Full Press Release Details
Novavax Reports Fourth Quarter and Full Year
2021 Financial Results and Operational Highlights
GAITHERSBURG, Md., February 28, 2022
- Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines
for serious infectious diseases, today announced its financial results and operational highlights for the fourth quarter and twelve months
ended December 31, 2021.
"NVX-CoV2373 has now received
regulatory authorizations globally, representing the potential to reach more than six billion lives. We are now delivering our vaccine
around the world, with immunizations already happening in the European Union, Asia and Australia to meet the continued need to achieve
high vaccination rates through primary immunization, boosting and protection of pediatric age groups," said Stanley C. Erck, President
and Chief Executive Officer, Novavax. "We also remain focused on expanding access to our vaccine through additional regulatory filings
and ongoing research to add to our robust body of clinical data. We are confident in NVX-CoV2373's potential as a vital vaccine
option due to its reassuring safety profile and demonstrated efficacy against variants with the benefits of refrigerator-stable storage."
Fourth Quarter 2021 and Recent Highlights
Achieved Multiple Regulatory
Authorizations Globally for COVID-19 Vaccine
Completed Multiple Regulatory
Submissions Globally for COVID-19 Vaccine
COVID-19 Vaccine Advanced
COVID-19 Vaccine Manufacturing,
Supply and Distribution
COVID-19 Vaccine Clinical Development
COVID-Influenza Combination Vaccine Clinical Development
Publication Highlights
Financial Results for the Three and Twelve
Months Ended December 31, 2021
Novavax revenue for the fourth quarter and full
year ended 2021 were $222 million and $1.1 billion, respectively, compared to $280 million and $476 million for the comparable periods
in 2020. The increase to royalties and other revenue in the fourth quarter and full year 2021 was primarily the result of NVX-CoV2373
sales by our license partners to South Korea and Indonesia. The increase to full year 2021 grants revenue reflects the significant NVX-CoV2373
activities funded by both the U.S. government and the Coalition for Epidemic Preparedness Innovations.
Research and development expenses for the fourth
quarter and full year ended 2021 were $963 million and $2.5 billion, respectively, compared to $401 million and $747 million for the comparable
periods in 2020. The increase was primarily due to the development and manufacturing of NVX-CoV2373, including pre-launch inventory buildup
in advance of regulatory authorizations.
General and administrative expenses for the fourth
quarter and full year ended 2021 were $84 million and $298 million, respectively, compared to $61 million and $145 million for the comparable
Net loss for the fourth quarter and full year
ended 2021 were $846 million and $1.7 billion, respectively, compared to a net loss of $178 million and $418 million for the comparable
As of December 31, 2021, Novavax had $1.5 billion
in cash, cash equivalents, marketable securities and restricted cash, compared to $0.8 billion as of December 31, 2020.
Novavax expects to achieve full year 2022 total
revenue of between $4 billion and $5 billion. Total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grants
revenue, royalties and other revenue.
Novavax will host its quarterly conference call
today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 870-4263 (Domestic) or (412) 317-0790 (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, 2022 until 11:59 p.m. ET on March 7, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412)
317-0088 (International) and use passcode 2206365.
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, 2022.
NVX-CoV2373 is a protein-based vaccine engineered
from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax'
recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax'
patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373
contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use
liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M
adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2 - 8 Celsius, enabling the use of existing vaccine supply
and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture,
commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with
Serum Institute of India (SII), the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional
manufacturing sites throughout Novavax' global supply chain.
NanoFlu is a recombinant hemagglutinin (HA) protein
nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences
that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M
About Matrix-M Adjuvant
Novavax' patented saponin-based Matrix-M adjuvant
has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing
antigen presentation in local lymph nodes, boosting immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology
company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent
serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering
to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19
vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the
World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine,
Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373
and NanoFlu, its quadrivalent influenza investigational vaccine candidate. These vaccine candidates incorporate Novavax' proprietary saponin-based
Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information,
visit www.novavax.com and connect with us on Twitter, LinkedIn, Instagram and Facebook.
Forward-Looking Statements
relating to the future of Novavax, its operating plans and prospects, its partnerships, financial guidance, the timing of clinical trial
results, the ongoing development of NVX-CoV2373, including Novavax' plans to initiate a pediatric study in Q2 2022, the timing
for data for the ongoing Phase 1/2 trial for a COVID-influenza combination vaccine candidate and plans to initiate a Phase 2 clinical
trial for a COVID-Influenza combination vaccine and NanoFlu standalone, the scope, timing and outcome of future regulatory filings and
actions, including Novavax' plans to supplement global regulatory filings in the first quarter of 2022 and to supplement existing authorizations
with data from additional manufacturing sites, the potential impact of Novavax and NVX-CoV2373 in addressing vaccine access, controlling
the pandemic and protecting populations, including the potential reach of NVX-CoV2373, the efficacy, safety and intended utilization
of NVX-CoV2373, and expected delivery of NVX-CoV2373, including a Omicron-specific vaccine, 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; unanticipated challenges or delays in conducting
clinical trials; 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; 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' Annual Report
on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange