What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2021-11-05 compared with 2021-08-05 · 202 added, 307 removed, 210 unchanged (71% of the section changed)

8 unchanged sentences

the development of our preclinical product candidates;

our expectations related to enrollment in our clinical trials;

the conduct, timing and potential results from clinical trials and other preclinical studies;

plans for and potential timing of regulatory filings;

our expectation of manufacturing capacity, timing, production and delivery for NVX-CoV2373;

our expectation of manufacturing capacity, timing, production, distribution and delivery for NVX-CoV2373 by us and our partners;

our expectations with respect to the anticipated ongoing development and potential commercialization or licensure of NVX-CoV2373 and NanoFlu™;

the expected timing and content of regulatory actions;

the expected timing, content and outcomes of regulatory actions;

funding from the U.S.

10 unchanged sentences

Such risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy each applicable regulatory authority, like the U.S.

Food and Drug Administration (“FDA”), World Health Organization (“WHO”), UK Medicines and Healthcare Products Regulatory Agency (“MHRA”), the European Medicines Agency (“EMA”), the Republic of Korea’s Ministry of Food and Drug Safety (“MFDS”), or Japan’s Ministry of Health, Labour and Welfare (“MHLW”);

Food and Drug Administration (“FDA”), World Health Organization (“WHO”), United Kingdom (“UK”) Medicines and Healthcare Products Regulatory Agency (“MHRA”), the European Medicines Agency (“EMA”), the Republic of Korea’s Ministry of Food and Drug Safety (“MFDS”), or Japan’s Ministry of Health, Labour and Welfare (“MHLW”);

difficulty obtaining scarce raw materials;

13 unchanged sentences

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

Matrix-M ™ Adjuvant

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

Our proprietary Matrix-M ™ 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 ™ adjuvant has been shown to increase neutralizing antibodies and induce 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 in preclinical models.

The potent immune-stimulating mechanism of action 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.

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

Our Matrix-M ™ adjuvant is being evaluated in combination with several malaria vaccine candidates, including in a Phase 3 trial for R21, a malaria vaccine candidate created by the Jenner Institute, University of Oxford.

The University of Oxford has partnered with SIIPL for commercial development of R21 and has granted them a license for the vaccine.

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

We believe the use of our Matrix-M ™ adjuvant in R21 may present a significant commercial opportunity for our adjuvant, pending possible licensure.

Near-term Clinical Development Pipeline

Our development pipeline encompasses vaccine candidates addressing therapeutic areas including coronavirus, seasonal influenza, respiratory syncytial virus (“RSV”) and other emerging infectious diseases.

At the forefront of our pipeline is NVX-CoV2373.

We have advanced NVX-CoV2373 through two Phase 3 clinical trials, which have demonstrated high efficacy against the original COVID-19 strain and commonly circulating variants of COVID-19 with a favorable safety profile.

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

We continue to evaluate the viability of certain combination vaccines, including combinations of our NanoFlu ™ , NVX-CoV2373 and respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”).

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

At the forefront of our pipeline is our COVID-19 vaccine candidate, NVX-CoV2373.

We advanced NVX-CoV2373 through two Phase 3 clinical trials, which demonstrated high efficacy against both the original COVID-19 strain and commonly circulating COVID-19 variants of concern ("VoC"), while maintaining a favorable safety profile.

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

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

RSV F Vaccine may be considered for further development.

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

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

We expect to leverage these clinical insights to advance our booster strategy given the evolving COVID-19 pandemic.

In addition to our COVID-19 clinical development, NanoFlu ™ continues to be a priority for our team, especially as it relates to development of our NanoFlu ™ / NVX-CoV2373 combination vaccine candidate (“qNIV/CoV2373”).

We expect to leverage these clinical insights to advance the use of our COVID-19 vaccine for both primary vaccination around the globe and to further develop a booster strategy amidst the ongoing and evolving COVID-19 pandemic.

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.

The pipeline chart below summarizes the clinical and preclinical development programs that we are focusing on in the near-term.

The pipeline chart below summarizes the clinical and preclinical development programs that we are focused on in the near-term.

We will continue to evaluate areas of development focus over time.

(1) Supported by funding from OWS, DoD, CEPI and BMGF

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

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

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

Ongoing Phase 3 clinical trial in the UK;

Ongoing Phase 2b clinical trial in South Africa

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

Ongoing Phase 3 clinical trial in Africa;

R21 is licensed to Serum Institute of India Private Limited ("SIIPL");

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

(4) Reflects malaria transmission blocking vaccine candidate (“R0.6C”) manufactured by Statens Serum Institut;

Ongoing Phase 1 clinical trial in the Netherlands to evaluate R0.6C, Matrix-M ™ adjuvant and common aluminum hydroxide adjuvant

Matrix-M ™ Adjuvant

Our Matrix-M ™ adjuvant 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 in preclinical models.

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

Our Matrix-M ™ adjuvant is being evaluated in combination with several other vaccine antigens produced by other manufacturers.

Phase 3 clinical trial in the UK

NVX-CoV2373 Clinical Development

We have evaluated NVX-CoV2373 in various preclinical and clinical trials, including two Phase 3 trials, one Phase 2b trial, and one Phase 1/2 trial.

Through our clinical development program to date, we confirmed the use of a 5-microgram dose of NVX-CoV2373 with Matrix-M ™ adjuvant for late-stage development.

We have also collected data that indicates a reassuring safety profile and high levels of efficacy for NVX-CoV2373 against original COVID-19 strain and commonly circulating variants.

A summary and status of our clinical development of NVX-CoV2373 follows:

PREVENT-19 Pediatric Expansion

In June 2021, we completed enrollment of the pediatric expansion of our PREVENT-19 Phase 3 trial in the U.S.

that was initiated in April 2021.

The pediatric expansion is a placebo-controlled study to evaluate efficacy, safety, and immunogenicity of NVX-CoV2373 in 2,248 adolescent participants aged 12 to 17 across up to 75 sites in the U.S.

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

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

All primary doses have been administered and a blinded crossover is planned to take place in August 2021 to ensure that all trial participants receive active vaccine before the start of the 2021-2022 school year.

Participants will be monitored for safety for up to two years following the final administered dose.

Our lead vaccine candidate, NVX-CoV2373 has progressed through multiple clinical trials, including two Phase 3 trials, one Phase 2b trial, and one Phase 1/2 trial.

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

and Mexico, and PREVENT-19 pediatric expansion trials.

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

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

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

PREVENT-19 Phase 3 U.S.

In June 2021, we announced results from the final analysis of our PREVENT-19 Phase 3 trial in the U.S.

and Mexico initiated in December 2020.

The final analysis was conducted on events accrued prior to participants receiving crossover vaccine.

In the final analysis, NVX-CoV2373 achieved its primary efficacy endpoint with an overall efficacy of 90.4% despite over half the illness cases being caused by Variants of Interest ("VoI") and Variants of Concern ("VoC").

Additionally, NVX-CoV2373 demonstrated 100% protection against moderate and severe disease, including those caused by variants.

PREVENT-19 was a randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in 29,960 participants aged 18 years or older across 119 sites in the U.S.

PREVENT-19 was a randomized, placebo-controlled, observer-blinded Phase 3 trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in 29,960 participants aged 18 years or older across 119 sites in the U.S.

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

The participant trial population was composed of the following:

22% Latin American, 12% African American, 7% Native American, 4% Asian American, 37% with underlying medical co-morbidities and 13% older adults aged 65 years and older.

The trial design was 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.

The trial’s primary endpoint was the first occurrence of PCR-confirmed, symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study

vaccination in participants who had not been previously infected with SARS-CoV-2.

Two-thirds of the participants were assigned to randomly receive two intramuscular injections of NVX-CoV2373 comprising 5 micrograms of antigen with 50 micrograms of Matrix-M ™ adjuvant, administered 21 days apart, while one-third of the trial participants received placebo.

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

Efficacy endpoints were accrued from January 25, 2021, through April 30, 2021, at a time when the Alpha (B.1.1.7) variant strain became the predominant strain in the U.S.

Other strains, including VoI and VoC, were also on the rise during the PREVENT-19 endpoint accrual window.

PREVENT-19 met a key secondary endpoint, demonstrating 100% efficacy against variants not considered VoC/VoI.

NVX-CoV2373 also demonstrated 92.6% efficacy against VoC/VoI, achieving a key exploratory endpoint of the study.

Among high-risk populations (participants over age 65, under age 65 with certain comorbidities, or having life circumstances with frequent COVID-19 exposure), NVX-CoV2373 demonstrated 91.0% efficacy.

Preliminary safety data showed NVX-CoV2373 to be generally well-tolerated, with serious and severe adverse events low in number and balanced between vaccine and placebo groups.

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

In October 2021, the final analysis of our PREVENT-19 Phase 3 trial in the U.S.

and Mexico was submitted for peer review and is available ahead of publication via the preprint server on medRxiv.

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

NVX-CoV2373 achieved its primary endpoint with an overall efficacy of 90.4% despite the majority (82%) of the sequenced cases of illness being attributed to Variants of Interest and VoC.

Notably, NVX-CoV2373 demonstrated 100% protection against moderate and severe disease, including those caused by variants.

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

Phase 3 United Kingdom (“UK”)

In August 2021, the U.S.

Centers for Disease Control and Prevention (“CDC”) provided guidance for our PREVENT-19 participants in the U.S.

stating that they meet the criteria to be considered fully vaccinated two weeks after completion of the active vaccine series.

With the CDC’s validation, we expect our participants to be considered fully vaccinated and in compliance with mandated vaccination policies.

PREVENT-19 Pediatric Expansion

In June 2021, we completed enrollment of the pediatric expansion of our PREVENT-19 Phase 3 trial in the U.S.

that was initiated in April 2021.

The pediatric expansion is a placebo-controlled trial to evaluate efficacy, safety, and immunogenicity of NVX-CoV2373 in 2,248 adolescent participants aged 12 to 17 years across up to 75 sites in the U.S.

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

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

All primary and crossover doses have been administered.

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

We expect to have a regulatory package available for global submission in the first quarter of 2022.

The subsequent pediatric clinical development plan has been agreed to by the FDA, MHRA and European Medicines Agency (“EMA”) and be initiated after this adolescent study reads out.

In June 2021, the final analysis of our Phase 3 UK trial was published in the New England Journal of Medicine .

2 unchanged sentences

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

The final analysis also demonstrated that initial vaccine side effects were mostly mild and transient, and that no imbalance was seen in more serious adverse events compared with the placebo arm.

The final analysis builds upon the interim analysis conducted in January 2021 and updated analysis announced in March 2021.

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

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

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

Phase 3 UK Co-Administration Sub-Study

In June 2021, we announced data from the co-administration sub-study of NVX-CoV2373 and an approved influenza vaccine, conducted as part of our Phase 3 UK trial.

In this study, 431 participants enrolled in our Phase 3 UK trial received an approved seasonal influenza vaccine (Seqirus, adjuvanted, trivalent seasonal influenza vaccine or a cell-based quadrivalent seasonal influenza vaccine).

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

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

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

Phase 3 UK Influenza Co-Administration Sub-Study

In October 2021, the final analysis of our Phase 3 UK influenza co-administration sub-study was accepted by a peer-reviewed journal and is available ahead of publication via the preprint server on medRxiv.

Previously, we announced data from this sub-study in June 2021.

In this sub-study, 431 participants from our Phase 3 UK trial received an approved seasonal influenza vaccine (Seqirus, adjuvanted, trivalent seasonal influenza vaccine or a cell-based quadrivalent seasonal influenza vaccine).

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

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

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

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

The majority of local and systemic reactogenicity events were absent or mild, with small increases in pain and tenderness at the injection site and muscle aches being elevated amongst participants who were co-vaccinated with NVX-CoV2373 and influenza vaccine.

Rates of severe adverse events ("SAEs") were low in all groups, and there were no additional early safety concerns associated with co-administration.

Rates of unsolicited adverse events (“AEs”), medically attended AEs, and SAEs were low and balanced between the groups.

Data from this study have been submitted for peer review and are available ahead of publication via the preprint server on medRxiv.

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

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

Phase 2b South Africa

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

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

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

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

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

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

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

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

While the interim analysis announced in January 2021 reported that prior infection with the original COVID-19 strain may not completely protect against subsequent infection by the variant predominantly circulating in South Africa, the complete analysis indicated that there may be a late protective effect of prior exposure with the original COVID-19 strain.

In placebo recipients, at 90 days the illness rate was 8.0% in baseline seronegative participants, with a rate of 5.9% in baseline seropositive participants.

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

NVX-CoV2373 Booster and Crossover Studies

Novavax-Led Crossover Studies

In April 2021, we initiated crossover arms in our Phase 3 UK, Phase 2b South Africa and PREVENT-19 Phase 3 trials.

In June 2021, we completed crossover arms in our Phase 3 UK trial.

As of August 2021, our Phase 2b South Africa and PREVENT-19 crossover arms are ongoing.

In our Phase 3 UK and PREVENT-19 trials, participants were offered the opportunity to receive an additional round of injections.

Participants who elected to do so received an additional two-dose regimen of either vaccine for those who originally received placebo or placebo for those who originally received vaccine.

In our Phase 2b South Africa trial, participants will receive either active vaccine for those who initially received placebo or a booster dose of active vaccine for those who initially received active vaccine.

Throughout our crossover arms, participants in all of our trials will remain blinded to their courses of treatment to preserve the ability to assess clinical data in an unbiased manner.

NVX-CoV2373 Booster Studies

Novavax-Led Booster Study

1 unchanged sentence

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

In this booster study, select participants in the 5 microgram dose cohort from the Phase 2 portion of the Phase 1/2 trial received a third 5 microgram dose (a booster dose) at six months to examine the functional immune response of our vaccine candidate.

Results from this study showed that twenty-eight days following boosting, anti-spike IgG increased approximately 4.6-fold compared to the peak response seen after the second dose (Day 217 GMEU = 200,408 (95% CI:

This boosted value represents a 3.7 to 4.4-fold increase in anti-spike IgG values that were associated with protection in our PREVENT-19 and Phase 3 UK trials.

Similarly, wild-type neutralization responses increased approximately 4.3-fold compared to the peak response seen after Dose 2 (IC50 neutralization titers = 6,231 (95% CI:

This boosted value represents a 4.6 to 5.5-fold increase over the neutralization response associated with protection in our PREVENT-19 and Phase 3 UK trials.

The data showed that functional hACE-2 inhibitory antibodies were induced with primary vaccination against Alpha (B.1.1.7), Beta (B.1.351) and Delta and that these levels increased 6- to 10-fold following a single 6-month boost with prototype vaccine.

Additionally, functional ACE-2 binding inhibition antibodies cross-reactive with the Delta (B.1.617.2) variant strain were more than 6-fold higher than the primary vaccination series.

The administration of booster doses was generally well-tolerated.

Local and systemic reactogenicity increased between dose one, dose two, and dose three, with 90% of symptoms rated as mild or moderate after the third dose.

Mix-and-Match COVID-19 Vaccine Booster Trial ("Cov-Boost")

In July 2021, enrollment was completed in Cov-Boost, a mix-and-match (vaccine interchangeability) COVID-19 vaccine booster trial, for which we announced our participation in May 2021.

The trial, which was initiated in June 2021, enrolled 2,886 participants aged 30 years and older.

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

Of the 2,886 participants enrolled, 230 participants received a full dose of NVX-CoV2373, while 216 participants received a half volume dose of NVX-CoV2373.

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

The trial is led by the University Hospital Southampton NHS

Foundation Trust and other UK National Institute for Health Research sites.

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

Comparing COVID-19 Vaccine Schedule Combinations - Stage 2 ("Com-COV2")

In May 2021, enrollment was completed in Com-COV2, a newly expanded investigator-initiated Phase 2 clinical trial, for which we announced our participation in April 2021.

The trial enrolled 1,072 adults aged 50 years and older who received their first vaccination during the previous 8-12 weeks.

NVX-CoV2373 is one of four COVID-19 vaccines that is being studied to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19.

Participants received one of four different vaccines as a second dose, 359 of whom were administered NVX-CoV2373.

The trial compares the immune system responses from those who receive a heterologous regimen to those who receive a homologous regimen.

Participants in this non-inferiority study are followed for reactogenicity (safety) and immune responses.

The trial is conducted by the University of Oxford and supported by the UK government Vaccines Taskforce.

The MHRA and Joint Committee on Vaccination and Immunisation formally assesses the safety and efficacy of any new vaccination regiment before it is made available to the public.

NVX-CoV2373 Clinical Development Conducted by Partners

Phase 2/3 India

In March 2021, SIIPL initiated a Phase 2/3 clinical trial of NVX-CoV2373 in India.

The initial cohort was fully enrolled in April 2021 and the total study includes approximately 1,600 participants aged 18 to 65 years.

Phase 1/2 Japan

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

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

Variant Strain (Monovalent and/or Bivalent) Vaccine Development

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

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

We are currently evaluating multiple variant strain vaccine candidates, including a recombinant spike protein antigen based on the Beta (B.1.351) virus lineage (“rS-B.1.351”).

COVID-19 Beta (B.1.351) Variant Strain Vaccine ("rS-B.1.351")

In June 2021, we announced data from three complementary non-clinical studies of our rS-B.1.351 variant strain vaccine.

The studies compared rS-B.1.351 to NVX-CoV2373 as standalone, in combination, and as a heterologous prime boost vaccine.

The data showed that rS-B.1.351 demonstrated strong immunogenicity and protection against the Alpha (B.1.1.7) variant strain, Beta (B.1.351) variant strain and the original COVID-19 virus in animal studies.

The findings also showed a broad array of cellular and humoral responses in animal models against all virus strains evaluated.

Data from these studies have been submitted for peer review and are available ahead of publication via the preprint server on bioRxiv.

We expect to initiate clinical evaluation of rS-B.1.351 in the fall of 2021.

In one study, thirty randomly selected human serum samples from Phase 2 clinical trial participants after their second dose of NVX-CoV2373 were assayed and analyzed for their ability to neutralize Alpha (B.1.1.7) and Beta (B.1.351) variant strains.

The trial participants’ sera demonstrated a neutralizing capacity of the Alpha (B.1.1.7) variant strain equal to NVX-CoV2373, with a modest reduction in neutralizing capacity again the Beta (B.1.351) variant strain.

These findings support the initial development and evaluation of a B.1.351-directed vaccine as a booster or in a combination vaccine approach.

In an additional preclinical study, mice were immunized with NVX-CoV2373 or rS-B.1.351 alone, in combination, or as a heterologous prime boost.

Preclinical data from this study demonstrated that rS-B.1.351 was highly immunogenic and produced neutralizing antibodies.

In another preclinical study, non-human primates (“NHPs”) that were originally immunized with NVX-CoV2373 were boosted approximately one year later with one or two doses of rS-B.1.351.

Preclinical data from this study showed that NHPs

boosted with rS-B.1.351 induced strong neutralizing immune responses to the original COVID-19 strain, as well as Alpha (B.1.1.7) and Beta (B.1.351) variant strains.

Data from this preclinical study builds upon initial data announced in May 2021.

Select participants in the 5 microgram dose cohort from the Phase 2 portion of the Phase 1/2 trial received a third 5 microgram dose (booster dose) at six months to examine the functional immune response of our vaccine candidate.

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

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

and Australia Phase 1/2 trial.

In this booster study, select participants in the 5 microgram dose cohort from our six-month booster study in the Phase 2 portion of the Phase 1/2 trial will receive an additional 5 microgram dose (a booster dose) at twelve months to examine the functional immune response of our vaccine candidate.

Partner-Led Vaccine Mix and Match Clinical Studies

We recognize the importance of exploring NVX-CoV2373 alongside the use of other COVID-19 vaccine manufacturers.

We continue to develop our booster strategy through our participation in multiple partner-led trials evaluating the potential for mixed vaccine regimens in primary and booster settings.

A summary and status of our participation in partner-led vaccine interchangeability trials follows:

NVX-CoV2373 Regulatory and Licensure

As of August 2021, we continue to work to complete various Chemistry, Manufacturing and Controls ("CMC") requirements, which ensure that our manufacturing processes are in accordance with regulatory standards (see further discussion of our manufacturing activities below under the heading "NVX-CoV2373 Manufacturing and Supply").

We have completed multiple regulatory submissions and expect to complete additional filings.

We are in constant discussions with regulatory authorities globally for our completed and anticipated submissions.

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

Below is a summary and status of our regulatory processes through the date of filing this Form 10-Q.

In August 2021, we filed regulatory submissions in partnership with SIIPL for emergency use authorization ("EUA") in multiple markets.

Regulatory submissions were filed with the Drugs Controller General of India ("DCGI"), as well as regulatory agencies in Indonesia and the Philippines.

In addition to these filings, we expect to file a submission to the WHO for emergency use listing ("EUL") in August of 2021.

In April 2021, SK bioscience Ltd.

("SK bioscience") initiated the regulatory submission process in collaboration with Novavax to the MFDS for authorization of NVX-CoV2373.

We expect to file for authorization with the MHRA in the third quarter of 2021.

We expect to complete additional filings for authorization within weeks of filing with the MHRA, including with EMA, Australian Therapeutic Goods Administration, Health Canada, and New Zealand Medsafe.

We are actively engaged in communications 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 plan to file submissions for EUA with the FDA in the fourth quarter of 2021.

In November 2021, in partnership with Serum Institute of India Pvt.

(“SIIPL”), we received emergency use authorization (“EUA”) from the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Pengawas Obat dan Makanan, following the August 2021 regulatory submission made by SIIPL with our support.

EUA was granted for our recombinant nanoparticle protein-based vaccine with our Matrix-M TM adjuvant, which will be manufactured and marketed in Indonesia by SIIPL under the brand name COVOVAX™.

Indonesia contracted with SIIPL for the purchase of 50 million doses of COVOVAX™.

This marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favorable safety profile.

In November 2021, we completed the rolling submission of all modules required by the EMA to support final regulatory review.

The final step to complete the application in the European Union will be an invitation from EMA to file for conditional marketing authorization ("CMA").

In October and November 2021, we completed rolling regulatory submissions in key markets for NVX-CoV2373.

We filed for CMA with the UK MHRA, leveraging our manufacturing partnership with SIIPL.

Additionally, we filed for provisional approval with Australia’s Therapeutic Goods Administration, authorization with Health Canada, and provisional approval with New Zealand Medicines and Medical Devices Authority and the WHO for emergency use listing ("EUL").

In partnership with SIIPL, in August 2021, for our COVID-19 vaccine that will be manufactured and commercialized with SIIPL, we filed regulatory submission for EUA with the Drugs Controller General of India, regulatory agencies in Indonesia and the Philippines, and EUL with the WHO.

The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.

These filings mark the first protein-based COVID-19 vaccine submitted in these markets.

In the U.S, we are in continued discussions with the FDA about submission of our investigational new drug application for NVX-CoV2373.

We continue to address and complete various Chemistry, Manufacturing and Controls ("CMC") requirements, which ensure that our manufacturing processes are in accordance with regulatory standards.

As of November 2021, we validated the potency and purity of our assays and are in the final process of testing our product using these assays.

We expect to submit the complete regulatory package to the FDA by the end of 2021.

COVID-19 Vaccine Funding

8 unchanged sentences

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

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

As of September 30, 2021, the Company's OWS agreement was amended to increase the contract ceiling by $52.9 million for a revised total of $1.8 billion.

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

In July 2021, the U.S.

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

manufacturing and further indicated that the U.S.

5 unchanged sentences

We have established a global manufacturing and supply chain to support the commercialization of NVX-CoV2373.

With significant progress made throughout 2020 and through the second quarter of 2021, our global supply chain spans over ten countries and includes Novavax-owned facilities in the Czech Republic and Sweden, as well as partnerships with contract manufacturing organizations around the world.

In the second quarter of 2021, we remained focused on readying our global supply chain for commercialization in order to ensure we promptly deliver NXV-CoV2373 upon anticipated regulatory authorizations.

We expect our global manufacturing capacity of NVX-CoV2373 to be approximately 100 million doses per month by the end of the third quarter of 2021.

We anticipate the remainder of our manufacturing capacity will be ready by the end of the fourth quarter of 2021, which we expect will support total global manufacturing capacity of approximately 150 million doses per month.

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

A summary and status of key manufacturing and supply developments during the second quarter of 2021 follows:

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

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

These developments build upon a Memorandum of Understanding (“MOU”) entered into in February 2021 with the Canadian government to produce

NVX-CoV2373 at the Biologics Manufacturing Centre in Canada.

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

In May 2021, we entered a non-binding MOU with the MOHW and SK bioscience to explore further cooperation in the development and manufacturing of vaccines, including NVX-CoV2373.

Under the agreement, we agreed to potentially explore the development of new vaccine products with SK bioscience, including COVID-19 variant vaccines, and/or an influenza/COVID-19 combination vaccine.

We will continue to collaborate with SK bioscience in manufacturing of the vaccines utilizing SK bioscience’s facility, with support from the Korean government.

The MOU builds upon previous agreements entered with SK bioscience, including a development and supply agreement entered into in August 2020 and a collaboration and license agreement entered into in February 2021, whereby we granted SK bioscience an exclusive license to develop, manufacture and commercialize NVX-CoV2373 in the Republic of Korea.

In May 2021, the MHLW announced it was in contract discussions to potentially order 150 million doses of our COVID-19 vaccine candidate from Takeda.

This development follows the exclusive license agreement we entered into with Takeda in February 2021 for the development, manufacturing and commercialization of NVX-CoV2373 in Japan.

We anticipate Takeda will have a manufacturing capacity of 250 million doses per year.

Takeda is in process of establishing vaccine procurement based on technology transfer by Novavax of NVX-CoV2373.

Distribution of NVX-CoV2373 in Japan by Takeda is expected to begin in late 2021 or early 2022.

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

With significant progress made throughout 2020 and through the third quarter of 2021, our global supply chain spans over ten countries and includes Novavax-owned facilities in the Czech Republic and Sweden, as well as partnerships with contract

manufacturing organizations around the world.

In the third quarter of 2021, we remained focused on readying our global supply chain for commercialization to ensure we will promptly deliver NXV-CoV2373 upon anticipated regulatory authorizations.

We have reached our global manufacturing capacity of NVX-CoV2373 of approximately 100 million doses per month as of the end of the third quarter of 2021.

We expect to have manufacturing capacity in excess of 2 billion annual doses in 2022.

NVX-CoV2373 Manufacturing Agreements

In October 2021, we entered into a supply agreement with SIIPL and Serum Life Sciences Limited (“SLS"), an affiliate of SIIPL, for the manufacture of NVX-CoV2373.

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

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

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

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

Following this agreement, we anticipate rapid scale-up in manufacturing of NVX-CoV2373 at Mabion’s Good Manufacturing Practice-certified facility located near Warsaw, Poland.

In September 2021, Takeda Pharmaceutical Company Limited (“Takeda”) finalized an agreement with the government of Japan’s Ministry of Health, Labour and Welfare (“MHLW”) for the purchase of 150 million doses of NVX-CoV2373.

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

These efforts include vaccine procurement by Takeda based on technology transfer from us, with Takeda in the process of manufacturing implementation at its facility, pursuant to the terms of the collaboration and license agreement we entered into with Takeda in February 2021, under which we granted Takeda an exclusive license to develop, manufacture and commercialize NVX-CoV2373 in Japan.

Under the agreement, Takeda purchases Matrix-M™ adjuvant from us to manufacture doses of finished NVX-CoV2373, and we are entitled to receive payments from Takeda based on the achievement of certain development and commercial milestones, as well as a portion of net profits from the sale of NVX-CoV2373.

Distribution of Novavax’ vaccine in Japan by Takeda is expected to begin in 2022.

Takeda anticipates the capacity to manufacture 250 million doses of NVX-CoV2373 per year.

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

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

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

NVX-CoV2373 Supply Agreements

3 unchanged sentences

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

A summary and status of key supply agreements executed since the beginning of the second quarter of 2021 and through the date of filing this Form 10-Q follows:

In May 2021, we finalized an APA with Gavi, the Vaccine Alliance ("Gavi"), building upon our MOU previously announced in February 2021.

Under the terms of the agreement, 1.1 billion doses of NVX-CoV2373 are to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.

We expect to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility.

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

We expect to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the investments previously received from CEPI (the "CEPI Funding Agreement").

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

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

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

Under the agreement, we received an upfront payment from Gavi of $350 million during the second quarter of 2021 and expect to receive an additional payment of $350 million if we secure EUL for NVX-CoV2373 by the WHO.

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

For example, in August 2021, we announced that we finalized the terms of an APA with the European Commission, which the parties expect to execute during the third quarter of 2021, for the purchase of up to 100 million initial doses of NVX-CoV2373, with the option of the European Commission to purchase an additional 100 million doses through 2023.

In addition to our supply agreements, we have committed 110 million doses of NVX-CoV2373 to the U.S.

government under the OWS Agreement and our contract with the DoD (the "DoD Contract").

Certain of the APAs and supply agreements may be terminated by the counterparty if we do not timely achieve requisite regulatory approval for NVX-CoV2373 in the relevant jurisdictions under such agreements.

If the APAs were terminated, the refundable portion of the upfront payments will be repaid.

In August 2021, we executed an APA with the European Commission acting on behalf of various European Union member states, to supply a minimum of 20 million and up to 100 million initial doses of NVX-CoV2373, with the option for the European Commission to purchase an additional 100 million doses through 2023.

Seasonal Influenza

NanoFlu ™ Vaccine Program (Older Adults)

To date, we have advanced NanoFlu ™ through a Phase 3 clinical trial in which NanoFlu ™ achieved all primary endpoints and achieved statistical significance in key secondary endpoints.

In 2020, we took steps to ensure the continued advancement of NanoFlu ™ in parallel with our COVID-19 activities and formed a leadership team solely dedicated to our NanoFlu ™ vaccine program.

This NanoFlu ™ vaccine development unit benefits from joint shared services with key cross-functional departments and builds on the Company’s established knowledge base in the discovery and development of innovative vaccines.

Our NanoFlu ™ vaccine team remains focused on advancing our combination NanoFlu ™ / NVX-CoV2373 vaccine candidate, qNIV/CoV2373, to clinical development.

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

We previously announced that NanoFlu TM achieved the trial’s primary endpoints,

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

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

Combination Vaccines

Our NanoFlu ™ vaccine team remains focused on advancing combination vaccine candidates.

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

Although testing is at an early stage, we believe that the combination of influenza with COVID-19, influenza with RSV, and influenza with both RSV and COVID-19 may be achievable, as these vaccines all use our recombinant nanoparticle technology and include our proprietary Matrix-M ™ adjuvant.

NanoFlu ™ /NVX-CoV2373 Combination Vaccine ("qNIV/CoV2373")

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

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

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

Human ACE2 receptor inhibiting antibody levels responded similarly.

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

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

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

We expect to initiate clinical evaluation of qNIV/CoV2373 later in 2021.

R21 - Malaria Vaccine

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

The University of Oxford has partnered with SIIPL for commercial development of R21 and has granted them a license for the vaccine.

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

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

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

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

R21 Clinical Development

In May 2021, the first doses were administered in a Phase 3 licensure trial of R21 to assess the efficacy and safety of the malaria vaccine candidate.

This double-blinded, randomized, controlled Phase 3 trial includes 4,800 participants aged five to 36 months across five sites in Burkina Faso, Kenya, Mali and Tanzania.

Participants will receive three vaccinations four weeks apart and a booster vaccination one year later.

In April 2021, we announced the pre-print publication of data in Preprints with The Lancet from a Phase 2b clinical trial evaluating R21.

The Phase 2b randomized, controlled, double-blind trial was conducted at the Clinical Research Unit of Nanoro / Institut de Recherche en Sciences de la Santé in Africa and recruited 450 participants aged five to 17 months from the catchment area of Nanoro, Burkina Faso.

In three study arms, participants received 5 micrograms of R21 with either 25 micrograms of Matrix-M ™ adjuvant, 50 micrograms of Matrix-M ™ adjuvant, or a rabies vaccine as a control.

R21 demonstrated

77% efficacy in the higher adjuvant dose group and 71% efficacy in the lower adjuvant dose group.

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

R0.6C - Malaria Transmission Blocking Vaccine

R0.6C is a novel malaria transmission blocking vaccine candidate manufactured by Statens Serum Institut that has been formulated in a preclinical study with our Matrix-M ™ adjuvant.

R0.6C is a vaccine candidate based on the protective epitopes of the Pfs48/45 protein.

Development of R0.6C is supported by grants from the European Union’s Horizon 2020 research and innovation program and funded by PATH’s Malaria Vaccine Initiative.

R0.6C Clinical Development

In June 2021, a Phase 1 clinical trial for R0.6C was initiated at Radboud University Medical Center in the Netherlands.

The trial enrolled healthy, adult volunteers and will assess the safety and immunogenicity of R0.6C.

The trial will also evaluate our Matrix-M ™ adjuvant and the common aluminum hydroxide adjuvant.

This Phase 1 trial follows a preclinical study of R0.6C formulated with our Matrix-M ™ adjuvant, which showed greater than 80% reduction of transmission of the parasite that causes malaria.

Phase 1/2 Clinical Trial of COVID-NanoFlu™ Combination Vaccine

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

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

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

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

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

Sales of Common Stock

During the six months ended June 30, 2021 and 2020, we sold 2.6 million and 28.5 million, respectively, of shares of our common stock resulting in net proceeds of approximately $565 million and $392 million, respectively, under our various At Market Issuance Sales agreements.

During the nine months ended September 30, 2021 and 2020, we sold 2.6 million and 29.1 million, respectively, of shares of our common stock resulting in net proceeds of approximately $565 million and $446 million, respectively, under our various At Market Issuance Sales agreements.

In June 2021, we entered into an At Market Issuance Sales Agreement (the "June 2021 Sales Agreement"), which allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock, and terminated our existing At Market Issuance Sales agreement.

As of June 30, 2021, no shares had been sold under the June 2021 Sales Agreement.

As of September 30, 2021, no shares had been sold under the June 2021 Sales Agreement.

Critical Accounting Policies and Use of Estimates

4 unchanged sentences

The following is a discussion of the historical financial condition and results of the Company’s operations that should be read in conjunction with the unaudited consolidated financial statements and notes set forth in this Quarterly Report.

Three Months Ended June 30, 2021 and 2020

Three Months Ended June 30,

Three Months Ended September 30, 2021 and 2020

Three Months Ended September 30,

2021 2020 Change

4 unchanged sentences

Total revenue $ 178,844 $ 157,024 $ 21,820

Revenue for the three months ended June 30, 2021 was $298.0 million as compared to $35.5 million for the same period in 2020, an increase of $262.5 million.

Revenue for the three months ended June 30, 2021 was primarily comprised of

revenue for services performed under the OWS Agreement and the CEPI Funding Agreement.

Revenue for the three months ended June 30, 2020 was primarily comprised of revenue for services performed under the CEPI Funding Agreement.

During the three month ended June 30, 2021, we recognized royalties of $23.5 million under our licensing arrangements.

The significant increase in revenue was due to increased development activities relating to NVX-CoV2373 under the OWS Agreement and the CEPI Funding Agreement.

We expect revenue in 2021 to significantly increase as compared with 2020 due to our NVX-CoV2373 program, which we anticipate will continue to be funded by OWS and CEPI and/or other revenue sources.

Further, we anticipate bringing our NVXCoV2373 vaccine candidate to market following global regulatory approvals which, if achieved, should significantly increase revenue.

Revenue for the three months ended September 30, 2021 was $178.8 million as compared to $157.0 million for the same period in 2020, an increase of $21.8 million.

Revenue for the three months ended September 30, 2021 was primarily comprised of revenue for services performed under the OWS Agreement and our funding agreements with CEPI (collectively, the "CEPI Funding Agreement") and royalties under our licensing arrangements.

Revenue for the three months ended September 30, 2020 was primarily comprised of revenue for services performed under the CEPI Funding Agreement.

The increase in revenue was due to increased development activities relating to NVX-CoV2373 under the OWS Agreement and royalties under our licensing arrangements, partially offset by decreased development activities under the CEPI Funding Agreement as we approach anticipated commercialization of NVX-CoV2373.

Revenue in 2021 increased significantly as compared with 2020 due to our NVX-CoV2373 program, which we anticipate will continue to be funded by OWS and CEPI and/or other revenue sources.

Further, we anticipate bringing our NVX-CoV2373 vaccine candidate to market following global regulatory approvals which, if achieved, should significantly increase revenue.

In anticipation, we have entered into various APA, as well as multiple supply and license agreements with strategic partners to supply NVX-CoV2373 in their specified territories under which we are entitled to receive royalties from the sale of NVX-CoV2373 by such partners.

Three Months Ended June 30,

Three Months Ended September 30,

2021 2020 Change

4 unchanged sentences

Research and Development Expenses

In the three months ended June 30, 2021, our research and development activities were primarily focused on the development of NVX-CoV2373 and included direct external research and development expenses related to NVX-CoV2373 of $497.2 million, primarily comprised of costs related to the following:

In the three months ended September 30, 2021, our research and development activities were primarily focused on the development of NVX-CoV2373 and included direct external research and development expenses related to NVX-CoV2373 of $341.6 million, primarily comprised of costs related to the following:

• expenses incurred under agreements with contract research organization ("CROs") that conduct our clinical trials and third-party consultants related to the development of NVX-CoV2373;

2 unchanged sentences

• other costs related to preclinical studies and regulatory consulting, as well as related program management activities to support our growing global operations.

Research and development expenses increased to $570.7 million for three months ended June 30, 2021 as compared to $34.8 million for three months ended June 30, 2020, an increase of $535.8 million primarily due to research and development of NVX-CoV2373, as summarized in the table below (in millions):

Three Months Ended June 30,

Research and development expenses increased to $408.2 million for three months ended September 30, 2021 as compared to $294.1 million for three months ended September 30, 2020, an increase of $114.1 million primarily due to research and development of NVX-CoV2373, as summarized in the table below (in millions):

Three Months Ended September 30,

NVX-CoV2373 $ 341,600 $ 249,789

6 unchanged sentences

Total research and development expenses $ 408,195 $ 294,087

For 2021, we expect research and development expenses to significantly increase over 2020 expenses due to our continued development activities for our NVX-CoV2373 program and increases in employee-related costs.

Following a potential regulatory approval of NVX-CoV2373, we expect products sales will result in certain types of costs that have been previously recorded as research and development in our Consolidated Statement of Operations to be capitalized as inventory and expensed as cost of goods sold when product is delivered.

Cost of goods sold expenses could be significant in 2021 depending on our commercial shipment levels for those shipments in which the costs were recorded into inventory.

For 2021, research and development expenses increased significantly over 2020 expenses due to our continued development activities for our NVX-CoV2373 program and increases in employee-related costs.

Following a potential regulatory approval of NVX-CoV2373, we expect product sales will result in certain types of costs that have been previously recorded as research and development in our Consolidated Statement of Operations to be capitalized as inventory and expensed as cost of goods sold when product is delivered.

We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with vaccine development.

11 unchanged sentences

General and Administrative Expenses

General and administrative expenses increased to $73.2 million for the three months ended June 30, 2021 from $17.7 million for the same period in 2020, an increase of $55.4 million.

The increase in general and administrative expenses is primarily due to increased employee-related costs, primarily stock-based compensation expense, and an increase in professional fees in support of our NVX-CoV2373 program.

As of June 30, 2021, we had 195 employees dedicated to general and administrative functions as compared with 61 employees as of June 30, 2020.

For 2021, we expect general and administrative expenses to significantly increase due to increased activities related to supporting our NVX-CoV2373 program and increases in employee-related costs and professional fees.

General and administrative expenses increased to $77.8 million for the three months ended September 30, 2021 from $56.9 million for the same period in 2020, an increase of $20.9 million.

The increase in general and administrative expenses is primarily due to an increase in professional fees in support of our NVX-CoV2373 program.

For 2021, general and administrative expenses increased significantly due to increased activities related to supporting our NVX-CoV2373 program and increases in employee-related costs and professional fees.

Other Income (Expense):

Three Months Ended June 30,

Three Months Ended September 30,

2021 2020 Change

2 unchanged sentences

Interest expense (5,182) (4,460) (722)

Other income 2,659 2,612 47

Other income (expense) (4,394) 952 (5,346)

Total other income (expense), net $ (9,246) $ (3,368) $ (5,878)

We had total other expense, net, of $2.9 million for the three months ended June 30, 2021 as compared to $0.5 million for the same period in 2020.

In the three months ended June 30, 2021, we also recorded interest expense of $1.8 million for finance leases.

We had total other expense, net, of $9.2 million for the three months ended September 30, 2021 as compared to $3.4 million for the same period in 2020.

In the three months ended September 30, 2021, we recorded a $3.9 million loss due to changes in the foreign exchange rates, primarily on an intercompany loan with Novavax CZ.

Income Tax Expense:

During the three months ended June 30, 2021, we recognized $3.5 million of income tax expense related to foreign withholding tax on royalties.

We did not recognize any income tax expense for the three months ended June 30, 2020.

Three Months Ended June 30,

During the three months ended September 30, 2021, we recognized $6.0 million of income tax expense related to foreign withholding tax on royalties.

We did not recognize any income tax expense for the three months ended September 30, 2020.

Three Months Ended September 30,

2021 2020 Change

3 unchanged sentences

Weighted average shares outstanding 74,745 61,554 13,191

Net loss for the three months ended June 30, 2021 was $352.3 million, or $4.75 per share, as compared to $17.5 million, or $0.30 per share, for the same period in 2020.

The increase in net loss was primarily due to a significant increase in development activities relating to NVX-CoV2373 and increase in employee-related costs, primarily stock-based compensation expense, partially offset by increased revenue under the OWS Agreement and CEPI Funding Agreement.

The increase in weighted average shares outstanding for the three months ended June 30, 2021 is primarily a result of sales of our common stock in 2021 and 2020.

Six Months Ended June 30, 2021 and 2020

Six Months Ended June 30,

Net loss for the three months ended September 30, 2021 was $322.4 million, or $4.31 per share, as compared to $197.3 million, or $3.21 per share, for the same period in 2020.

The increase in net loss was primarily due to a significant increase in development activities relating to NVX-CoV2373, partially offset by increased revenue under the OWS Agreement and royalties under our licensing arrangements.

The increase in weighted average shares outstanding for the three months ended September 30, 2021 is primarily a result of sales of our common stock in 2021 and 2020.

Nine Months Ended September 30, 2021 and 2020

Nine Months Ended September 30,

2021 2020 Change

4 unchanged sentences

Total revenue $ 924,090 $ 195,939 $ 728,151

Revenue for the six months ended June 30, 2021 was $745.2 million as compared to $38.9 million for the same period in 2020, an increase of $706.3 million.

Revenue for the six months ended June 30, 2021 was primarily comprised of revenue for services performed under the OWS Agreement and CEPI Funding Agreement.

Revenue for the six months ended June 30, 2020 was primarily comprised of revenue for services performed under the CEPI Funding Agreement.

The significant increase in revenue was due to increased development activities relating to NVX-CoV2373 under the OWS Agreement and CEPI Funding Agreement.

Six Months Ended June 30,

Revenue for the nine months ended September 30, 2021 was $924.1 million as compared to $195.9 million for the same period in 2020, an increase of $728.2 million.

Revenue for the nine months ended September 30, 2021 was primarily comprised of revenue for services performed under the OWS Agreement and CEPI Funding Agreement and royalties under our licensing arrangements.

Revenue for the nine months ended September 30, 2020 was primarily comprised of revenue for

services performed under the CEPI Funding Agreement.

The significant increase in revenue was due to increased development activities relating to NVX-CoV2373 under the OWS Agreement and, to a lesser extent, royalties under our licensing arrangements.

Nine Months Ended September 30,

2021 2020 Change

4 unchanged sentences

Research and Development Expenses

In the six months ended June 30, 2021, our research and development activities were primarily focused on the development of NVX-CoV2373 and included direct external research and development expenses related to NVX-CoV2373 of $1.0 billion, primarily comprised of costs related to the following:

In the nine months ended September 30, 2021, our research and development activities were primarily focused on the development of NVX-CoV2373 and included direct external research and development expenses related to NVX-CoV2373 of $1.4 billion, primarily comprised of costs related to the following:

• expenses incurred under agreements with CROs that conduct our clinical trials and third-party consultants related to the development of NVX-CoV2373;

2 unchanged sentences

• other costs related to preclinical studies and regulatory consulting, as well as related program management activities to support our growing global operations.

Research and development expenses increased to $1.2 billion for the six months ended June 30, 2021 from $51.7 million for the same period in 2020, an increase of $1.1 billion, primarily due to increased development activities relating to NVX-CoV2373, as summarized in the table below (in millions):

Six Months Ended June 30,

Research and development expenses increased to $1.6 billion for the nine months ended September 30, 2021 from $345.8 million for the same period in 2020, an increase of $1.2 billion, primarily due to increased development activities relating to NVX-CoV2373, as summarized in the table below (in millions):

Nine Months Ended September 30,

NVX-CoV2373 $ 1,376,921 $ 268,642

7 unchanged sentences

General and Administrative Expenses

General and administrative expenses increased to $136.4 million for the six months ended June 30, 2021 from $27.1 million for the same period in 2020, an increase of $109.3 million.

General and administrative expenses increased to $214.1 million for the nine months ended September 30, 2021 from $84.0 million for the same period in 2020, an increase of $130.1 million.

As of June 30, 2021, we had 195 employees dedicated to general and administrative functions versus 61 employees as of June 30, 2020.

Other Income (Expense):

Six Months Ended June 30,

Nine Months Ended September 30,

2021 2020 Change

4 unchanged sentences

Total other income (expense), net $ (23,256) $ (6,829) $ (16,427)

We had total other expense, net of $14.0 million for the six months ended June 30, 2021 as compared to $3.5 million for the same period in 2020.

In the six months ended June 30, 2021, we also recorded an interest expense of $4.0 million for finance leases.

In the six months ended June 30, 2021 and 2020, other income included a loss of $3.1 million and a gain of $2.7 million, respectively, on the intercompany loan with Novavax CZ due to changes in the exchange rates.

We had total other expense, net of $23.3 million for the nine months ended September 30, 2021 as compared to $6.8 million for the same period in 2020.

In the nine months ended September 30, 2021, we also recorded an interest expense of $5.6 million for finance leases.

In the nine months ended September 30, 2021 and 2020, other income included a loss of $7.0 million and a gain of $3.5 million, respectively, due to changes in the foreign exchange rates, primarily on an intercompany loan with Novavax CZ.

Income Tax Expense:

During the six months ended June 30, 2021, we recognized $6.6 million of income tax expense related to foreign withholding tax on royalties.

We did not recognize any income tax expense for the six months ended June 30, 2020.

Six Months Ended June 30,

During the nine months ended September 30, 2021, we recognized $12.6 million of income tax expense related to foreign withholding tax on royalties.

We did not recognize any income tax expense for the nine months ended September 30, 2020.

Nine Months Ended September 30,

2021 2020 Change

3 unchanged sentences

Weighted average shares outstanding 73,972 54,810 19,162

Net loss for the six months ended June 30, 2021 was $575.0 million, or $7.82 per share, as compared to $43.4 million, or $0.84 per share, for the same period in 2020.

The increase in net loss was primarily due to increased development activities relating to NVX-CoV2373, increased employee-related costs, primarily stock-based compensation expense, partially offset by increased revenue under the OWS Agreement and CEPI Funding Agreement.

The increase in weighted average shares outstanding for the six months ended June 30, 2021 is primarily a result of sales of our common stock in 2021 and 2020.

Net loss for the nine months ended September 30, 2021 was $897.5 million, or $12.13 per share, as compared to $240.7 million, or $4.39 per share, for the same period in 2020.

The increase in weighted average shares outstanding for the nine months ended September 30, 2021 is primarily a result of sales of our common stock in 2021 and 2020.

Liquidity Matters and Capital Resources

Our future capital requirements depend on numerous factors including, but not limited to, our projected activities related to the development of NVX-CoV2373, including significant commitments under various CRO, CMO and CDMO agreements, the progress of preclinical studies and clinical trials, the time and costs involved in obtaining regulatory approvals, the costs of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights and other manufacturing, sales and distribution costs.

We plan to continue developing other vaccines and product candidates, such as NanoFlu ™ vaccine and potential combination vaccines candidates, which are in various stages of development.

We believe our operating expenses and capital requirements will fluctuate depending upon the timing of events, such as the progress of our NVX-CoV2373 clinical trials and approval for the use of NVX-CoV2373 in the U.S.

We plan to continue developing other vaccines and product candidates, such as our NanoFlu ™ vaccine candidate and potential combination vaccines candidates, which are in various stages of development.

We believe our operating expenses and capital requirements will fluctuate depending upon the timing of events, such as the progress of our NVX-CoV2373 clinical trials and regulatory approval for the use of NVX-CoV2373 in the U.S.

and internationally, as well as the scope, initiation and progress of our preclinical studies and clinical trials related to other research and development activities.

We have entered into APAs or supply agreements with various countries globally that, if our product candidate is approved, are expected to result in the delivery of approximately 550 million doses, including Gavi, of NVX-CoV2373 throughout 2021 and into the first half of 2022.

The APAs or supply agreements 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.

We have entered into APAs or supply agreements with Gavi, the European Commission, and various countries globally that, if our COVID-19 vaccine candidate is approved, are expected to result in the delivery of approximately 570 million doses of NVX-CoV2373.

The APAs or supply agreements 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 and commercial milestones.

However, certain of the APAs and supply agreements may be terminated by the counterparty if we do not timely achieve requisite regulatory approval for NVX-CoV2373 in the relevant jurisdictions under such agreements.

If the APAs or supply agreements were terminated, the refundable portion of the upfront payments will be repaid.

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

8 unchanged sentences

Under the agreement, we received an upfront payment of $350 million from Gavi during the second quarter of 2021 and expect to receive an additional payment of $350 million if we secure EUL for NVX-CoV2373 by the WHO.

We have also entered into supply and license agreements with strategic partners to supply NVX-CoV2373 in their specified territories under which we are entitled to receive royalties primarily from the sale of NVX-CoV2373 by our partners.

During the three and six months ended June 30, 2021, we received royalties of $23.5 million under these licensing arrangements.

In the six months ended June 30, 2021, we funded our operations with cash and marketable securities on hand, upfront payments under APAs, proceeds from the sale of common stock together with revenue under the OWS Agreement and CEPI Funding Agreement that support our NVX-CoV2373 vaccine development activities.

During the three and nine months ended September 30, 2021, we received royalties of $39.9 million and $63.4 million, respectively, under these licensing arrangements.

In the nine months ended September 30, 2021, we funded our operations with cash and marketable securities on hand, upfront payments under APAs, proceeds from the sale of common stock together with revenue under the OWS Agreement and CEPI Funding Agreement that support our NVX-CoV2373 vaccine development activities.

We anticipate our future operations to be funded by our cash, cash equivalents and marketable securities, upfront payments under our APAs, revenue under our OWS Agreement and CEPI Funding Agreement, and following any potential global regulatory approvals, revenue from product sales, royalties under licensing arrangements with our strategic partners and/or other potential funding sources.

As of June 30, 2021, we had $2.1 billion in cash and cash equivalents, marketable securities and restricted cash as compared to $806.4 million as of December 31, 2020.

These amounts consisted of $2.1 billion in cash and cash equivalents and $47.9 million in restricted cash as of June 30, 2021 as compared to $553.4 million in cash and cash equivalents $157.6 million in marketable securities and $95.3 million in restricted cash as of December 31, 2020.

The following table summarizes cash flows for the six months ended June 30, 2021 and 2020 (in thousands):

As of September 30, 2021, we had $1.9 billion in cash and cash equivalents, marketable securities and restricted cash as compared to $806.4 million as of December 31, 2020.

These amounts consisted of $1.9 billion in cash and cash equivalents and $9.8 million in restricted cash as of September 30, 2021, as compared to $553.4 million in cash and cash equivalents, $157.6 million in marketable securities and $95.3 million in restricted cash as of December 31, 2020.

The following table summarizes cash flows for the nine months ended September 30, 2021 and 2020 (in thousands):

2021 2020 Change

7 unchanged sentences

Cash, cash equivalents and restricted cash at end of period $ 1,946,826 $ 401,736 $ 1,545,090

Net cash provided by operating activities increased to $807.5 million for the six months ended June 30, 2021, as compared to $92.5 million for the same period in 2020.

The increase in cash provided is primarily due to payments under APAs recorded as deferred revenue and the timing of payments to third-parties.

During the six months ended June 30, 2021 and 2020, our investing activities consisted primarily of maturities and sale of marketable securities, net of purchases, our acquisition of Novavax CZ in 2020 and, to a much lesser extent, capital expenditures.

Capital expenditures for the six months ended June 30, 2021 and 2020 were $28.9 million and $3.9 million, respectively, and the increase in capital expenditures was primarily due to the build out of our facilities and related capital expenditures to support NVX-CoV2373.

For 2021, we expect an increase in our capital expenditures due to further development activities for our NVX-CoV2373 program, including the additional build-out of research and development and manufacturing facilities and related equipment, and the build-out of our new corporate office facility to accommodate anticipated increases in headcount.

Net cash provided by operating activities increased to $665.4 million for the nine months ended September 30, 2021, as compared to $86.0 million for the same period in 2020.

The increase in cash provided is primarily due to payments under APAs recorded as deferred revenue, partially offset by funding of our increased net loss and the timing of payments to third parties.

During the nine months ended September 30, 2021 and 2020, our investing activities consisted primarily of maturities and sale of marketable securities, net of purchases, our acquisition of Novavax CZ in 2020 and, to a much lesser extent, capital expenditures.

Capital expenditures for the nine months ended September 30, 2021 and 2020 were $41.1 million and $12.6 million, respectively, and the increase in capital expenditures was primarily due to the build out of our facilities and related capital expenditures to support NVX-CoV2373.

For 2021, we expect our capital expenditures to continue to increase due to further development activities for our NVX-CoV2373 program, including the additional build-out of research and development and manufacturing facilities and related equipment, and the build-out of our new corporate office facility to accommodate anticipated increases in headcount.

Our financing activities consisted primarily of sales of our common stock under our At Market Issuance Sales Agreements, payments of finance lease liabilities and exercise of stock-based awards.

In the six months ended June 30, 2021 and 2020, we received net proceeds of approximately $565 million and $392 million, respectively, from selling shares of common stock through our At Market Issuance Sales Agreements.

In the nine months ended September 30, 2021 and 2020, we received net proceeds of approximately $565 million and $446 million, respectively, from selling shares of common stock through our At Market Issuance Sales Agreements.

Further, during the nine months ended September 30, 2020, we received approximately $200 million through the issuance of preferred stock in a private placement.

Off-Balance Sheet Arrangements

We did not have any material off-balance sheet arrangements as of June 30, 2021.

We did not have any material off-balance sheet arrangements as of September 30, 2021.

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-Q

Item 2. Management’s Discussion and Analysis