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Item 1. Business

2024-02-28 compared with 2023-02-28 · 428 added, 490 removed, 238 unchanged (79% of the section changed)

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

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 genetically engineered nanostructures of conformationally correct recombinant proteins that mimic those found on natural pathogens.

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

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 and begun commercialization of a COVID-19 vaccine, NVX-CoV2373 (“Nuvaxovid™,” “Covovax™,” “Novavax COVID-19 Vaccine, Adjuvanted”), that has received approval, interim authorization, provisional approval, conditional marketing authorization (“CMA”), and emergency use authorization (“EUA”) from multiple regulatory authorities globally for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications and are developing an influenza vaccine candidate, a COVID-19-Influenza Combination (“CIC”) vaccine candidate, and additional vaccine candidates, including a COVID-19 variant strain-containing monovalent or bivalent formulation.

In addition to COVID-19 and seasonal influenza, our other areas of focus include respiratory syncytial virus (“RSV”) and malaria.

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.

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

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

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

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

Technology Overview

We believe our recombinant nanoparticle vaccine technology, 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 emerging infectious diseases at scale.

Recombinant Nanoparticle Vaccine Technology

Once a pathogenic threat has been identified, the genetic sequence encoding the antigen is selected for subsequent use in developing the vaccine construct.

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

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

This genetic construct is inserted into the baculovirus Spodoptera frugiperda (“Sf-/BV”) insect cell-expression system, which enables efficient, large-scale expression of the optimized protein.

The Sf-/BV system produces proteins that are properly folded and modified—which can be critical for functional, protective immunity—as the vaccine antigen.

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.

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

This adjuvant has demonstrated 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, an immune boosting response.

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

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

These immune-boosting and dose-sparing capabilities contribute to the adjuvant’s highly unique profile.

We continue to evaluate 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 in a Phase 3 trial for R21, a malaria vaccine candidate created by the Jenner Institute, University of Oxford.

The University of Oxford has partnered with Serum Institute of India Pvt.

(“SIIPL”) for commercial development of R21 and has granted SIIPL a license for R21.

We expect to manufacture and supply the Matrix-M™ adjuvant component of R21 to SIIPL, which represents a significant commercial opportunity for our adjuvant, pending possible licensure.

We have commercial rights to sell and distribute the SIIPL-manufactured R21 in certain countries, primarily in the travelers’ and military vaccine markets.

We are also supplying Matrix-M™ adjuvant for two Phase 1 vaccine trials led by National Institutes of Health teams, focused on Epstein-Barr virus and malaria transmission blocking.

NVX-CoV2373 Regulatory and Licensure

We have made substantial progress in advancing NVX-CoV2373 toward regulatory approvals.

We have received authorizations in over 40 countries globally within the adult population, aged 18 and older, and the adolescent population, aged 12 through 17, for primary series and both homologous and heterologous booster indications.

To date, we have received approval, interim authorization, provisional approval, CMA, and EUA for both adult and adolescent populations.

working to continue to expand our label for heterologous boosting in adults, adolescents, and younger children, and 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 equitable global access to our COVID-19 vaccine.

For the territories in which our vaccine has gained authorization, NVX-CoV2373 is marketed under the brand names (i) Nuvaxovid™ (SARS-CoV-2 rS Recombinant, adjuvanted), (ii) Covovax™ (manufacturing and commercialization by SIIPL), or (iii) Novavax COVID-19 Vaccine, Adjuvanted.

A summary of regulatory authorizations for NVX-CoV2373 through the date of filing this Annual Report on Form 10-K is presented below:

(1) Regulatory approval received in partnership with SIIPL.

(2) Regulatory manufacturing and marketing approval received by partner Takeda Pharmaceutical Company Limited (“Takeda”).

(3) Regulatory approval received in partnership with SK bioscience, Co., Ltd.

(“SK bioscience”).

Below we highlight the fourth quarter 2022 and subsequent regulatory authorizations received through the date of this filing on Form 10-K.

In January 2023, our partner SK bioscience received expanded manufacturing and marketing approval from Korean Ministry of Food and Drug Safety (“KMFDS”) for Nuvaxovid™ for use as a booster in adults aged 18 and older.

In December 2022, Health Canada approved a supplement to a New Drug Submission for Nuvaxovid™ as a primary series of two doses in adolescents aged 12 to 17 years.

In November 2022, the World Health Organization (“WHO”) issued an updated EUL for Nuvaxovid™ as a primary series of two doses in adolescents aged 12 to 17 years and as a booster in adults aged 18 and older.

Additionally in November 2022, Health Canada granted expanded authorization for Nuvaxovid™ as a homologous booster in adults aged 18 and older.

Within the same month, the Medicines and Healthcare products Regulatory Agency in the United Kingdom (“U.K.”) expanded CMA for Nuvaxovid™ as a homologous and heterologous booster dose after the primary series of Nuvaxovid™ or of an mRNA or adenoviral vector in adults aged 18 and older.

In October 2022, the U.S.

FDA granted EUA to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to adults aged 18 and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to adults aged 18 and older who elect to receive NVX-CoV2373 because they would otherwise not receive a booster dose of a COVID-19 vaccine.

We completed additional regulatory submissions in major markets for both adult and adolescent populations for primary and booster indications, and we are in active discussions with regulatory authorities regarding several of those submissions.

We remain focused on expanding our label in multiple countries for NVX-CoV2373.

In February 2023, we had several additional regulatory submissions.

We submitted an application to the U.S.

FDA for expanded EUA of NVX-CoV2373 as a booster in adolescents aged 12 to 17 years.

The application for expanded EUA is supported by data from the pediatric arm of our Phase 3 PREVENT-19 trial conducted in the U.S.

We submitted an application to the European Medicines Agency (“EMA”) for expanded CMA to include a booster in adolescents aged 12 to 17 years.

We submitted an application to Taiwan’s Food and Drug Administration for EUA in adults aged 18 and older.

We submitted an application to Singapore’s Health Sciences Authority for full BLA for primary series in adolescents aged 12 to 17 years and for a booster indication in adults aged 18 and older.

Advance Purchase Agreements (“APA”)

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

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.

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.

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 $2.1 billion in committed APAs anticipated for future delivery.

We have 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 NVX-CoV2373, 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.

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 and are expected to be delivered in 2023.

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 NVX-CoV2373 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 NVX-CoV2373, 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 does not purchase the Conditional Doses or the number of such Conditional Doses is reduced below 15 million doses of NVX-CoV2373, 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.

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 yet made a supportive recommendation with respect to NVX-CoV2373, 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 are 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, which is reflected in our consolidated balance sheet as Other current liabilities, with the remaining upfront payment balance of $112.5 million reflected in current Deferred revenue.

Under the terms of an APA dated May 5, 2021, by and between the Company and Gavi, the Vaccine Alliance (“Gavi” and “the Gavi APA”), we received an upfront payment of $350.0 million from Gavi in 2021 and an additional payment of $350.0 million in the first quarter of 2022 related to our achieving EUL for NVX-CoV2373 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 NVX-CoV2373 from us as required by the Gavi APA.

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 the Company repudiated the agreement and, therefore, materially breached the Gavi APA.

Gavi also contends that, based on its purported termination of the Gavi APA, it is 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.

As of December 31, 2022, the remaining Gavi Advance Payment Amount of $697.4 million, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, was reclassified from Deferred revenue to Other current liabilities in our consolidated balance sheet.

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.

Our response is currently due by March 2, 2023.

Arbitration is inherently uncertain, and while we believe that we are entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that we could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi.

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 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.

Product Pipeline

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

and Nuvaxovid™.

(2) Ongoing Phase 3 strain change trial.

(3) Ongoing Phase 3 trial for R21, a malaria candidate developed by the Jenner Institute, University of Oxford and formulated with Matrix-M™ adjuvant.

(4) Clinical development conducted in older adults with previous construct through Phase 3 trial.

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.

Pipeline Overview

Our clinical pipeline encompasses vaccine candidates spanning multiple therapeutic areas, with our COVID-19 vaccine, NVX-CoV2373, as our lead product, which has received approval, interim authorization, provisional approval, CMA, or EUA for both adult and adolescent populations in over 40 countries.

We advanced NVX-CoV2373 through two pivotal Phase 3 clinical trials that demonstrated high efficacy against both the original COVID-19 strain and commonly circulating COVID-19 variants, while maintaining a favorable safety profile.

Beyond COVID-19, our clinical pipeline encompasses seasonal influenza and CIC vaccine, in addition to providing Matrix-M TM adjuvant for collaborations investigating the prevention of malaria.

We are developing our quadrivalent nanoparticle influenza vaccine (“qNIV”) candidate, previously known as NanoFlu, which we advanced through a successful Phase 3 study published in September 2021, demonstrating the utility for a stand-alone influenza vaccine or for use in a combination vaccine.

We have subsequently updated our qNIV for further development.

We continue to progress in a Phase 2 trial our stand-alone influenza vaccine candidate, qNIV and our CIC vaccine candidate, which combines NVX-CoV2373 and our updated qNIV approach in a single formulation.

In October 2022, we announced positive results from the Phase 1/2 CIC clinical trial demonstrating the CIC vaccine’s ability to generate both antibody and polyfunctional CD4+ T-cell (lymphocytes that help coordinate the immune response) responses against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and homologous and heterologous influenza strains.

In December 2022, we initiated a Phase 2 CIC dose-refinement trial that also includes further stand-alone updated qNIV evaluation.

In addition to COVID-19 and seasonal influenza, we remain interested in continuing the development of both our RSV Program for respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”) and Matrix-M™ adjuvant collaborations for malaria.

An ongoing Phase 3 trial is being conducted for R21, a malaria candidate, by our partner, the Jenner Institute, University of Oxford, which is formulated with our Matrix-M™ adjuvant.

We remain focused on expanding our NVX-CoV2373 vaccine label within the booster and adolescent market following global regulatory authorizations.

We continue to evaluate vaccine efficacy through ongoing booster studies in our

clinical trials and continued development of our COVID-19 variant strain containing monovalent or bivalent formulation.

We expect to leverage these clinical insights to advance additional regulatory approvals of our COVID-19 vaccine for primary, booster, and pediatric indications globally, amidst the ongoing COVID-19 landscape.

Although our COVID-19, CIC, and influenza stand-alone vaccine candidates are our near-term priorities, our partner-led malaria candidates present strong opportunities for future development.

NVX-CoV2373 Clinical Development

NVX-CoV2373 has progressed through multiple clinical trials, including a Phase 3 Lot Consistency Study, two Phase 3 pivotal efficacy trials, one Phase 3 Omicron boosting trial, one Phase 2b trial, and one Phase 1/2 trial, along with numerous others.

We have expanded our clinical trials to evaluate heterologous and homologous boosting for populations spanning adults, adolescents, and children.

Through our clinical development program, we established a dose of 5 micrograms of recombinant spike protein plus 50 micrograms of Matrix-M™ adjuvant.

We continue to collect data that indicates a reassuring safety profile, and the induction robust cellular and humoral immune responses that were associated with high levels of efficacy in two independent Phase 3 studies.

A summary and status of our clinical development of NVX-CoV2373 by trial is as follows:

PREVENT-19 Phase 3 U.S.

PREVENT-19 was a randomized, placebo-controlled, observer-blinded Phase 3 trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in 29,949 participants aged 18 years or older across 119 sites in the U.S.

In the trial, NVX-CoV2373 achieved 90.4% efficacy overall, was generally well tolerated, and elicited a robust antibody response after the second dose.

In December 2021, full results of the trial were published in The New England Journal of Medicine .

In December 2021, we also initiated a PREVENT-19 Phase 3 boosting study.

In October 2022 at the World Vaccine Congress in Europe, we presented PREVENT-19 Phase 3 boosting data in both adults aged 18 years or older and adolescents aged 12 to 17 years, showing NVX-CoV2373 achieved its pre-specified immunologic endpoint.

In October 2022 at IDWeek, we presented additional data from the PREVENT-19 booster study, including an evaluation of the effect of age (18 to 64 years, and ≥ 65 years) and schedule on boosted immunologic response demonstrating significant boosting in all age groups.

Booster doses were generally well tolerated, with mostly mild to moderate reactogenicity that was of short duration.

PREVENT-19 Phase 3 Pediatric Expansion

PREVENT-19 Pediatric Expansion was a randomized, placebo-controlled, observer-blinded study to evaluate the safety, effectiveness (immunogenicity), and efficacy of NVX-CoV2373 in 2,247 adolescents aged 12 to 17 years in 73 locations in the U.S., with an emphasis on ensuring well-balanced racial and ethnic representation among participants.

Participants randomly received either the vaccine candidate or placebo in two doses, administered 21 days apart.

In October 2022 at the World Vaccine Congress in Europe, we presented PREVENT-19 Phase 3 pediatric expansion homologous boosting data, where a single boost dose was generally well tolerated and induced robust immune responses against prototype-strain as well as against Omicron BA.1, BA.2, and BA.5 subvariants.

A third dose suggested benefit for the prevention of COVID-19 against contemporary variants such as Omicron.

Additionally, booster doses were generally well tolerated, with mostly mild to moderate reactogenicity that was of short duration.

In April 2022, we announced initiation of PREVENT-19 Phase 3 booster study in adolescent trial participants with the booster dose administered at least 5 months after receipt of active vaccine.

In February 2022, we announced positive results from our Phase 3 PREVENT-19 pediatric expansion in adolescents.

The results achieved their primary effectiveness endpoint and demonstrated 80% efficacy overall, with 82% clinical efficacy

against the Delta variant.

Immune responses were two-to-three-fold higher in adolescents than in adults against all variants studied.

NVX-CoV2373 was well-tolerated with no safety signals identified.

Phase 2b/3 Hummingbird™ Trial

In August 2022, we initiated the Phase 2b/3 Hummingbird™ Global Clinical Trial to evaluate the safety, effectiveness (immunogenicity), and efficacy of two doses of NVX-CoV2373 in younger children aged 6 months to 11 years, followed by a booster at 6 months after the primary vaccination series.

The trial is an age de-escalation trial and age groups will be tested sequentially to assess NVX-CoV2373 in infants (6 through 23 months of age), toddlers (2 to 5 years), and children (6 to 11 years).

Enrollment is ongoing, expanding into the cohort aged 2- to 5-years in January 2023.

The trial seeks to enroll 3,600 total participants in the U.S.

and other countries.

Phase 3 Lot Consistency Study

In October 2022 at the World Vaccine Congress in Europe, we presented Lot Consistency data.

The study achieved its primary endpoint showing that three lots of NVX-CoV2373 induced consistent immune responses in adults aged 18 to 49 years and demonstrated manufacturing consistency.

Heterologous boosting responses for NVX-CoV2373 were consistent across participants who received primary vaccines from other approved U.S.

FDA COVID-19 vaccines.

In February 2022, we announced an extended analysis from our pivotal Phase 3 U.K.

trial showing that a high level of efficacy for NVX-CoV2373 was maintained over a 6-month period of surveillance.

The analysis showed vaccine efficacy of 82.5% in protection against all COVID-19 infection, both symptomatic and asymptomatic.

These data were published in Clinical Infectious Diseases in October 2022 and build upon the final analysis of our Phase 3 U.K.

trial, published in The New England Journal of Medicine in June 2021, which highlighted the robust safety and efficacy data for NVX-CoV2373 and demonstrated a vaccine efficacy of 89.7%.

Phase 2b South Africa

In May 2022, results from our Phase 2b South Africa trial were published in The Lancet , which highlighted safety and immunogenicity of two doses of NVX-CoV2373 in people living with and without HIV.

The Phase 2b South Africa trial was a randomized, observer-blinded, placebo-controlled study that enrolled 4,419 participants.

The results show that due to a lower observed antibody response in baseline SARS-CoV2 people living with HIV than compared to the HIV-negative participants, there is a need to investigate alternative dosing approaches, including potentially adding a third vaccine dose to the priming series.

Phase 2 South Africa

In February 2022, we initiated a Phase 2 South Africa trial evaluating the safety and immunogenicity of NVX-CoV2373 in adults aged 18 to 65 years, living with human immunodeficiency virus (“HIV”).

The Phase 2 South Africa trial was a randomized, observer-blinded, placebo-controlled study that enrolled 360 participants living with HIV to evaluate different dosing regimens.

Data are being evaluated to support extended primary vaccination schedules for immunocompromised adults.

NVX-CoV2373 Clinical Development Conducted by Partners

Phase 2/3 India

In January 2023, immunogenicity and safety results from SIIPL and India Council of Medical Research Phase 2/3 trial were published in The Lancet and in the preprint server for health sciences on medRxiv .

This Phase 2/3 trial was expanded from

adults to include a pediatric cohort.

The trial was an observer-blind, randomized, controlled study in 920 total enrolled children aged 2 to 17 years and was found to be well tolerated and immunogenic.

Phase 1/2 Japan

In April 2022, Takeda reported primary data analysis of a Phase 1/2 clinical trial of NVX-CoV2373 in Japan.

This placebo-controlled trial evaluated the immunogenicity and safety of NVX-CoV2373 in 200 participants aged 20 years and older.

Primary data analysis demonstrated acceptable safety results and induced robust immune responses.

Phase 1/2 Boosting Study – Led by National Institute of Allergy and Infectious Diseases

In March 2022, we announced participation in an ongoing Phase 1/2 trial sponsored by the National Institute of Allergy and Infectious Diseases to evaluate safety, reactogenicity, and immunogenicity of delayed heterologous or homologous boosting regimens in participants who received a primary series of a COVID-19 vaccine which has received full approval or EUA from FDA.

Participants will be given a third dose (greater than or equal to 12 weeks later) of either NVX-CoV2373 or one of three COVID-19 vaccines approved for use by the FDA.

The full results are expected in 2023.

Phase 3 United Arab Emirates

In March 2022, we announced participation in a Phase 3 study in the United Arab Emirates to evaluate the safety and immunogenicity of a single booster dose of NVX-CoV2373 in approximately 1,000 adults aged 18 or older who have already been immunized with Sinopharm’s inactive COVID-19 vaccine.

Data from the head-to-head comparison is expected in 2023.

Phase 2 Com-COV3 Booster Trial – Led by University of Oxford

In May 2022, we announced our participation in University of Oxford’s Phase 2 Com-COV3 vaccine trial where our COVID-19 vaccine, NVX-CoV2373 is one of two COVID-19 vaccines that are being studied as a third booster in approximately 380 adolescents aged 12 to 15 years.

Variant Strain-Containing Monovalent or Bivalent Vaccine Development

Our nanoparticle vaccine technology is purpose-built to rapidly address evolving infectious disease threats.

As variants of COVID-19 emerge, we proactively evaluate NVX-CoV2373’s ability to protect against variant strains and evaluate the potential need for variant-specific monovalent or bivalent vaccine constructs.

In January 2023, we participated in U.S.

FDA Vaccine and Related Biological Products Advisory Committee’s meeting, which resulted in a unanimous vote harmonizing vaccine strain composition of primary series and booster doses.

Within the meeting we shared data demonstrating NVX-CoV2373, when used as a booster induces broad functional immune responses, including against forward drift variants.

We intend to deliver an updated vaccine following FDA guidance on strain change.

COVID-19 Phase 3 Omicron Variant Strain Vaccine

In November 2022, we announced topline results from our Phase 3 boosting trial showing that our Omicron BA.1 vaccine candidate met the primary strain-change endpoint.

We expect to advance group 2 of our Phase 3 Omicron boosting trial as part of our variant strategy to be ready for the fall season.

Group 2 of the trial will build upon the first portion of our trial and will evaluate Omicron BA.5 vaccine in a monovalent and bivalent format in comparison to our monovalent prototype strain vaccine.

These data will support regulatory filing authorization of a strain change.

We expect to initiate part 2 of this study to evaluate our prototype vaccine compared to an Omicron BA.5 vaccine, as well as a bivalent containing prototype and Omicron BA.5 vaccine.

and Australia Homologous Booster Study – Including Variant Results

In August 2022, exploratory analysis results of our Phase 2 homologous booster study were published within The Lancet Infectious Diseases , which was a randomized study to assess a single booster of NVX-CoV2373 in 1,282 healthy adults aged 18 to 84 years.

Overall, a single booster dose of NVX-CoV2373 administered approximately 6 months after the primary

series induced substantial increases in humoral antibodies for both the prototype strain and all evaluated variants including Alpha, Delta, and Omicron (BA.1 and BA.2).

Additionally, immunogenicity data from a fourth homologous booster dose of NVX-CoV2373 was published as a letter in the New England Journal of Medicine in January 2023.

The study showed that a fourth dose of NVX-CoV2373 enhanced immunogenicity without increasing reactogenicity.

Antigenic cartography mapping demonstrated a broad response against contemporary SARS-CoV-2 variants after a fourth dose of NVX-CoV2373, indicating that updates to the vaccine composition may not be warranted for the evaluated variants.

Additional data are forthcoming.

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.

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.

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.

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.

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 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 have secured critical funding from the U.S.

government to support the development of NVX-CoV2373 for the U.S.

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.

5 unchanged sentences

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 NVX-CoV2373, and to manufacture and deliver to the U.S.

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.

4 unchanged sentences

government’s interest.

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

In July 2022, we entered into a modification to the USG Agreement that amended the terms of such agreement to provide for (i) an initial delivery to the U.S.

government of approximately 3 million doses of NVX-CoV2373 and (ii) any additional manufacture and delivery to the U.S.

government up to an aggregate of 100 million doses of NVX-CoV2373 contemplated by the original USG Agreement (inclusive of the initial batch of approximately 3 million doses) dependent on U.S.

government demand, FDA guidance on strain selection, agreement between the parties on the price of such doses, and available funding.

The 3 million initial doses were delivered in July 2022.

In February 2023, we entered into a modification to the USG Agreement that amended the terms of such agreement to provide for additional deliveries to the U.S.

government of up to 1.5 million doses of NVX-CoV2373.

The performance period under the Project Agreement extends through 2023 to cover clinical trial activities, subject to early termination by the U.S.

government or extension by mutual agreement of the parties.

Under the USG Agreement, we were originally entitled to receive funding of up to $1.75 billion to support certain activities related to the development of NVX-CoV2373 and the manufacture and delivery of the vaccine candidate to the U.S.

In subsequent modifications, the USG Agreement was amended to increase the contract funding and ceiling to $1.8 billion, which allows us to make expenditures or incur obligations of up to $1.8 billion for support of the USG Agreement.

Our funding agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”), under which CEPI has agreed to provide funding of up to $399.5 million to us to support the development of NVX-CoV2373, provides 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 in order to prepay certain manufacturing activities and are not subject to restrictive or financial covenants.

Payments received under the CEPI Forgivable Loan Funding are only repayable if NVX-CoV2373 manufactured by the contract manufacturing organization (“CMO”) network funded by CEPI is sold to one or more third parties (which would have previously included, but is not limited to, any sales under our Gavi APA prior to its termination), and such sales cover our costs of manufacturing such vaccine, not including manufacturing costs funded by CEPI.

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.

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Funding Partner Amount Additional Details

CEPI $399.5 million • Entitled to received up to $399.5 million of funding to support the development of NVX-CoV2373

• To supply NVX-CoV2373 through the COVAX Facility

Department of Defense (“DoD”) $45.7 million • Entitled to received up to $45.7 million of funding to support the development of NVX-CoV2373

• To manufacture and deliver up to 10 million doses of NVX-CoV2373 to the U.S.

• Contract term ended in December 2022

Government through USG Agreement $1.8 billion • Allotted $1.8 billion to support the development of NVX-CoV2373

• To manufacture and deliver up to 100 million doses of NVX-CoV2373 to the U.S.

Seasonal Influenza

Influenza Program (Older Adults)

Influenza is a world-wide infectious disease with serious illness generally occurring in more susceptible populations such as children and older adults, but also occurring in the general population.

According to a 2022 Fortune Business Insights research report forecast of influenza vaccines, the market for seasonal influenza vaccines is expected to grow from approximately $7.54 billion in 2022 to approximately $13.58 billion in 2029.

In October 2022 at the World Vaccine Congress in Europe, we reviewed key findings from the Phase 3 stand-alone qNIV candidate, previously referred to as NanoFlu, which met its primary immunogenicity endpoints.

The final analysis of these results was previously published in September 2021, in The Lancet Infectious Diseases .

The results demonstrated non-inferior immunogenicity to Fluzone® Quadrivalent against all four influenza virus strains included in the vaccine, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous strains (22-66% increased) and six heterologous A/H3N2 strains (34-46% increased) as compared to Fluzone® Quadrivalent.

Additionally, qNIV showed potent induction of polyfunctional antigen-specific CD4+ T-cells against A(H3N2) and B/Victoria strains, with a 126–189% increase in various post vaccination cell-mediated immunity markers as compared to Fluzone® Quadrivalent.

Combination Vaccines

Our Influenza Program team remains focused on advancing combination vaccine candidates.

With the ongoing development of Influenza Program, NVX-CoV2373, and our RSV Program, a strong rationale exists for developing combination respiratory vaccines designed to protect susceptible populations against these diseases.

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 December 2022, we initiated a Phase 2 trial for CIC, which includes study arms for our stand-alone updated qNIV vaccine candidate.

The dose-confirming trial will be conducted in two parts and will seek to enroll approximately 2,300 adults aged 50 to 80 years in Australia and New Zealand.

The trial is randomized, observer-blinded with primary and secondary objectives of the study to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates.

As of January 2023, we completed enrollment of 1,500 participants.

The initial results are expected mid-year 2023 with data informing the second part of the trial and future clinical development for both influenza stand-alone and CIC candidates.

Phase 1/2 Clinical Trial of COVID-19-Influenza Combination Vaccine

In October 2022 at the World Vaccine Congress in Europe, we announced additional positive results from Phase 1/2 CIC trial, which combines NVX-CoV2373 and our updated qNIV candidate.

The results demonstrated CIC’s ability to generate immune responses, including both antibody and polyfunctional CD4+ T-cell (lymphocytes that help coordinate the immune

response) responses against an evolving SARS-CoV-2 virus, along with homologous and heterologous influenza strains.

The CIC vaccine was well tolerated, and the safety and tolerability profile was consistent with the stand-alone NVX-CoV2373 prototype vaccine and quadrivalent influenza vaccine candidate reference formulations in the trial.

Respiratory Syncytial Virus (“RSV”)

Currently, there is no approved RSV vaccine available to combat the estimated 64 million RSV infections and 160 thousand deaths that occur globally each year.

Older adults (60 years and older) are at increased risk for RSV disease due in part to immunosenescence, the age-related decline in the human immune system.

RSV infection can also lead to exacerbation of underlying co-morbidities such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.

RSV Program (Older Adults)

Previous clinical development through a Phase 2 clinical trial demonstrated that our RSV Program for older adults with either aluminum phosphate or our proprietary Matrix-M TM adjuvant increased the magnitude, duration, and quality of the immune response versus the non-adjuvanted RSV F Vaccine.

We continue to assess the preclinical development opportunities for our updated RSV vaccine for older adults.

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

According to the 2022 WHO World Malaria Report, in 2021, there were an estimated 247 million malaria cases and 619 thousand deaths worldwide in 2021.

We believe malaria has the potential to be preventable through the R21 vaccine candidate, which is being developed through several partner-led trials and is formulated with our Matrix-M TM adjuvant.

R21 - Malaria Vaccine

R21 is a malaria vaccine candidate created by the Jenner Institute, University of Oxford, and formulated with our Matrix-M ™ adjuvant.

The University of Oxford has granted SIIPL a license for R21.

SIIPL has committed to manufacture at least 200 million doses per year of R21 after licensure, if granted.

Additionally, SIIPL has rights to use Matrix-M ™ adjuvant in R21 in regions where the disease is endemic and will pay royalties to us on its market sales of the vaccine.

We will have commercial rights to sell and distribute the SIIPL-manufactured R21 in certain countries, primarily in the travelers’ and military vaccine markets.

R21 Clinical Development

R21 is being evaluated in an ongoing Phase 3 trial being conducted by our partner, Jenner Institute, University of Oxford, for R21, a malaria candidate which is formulated using our Matrix-M™ adjuvant.

In September 2022, positive results from an ongoing Phase 1/2b study were published in The Lancet Infectious Diseases reporting safety, immunogenicity, and efficacy results at 12 months following administration of a booster vaccination in children aged 5 to 17 years in Nanoro, Burkina Faso.

A total of 409 children received a booster dose of R21 formulated with our Matrix-M™ adjuvant at 1 year following the primary three-dose regimen maintaining high efficacy against first and multiple episodes of clinical malaria, demonstrating 71% efficacy when formulated with 25 micrograms of Matrix-M™ adjuvant and 80% efficacy when formulated with 50 micrograms of Matrix-M™ adjuvant.

The trial is continuing for a further 2 years to assess long-term follow-up of the participants and the value of further booster vaccinations.

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.

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.

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

According to the 2023 WHO World Malaria Report, in 2022, there were an estimated 249 million malaria cases and 608,000 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.

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.

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

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

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

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

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

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

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

In December 2023, the WHO announced it prequalified the R21/Matrix-M™ adjuvant malaria vaccine to prevent malaria disease in children caused by the P.

falciparum parasite in endemic areas.

Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and will enable 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.

License and Collaboration

Our commitment to partnering globally in efforts to end the COVID-19 pandemic is demonstrated through our partnership with SIIPL to supply NVX-CoV2373 to India and low- and middle-income countries.

We have also partnered with both Takeda in Japan and SK bioscience in South Korea to expand our manufacturing and supply capabilities.

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.

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A summary of our license and collaboration agreements follows:

We previously granted exclusive and non-exclusive licenses to SIIPL under a supply and license agreement for the development, co-formulation, filling and finishing, registration, and commercialization of NVX-CoV2373.

SIIPL agreed to purchase our Matrix-M TM adjuvant and we granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of NVX-CoV2373 in SIIPL’s licensed territory solely for use in the manufacture of NVX-CoV2373.

We equally split the revenue from SIIPL's sale of NVX-CoV2373 in its licensed territory, net of agreed costs.

We granted to SIIPL (i) an exclusive license in India during the agreement, and (ii) a non-exclusive license (a) during the “Pandemic Period” (as declared by the World Health Organization), in all countries other than specified countries designated by the World Bank as upper-middle or high-income countries, with respect to which we retains rights, and (b) after the Pandemic Period, in only those countries designated as low or middle-income by the World Bank.

Following the Pandemic Period, we may notify SIIPL of any bona fide opportunities for us to license NVX-CoV2373 to a third party in such low- and middle-income countries and SIIPL would have an opportunity to match or improve such third-party terms, failing which, we would have the discretion to remove one or more non-exclusive countries from SIIPL’s license.

We also have a supply agreement with SIIPL and Serum Life Sciences Limited (“SLS”) under which SIIPL and SLS will supply us with NVX-CoV2373 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 May and August 2022, we expanded our license and supply arrangements with SIIPL to include our proprietary COVID-19 variant antigen candidate(s), our quadrivalent influenza vaccine candidate, and our CIC vaccine candidate, so that SIIPL can manufacture and commercialize a vaccine targeting COVID-19 variants, including the Omicron subvariants, a quadrivalent influenza vaccine, and CIC vaccine, and supply such vaccines to us.

In March 2020, we granted SIIPL a non-exclusive license for the use of Matrix-M™ adjuvant supplied by us to develop, manufacture, and commercialize R21, a malaria candidate developed by the Jenner Institute, University of Oxford.

We have a collaboration and license agreement with Takeda under which we granted Takeda an exclusive license to develop, manufacture, and commercialize NVX-CoV2373 in Japan.

Under the agreement, Takeda purchases Matrix-M™ adjuvant from us to manufacture doses of NVX-CoV2373 and we are entitled to receive 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 NVX-CoV2373.

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 NVX-CoV2373.

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

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

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.

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 NVX-CoV2373 for sale to the governments of South Korea, Thailand, and Vietnam.

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.

Additionally, we have a manufacturing supply arrangement with SK bioscience under which SK bioscience supplies the antigen component of NVX-CoV2373 to us for use in the final drug product globally, including product distributed by the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and

In July 2022, we signed an additional agreement with SK bioscience for the technology transfer of our proprietary COVID-19 variant antigen materials so that SK bioscience can manufacture the drug substance targeting COVID-19 variants, including the Omicron subvariants.

We also have an agreement with SK bioscience, pursuant to which it supplies us with our COVID-19 vaccine in a prefilled syringe.

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 NVX-CoV2373.

In 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 NVX-CoV2373.

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.

A summary of our key manufacturing and supply arrangements follows:

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We also have contract manufacturing arrangements with AGC Biologics and the Polypeptide Group to provide contract development and manufacturing services, supplying us with large-scale production of Matrix-M™ adjuvant.

Antigen Component of NVX-CoV2373

We manufacture the antigen component of NVX-CoV2373 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 NVX-CoV2373 and the co-formulation, fill, and finishing of the finished vaccine product.

Additionally, we have a manufacturing supply arrangement with SK bioscience under which SK bioscience supplies us with the antigen component of NVX-CoV2373 for use in the final drug product globally.

We have a partnership with FUJIFILM Diosynth Biotechnologies through an agreement for long-term commercial manufacturing of NVX-CoV2373, under which it manufactures the antigen component of NVX-CoV2373 at its Billingham, UK site.

We have an arrangement with the National Research Council of Canada (“NRCC”) for the ongoing technology transfer for the production of NVX-CoV2373 at the NRCC’s Biologics Manufacturing Centre.

Engineering runs are currently underway at the facility and, once complete, process performance qualification and large-scale GMP production can begin.

Finished NVX-CoV2373

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.

We currently depend exclusively on SIIPL and SLS for co-formulation, filling, and finishing NVX-CoV2373.

We also have an agreement with SK bioscience, pursuant to which it supplies us with our COVID-19 vaccine in a prefilled syringe.

Competition in COVID-19, Influenza, and RSV

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

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

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

We believe this baculovirus expression system with our nanoparticle configuration formulated with our Matrix-M™ adjuvant offers many advantages such as enabling dose-sparing effects and refrigerator temperature storage when compared to other technologies creating a best-in-class vaccine, and is uniquely well suited for developing COVID-19, influenza, and RSV vaccines, as well as vaccines against a number of other infectious diseases.

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

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.

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

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

According to a coronavirus vaccine tracker published by The New York Times , updated as of August 31, 2022, there are 33 vaccines approved for limited or full use and 123 vaccines in clinical trials.

Novavax is the first protein-based COVID-19 vaccine that received EUA by the FDA and a CMA by EMA in the European Union.

As of February 2023, Novavax is one of four manufacturers that have a COVID-19 vaccine that has received EUA by the FDA, with the other manufacturers being Pfizer, Moderna, and Johnson & Johnson.

As of February 2023, Pfizer and Moderna have received BLA approval by the FDA in the U.S.

for their monovalent COVID-19 vaccines and received EUA by the FDA in the U.S.

for their bivalent COVID-19 vaccines.

Novavax and Johnson & Johnson have received EUA by the FDA in the U.S.

for their monovalent vaccines.

Based on NVX-CoV2373’s 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 U.K.

and U.S., we believe our vaccine candidate will continue to play an important role in addressing this global public health crisis.

A number of companies are selling vaccines for seasonal influenza employing both traditional (egg-based) and new vaccine technologies (cell-based).

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® and Flublok® manufactured by Sanofi and Fluad® 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 and/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 3 and Phase 1/2 trial results, we believe that our Influenza Program, our adjuvanted nanoparticle seasonal influenza product, could be as efficacious as, or more so than, current products or products being developed by our competitors.

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.

As of February 2024, Novavax is one of three manufacturers that have a COVID-19 vaccine that has received authorization by the U.S.

FDA for the 2023-2024 vaccination season, with the other manufacturers being Pfizer and Moderna.

As of February 2024, the U.S.

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

FDA for our updated 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.

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

Following our Phase 1/2 trial results, we are currently in a Phase 2 trial for our CIC and influenza standalone vaccine candidates to evaluate the safety and effectiveness (immunogenicity) of different formulations in adults aged 50 through 80.

Other manufacturers, most notably Moderna and Pfizer, are in Phase 1/2 and Phase 1 clinical trials with COVID-19-influenza combination candidates.

There is currently no approved RSV vaccine for sale in the world;

however, a number of vaccine manufacturers, academic institutions, and other organizations currently have, or have had, programs to develop such a vaccine.

These groups are developing products to prevent disease caused by RSV using a variety of technology platforms, including viral vectors, nucleic acid (“RNA/DNA”), live attenuated chimeric, antigens or monoclonal antibodies (“Mab”), and competitive recombinant technologies.

We continue to believe that our updated RSV F Vaccine candidate, which is a recombinant F-protein nanoparticle, is likely to be as effective as other RSV vaccine candidates or other products in development by our competitors.

At this time, there are a number of companies and other organizations with vaccine candidates in late-stage clinical trials.

In older adults, GSK, Pfizer, and Moderna have announced data from their Phase 3 studies, with GSK and Pfizer completing regulatory submission to the FDA in the U.S.

with Prescription Drug User Fee Act (“PDUFA”) dates in May 2023 and Moderna planning regulatory submission to the FDA in the first half of 2023.

Janssen and Bavarian Nordic currently are in

Phase 3 trials.

In infants Pfizer announced Phase 3 data and completed regulatory submission to the FDA for their vaccine candidate via maternal immunization and have a PDUFA date in August 2023.

Additionally, in infants, AstraZeneca / Sanofi partnered monoclonal antibody is approved in Europe and has a PDUFA date with the FDA in the U.S.

in the third quarter of 2023, and Merck’s monoclonal antibody is in Phase 3 trials.

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

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jurisdictions.

We also have been issued patents directed to other core programs, including our RSV and influenza programs.

Issued patents directed to various aspects of the RSV program include U.S.

8,715,692, 9,675,685, 9,731,000, 9,717,786, 10,022,437, 10,426,829, and 11,253,585.

Additional patents in the family include EP237009 in Europe, as well as others throughout the world.

Patents related to our rabies program include 9,724,405 and 10,086,065 in the U.S., and EP2635257 and EP3246019 in Europe.

Related patents have been issued in other world markets.

Issued patents in our influenza nanoparticle program include US Patent Nos.

11,364,294 and 11,278,612.

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

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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).

We continue to prepare, file, and prosecute patent applications to provide broad and strong protection of our proprietary rights, including our RSV Program, our influenza nanoparticle program, our COVID-19 program, and our adjuvant program.

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.

The Federal Technology Transfer Act of 1986 and related statutory guidance encourages the dissemination of science and technology innovation.

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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.

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;

Health and Wellness

Our total rewards package is designed to attract, engage, motivate, and retain top talent.

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.

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

income protection through our short- and long-term disability programs and life insurance;

adoption assistance and paid parental leave programs;

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.

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.

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.

We believe that equity compensation has been, and will continue to be, a critical component of our compensation package because it develops a culture of ownership among our employees and aligns their interests with the interests of our stockholders.

Recruitment, Development, and Training

The attraction, development, and retention of employees is a critical factor for our success.

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

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

At Novavax, everyone is a leader and this model and associated tools, resources, and programs develops 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 addition, approximately 135 employees have participated in spot coaching.

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.

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.

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.

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.

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

• 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.

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”).

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

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

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

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

• 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.

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

• Standard operating procedures guide decision-making.

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

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

• Ongoing employee training for updated Safety Policy.

Government Regulations

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We focus on the U.S.

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

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

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

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

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

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

The process of obtaining FDA licensure for a new vaccine is costly and time-consuming.

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

The process of obtaining U.S.

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

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

Before applying for FDA licensure to market any new vaccine candidate, we expect to first submit an investigational new drug application (“IND”) that explains to the FDA, among other things, the results of preclinical toxicology testing conducted in laboratory animals, the method of manufacture, quality control tests for release, the stability of the investigational product, and our proposed plans for human testing.

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

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

Following successful completion of all three phases of clinical development, a BLA can be submitted to the FDA requesting licensure of the vaccine for marketing based on the vaccine’s safety and efficacy.

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

At this stage, the U.S.

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

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

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

Similar pathways exist in Europe and other geographies.

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

During the FDA’s review of a BLA, the proposed manufacturing facility undergoes a pre-approval inspection during which the FDA examines in detail the production of the vaccine, the manufacturing facility, and the quality documentation related to the vaccine.

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

During the U.S.

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

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

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

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

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

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

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

Thus, the U.S.

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

The Commissioner of the U.S.

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

When issuing an EUA, the U.S.

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

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

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

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

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

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

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

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

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

Therefore, although the Biden Administration has announced that it intends for the COVID-19 PHE, first declared in February 2020, to expire on May 11, 2023, that expiration will not terminate EUAs issued by the FDA.

In order to ensure continuing safety, the FDA and most other non-U.S.

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

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

FDA and most other non-U.S.

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

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

In addition to obtaining FDA licensure for each product, each domestic manufacturing establishment must be registered with the FDA, is subject to FDA inspection, and must comply with current Good Manufacturing Practices (“GMP”) regulations.

In addition to obtaining U.S.

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

FDA, is subject to U.S.

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

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

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

and foreign manufacturing establishments, including third-party facilities, must comply with GMP regulations and are subject to periodic inspection by the FDA or by corresponding regulatory agencies in their home country.

The EU and the U.K.

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 marketing authorization will eventually become unconditional.

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

FDA or by corresponding regulatory agencies in their home country.

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

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

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.

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

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

For Fast Track products, sponsors may have more frequent interactions with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete.

The FDA granted Fast Track Designation for NVX-CoV2373 in November 2020 and for NanoFlu, our recombinant quadrivalent seasonal influenza vaccine candidate, in January 2020.

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

First, the U.S.

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

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

FDA and the U.S.

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

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

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.

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

FDA may hold meetings with the sponsor throughout the development process, provide timely advice to

the product sponsor regarding development and approval, involve more senior staff in the review process, assign a cross-disciplinary project lead for the review team, and take other steps to design the clinical trials in an efficient manner.

Third, the U.S.

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

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

A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and, for a drug product (including a vaccine), to shorten the FDA’s goal for taking action on a marketing application from ten months to six months.

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

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

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

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

As a condition of approval, the 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 FDA acknowledged that the accelerated approval pathway is available for NanoFlu.

As a condition of approval, the U.S.

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

In 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.

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

FDA licensure does not guarantee approval by other regulatory authorities.

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

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

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

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

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

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We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of our products.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the indications for which the product is approved by the FDA or similar regulatory authorities outside the United States.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the indications for which the product is approved by the U.S.

FDA or similar regulatory authorities outside the United States.

Our product candidates may not be considered cost-effective at certain prices.

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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.

For example, in March 2010, the U.S.

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

Under the Trump administration, there were several efforts to modify or repeal all or certain provisions of the Healthcare Reform Act, and some modifications were implemented.

In March 2010, the U.S.

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

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

Adoption of price controls and cost-containment measures and adoption of more restrictive policies in jurisdictions with existing controls and measures could further limit our net revenue and results.

Other legislative changes have been proposed and adopted in the United States since the Healthcare Reform Act was enacted.

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 due to subsequent legislative amendments contained in the Coronavirus Aid, Relief, and Economic Security Act, commonly referred to as the “CARES Act.” In November 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued an interim final rule that seeks to lower prescription drug costs by paying no more for certain Medicare Part B drugs than the lowest price paid for such drugs in certain other countries (the “Most Favored Nation Rule”).

Under the rule, the lower payment rates for affected drugs would be phased in over a period of four years, beginning in 2021.

The rule has been challenged by industry associations on a number of grounds.

On December 28, 2020, the U.S.

District Court for the Northern District of California issued a nationwide preliminary injunction in Biotechnology Innovation Organization v.

3:20-cv-08603, which preliminarily enjoins CMS from implementing the Most Favored Nation Rule.

Given this preliminary injunction, the Most Favored Nation Rule was not implemented on January 1, 2021 and will not be implemented without further rule-making.

However, this interim final rule or any similar type of reference pricing regulation could potentially harm our business if expanded to include our products.

Recently, there has been considerable public and government scrutiny in the U.S.

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

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.

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

of pharmaceutical pricing and proposals to address the perceived high cost of pharmaceuticals.

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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.

Effective January 1, 2022, in advance of the calendar year 2022 Part D plan year, safe harbor protection will be eliminated for manufacturer rebates paid directly (or indirectly through a pharmacy benefit manager) to Part D prescription drug plans and Medicare Advantage prescription drug plans.

Effective December 30, 2020, the Rebate Rule established two new safe harbors.

The first new safe harbor protects price reductions paid by manufacturers to prescription drug plans (including prescription drug plans offered by Medicare Advantage organizations) and Medicaid managed care organizations, which are fully reflected at the point-of-sale.

The second new safe harbor protects fair-market-value service fees paid to pharmacy benefit managers by manufacturers.

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 changes may impact our business and operations if our products are commercialized in the U.S.

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

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

manufactures for preferred formulary placement.

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

Within the European Union and the United Kingdom, the provision of benefits or advantages to physicians 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 U.K.

Bribery Act 2010.

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.

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

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

While pharmaceutical

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

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

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

There has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers.

The Physician Payments Sunshine Act imposes annual reporting requirements on certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, for payments made by them to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Beginning in 2022, applicable manufacturers will also be required to report information related to payments and other transfers of value provided in the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.

There also are U.S.

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

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

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

Within the European Union and the United Kingdom, payments made to physicians must be publicly disclosed.

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

government under the Defense Production Act of 1950, as amended, which could directly or indirectly have the effect of diminishing some of our rights or opportunities with respect to NVX-CoV2373 and the economic value of a COVID-19 vaccine to us could be limited.

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

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

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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 October 1, 2024, unless it is renewed.

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

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

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

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

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

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

Human Capital

As of February 21, 2023, we have 1,992 full-time employees, of whom approximately 9% hold M.D.

degrees and approximately 21% hold other advanced degrees.

Of our total workforce, approximately 63% of employees are engaged primarily in research, development, and manufacturing activities and approximately 37% of employees are engaged primarily in executive, business development, commercial, finance and accounting, legal, and administrative functions.

Except for certain employees located in Sweden, 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 been recognized in the 2021 Top Workplaces USA list based on employee surveys.

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

Employee Safety and Well-Being

Employee safety is our highest priority.

As we moved through the pandemic in 2022, we continued to encourage employees who were able to work from home to do so.

We have continued to follow all CDC guidelines related to COVID-19 safety.

In addition, we implemented our Ways of Working guidelines, which allow employees the flexibility to work remotely either full time or in a hybrid manner to provide employees with continued flexibility based on business needs.

We provide employees with updated information on COVID-19 through our COVID-19 Resources page on our intranet.

This resource provides employees with information on COVID-19 safety, both inside and outside of the workplace.

Resources on this site include our COVID-19 Protocols and Guide, our policies on face coverings and social distancing, a list of infection control measures, and mental wellness support resources.

Our 700 Quince Orchard office space located in Gaithersburg, Maryland received WELL Platinum certification in 2022.

WELL is the leading tool for advancing health and well-being in buildings globally.

As one of 35 WELL certified buildings in North America, this building will meet rigorous standards for materials selection, indoor air quality, and acoustics.

In addition, our operations and policies contribute to earning high marks in all of the 10 WELL Concepts:

Air, Water, Nourishment, Light, Movement, Thermal Comfort, Sound, Materials, Mind, and Community.

Compensation and Benefits;

Health and Wellness

Our total rewards package is designed to attract, engage, motivate, and retain top talent.

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

Our generous total rewards package includes competitive market pay and comprehensive benefits, including insurance to protect and maintain health;

income protection through our short- and long-term disability programs;

adoption assistance and paid parental leave programs;

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.

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

To assist employees with work/life balance, we offer a concierge service that helps employees with managing various personal tasks including finding and booking auto services;

sourcing pet sitters and boarders;

researching online and in-person tutors;

suggesting community events;

providing vacation ideas;

finding and booking home cleaners, plumbers, HVAC, and

landscaping services;

finding and booking yoga, personal training sessions, and spin classes;

suggesting nutritional meals and recipes;

and researching day care center availability and ratings.

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

Recruitment, Development, and Training

The attraction, development, and retention of employees is a critical factor for our success.

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

In 2022, we held an Early Career Summit to engage, retain, and develop over 150 employees and college interns.

The Summit provided a forum for this group to network, build relationships, and learn from Novavax leaders and one another.

In the last 12 months, videos were viewed and completed over 50,000 times by our employees.

In addition, approximately 200 employees have participated in spot coaching.

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.

The 2023 Executive Development Program includes a diverse and global group of 34 employees.

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.

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.

We recently completed an evidence-based analysis of our current DEI state, resulting in a multi-year roadmap and strategy that will enable our mission, our people, and our best work.

It is designed around three pillars:

• Embed DEI into our people 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 started implementing our roadmap in 2022 and are making progress.

We hired a DEI and Employee Engagement Manager who will facilitate and help focus our actions to build an inclusive workforce.

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

The second annual Novavax Women’s Leadership Forum was held and resulted in building networks, developing skills, sharing voices and ideas, and becoming agents of positive change for nearly 300 Novavax women.

In 2022, 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.

Environmental, Social, and Governance

In addition to the DEI and human capital initiatives described above, we have several other Environmental, Social, and Governance (“ESG”) related initiatives that are underway.

These initiatives are centered around four focus areas including environmental sustainability, innovating for vaccine access and improving global health, empowering our employees, and governing responsibility.

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 (“GHG”) reduction strategy with tracking and reporting GHG emissions

• Procurement approach that incorporates sustainability metrics into vendor evaluation rubrics

• Lease of approximately 170,000 square foot property in Gaithersburg, Maryland at 700 Quince Orchard Road that is designed with carbon-conscious initiatives in place such as a net zero parking structure

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

• Award of WELL certifications at multiple leased facilities

• Sustainable saponin sourcing with our partner Desert King, who is the key supplier of the Q uillaja saponaria (Soapbark) tree found native to central Chile, used to produce our Matrix-M™ adjuvant

Innovating for Vaccine Access and Improving Global Health

• R21 malaria vaccine candidate, developed by the Jenner Institute, University of Oxford, and formulated with our Matrix-M™ adjuvant

• Vaccine access through community partnerships such as collaboration with representatives from Hip Hop Public Health, Anthem, and the CDC Foundation to host a discussion entitled “The Last Mile:

Coming Together to Make Vaccines Make a Difference” at Aspen Ideas:

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

• Efforts focused on clinical trial diversity

Empowering our Employees

• Introduced an employee donation matching program to elevate Novavax’ charitable contributions, collaborated with local community groups (Montgomery Country Community College, Fairfax Country SkillSource Center), and supported local non-profits

• Introduced a program to help build community and establish corporate values, and provide tuition and education reimbursement, access to professional coaching, and Executive Development programming for high-potential employees

Governing Responsibly

• In 2021, we hired a Head of Global Quality Assurance and Quality Control to focus on building quality control and functions of global technical quality, clinical quality, control systems, and compliance operations

• Policy 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”)

• Hired a Chief Compliance Officer and published “The NovaCode,” a robust handbook of written standards and business ethics policies

• Global hotline for reporting compliance concerns with established internal investigating protocols

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

• Company-wide business ethics training, guidance, and raw materials review

• Standard operating procedures drafted to guide decision-making

• Robust cybersecurity standards, meeting elevated government contracting requirements

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

• Ongoing employee training for updated Safety Policy and Standards

Availability of Information

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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.

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

What changed 10-K

Item 1. Business