What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-02-27 compared with 2024-02-28 · 343 added, 361 removed, 305 unchanged (70% of the section changed)

Novavax, Inc., together with our wholly owned subsidiaries, is a biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

Our proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticle vaccines designed to address urgent global health needs.

Our vaccine candidates are nanostructures of conformationally correct recombinant proteins that mimic those found on pathogens.

This technology enables the immune system to recognize target proteins and develop protective immune responses.

We believe that our vaccine technology may lead to the induction of a differentiated immune response that may be more efficacious than naturally occurring immunity or other vaccine approaches.

Our vaccine candidates also incorporate our proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response, stimulate higher levels of functional antibodies, and induce a cellular immune response.

We have developed an updated COVID-19 vaccine for the 2023-2024 vaccination season.

In October 2023, the U.S.

FDA granted EUA for our updated vaccine for active immunization to prevent COVID-19.

The updated vaccine is authorized as (1) a single dose in individuals 12 years and older who have been vaccinated with any COVID-19 vaccine at least 2 months after receipt of the last previous dose of COVID-19 vaccine, and (2) a series of 2 doses administered 3 weeks apart to individuals 12 years and older who were not previously vaccinated with any COVID-19 vaccine.

Our updated vaccine is available within the U.S.

at many major pharmacy retailers.

Outside the U.S.

for our updated vaccine, in January 2024, we were granted marketing authorization by the United Kingdom’s (“UK”) Medicines and Healthcare Products Regulatory Agency (“MHRA”), in December 2023, we were granted expanded authorization by Health Canada, and in October 2023, we were granted approval by the European Commission (“EC”).

We are committed to supplying of our key target markets through advance purchase agreements (“APAs”) covering such markets.

We continue to work closely with regulatory authorities in many jurisdictions for authorization of our updated vaccine.

We previously developed a prototype COVID-19 vaccine, which has received full marketing authorization (“MA”), marketing approval, interim authorization, provisional approval, CMA, from multiple regulatory authorities in over 40 countries globally.

We continue to progress our regulatory authorizations for our prototype vaccine in select territories, as we believe these may facilitate authorization of our vaccine candidates for updated strains in the future.

Additionally, we are developing a COVID-19 Influenza Combination (“CIC”) vaccine candidate.

Our other areas of focus include providing Matrix-M™ adjuvant for collaborations, including in R21/Matrix-M™ adjuvant malaria vaccine, which in December 2023 received prequalification from the World Health Organization (“WHO”) and previously received authorization in several countries, as well as other preclinical vaccine research with our Matrix-M™ adjuvant, including through a partnership with the Bill & Melinda Gates Medical Research Institute.

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

Table o f Contents

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.

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.

Our proprietary Matrix-M ™ adjuvant when added to vaccines, has been shown to help induce a stronger and longer-lasting immune response.

Our recombinant protein-based nanoparticle technology has been shown to be highly immunogenetic.

Together, we believe that our technology platform can induce potent, durable and broad immune responses, with the potential to be antigen-sparing.

Our Matrix-M ™ adjuvant can increase both antibody and cell-mediated immune responses to 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.

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.

Table o f Contents

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.

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

2 unchanged sentences

Technology Overview

We believe our recombinant nanoparticle vaccine technology, together with our proprietary Matrix-M™ adjuvant, is well suited for the development and commercialization of vaccine candidates targeting a broad scope of respiratory and other endemic and emerging infectious diseases at scale.

We believe our recombinant nanoparticle vaccine technology and our proprietary Matrix-M™ adjuvant are well suited for the development and commercialization of vaccine candidates targeting areas both within and beyond the infectious disease space.

Recombinant Nanoparticle Vaccine Technology

Once a target of interest has been identified, the genetic sequence encoding the antigen is selected for developing the vaccine construct.

Once a target of interest has been identified, the genetic sequence encoding an antigen is selected for developing the vaccine construct.

The genetic sequence may be optimized to enhance protein stability or confer resistance to degradation.

1 unchanged sentence

The Sf-/BV system produces protein-based antigens that are properly folded and modified, which can be critical for functional, protective immunity.

Protein antigens are purified and organized around a polysorbate-based nanoparticle core in a configuration that resembles their native presentation.

This results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M™ adjuvant.

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

Matrix-M™ Adjuvant

Our proprietary Matrix-M™ adjuvant has been a key differentiator within our platform.

Our proprietary Matrix-M™ adjuvant is a key differentiator within our platform.

This adjuvant has enabled potent, well tolerated, and durable efficacy by stimulating the entry of antigen presenting cells (“APCs”) into the injection site and enhancing antigen presentation in local lymph nodes.

This in turn activates APCs, T-cell and B-cell populations, and plasma cells, which promotes the production of high-affinity antibodies.

This in turn activates APCs, T-cell and B-cell populations, and plasma cells, which promote the production of high affinity antibodies, an immune boosting response.

This potent mechanism of action enables a lower dose of antigen to achieve the desired immune response, thereby contributing to increased vaccine supply and manufacturing capacity.

1 unchanged sentence

We continue to evaluate commercial opportunities for the use of our Matrix-M™ adjuvant alongside vaccine antigens produced by other manufacturers.

Matrix-M™ adjuvant is being evaluated in combination with several partner-led malaria vaccine candidates, including the R21/Matrix-M™ adjuvant malaria vaccine created by the Jenner Institute, University of Oxford.

The R21/Matrix-M™ adjuvant vaccine has been licensed to Serum Institute of India Pvt.

(“SIIPL”) for commercialization and in December 2023 received prequalification by the WHO, along with authorizations received earlier in the year in Burkino Faso, Ghana, and Nigeria.

Additionally, in May 2023, we entered into a 3-year agreement with the Bill & Melinda Gates Medical Research Institute to provide our Matrix-M™ adjuvant for use in preclinical vaccine research.

In June 2023, we signed a material transfer agreement with SK bioscience Co., Ltd.

(“SK”) for use of our Matrix-M™ adjuvant in preclinical vaccine experiments for shingles, influenza, and pan-sarbecovirus vaccine.

Our adjuvant technology is also being used by commercial partners as a key component in veterinary vaccines against equine influenza and Strangles, as well as the manufacture of black-widow anti-venom.

Matrix-M™ adjuvant is being evaluated in combination with several partner-led malaria vaccine candidates, including for R21/Matrix-M™ adjuvant malaria vaccine.

The R21/Matrix-M™ adjuvant malaria vaccine has been licensed to SII for commercialization.

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

We have received full authorizations in select territories for our prototype vaccine developed for the 2022-2023 COVID-19 vaccination season and continue to receive authorizations for our updated vaccine developed for the 2023-2024 COVID-19 vaccination season in accordance with the updated strain protocol guidance.

Additionally, we progress our regulatory authorizations for our updated vaccine and plan to continue to do so for subsequent future variant strains for each annual respiratory season.

Within the U.S.

market, our updated vaccine received EUA in October 2023 from the U.S.

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

Our updated vaccine is marketed in the U.S.

under the name Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).

The formulation for our updated vaccine aligns with global harmonized guidance from the U.S.

FDA, the European Medicines Agency (“EMA”), and WHO recommendations for the 2023-2024 vaccination season.

In September 2023, the U.S.

Centers for Disease Control and Prevention (“CDC”) Advisory Committee on Immunization Practices (“ACIP”) voted in favor of a recommendation for the use of 2023-2024 monovalent XBB containing COVID-19 vaccines authorized under EUA or approved by Biologics License Application (“BLA”) in individuals 6 months and older, which was adopted by the CDC Director.

FDA’s grant of EUA and CDC’s September 2023 recommendation makes our updated vaccine the only protein-based non-mRNA COVID-19 vaccine available in the U.S.

Outside of the U.S.

market, we continue to progress regulatory authorizations for our updated vaccine globally.

We highlight as follows our fourth quarter 2023 and subsequent authorizations received through the date of filing this Annual Report on Form 10-K.

In January 2024, we were granted marketing authorization by the UK MHRA for our updated vaccine, marketed under the name Nuvaxovid™ XBB.1.5 Vaccine, in individuals aged 12 and older.

In December 2023, we were granted expanded authorization by Health Canada and EUA by the Taiwan Food and Drug Administration for our updated vaccine, marketed under the name Nuvaxovid™ XBB.1.5 Vaccine, in individuals aged 12 and older.

In November 2023, our updated vaccine received EUA in South Korea where SK bioscience has exclusive commercial rights to our updated vaccine.

Additionally, in November 2023, we were granted emergency use license (“EUL”) by the WHO for our updated vaccine, marketed under the name Nuvaxovid™ XBB.1.5 Vaccine, in individuals aged 12 and older.

The EUL assists WHO member states in assessing vaccines with the aim of expediting availability and enables the WHO’s 194 member states to expedite regulatory approvals to import and administer the vaccine.

In October 2023, we were granted approval by the EC for our updated vaccine in individuals aged 12 and older, which followed the positive opinion for approval from the Committee for Medicinal Products for Human Use of the EMA.

We expect to deliver doses to European countries pursuant to existing APAs.

We have previously received authorizations for our prototype COVID-19 vaccine in over 40 countries globally including from major regulatory agencies such as the U.S.

FDA, WHO, EMA, and MHRA.

To date, we have received full MA, approval, interim authorization, provisional approval, CMA, and EUA for the adult population, aged 18 and older, the adolescent population, aged 12 to 17 years, and the pediatric population, aged 7 to 11 years in select territories.

The regulatory authorizations for our prototype vaccine include primary series and both homologous and heterologous booster indications within specific countries.

For the territories in which our vaccine has received regulatory authorizations, our prototype vaccine

is marketed under the names (i) Nuvaxovid™ (SARS-CoV-2 rS Recombinant, adjuvanted), (ii) Covovax™ (manufacturing and commercialization by SIIPL), or (iii) Novavax COVID-19 Vaccine, Adjuvanted.

In October 2023, our prototype vaccine received full marketing authorization in the UK from the MHRA in individuals aged 12 and older, full approval in Singapore from Singapore’s Health Sciences Authority in individuals aged 12 and older, full registration in Australia from Australia’s Therapeutic Goods Administration as a booster in individuals aged 12 and older, and authorization in the EU from EMA for use as a booster in adolescents aged 12 through 17 years.

We believe these authorizations for our prototype vaccine may facilitate authorizations of our vaccine candidates for our COVID-19 vaccine strain updates in the future.

We are working to continue to expand our label for heterologous boosting in adults and adolescents, to expand our label for primary and re-vaccination in younger children, and to achieve supportive policy recommendations enabling broad market access.

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

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

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.

Table o f Contents

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.

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 approximately $2 billion in committed APAs anticipated for future delivery.

We had an APA with the EC, acting on behalf of various European Union member states to supply a minimum of 20 million and up to 100 million initial doses of prototype vaccine, with the option for the EC to purchase an additional 100 million doses up to a maximum aggregate of 200 million doses in one or more tranches through 2023.

In 2022, we were notified by the EC that it was cancelling approximately 7 million doses of its prior commitment originally scheduled for delivery in the first and second quarters of 2022, in accordance with the APA, and reducing the order to approximately 63 million doses.

In January 2023, we finalized a revised delivery schedule for the remaining 20 million committed doses under the APA that were originally scheduled for delivery during the first and second quarters of 2022.

The APA expired in August 2023 and required that any open and outstanding orders from European Union member states be satisfied by February 2024.

Since August 2023, any additional doses have been managed by amending outstanding orders with deliveries made by February 2024.

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

In April 2023, we amended the Australia APA to reduce the number of doses to be delivered with a commensurate increase in the per-dose price, such that the total contract value of the Australia APA is maintained with doses to be delivered through 2024.

In May 2023, we extended a credit for certain doses delivered in 2022 to Australia that qualified for replacement under the Australia APA.

This credit is the result of a single lot sold to the Australian government that upon pre-planned 6-month stability testing was found to have fallen below the defined specifications and the lot therefore was removed from the market.

The credit will be applied against the future sale of doses to Australia.

In July 2023, we amended the Australia APA to provide for replacement doses and to extend the delivery schedule through 2025.

As of February 2024, we had not yet received Therapeutic Goods Administration (“TGA”) authorization or delivered doses as contemplated in the July 2023 amendment and are in active discussions with the Australian government on both the TGA authorization and delivery of the doses previously scheduled for the fourth quarter of 2023.

In February 2024, we received notice from the Australian government purporting to cancel its order for such prototype vaccine doses.

We believe the cancellation was not proper under the amended Australia APA.

However, if such a cancellation were determined to be allowable, $6.0 million of the deferred revenue would become a credit towards future deliveries of doses and approximately $48 million of the contract value related to future deliverables would no longer be available.

We have 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 (the “Canada APA”).

In April 2023, we amended the Canada APA, pursuant to which the Canadian government forfeited certain doses originally scheduled for delivery in 2022 for a payment of $100.4 million, which we received in the second quarter of 2023.

In June 2023, we entered into an additional amendment (the “June 2023 Amendment”) to the Canada APA.

Pursuant to the June 2023 Amendment, (i) the Canadian government forfeited certain doses of COVID-19 Vaccine previously scheduled

for delivery and agreed to pay a total amount of $349.6 million to us in two equal installments, which total amount equaled the remaining balance owed by the Canadian government with respect to such forfeited vaccine doses, (ii) the amount of doses of COVID-19 Vaccine due for delivery was reduced, (iii) the delivery schedule for the remaining doses of COVID-19 Vaccine to be delivered was revised, and (iv) the parties agreed Novavax would use the Biologics Manufacturing Centre (“BMC”) Inc.

to produce bulk antigen for doses in 2024 and 2025.

The June 2023 Amendment maintained the total contract value of the original Canada APA.

The first Installment of $174.8 million was payable upon execution of the June 2023 Amendment and received by Novavax in July 2023, and the second installment of $174.8 million was contingent and payable upon the delivery of vaccine doses in the second half of 2023 and received by Novavax in January 2024.

The Canadian government may terminate the Canada APA, as amended, if we fail to receive regulatory approval for our COVID-19 Vaccine using bulk antigen produced at BMC on or before December 31, 2024.

Our 2024 plans do not currently anticipate the submission for regulatory approval of our COVID-19 Vaccine using bulk antigen produced at BMC, and we plan to work with the Canadian government on an amendment that addresses possible alternatives, which may not be achievable.

As of December 31, 2023, $102.8 million was classified as short-term Deferred revenue and $485.3 million was classified as long-term Deferred revenue with respect to the Canadian APA on our consolidated balance sheet.

If the Canadian government terminates the Canada APA, $28.0 million of the deferred revenue would become refundable and approximately $224 million of the contract value related to future deliverables would no longer be available (see Note 3 to our consolidated financial statements).

In the event that the contract is terminated, we would consider competing in the Canadian commercial market.

Pursuant to the June 2023 Amendment, Novavax and the Canadian government will endeavor to expand the previously agreed in-country commitment to Canada and to further partner to provide health, economic, and future pandemic preparedness benefits to Canada, which value may be provided through a number of activities, including without limitation, capital investments, the performance of activities or services, or the provision of technology or intellectual property licenses.

Further, the parties will endeavor to enter into a memorandum of understanding (the “MOU”) to illustrate our ability to deliver such benefits over a 15-year period with an aggregate value of not less than 100% of the amount remaining to be paid under the June 2023 Amendment and ultimately received by us.

As of December 31, 2023, discussions regarding the MOU were ongoing.

We agreed to hold $20.0 million of the second installment payment received in January 2024 in escrow for the benefit of the Canadian government, which amount is the sole recourse available to the Canadian government in the event of non-performance under the MOU.

In July 2022, we entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (as amended on September 26, 2022, the “Amended and Restated UK Supply Agreement”) with The Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), which amended and restated in its entirety the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the parties (the “Original UK Supply Agreement”).

Under the Original UK Supply Agreement, the Authority agreed to purchase 60 million doses of prototype vaccine and made an upfront payment to us.

Under the terms of the Amended and Restated UK Supply Agreement, the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses (the “Conditional Doses”) of prototype vaccine, with the number of Conditional Doses contingent on, and subject to reduction based on, our timely achievement of supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”) that is approved by the UK Secretary of State for Health, with respect to use of the vaccine for (a) the general adult population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or (b) the general adolescent population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or as a primary series SARS-CoV-2 vaccination, excluding where that recommendation relates only to one or more population groups comprising less than one million members in the United Kingdom.

If the Authority did not purchase the Conditional Doses or if the number of such Conditional Doses was reduced below 15 million doses of prototype vaccine, we would have to repay up to $225 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement.

Under the Amended and Restated UK Supply Agreement, the Authority also has the option to purchase up to an additional 44 million doses, in one or more tranches, through 2024.

As of November 30, 2022, the JCVI had not made a supportive recommendation with respect to prototype vaccine, thereby triggering, under the terms of the Amended and Restated UK Supply Agreement, (i) a reduction of the number of Conditional Doses from 15 million doses to 7.5 million doses, which reduced number of Conditional Doses were contingent on, and subject to further reduction based on, our timely achievement by November 30, 2023 of a supportive recommendation from JCVI that is approved by the UK Secretary of State for Health as described in the paragraph above, and (ii) an obligation for us to repay $112.5 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement.

In April 2023, we repaid the $112.5 million related to the November 30, 2022 triggering event.

As of November 30, 2023, the JCVI had not made a supportive recommendation with respect to the prototype vaccine, thereby triggering a reduction in the number of Conditional Doses from 7.5 million doses to zero.

As of February 2024, the Company is in

discussions with the Authority regarding the treatment of the remaining upfront payment previously received of $112.5 million, which is reflected in Other current liabilities.

In May 2021, we entered into an APA with Gavi, the Vaccine Alliance (“Gavi” and “the Gavi APA”).

Under the terms of the Gavi APA and a separate purchase agreement between Gavi and SIIPL, 1.1 billion doses of the prototype vaccine were to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.

We expected to manufacture and distribute 350 million doses of the prototype vaccine to countries participating in the COVAX Facility.

Under a separate purchase agreement with Gavi, SIIPL was expected to manufacture and deliver the balance of the 1.1 billion doses of prototype vaccine to low- and middle-income countries participating in the COVAX Facility.

We expected to deliver doses with antigen and adjuvant manufactured at facilities directly funded under our funding agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”), with initial doses supplied by SIIPL and Serum Life Sciences Limited (“SLS”) under a supply agreement.

We expected to supply significant doses that Gavi would allocate to low-, middle- and high-income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi could prioritize such doses to low- and middle- income countries, at lower prices.

Additionally, we could provide additional doses of prototype vaccine, to the extent available from CEPI-funded manufacturing facilities, in the event that SIIPL could not materially deliver expected vaccine doses to the COVAX Facility.

Under the agreement, we received an upfront payment of $350.0 million from Gavi in 2021 and an additional payment of $350.0 million in 2022 related to our achieving an emergency use license for our prototype vaccine by the WHO (the “Advance Payment Amount”).

On November 18, 2022, we delivered written notice to Gavi to terminate the Gavi APA on the basis of Gavi’s failure to procure the purchase of 350 million doses of our prototype vaccine from us as required by the Gavi APA.

As of November 18, 2022, we had only received orders under the Gavi APA for approximately 2 million doses.

On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that we had repudiated the agreement and, therefore, materially breached the Gavi APA.

Gavi also contended that, based on its purported termination of the Gavi APA, it was entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility.

The remaining Gavi Advance Payment Amount, which was $696.4 million as of December 31, 2023 has been classified within Other current liabilities in the Company’s consolidated balance sheet.

On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above.

We filed our Answer and Counterclaims on March 2, 2023.

On April 5, 2023, Gavi filed its Reply to our Counterclaims.

On February 16, 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 Settlement Agreement, we are responsible for payment to Gavi of (i) an initial settlement payment of $75 million, which we paid on February 20, 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 first 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 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 at our discretion, and, when utilized by Gavi, we will credit the actual price per vaccine paid against the applicable credit.

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.

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

Table o f Contents

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 in the Settlement Agreement, we grant Gavi an additional credit of up to $225 million, which may be applied against any additional qualifying sales, exceeding the $80 million deferred payment amount in any calendar year, of our vaccines in such countries during such deferred payment term.

In addition, we and Gavi entered into a security agreement pursuant to which we granted Gavi a security interest in accounts receivable from SIIPL under the SIIPL R21 Agreement (see Note 4 to our consolidated financial statements for more details on SIIPL R21 Agreement), which will continue for the deferred payment term of the Gavi Settlement Agreement.

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,

Table o f Contents

$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

(1) Authorized in select geographies under trade names Novavax COVID-19 Vaccine, Adjuvanted;

and Nuvaxovid™, and authorized in the U.S.

under trade name, Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula);

Ongoing post-authorization Phase 3 strain change trial.

(2) Authorized in Ghana, Nigeria, and Burkina Faso;

Commercialized by Serum Institute of India;

Granted prequalification by the WHO.

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.

Table o f Contents

Pipeline Overview

Our clinical pipeline encompasses vaccine candidates for infectious diseases, with our COVID-19 prototype vaccine (NVX-CoV2373) and our COVID-19 updated vaccine (NVX-CoV2601), as our lead products.

Our prototype and updated vaccine has received authorizations for both adult and adolescent populations globally.

Our updated vaccine has received authorization from the U.S.

FDA, the EC, the WHO, and several other countries globally.

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

Beyond our COVID-19 vaccine, our clinical pipeline includes a CIC vaccine candidate, in addition to our Matrix-M™ adjuvant being used for collaboration in R21/Matrix-M™ adjuvant malaria vaccine.

We are developing a CIC vaccine candidate, which combines our COVID-19 vaccine and our updated seasonal nanoparticle influenza vaccine candidate in a single formulation.

We continue to progress a Phase 2 trial of our CIC vaccine candidate.

We have selected the CIC dose formulation for advanced development, and contingent upon U.S.

FDA concurrence, we are prepared to move directly into a Phase 3 trial in the second half of 2024 to support accelerated approval, with a potential launch in the U.S.

in the fall of 2026.

In addition to our CIC vaccine candidate, we believe our partner-led R21/Matrix™ adjuvant malaria vaccine presents significant potential.

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.

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.

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.

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

Table o f Contents

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

Coronavirus Vaccine Clinical Development

We remain focused on expanding our COVID-19 vaccine label within the booster, adolescent, and pediatric indications.

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

We expect to leverage these clinical insights to advance additional regulatory approvals of our COVID-19 vaccine globally, amidst the evolving COVID-19 landscape.

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

Study 311 Part 2:

In August 2023, we announced topline results demonstrating immunologic superiority of our bivalent prototype and Omicron BA.5 vaccine compared to our prototype vaccine (NVX-CoV2373) for Omicron BA.5 specific responses.

This study is ongoing with the last patient visit expected to occur in the first quarter of 2024.

This study design was developed in consultation with regulatory agencies to support our U.S.

BLA and regulatory filings in other territories for our strain-change request for our updated vaccine (NVX-CoV2601), and to demonstrate that our protein-based vaccine can be successfully adapted to new variant strains.

In September 2023, we fully enrolled 332 adults aged 18 and older in Part 1 of the study to evaluate the immunogenicity and safety of our updated vaccine (NVX-CoV2601) in previously mRNA vaccinated individuals.

Preliminary topline results indicate that the study achieved its co-primary endpoints and successfully demonstrated immunological

superiority of NVX-CoV2601 compared to our prototype vaccine for Omicron XBB.1.5 specific immune responses.

In November 2023, we fully enrolled 338 adults aged 18 and older in Part 2 of the study which will evaluate the immunogenicity of our updated vaccine (NVX-CoV2601) in previously unvaccinated individuals.

Part 2 topline results are expected in the second quarter of 2024.

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.

In September 2023, we fully enrolled 401 adolescents aged 12 to 17 years who were previously vaccinated with mRNA vaccines to evaluate the immunogenicity of boosting with our updated vaccine (NVX-CoV2601) and with a bivalent format vaccine containing our updated vaccine (NVX-CoV2373 + NVX-CoV2601).

These data are intended to support adolescent heterologous booster label expansion in some territories with topline results expected in the second quarter of 2024.

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.

We remain on track to submit data for this cohort to the U.S.

FDA in the first half of 2024.

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

The trial includes three age de-escalation cohorts of 1,200 children each.

The next cohort aged 2 through 5 years is fully enrolled, with topline results expected in the first quarter of 2024.

The last cohort aged 6 to 23 months is fully enrolled and topline results are expected in the second quarter of 2024.

COVID-19 Vaccine Funding

We obtained critical funding from the U.S.

government to support the development of COVID-19 Vaccine for the U.S.

population, including $1.8 billion from a partnership formerly known as Operation Warp Speed.

In July 2020, we entered into a Project Agreement (the “Project Agreement”) with Advanced Technology International, Inc.

(“ATI”), the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership.

The partnership was among components of the U.S.

Department of Health and Human Services and the U.S.

Department of Defense working to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

The Project Agreement relates to the Base Agreement we entered into with ATI in June 2020 (the “Base Agreement,” together with the Project Agreement, the “USG Agreement”).

The original USG Agreement required us to conduct certain clinical, regulatory, and other activities, including a pivotal Phase 3 clinical trial to determine the safety and efficacy of prototype vaccine, and to manufacture and deliver to the U.S.

government 100 million doses of the vaccine candidate.

Funding under the USG Agreement is payable to us for various development, clinical trial, manufacturing, regulatory, and other activities.

The USG Agreement contains terms and conditions that are customary for U.S.

government agreements of this nature, including provisions giving the U.S.

government the right to terminate the Base Agreement or the Project Agreement based on a reasonable determination that the funded project will not produce beneficial results commensurate with the expenditure of resources and that termination would be in the U.S.

government’s interest.

If the Project Agreement was terminated prior to completion, we were entitled to be paid for work performed and costs or obligations incurred prior to termination and consistent with the terms of the USG Agreement.

As of December 31, 2023, we have recognized the full $1.8 billion-funding under the USG Agreement in grant revenue.

Our funding agreement with CEPI, under which CEPI agreed to fund up to $399.5 million to us to support the development of prototype vaccine, provided up to $257.0 million in CEPI Grant Funding and up to $142.5 million in CEPI Forgivable Loan Funding, which are loans in the form of one or more forgivable no-interest term loans to fund certain manufacturing activities and are not subject to restrictive or financial covenants.

Payments received under the CEPI Forgivable Loan Funding are only repayable if project vaccine, as defined under the CEPI funding agreement, manufactured by the contract manufacturing organization (“CMO”) network funded by CEPI is sold to one or more third parties (which could include sales credited under the Gavi Settlement Agreement), and such sales cover our costs of manufacturing such vaccine, not including manufacturing costs funded by CEPI.

The timing and amount of any loan repayments is currently uncertain.

A summary and status of our historical COVID-19 funding developments follows:

Funding Partner Amount Additional Details

CEPI $399.5 million • Funding of up to $399.5 million to support the development of prototype vaccine

• To supply prototype vaccine through the COVAX Facility

Government through USG Agreement $1.8 billion • Allotted $1.8 billion to support the development of prototype vaccine

• Full $1.8 billion recognized in revenue as of December 31, 2023

COVID-19-Influenza Combination Vaccine

Phase 2 Clinical Trial of COVID-19-Influenza Combination Vaccine

In November 2023, we shared that we previously evaluated 11 discrete CIC formulations in our Phase 2 dose-confirming trial, in which we then selected the CIC dose formulation and remain on track to initiate the Phase 3 trial.

We also observed a favorable reactogenicity profile with our combination vaccine that was clinically indistinguishable from the licensed influenza vaccine comparators.

This preliminary data suggests that our technology can increase the antigen load while maintaining acceptable tolerability.

Pending regulatory concurrence from the U.S.

FDA, we expect to initiate a pivotal Phase 3 trial for our CIC vaccine candidate in the second half of 2024, with potential accelerated approval and launch in the fall of 2026.

In May 2023, we announced preliminary topline data from our Phase 2 trial for CIC, stand-alone influenza, and high-dose COVID-19 vaccine candidates.

All three vaccine candidates contain our Matrix-M™ adjuvant, 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 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 vaccine.

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.

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

Table o f Contents

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.

High-dose COVID-19 Vaccine Study

In October 2023, we completed enrollment in a Phase 2 trial to evaluate our high-dose COVID-19 vaccine for annual vaccination in 994 adults ages 50 years and older.

The trial will compare immunogenicity levels of 5 micrograms of our prototype vaccine (NVX-CoV2373) against 5 micrograms, 35 micrograms, and 50 micrograms of our updated vaccine (NVX-CoV2601) that are matched with different levels of adjuvant.

Data from this trial is intended to potentially support further development of a higher-dose formulation for older adults, similar to that of influenza vaccines.

Topline results are expected in the first quarter of 2024.

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.

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

According to the 2024 WHO World Malaria Report, in 2023, there were an estimated 263 million malaria cases and 597,000 malaria-related deaths worldwide.

We believe malaria has the potential to be preventable through our partner-led R21/Matrix-M™ adjuvant malaria vaccine, which in 2023 received authorization in several countries and prequalification by the WHO.

We believe malaria has the potential to be preventable through our partner-led R21/Matrix-M™ adjuvant malaria vaccine, which in 2024 the first doses were distributed and administered across the African region after in 2023 having received authorization in several countries and prequalification by the WHO.

R21/Matrix-M™ Adjuvant Malaria Vaccine

R21/Matrix-M™ adjuvant malaria vaccine, formulated with our Matrix-M™ adjuvant is developed by our partner, the Jenner Institute, University of Oxford, and manufactured by SIIPL.

We have an agreement with SIIPL related to its manufacture of R21/Matrix-M™ adjuvant malaria vaccine under which SIIPL 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.

R21/Matrix-M™ adjuvant malaria vaccine, formulated with our Matrix-M™ adjuvant is developed by our partner, the Jenner Institute, University of Oxford, and manufactured by SII.

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

7 unchanged sentences

falciparum parasite in endemic areas.

Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and will enable rollout of the vaccine in mid-2024.

Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and enabled rollout of the vaccine in mid-2024.

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

In July 2023, R21/Matrix-M™ adjuvant malaria vaccine received authorization in Burkina Faso and in April 2023, received authorizations in Ghana and Nigeria.

Table o f Contents

License and Collaboration

Our commitment to partnering globally in efforts to further develop our COVID-19 Vaccine is demonstrated through our partnership with SIIPL to supply COVID-19 vaccines to India and low- and middle-income countries.

Marketed Under

Serum Institute of India Private Limited

• COVAX Facility

• The Philippines

• South Africa

Takeda Pharmaceutical Company Limited

• South Korea

SK bioscience Co., Ltd.

• South Korea (1)

(1) SK bioscience also has non-exclusive licenses in Thailand and Vietnam.

A summary of our license and collaboration agreements follows:

We previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of our prototype vaccine, our proprietary COVID-19 variant antigen candidate(s), and our CIC vaccine candidate.

SIIPL agreed to purchase our Matrix-M™ adjuvant, and we granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of our COVID-19 Vaccine in SIIPL’s licensed territory solely for use in the manufacture of COVID-19 Vaccine.

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

We also have a supply agreement with SIIPL and SLS under which SIIPL and SLS supply us with prototype vaccine, our proprietary COVID-19 variant antigen candidate(s), and our CIC vaccine candidate for commercialization and sale in certain territories, as well as a contract development manufacture agreement with SLS, under which SLS manufactures and supplies finished vaccine product to us using antigen drug substance and Matrix-M™ adjuvant supplied by us.

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

R21/Matrix-M™ adjuvant vaccine has been licensed to SIIPL for commercialization and in December 2023 received prequalification by the WHO.

Under the agreement, SIIPL 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 the Company’s COVID-19 Vaccine in Japan.

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.

SII agreed to purchase our Matrix-M™ adjuvant and we granted SII a non-exclusive license to manufacture the antigen drug substance component of our COVID-19 Vaccine in SII’s licensed territory solely for use in the manufacture of COVID-19 Vaccine.

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.

The 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.

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.

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.

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 September 2021, Takeda finalized an agreement with the Government of Japan’s Ministry of Health, Labour and Welfare ("MHLW") for the purchase of 150 million doses of its prototype vaccine.

In February 2023, MHLW canceled the remainder of doses under its agreement with Takeda.

As a result, it is uncertain whether we will receive future sales-based royalty payments from Takeda under the terms and conditions of their current collaboration and licensing agreement.

SK bioscience

We have a collaboration and license agreement with SK bioscience to manufacture and commercialize our prototype vaccine for sale to the governments of South Korea, Thailand, and Vietnam.

SK bioscience pays a royalty in the low to middle double-digit range.

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.

Table o f Contents

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 and are exploring a number of combination vaccine candidates, including a CIC vaccine, directly and by leveraging our strategic global partnerships.

In 2021 and 2020, we established a global supply chain and worldwide partnerships to support the commercialization of our prototype vaccine.

In 2023 and 2022, 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.

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.

A summary of our key manufacturing and supply arrangements follows:

3 unchanged sentences

Antigen Component of COVID-19 Vaccine

We manufacture the antigen component of our COVID-19 Vaccine at our Novavax CZ facility in the Czech Republic.

We have a supply agreement with SIIPL and SLS, an affiliate of SIIPL, for the manufacture of the antigen component of COVID-19 Vaccine and the co-formulation, fill, and finishing of the finished vaccine product.

In May and August 2022, we expanded our license and supply arrangements with SIIPL to include our proprietary COVID-19 variant antigen candidate(s), and our CIC vaccine candidate, so that SIIPL can manufacture and commercialize a vaccine targeting COVID-19 variants, including the Omicron subvariants, and CIC vaccine, and supply such vaccines to us.

Finished COVID-19 Vaccine

In addition to the supply agreement with SIIPL and SLS for the co-formulation, fill, and finishing of the finished vaccine product, we have a contract development manufacture agreement with SLS, pursuant to which SLS will manufacture and supply finished vaccine product to us using antigen drug substance and Matrix-M™ adjuvant supplied by us.

Currently, we depend primarily on this supply agreement for co-formulation, filling and finishing (other than in Europe) and our service agreement with PCI Pharma Services (“PCI”) for finishing in Europe.

Competition in COVID-19 and Combination Vaccines

We have a supply agreement with SII and SLS for the manufacture of the antigen component of COVID-19 Vaccine and the co-formulation, fill, and finishing of the finished vaccine product.

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.

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

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

Currently, we depend primarily on this supply agreement for co-formulation, filling and finishing of COVID-19 Vaccine doses.

The vaccine market is intensely competitive, characterized by rapid technological progress.

1 unchanged sentence

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 other technologies, such as enabling dose-sparing effects and refrigerator temperature storage that is well suited for developing COVID-19 and combination vaccines, as well as vaccines against a number of other infectious diseases.

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

Table o f Contents

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.

We face competition in the development of our COVID-19 Vaccine, seasonal influenza vaccine candidate, CIC vaccine candidate and the other vaccine candidates in our pipeline, including our early-stage vaccine candidates.

A number of vaccine manufacturers, research institutions, and other organizations have developed a vaccine for SARS-CoV-2, the virus that causes COVID-19.

1 unchanged sentence

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

FDA and a CMA by EMA in the European Union.

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.

2 unchanged sentences

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 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 vaccine candidate will continue to play an important role in addressing this global public health crisis.

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.

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

Starting in the 2024-2025 season, all flu vaccines in the U.S.

were trivalent vaccines designed to protect against three different influenza viruses, including two influenza A viruses and an influenza B / Victoria virus.

Many seasonal influenza vaccines are currently approved and marketed, and most of these are marketed by major pharmaceutical companies such as Sanofi, GSK, and Seqirus.

Competition in the sale of seasonal influenza vaccines is intense.

For the older adult segment in the U.S., the CDC preferentially recommends Fluzone-HD®, an egg-based high-dose flu vaccine, Flublok®, a recombinant flu vaccine manufactured by Sanofi and Fluad®, an egg-based adjuvanted flu vaccine manufactured by Seqirus.

Therefore, newly developed and approved products must be differentiated from existing vaccines in order to have commercial success.

In order to show differentiation in the seasonal influenza market, a product may need to be more efficacious or be less expensive and quicker to manufacture, all while still showing a comparable or improved tolerability profile.

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.

Following our Phase 2 trial results, we have selected a CIC dose formulation and pending regulatory concurrence are on track to initiate a pivotal Phase 3 trial in the second half of 2024, with potential accelerated approval and launch in the fall of 2026.

Other manufacturers, including Moderna and Pfizer, are in Phase 3 clinical trials with COVID-19-influenza combination candidates and have publicly disclosed an expected launch date as early as 2025.

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.

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.

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

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

2 unchanged sentences

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 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.

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

Table o f Contents

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

We generally seek patent protection for our technology and product candidates in the U.S.

The patent position of biotechnology and pharmaceutical firms generally is highly uncertain and involves complex legal and factual questions.

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.

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

2 unchanged sentences

• protect our trade secrets and know-how.

• operate without infringing the intellectual property and proprietary rights of others.

Patent Rights;

1 unchanged sentence

Currently, we have or have rights to over 680 U.S.

and foreign patents and patent applications relating to vaccines and vaccine-related technologies.

Patents related to our Virus-Like Particle (“VLP”) program include U.S.

7,763,450, which covers, in part, the use of influenza gene sequences for high-yield production of consistent influenza VLP vaccines to protect against current and future seasonal and pandemic strains of influenza viruses.

Corresponding European patent, European Patent No.

1644037 also covers this technology.

8,080,255, 8,551,756, 8,506,967 and 8,592,197 are directed to methods of producing VLPs and inducing substantial immunity to an influenza virus infection by administering VLPs comprising HA and NA proteins, and our M1 protein derived from the avian influenza strain, A/Indonesia/5/05.

Certain claims also encompass similar methods and compositions where the M1 protein is from a different strain of influenza virus than the influenza HA protein and the influenza NA protein.

Related patent protection in Europe is provided by European Patent No.

2343084, which covers, in part, vaccine compositions containing VLPs that contain M1, HA, and NA proteins.

Our VLP patent portfolio contains many other patents, including U.S.

8,951,537, 8,992,939, 9,144,607, 9,050,290, 9,180,180, 9,381,239, 9,464,276, 9,474,799, and other patents in multiple ex-U.S.

jurisdictions.

In addition to our focus on vaccine programs, we also pursue patent protection for our Matrix Adjuvant program.

7,838,019, 9,205,147, 9,901,634, 8,821,881, and 10,729,764 provide examples of patents related to our Matrix Adjuvant program.

We pursue patents related to our COVID-19 vaccine program, including to NVX-CoV2373, our COVID-19 vaccine candidate.

10,953,089, 11,253,586, 11,541,112 provide examples of patents related to our COVID-19 program.

We also have four pending PCT applications directed to our COVID program (PCT/US2022/020974, PCT/US2022/080700, PCT/US2022/082331 and PCT/US2022/027465) and two pending PCT applications directed to our malaria program (PCT/US2022/078665 and PCT/US2022/080334).

and foreign patents and patent applications relating to vaccines and vaccine-related technologies, including:

We have more than 150 combined patents and pending applications in the US and internationally relating to respiratory syncytial virus (RSV) glycoproteins, compositions, and methods of treatment.

These patents will expire from 2029 to beyond 2041.

• Clostridium Difficile:

We have more than 15 combined patents and pending applications in the US and internationally relating to methods and compositions for treating or preventing C.

Difficile infection.

These patents will expire from 2038 to beyond 2039.

We currently have 2 U.S.

patents and pending US and international applications related to multivalent influenza compositions.

These patents are anticipated to expire in 2039 and beyond

• COVID/Influenza:

We have more than 40 combined patents and pending applications in the US and internationally related to compositions and methods for inducing immune responses against both influenza and coronaviruses that will expire beyond 2042 when issued.

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.

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.

7 unchanged sentences

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

We also require

Table o f Contents

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.

Human Capital

As of February 23, 2024, we have 1,543 full-time employees, of whom approximately 9% hold M.D.

degrees and approximately 20% hold other advanced degrees.

Of our total workforce, approximately 68% of employees are engaged primarily in research, development, and manufacturing activities and approximately 32% of employees are engaged primarily in executive, business development, commercial, finance and accounting, legal, and administrative functions.

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.

To nurture, grow, and treat our employees fairly is an integral part of our culture.

We are proud to have won a Silver Stevie Award in 2023 for Great Employer in the Pharmaceutical category.

We believe this award reflects our investment in an exceptional work culture.

Compensation and Benefits;

2 unchanged sentences

We strive to provide compensation, benefits and services that help meet the varying needs of our employees.

Our generous total rewards package for employees in the U.S.

Our total rewards package for employees in the U.S.

includes competitive market pay and comprehensive benefits, including insurance to protect and maintain health;

2 unchanged sentences

and services to assist in balancing work and personal life, such as backup child, adult and elder care, and financial well-being programs, including monthly financial wellness seminars, one-on-one financial planning sessions, and debt and credit management support.

Our wellness initiatives include a monthly newsletter, which highlights organizations and partners, tools, and resources intended to help our employees lead healthier and happier lives.

Our wellness initiatives include a monthly newsletter, which highlights organizations and partners, tools, and resources intended to enrich and improve our employees’ physical and mental well-being.

We offer several digital apps that allow our employees to connect to an online licensed therapist or to access activities that are designed to reduce stress and anxiety and increase mindfulness and emotional well-being.

We have a robust employee assistance program for employees to access support for a variety of life events.

We have a robust employee assistance program that allows employees to access support for a variety of life events.

In addition, we offer the majority of employees the benefit of equity ownership in the Company through equity grants or participation in our employee stock purchase plan.

4 unchanged sentences

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 develops leadership skills at all levels of the organization.

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.

In the last 12 months, videos were viewed and completed over 40,000 times by our employees.

In the last 12 months, our employees have viewed and completed videos over 40,000 times.

In addition, approximately 35 employees have participated in spot coaching.

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

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 Development Program includes a diverse and global group of 34 employees.

The Executive

Table o f Contents

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 tools to facilitate open and direct communication, including global forums with executives, employee surveys, and engagement through forums and committees.

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.

Diversity, Equity and Inclusion

Our culture of diversity, equity and inclusion (“DEI”) helps us to create, develop and leverage the strengths of our workforce to meet our growth objectives.

Our multi-year DEI roadmap includes three pillars:

• Embed DEI into our hiring decisions and processes.

• Enable our employees, who we refer to as our SuperNovas, to live our values and thrive in a culture of inclusion.

• Equip our leaders and SuperNovas with the understanding, capability, education, tools and resources on DEI.

We acknowledge global DEI-related observances and we invest in training to build an inclusive culture and develop our leaders to access different perspectives when generating ideas and decision making.

In 2023, we also made progress in increasing representation for women and minorities at the Executive level.

We commenced and completed the reviews of three people processes, namely, Talent Acquisition, Promotion and Performance Management.

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

We believe our multi-year DEI strategy and roadmap will enable us to continuously improve and excel.

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 2023, Novavax sought to motivate and empower employees through a variety of programs:

• Made charitable donations in employees’ name to other mission-driven organizations in the U.S., Sweden and Czech Republic through employee match and direct giving.

• Furthered personal and professional development by providing tuition and education reimbursement and providing access to professional coaching and Executive Development programming for high-potential employees.

Environmental, Social, and Governance

In addition to the DEI and human capital initiatives described above, a range of other initiatives related to environmental, social and governance (“ESG”) are underway.

These include environmental sustainability, innovating for vaccine access and improving global health, empowering our employees and governing responsibly.

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:

Environmental 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.

• Lease of approximately 170,000 square foot property in Gaithersburg, Maryland at 700 Quince Orchard Road, certified LEED Silver and designed with energy efficiency and sustainability measures in place.

• Conserving water (e.g., by replacing single-serve water bottles with refillable options) and monitoring energy use across multi-use leased and owned facilities.

• Award of WELL certifications at multiple leased 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 our Matrix-M™ adjuvant.

Innovating for Vaccine Access and Improving Global Health

• R21/Matrix-M™ 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 now approved in three countries and prequalified by the WHO.

• Advocacy efforts to build a bureau of third-party organizations who are registered with the CDC to provide public commentary on behalf of Novavax, including the National Health Council, Vaccinate Your Families and the National Black Nurses Association.

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

Affordability

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.

• 100% returns for certain vaccinators offered with Novavax assuming all financial risk related to returns.

• 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.

• In the U.S., participated in the 317 Program, which serves uninsured and underinsured adults and supports Federal Qualified Health Centers that potentially vaccinate uninsured and underinsured patients.

• In the U.S., 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.

• 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”).

Table o f Contents

• 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.

2 unchanged sentences

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

• Chief Compliance Officer elevated to report to the CEO with a dotted line to the Audit Committee.

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

3 unchanged sentences

• 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 for updated Safety Policy.

• 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.

Government Regulations

13 unchanged sentences

Before applying for U.S.

FDA licensure to market any new vaccine candidate, we expect to first submit an investigational new drug application (“IND”) that explains to the 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.

2 unchanged sentences

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.

Table o f Contents

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.

35 unchanged sentences

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.

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.

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.

4 unchanged sentences

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 vaccine in November 2020 and for our recombinant quadrivalent seasonal influenza vaccine candidate, in January 2020.

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.

Table o f Contents

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.

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.

7 unchanged sentences

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 June 2019, we announced that the U.S.

FDA acknowledged that the accelerated approval pathway is available for our recombinant quadrivalent seasonal influenza vaccine candidate.

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.

3 unchanged sentences

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, the Czech Republic 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.

14 unchanged sentences

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.

Table o f Contents

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.

The participation in such programs or the sale of products to such agencies is subject to regulation.

In exchange for

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

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

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.

5 unchanged sentences

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.

Under the American Rescue Plan Act of 2021 (“ARPA”), Medicaid and Children’s Health Insurance Program (“CHIP”) programs must cover without cost-sharing COVID-19 vaccines for most Medicaid and CHIP enrollees through September 30, 2024.

After such date, under the Inflation Reduction Act of 2022 (“IRA”), Medicaid and CHIP programs will be required to cover without cost-sharing only U.S.

FDA-approved COVID-19 vaccines for adults as recommended by the ACIP.

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.

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

5 unchanged sentences

There is no assurance that federal or state health care reform will not adversely affect our future business and financial results.

Similarly, in many countries outside the U.S., pharmaceutical pricing is subject to regulatory control, particularly in countries where healthcare is provided mainly through government funding or government backed insurers.

In such countries governmental organizations will generally determine firstly if a medicinal product might be reimbursed and secondly the maximum price payable.

Similarly, in many countries outside the U.S., pharmaceutical pricing is subject to regulatory market access control, particularly in countries where healthcare is provided mainly through government funding or government backed insurers.

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.

7 unchanged sentences

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 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.

Table o f Contents

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.

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 to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited.

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

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.

4 unchanged sentences

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 is expensive and difficult, particularly in countries in which corruption is a recognized problem.

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.

17 unchanged sentences

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”).

Table o f Contents

There also are U.S.

2 unchanged sentences

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 must be publicly disclosed.

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.

17 unchanged sentences

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.

The current declaration will end on December 31, 2024, unless it is renewed.

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.

2 unchanged sentences

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

Table o f Contents

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.

Availability of Information

1 unchanged sentence

We make available, free of charge and through our website, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and our other filings with the SEC, and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after filed with or furnished to the SEC.

The SEC maintains an Internet site

that contains reports, proxy, and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov.

The SEC maintains an Internet site that contains reports, proxy, and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov.

We use our website (www.novavax.com) as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation Fair Disclosure promulgated by the SEC.

6 unchanged sentences

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.

Table o f Contents

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

What changed 10-K

Item 1. Business