What changed in this filing

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Item 1. Business

2021-03-01 compared with 2020-03-11 · 551 added, 591 removed, 33 unchanged (97% of the section changed)

Novavax, Inc., together

with our wholly-owned Swedish subsidiary, Novavax AB, is a late-stage biotechnology company that promotes improved global health

through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases.

Using innovative

proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to

both known and emerging disease threats.

We were incorporated

in 1987 under the laws of the State of Delaware.

Our principal executive offices are located at 21 Firstfield Road, Gaithersburg,

Maryland, 20878, and our telephone number is (240) 268-2000.

Our common stock is listed on the Nasdaq Global Select Market under

the symbol “NVAX.”

Our vaccine candidates,

including our lead candidates, NanoFlu™

and ResVax™, are genetically engineered, three-dimensional nanostructures of

recombinant proteins critical to disease pathogenesis and may elicit differentiated immune responses, which may be more efficacious

than naturally occurring immunity or traditional vaccines.

Our technology targets a variety of infectious diseases.

developing proprietary immune stimulating saponin-based adjuvants at Novavax AB, our wholly owned Swedish subsidiary.

adjuvant, Matrix-M™, has been shown to enhance immune responses and has been well-tolerated in multiple clinical trials.

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.

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.”

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Product Pipeline

Development Stage

Seasonal Influenza

NanoFlu (Older Adults) (1)

Respiratory Syncytial Virus (“RSV”)

ResVax (2) (Infants via Maternal Immunization)

Older Adults (1 )

Combination Seasonal Influenza/RSV (1)

Ebola Virus (“EBOV”) (1)

Coronavirus (“COVID-19”) (1)

(1) Includes Matrix-M adjuvant

(2) Supported by a grant of up to $89.1 million from the

Bill & Melinda Gates Foundation (“BMGF”)

A summary and status

of these vaccine programs follows:

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

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

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.

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

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

This genetic construct is inserted into the baculovirus Spodoptera frugiperda (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

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

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

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.

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.

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 .

NVX-CoV2373 Clinical Development

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

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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.

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

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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

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.

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

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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

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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

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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

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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.

Seasonal Influenza

NanoFlu Program (Older Adults)

Influenza is a world-wide

infectious disease with serious illness generally occurring in more susceptible populations such as children under 18 years old

and older adults, but also occurring in the general population.

According to influenza vaccines forecasts by Datamonitor in 2013,

the market for seasonal influenza vaccines is expected to grow from approximately $3.2 billion in the 2015-16 flu season to approximately

$5.3 billion in the 2021-22 flu season (in the countries comprising the top seven markets).

Recent flu seasons have shown an increase

in the influenza disease burden.

For the 2017-18 flu season, the Centers for Disease Control and Prevention estimates that influenza

resulted in 48.8 million illnesses, 959,000 hospitalizations and 79,400 deaths, a dramatic increase across all categories

compared to previous years.

In October 2019, we

initiated a pivotal Phase 3 clinical trial of NanoFlu in older adults (65 years and older).

This randomized, observer-blinded,

active-controlled trial will evaluate the immunogenicity and safety of NanoFlu with its proprietary Matrix-M adjuvant, compared

to a U.S.-licensed quadrivalent vaccine, Fluzone ®

Quadrivalent.

The trial’s primary objective is to demonstrate

non-inferior immunogenicity as measured by hemagglutination inhibition (“HAI”) titers of vaccine homologous influenza

strains compared to a licensed seasonal vaccine, and to describe its safety profile.

In October 2019, we completed enrollment of

2,652 healthy older adults across 19 clinical sites in the U.S.

and we expect to report top-line clinical data by the end of the

first quarter of 2020.

Positive data will support a subsequent U.S.

biologics license application (“BLA”) and licensure

of NanoFlu using the U.S.

Food and Drug Administration’s (“FDA”) accelerated approval pathway.

January 2020, we announced that the FDA granted NanoFlu 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 program is designed to facilitate development and expedite review of drugs to treat serious and life-threatening

conditions so that approved products can reach the market expeditiously.

Specifically, Fast Track designation facilitates meetings

to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling

basis as data become available.

This permits the FDA to review modules of the BLA as they are received instead of waiting for the

entire BLA submission.

In addition, priority review (six-month review versus standard 10-month review) is an additional benefit

that may potentially be available for NanoFlu in the future.

In June 2019, we announced

that the FDA acknowledged that the accelerated approval pathway is available for NanoFlu.

An accelerated approval may be granted

for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening

illnesses and that provide meaningful therapeutic benefit over existing treatments.

Such an approval will be based on adequate

and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably

likely to predict clinical benefit.

For seasonal influenza vaccines, the HAI antibody response is considered an acceptable surrogate

marker of activity that is reasonably likely to predict clinical benefit.

To be considered for accelerated approval, a BLA for

a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity

endpoints along with a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

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.

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.

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.

Data from our Prepare

trial, which was initiated in December 2015, was announced in February 2019.

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 these 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.

ResVax is thus the first RSV vaccine

to show efficacy in a Phase 3 clinical trial, and in addition, showed important effects against a variety of pre-specified exploratory

endpoints and post-hoc analyses.

This included a ~60% reduction in RSV-related severe hypoxemia and a ~74% reduction in RSV-related,

radiographically-confirmed pneumonia through day 90.

As in previous clinical trials, ResVax also showed favorable safety and tolerability

In light of the fact that the trial failed to meet the primary endpoints, the FDA and European Medicines Agency (“EMA”)

recommended that we conduct an additional Phase 3 clinical trial to confirm efficacy.

BMGF has supported the Prepare trial for

ResVax through a grant of up to $89.1 million;

BMGF continues to financially support our efforts to conduct certain follow-on analyses

of the Phase 3 data.

We are currently in discussions with multiple potential commercial partners about the opportunity to bring

ResVax to market globally, including assisting us with the regulatory licensure pathways in the U.S., the European Union and other

RSV Older Adults

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

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.

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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 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

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.

Combination Seasonal Influenza/RSV F

With the ongoing development

of our NanoFlu and RSV F Vaccine, a strong rationale exists for developing a combination respiratory vaccine that is designed to

protect susceptible populations against both diseases.

Although testing is at an early stage, we believe that a combination vaccine

against both influenza and RSV may be achievable.

Ebola virus (“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 no licensed treatments proven to prevent EBOV, although a range

of blood, immunological and drug therapies are under development.

We have developed an

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

In five separate studies, carried out in collaboration with the National Institute of Allergy and Infectious Disease,

active immunization with Ebola GP Vaccine was shown to be highly immunogenic and efficacious in preventing lethal disease in non-human

primates challenged with EBOV.

Our 2015 Phase 1 clinical trial demonstrated that our Ebola GP Vaccine is highly immunogenic in

humans, well-tolerated and, in conjunction with our proprietary Matrix-M adjuvant, demonstrated marked antigen dose-sparing and

induced significant increases in neutralizing antibody titers.

While we intend to advance our Ebola GP Vaccine, doing so will be

dependent upon funding or a partner.

Coronaviruses (“CoV”),

so named for their “crown-like”

appearance, are a large family of viruses that spread from animals to humans and include

diseases such as Middle East Respiratory Syndrome (“MERS”) and Severe Acute Respiratory Syndrome (“SARS”).

Historically, we developed a vaccine candidate against MERS, a novel coronavirus first identified in 2012, as well as 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.

Recently, a new strain

of coronavirus (“COVID-19”) causing pneumonia-like symptoms has emerged in China, marking the beginning of a spread

of the virus across the globe.

Researchers have now confirmed that the virus can spread via human-to-human transmission.

are currently no licensed treatments proven to prevent COVID-19, although a range of vaccine candidates are under development.

We have successfully produced a vaccine candidate designed to provide protection against COVID-19.

Using our recombinant nanoparticle

technology, we have generated antigen for our initial vaccine candidate derived from the coronavirus spike (S) protein.

candidate has been engineered from the genetic sequence of COVID-19 virus and binds efficiently with the same human receptors targeted

by the virus, a critical aspect for effective vaccine protection.

We intend to combine our proprietary Matrix-M adjuvant into our

experimental vaccine candidate to potentially provide an additional immune response.

We were recently awarded initial funding from

the Coalition for Epidemic Preparedness Innovations (“CEPI”) to facilitate our development of a COVID-19 vaccine in

preparation for potential future clinical trials.

A subsequent CEPI award may be available to cover our program expenditures through

Phase 1 clinical trial results.

CPLB Joint Venture

CPL Biologicals Private

Limited (“CPLB”), our joint venture between Novavax and Cadila Pharmaceuticals Limited (“Cadila”), is actively

developing a number of vaccine candidates in India.

CPLB is owned 20% by Novavax and 80% by Cadila.

Vaccine Technology

Our recombinant protein

nanoparticle vaccine technology is based on self-assembly of surface protein antigens from pathogenic organisms including viruses,

bacteria or parasites.

The conformations of these nanoparticles are similar but not identical to the natural structure of surface

antigens of disease organisms, and lack the genetic material required for replication and therefore are not infectious.

immunological advantages of protein nanoparticles may be associated with the nanoparticle conformation and the presentation of

key functional epitopes that are often immunologically hidden in the native pathogen.

This leads to efficient recognition by the

immune system’s antigen presenting cells that trigger robust immune responses.

Recognition of the nanoparticle vaccine’s

repeating protein patterns by the antigen presenting cells’

toll-like receptors to stimulate innate immunity and the high

purity and lack of synthetic material adds to the potential safety of recombinant nanoparticle vaccines.

Protein nanoparticle vaccine

technology has expanded our early-stage vaccines in development to include both virus and non-virus disease targets.

Our most advanced

protein nanoparticle vaccine candidate is our RSV F Vaccine, which self-assembles from our highly purified F-protein antigen.

Matrix Adjuvants

Adjuvants are predominantly

used to enable a vaccine to increase the amplitude of the immune response and qualitatively change it, broadening the immune system’s

attack against microorganisms and allowing for effective immunization with much lower doses of antigen.

Novavax AB has developed

a number of adjuvant formulations, all based on our proprietary Matrix technology.

These adjuvant formulations possess excellent

immunostimulatory features with the ability to increase and prolong the protective benefits of vaccines.

While adjuvants based

on novel, poorly characterized substances have been hampered by safety concerns and limited efficacy, Matrix adjuvants stimulate

strong antibody and cell-mediated immune responses.

Matrix adjuvants may allow for lower antigen doses, longer-duration immune

responses and carry a lower risk for allergic reactions or other adverse events.

Our Matrix technology typically induces strong

cellular activation of both Th1 and Th2 types, thereby generating all classes and subclasses of antibodies, as well as potent cellular

responses, including cytotoxic T lymphocytes.

Our Matrix-M adjuvant provides a potent adjuvant effect that has been well-tolerated

in clinical trials.

We also believe that the strong immune response and opportunity to reduce the quantity of antigen dose can

significantly reduce the production cost of our vaccines.

This means that our Matrix-M adjuvant has the potential to be of significant

value when there is inadequate vaccine manufacturing capacity during an emerging disease threat such as an influenza pandemic.

Competition in RSV and Influenza

The vaccine market

is intensely competitive, characterized by rapid technological progress.

Our technology is based upon utilizing the baculovirus

expression system in insect cells to make recombinant vaccines.

We believe this system offers many advantages when compared to

other technologies and is uniquely well-suited for developing RSV and influenza vaccines, as well as vaccines against a number

of other infectious diseases.

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.

Despite the announcement of results from

the Prepare trial of ResVax, 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,

and may prove effective.

We further believe that ResVax, our RSV vaccine program for infants via maternal immunization, is the

only RSV vaccine to have ever demonstrated some degree of efficacy in a Phase 3 clinical trial.

At this time, there are a number

of companies and other organizations with vaccine candidates in Phase 1 and 2 trials, including Pfizer, GlaxoSmithKline, Sanofi,

Bavarian Nordic, Janssen, Moderna, Ablynx, Immunovaccine, Intravaac, Vaxart and the NIAID.

Presently, the two lead Mab programs

seeking to develop product candidates to prevent RSV in infants are being conducted by AstraZeneca PLC (“AstraZeneca”),

The AstraZeneca Mab, Nirsevimab (previously known as MEDI-8897), which is partnered with Sanofi Pasteur and Swedish

Orphan Biovitrum AB, completed Phase 2 trials for preterm infants and is in Phase 3 trial for full-term infants.

Additionally,

it has obtained Breakthrough designation from the FDA.

The Merck Mab MK-1654 is currently in Phase 2 trials in preterm and full-term

There are a number

of companies developing and selling vaccines for seasonal influenza employing both traditional (egg-based) and new vaccine technologies

(cell-based).

Many seasonal influenza vaccines are currently approved and marketed, and most of these are marketed by major pharmaceutical

companies that have significantly greater financial and technical resources, experience and expertise.

Competition in the sale

of seasonal influenza vaccines is intense.

For the older adult segment, Sanofi currently supplies Fluzone-HD®

and Flublok®

to the majority (>60%) of U.S.

older adults.

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.

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 2 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.

However, our seasonal influenza vaccine may not prove to be efficacious or our manufacturing system

may not prove to be sufficiently effective and differentiated to ensure commercial success.

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’

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.

Other factors affecting

our competitive position include our ability to attract and retain qualified personnel, obtain patent protection or otherwise develop

proprietary products or processes and secure sufficient capital resources for the lengthy period between technological conception

and commercial sale.

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.

Competition in COVID-19, Influenza and RSV

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

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.

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.

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

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

Competition in the sale of seasonal influenza vaccines is intense.

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

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.

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.

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.

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

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

Patents and Proprietary Rights

We generally seek

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

The patent position of biotechnology and pharmaceutical

firms generally is highly uncertain and involves complex legal and factual questions.

Our success will depend, in part, on whether

obtain patents

to protect our own technologies and product candidates;

obtain licenses

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

our trade secrets and know-how;

without infringing the intellectual property and proprietary rights of others.

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

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

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

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

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

• protect our trade secrets and know-how;

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

Patent Rights;

We have intellectual

property (patents, licenses, know-how) related to our vaccines, manufacturing processes and other technologies.

Currently, we have

or have rights to over 400 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.

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.

We have intellectual property (patents, licenses, know-how) related to our vaccines, manufacturing processes and other technologies.

Currently, we have or have rights to over 450 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.

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

Corresponding European patent, European Patent No.

1644037 also covers this technology.

8,080,255, 8,551,756,

8,506,967 and 8,592,197 are directed to methods of producing VLPs and inducing substantial immunity to an influenza virus infection

by administering VLPs comprising HA and NA proteins, and our M1 protein derived from the avian influenza strain, A/Indonesia/5/05.

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

than the influenza HA protein and the influenza NA protein.

Related patent protection in Europe is provided by European Patent

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.

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

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

Our VLP patent portfolio

contains many other patents, including U.S.

8,951,537, 8,992,939, 9,144,607, 9,050,290, 9,180,180, 9,381,239, 9,464,276,

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

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

jurisdictions.

We also have issued

patents directed to other core programs, including our RSV and influenza programs.

Issued patents directed to various aspects of

the RSV program include U.S.

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

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

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

Additional patents

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

Patents related to our rabies program include

9,724,405 and 10,086,065 in the U.S.

and EP2635257 in Europe.

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

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

Related patents have been issued in other world markets.

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

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

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

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

We continue to prepare,

file, and prosecute patent applications to provide broad and strong protection of our proprietary rights, including next generation

applications focused on our RSV Program, our influenza nanoparticle program, and our adjuvant program.

The Federal Technology

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

expired contract with the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (“HHS

BARDA”) provided us with the right to retain ownership in our inventions that may have arisen during performance of that

contract, with respect to certain other collaborative research efforts with the U.S.

government, certain developments and results

that may have commercial potential are to be freely published, not treated as confidential, and we may be required to negotiate

a license to developments and results in order to commercialize products.

There can be no assurance that we will be able to successfully

obtain any such license at a reasonable cost, or that such development and results will not be made available to our competitors

on an exclusive or non-exclusive basis.

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

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

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

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

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

While our expired contract with the U.S.

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

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

There can be no assurance that we will be able to successfully obtain any such license at a reasonable cost, or that such development and results will not be made available to our competitors on an exclusive or non-exclusive basis.

Trade Secrets

We also rely significantly

on trade secret protection and confidentiality agreements to protect our interests.

It is our policy to require employees, consultants,

contractors, manufacturers, collaborators and other advisors to execute confidentiality agreements upon the commencement of employment,

consulting or collaborative relationships with us.

We also require confidentiality agreements from any entity that is to receive

confidential information from us.

With respect to employees, consultants and contractors, the agreements generally provide that

all inventions made by the individual while rendering services to us shall be assigned to us as our property.

We also rely significantly on trade secret protection and confidentiality agreements to protect our interests.

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

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

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

Government Regulations

The development, production

and marketing of biological products, which include the vaccine candidates being developed by Novavax or our collaborators, are

subject to regulation for safety, efficacy and quality by numerous governmental authorities in the U.S.

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

and other countries.

we focus on the U.S.

regulatory process and the standards imposed by the FDA, the International Conference on Harmonisation (“ICH”)

and other agencies because we believe meeting U.S.

and ICH standards generally allows us to satisfy regulatory agencies in other

countries where we intend to do business;

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.

Although we focus on the U.S.

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

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

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.

regulatory agencies.

In the U.S., the development, manufacturing and marketing

of human pharmaceuticals and vaccines are subject to extensive regulation under the Federal Food, Drug, and Cosmetic Act, and biological

products are subject to regulation under provisions of that act and the Public Health Service Act.

The FDA not only assesses the

safety and efficacy of these products but it also regulates, among other things, the testing, manufacture, labeling, storage, record-keeping,

advertising and promotion of such products.

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

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

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

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 and what we propose to do for human testing.

At this stage,

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

We must then conduct

Phase 1 clinical trials and larger-scale Phase 2 and 3 clinical trials that demonstrate the safety, immunogenicity and efficacy

of our vaccine candidate to the satisfaction of the FDA.

Following successful completion of all three phases of clinical development,

a BLA can be submitted to the FDA requesting licensure of the vaccine for marketing based on the vaccine’s safety and efficacy.

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

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and what we propose to do for human testing.

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

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

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

Similar pathways exist in Europe and other geographies.

The FDA will only approve

a BLA if the vaccine is demonstrated to be safe, pure and potent.

During the FDA’s review of a BLA, the proposed manufacturing

facility undergoes a pre-approval inspection during which the FDA examines in detail the production of the vaccine, the manufacturing

facility and the quality documentation related to the vaccine.

Vaccine licensure also requires the provision of adequate product

labeling to allow health care providers to understand the vaccine’s proper use, including its potential benefits and risks,

to communicate with patients and parents, and to safely deliver the vaccine to the public.

Until a vaccine is given to the general

population, all potential adverse events cannot be anticipated.

Thus, the FDA typically requires Phase 4 post-marketing clinical

trials for vaccines after licensure to continue gathering safety, and sometimes effectiveness/efficacy data in the indicated and

additional populations.

In order to ensure

continuing safety, the FDA and most other non-U.S.

based regulatory agencies continue to oversee the production of vaccines even

after the vaccine and manufacturing processes are approved.

For example, monitoring of the vaccine and of production activities,

including periodic facility inspections, must continue as long as the manufacturer holds a license for the product.

Manufacturers

may also be required to submit the results of their own tests for potency, safety and purity for each vaccine lot, if requested

by the relevant regulatory agency.

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

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

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

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

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

The Commissioner of the FDA may, under delegated authority from the Secretary of the DHHS, and under certain circumstances, issue an EUA, that would permit the use of an unapproved medical product or unapproved use of an approved medical product to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.

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

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

The EUA is only effective for the duration of the public health emergency.

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

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

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

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

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

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

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

In addition to obtaining

FDA licensure for each product, each domestic manufacturing establishment must be registered with the FDA, is subject to FDA inspection

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

To supply products for use either in

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

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

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

and foreign manufacturing establishments, including third-party facilities,

must comply with GMP regulations and are subject to periodic inspection by the FDA or by corresponding regulatory agencies in their

home country.

In 1992, the FDA instituted

regulations that allow accelerated approval of certain products that treat serious or life-threatening illnesses and provide meaningful

therapeutic benefit over existing treatments based on a surrogate endpoint, versus a clinical outcome, which can take many more

years to demonstrate.

Surrogate endpoints, generally a laboratory measurement or other physical sign shown to have some correlation

with clinical benefit, can considerably shorten the development time leading up to FDA licensure.

The FDA bases its decision on

whether to accept a proposed surrogate endpoint on the scientific support for that endpoint.

The company developing the product

is required to conduct further studies to confirm the clinical benefit in Phase 4 confirmatory efficacy trials.

In June 2019, we

announced that the FDA acknowledged that the accelerated approval pathway is available for NanoFlu.

In addition to regulatory

approvals that must be obtained in the U.S., an investigational product is also subject to regulatory approval in other countries

in which it is intended to be marketed.

No such product can be marketed in a country until the regulatory authorities of that country

have approved an appropriate marketing application.

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

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

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

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

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

The FDA may hold meetings with the sponsor throughout the development process;

provide timely advice to the product sponsor regarding development and approval;

involve more senior staff in the review process;

assign a cross-disciplinary project lead for the review team;

and take other steps to design the clinical trials in an efficient manner.

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

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

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

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

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

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

In June 2019, we announced that the FDA acknowledged that the accelerated approval pathway is available for NanoFlu.

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

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

FDA licensure does not guarantee approval by other regulatory authorities.

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

In such cases, the pricing review period

often begins after market approval is granted.

We are also subject

to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act,

the Resource Conservation and Recovery Act and other present and potential federal, state or local regulations, including national

and local regulations that govern our facility in Sweden.

These and other laws govern our use, handling and disposal of various

biological and chemical substances used in, and waste generated by our operations.

Our research and development involves the controlled

use of hazardous materials, chemicals and viruses.

Although we believe that our safety procedures for handling and disposing of

such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury

from these materials cannot be completely eliminated.

In the event of such an accident, we could be held liable for any damages

that result and any such liability could exceed our resources.

Additionally, for formulations containing controlled substances,

we are subject to Drug Enforcement Act regulations.

In both domestic and

foreign markets, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the

availability of reimbursement from third-party payers.

Third-party payers include government authorities or programs, private health

insurers (including managed care plans) and other organizations.

These third-party payers are increasingly challenging the price

and examining the cost-effectiveness of medical products and services.

In addition, significant uncertainty exists as to the reimbursement

status of newly approved healthcare products.

We may need to conduct expensive pharmacoeconomic studies in order to demonstrate

the cost-effectiveness of our products.

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

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

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

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

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

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

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

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

Third-party payers include government authorities or programs, private health insurers (including managed care plans) and other organizations.

These third-party payers are increasingly challenging the price and examining the cost-effectiveness of medical products and services.

In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products.

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

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

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

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.

Within the U.S., if

we obtain appropriate approval in the future to market any of our product candidates, those products could potentially be covered

by various government health benefit programs as well as purchased by government agencies.

The participation in such programs or

the sale of products to such agencies is subject to regulation.

In exchange for coverage, we may be obligated to provide rebates

or offer discounts under government health programs or to government and private purchasers.

governments continue to propose and pass legislation designed to reform delivery of, or payment for, health care, including initiatives

to reduce the cost of healthcare.

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.

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

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

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

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

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

Congress enacted the Patient Protection and Affordable Care

Act and the Health Care and Education Reconciliation Act (“Healthcare Reform Act”) which includes changes to the coverage

and reimbursement of drug products under government health care programs.

Under the Trump administration, there have been ongoing

efforts to modify or repeal all or certain provisions of the Healthcare Reform Act, and some modifications have been implemented.

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

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

Adoption of price controls and cost-containment measures and

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

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

For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2030 due to subsequent legislative amendments contained in the Coronavirus Aid, Relief, and Economic Security Act, commonly referred to as the “CARES Act”.

In November 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued an interim final rule that seeks to lower prescription drug costs by paying no more for certain Medicare Part B drugs than the lowest price paid for such drugs in certain other countries (the "Most Favored Nation Rule”).

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

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

On December 28, 2020, the U.S.

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

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

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

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

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

of pharmaceutical pricing and proposals to address

the perceived high cost of pharmaceuticals.

There have also been several recent state legislative efforts to address drug costs,

which generally have focused on increasing transparency around drug costs or limiting drug prices or price increases.

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

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

There have also been several recent state legislative efforts to address drug costs, which generally have focused on increasing transparency around drug costs or limiting drug prices or price increases.

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

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

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

There is no assurance that

federal or state health care reform will not adversely affect our future business and financial results.

Within the U.S., we

may be subject to various federal and state laws pertaining to health care “fraud and abuse,”

including anti-kickback

laws and false claims laws, for activities related to future sales of any of our product candidates that may in the future receive

regulatory and marketing approval.

Anti-kickback laws generally prohibit a pharmaceutical manufacturer from soliciting, offering,

receiving or paying any remuneration to generate business, including the purchase, prescription or use of a particular drug.

the specific provisions of these laws vary, their scope is generally broad and there may not be regulations, guidance or court

decisions that apply the laws to particular industry practices.

There is therefore a possibility that our practices might be challenged

under such anti-kickback laws.

False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented,

any claims for payment for reimbursed drugs or services to third party payers (including Medicare and Medicaid) that are false

or fraudulent.

Laws and regulations

have been enacted by the federal government and various states to regulate the sales and marketing practices of pharmaceutical

manufacturers with marketed products.

The laws and regulations generally limit financial interactions between manufacturers and

health care providers and/or require disclosure to the government and public of such interactions.

Many of these laws and regulations

contain ambiguous requirements or require administrative guidance for implementation.

Given the lack of clarity in laws and their

implementation, any future activities (if we obtain approval and/or reimbursement from federal healthcare programs for our product

candidates) could be subject to challenge.

Manufacturing

Our primary manufacturing

facility is located in Uppsala, Sweden, where Novavax AB produces our Matrix adjuvants in an approximately 24,000 square foot facility

comprised of GMP manufacturing, laboratory and office space.

Sources of Supply

Most of the raw materials

and other supplies required in our business are generally available from established vendors in quantities adequate to meet our

In some cases, only one vendor has been qualified for certain of our manufacturing components.

Prior to the initiation of

commercial production, we plan, where feasible, to qualify multiple vendors of critical raw materials.

One key vendor is GE Healthcare

Company (“GEHC”), which supplies disposable components, resins, media and buffers used in our manufacturing process.

GEHC and other vendors that supply our key manufacturing materials have been or will be audited for compliance with GMP standards.

An important component

of our Matrix adjuvant technology is extracted from a species of soap-bark tree ( Quillaja saponaria ) that grows mainly in

Chile, and we have been able to acquire high-quality quillaja extract as needed from our current suppliers.

Business Development

We strive to create

sustainable value by evaluating all options, including working to obtain non-dilutive funding, similar to our agreement with BMGF

related to our maternal RSV program, from both governmental and non-governmental funding sources, that would allow for:

continued development

of our vaccine candidates until such vaccines can be licensed;

retained commercial

rights in one or more major markets;

product sales revenue;

commercialization through

partners and other strategic relationships.

As of March 6, 2020,

we have 165 full-time employees, of whom 24 hold M.D.

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

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

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

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

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

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

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

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

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

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

On November 20, 2020, the DHHS published a Final Rule entitled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection,” commonly referred to as the “Rebate Rule”, which amends the federal Anti-Kickback Statute discount safe harbor by eliminating protection for price concessions, including rebates, that are offered by pharmaceutical manufacturers to plan sponsors, or pharmacy benefit managers under contract with them, under the Medicare Part D program and Medicare Advantage Plans, unless the price reduction is one required by law.

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

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

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

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

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

At this time we cannot predict how these changes 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

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

Bribery Act 2010.

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

We are also subject to the U.S.

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

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

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

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

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

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

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

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

or the sharing with certain non-U.S.

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

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

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

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

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

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

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

exchanges for violations of the FCPA’s accounting provisions.

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

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

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

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

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

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

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

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

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

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

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Union Member States.

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

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

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

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

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

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

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

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

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

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

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

Claims could also be asserted under state consumer protection acts.

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

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

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

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

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

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

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

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

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

HUMAN CAPITAL

As of February 24, 2021, we have 791 full-time employees, of whom 90 hold M.D.

degrees and 189 of whom hold other advanced degrees.

workforce, 127 are engaged primarily in research, development and manufacturing activities and 38 are engaged primarily in executive,

business development, finance and accounting, legal and administrative functions.

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.

None of our U.S.

employees are represented by

labor unions or covered by collective bargaining agreements;

48 of our 49 Swedish employees are covered by typical collective bargaining

We consider our relations with our employees to be good.

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

68 of our 69 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

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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.

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.

Recruitment, Development and Training

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

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.

In the last 12 months, videos were viewed and completed over 7000 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.

Internal Communications

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

Our executive leadership team continues to recognize the importance of increased employee engagement.

Diversity and Inclusion

Our culture of diversity, equity and inclusion 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.

Availability of Information

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.

The SEC maintains an Internet site

that contains reports, proxy and information statements, and other information regarding issuers that file electronically with

the SEC at www.sec.gov .

We use our website

(www.novavax.com) as a means of disclosing material non-public information and for complying with our disclosure obligations under

Regulation Fair Disclosure promulgated by the SEC.

These disclosures are included on our website (www.novavax.com) in the “Investors”

or “News”

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

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.

We webcast our earnings

calls and certain events we participate in or host with members of the investment community on the investor relations section of

Additionally, we provide notifications of news or announcements regarding press and earnings releases as part of the

investor relations section of our website.

The contents of our website are not part of this Annual Report on Form 10-K, or any

other report we file with, or furnish to, the SEC.

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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.

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

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

These disclosures are included on our website (www.novavax.com) in the “Investors” or “News” sections.

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.

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.

We webcast our earnings calls and certain events we participate in or host with members of the investment community on the investor relations section of our website.

Additionally, we provide notifications of news or announcements regarding press and earnings releases as part of the investor relations section of our website.

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

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

What changed 10-K

Item 1. Business