Full Press Release Details
Novavax Reports Fourth Quarter and Full
Year 2019 Financial Results
MD, March 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 fourth
quarter and twelve months ended December 31, 2019.
remain on track to announce top-line results from our pivotal Phase 3 clinical trial for NanoFlu by the end of this month. Positive
clinical data from this trial would support a subsequent U.S. BLA using the FDA's accelerated approval pathway," said
Stanley C. Erck, President and Chief Executive Officer of Novavax. "We continue to make progress towards partnering our ResVax
program and recently announced progress in our efforts to develop a vaccine against COVID-19, with the goal of moving one or more
optimized COVID- 19 candidates into the clinic by the end
Fourth Quarter 2019 and Subsequent Operational
Financial Results for the Three and
Twelve Months Ended December 31, 2019
Share and per share data have been restated
to reflect the reverse stock split that was completed in May 2019.
Novavax reported a net loss of $31.8 million,
or $1.13 per share, for the fourth quarter of 2019, compared to a net loss of $49.3 million, or $2.57 per share, for the fourth
quarter of 2018. For the twelve months ended December 31, 2019, the net loss was $132.7 million, or $5.51 per share, compared to
a net loss of $184.7 million, or $9.99 per share, for the same period in 2018.
Novavax revenue in the fourth quarter of
2019 was $8.8 million, compared to $6.1 million in the same period in 2018. This 44% increase was driven by $7.5 million in revenue
for the recovery of additional costs under the closeout of the HHS BARDA contract, partially offset by lower revenue from the completion
of enrollment of participants in the Prepare trial in second quarter of 2018.
Research and development expenses decreased
32% to $29.3 million in the fourth quarter of 2019, compared to $43.4 million in the same period in 2018. This decrease was primarily
due to decreased development activities of ResVax, lower employee-related costs and other cost savings due to the Catalent transaction,
partially offset by NanoFlu's Phase 3 clinical trial and development activities.
General and administrative expenses decreased
to $8.2 million in the fourth quarter of 2019, compared to $9.2 million for the same period in 2018.
Interest income (expense), net for the
fourth quarter of 2019 was ($3.1) million, compared to ($2.8) million for the same period of 2018.
As of December 31, 2019, Novavax had $82.2
million in cash, cash equivalents, marketable securities and restricted cash, compared to $103.9 million as of December 31, 2018.
Net cash used in operating activities for the twelve months of 2019 was $136.6 million, compared to $184.8 million for same period
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 5695528. A replay of the conference call will be available starting at 7:30 p.m. ET on March 11, 2020 until 7:30 p.m.
ET on March 18, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use
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 June 11, 2020.
About NanoFlu and Matrix-M
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, which 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. Top-line data from Novavax'
ongoing Phase 3 clinical trial of NanoFlu is expected late in the first quarter of 2020.
A new strain of coronavirus first appeared
in late 2019 in China before beginning its rapid spread across the globe. The disease, named COVID-19, continues to cause severe
pneumonia-like symptoms in many of those infected. Coronaviruses, so named for their "crown-like" appearance, are a
large family of viruses that spread from animals to humans and include diseases such as Middle East Respiratory Syndrome (MERS)
and Severe Acute Respiratory Syndrome (SARS) in addition to COVID-19. While much remains unknown about the new coronavirus, it
is known that the virus can spread via human-to-human transmission before any symptoms appear.
Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that drives improved health globally through the discovery, development,
and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu , its quadrivalent influenza
nanoparticle vaccine, is currently in a pivotal Phase 3 clinical trial to address key factors that can lead to the poor effectiveness
of currently approved flu vaccines. ResVax , its RSV vaccine for infants via maternal immunization, is the only vaccine in
a Phase 3 clinical program and is designed to prevent severe lower respiratory tract infection, which is the second leading cause
of death in children under one year of age worldwide. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant
technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic
nanoparticles addressing 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except per share information)
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31 | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| (unaudited) | ||||||||||||||||
| Revenue | $ | 8,816 | $ | 6,127 | $ | 18,662 | $ | 34,288 | ||||||||
| Expenses: | ||||||||||||||||
| Research and development | 29,341 | 43,415 | 113,842 | 173,797 | ||||||||||||
| Gain on Catalent transaction | -- | -- | (9,016 | ) | -- | |||||||||||
| General and administrative | 8,180 | 9,224 | 34,417 | 34,409 | ||||||||||||
| Total expenses | 37,521 | 52,639 | 139,243 | 208,206 | ||||||||||||
| Loss from operations | (28,705 | ) | (46,512 | ) | (120,581 | ) | (173,918 | ) | ||||||||
| Interest income (expense), net | (3,127 | ) | (2,819 | ) | (12,100 | ) | (10,938 | ) | ||||||||
| Other income (expense) | 2 | (3 | ) | (13 | ) | 108 | ||||||||||
| Net loss | $ | (31,830 | ) | $ | (49,334 | ) | $ | (132,694 | ) | $ | (184,748 | ) | ||||
| Basic and diluted net loss per share | $ | (1.13 | ) | $ | (2.57 | ) | $ | (5.51 | ) | $ | (9.99 | ) | ||||
| Basic and diluted weighted average | ||||||||||||||||
| number of common shares outstanding | 28,063 | 19,159 | 24,100 | 18,488 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| December 31, 2019 | December 31, 2018 | |||||||
| Cash and cash equivalents | $ | 78,823 | $ | 70,154 | ||||
| Marketable securities | -- | 21,980 | ||||||
| Total restricted cash | 3,357 | 11,805 | ||||||
| Total current assets | 97,247 | 119,276 | ||||||
| Working capital | 71,452 | 73,737 | ||||||
| Total assets | 172,957 | 207,978 | ||||||
| Notes payable | 320,611 | 319,187 | ||||||
| Total stockholders' deficit | (186,017 | ) | (167,935 | ) |
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