Full Press Release Details
Novavax Reports Third Quarter 2021 Financial
Operational Highlights
GAITHERSBURG, Md., November 4, 2021 --
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 third quarter ended September 30, 2021.
"We are excited by the significant progress
made over the quarter, including our landmark milestone of gaining the first regulatory approval for our COVID-19 vaccine," said
Stanley C. Erck, President and Chief Executive Officer, Novavax. "With additional regulatory submissions around the world, we are
prepared to deliver our vaccine globally. We believe the highly encouraging results from our six-month booster study complement the strong
efficacy demonstrated by NVX-CoV2373 to date, and we remain confident that our vaccine will serve as an important tool to fight COVID-19
in the years to come."
Third Quarter 2021 and Recent Highlights
COVID-19 Vaccine Regulatory
COVID-19 Vaccine Advanced
COVID-19 Vaccine Manufacturing
COVID-19 Vaccine Clinical Development
Publication Highlights
Corporate Highlights
Financial Results for the Three Months Ended
Novavax reported a net loss of $322.4 million,
or $4.31 per share, for the third quarter of 2021, compared to a net loss of $197.3 million, or $3.21 per share, for the third quarter
Novavax revenue in the third quarter of 2021 was
$178.8 million, compared to $157.0 million in the same period in 2020. This increase was due to increased development activities relating
to NVX-CoV2373 for services performed under the U.S. government agreement and royalties under Novavax' licensing agreements.
Research and development expenses increased to
$408.2 million in the third quarter of 2021, compared to $294.1 million in the same period in 2020. The increase was primarily due to
the development and manufacturing for NVX-CoV2373.
General and administrative expenses increased
to $77.8 million in the third quarter of 2021, compared to $56.9 million for the same period in 2020. The increase was primarily due to
costs associated supporting our NVX-CoV2373 program.
As of September 30, 2021, Novavax had $1.9
billion in cash, cash equivalents and restricted cash, compared to $0.8 billion as of December 31, 2020. The increase in cash provided
was primarily due to $1.2 billion in payments under advance purchase agreements recorded as deferred revenue and $565 million net proceeds
raised through utilization of At-the-market (ATM) offerings during the first quarter of 2021.
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 November 4, 2021 until 11:59 p.m. ET on November 11, 2021. To access the replay by telephone, dial
(877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 10161242.
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 February 4,
NVX-CoV2373 is a protein-based vaccine candidate
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 microgram antigen and 50 microgram
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.
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.
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 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. Both vaccine candidates
incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing
For more information, visit www.novavax.com
and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
Statements herein relating to the future of Novavax,
its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, COVID-NanoFlu combination vaccine
and other Novavax vaccine product candidates, including the timing of anticipated clinical trial results, the scope, timing and outcome
of future regulatory filings and actions, the anticipated manufacturing capacity for Novavax' COVID-19 vaccine, the preparedness
of Novavax to deliver vaccine doses, and the anticipated role that NVX-CoV2373 will play in fighting COVID-19 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 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 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 178,844 | $ | 157,024 | $ | 924,090 | $ | 195,939 | ||||||||
| Expenses: | ||||||||||||||||
| Research and development | 408,195 | 294,087 | 1,571,551 | 345,828 | ||||||||||||
| General and administrative | 77,793 | 56,879 | 214,144 | 83,977 | ||||||||||||
| Total expenses | 485,988 | 350,966 | 1,785,695 | 429,805 | ||||||||||||
| Loss from operations | (307,144 | ) | (193,942 | ) | (861,605 | ) | (233,866 | ) | ||||||||
| Interest income (expense), net | (4,852 | ) | (4,320 | ) | (14,928 | ) | (10,394 | ) | ||||||||
| Other income (expense) | (4,394 | ) | 952 | (8,328 | ) | 3,565 | ||||||||||
| Net loss before income tax expense | (316,390 | ) | (197,310 | ) | (884,861 | ) | (240,695 | ) | ||||||||
| Income tax expense | 6,041 | -- | 12,606 | -- | ||||||||||||
| Net loss | $ | (322,431 | ) | $ | (197,310 | ) | $ | (897,467 | ) | $ | (240,695 | ) | ||||
| Basic and diluted net loss per share | $ | (4.31 | ) | $ | (3.21 | ) | $ | (12.13 | ) | $ | (4.39 | ) | ||||
| Basic and diluted weighted average | ||||||||||||||||
| number of common shares outstanding | 74,745 | 61,554 | 73,972 | 54,810 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| September 30, 2021 | December 31, 2020 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 1,936,998 | $ | 553,398 | ||||
| Marketable securities | -- | 157,649 | ||||||
| Total restricted cash | 9,828 | 95,340 | ||||||
| Total current assets | 2,174,181 | 1,248,203 | ||||||
| Working capital | 420,766 | 668,531 | ||||||
| Total assets | 2,565,941 | 1,582,479 | ||||||
| Notes payable | 323,102 | 322,035 | ||||||
| Total stockholders' equity | 461,336 | 627,209 |
Erika Schultz | 240-268-2022
Alexandra Roy | 617-221-9197
Alison Chartan | 240-720-7804
Laura Keenan | 202-709-7521