Full Press Release Details
Novavax Reports Fourth Quarter and Full
Year 2020 Financial Results and Operational Highlights
Md., March 1, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing 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, 2020.
"Novavax continues to make significant
strides towards bringing NVX-CoV2373, our COVID-19 vaccine candidate, to market," said Stanley C. Erck, President and Chief
Executive Officer of Novavax. "With positive efficacy results, including against evolving variant strains, NVX-CoV2373 offers
a highly unique profile, including the ability to ship and store the vaccine at traditional refrigerated temperatures. We believe
these attributes support emergency use authorization and have initiated dialogue with regulators to pursue appropriate regulatory
authorization. In addition, we have secured agreements for the delivery of approximately 300 million doses of NVX-CoV2373. In our
efforts to provide fair and equitable access to our vaccine around the world, we are proud to partner with the Serum Institute
of India to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX Facility. We continue to work tirelessly
to make final commercial preparations in advance of delivering our product across the globe."
Fourth Quarter 2020 and Recent Highlights
Corporate Highlights
Financial Results for the Three and
Twelve Months Ended December 31, 2020
Novavax reported a net loss of $177.6 million,
or $2.70 per share, for the fourth quarter of 2020, compared to a net loss of $31.8 million, or $1.13 per share, for the fourth
quarter of 2019. For the twelve months ended December 31, 2020, the net loss was $418.3 million, or $7.27 per share, compared to
a net loss of $132.7 million, or $5.51 per share, for the same period in 2019.
Novavax revenue in the fourth quarter of
2020 was $279.7 million, compared to $8.8 million in the same period in 2019. The significant increase in revenue was comprised
of revenue for services performed under the CEPI agreement and participation in OWS.
Research and development expenses increased
to $401.2 million in the fourth quarter of 2020, compared to $29.3 million in the same period in 2019. The increase was primarily
due to increased development activities relating to NVX-CoV2373 and increased employee-related costs, including stock-based compensation
General and administrative expenses increased
to $61.3 million in the fourth quarter of 2020, compared to $8.2 million for the same period in 2019. The increase was primarily
due to increased employee-related costs, primarily stock-based compensation expense, and increased professional fees to support
of our NVX-CoV2373 program.
As of December 31, 2020, Novavax had $806.4
million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019.
Net cash used in operating activities for the twelve months of 2020 was $42.5 million, compared to $136.6 million for same period
Through utilization of At-the-market (ATM)
offerings, Novavax raised net proceeds of $428 million and $874 million during the three and twelve months of 2020, respectively.
In addition, in the second quarter of 2020, Novavax received gross proceeds of $200 million upon entering into an agreement to
sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated
with RA Capital Management (RA Capital) in a private placement. There shares were converted to common stock in the fourth quarter
host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076
(Domestic) or (707) 287-9331 (International), passcode 3797013. A replay of the conference call will be available starting at 7:30
p.m. ET on March 1, 2021 until 7:30 p.m. ET on March 8, 2021. To access the replay by telephone, dial (855) 859-2056 (Domestic)
or (404) 537-3406 (International) and use passcode 3797013.
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 June 1, 2021.
is a protein-based vaccine candidate engineered from the genetic sequence 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 adjuvanted with Novavax' patented saponin-based Matrix-M 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. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of the spike protein to cellular
receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response
numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated
in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against
the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December.
It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated
50-60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.
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 adjuvant.
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.
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 combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine
candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu , its quadrivalent influenza nanoparticle vaccine,
met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission.
Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response
and stimulate high levels of neutralizing antibodies.
more information, visit www.novavax.com and connect with us on Twitter
Forward-Looking Statements
Statements herein relating to the future
of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that
these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially
from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk
Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, 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 sec.gov, 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| (unaudited) | ||||||||||||||||
| Revenue | $ | 279,659 | $ | 8,816 | $ | 475,598 | $ | 18,662 | ||||||||
| Expenses: | ||||||||||||||||
| Research and development | 401,199 | 29,341 | 747,027 | 113,842 | ||||||||||||
| Gain on sale of assets | -- | -- | -- | (9,016 | ) | |||||||||||
| General and administrative | 61,313 | 8,180 | 145,290 | 34,417 | ||||||||||||
| Total expenses | 462,512 | 37,521 | 892,317 | 139,243 | ||||||||||||
| Loss from operations | (182,853 | ) | (28,705 | ) | (416,719 | ) | (120,581 | ) | ||||||||
| Interest income (expense), net | (3,737 | ) | (3,127 | ) | (14,131 | ) | (12,100 | ) | ||||||||
| Other income (expense) | 9,026 | 2 | 12,591 | (13 | ) | |||||||||||
| Net loss | $ | (177,564 | ) | $ | (31,830 | ) | $ | (418,259 | ) | $ | (132,694 | ) | ||||
| Basic and diluted net loss per share | $ | (2.70 | ) | $ | (1.13 | ) | $ | (7.27 | ) | $ | (5.51 | ) | ||||
| Basic and diluted weighted average number of common shares outstanding | 65,725 | 28,063 | 57,554 | 24,100 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| December 31, 2020 | December 31, 2019 | |||||||
| Cash and cash equivalents | $ | 553,398 | $ | 78,823 | ||||
| Marketable securities | 157,649 | -- | ||||||
| Total restricted cash | 95,340 | 3,357 | ||||||
| Total current assets | 1,248,203 | 97,247 | ||||||
| Working capital | 668,531 | 71,452 | ||||||
| Total assets | 1,582,479 | 172,957 | ||||||
| Notes payable | 322,035 | 320,611 | ||||||
| Total stockholders' equity (deficit) | 627,209 | (186,017 | ) |
Erika Schultz | 240-268-2022
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