness criteria to be evaluated.

A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments.

While the IND is active, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.

Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.

Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward

at designated check points based on access to certain data from the study, and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or on other grounds, such as failure to demonstrate efficacy.

There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries, including clinicaltrials.gov.

For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

• Phase 1—The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition.

These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

• Phase 2—The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.

Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

• Phase 3—The investigational product is administered to an expanded patient population to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

In some cases, the FDA may require, or sponsors may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product.

These so-called Phase 4 studies may also be made a condition to approval of the BLA.

Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the vaccine candidate, and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the vaccine candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product.

Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the candidate does not undergo unacceptable deterioration over its shelf life.

BLA submission and review by the FDA

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, preclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product candidate for one or more indications.

The BLA must include all relevant data available from preclinical and clinical studies, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things.

Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of a use of the product candidate, or from a number of alternative sources, including studies initiated by independent investigators.

The submission of a BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

In addition, the Pediatric Research Equity Act (“PREA”), requires a sponsor to conduct pediatric clinical trials for most drugs and biologics, for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration.

Under PREA, original BLAs and certain supplements must contain a pediatric assessment unless the sponsor has received a deferral or waiver.

The required assessment must evaluate the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is deemed safe and effective.

The sponsor or FDA may request a deferral of pediatric clinical trials for some or all of the pediatric subpopulations.

A deferral may be granted for several reasons, including a finding that the candidate is ready for approval for use in adults before pediatric clinical trials are complete or that additional safety or effectiveness data needs to be collected before the pediatric clinical trials begin.

The FDA must send a non-compliance letter to any sponsor that fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.

Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the FDA accepts it for filing.

The FDA may refuse to file any BLA that it deems incomplete or

not properly reviewable at the time of submission and may request additional information.

In this event, the BLA must be resubmitted with the additional information.

Once a BLA has been accepted for filing, the FDA’s goal is to review standard applications within ten months after the filing date, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing.

In both standard and priority reviews, the review process may also be extended by FDA requests for additional information or clarification.

The FDA reviews a BLA to determine, among other things, whether the vaccine candidate is safe, pure and potent for the proposed indication, and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency.

The FDA may also convene an advisory committee to provide clinical insight on application review questions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured.

The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate to assure consistent production of the product within required specifications.

Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.

If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information.

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter (“CRL”).

An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.

A CRL indicates that the review cycle of the application is complete, and the application will not be approved in its present form.

A CRL usually describes the specific deficiencies in the BLA identified by the FDA and may require additional clinical data, including additional clinical trials, or other significant and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing.

If a CRL is issued, the sponsor must resubmit the BLA or, addressing all of the deficiencies identified in the letter, or withdraw the application.

Even if such data and information are submitted, the FDA may decide that the BLA does not satisfy the criteria for approval.

If regulatory approval of a product is granted, such approval will be granted for particular indications and may include limitations on the indicated uses for which such product may be marketed.

For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy (“REMS”), to ensure the benefits of the product outweigh its risks.

A REMS is a safety strategy implemented to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications.

The FDA may also require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety, purity and potency after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

Expedited development and review programs

The FDA offers a number of expedited development and review programs for qualifying product candidates.

For example, the fast track program is intended to expedite or facilitate the process for reviewing product candidates that are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

Fast track designation applies to the combination of the product candidate and the specific indication for which it is being studied.

The sponsor of a fast track product candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the product application may be eligible for priority review.

A fast track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review.

A product candidate can receive breakthrough therapy designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an

organizational commitment to expedite the development and review of the product candidate, including involvement of senior managers.

Any marketing application for a biologic product candidate submitted to the FDA for approval, including a product candidate with a fast track designation and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval process, such as priority review.

A BLA is eligible for priority review if the product candidate is designed to treat a serious or life-threatening disease or condition, and if approved, would provide a significant improvement in safety or effectiveness compared to available alternatives for such disease or condition.

For original BLAs, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (as compared to ten months under standard review).

Additionally, depending on the design of the applicable clinical trials, candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit, and may require that such studies be underway before granting any accelerated approval.

Products receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required post-marketing studies or if such studies fail to verify the predicted clinical benefit.

In addition, the FDA requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Fast track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for approval but may expedite the development or approval process.

Even if a candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Post-approval requirements

Biologics are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.

After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval.

There also are continuing, annual program fees for any marketed products.

Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain procedural and documentation requirements up.

Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented.

FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements.

Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information;

imposition of post-market studies or clinical studies to assess new safety risks;

or imposition of distribution restrictions or other restrictions under a REMS program.

Other potential consequences include, among other things:

• restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

• fines, warning letters, or untitled letters;

• clinical holds on clinical studies;

• refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

• product seizure or detention, or refusal to permit the import or export of products;

• consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

• mandated modification of promotional materials and labeling and the issuance of corrective information;

• the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product;

• injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising and promotion of biologics.

A company can make only those claims that are in accordance with the provisions of the approved label.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties.

Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested and approved by the FDA.

Such off-label uses are common across medical specialties.

Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances.

The FDA does not regulate the behavior of physicians in their choice of treatments.

The FDA does, however, restrict a manufacturer’s communications on the subject of off-label use of their products.

Biosimilars and reference product exclusivity

The Affordable Care Act, signed into law in 2010, includes a subtitle called the Biologics Price Competition and Innovation Act (“BPCIA”), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.

Biosimilarity, which requires that the biological product be highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies.

Interchangeability requires that a product is biosimilar to the reference product and the product can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA.

In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed.

During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product.

The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products.

A biological product can also obtain pediatric market exclusivity in the United States.

Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.

This six-month exclusivity, which runs from the end of all existing exclusivity protection or patent terms, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study.

Coverage and Reimbursement

In both domestic and foreign markets, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payers.

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Adequate third-party reimbursement may not be available in certain markets to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

Third-party payors may also control access to, or manage utilization of, our products with various utilization management techniques.

Third-party payors may also control access to, or manage utilization of, our products with various

utilization management techniques.

Decreases in third-party reimbursement for our product candidates or a decision by a third-party payer to not cover our product candidates could reduce physician utilization of our products and have a material adverse effect on our sales, results of operations, and financial condition.

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Within the U.S., if we obtain appropriate approval in the future to market any of our product candidates, those products could potentially be covered by various government health benefit programs, as well as purchased by government agencies.

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In exchange for coverage, we may be obligated to provide rebates or offer discounts under government health programs or to government and private purchasers.

Certain Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”) marketplace and other private payor plans are required to include coverage for certain preventative services, including vaccinations recommended by the ACIP without cost share obligations (i.e., co-payments, deductibles or co-insurance) for plan members.

For Medicare beneficiaries, vaccines may be covered under either the Part B program or Part D depending on several criteria, including the type of vaccine and the beneficiary’s coverage eligibility.

Medicare Part B vaccine coverage includes vaccines to prevent influenza, pneumococcal disease, hepatitis B for beneficiaries who are at medium or high risk, and COVID-19.

Vaccines for such conditions do not have any cost-sharing requirements.

Effective January 1, 2023, the Inflation Reducation Act (“IRA”) modified the legal requirements to provides access to the Centers for Disease Control and Prevention (“CDC”) and ACIP-recommended vaccines covered under Medicare Part D, Medicaid and Children’s Health Insurance Program (“CHIP”) without cost-sharing.

At the state level, payment rates for covered vaccines and their administration are set by the states or their contracted managed care plans.

Children through 18 years of age without health insurance coverage for vaccines may also be eligible to receive such vaccinations free-of-charge through the CDC’s Vaccines for Children program (“VFC”).

Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor.

Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations.

As such, one third-party payor’s decision to cover a particular medical product or service does not ensure that other payors will also provide coverage for the medical product or service or will provide coverage at an adequate reimbursement rate.

Further, coverage policies and third party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status is attained for one or more products that receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Healthcare Reform

and state governments continue to propose and pass legislation designed to reform delivery of, or payment for, health care, including initiatives to reduce the cost of healthcare.

In March 2010, the U.S.

Congress enacted the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (“ACA”), which includes changes to the coverage and reimbursement of drug products under government health care programs.

Congress enacted the ACA, which included changes to the coverage and reimbursement of drug products under government health care programs.

Since its enactment, there have been several executive, judicial and Congressional challenges to certain aspects of the ACA, and additional challenges and amendments to the ACA may reduce the profitability of drug products.

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Other legislative changes have been proposed and adopted in the United States since the ACA was enacted that impact drug pricing.

For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2030.

Medicare establishes payment allowances annually for COVID-19 vaccines.

The Medicare payment rate for COVID-19 vaccine products and their administration is 95% of the Average Wholesale Price in the physician office setting and at reasonable cost in hospital outpatient departments.

Under the Inflation Reduction Act of 2022 (“IRA”), Medicaid and CHIP programs and the Children’s Health Insurance Program (“CHIP”) are required to cover, without cost-sharing, only U.S.

FDA-approved COVID-19 vaccines recommended by the ACIP.

At the state level, payment rates for covered vaccines and their administration are set by the states or their contracted managed care plans.

For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers, which went into effect in April 2013 and will remain in effect through 2032.

In addition, the current Presidential administration’s policies have resulted in changes to vaccine mandates and recommendations and public perception of vaccine importance.

Because recommendations by the ACIP of a vaccine has significant impacts on the coverage and reimbursement of the vaccine from commercial and governmental payers, changes to the composition of the committee could, among other things, result in adverse recommendations from ACIP or delay ACIP decisions or other elements of the approval pathway, potentially adversely impacting vaccine availability and recommendations.

By way of example, the U.S.

Department of Health and Human Services (“DHHS”) Secretary Robert F.

populated ACIP with members who generally have voiced negative views regarding COVID-19 vaccines.

The CDC removed the COVID-19 vaccine for healthy children and healthy pregnant women from the CDC recommended immunization schedules, and the DHHS Secretarial Directives ratifying CDC recommendations for use of COVID-19 vaccines for children ages six months to 17 years were also rescinded.

The FDA’s Vaccines and Related Biological Products Advisory Committee makes recommendations to FDA regarding novel vaccine products, and the Trump administration has so far removed at least one member from the committee.

The Trump administration’s changes to the immunization schedule for children and adolescents

and vaccine recommendations to date, and similar changes that could be adopted in the future could have a material adverse effect on the industry.

There has been considerable public and government scrutiny in the U.S.

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Adoption of new legislation at the federal or state level could affect demand for, or pricing of, our product candidates if approved for sale.

It is also possible that additional governmental action will be taken in response to the COVID-19 pandemic.

We cannot predict the ultimate content, timing, or effect of any federal and state reform efforts.

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In such countries governmental organizations will generally determine firstly if a medicinal product might be adopted for use in the national health systems and reimbursed and secondly the maximum price payable.

Within the U.S., we may be subject to various federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims laws, for activities related to future sales of any of our product candidates that may in the future receive regulatory and marketing approval.

Anti-kickback laws generally prohibit a pharmaceutical manufacturer from soliciting, offering, receiving, or paying any remuneration to generate business, including the purchase, prescription, or use of a particular drug.

Although the specific provisions of these laws vary, their scope is generally broad and there may not be regulations, guidance, or court decisions that apply the laws to particular industry practices.

There is therefore a possibility that our practices might be challenged under such anti-kickback laws.

False claims laws, including the federal False Claims Act (“FCA”), prohibit anyone from knowingly and willingly presenting, or causing to be presented, any claims for payment for reimbursed drugs or services to third party payers (including Medicare and Medicaid) that are false or fraudulent.

Our activities relating to the sale and marketing of our products may be subject to scrutiny under these laws.

Violations of fraud and abuse laws may be punishable by criminal or civil sanctions, including fines and civil monetary penalties, and exclusion from federal health care programs (including Medicare and Medicaid).

In the U.S., federal and state authorities are paying increased attention to enforcement of these laws within the pharmaceutical industry and private individuals have been active in alleging violations of the laws and bringing suits on behalf of the government under the FCA.

If we were subject to allegations concerning, or were convicted of violating, these laws, our business could be harmed.

On November 20, 2020, the DHHS published a Final Rule entitled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection,” commonly referred to as the “Rebate Rule,” which amends the federal Anti-Kickback Statute discount safe harbor by eliminating protection for price

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concessions, including rebates, that are offered by pharmaceutical manufacturers to plan sponsors, or pharmacy benefit managers under contract with them, under the Medicare Part D program and Medicare Advantage Plans, unless the price reduction is one required by law.

The IRA will delay implementation of this Rebate Rule until 2032.

This new rule could result in a change in incentives for health plans and pharmacy benefit managers in negotiating rebates and discounts with manufactures for preferred formulary placement.

At this time, we cannot predict how these developments may impact our business and operations if our products are commercialized in the U.S.

Within the European Union and the United Kingdom, the provision of benefits or advantages to physicians or others to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited.

The improper provision of benefits or advantages to physicians or other individuals is also governed by the national anti-bribery laws of EU Member States and the United Kingdom, such as the UK Bribery Act 2010.

Infringement of these laws could result in substantial fines and imprisonment.

We are also subject to the U.S.

Foreign Corrupt Practices Act (“FCPA”), which prohibits any U.S.

individual or business from paying, offering, authorizing payment of, or offering anything of value, directly or indirectly, to any foreign official, political party, or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business.

The FCPA also obligates companies whose securities are listed in the U.S.

to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

Compliance with the FCPA can be expensive and difficult, particularly in countries in which corruption is a recognized problem.

In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials.

Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

Companies can also be held liable for the improper actions of third parties with whom they contract to conduct business on their behalf.

Various laws, regulations, and executive orders also restrict the use and dissemination outside the U.S.

or the sharing with certain non-U.S.

nationals of information classified for national security purposes, as well as certain products and technical data relating to those products.

As we expand our presence outside the U.S., it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside the United States, which could limit our growth potential and increase our development costs.

We cannot guarantee that we, our employees, our consultants, or our third-party contractors are or will be in compliance with all federal, state, and foreign regulations regarding bribery and corruption.

Moreover, our strategic collaborators and third-party contractors located outside the U.S.

may have inadequate compliance programs or may fail to respect the laws and guidance of the territories in which they operate.

The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting.

The Securities and Exchange Commission (“SEC”) also may suspend or bar issuers from trading securities on U.S.

exchanges for violations of the FCPA’s accounting provisions.

Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could also have an adverse effect on our business, financial condition, and results of operations.

The Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), created additional federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors;

knowingly and willfully embezzling or stealing from a healthcare benefit program;

willfully obstructing a criminal investigation of a healthcare offense;

and knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items, or services.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, impose requirements regarding the privacy and security of individually identifiable health information, including mandatory contractual terms, for covered entities, or certain healthcare providers, health plans, and healthcare clearinghouses, and their business associates that provide services to the covered entity that involve individually identifiable health information and their subcontractors that use, disclose, or otherwise process individually identifiable health information.

HITECH also increased the civil and criminal penalties that may be imposed against covered entities and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA.

While pharmaceutical and biotechnology companies are typically not directly regulated by HIPAA, our business may be indirectly impacted by HIPAA in our interactions with providers, payors, and others that have HIPAA compliance obligations.

We are also subject to state and foreign laws governing the privacy and security of health or personal information such as the European Union General Data Protection Regulation (“GDPR”) and the California Consumer Privacy Act of 2018 (“CCPA”).

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There also are U.S.

federal transparency requirements under the Physician Payments Sunshine Act that require manufacturers of U.S.

FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to CMS information related to payments and other transfers of value to physicians, teaching hospitals, and certain advanced non-physician health care practitioners and physician ownership and investment interests.

states have transparency laws requiring the reporting of information that differs from the scope of information reported under the federal law, which permits these additional state requirements.

Within the European Union and the United Kingdom, payments made to physicians are subject to public disclosure governed by either national statutory or non-statutory industry self-regulatory rules.

Moreover, agreements with physicians must in some countries be the subject of prior notification and approval by the physician’s employer, their competent professional organization, or the regulatory authorities of the individual country.

These requirements are provided in the national laws, industry codes, or professional codes of conduct, applicable in the European Union Member States.

Other Healthcare Laws

In addition to FDA restrictions on marketing of pharmaceutical and biological products, other healthcare regulatory laws restrict business practices in the biotechnology industry, which include, but are not limited to, anti-kickback, false claims, and transparency laws regarding drug pricing and payments and other transfers of value made to physicians and other healthcare providers.

The federal Anti-Kickback Statute prohibits the offer, receipt, or payment of remuneration in exchange for or to induce the referral of patients or the use of products or services that would be paid for in whole or part by Medicare, Medicaid or other federal healthcare programs.

Remuneration has been broadly interpreted to include anything of value, including cash, improper discounts and free or reduced-price items and services.

Further, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation.

Many states have similar laws that apply to their state healthcare programs as well as private payors.

The False Claims Act, or FCA, imposes liability on persons who, among other things, knowingly present or cause to be presented, a false, fictitious or fraudulent claim for payment to, or approval by, the federal government, knowingly make, use, or cause to be made or used a false record or statement material to a false or fraudulent claim to the federal government, or knowingly make a false statement to avoid, decrease or conceal an obligation to pay money to the U.S.

federal government.

The FCA has been used to prosecute persons submitting claims for payment that are inaccurate or fraudulent, that are for services not provided as claimed, or for services that are not medically necessary.

In addition, the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Actions under the FCA may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government.

The federal government is using the FCA, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country, and has obtained multi-million and multi–billion-dollar settlements under the FCA in addition to individual criminal convictions under applicable criminal statutes.

In addition, companies have been forced to implement extensive corrective action plans and have often become subject to consent decrees or corporate integrity agreements, severely restricting the manner in which they conduct their business.

Given the significant size of actual and potential settlements, it is expected that the government authorities will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.

In addition, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration, including waivers of co-payments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services may be liable for civil monetary penalties for each wrongful act.

Moreover, in certain cases, providers who routinely waive copayments and deductibles for Medicare and Medicaid beneficiaries can also be held liable under the Anti-Kickback Statute and civil False Claims Act, which can impose additional penalties associated with the wrongful act.

One of the statutory exceptions to the prohibition is non-routine, unadvertised waivers of copayments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection efforts.

The Office of Inspector General of the Department of Health and Human Services emphasizes, however, that this exception should only be used occasionally to address special financial needs of a particular patient.

Although this prohibition applies only to federal healthcare program beneficiaries, the routine waivers of copayments and deductibles offered to patients covered by commercial payers may

implicate applicable state laws related to, among other things, unlawful schemes to defraud, excessive fees for services, tortious interference with patient contracts and statutory or common law fraud.

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers.

The ACA, among other things, imposed new reporting requirements through the Physician Payments Sunshine Act on certain manufacturers of drugs covered by a federal healthcare program for payments made by them to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anaesthesiology assistants, and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Failure to submit required information may result in civil monetary penalties for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission.

Manufacturers must submit reports by the 90th day of each calendar year.

Certain states also mandate implementation of compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians, and pricing information and marketing expenditures.

The shifting commercial compliance environment and the need to build and maintain robust systems to comply with different compliance and/or reporting requirements in multiple jurisdictions increase the possibility that a healthcare company may violate one or more of the requirements.

Violations of any of such laws or any other governmental regulations that apply to drug manufacturers may result in significant penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, exclusion from participation in federal and state healthcare programs, reporting obligations and integrity oversight, and imprisonment.

Within the EU and the UK, payments made to healthcare professionals are subject to public disclosure governed by either national statutory or non-statutory industry self-regulatory rules.

Moreover, agreements with healthcare professionals and organizations must in some countries be the subject of prior notification and approval by healthcare professionals’ employer, their competent professional organization, or the regulatory authorities of the individual country.

These requirements are provided in the national laws, industry codes, or professional codes of conduct, applicable in the EU member states.

Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines, or imprisonment.

Laws and regulations have been enacted by the federal government and various states to regulate the sales and marketing practices of pharmaceutical manufacturers with marketed products.

The laws and regulations generally limit financial interactions between manufacturers and health care providers and/or require disclosure to the government and public of such interactions.

Many of these laws and regulations contain ambiguous requirements or require administrative guidance for implementation.

Given the lack of clarity in laws and their implementation, any future activities (if we obtain approval and/or reimbursement from federal healthcare programs for our product candidates) could be subject to challenge.

Given the significant global impact of the COVID-19 pandemic, it is possible that one or more government entities may take actions, including the U.S.

government under the Defense Production Act of 1950, as amended, which could directly or indirectly have the effect of diminishing some of our rights or opportunities with respect to our COVID-19 Vaccine and the economic value of a COVID-19 vaccine to us could be limited.

In addition, during a global health crisis, such as the COVID-19 pandemic, where the spread of a disease needs to be controlled, closed or heavily regulated national borders will create challenges and potential delays in our development and production activities and may necessitate that we pursue strategies to develop and produce our vaccine candidates within self-contained national or international borders, at potentially much greater expense and with longer timeframes for public distribution.

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and commercialization of our products.

For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing, or sale.

Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranties.

Claims could also be asserted under state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates.

In the United States, the Public Readiness and Emergency Preparedness Act (the “PREP Act”), when applicable, provides immunity for manufacturers from all claims under state or federal law for “loss” arising out of the administration or use of a “covered countermeasure.” However, injured persons may still bring a suit for “willful misconduct” against the manufacturer under some circumstances.

“Covered countermeasures” include security countermeasures and “qualified pandemic or epidemic products,” including products intended to diagnose or treat pandemic or epidemic disease, such as pandemic vaccines, as well as treatments intended to address conditions caused by such products.

In addition, in the United States, the Public Readiness and Emergency Preparedness Act (the “PREP Act”), when applicable, provides immunity for manufacturers from all claims under state or federal law for “loss” arising out of the administration or use of a “covered countermeasure.” However, injured persons may still bring a suit for “willful misconduct” against the manufacturer under some circumstances.

“Covered countermeasures” include “security countermeasures,” “qualified pandemic or epidemic products,” which include products intended to diagnose or treat pandemic or epidemic disease, such as pandemic vaccines and treatments intended to address conditions caused by such products, and drugs and biological products authorized for emergency use in accordance with sections 564, 564A, and 564B of the FDCA.

For these immunities to apply, the Secretary of DHHS must invoke the PREP Act by issuing a declaration that a public health emergency or “credible risk” of a future public health emergency exists.

On March 17, 2020, the Secretary of DHHS issued a declaration under the PREP Act and has issued subsequent amendments thereto since then to provide liability immunity for activities related to certain countermeasures against the ongoing COVID-19 pandemic.

On December 11, 2024, the Secretary of DHHS signed the 12th amendment to the declaration under the PREP Act to extend the duration of the PREP Act declaration to December 31, 2029.

While we believe our products would be covered under the current PREP Act declaration, this cannot be assured.

Also, there can be no assurance that the Secretary of the DHHS will make other declarations in the future that cover any of our other product candidates or that the U.S.

Congress will not act in the future to reduce coverage under the PREP Act or to repeal it altogether.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

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The impacts of the 2024 U.S.

election are unpredictable.

Changes in leadership, especially within DHHS, have the potential to significantly impact vaccine-related policies and public health initiatives.

Changes could have impacts that may include reduced funding for vaccine research and development, reduced reimbursement for vaccines and their administration, increased skepticism about vaccines among the public, and changes in vaccine mandates and recommendations.

On March 17, 2020, the Secretary of DHHS issued a declaration under the PREP Act for medical countermeasures against COVID-19, effective as of February 4, 2020, and has issued subsequent amendments since then to provide liability immunity for activities related to certain countermeasures against the ongoing COVID-19 pandemic.

On December 11, 2024, the Secretary of DHHS issued the 12th amendment to the PREP Act declaration to extend time period of PREP Act coverage to December 31, 2029.

While we believe our products are Covered Countermeasures under the current PREP Act declaration, coverage cannot be assured.

Further, it remains possible that the HHS Secretary will amend the PREP Act declaration for medical countermeasures against COVID-19 to, among other things, shorten the duration of its coverage.

Certain members of Congress have also sought to amend or repeal the PREP Act in effort to restrict or eliminate PREP Act immunity.

As a result, the PREP Act remains subject to significant uncertainty.

Availability of Information

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The contents of our website are not part of this Annual Report on Form 10-K, or any other report we file with, or furnish to, the SEC.

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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.

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Item 1. Business