What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-08-05 compared with 2021-05-10 · 330 added, 234 removed, 187 unchanged (75% of the section changed)

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Such forward-looking statements include, without limitation, statements about our capabilities, goals, expectations regarding future revenue and expense levels and capital raising activities;

our operating plans and prospects;

potential market sizes and demand for our product candidates;

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

funding under our advance purchase agreements and supply agreements;

our available cash resources and usage and the availability of financing generally;

plans regarding partnering activities, business development initiatives;

plans regarding partnering activities and business development initiatives;

and other matters referenced herein.

Generally, forward-looking statements can be identified through the use of words or phrases such as “believe,” “may,” “could,” “will,” “would,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,” “plan,” “project,” “expect,” “should,” “would,” “aim,” or “assume,” the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed or implied in the statements.

Any or all of our forward-looking statements in this Quarterly Report may turn out to be inaccurate or materially different from actual results.

Risk factors discussed in this Quarterly Report, identified in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and those of which we are not currently aware, could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements made by or on behalf of us, therefore, you should not place undue reliance on any such forward-looking statements.

We have included important factors that could cause results to differ in the cautionary statements included in this Quarterly Report, particularly those identified in Part II, Item 1A “Risk Factors” of this Quarterly Report and in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K.

These and other risks may also be detailed and modified or updated in our reports and other documents filed with the Securities and Exchange Commission (“SEC”) from time to time.

Forward-looking statements are neither historical facts nor assurances of future performance.

Instead, they are based only on our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions.

Forward-looking statements involve estimates, assumptions, risks and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements.

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”);

difficulty obtaining scarce raw materials;

resource, including human capital and manufacturing capacity, constraints on our ability to pursue these regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings and potential regulatory actions;

challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities;

and other risks and uncertainties identified in Part II, Item 1A “Risk Factors” of this Quarterly Report and in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K, which may be detailed and modified or updated in other documents filed with the United States Securities and Exchange Commission (“SEC”) from time to time, and are available at www.sec.gov and at www.novavax.com.

You are encouraged to read these filings as they are made.

We cannot guarantee future results, events, level of activity, performance or achievement.

Any or all of our forward-looking statements in this Quarterly Report may turn out to be inaccurate or materially different from actual results.

Further, any forward-looking statement speaks only as of the date when it is made, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

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

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

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

Our Matrix-M adjuvant, which enables dose-sparing, has been shown to enhance functional immune responses and has been well-tolerated in multiple clinical trials to date.

Near-term Clinical Development Pipeline

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At the forefront of our pipeline is NVX-CoV2373.

We have also advanced our NanoFlu program through a Phase 3 clinical trial, demonstrating positive top-line results and achieving statistical significance in key secondary endpoints.

We continue to evaluate the viability of certain

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combination vaccines, including combinations of our NanoFlu, NVX-CoV2373 and respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (“RSV F Vaccine”).

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.

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

We expect these continued clinical insights will enable us to evolve our booster strategy to most effectively address 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 a potential combined NanoFlu / NVX-CoV2373 vaccine.

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.

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”).

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.

A summary and status of our near-term clinical and preclinical development program follows:

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

(1) Supported by funding from OWS, DoD, CEPI and 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) Reflects malaria vaccine candidate ("R21"), created by the University of Oxford and formulated with Matrix-M adjuvant;

(2) Ongoing 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;

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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

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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.

The potent immune-stimulating mechanism of action is designed to enable a lower dose of antigen required to achieve the desired immune response,

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ultimately contributing to increased supply and manufacturing capacity.

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.

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

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, announcing a number of significant developments in moving our program forward in the first quarter of 2021.

Through our clinical development program to date, we have collected data that indicates a reassuring safety profile and high levels of efficacy for NVX-CoV2373, as well as confirmed the use of a 5 microgram dose of NVX-CoV2373 with Matrix-M adjuvant for our late-stage 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 April 2021, we initiated a pediatric expansion of our PREVENT-19 pivotal Phase 3 U.S.

and Mexico trial.

This expansion of PREVENT-19 will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescent participants aged 12 to 17 across up to 75 sites in the U.S.

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.

A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine.

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

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.

PREVENT-19 Phase 3 U.S.

In February 2021, we completed enrollment of PREVENT-19, which we initiated in December 2020.

PREVENT-19 is a randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373.

The trial enrolled approximately 30,000 participants aged 18 years or older, notably representing a broad demographic subset.

The trial enrolled participants who are most impacted by COVID-19, including individuals with medical co-morbidities.

The participant trial population is composed of the following:

20% Latin American, 12% African American, 6% Native American, 5% Asian American, and 13% older adults aged 65 years and older.

The trial design has been 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 participants who have 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 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.

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.

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.

We expect to collect adequate cases in order to conduct a final analysis in the second quarter of 2021.

PREVENT-19 is being conducted with support from OWS, including a $1.75 billion agreement.

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

Phase 3 United Kingdom (“UK”)

In March 2021, we announced the results from our final analysis of the Phase 3 UK trial, which we initiated in September 2020.

In the final analysis, NVX-CoV2373 demonstrated 89.7% overall efficacy, 96.4% efficacy against the original COVID-19 strain and 86.3% efficacy against the B.1.1.7 variant strain, first identified in the UK.

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

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

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

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

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

The analysis also confirmed 96.4% efficacy against non-Alpha (non-B.1.1.7) variant strains, 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 primary endpoint was first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second study vaccination in participants who have not been previously infected with SARS-CoV-2.

The final analysis from this trial expanded upon an interim analysis announced in January 2021.

Fourteen days after dose one, vaccine efficacy was 83.4%.

There were no cases of severe disease, including all hospitalization and death, in the vaccine group.

In participants 65 years of age and older, 10 cases of COVID-19 were observed, with 90% of those cases occurring in the placebo group, leading to a vaccine efficacy of 88.9%.

Over 40% of the trial participants had medical comorbidities that placed them at high risk for severe COVID disease (e.g.

hypertension,

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cardiovascular disease, obesity, diabetes) and the vaccine efficacy was 90.9% in this group.

The final analysis also showed that NVX-CoV2373 is well-tolerated, with low levels of severe, serious and medically attended adverse events ("SAEs") at day 35, balanced between vaccine and placebo groups.

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.

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.

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 March 2021, we announced the complete analysis of our Phase 2b South Africa trial, which we initiated in August 2020.

In the complete analysis, 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 B.1.351 escape variant, with the complete analysis showing that NVX-CoV2373 achieved its primary efficacy endpoint in the overall trial population.

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

The trial enrolled over 4,400 participants.

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.

The complete analysis from this trial expanded upon an interim analysis announced in January 2021.

The complete analysis showed that vaccine-induced protection began 14 days after dose one, although increased efficacy was observed seven days after dose two, the primary endpoint for the trial.

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 an 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.

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.

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

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 Booster and Crossover Studies

As of May 2021, we completed the administration of six-month boost doses in the Phase 2 portion of our U.S.

and Australia Phase 1/2 trial, which we began 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 booster doses at six months to examine the functional immune response of our vaccine candidate.

Two treatment groups were boosted:

a group that previously received only one dose (Day 0) and a group that previously received two doses (Day 0 and Day 21).

Immunology results from this booster study are expected in the third quarter of 2021.

In April 2021, we announced the initiation of crossover arms in both our PREVENT-19 and UK Phase 3 trials.

Under the updated clinical trial protocols, participants will be offered the opportunity to receive an additional round of injections.

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

Participants in these trials will remain blinded to their courses of treatment to preserve the ability to assess efficacy in the trials and will continue to be followed to monitor the safety and durability of protection of the vaccine.

In April 2021, we announced the initiation of crossover arms in our Phase 2b South Africa trial.

Under the updated clinical trial protocol, 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.

Participants in the trial will remain blinded to their courses of treatment to preserve the ability to assess efficacy in the trial and will continue to be followed to monitor the safety and durability of protection of the vaccine.

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.

Novavax-Led Booster Study

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

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

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 April 2021, we announced our participation in Com-COV2, a newly expanded investigator-initiated Phase 2 clinical trial conducted by the University of Oxford and supported by the UK Vaccines Taskforce.

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

The trial will enroll 1,050 adults 50 years of age or older who received their first vaccination during the prior 8-12 weeks.

Participants will receive one of four different vaccines as a second dose, 350 of whom will be administered NVX-CoV2373.

The trial will compare the immune system responses from those who

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receive a heterologous regimen to those who receive a homologous regimen.

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

The UK Medicines Healthcare products Regulatory Agency (“MHRA”) and Joint Committee on Vaccination and Immunisation will formally assess the safety and efficacy of any new vaccination regiment before it is made available to the public.

Top-line data from this clinical trial are expected in the third quarter of 2021.

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

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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.

In May 2021, we announced data from a preclinical study of our B.1.351 variant strain vaccine candidate in non-human primates ("NHPs").

In this preclinical study, NHPs originally received a two-dose regimen of NVX-CoV2373.

A year after initial vaccination, NHPs received two doses of our B.1.351 variant strain vaccine candidate, with Matrix-M adjuvant and administered 21 days apart.

Within seven days of receiving boost doses, NHPs exhibited a strong antibody response, as well as a strong functional immune response.

We are currently conducting preclinical studies on multiple variant strain vaccine candidates.

We expect to initiate clinical evaluation of one or more of our candidates.

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.

NVX-CoV2373 Regulatory and Licensure

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

We expect to complete multiple filings for authorization in the third quarter of 2021.

Below is a summary and status of our regulatory processes.

In February 2021, we announced the initiation of a rolling review processes with non-clinical data to the MHRA and the European Medicines Agency (“EMA”).

As a part of the rolling reviews, we continue to submit information, including clinical and manufacturing data.

We aim to file for authorization with these regulatory authorities in the third quarter of 2021.

Through the date of filing this Form 10-Q, 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 plan to file submissions for Emergency Use Authorization (“EUA”) with the FDA and aim to complete our EUA filing in the third quarter of 2021.

NVX-CoV2373 has previously been granted Fast Track designation by the FDA, 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.

We have also initiated the rolling review process with submissions to several other regulatory agencies worldwide, including Health Canada, Australian Therapeutic Goods Administration (“TGA”) and New Zealand Medsafe.

Additionally, we anticipate starting rolling submissions to the World Health Organization for Emergency Use Listing.

As part of the rolling reviews, 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.

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In addition to these rolling review processes, in April 2021, SK bioscience Ltd.

("SK bioscience") initiated the regulatory submission process in collaboration with Novavax to the Republic of Korea's Ministry of Food and Drug Safety ("MFDS") for authorization of NVX-CoV2373.

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").

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.

COVID-19 Vaccine Funding

We have secured critical funding throughout 2020 and into 2021 that fueled the development of NVX-CoV2373.

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

In April 2021, our Base 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, was amended to fully fund the agreement up to $1.75 billion to support certain activities related to the development of NVX-CoV2373.

We have secured critical funding throughout 2020 and into 2021 to support the development of NVX-CoV2373.

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

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

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

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

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

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

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

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

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

manufacturing and further indicated that the U.S.

government will not fund additional U.S.

manufacturing until such agreement has been made.

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

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

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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 first quarter of 2021, our global supply chain now spans over 10 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 first quarter of 2021, we took additional steps to expand our global supply chain and ready our company for commercialization.

These developments included securing additional manufacturing capacity for NVX-CoV2373, as well as furthering existing collaborations with manufacturing partners globally.

During the first quarter of 2021, we experienced a shortage of raw materials, which has impacted the timing by which we expect to realize our anticipated total manufacturing capacity.

In the quarter, we also continued to advance CMC activities.

These include ongoing analytical testing and product characterization, as well as the qualification and validation of assays

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needed to demonstrate process consistency across our network of manufacturing facilities.

Completion of these CMC activities and final determination of doses available for distribution upon potential regulatory approvals is dependent on availability of critical manufacturing supplies, results of analytical testing, and the ultimate efficiency of our manufacturing processes at each facility.

Considering the above, 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 come online in the fourth quarter of 2021, which we expect will support total global manufacturing capacity of approximately 150 million doses per month.

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 entered into or amended during the first quarter of 2021 follows:

In March 2021, we announced an agreement in principle with GSK and the UK Government Vaccines Taskforce to support the manufacturing of up to 60 million doses of NVX-CoV2373 for use in the UK.

Under the agreement, GSK will provide fill and finish manufacturing capacity at its Barnard Castle Facility in the North East of England beginning as early as May 2021.

We expect to negotiate a final agreement with GSK to include additional terms and conditions.

In February 2021, we entered into a non-exclusive manufacturing agreement with Jubilant HollisterStier.

Under the terms of the agreement, Jubilant HollisterStier will provide fill and finish manufacturing services for the production of NVX-CoV2373.

Jubilant HollisterStier’s facility in Spokane, Washington has begun production activities of NVX-CoV2373 final drug product intended for commercial distribution in the U.S.

In February 2021, we reached a Memorandum of Understanding ("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 February 2021, we announced a collaboration and license agreement with SK bioscience, which expanded upon our development and supply agreement entered into in August 2020.

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.

SK bioscience will also purchase a certain quantity of NVX-CoV2373 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 NVX-CoV2373 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.

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

This agreement followed a collaboration agreement with Takeda announced in August 2020.

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

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

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

In May 2021, the MHLW announced that contract discussions were ongoing with Takeda to potentially order 150 million doses of NVX-CoV2373.

Distribution of NVX-CoV2373 in Japan by Takeda is expected to begin in late 2021 or early 2022 and will continue into 2022 onwards.

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

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”).

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

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

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

government in relation to the funding received from OWS and the DoD.

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

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.

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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.

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, 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 the cumulative 1.1 billion doses in the third quarter of 2021, pending receipt of appropriate regulatory authorizations.

Under the agreement, we expect to receive an upfront payment from Gavi and an additional payment after securing emergency use listing for NVX-CoV2373 by the World Health Organization ("WHO").

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 million doses.

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

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").

Seasonal Influenza

NanoFlu Program (Older Adults)

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 program.

This NanoFlu 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 team remains focused on seeking regulatory approval from the FDA under the accelerated approval pathway previously granted and exploring the potential for a combination NanoFlu / NVX-CoV2373 vaccine.

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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.

Combination Vaccines

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

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

In May 2021, we completed a preclinical study of our NanoFlu / NVX-CoV2373 vaccine candidate to assess its immunogenicity and protective efficacy in animal models.

Preclinical data from this study showed that the combination vaccine induced strong functional antibodies, with hemagglutination inhibition ("HAI") and ACE2 receptor inhibiting titers that were comparable to immunization with the respective component vaccines alone.

The combination vaccine also induced high levels of anti-S IgG and neutralizing antibody titers, as well as induced antibodies against the SARS-CoV-2 spike protein neutralizing epitopes.

We expect to initiate clinical evaluation of NanoFlu / NVX-CoV2373 later in 2021.

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

The University of Oxford has partnered with SIIPL for commercial development of R21, as well as granted a license to SIIPL for the vaccine.

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.

As of May 2021, SIIPL has committed to the provision of over 200 million doses per year of R21 after licensure.

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.

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

Results from this Phase 3 trial could potentially lead to licensure of R21 by 2023.

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

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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.

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.

Sales of Common Stock

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

During the first quarter of 2021, we sold 1.7 million shares of common stock under the January 2021 Sales Agreement resulting in $ 452.0 million in net proceeds, leaving $ 42.2 million remaining.

In November 2020, we entered into an At Market Issuance Sales Agreement ("November 2020 Sales Agreement"), which allowed us to issue and sell up to $ 500 million in gross proceeds of its common stock.

From January 1, 2021 through January 20, 2021, we sold 0.9 million shares of common stock resulting in $ 113.0 million in net proceeds, leaving $ 27.2 million remaining under the agreement.

We terminated the November 2020 Sales Agreement by mutual agreement upon entering into the January 2021 Sales Agreement.

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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.

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.

Critical Accounting Policies and Use of Estimates

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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 March 31, 2021 and 2020

Three Months Ended March 31,

Three Months Ended June 30, 2021 and 2020

Three Months Ended June 30,

2021 2020 Change

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Grants and other 34,026 35,538 (1,512)

Royalties 23,457 — 23,457

Total revenue $ 298,017 $ 35,538 $ 262,479

Revenue for the three months ended March 31, 2021 was $447.2 million as compared to $3.4 million for the same period in 2020, an increase of $443.9 million.

Revenue for the three months ended March 31, 2021 was primarily comprised of revenue for services performed under the OWS Agreement and the CEPI Funding Agreement.

Revenue for the three months ended March 31, 2020 was primarily comprised of revenue for services performed under the CEPI Funding Agreement, BMGF Grant Agreement and revenue from Novavax AB.

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.

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

In anticipation, we have entered into various advance purchase agreements 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 royalty revenue from the sale of NVX-CoV2373 by such partners.

Three Months Ended March 31,

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,

2021 2020 Change

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Research and Development Expenses

In the three months ended March 31, 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 $538.1 million, primarily comprised of costs related to the following:

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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:

• 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;

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• 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 $592.7 million for three months ended March 31, 2021 as compared to $16.9 million for three months ended March 31, 2020, an increase of $575.8 million primarily due to research and development of NVX-CoV2373, as summarized in the table below (in millions):

Three Months Ended March 31,

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,

NVX-CoV2373 $ 497,196 $ 17,293

NanoFlu 1,126 3,845

Other vaccine development programs 210 738

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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 in 2021 and beyond.

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.

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• the cost and timing of, and the ability to secure, regulatory approvals.

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As a result of these uncertainties, we are unable to determine the duration and completion costs of our research and development projects or when, and to what extent, we will generate future cash flows from our research projects.

General and Administrative Expenses

General and administrative expenses increased to $63.2 million for the three months ended March 31, 2021 from $9.4 million for the same period in 2020, an increase of $53.8 million.

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

As of March 31, 2021, we had 155 employees dedicated to general and administrative functions as compared with 40 employees as of March 31, 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.

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.

Other Income (Expense):

Three Months Ended March 31,

Three Months Ended June 30,

2021 2020 Change

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Interest expense (5,968) (3,403) (2,565)

Other income (expense) (6,593) — (6,593)

Other income 2,659 2,612 47

Total other income (expense), net $ (2,940) $ (494) $ (2,446)

We had total other expense, net, of $11.1 million for the three months ended March 31, 2021 as compared to $3.0 for the same period in 2020.

In the three months ended March 31, 2021, we recorded a $5.9 million loss on the intercompany loan with Novavax CZ due to changes in the exchange rates and additional interest expense of $2.1 million for finance leases.

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.

Income Tax Expense:

During the three months ended March 31, 2021, we recognized $3.0 million of income tax expense related to foreign withholding tax on an advance payment of a license fee.

We did not recognize any income tax expense for the three months ended March 31, 2020.

Three Months Ended March 31,

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,

2021 2020 Change

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Weighted average shares outstanding 74,118 58,618 15,500

Net loss for the three months ended March 31, 2021 was $222.7 million, or $3.05 per share, as compared to $25.9 million, or $0.58 per share, for the same period in 2020.

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 March 31, 2021 is primarily a result of sales of our common stock in 2021 and 2020.

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,

2021 2020 Change

Revenue (in thousands):

Government contracts $ 623,238 $ — $ 623,238

Grants and other 98,551 38,915 59,636

Royalties 23,457 — 23,457

Total revenue $ 745,246 $ 38,915 $ 706,331

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,

2021 2020 Change

Expenses (in thousands):

Research and development $ 1,163,356 $ 51,741 $ 1,111,615

General and administrative 136,351 27,098 109,253

Total expenses $ 1,299,707 $ 78,839 $ 1,220,868

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:

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

• expenses incurred on developing and manufacturing the antigen drug substance and Matrix-M ™ components of NVX-CoV2373 under agreements that we established with third-party CMOs and CDMOs;

• expenses incurred for the procurement of raw materials, laboratory supplies and equipment;

• 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,

NVX-CoV2373 $ 1,035,320 $ 18,851

Other vaccine development programs 514 1,902

Total direct external research and development expense 1,040,128 29,209

Employee expenses 49,511 9,363

Stock-based compensation expense 48,569 6,005

Facility expenses 6,405 2,090

Other expenses 18,743 5,074

Total research and development expenses $ 1,163,356 $ 51,741

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.

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 versus 61 employees as of June 30, 2020.

Other Income (Expense):

Six Months Ended June 30,

2021 2020 Change

Other Income (Expense) (in thousands):

Investment income $ 731 $ 732 $ (1)

Interest expense (10,807) (6,806) (4,001)

Other income (expense) (3,934) 2,613 (6,547)

Total other income (expense), net $ (14,010) $ (3,461) $ (10,549)

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.

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,

2021 2020 Change

Net Loss (in thousands, except per share information):

Net loss $ (575,036) $ (43,385) $ (531,651)

Net loss per share $ (7.82) $ (0.84) $ (6.98)

Weighted average shares outstanding 73,580 51,401 22,179

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.

Liquidity Matters and Capital Resources

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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 and potential combination vaccines candidates, which are in various stages of development.

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.

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 200 million doses of NVX-CoV2373 throughout 2021 and into the first half of 2022.

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.

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Under the agreement, we expect to receive an upfront payment from Gavi and an additional payment after securing emergency use listing 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 royalty revenue primarily from the sale of NVX-CoV2373 by our partners.

In the three months ended March 31, 2021, we funded our operations with December 31, 2020 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 our 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, royalty arrangements with our strategic partners and/or other potential funding sources.

As of March 31, 2021, we had $2.0 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 $2.0 billion in cash and cash equivalents, $2.2 million in marketable securities and $33.6 million in restricted cash as of March 31, 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 three months ended March 31, 2021 and 2020 (in thousands):

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Additionally, we may provide additional doses, 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 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.

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):

2021 2020 Change

Summary of Cash Flows (in thousands):

Net cash provided by (used in):

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Cash, cash equivalents and restricted cash at end of period $ 2,122,739 $ 531,574 $ 1,591,165

Net cash provided by operating activities increased to $663.1 million for the three months ended March 31, 2021, as compared cash used in operating activities of $23.1 million for the same period in 2020.

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 three months ended March 31, 2021 and 2020, our investing activities consisted primarily of maturities and sale of marketable securities, net of purchases, and, to a much lesser extent, capital expenditures.

Capital expenditures for the three months ended March 31, 2021 and 2020 were $13.8 million and $0.1 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.

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.

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 three months ended March 31, 2021 and 2020, we received net proceeds of $564.9 million and $185.9 million, respectively, from selling shares of common stock through our At Market Issuance Sales Agreements.

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.

Off-Balance Sheet Arrangements

We did not have any material off-balance sheet arrangements as of March 31, 2021.

We did not have any material off-balance sheet arrangements as of June 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