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Novavax Reports First Quarter 2020 Financial Results CEPI increases investment up to $388 million for NVX-CoV2373 vaccine development & manufacturing NVX - CoV2373 Phase I trial initiating in May with preliminary results

Key Takeaway: Novavax Reports First Quarter 2020 Financial CEPI increases investment up to $388 million for NVX-CoV2373 vaccine development & Phase I trial initiating in May with preliminary results in July NanoFlu recently achieved all primary endpoints in pivotal Phase 3 clinical trial C

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Novavax Reports First Quarter 2020 Financial
CEPI increases investment up to $388 million for NVX-CoV2373 vaccine development &
Phase I trial initiating in May with preliminary results in July
NanoFlu recently achieved all primary endpoints in pivotal Phase 3 clinical trial
Company to host conference call today at 4:30 p.m. ET
MD, May 11, 2020 (GLOBE NEWSWIRE) - Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation
vaccines for serious infectious diseases, today announced its financial results and operational highlights for the first
quarter ended March 31, 2020.
"Our accomplishments to-date in 2020,
including significant progress in our influenza and COVID-19 vaccine programs, are the most impressive in the company's history,"
said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We shared successful pivotal Phase 3 results for
NanoFlu that demonstrated both efficacy and safety in a pivotal trial, a significant milestone towards bringing this innovative
product to an influenza market in need of new options. We also reacted quickly to the coronavirus pandemic by developing and quickly
advancing NVX-CoV2373, our COVID-19 vaccine candidate, which shows strong potential
to have a positive impact on this global health crisis. Looking ahead, with a strengthened balance sheet and CEPI's substantial
funding, we will focus on scaling up manufacturing and delivering clinical data for NVX-CoV2373,
while simultaneously completing the necessary actions needed to prepare our BLA filing for NanoFlu."
First Quarter 2020 and Subsequent Operational
Financial Results for the Three Months
Ended March 31, 2020
Novavax reported a net loss of $25.9 million,
or $0.58 per share, for the first quarter of 2020, compared to a net loss of $43.2 million, or $2.11 per share, for the first quarter
Novavax revenue in the first quarter of
2020 was $3.4 million, compared to $4.0 million in the same period in 2019. This 15% decrease was primarly due to the conclusion
of the Prepare trial in 2019, partially offset by revenue from CEPI's funding.
Research and development expenses decreased
52% to $16.9 million in the first quarter of 2020, compared to $35.5 million in the same period in 2019. This decrease was primarily
due to decreased development activities of ResVax, lower employee-related costs and other cost savings due to the Catalent transaction
General and administrative expenses increased
to $9.4 million in the first quarter of 2020, compared to $8.7 million for the same period in 2019.
Interest income (expense), net for the
first quarter of 2020 and 2019 was ($3.0) million.
As of March 31, 2020, Novavax had $244.7
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 first quarter of 2020 was $23.1 million, compared to $50.6 million for same period
Share and per share data have been restated
to reflect the reverse stock split that was completed in May 2019.
Novavax will 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 1274143. A replay of the conference call will be available starting at 7:30 p.m. ET on May 11, 2020 until 7:30 p.m. ET
on May 18, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode
A webcast of the conference call can also
be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events"
tab on the Novavax website. A replay of the webcast will be available on the Novavax website until August 11, 2020.
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. Top-line data from Novavax' ongoing Phase 3 clinical trial of NanoFlu is expected
late in the first quarter of 2020.
is a 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 contains Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate
high levels of neutralizing antibodies. In preclinical trials, NVX-CoV2373 demonstrated
efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical
trial of NVX-CoV2373 will initiate in May 2020 with preliminary immunogenicity and
safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million
of funding to advance clinical development of NVX-CoV2373.
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.
Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development,
and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. Novavax
recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase
1 clinical trial results expected in July of 2020. 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 in order to enhance the immune response and stimulate high levels of neutralizing antibodies.
Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and
speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
For more information, visit www.novavax.com
and connect with us on Twitter and LinkedIn.
Forward-Looking 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, 2019, as
filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the 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.
NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information) (unaudited)
Three Months Ended
March 31
2020 2019
Revenue $ 3,377 $ 3,982
Expenses:
Research and development 16,895 35,473
General and administrative 9,379 8,732
Total expenses 26,274 44,205
Loss from operations (22,897 ) (40,223 )
Interest income (expense), net (2,967 ) (2,983 )
Other income (expense) -- (12 )
Net loss $ (25,864 ) $ (43,218 )
Basic and diluted net loss per share $ (0.58 ) $ (2.11 )
Basic and diluted weighted average
number of common shares outstanding 44,421 20,442
SELECTED CONSOLIDATED BALANCE SHEET DATA
March 31, 2020 December 31, 2019
(unaudited)
Cash and cash equivalents $ 179,881 $ 78,823
Marketable securities 57,474 --
Total restricted cash 7,311 3,357
Total current assets 255,232 97,247
Working capital 236,250 71,452
Total assets 328,068 172,957
Notes payable 320,967 320,611
Total stockholders' deficit (23,971 ) (186,017 )
Brandzone/COGS Communication
Last updated: May 11, 2020