What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-03-01 compared with 2021-03-01 · 422 added, 315 removed, 269 unchanged (73% of the section changed)

Novavax, Inc., together with our wholly-owned subsidiaries, Novavax AB and Novavax CZ, is a biotechnology company promoting improved global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs.

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

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

Our technology may be used to target a variety of infectious diseases.

Our unique technology is paired with our proprietary immune stimulating adjuvants, developed at Novavax AB, our wholly owned Swedish subsidiary.

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.

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

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

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

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

Table of C onten ts

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 unchanged sentence

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

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

(2) Ongoing PREVENT-19, a Phase 3 clinical trial in U.S.

Ongoing Phase 3 in UK;

Ongoing Phase 2b in South Africa

(3) Supported by a grant from BMGF

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

Recombinant Nanoparticle Vaccine Technology

Novavax’ 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.

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.

1 unchanged sentence

This genetic construct is inserted into the baculovirus Spodoptera frugiperda (Sf9/BV) insect cell-expression system, which enables efficient, large-scale expression of the optimized protein.

The Sf9/BV system produces proteins that are properly folded and modified – which can be critical for functional, protective immunity – as the vaccine

Table of C onten ts

The Sf9/BV system produces proteins that are properly folded and modified – which can be critical for functional, protective immunity – as the vaccine antigen.

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.

Matrix-M ™ Adjuvant

Matrix-M is composed of 40 nanometer particles derived from saponin extracted from the bark of the Quillaja saponaria Molina tree .

Once purified these particles are fused with a unique formulation of cholesterol and phospholipid.

This proprietary 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 T cell, B cell, and APC populations, thereby boosting immune response.

Matrix-M has been shown to increase neutralizing antibodies and induces long-lasting memory B cells, which enhances B-cell immunity and recruits and increases the frequency of CD4+ and CD8+ T cells to enhance T cell immunity.

The potent immune-stimulating mechanism of action is designed to enables a lower dose of antigen required to achieve the desired immune response, ultimately contributing to increased supply and manufacturing capacity.

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 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.

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

To date, we have formulated many of the vaccine candidates in our pipeline with Matrix-M, including NVX-CoV2373 and NanoFlu.

Matrix-M has been well tolerated in human studies to date.

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.

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.

Pipeline Overview

As the world continues to address the global COVID-19 pandemic, we remain focused today on bringing our NVX-CoV2373 vaccine candidate to market following global regulatory approvals.

In addition to this focus, NanoFlu continues to be a priority for our team, especially as it relates to a potential combined NanoFlu / NVX-CoV2373 vaccine.

Although NVX-CoV2373 and NanoFlu are our near-term priorities, we remain optimistic that the additional programs in our pipeline including our vaccine candidates for RSV and other emerging infectious diseases, present viable opportunities for future development.

Coronaviruses (“CoV”), so named for their “crown-like” appearance, are a large family of viruses, some of which are believed to have spread from animals to humans.

These viruses cause human diseases such as Middle East Respiratory Syndrome (“MERS”) and Severe Acute Respiratory Syndrome (“SARS”), and COVID-19, the disease resulting from the SARS CoV-2 coronavirus.

COVID-19 first emerged in late 2019 in China, and, as of March 2020, the World Health Organization declared it a global pandemic.

We have successfully produced NVX-CoV2373, designed to provide protection against SARS-CoV-2.

We engineered NVX-CoV2373 from the genetic sequence of SARS-CoV-2 using our recombinant nanoparticle technology to generate the antigen derived from the coronavirus spike (S) protein.

NVX-CoV2373 includes our proprietary Matrix-M adjuvant.

NVX-CoV2373 Preclinical Development

In April 2020, we announced that NVX-CoV2373 demonstrated high immunogenicity in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor and high levels of wild-type virus neutralizing antibodies .

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.

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.

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

PREVENT-19 Phase 3 U.S.

In February 2021, we completed enrollment of our PREVENT-19 pivotal Phase 3 study in the U.S.

and Mexico initiated in December 2020.

PREVENT-19 is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant that enrolled more than 30,000 participants aged 18 years or older.

The trial largely reached its demographic goal of enrolling participants at high-risk for COVID-19 including adults over the age of 65, people with medical co-morbidities and racial/ethnic subgroups who are at greater risk of infection and disease.

The participant study population is composed of the following:

20% LatinX, 13% African American, 6% Native American, 5% Asian American, and 13% older adults aged 65 years and older.

The trial design has been

Table of C onten ts

harmonized to align with other Phase 3 trials conducted under the auspices of OWS, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19.

The primary and secondary endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

Two thirds of the participants will be assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants will receive placebo.

The primary efficacy analysis is event-driven, based on the number of participants with symptomatic mild, moderate or severe COVID-19 disease.

Participants will be followed for 24 months following the second injection.

Dependent on the overall COVID-19 attack rate, interim data in this event-driven trial are expected in the second quarter of 2021.

PREVENT-19 is being conducted with support from OWS, including a $1.7 billion agreement.

Our blinded crossover protocol for this Phase 3 trial has been submitted to the FDA.

We have posted that updated protocol, including details of the crossover, on our website under resources .

Phase 3 United Kingdom (“UK”)

In January 2021, we announced that NVX-CoV2373 demonstrated 89.3% efficacy in an interim analysis of our Phase 3 UK study initiated in September 2020.

Our Phase 3 study in the UK was in partnership with the UK Government’s Vaccines Taskforce.

The trial was a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in over 15,000 enrolled participants aged 18 to 84 years, including 27 percent of participants over the age of 65.

Half of the trial participants received two intramuscular injections of NVX‑CoV2373 comprising 5 micrograms of antigen with 50 micrograms of Matrix‑M, administered 21 days apart, while the other half of the trial participants received placebo.

The primary endpoint was first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

Preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases.

Interim results from this trial showed that efficacy by strain was 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain.

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

PREVENT-19 was a randomized, placebo-controlled, observer-blinded Phase 3 trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in 29,960 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.

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 South Africa

In January 2021, we announced that NVX-CoV2373 demonstrated 60% efficacy for the prevention of mild, moderate and severe COVID-19 disease for the portion of the study population that was HIV-negative (94% of study participants) in an interim analysis of our South Africa Phase 2b clinical trial initiated in August 2020.

The Phase 2b clinical trial in South Africa enrolled over 4,400 participants.

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

Interim results from this trial showed that NVX-CoV2373 achieved its primary efficacy endpoint in the overall trial population, with efficacy of 49.4%, including HIV-positive and HIV-negative participants.

Data suggested that NVX-CoV2373 provided significant protection from the South Africa escape variant, which was widely circulating at the time and attributable for approximately 92.6% of sequenced cases.

Importantly in this trial, approximately 1/3 of the participants enrolled, but not included in the primary analyses, were seropositive, demonstrating prior COVID-19 infection at baseline.

Based on temporal epidemiology data in the region, the pre-trial infections are thought to have been caused by the original COVID-19 strain (i.e., non-variant), while the subsequent infections during the study were largely attributable to the variant virus.

These data suggest that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection.

Phase 1/2 U.S.

and Australia

In August 2020, we announced positive preliminary immunogenicity and safety results from our Phase 1 portion of the Phase 1/2 clinical trial of NVX-CoV2373 initiated in May 2020.

The Phase 1 portion was a randomized, observer-blinded, placebo-controlled trial in 131 participants at two sites in Australia.

The trial was designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted.

The protocol’s two-dose trial regimen assessed two dose levels (5 and 25 micrograms) with Matrix‑M and without.

Results from this trial showed that NVX-CoV2373 was generally well-tolerated, elicited robust antibody responses numerically superior to that seen in human convalescent sera and induced robust polyfunctional CD4+ T cell responses.

In September 2020, the Phase 1 portion clinical results were published in The New England Journal of Medicine.

In January 2021, we reported favorable six-month immunogenicity (IgG ELISA) data during the J.P.

Morgan 39th Annual Healthcare Conference.

In August 2020, we initiated the Phase 2 portion of the Phase 1/2 clinical trial.

The Phase 2 portion is designed to evaluate the safety and immunogenicity of NVX-CoV2373 with Matrix-M in participants aged 18 to 84 years.

The Phase 2 portion will assess two dose levels (5 and 25 micrograms), each with 50 micrograms of Matrix‑M.

We completed enrollment of 1,288 healthy volunteers in October

Table of C onten ts

2020, with approximately 50 percent of participants 60 years of age and older, at up to 40 sites in the U.S.

and Australia.

In late October 2020, we reported favorable preliminary reactogenicity data from the Phase 2 portion of the trial during the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices meeting.

As of March 2021, some participants from this trial are receiving a six-month boost dose of NVX-CoV2373 to examine the functional immune response of our vaccine candidate.

NVX-CoV2373 Clinical Development Conducted by Partner

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.

The Phase 2b South Africa trial was a randomized, observer-blinded, placebo-controlled study that enrolled 4,404 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.

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.

Phase 1/2 Japan

In February 2021, Takeda Pharmaceutical Company Limited (“Takeda”) initiated a Phase 1/2 clinical trial of NVX-CoV2373 in Japan.

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

Variant Strain (Booster and/or Bivalent)

In January 2021, we initiated development of new constructs against the emerging strains of COVID-19, and in February 2021, we selected candidates for variant strain vaccines as standalone and bivalent candidates.

We are currently evaluating these candidates in ongoing non-human primate studies and plan to begin clinical evaluation of variant vaccine candidates in mid-2021.

NVX-CoV2373 Regulatory and Licensure

In February 2021, we announced the initiation of a rolling submission with non-clinical data to the UK Medicines and Healthcare products Regulatory Agency (“MHRA”).

We expect to file for authorization by early second quarter of 2021 after we have gathered sufficient data.

In November 2020, we announced that the U.S.

Food and Drug Administration ("FDA") granted NVX-CoV2373 Fast Track designation, which is intended for products that treat serious or life-threatening diseases or conditions and that demonstrate the potential to address unmet medical needs for such diseases or conditions.

The Fast Track program is designed to facilitate development and expedite the review of drugs to treat serious conditions, with the intent of providing patients with earlier access to important new drugs.

Specifically, Fast Track designation facilitates meetings with the FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a Biologics Licensing Application (“BLA”) on a rolling basis as data become available.

We continue to be in communication with the FDA through submissions to our open investigational new drug application (“IND”) and discussions on various aspects of the program required to support the regulatory approval process.

We also plan to file submissions for Emergency Use Authorization (“EUA”) with the FDA and expect to complete our EUA filing in the second quarter of 2021.

In addition, we initiated the rolling review process with submissions to several regulatory agencies worldwide, including the European Medicines Agency (“EMA”), Health Canada, Australian Therapeutic Goods Administration (“TGA”) and New Zealand Medsafe.

As part of the rolling review, we will continue to submit additional information, including clinical and manufacturing data as they become available.

These rolling reviews are initiated to expedite the assessment of vaccines, particularly during public health emergencies.

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

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.

COVID-19 Vaccine Funding

In May 2020, we signed a restated funding agreement which was amended in November 2020, with CEPI (the “CEPI Funding Agreement”), under which we are entitled to receive funding of up to $399.5 million to be used by us for the development of NVX-CoV2373.

Pursuant to the CEPI Funding Agreement, if approved, a portion of the NVX-CoV2373 supply produced by us, other than vaccine manufactured under the OWS Agreement (as defined below), is expected to be procured and allocated through the COVAX Facility component of the Access to COVID‑19 Tools (ACT) Accelerator, an international equitable vaccine purchasing initiative launched by the World Health Organization, Gavi the Vaccine Alliance ("Gavi"), CEPI and other global non-governmental organizations and governmental leaders in 2020.

In June 2020, we were awarded a contract by the DoD which was last amended in January 2021 under which we are entitled to receive funding of up to $45.7 million to support certain activities related to the development of NVX-CoV2373, including the manufacturing and delivery of 10 million doses of NVX-CoV2373 to the U.S.

In July 2020, we were selected to participate in OWS, a U.S.

government sponsored program working to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.

Through a Base

Table of C onten ts

Agreement and a Project Agreement (together, 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, which was last amended in December 2020, we have been allotted funding of $1.6 billion and are entitled to receive maximum funding up to $1.75 billion to support certain activities related to the development of NVX-CoV2373, and including 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 potentially for commercial sale, if authorized for emergency use or licensed.

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

Funding under the OWS Agreement is also expected to support our plans to file submissions for EUA and licensure with the FDA.

NVX-CoV2373 Manufacturing and Supply

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

The acquisition of Praha Vaccines a.s.

(“Praha Vaccines”) 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.

We remain committed to partnering globally in efforts to end the COVID-19 pandemic, as demonstrated through our partnership with Serum Institute of India Private Limited ("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 Co., Ltd.

(“SK bioscience”) in South Korea and furthered these collaborations in February 2021.

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

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, which we expect to occur in mid-2021.

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

NVX-CoV2373 and its components are being manufactured at the following Novavax (in bold) and partnered sites:

A summary and status of key manufacturing and supply developments follows:

In February 2021, we announced a Memorandum of Understanding ("MOU") with Gavi to provide 1.1 billion doses of NVX-CoV2373 for the COVAX Facility.

The vaccine doses will be manufactured and distributed globally by us and SIIPL, the latter under an existing agreement between Gavi and SIIPL.

We expect to work with Gavi, which leads the design and implementation of the COVAX Facility, to finalize an advance purchase agreement for vaccine supply and global

Table of C onten ts

distribution via the COVAX Facility and its partners.

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 primarily high-income countries, with SIIPL providing the majority of supply for low-, middle, and upper-middle-income countries, utilizing a tiered pricing schedule.

In February 2021, we also reached a MOU with the Canadian government to produce NVX-CoV2373 in Canada.

We plan to produce NVX-CoV2373 at the National Research Council’s Biologics Manufacturing Centre in Montreal once both the vaccine candidate and the facility receive Health Canada approvals.

The MOU also includes a broader intention for the Government of Canada and us to work together to increase our Canadian presence.

We will explore a range of partnership opportunities for us to expand vaccine production in Canada, including partnerships with Canadian contract manufacturers.

We recently initiated the rolling submission process for regulatory approval to Health Canada.

In August 2020, we entered into a development and supply agreement with SK bioscience, and in February 2021, announced an expanded collaboration and license agreement with SK bioscience.

Under these agreements, SK bioscience has been granted an exclusive license to develop, manufacture and commercialize NVX-CoV2373 in the Republic of Korea.

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

SK bioscience will expand its capacity to manufacture the antigen component of NVX-CoV2373 for use in the final drug product globally, including product distributed by the COVAX Facility, during the COVID-19 pandemic.

SK bioscience will also purchase a certain quantity of the finished vaccine product directly from us, subject to the approval by relevant regulatory authority, and sufficient doses of our Matrix-M adjuvant to manufacture the remainder of the 40 million doses of finished vaccine product SK bioscience expects to sell to the Korean government.

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, net of certain agreed costs.

In August 2020, we announced a collaboration agreement with Takeda, and in February 2021, we finalized an exclusive license agreement with Takeda for the development, manufacturing and commercialization of NVX-CoV2373 in Japan.

We will transfer technology and supply our Matrix-M adjuvant to Takeda, who will manufacture the vaccine antigen.

Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare to support the technology transfer, establishment of infrastructure and scale-up of manufacturing.

We anticipate that Takeda has a manufacturing capacity of over 250 million doses per year.

We will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of net profits from vaccine sales.

Takeda is responsible for regulatory submission to Japan’s Pharmaceutical and Medical Devices Agency (“PMDA”).

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.

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

SIIPL has agreed to purchase Matrix-M adjuvant from us and we have 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 under the terms of the agreement.

We will equally split with SIIPL 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 WHO), in all countries other than specified countries designated by the World Bank as upper-middle or high-income countries, with respect to which we retain rights, and (b) after the Pandemic Period, in only those countries designated as low or middle-income by the World Bank.

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

We anticipate SIIPL will manufacture approximately one billion doses of NVX‑CoV2373 in 2021.

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.

In May 2020, we announced the acquisition of Praha Vaccines, formerly part of the Cyrus Poonawalla Group, in an all cash transaction of approximately $167 million.

The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic.

The acquisition included a 150,000-square foot state-of-the-art vaccine and biologics manufacturing facility and other support buildings, along with the existing employees and all related and required infrastructure.

The facility is expected to provide annual capacity of over 1 billion doses of antigen starting in 2021 for NVX-CoV2373.

The facility is completing a renovation that includes Biosafety Level-3 (BSL-3) capabilities.

As part of the

Table of C onten ts

transaction, approximately 150 employees with significant experience in vaccine manufacturing and support joined Novavax.

The acquisition of Praha Vaccines was supported by our funding arrangements with CEPI, which we expect will enable us to dramatically expand our manufacturing capacity.

NVX-CoV2373 Supply Agreements

We have entered into advance purchase agreements (referred to as "APAs" or "supply agreements" throughout this Annual Report on Form 10-K) with various countries globally that, if our product candidate is approved, are expected to result in the delivery of approximately 200 million doses of NVX-CoV2373 throughout 2021 and into the first half of 2022.

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

A summary and status of these supply agreements follows:

In October 2020, we entered into a SARS-CoV-2 vaccine supply agreement with The Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the government of the UK (the “Authority”), for the purchase of 60 million doses of NVX-CoV2373, plus such additional orders as the Authority may make from time to time.

We agreed to continue to conduct a UK-based Phase 3 clinical trial of NVX-CoV2373 to assess the efficacy of NVX-CoV2373 in the UK population, establish a dedicated supply chain for NVX-CoV2373 in the UK and seek regulatory approval for the NVX‑CoV2373 in the UK.

FDB’s UK site is expected to produce up to 180 million doses annually.

Excess supply of antigen manufactured at the FDB’s site in Billingham, Stockton-on-Tees may be available for us to sell to additional markets outside the UK.

In January 2021, we finalized an APA with the Government of Canada to supply up to 76 million doses of NVX-CoV2373.

Canada has committed to purchase 52 million doses of NVX-CoV2373 with the option for up to an additional 24

Table of C onten ts

million doses.

Under the agreement, we expect to supply doses of NVX-CoV2373 to Canada following authorization by Canada’s regulatory agency.

In December 2020, we finalized an APA with the Australian Federal Government to supply up to 61 million doses.

Australia is committed to purchase 51 million doses of NVX-CoV2373 with the option for up to an additional 10 million doses.

We will work with Australia’s regulatory agency, the Therapeutics Goods Administration (TGA), to seek product approvals upon demonstrating efficacy in clinical studies.

In December 2020, we finalized an APA with the government of New Zealand for the purchase of 10.72 million doses of NVX-CoV2373.

Under the terms of the agreement, we will manufacture all doses of NVX-CoV2373 delivered to New Zealand under the agreement.

In February 2021, we executed a binding Heads of Terms with the government of Switzerland to supply six million doses of NVX-CoV2373.

Following this Heads of Terms, we intend to negotiate a final agreement with Switzerland, with initial delivery of vaccine doses slated to ship following successful clinical development and regulatory review.

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.

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.

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

Seasonal Influenza

1 unchanged sentence

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.

According to a 2019 Global Data forecast of influenza vaccines, the market for seasonal influenza vaccines is expected to grow from approximately $4.6 billion in 2018 to approximately $6.5 billion in 2028 (in the countries comprising the eight major markets).

In March 2020, we announced positive top-line results from our Phase 3 clinical trial of NanoFlu, which includes our proprietary Matrix-M adjuvant.

In October 2020, we announced the formation of a leadership team within the Company focused on advancing NanoFlu to regulatory licensure.

The leadership team has established a separate NanoFlu development unit within our Company, which benefits from joint shared services with key cross-functional departments within the Company and builds on the Company’s established knowledge base in the discovery and development of innovative vaccines to prevent serious infectious diseases.

We continue to seek regulatory approval from the FDA under the accelerated approval pathway previously granted to the Company and explore the potential for a combination NanoFlu / NVX-CoV2373 vaccine to be used in a post-pandemic setting.

According to a 2021 Fortune Business Insights research report forecast of influenza vaccines, the market for seasonal influenza vaccines is expected to grow from approximately $6.6 billion in 2021 to approximately $10.73 billion in 2028.

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.

Combination Vaccines

With the ongoing development of NanoFlu, NVX-CoV2373, and respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”), a strong rationale exists for potentially developing three combination respiratory vaccines designed to protect susceptible populations against these diseases.

Although testing is at an early stage, we believe that combination vaccines against influenza in combination with COVID-19, influenza in combination with RSV, and influenza in combination with both RSV and COVID-19 may be achievable since these vaccines are created using our recombinant nanoparticle technology and include our proprietary Matrix-M adjuvant.

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.

COVID / Influenza Combination Vaccine

Phase 1/2 Clinical Trial of COVID-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.

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.

We have identified three susceptible target populations that we believe could benefit from the development of our respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”) in different formulations:

(1) infants via maternal immunization, (2) older adults (60 years and older) and (3) children six months to five years old (“pediatrics”).

With our current estimates of the annual global cost burden of RSV in excess of $88 billion, we believe our RSV F Vaccine represents a multi-billion dollar worldwide opportunity.

ResVax Program (Infants via Maternal Immunization)

ResVax is our adjuvanted RSV F Vaccine for infants via maternal immunization.

RSV is the most common cause of lower respiratory tract infections (“LRTI”) and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide.

In the U.S., RSV is the leading cause of hospitalization of infants and, globally, is second only to malaria as a cause of death in children under one year of age.

Table of C onten ts

In February 2019, we announced data from our Prepare trial, initiated in December 2015.

The Prepare trial was conducted to determine whether ResVax reduced incidence of medically significant RSV-positive LRTI in infants through a minimum of the first 90 days of life and up through the first six months of life.

While the data did not meet the trial’s primary efficacy endpoint, it did demonstrate efficacy against a secondary objective by reducing RSV LRTI hospitalizations in treated infants.

In July 2020, these data were published in the New England Journal of Medicine.

BMGF supported the Prepare trial for ResVax through a grant of up to $89.1 million pursuant to a grant agreement we entered into with BMGF in September 2015 (the “BMGF Grant Agreement”) data.

We are assessing opportunities to bring ResVax to market, in conjunction with our pursuit of a regulatory licensure approach for the U.S., the European Union and other geographies.

RSV Older Adults Program

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

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

alone, a reported RSV incidence rate of 5.5% in older adults would account for approximately 2.5 million infections per year.

We estimate that approximately 900,000 medical interventions are caused by RSV disease in this U.S.

population each year.

We followed up the 2016 Phase 3 clinical trial of our RSV F Vaccine, which failed to meet its pre-specified primary or secondary efficacy objectives, with a 2017 Phase 2 clinical trial in older adults, to assess safety and immunogenicity of one and two dose regimens of our RSV F Vaccine, with and without aluminum phosphate or our proprietary Matrix-M adjuvant.

Immunogenicity results from the 2017 trial indicate that both adjuvants increase 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 F Vaccine in older adults.

RSV Pediatrics Program

By the age of five, essentially all children will have been exposed to RSV and will likely develop natural immunity against the virus;

however, children under five remain vulnerable to RSV disease, offering a strong rationale for a pediatric vaccine that could offer enhanced protection.

In 2015, we announced positive results in our Phase 1 clinical trial evaluating the safety and immunogenicity of our RSV F Vaccine in healthy children between two and six years of age.

We continue to assess the development opportunities for our RSV F Vaccine for pediatrics.

Other Emerging Infectious Diseases

We have extensive history working with coronaviruses and developing vaccine candidates, notably our successful production of a vaccine candidate designed to provide protection against MERS, as well as preclinical work associated with SARS.

Through this experience, we have demonstrated our ability to quickly produce viable vaccine candidates for emerging infectious diseases, including both MERS/SARS and Ebola virus (“EBOV”).

Historically, we developed a vaccine candidate against MERS, a novel coronavirus first identified in 2012, and a vaccine candidate against SARS in 2005.

In 2012, within weeks of obtaining the sequence of the circulating MERS strain, we successfully produced a vaccine candidate designed to provide protection.

Our MERS candidate was based on the major surface spike protein, which we had previously identified as the antigen of choice in our work with our SARS vaccine candidate.

In 2014, in collaboration with the University of Maryland, School of Medicine, we published results that showed our MERS and SARS vaccine candidates both blocked infection in laboratory studies.

Although not in active development, our MERS and SARS vaccine candidates remain viable opportunities to potentially develop independently or in conjunction with other coronavirus development activities.

EBOV is a filovirus that produces severe, often fatal illness in humans.

Within the last decade, it has produced two large outbreaks in Sub-Saharan Africa with high mortality.

There are currently two vaccines licensed to prevent EBOV.

We developed an EBOV glycoprotein vaccine candidate (“Ebola GP Vaccine”) expressed in insect cells, using our core recombinant baculovirus technology.

Although not in active development, our Ebola GP Vaccine is a viable development opportunity.

RSV Program (Older Adults)

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

We continue to assess the development opportunities for our RSV Program 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.

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

R21 - Malaria Vaccine

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

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

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.

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

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

R21 Clinical Development

R21 is 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.

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

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.

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 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.

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.

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.

A summary of our key manufacturing and supply arrangements follows:

Matrix-M TM Adjuvant

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

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.

Competition in COVID-19, Influenza, and RSV

1 unchanged sentence

Our technology is based upon utilizing the baculovirus expression system in insect cells to make recombinant vaccines.

We believe this system offers

Table of C onten ts

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.

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.

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, there are 69 vaccines in clinical trials and 20 have reached the final stages of testing.

As of February 2021, Pfizer, Moderna, and Johnson & Johnson have each received approval under Emergency Use Authorization by the FDA in the U.S for their COVID-19 vaccines.

NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials:

a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S.

and Mexico that began in December.

It is also being tested in two ongoing Phase 2 studies that began in August:

a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S.

and Australia.

Based on the interim efficacy from the Phase 3 in the UK and the Phase 2b in South Africa, our vaccine candidate has demonstrated strong efficacy and will play an important role in solving this global public health crisis.

Importantly, we are the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the U.K.

and South Africa.

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.

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).

3 unchanged sentences

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

In order to show differentiation in the seasonal influenza market, a product may need to be more efficacious and/or be less expensive and quicker to manufacture.

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

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

Despite the significant competition and advancing technologies, some of which are similar to our own, based on our completed Phase 3 trial results, we believe that NanoFlu, 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.

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.

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

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

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

We continue to believe that our 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.

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 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.

11 unchanged sentences

Currently, we have or have rights to over 550 U.S.

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

Patents related to our VLP program include U.S.

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

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

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

1 unchanged sentence

1644037 also covers this technology.

8,080,255, 8,551,756, 8,506,967 and 8,592,197 are directed to methods of producing VLPs and inducing substantial immunity to an influenza virus infection by administering VLPs comprising HA and NA proteins, and

Table of C onten ts

our M1 protein derived from the avian influenza strain, A/Indonesia/5/05.

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

33 unchanged sentences

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

however, we are mindful that expectations in some venues, notably in the European Union, 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.

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

regulatory agencies.

2 unchanged sentences

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

Vaccine clinical development 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

Table of C onten ts

and what we propose to do for human testing.

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

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

16 unchanged sentences

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.

3 unchanged sentences

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

The EU and the U.K.

similarly provide a faster means to achieve approval by offering 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.

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.

8 unchanged sentences

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

Table of C onten ts

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

23 unchanged sentences

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

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

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

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

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

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

5 unchanged sentences

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

Adoption of price controls and cost-containment measures and

Table of C onten ts

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

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

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

15 unchanged sentences

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

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

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

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

14 unchanged sentences

At this time we cannot predict how these changes will impact our business and operations once our product candidates are commercialized.

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

The provision

Table of C onten ts

of benefits or advantages to physicians is also governed by the national anti-bribery laws of EU Member States, such as the U.K.

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

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

Bribery Act 2010.

16 unchanged sentences

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 SEC also may suspend or bar issuers from trading securities on U.S.

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

exchanges for violations of the FCPA’s accounting provisions.

8 unchanged sentences

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

Within the European Union, payments made to physicians in certain EU Member States must be publicly disclosed.

Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, their competent professional organization, or the regulatory authorities of the individual EU Member States.

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

Table of C onten ts

Union Member States.

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

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

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

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

11 unchanged sentences

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”), 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.

8 unchanged sentences

degrees and 499 of whom hold other advanced degrees.

Of our total workforce, 653 are engaged primarily in research, development and manufacturing activities and 139 are engaged primarily in executive, business development, finance and accounting, legal and administrative functions.

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.

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

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.

We were recognized as the Top 50 employers to work for in the US by our employees.

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

COVID-19 Employee Safety and Benefits

Table of C onten ts

With the emergence of the COVID-19 global pandemic, we took precautions to reduce the risk of virus exposure for all employees.

We encouraged all of our employees who were able to work from home to do so and reduced the number of people in our offices significantly with the remote work option.

Because of our business, it was necessary for essential employees to remain onsite.

For those employees and any other employees who entered our offices, we adopted new safety protocols including, social distancing, face mask requirements, temperature screening and health questionnaires.

In March 2020, we recognized the severity of COVID-19 and offered a special enrollment period to our employees to provide them with an additional opportunity to participate in our health insurance plan.

We have also established an emergency relief fund for our employees whose immediate families have been materially and negatively impacted by the COVID-19 emergency.

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

Employee Safety and Benefits

Employee safety is our highest priority.

As we moved through the pandemic in 2021, 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.

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.

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:

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

Compensation and Benefits;

Health and Wellness

Our total rewards are designed to attract, motivate, and retain top talent in the industry.

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

Our generous total rewards package includes competitive market pay, fully covered healthcare benefits for employees, a health savings account, a 401(k) retirement savings plan, paid vacation, family leave, flexible work schedules, an employee assistance program, and onsite and online concierge services.

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

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

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

Our generous total rewards package includes competitive market pay and comprehensive benefits 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 wellness initiatives include a monthly newsletter, which highlights organizations and partners, tools, and resources intended to help our employees lead healthier and happier lives.

We offer several digital apps that allow our employees to connect to an online licensed therapist or to access activities that are designed to reduce stress and anxiety and

increase mindfulness and emotional well-being.

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

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;

• sourcing pet sitters and boarders;

• researching online and in-person tutors;

• suggesting community events;

• providing vacation ideas;

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

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

• suggesting nutritional meals and recipes;

• 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.

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 Novavax.

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

Since March 2020, we have hired over 400 full-time and part-time employees to address the global COVID-19 pandemic and bring our NVX-CoV2373 vaccine candidate to market following global regulatory approvals.

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 skill, knowledge and behaviors related to business, leadership, technology, and creativity.

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 25,000 times by our employees.

We provide an Executive Development Program for employees identified as having high potential and for potential successors to leadership positions, executive coaching engagements, and leadership development programs to strengthen our leadership bench and accelerate and prepare our top talent for future growth.

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.

Internal Communications

2 unchanged sentences

Diversity and Inclusion

Our culture of diversity, equity and inclusion 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 current state on diversity, equity and inclusion to understand how best to create a culture of inclusion and diverse workforce and how to build a sustainable strategy to drive diversity and inclusion at Novavax.

We are very fortunate to have a diverse workforce and we believe our DEI strategy will enable us to continuously improve and excel.

Corporate Social Responsibility

We are endeavoring to develop relationships, give back to our communities and engage in corporate social responsibility and sustainability initiatives.

As we grow our employee base, we are focused on extending our efforts in these areas.

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.

Availability of Information

Table of C onten ts

Our website address is www.novavax.com .

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

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

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

2 unchanged sentences

Accordingly, investors should monitor these portions of our website (www.novavax.com), in addition to following our press releases, SEC filings and public conference calls and webcasts.

Also available on our website is information relating to corporate governance at Novavax and our Board of Directors, including our Code of Business Conduct and Ethics.

Also available on our website is information relating to corporate governance at Novavax and our Board of Directors, including our Code of Conduct.

We intend to disclose on our website any future amendments to and waivers from this code that apply to our Chief Executive Officer, Principal Financial Officer, Principal Accounting Officer and Controller, and persons performing similar functions, as promptly as practicable, as may be required under applicable SEC and Nasdaq rules.

2 unchanged sentences

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

Table of C onten ts

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

What changed 10-K

Item 1. Business