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Item 1. Business

2023-02-28 compared with 2022-03-01 · 417 added, 380 removed, 311 unchanged (72% of the section changed)

Novavax, Inc., together with our wholly-owned subsidiaries, Novavax AB and Novavax CZ, is a biotechnology company that promotes improved health globally 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 nanoparticles designed to address urgent global health needs.

The vaccine candidates in our near-term pipeline, including both our coronavirus vaccine candidate (“NVX-CoV2373”) and our seasonal quadrivalent influenza vaccine candidate (“NanoFlu”), are genetically engineered, three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis.

NVX-CoV2373 has received provisional approval, conditional marketing authorization (“CMA”) and emergency use authorization (“EUA”) from multiple regulatory authorities globally.

In January 2022, we also submitted a request to the U.S.

Food and Drug Administration (“FDA”) for EUA of NVX-CoV2373.

We also advanced our NanoFlu Program vaccine program through a Phase 3 clinical trial, which demonstrated positive top-line results and achieved statistical significance in key secondary endpoints.

Additionally, we are exploring a number of combination vaccine candidates including a COVID-Influenza combination vaccine currently in a Phase 1/2 clinical trial.

We believe that our protein-subunit-based candidates elicit differentiated immune responses that may be more efficacious than naturally occurring immunity or other vaccine approaches.

These vaccine candidates incorporate our proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate higher levels of neutralizing antibodies.

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.

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.

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

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

NVX-CoV2373 Regulatory and Licensure

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

We have received several authorizations, which collectively have the potential to reach over six billion individuals, and we have completed additional regulatory submissions in other major markets.

We are in active discussions with regulatory authorities and remain focused on seeking additional authorizations for NVX-CoV2373.

We continue to work closely with governments, regulatory authorities, and non-governmental organizations in our commitment to facilitating 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 name of Covovax™ (manufacturing and commercialization by the Serum Institute of India Pvt.

(“SIIPL”)) or as Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]).

Through the date of filing this Annual Report on Form 10-K, the below is a summary of regulatory authorizations for NVX-CoV2373, the first protein-based COVID-19 vaccine to be approved for commercial use based on Phase 3 data:

(1) Regulatory approval received in partnership with SIIPL

In February 2022, in partnership with SIIPL, the Directorate General of Drug Administration granted EUA for NVX-CoV2373 in Bangladesh, in individuals aged 18 years and older, which will be manufactured and marketed in India by SIIPL under the brand name Covovax TM .

Within the same month, Health Canada granted authorization for NVX-CoV2373 in individuals aged 18 years and older, to be marketed under Nuvaxovid™.

The Singapore Health Authority also issued interim authorization for NVX-CoV2373 in individuals aged 18 years and older, to be marketed under Nuvaxovid™.

New Zealand’s Medsafe granted provisional approval for NVX-CoV2373 in individuals aged 18 years and older, to be supplied to New Zealand under the brand name Nuvaxovid™.

Additionally, in February 2022, the Medicines and Healthcare products Regulatory Agency (“MHRA”) in Great Britain granted CMA for NVX-CoV2373 in individuals aged 18 years and older, to be authorized for use in Great Britain marketed under the brand name Nuvaxovid™.

In January 2022, the Australia’s Therapeutic Goods Administration (“TGA”) granted provisional registration for NVX-CoV2373 in individuals aged 18 years and older, to be supplied to Australia under the brand name Nuvaxovid™.

Additionally, in January 2022, South Korea’s Ministry of Food and Drug Safety approved a Biologics License Application (“BLA”) from SK bioscience for Nuvaxovid TM , to be manufactured and marketed in the country by SK bioscience.

In December 2021, the Ministry of Health Prevention granted EUA for NVX-CoV2373 in the United Arab Emirates (“UAE”) in individuals aged 18 years and older under the brand name Nuvaxovid™.

Additionally, in December 2021, in partnership with SIIPL, the Drugs Controller General of India granted EUA for NVX-CoV2373 in individuals aged 18 years and older, which will be manufactured and marketed in India by SIIPL under the brand name Covovax TM .

In the same month, the World Health Organization (“WHO”) granted EUL for NVX-CoV2373 to be manufactured and marketed by SIIPL as Covovax TM .

The WHO then granted a second EUL for NVX-CoV2373 to be marketed by us as Nuvaxovid TM in Europe and other markets.

This second EUL by the WHO followed the recommendation of the WHO Strategic Advisory Group of Experts on Immunization (“SAGE”) for a primary two-dose vaccination series of NVX-CoV2373 in persons aged 18 years and older and a third dose of NVX-CoV2373 administered to immunocompromised persons.

Within the same month, the European Commission (“EC”) granted CMA for Nuvaxovid TM , in individuals aged 18 years and older, which prequalifies NVX-CoV2373 as meeting WHO standards for quality, safety and efficacy.

The authorization follows the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use recommendation to authorize the vaccine and is applicable in all 27 European Union (E.U.) member states.

In November 2021, in partnership with SIIPL, we received EUA in individuals aged 18 years and older from the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Pengawas Obat dan Makanan.

NVX-CoV2373 will be manufactured in India and marketed in Indonesia by SIIPL under the brand name Covovax TM .

Additionally, in November 2021, in partnership with SIIPL, the Philippine Food and Drug Administration granted EUA for NVX-CoV2373 in individuals aged 18 years and older to be manufactured in India and marketed in the Philippines by SIIPL under the brand name Covovax TM .

Below is a summary and status of our regulatory submissions completed through the date of filing this Annual Report on Form 10-K.

(1) Regulatory filing submitted in partnership with SIIPL

(2) Regulatory filing submitted in partnership with Takeda Pharmaceutical Company Limited (“Takeda”)

In February 2022, we completed submission to Swissmedic, the Swiss Agency for Therapeutic Products for CMA for NVX-CoV2373.

In January 2022, we completed submission to the FDA for EUA for NVX-CoV2373.

This submission follows the December 2021 submission of the final data package including the complete chemistry, manufacturing, and controls module, to the U.S.

In January 2022, in partnership with SIIPL, we completed submission to the South African Health Products Regulatory Agency for EUA of NVX-CoV2373.

If authorized, NVX-CoV2373 will be manufactured by and commercialized by SIIPL in South Africa under the brand name Covovax™.

In December 2021, our partner Takeda completed submission of a New Drug Application to the Ministry of Healthy, Labour and Welfare (“MHLW”) in Japan for NVX-CoV2373.

With the support of the MHLW, the companies are working to establish the capability to manufacture TAK-019 at Takeda's facilities in Japan and aim to begin distribution in early 2022, pending regulatory approval.

Product Pipeline

(1) Supported by funding from the U.S.

government partnership formerly known as Operation Warp Speed (“OWS”), U.S.

Department of Defense (“DoD”), Coalition for Epidemic Preparedness Innovations (“CEPI”), and Bill & Melinda Gates Foundation (“BMGF”).

(2) Authorized for provisional approval, CMA or EUA in select geographies under trade names Covovax TM and Nuvaxovid TM .

Request submitted to the FDA for EUA.

PREVENT-19, a Phase 3 clinical trial in the U.S.

Ongoing PREVENT-19 pediatric expansion in the U.S.;

Phase 3 clinical trial in the United Kingdom (“UK”);

Ongoing Phase 2b clinical trial in South Africa.

We, along with our partners, will have commercial rights in authorized geographies to sell and distribute NVX-CoV2373.

(3) Reflects malaria vaccine candidate (“R21”) created by the University of Oxford and formulated with Matrix-M ™ adjuvant;

Ongoing Phase 3 clinical trial in Africa;

R21 is licensed to SIIPL;

we will have commercial rights to sell and distribute R21 in certain countries, primarily in travelers' and military vaccine markets.

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

Our recombinant nanoparticle vaccines combine the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic vaccines that target a variety of viral pathogens.

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

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

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

We believe our vaccine technology is well-suited for the development of additional vaccine candidates targeting a broad scope of respiratory and other emerging infectious diseases.

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

Matrix-M™ Adjuvant

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

This adjuvant has demonstrated potent and well-tolerated efficacy by stimulating the entry of antigen presenting cells (“APCs”) into the injection site and enhancing antigen presentation in local lymph nodes, which in turn activates APC cells, T-cells, and B-cell populations, thereby boosting immune response.

Matrix-M™ adjuvant has been shown to produce a long-lasting memory response, through the production of plasma cells, memory B-cells, high affinity antibodies, and CD4+ T-cells.

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.

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

Matrix-M™ 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 SIIPL for commercial development of R21 and has granted SIIPL a license for R21.

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 clinical trials led by National Institutes of Health teams, focused on Epstein-Barr virus and Malaria transmission blocking.

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.

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.

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.

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 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.

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 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 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.

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.

Pipeline Overview

Our development pipeline encompasses vaccine candidates spanning multiple therapeutic areas, with our COVID-19 vaccine candidate, NVX-CoV2373, as the leading product candidate, which has received provisional registration, CMA, or EUA in a number of jurisdictions.

We have also submitted a request to the FDA for EUA of NVX-CoV2373.

Beyond COVID-19, our pipeline includes programs for seasonal influenza, a combination vaccine consisting of NanoFlu and NVX-CoV2373, RSV, and Matrix-M TM adjuvant collaborations for the treatment of malaria.

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 of concern (“VoC”), while maintaining a favorable safety profile.

We also advanced our NanoFlu Program through a Phase 3 clinical trial, which demonstrated positive top-line results and achieved statistical significance in key secondary endpoints.

We initiated a trial of a combination vaccine consisting of our NanoFlu Program and NVX-CoV2373 and remain interested in further development of our RSV Program for respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”).

Ongoing Phase 3 trials are being conducted for R21, a malaria candidate, by our partners, Jenner Institute, University of Oxford, which is formulated with our Matrix-M ™ adjuvant.

We remain focused on bringing our NVX-CoV2373 vaccine candidate to market following global regulatory authorizations.

Through ongoing booster studies in our clinical trials, as well as the development of COVID-19 variant strain vaccine candidates, we continue to collect data to characterize and improve vaccine performance.

We expect to leverage these clinical insights to advance the use and additional regulatory approvals of our COVID-19 vaccine for both primary

vaccination around the globe, to use within a booster setting, and for the pediatric population amidst the ongoing and evolving COVID-19 pandemic.

Although NVX-CoV2373 and our NanoFlu Program are our near-term priorities, we remain optimistic that the additional programs in our pipeline, including our RSV Program, and our partner-led malaria candidate, present strong opportunities for future development.

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.

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 two Phase 3 trials, one Phase 2b trial, and one Phase 1/2 trial.

We have completed crossover arms in our Phase 3 UK, Phase 2b South Africa, PREVENT-19 Phase 3 U.S.

and Mexico, and PREVENT-19 pediatric expansion trials.

Through our clinical development program to date, we have established a dose of 5 micrograms of NVX-CoV2373 with Matrix-M ™ adjuvant for late-stage development.

We have collected data that indicates a reassuring safety profile and statistically significant levels of efficacy for NVX-CoV2373 against the original COVID-19 strain and commonly circulating VOC.

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:

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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.

Enrollment for PREVENT-19 emphasized recruiting high-risk groups most impacted by COVID-19.

In December 2021, the full results from the PREVENT-19 Phase 3 trial in the U.S.

and Mexico were published in The New England Journal of Medicine .

The analysis, previously announced in June 2021, was conducted on events accrued prior to participants receiving crossover vaccine.

NVX-CoV2373 achieved 100% protection against moderate and severe disease, 92.6% efficacy against any VOC and variants of interest (“VOI”), and the primary endpoint of 90.4% efficacy against COVID-19 of any severity during the time period evaluated, despite the majority (79%) of the sequenced cases of illness being attributed to VOC and VOI.

PREVENT-19 was conducted with support and funding from OWS.

In November 2021, the U.S.

Centers for Disease Control and Prevention (“CDC”) provided guidance stating that our PREVENT-19 participants from sites outside the U.S., as well as previously stated guidance stating participants from within the U.S., are considered fully vaccinated.

In January 2022, we also submitted a request to the FDA for EUA of NVX-CoV2373.

PREVENT-19 Pediatric Expansion

In February 2022, we announced positive results from our Phase 3 PREVENT-19 pediatric expansion in adolescents aged 12 to 17, for which we completed enrollment in June 2021.

The study results achieved their primary effectiveness endpoint and demonstrated 80% efficacy overall, with 82% clinical efficacy against the Delta (B.1.617.2) variant, as the trial was conducted when the Delta (B.1.617.2) variant was the predominant circulating strain 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.

The study enrolled 2,247 adolescents across 73 sites in the U.S.

to evaluate safety, effectiveness (immunogenicity), and efficacy, 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.

Two-thirds of participants received intramuscular injections of the vaccine and one-third received placebo.

Participants are being monitored for safety for up to two years following the final administered dose.

We expect to submit our regulatory filing to global regulatory authorities during the first quarter of 2022.

The subsequent pediatric clinical development plan has been agreed to by the FDA, the MHRA, and EMA and we expect to initiate additional studies globally evaluating younger age groups during the second quarter of 2022.

In December 2021, we announced initial data evaluating the immune response of NVX-CoV2373 against the Omicron (B.1.1.529) variant strain from our ongoing PREVENT-19 pediatric expansion.

Data from this study showed immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern.

In February 2022, we announced extended analysis from our pivotal Phase 3 UK 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, as measured by PCR+ or anti-N seroconversion.

NVX-CoV2373 showed a reassuring safety profile during over the 6-month period, with adverse events that were balanced between vaccine and placebo groups.

Additionally, the trial demonstrated continued protection with an overall vaccine efficacy of 82.7% and vaccine efficacy against severe disease was 100% during the 6-month efficacy collection window, in line with the initial analysis.

This data builds upon the final analysis of our Phase 3 UK trial was published in The New England Journal of Medicine in June 2021.

The publication of the final analysis highlights the robust safety and efficacy data for NVX-CoV2373.

The final analysis confirmed 89.7% overall efficacy, with over 60% of the cases caused by the Alpha (B.1.1.7) variant strain.

The analysis also confirmed 96.4% efficacy against non-Alpha (non-B.1.1.7) variant strains present at the time of the study, which represents strains most similar to the original COVID-19 virus.

The trial was a randomized, observer-blinded, placebo-controlled study that enrolled 15,203 adults aged 18 to 84.

The trial was conducted in partnership with the UK government Vaccines Taskforce (“VTF”) and led by researchers at St George’s, University of London, and St George’s Hospital, London.

In June 2021, the National Health Service (“NHS”), UK government VTF, and National Institute for Health Research determined participants in our Phase 3 UK trial may be considered fully vaccinated under the standard NHS program.

Phase 3 UK Influenza Co-Administration Sub-Study

In November 2021, positive results from our Phase 3 UK influenza co-administration sub-study, the first co-administration study of a SARS-CoV2 vaccine candidate and an approved influenza vaccine were published in The Lancet Respiratory Medicine .

In the sub-study, with initial data announced in June 2021, 431 participants from our Phase 3 UK trial received an approved seasonal influenza vaccine (Seqirus, adjuvanted, trivalent seasonal influenza vaccine or a cell-based quadrivalent seasonal influenza vaccine).

Approximately half of the participants in the study were co-vaccinated with NVX-CoV2373, while the remainder received placebo.

Results demonstrated a robust immune response and a favorable safety and reactogenicity profile.

Immunogenicity of the influenza vaccine was preserved with concomitant administration, while a modest decrease in the immunogenicity of NVX-CoV2373 was found.

There was an adequate number of participants aged 18 to 64 years to confirm an efficacy trend of 87.5% against COVID-19.

The co-administration sub-study represents the first study of a SARS-CoV-2 vaccine candidate and an approved influenza vaccine, and was led by researchers at St George’s, University of London and St George’s Hospital, London.

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 2021, results from the initial primary analysis of our Phase 2b South Africa trial were published in The New England Journal of Medicine .

The publication of the initial primary analysis, which was previously announced in January 2021, highlights NVX-CoV2373’s cross-protection against the Beta (B.1.351) variant strain prevalent in South Africa during the study.

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.

Half of the trial participants received two intramuscular injections of NVX-CoV2373, administered 21 days apart, while the other half of the trial participants received placebo.

In the complete analysis announced in March 2021, NVX-CoV2373 demonstrated 55.4% efficacy for the prevention of mild, moderate, and severe COVID-19 disease in the 95% of the trial population that was HIV-negative.

Overall efficacy, including both HIV-positive and HIV-negative participants, was 48.6% predominantly against the Beta (B.1.351) variant strain, with the complete analysis showing that NVX-CoV2373 achieved its primary efficacy endpoint in the overall trial population.

During the efficacy analysis, the Beta (B.1.351) variant strain circulating in South Africa accounted for approximately 93% of sequenced cases in our Phase 2b trial.

There were no cases of severe disease in the NVX-CoV2373 group, and all hospitalization and death occurred in the placebo group.

This trial also showed that the vaccine is well-tolerated, with low levels of serious adverse events, or SAEs, through day 35, balanced between vaccine and placebo groups.

CEPI funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial, which was also supported in part by a $15.0 million grant from BMGF.

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

SIIPL has expanded their Phase 2/3 clinical trial of NVX-CoV2373 in India to include a pediatric cohort.

In the pediatric cohort, SIIPL has initiated recruitment of participants aged 2-17 years, with the intention of completing enrollment of 920 total participants.

Previously, in April 2021, SIIPL completed enrollment of approximately 1,600 participants aged 18 years and older in their initial cohort.

This study, which was initiated in March 2021, will evaluate the safety and immune response of NVX-CoV2373.

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 March 2021, Takeda completed enrollment of a Phase 1/2 clinical trial of NVX-CoV2373 in Japan.

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

The interim clinical study report has been completed with the safety and immunogenicity data needed to support the Japan Pharmaceuticals and Medical Device Agency application.

Participants are currently in their twelve-month safety follow-up.

Variant Strain (Monovalent and/or Bivalent) Vaccine Development

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 vaccine constructs.

COVID-19 Omicron (B.1.1.529) Variant Strain Vaccine

In December 2021, we began development of an Omicron-specific vaccine construct of the SARS-CoV-2 Spike protein (rS) antigen, currently in use in NVX-CoV2373, and initiated GMP manufacturing.

We expect delivery towards the end of the first quarter of 2022.

NVX-CoV2373 Booster Studies

PREVENT-19 Booster Study

In December 2021, we initiated PREVENT-19 Phase 3 trial booster study for NVX-CoV2373.

The study will evaluate the safety the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373.

All the PREVENT-19 trial participants are eligible to receive a third booster dose.

The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant Spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least six months after receipt of active vaccine.

The primary endpoint is the first occurrence of polymerase chain reaction (PCR)-confirmed mild, moderate or severe COVID-19 with onset at least seven days after the third (booster) vaccine dose.

Two additional groups will be evaluated in this portion of the trial.

Trial participants who initially received placebo and subsequently received a different COVID-19 vaccine are also eligible for a booster dose of NVX-CoV2373.

Participants who were unblinded after initially receiving active vaccine and did not subsequently receive another vaccine will also be eligible to be boosted with NVX-CoV2373.

and Australia Booster Study - Including Omicron (B.1.1.529) Variant Results

In December 2021, we announced initial data evaluating the immune response of NVX-CoV2373 against the Omicron (B.1.1.529) variant strain as well as additional data from our ongoing Phase 2 booster study.

These results demonstrated broad cross-reactivity against the Omicron variant and other circulating variants for primary 2-dose regimen, with enhanced responses following a third dose at six months.

The third dose produced increased immune responses to the Omicron (B.1.1.529) variant strain comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold increase in hACE2 inhibition increase after booster dose.

Data from this study are available ahead of publication via the preprint server for biology on medRxiv.

In September 2021, we initiated a twelve-month booster dose for select participants in the Phase 2 portion of our U.S.

and Australia Phase 1/2 trial.

Select participants received a fourth 5 microgram dose at twelve months to examine the immune responses produced by our vaccine candidate.

In August 2021, we announced data from our six-month booster study in the Phase 2 portion of our U.S.

and Australia Phase 1/2 trial, which we initiated in March 2021.

Select participants in the 5 microgram dose cohort received a third 5 microgram dose (booster dose) at six months to examine the immune responses of our vaccine candidate.

Analysis of sera from primary vaccination series notably showed cross-reactive, functional antibodies to Alpha (B.1.1.7), Beta (B.1.351) and Delta (B.1.617.2) variant spike proteins, all of which increased 6- to 10-fold with the booster dose.

Partner-Led Vaccine Mix and Match Clinical Study

Mix-and-Match COVID-19 Vaccine Booster Trial ("Cov-Boost") – Led by University Hospital Southampton NHS

In December 2021, the UK government VTF announced top-line data from the heterologous boosting, Phase 2 Cov-Boost study published in The Lancet from the University Hospital Southampton NHS Foundation Trust.

NVX-CoV2373 was one of seven COVID-19 vaccines studied for the potential to provide a booster dose from a different manufacturer for individuals who previously received two doses of an authorized vaccine.

The results demonstrated that administration of NVX-CoV2373 among other studied COVID-19 vaccines, resulted in substantial increases in functional antibody titers when given as a third dose in two heterologous vaccination regiments.

This study reinforces our confidence in the potential for NVX-CoV2373 to serve as a well-tolerated third dose to boost immune levels and provide broad protection against disease without a burdensome side effect profile.

The trial, which was initiated in June 2021, completed enrollment in July of 2,886 participants aged 30 years and older.

NVX-CoV2373 is one of seven COVID-19 vaccines evaluating the potential for providing a booster dose from different manufacturers to individuals who have previously received two doses of an authorized vaccine.

The trial assesses the safety and immune response against COVID-19 provided by the various vaccine schedules.

The trial is led by the University Hospital Southampton NHS Foundation Trust and other UK National Institute for Health Research sites.

Cov-Boost is receiving support from the UK government VTF and Department of Health and Social Care.

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.

COVID-19 Vaccine Funding

We have secured critical funding to support the development of NVX-CoV2373.

Through the date of filing this Annual Report on Form 10-K, funding for NVX-CoV2373 encompasses over $2 billion from sources including CEPI, DoD, and OWS.

In April 2021, our Base Agreement and a Project Agreement (together, as amended and supplemented, the “OWS Agreement”) entered into with Advanced Technology International, Inc., the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with OWS, was amended to fully fund the agreement up to $1.75 billion to support certain activities related to the development of NVX-CoV2373.

This includes the manufacture and delivery of 100 million doses of NVX-CoV2373 to the U.S.

We expect this funding will assist in rapidly developing our large-scale manufacturing capacity and transitioning into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 for use in clinical trials and for commercial sale.

The OWS Agreement is funding the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including PREVENT-19.

Funding under the OWS Agreement supported our file submission for EUA with the FDA and is expected to support our plans to submit a BLA with the FDA.

Accepted analytical methods that we can use to demonstrate our vaccine’s purity, potency, and consistent lot manufacturing are critical to attaining licensure in all the territories we intend to sell our vaccine.

In the U.S., these analytical methods will be reviewed and approved by the FDA.

As of December 31, 2021, the Company's OWS agreement was amended to increase the contract ceiling by $52.9 million for a revised total of $1.8 billion.

The agreement’s authorized funding and scope remains unchanged at $1.75 billion for support of certain activities related to the development of NVX-CoV2373 and the manufacture and delivery of 100 million doses of the vaccine candidate to the U.S.

The Company and the U.S.

government will determine the timing and amounts for delivery of NVX-CoV2373 doses upon U.S authorization and the Company intends to pursue additional U.S.

procurement agreements for supply of NVX-CoV2373 doses.

In July 2021, the U.S.

government instructed us to prioritize alignment with the FDA on our analytic methods before conducting additional U.S.

manufacturing and further indicated that the U.S.

government will not fund additional U.S.

manufacturing until such agreement has been made.

government also instructed us to proceed with work under the OWS Agreement related to all other activities including ongoing clinical trials and nonclinical studies, regulatory interactions, analytics/assays, and characterization of manufactured vaccine and project management.

In October 2021 and January 2022, the U.S.

government extended the prescribed time to meet its July 2021 instructions until April 2022.

In February 2022, the Company’s Project Agreement with ATI was modified to include a Phase 3 efficacy study with respect to 2019n-CoV-301 in adolescents with a booster component and accordingly, the performance period under the Project Agreement was extended to December 31, 2023.

We have secured critical funding from the U.S.

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

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

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

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

The partnership was among components of the U.S.

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

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

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

The original USG Agreement required us to conduct certain clinical, regulatory, and other activities, including a pivotal Phase 3 clinical trial to determine the safety and efficacy of NVX-CoV2373, and to manufacture and deliver to the U.S.

government 100 million doses of the vaccine candidate.

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

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

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

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

government’s interest.

If the Project Agreement 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.

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

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

Funding Partner Amount Additional Details

CEPI $399.5 million • 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

NanoFlu Program (Older Adults)

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

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 September 2021, the final analysis of the primary endpoint of our pivotal Phase 3 clinical trial for the NanoFlu Program was published in The Lancet Infectious Diseases .

We previously announced that the NanoFlu Program achieved the trial’s primary endpoints, demonstrating 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, the NanoFlu Program 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.

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 NanoFlu Program team remains focused on advancing combination vaccine candidates.

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

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.

COVID / Influenza Combination Vaccine

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

In October 2021, we completed enrollment of our Phase 1/2 study in Australia, which we initiated in September 2021.

The trial enrolled 642 healthy adults aged 50 to 70 years across 10 sites and will evaluate the safety, tolerability and immune response of a combination vaccine using NanoFlu Program and NVX-CoV2373, combined with our Matrix-M™ adjuvant.

Participants have been either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through an authorized vaccine at least eight weeks prior to enrollment.

All participants will be randomly assigned to cohorts to evaluate multiple formulations and will be administered doses on Day 0 and again at Day 56.

Data from this Phase 1/2 trial are expected in the second quarter of 2022.

Data from this Phase 1/2 trial are expected in April of 2022.

We expect to initiate a Phase 2 clinical trial for the COVID-Influenza combination vaccine and NanoFlu Program as a standalone vaccine in the second half of 2022.

In May 2021, we announced data from a preclinical study of qNIV/CoV2373 to assess its immunogenicity and protective efficacy in animal models.

Preclinical data from this study showed that qNIV/CoV2373 induced functional influenza and COVID-19 antibody responses, with hemagglutination inhibition and ACE2 receptor-inhibiting titers that were comparable between immunization with the combination vaccine and with its respective component vaccines.

qNIV/CoV2373 also induced elevated levels of SARS-CoV-2 anti-S IgG two weeks after the first immunization, which increased significantly after the second dose, with levels comparable to animals that received NVX-CoV2373 alone.

Human ACE2 receptor inhibiting antibody levels responded similarly.

qNIV/CoV2373 also induced antibodies against SARS-CoV-2 neutralizing epitopes that are common between the original COVID-19 strain and the Beta (B.1.351) variant strain.

When challenged with SARS-CoV-2, examination of viral load in the upper and lower respiratory tract showed little or no virus was detected four days after infection in animals immunized with either qNIV/CoV2373 or with NVX-CoV2373 alone.

Data from this study are available ahead of publication via the preprint server for biology on bioRxiv.

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 that occur globally each year.

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.

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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 development opportunities for our RSV Program for older adults.

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 2021 WHO World Malaria Report, in 2020, there was an estimated 241 million malaria cases and 627 thousand deaths worldwide in 2020.

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.

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

We expect to manufacture and supply the Matrix-M ™ adjuvant component of R21 to SIIPL.

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

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R21 Clinical Development

R21 is currently being evaluated in a Phase 3 licensure trial initiated in May 2021.

Data from this trial are expected in the second half of 2022.

Previously, in April 2021, data from the Phase 2b trial evaluating R21 was published in The Lancet , demonstrating 77% efficacy when formulated with 50 micrograms of Matrix-M TM adjuvant and 71% efficacy when formulated with 25 micrograms of Matrix-M TM adjuvant.

Both adjuvant dose levels were well tolerated in young children, with no severe reactions to R21 reported.

Advance Purchase Agreements (“APA”)

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

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

We expect to sign additional APAs that are currently in active discussions and negotiations.

A summary of our APAs follows:

(1) The APA includes an option to order additional doses as may be required from time to time.

Under the terms of our APA with Gavi, 1.1 billion doses of NVX-CoV2373 are 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 expect to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility.

Under a separate purchase agreement with Gavi, SIIPL is expected to manufacture and deliver the balance of the 1.1 billion doses of NVX-CoV2373 for low- and middle-income countries participating in the COVAX Facility.

We expect to deliver doses with antigen and Matrix-M TM adjuvant manufactured at facilities directly funded by the investments previously received from CEPI (the “CEPI Funding Agreement”).

We expect 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 may prioritize such doses to low- and middle-income countries at lower prices.

Additionally, we may provide additional doses of NVX-CoV2373, to the extent available from CEPI-funded manufacturing facilities, in the event that SIIPL cannot materially deliver expected vaccine doses to the COVAX Facility.

Together with SIIPL, we expect to initiate delivery of doses following receipt of appropriate regulatory authorizations.

Under the agreement, we received an upfront payment from Gavi of $350 million in 2021 and recorded a receivable as of December 31, 2021, for an additional payment of $350 million because we secured EUL for NVX-CoV2373 from the WHO in December 2021.

Under the terms of our APA with the EC, acting on behalf of various E.U.

member states, we are committed 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 through 2023.

We have received orders for 69 million doses under this agreement.

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.

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.

In August 2020, we expanded upon our manufacturing and supply capabilities to include partnerships with both Takeda in Japan and SK bioscience in South Korea and furthered these collaborations in February and December 2021.

These additional partnerships will increase our production capacity and are expected to support a rapid roll-out of NVX-CoV2373 globally.

(1) Geographies pending regulatory authorizations and not yet authorized under the brand name

(2) SK bioscience received non-exclusive licenses in Thailand and Vietnam

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

Marketed Under

Serum Institute of India Private Limited

• COVAX Facility

• The Philippines

• South Africa

Takeda Pharmaceutical Company Limited

• South Korea

SK bioscience Co., Ltd.

• South Korea (1)

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

A summary of our license and collaboration agreements follows:

In July 2020, we entered into a supply and license agreement with SIIPL, which was amended in September 2020 and amended and restated in July 2021, under which we granted exclusive and non-exclusive licenses to SIIPL for the development, co-formulation, filling and finishing, registration, and commercialization of NVX-CoV2373.

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

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.

In October 2021, we entered into a supply agreement and a contract development manufacturing 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.

In February 2021, we finalized 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 finished 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 MHLW for the purchase of 150 million doses of NVX-CoV2373.

The announcement followed an update from MHLW on its ongoing efforts to secure coronavirus vaccine for the citizens of Japan.

These efforts include vaccine procurement by Takeda pursuant to the terms of the collaboration and license agreement we entered into with Takeda in February 2021.

Distribution of our vaccine in Japan by Takeda is expected to begin in 2022, pending regulatory approval.

Takeda anticipates the capacity to manufacture 150 million doses of NVX-CoV2373 per year.

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.

SK bioscience

In February 2021, we finalized an expanded collaboration and license agreement with SK bioscience to manufacture and commercialize NVX-CoV2373 for sale to the government of Korea.

Concurrently, SK bioscience finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021.

Our agreement is in addition to our existing manufacturing arrangement with SK bioscience entered into in August 2020.

Under the collaboration agreement, SK bioscience was granted an exclusive license to develop, manufacture, and commercialize NVX-CoV2373 in the Republic of Korea.

SK bioscience will pay a tiered royalty in the low to middle double-digit range on the sale of NVX-CoV2373 in the Republic of Korea.

In May 2021, we entered a non-binding

Memorandum of Understanding (“MOU”) with the Ministry of Health and Welfare of Korea and SK bioscience to explore further cooperation in the development and manufacturing of vaccines, including NVX-CoV2373 and to potentially explore the development of new vaccine products with SK bioscience, including COVID-19 variant vaccines and/or an influenza/COVID-19 combination vaccine.

In December 2021, we amended the collaboration and license agreement to grant a non-exclusive license to cover Thailand and Vietnam, subject to a low to middle double-digit royalty, and for SK biosciences to supply the antigen component of NVX-CoV2373 to us for use in the final drug product globally, including product distributed by the COVAX Facility.

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.

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 COVID-influenza combination vaccine directly and by leveraging our strategic global partnerships.

In 2021 and 2020, we established a global supply chain to support the commercialization of NVX-CoV2373.

The acquisition of Novavax CZ (formerly Praha Vaccines, a.s.) in the Czech Republic in May 2020 demonstrated the Company’s first major step toward building out our global manufacturing capabilities.

Since May 2020, we have established partnerships worldwide to amplify and solidify our global reach.

To date, we have increased our projected global manufacturing production rate of NVX-CoV2373 to be over two billion annualized doses when we are at full capacity.

Of this anticipated capacity, approximately one billion doses will be manufactured by SIIPL.

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.

A summary of our key manufacturing and supply arrangements follows:

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

In June 2020, we entered into 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.

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

In October 2021, we entered into a supply agreement with SIIPL and SLS, an affiliate of SIIPL, for the manufacture of NVX-CoV2373.

In October 2021, we also entered into a contract development manufacture agreement with SLS, where SLS will manufacture and supply finished vaccine product to us using antigen drug substance and Matrix-M™ adjuvant supplied by us.

In October 2021, we entered into a contract manufacturing agreement with Mabion S.A.

(“Mabion”) for the large-scale manufacturing of NVX-CoV2373 through 2026.

This agreement follows the successful completion of technology transfer to Mabion for antigen production of NVX-CoV2373.

We are scaling up manufacturing of NVX-CoV2373 at Mabion’s Good Manufacturing Practice-certified facility located near Warsaw, Poland.

In August 2021, we extended our partnership with FUJIFILM Diosynth Biotechnologies through an agreement for long-term commercial manufacturing of NVX-CoV2373 through 2025.

Under this agreement, FUJIFILM Diosynth Biotechnologies has continued to manufacture the antigen component of NVX-CoV2373 at its sites in Morrisville, North Carolina, College Station, Texas, and Billingham, UK.

This development follows a previous manufacturing agreement with FUJIFILM Diosynth Biotechnologies, which we entered into in July 2020.

In June 2021, we announced the completion of construction of the National Research Council of Canada’s Biologics Manufacturing Centre and ongoing technology transfer for the production of NVX-CoV2373.

Technology transfer to establish a step-by-step process of producing NVX-CoV2373 at the Biologics Manufacturing Centre began in April 2021 following a collaboration agreement entered into with the National Research Council of Canada in March 2021.

These developments build upon a MOU entered into in February 2021 with the Canadian government to produce NVX-CoV2373 at

the Biologics Manufacturing Centre in Canada.

Large-scale GMP production is expected to begin once the facility has received Health Canada approval.

Pursuant to our APA with Gavi, we have licensed our NVX-CoV2373 technology to SIIPL and are jointly committed with SIIPL to deliver the 1.1 billion doses to the COVAX Facility.

We expect to supply doses to Gavi utilizing a tiered pricing schedule.

In July 2020, we announced a manufacturing agreement with FDB allowing for the large-scale contract production of NVX-CoV2373 in connection with our OWS Agreement, beginning at FDB’s North Carolina facility.

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

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

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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 offers many advantages when compared to other technologies 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 disease.

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.

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 February 23, 2022, there are 115 vaccines in clinical trials and 49 have reached the final stages of testing.

As of January 2022, Novavax is one of five manufacturers that have a COVID-19 vaccine that has received Conditional Marketing Authorization by the EMA in the European Union, with the other manufacturers being Pfizer, Moderna, Johnson & Johnson and AstraZeneca.

As of January 2022, Pfizer has received BLA approval and Moderna and Johnson & Johnson have each received EUA by the FDA in the U.S for their COVID-19 vaccines.

As of January 2022, we submitted for EUA by the FDA for NVX-CoV2373, marking the first protein-based COVID-19 vaccine filing.

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 play an important role in addressing this global public health crisis.

A number of companies are developing and 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 Pasteur, GSK and Seqirus.

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, Sanofi currently supplies Fluzone-HD® and Flublok® to the majority of older adults in the U.S.

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.

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

Several competitors are working on developing seasonal influenza vaccines using different technologies than those in existing marketed vaccines, the most notable being mRNA.

Despite the significant competition and advancing technologies, based on our completed Phase 3 trial results, we believe that NanoFlu 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.

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.

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;

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

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 Janssen are in Phase 3 trials.

GSK and Pfizer both are in Phase 3 trials for infants via maternal immunization.

Additionally, both the AstraZeneca / Sanofi partnered monoclonal antibody and Merck monoclonal antibody are in Phase 3 trials in infants.

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.

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

An important factor is the relative timing of the market introduction of our products and our competitors’ products.

Accordingly, the speed with which we can develop products, complete the clinical trials and

approval processes and supply commercial quantities of the products to the market is an important competitive factor.

Accordingly, the speed with which we can develop products, complete the clinical trials and approval processes, and supply commercial quantities of the products to the market is an important competitive factor.

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

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Related patents have been issued in other world markets.

Issued patents in our influenza nanoparticle program include US Patent No.

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.

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

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

Our applications include PCT/US2021/015220 and U.S.

16,997,001, which the U.S Patent Office has allowed.

We continue to prepare, file, and prosecute patent applications to provide broad and strong protection of our proprietary rights, including next generation applications focused on our RSV Program, our influenza nanoparticle program, and our adjuvant program.

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

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

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

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.

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

While our expired contract with the U.S.

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

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

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

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and other countries.

Although we focus on the U.S.

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

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

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.

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

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

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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 what we propose to do for human testing.

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

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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, under delegated authority from the Secretary of the DHHS, and under certain circumstances, 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.

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.

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 public health emergency.

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 emergency 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.

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.

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.

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

Manufacturers may also be required to submit the results of their own tests for

potency, safety and purity for each vaccine lot, if requested by the relevant regulatory agency.

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

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

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The EU and the U.K.

similarly provide a faster means to achieve approval by offering conditional marketing authorizations which are granted with the proviso of obtaining additional data to eventually become unconditional, but which allow authorization to be granted earlier albeit with a more limited set of clinical data.

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.

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.

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

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.

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.

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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, or IMM that is reasonably likely to predict an effect on IMM or other clinical benefit.

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.

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

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”).

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.

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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.

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.

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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 will impact our business and operations once our product candidates are commercialized.

At this time we cannot predict how these changes 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.

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

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

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

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

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

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

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

exchanges for violations of the FCPA’s accounting provisions.

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

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

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

willfully obstructing a criminal investigation of a healthcare offense;

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

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

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

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

While pharmaceutical

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

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

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

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products.

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

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

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

In the United States, the Public

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

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

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

For these immunities to apply, the Secretary of DHHS must issue a declaration in cases of public health emergency or “credible risk” of a future public health emergency.

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

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

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

The current declaration will end on October 1, 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.

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Human Capital

As of February 21, 2022, we have 1,541 full-time employees, of whom 198 hold M.D.

degrees and 499 of whom hold other advanced degrees.

Of our total workforce, 1,088 employees are engaged primarily in research, development, and manufacturing activities and 453 employees are engaged primarily in executive, business development, commercial, finance and accounting, legal, and administrative functions.

None of our U.S.

or Czech employees are represented by labor unions or covered by collective bargaining agreements;

135 of our 136 Swedish employees are covered by typical collective bargaining agreements.

To nurture, grow, and treat our employees fairly is imbued in our culture.

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 Benefits

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 implemented a Covid Resources page on our intranet, which provides employees with information on Covid-19 safety, both inside and outside of the workplace.

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.

We implemented temperature screenings for everyone who enters our facilities and require visitors to complete a health assessment before entering.

Our 700 Quince Orchard office space located in Gaithersburg, Maryland is on track to receive WELL Platinum certification.

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 the 10 WELL Concepts:

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.

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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 that are among the best in our industry, including insurance to protect and maintain health, income protection through our short- and long-term disability programs, 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 wellbeing programs, including monthly financial wellness seminars, one-on-one financial planning sessions, and debt and credit management support.

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;

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 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.

To assist employees with work/life balance, we provide employees with a concierge service to assist employees with tasks including, but not limited to:

• finding and booking auto services;

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;

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providing vacation ideas;

• finding and booking home cleaners, plumbers, HVAC, and landscaping services;

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;

• researching day care center availability and ratings.

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

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.

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 success factor for our success.

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.

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 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.

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.

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

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 continues to recognize the importance of increased employee engagement.

Diversity and Inclusion

Our culture of diversity, equity, and inclusion (“DEI”) enables us to create, develop, and fully 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 road map and strategy to drive diversity and inclusion by developing inclusive leaders, enabling an inclusive culture, and building diverse teams.

The first annual Novavax Women’s Leadership Forum was successfully

launched and resulted in building networks, developing skills, sharing voices and ideas, and becoming agents of positive change.

We are focused on growing and maintaining our diverse workforce and we believe our DEI strategy will enable us to continuously improve and excel.

In 2022, we hired a DEI and Employee Engagement Manager focused on actions to build an inclusive workforce, and we are investing in training to develop our leaders to access different perspectives when generating ideas and decision making.

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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What changed 10-K

Item 1. Business