Full Press Release Details
Novavax Reports Fourth Quarter and Full Year
2022 Financial Results and Operational Highlights
| Appointed John C. Jacobs as President and Chief Executive Officer | ||
| Updated U.S. government agreement to include up to 1.5 million additional doses of Novavax's COVID-19 vaccine for delivery in 2023 |
GAITHERSBURG, Md., February 28, 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 fourth quarter and twelve months ended December 31, 2022.
"I am excited to be joining Novavax at this
important time in the company's history," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Much
has been achieved over the past three years, and based on the foundation that has been laid to date, I believe that Novavax has significant
potential for a bright future."
"Over the past few weeks, the management
team and I have identified three near-term priorities that we believe are essential to our success this year and beyond: 1) to deliver
a competitive product for the upcoming 2023 fall vaccination season; 2) to reduce our rate of spend, manage our cash flow, and evolve
our scale and structure; and 3) to leverage our technology platform, our capabilities and our portfolio of assets to drive additional
value beyond Nuvaxovid alone. We believe that if we succeed in executing against these priorities, we will position the company well for
Fourth Quarter 2022 and Recent Highlights
COVID-19 Vaccine Orders and Plans for the
2023 Fall Vaccination Season
COVID-19 Vaccine Clinical Development Program
and Expanded Authorizations
COVID-19-Influenza Combination (CIC) Vaccine
Candidate Clinical Development
Corporate Highlights
Fourth Quarter and Full Year 2022 Financial
In 2023, Novavax intends to focus the organization
to align our investments and activities with our top priority of delivering an updated Covid-19 vaccine consistent with public health
recommendations for strain composition for the 2023 fall vaccination season. To maximize our opportunities and mitigate the significant
risks and uncertainties of the COVID-19 market, our goal is to reduce spend, extend our cash runway and operate efficiently to best position
the company to deliver long-term growth.
While our current cash flow forecast for the one-year
going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to
significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government, and pending arbitration. Given these
uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these
financial statements are issued.
The accompanying condensed consolidated financial
statements have been prepared assuming Novavax will continue as a going concern. A more detailed discussion of Novavax's liquidity
position and risk related thereto will be set forth in Novavax's Annual Report on Form 10-K that will be filed with the SEC.
Novavax will host its quarterly conference call
today at 4:30 p.m. ET. The dial-in numbers for the conference call are (833) 974-2381 (Domestic) or (412) 317-5774 (International). Participants
will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET
on February 28, 2023 until 11:59 p.m. ET on March 7, 2023. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412)
317-0088 (International) and use passcode 1137418.
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 May 28, 2023.
Trade Name in the U.S.
The trade name Nuvaxovid has not yet been
approved by the U.S. Food and Drug Administration.
About Nuvaxovid (NVX-CoV2373)
Novavax's COVID-19 vaccine is a protein-based
vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. 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.
About Matrix-M Adjuvant
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.
About the COVID-19-Influenza Combination (CIC)
Vaccine Candidate Phase 2 Trial
The COVID-19-Influenza Combination (CIC) Vaccine
Candidate 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 in adults aged 50 through 80. The trial will assess a CIC vaccine
comprised of Novavax's recombinant protein-based COVID-19 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 and influenza vaccine candidates. The Phase 2 dose-confirmation trial will be conducted in two parts. The first
part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. Initial results are expected mid-year 2023.
These data will inform the phase 3 trials for both influenza stand-alone and COVID-19-influenza combination vaccine candidates.
Novavax, Inc. (Nasdaq: NVAX) promotes improved
health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax, a
global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach,
innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the world's
most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza, and COVID-19 and influenza combined.
Please visit novavax.com and LinkedIn for more
Forward-Looking Statements
Statements herein relating to the future of Novavax,
its near term priorities including delivering an updated vaccine for the 2023 fall vaccination season, streamlining its investment and
organizational structure and building value for Novavax from its technology platform and Matrix-M adjuvant, its operating plans, objectives
and prospects, including Novavax's ability to continue as a going concern within one year after the issuance date of the financial
statements for the year ended December 31, 2022, its anticipated strategic plan, its future financial or business performance, conditions
or strategies, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, and a bivalent or monovalent
Omicron-based / original strain based vaccine, the CIC investigational vaccine candidate, a quadrivalent influenza investigational vaccine
candidate, the scope, timing and outcome of future and pending regulatory filings and actions and additional worldwide authorizations
of NVX-CoV2373 for use in adults and adolescents and as a booster, 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; 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.