•Announced global restructuring and cost reduction initiative with expected 2024 full-year R&D and SG&A reduction of approximately 40% to 50% vs 2022

•Provided full year 2023 total revenue guidance of between $1.4 and $1.6 billion

•First quarter revenue reflects shift to seasonal demand pattern; on-track to deliver updated COVID vaccine for Fall season

•Announced positive Phase 2 topline results for COVID-Influenza Combination, standalone influenza, and high dose COVID vaccine candidates

•Company to host conference call today at 8:30 a.m. ET

GAITHERSBURG, Md., May 9, 2023 – Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced its financial results and operational highlights for the first quarter ended March 31, 2023.

“Today we outlined significant measures intended to reduce spend, extend our cash runway, and operate more efficiently. Combined with our focus on revenue generation from Nuvaxovid™ and management of our current liabilities, these measures should strengthen our cash position and our potential for the long-term growth and stability of Novavax,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “We also made significant progress on our other key priorities, including our efforts to deliver an updated COVID vaccine for the Fall season. And, today we announced positive Phase 2 data that we believe supports the further development of our combination COVID-influenza, standalone influenza, and high-dose COVID vaccines.

Reducing our workforce has been a difficult decision, but we believe it was necessary to better align our infrastructure and scale to the endemic COVID opportunity,” continued Mr. Jacobs. “Though we still have substantial challenges ahead of us in 2023, we are encouraged by the progress we have made in the last quarter and are determined to continue executing on our top priorities.”

During the quarter, the company has made progress delivering on the three near-term priorities laid out during its fourth quarter 2022 earnings call.

Novavax remains focused on our top priority of delivering an updated, competitive COVID vaccine consistent with public health recommendations for the 2023 Fall vaccination season.

•Ongoing discussions with global regulators on strain selection guidance and advancement of commercial preparedness for Fall 2023

oInvited to join the U.S. Food and Drug Administration’s Technology Working Group to evaluate emerging variants in preparation for strain selection at the June VRBPAC meeting

oOngoing development of variant strains “at risk” to support regulatory and commercial readiness

oModified U.S. government agreement for up to 1.5 million additional doses of Novavax’s COVID vaccine for delivery in 2023, with initial delivery supplied in five-dose vials in the first quarter of 2023

•Continued expansion of Nuvaxovid label to enable broader uptake in the long-term commercial market

•Completed enrollment and on track to receive topline results mid-2023 for Part 2 of Phase 3 strain change study, which is a regulatory prerequisite for updating our 2023-2024 vaccine composition

•Expect to file U.S. Biologics License Application in second half of 2023

Novavax is focused on significantly reducing our expenses while retaining the key capabilities needed to execute our operating plans.

•Announced a global restructuring and cost reduction plan, which is expected to reduce our annual combined 2024 R&D and SG&A expenses by approximately 40% to 50% versus 2022

oIncludes consolidation of facilities and infrastructure and approximately 25% reduction in global workforce

o2023 R&D and SG&A expense reduction expected to be 20% to 25% versus 2022, based on timing of implementation, local laws and regulations and other factors, as adjusted to exclude one-time charges

Novavax continues to leverage our pipeline and technology with the intent of delivering long-term growth and protecting global health.

•Announced positive Phase 2 COVID-Influenza Combination (CIC) vaccine, standalone influenza, and high-dose COVID vaccine data, which evaluated safety and immunogenicity of different formulations

oAll three vaccine candidates were well-tolerated, demonstrated a reassuring preliminary safety profile, and had reactogenicity comparable to authorized comparators

oPreliminary topline immune responses for all three vaccine candidates were robust

oAdditional details found here

•Serum Institute of India has received authorizations in Ghana and Nigeria for R21/Matrix-M adjuvanted malaria vaccine

oVaccine was developed by Jenner Institute, University of Oxford, and formulated with our proprietary Matrix-M adjuvant

•Total revenue: Due to an emerging seasonal demand pattern for COVID vaccines, total revenue for the first quarter of 2023 was $81 million compared to $704 million in the same period in 2022. First quarter 2023 product sales include a $65 million revenue reversal associated with doses delivered in 2022 that are scheduled for future replacement.

•Cost of sales for the first quarter of 2023 were $34 million, compared to $15 million in the same period in 2022. This includes $20 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments.

•Research and development expenses (R&D) for the first quarter of 2023 were $247 million, compared to $383 million in the same period in 2022. The decrease was primarily due to a reduction in clinical and manufacturing spend.

•Selling, general and administrative expenses (SG&A) for the first quarter of 2023 were $113 million, compared to $96 million for the same period in 2022. The increase is related to expansion of our commercial sales operations in Europe and commercial investment in preparation for the Fall 2023 vaccination campaign, partially offset by certain cost containment measures to reduce our operating spend.

•Net loss for the first quarter 2023 was $294 million, compared to a net income of $203 million in the same period in 2022.

•Cash, cash equivalents, and restricted cash were $637 million as of March 31, 2023, compared to $1.3 billion as of December 31, 2022. During the first quarter of 2023 Novavax reduced its outstanding current liabilities by $541 million, including funding the maturity of the $325 million convertible debt in January 2023.

•Combined R&D and SG&A expenses of between $1.3 billion and $1.4 billion, as adjusted to exclude one-time restructuring costs3

•Secured a $100 million payment in the second quarter of 2023 related to a negotiated APA to reduce a portion of committed dose deliveries. This payment is excluded from full year 2023 sales guidance

1.Total revenue includes Product Sales, Grants and Royalties/Other

2.APAs based on 2023 committed dose delivery schedules of approximately $800 million and U.S. market sales, subject to updated variant manufacturing and regulatory approvals

3.Novavax expects to record a restructuring charge of $10 million to $15 million related to employee severance and benefit costs, the majority of which are expected to be incurred in the second quarter

Full year 2023 R&D expense guidance excludes the potential costs associated with a Phase 3 Flu/CIC program. We plan to evaluate our positive Phase 2 Flu/CIC results announced today to frame our options to advance and finance this program via strategic collaborations and/or available financing alternatives.

•Reduced outstanding current liabilities in the first quarter of 2023 by $541 million, including funding the maturity of the $325 million convertible debt in January 2023

•During April 2023, addressed additional liabilities totaling $140 million, including a $27 million payment to resolve the Par arbitration and a $113 million payment to the UK government per the terms of our APA

Novavax will host its quarterly conference call today at 8:30 a.m. ET. The dial-in numbers for the conference call are (877) 883-0383 (Domestic) or (412) 902-6506 (International). Participants will be prompted to request to join the Novavax, Inc. call. The passcode entry number is 3370620. A replay of the conference call will be available starting at 11:30 a.m. ET on May 9, 2023 until 11:59 p.m. ET on May 16, 2023. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1969560.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until August 7, 2023.

The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration.

The Company has used a non-GAAP financial measure in this press release, which is R&D and SG&A expense, as adjusted to exclude one-time restructuring costs including a restructuring charge of $10 million to $15 million related to employee severance and benefit costs. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP).

The Company believes that the presentation of this adjusted financial measure is useful to investors as it provides additional information on comparisons between periods by excluding certain items that affect overall comparability. The Company uses this non-GAAP financial measure for business planning purposes and to consider underlying trends of its business, and believes presenting this measure also provides useful information to investors and others for understanding and evaluating trends in the Company’s expenses in the same manner as the Company’s management. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company’s reported results prepared in accordance with GAAP. The use of this non-GAAP financial measure may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. The company is unable to reconcile this forward-looking non-GAAP financial measure to the most directly comparable GAAP measure without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of the anticipated costs related to the consolidation of facilities and infrastructure that would be expected to impact GAAP measure for the period but would not impact the non-GAAP measure.

Statements herein relating to the future of Novavax, its near term priorities including delivering an updated, competitive COVID vaccine for the 2023 Fall vaccination season, reducing spend, extending its cash runway and operating efficiently, the amount and impact of Novavax’s global restructuring and cost reduction plan, its operating plans, objectives and prospects full year 2023 financial guidance, its future financial or business performance, conditions or strategies, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including Part 2 of the Phase3 strain change study, the CIC investigational vaccine candidate, the scope, timing and outcome of future and pending regulatory filings and actions, including expected U.S. Biologics License Application filing in second half of 2023, future deliveries under APAs and Novavax’s ability to advance and finance a Phase 3 Flu/CIC program via strategic collaborations and / or financing alternatives are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These 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 applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; manufacturing delays or challenges, including as a result of the timing of the anticipated regulatory requirements for the Fall 2023 vaccination season; the loss of future funding from the U.S. government; the potential for an unfavorable outcome in disputes, including the pending arbitration with Gavi; challenges in implementing our global restructuring and cost reduction plan; challenges in obtaining commercial adoption of NVX-CoV2373 or a COVID variant strain-containing formulation; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties.

The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

*Included in noncurrent liabilities as of March 31, 2023 and current and non-current liabilities as of December 31, 2022.

Investors

Erika Schultz | 240-268-2022

ir@novavax.com

Media

Ali Chartan | 240-720-7804

media@novavax.com

•This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID

•Preliminary topline immune responses for all three vaccine candidates were robust versus authorized comparators

•For the stand-alone influenza vaccine candidate, HAI responses were 31 to 56% higher for all four influenza strains compared to Fluad®, and were 44 to 89% higher for A strains compared to Fluzone HD®

•For the COVID-Influenza Combination vaccine candidate, anti-S IgG and neutralization responses achieved levels seen in Phase 3 trial with Novavax’s prototype vaccine, with HAI responses generally consistent with Fluad® and Fluzone HD®

•All three vaccine candidates were well-tolerated and demonstrated a reassuring preliminary safety profile, with reactogenicity comparable to authorized comparators

•These Phase 2 results support continued development for all three vaccine candidates

GAITHERSBURG, Md., May 9, 2023 – Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that its COVID-Influenza Combination (CIC), stand-alone influenza and high-dose COVID vaccine candidates all showed a reassuring preliminary safety profile as well as comparable reactogenicity to individual Novavax influenza and COVID vaccine candidates or authorized influenza vaccine comparators. Additionally, all three vaccines demonstrated preliminary robust immune responses.

The primary endpoint evaluated the safety of different formulations of the CIC vaccine candidate and the quadrivalent influenza vaccine candidate compared to Fluad®* and Fluzone High-Dose Quadrivalent®** (Fluzone HD), as well as a high-dose COVID vaccine candidate in adults aged 50 through 80. All three vaccine candidates contained Novavax’s patented Matrix-M adjuvant and showed reassuring preliminary safety profiles and reactogenicity that was comparable to Fluad and Fluzone HD. The reactogenicity profile remained consistent as the adjuvant or antigen dose was increased.

In all groups there were no adverse events (AE) of special interest, no potentially immune mediated medical conditions and no treatment-related serious AEs. Unsolicited AEs occurred in 25% or fewer of any group and were consistent with diagnoses in the older adult population. Local and systemic symptoms were mostly mild and moderate and occurred at rates comparable to Fluad and Fluzone HD.

“The reactogenicity results support our previous observations that this technology is well suited for combination vaccines because large amounts of antigen can be incorporated without impacting tolerability,” said Filip Dubovsky President, Research and Development, Novavax. “The immune responses we observed were robust, and the data we have shared today significantly increase the probability of Phase 3 success.”

The CIC vaccine candidate achieved both immunoglobulin G (IgG) and neutralizing levels comparable to Novavax’s prototype COVID vaccine (NVX-CoV2373). In addition, several of the combination formulations achieved responses to both SARS-CoV-2 and to the four homologous influenza strains that were comparable to the reference comparators, supporting their prioritization for advanced development.

The stand-alone influenza vaccine candidate achieved statistically significant hemagglutination inhibition (HAI) antibody responses 31 to 56% higher for all four strains compared to Fluad. Titers were 44 (H1N1) to 89% (H3N2) higher for A strains and statistically non-inferior for B-strains compared to Fluzone HD.

The highest dose stand-alone COVID vaccine candidate achieved statistically significant anti-S IgG and neutralization responses approximately 30% higher than Novavax’s prototype COVID vaccine while maintaining comparable safety and reactogenicity to currently authorized dose level of Nuvaxovid.

“Today’s positive data are encouraging and further validate the value of our technology platform and its potential to improve global public health,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “This is an important milestone in our journey to create additional value and diversify our portfolio of vaccines.”

The Phase 2 Trial is a dose-confirming, randomized, observer-blinded trial evaluating the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates, and higher doses of Novavax’s COVID vaccine in adults aged 50 through 80. The trial is assessing a CIC vaccine candidate comprised of Novavax's recombinant protein-based COVID vaccine, quadrivalent influenza vaccine candidate and patented saponin-based Matrix-M adjuvant. Primary and secondary objectives of the study are to assess the safety, tolerability and immune responses to various formulations of the CIC, influenza and high-dose COVID vaccine candidates. The Phase 2 dose-confirmation trial is being conducted in two parts.

NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels. 

When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, the CIC, the high-dose COVID vaccine candidates, the quadrivalent influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax's plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax's global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety intended utilization, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These 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 applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

*Fluad® is a registered trademark of Seqirus UK Limited

**Fluzone High-Dose Quadrivalent®* is a registered trademark of Sanofi Pasteur Inc.

Investors

Erika Schultz

240-268-2022

ir@novavax.com

Media

Ali Chartan

240-720-7804

media@novavax.com