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Novavax Reports Fourth Quarter and Year-End 2018 Financial Results Company to Host Conference Call Today at 4:30 p.m. ET Gaithersburg, MD

Key Takeaway: Novavax Reports Fourth Quarter and Year-End 2018 Financial Results Company to Host Conference Call Today at 4:30 p.m. ET MD, March 18, 2019 - Novavax, Inc., (Nasdaq: NVAX) today announced its financial results and operational highlights for the fourth quarter and twelve mont

Full Press Release Details

Novavax Reports Fourth Quarter and Year-End
2018 Financial Results
Company to Host Conference
Call Today at 4:30 p.m. ET
MD, March 18, 2019 - Novavax, Inc., (Nasdaq: NVAX) today announced its financial results and operational highlights for
the fourth quarter and twelve months ended December 31, 2018.
2018, we committed to focus on our two lead programs, ResVax and Nanoflu , and reflecting on last year's activities,
I am proud to say we have achieved significant results for both," said Stanley C. Erck, President and CEO of Novavax, Inc.
"Although we were disappointed to miss the primary endpoint of our Prepare trial, ResVax is the first RSV vaccine to demonstrate
efficacy for the prevention of RSV disease in a Phase 3 clinical trial. In addition, the successful Phase 2 results for our NanoFlu
vaccine provide an opportunity to now confirm with the FDA the use of accelerated approval for licensure. We are now prepared to
make meaningful advances on these programs during 2019."
Quarter 2018 and Subsequent Operational Highlights
Results for the Three and Twelve Months Ended December 31, 2018
reported a net loss of $49.3 million, or $0.13 per share, for the fourth quarter of 2018, compared to a net loss of $50.8 million,
or $0.16 per share, for the fourth quarter of 2017. For the twelve months ended December 31, 2018, the net loss was $184.7 million,
or $0.50 per share, compared to a net loss of $183.8 million, or $0.63 per share, for the same period in 2017.
revenue in the fourth quarter of 2018 was $6.1 million, compared to $10.4 million in the same period in 2017. This 41% decrease
was driven by the completion of enrollment of participants in the Prepare trial in the second quarter of 2018.
and development expenses decreased 13% to $43.4 million in the fourth quarter of 2018, compared to $49.7 million for the same period
in 2017. This decrease was primarily due to decreased development activities of ResVax and lower employee-related costs, partially
offset by increased development activities of NanoFlu.
and administrative expenses increased 8% to $9.2 million in the fourth quarter of 2018, compared to $8.5 million for the same period
in 2017. The increase was primarily due to higher professional fees.
income (expense), net for the fourth quarter of 2018 was ($2.8) million, compared to ($3.1) million for the same period of 2017.
of December 31, 2018, Novavax had $103.9 million in cash, cash equivalents, marketable securities and restricted cash, compared
to $186.4 million as of December 31, 2017. Net cash used in operating activities for the fourth quarter of 2018 was $45.3 million,
compared to $43.4 million for same period in 2017.
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 9559037. A replay of the conference call will be available starting at 7:30
p.m. ET on March 18, 2019 until 7:30 p.m. ET on March 25, 2019. To access the replay by telephone, dial (855) 859-2056 (Domestic)
or (404) 537-3406 (International) and use passcode 9559037.
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 18, 2019.
About RSV in Infants
RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children.1
It is the second leading cause of death in children under one year of age.2 Estimated annual hospitalizations of 1.4
million and an estimated 27,300 in-hospital deaths were due to RSV acute lower respiratory infection in children under six months
of age.3 RSV results in a total global economic burden of $6.2 billion annually.
the U.S., RSV is the leading cause of hospitalization of infants.4 Estimated annual hospitalizations are up to 76,000.5,6
While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year
RSV infections occur before six months. In the U.S., the total economic burden is $2.7 billion annually.
is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to
protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants
through the first months of life. In February 2019, Novavax announced top-line data from Prepare , a global Phase 3 clinical
trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an
$89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).
is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death.
Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general
population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies
in humans. An estimated one million deaths globally each year are attributed to influenza.7 Current estimates for
seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential
increase from approximately $3.2 billion in 2012-13 season to $5.3 billion by the 2021-22 season.8
(2010) Lancet. 375:1545-1555
(2012/Dec15) Lancet. 380: 2095
3 Ting S/Nair H. Lancet.
(2003) J Pediatr. 143: S127
Pediatr Infect Dis J 2012;31:5
of the World Health Assembly. (2003) WHA56.19.28
Vaccines Forecasts. Datamonitor (2013)
About NanoFlu and Matrix M
is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus
system. NanoFlu uses HA protein amino acid sequences that are the same as the recommended wild-type circulating virus HA sequences.
NanoFlu contains Novavax' patented saponin-based Matrix-M adjuvant, which is potent and well- stimulates both high
quality and durable antibody responses as well as multifunctional CD4 and CD8 T-cell responses.
In January 2019, Novavax announced positive top-line data from its Phase 2 clinical trial in older adults of quadrivalent formulations
of NanoFlu in 1,375 healthy older adults across clinical sites in the U.S.
Accelerated approval
may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or
life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based
on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint
that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody
response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered
for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one
or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing
studies of clinical effectiveness in preventing influenza.
(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. Its two priority programs are ResVax , its
RSV vaccine for infants via maternal immunization, and NanoFlu , its quadrivalent influenza nanoparticle vaccine. Novavax'
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.
more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
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, 2018 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
(in thousands, except per share information)
Three Months Ended Twelve Months Ended
December 31, December 31
2018 2017 2018 2017
(unaudited)
Revenue $ 6,127 $ 10,412 $ 34,288 $ 31,176
Expenses:
Research and development 43,415 49,657 173,797 168,435
General and administrative 9,224 8,540 34,409 34,451
Total expenses 52,639 58,197 208,206 202,886
Loss from operations (46,512 ) (47,785 ) (173,918 ) (171,710 )
Interest income (expense), net (2,819 ) (3,105 ) (10,938 ) (12,126 )
Other income (expense) (3 ) 47 108 67
Net loss $ (49,334 ) $ (50,843 ) $ (184,748 ) $ (183,769 )
Basic and diluted net loss per share $ (0.13 ) $ (0.16 ) $ (0.50 ) $ (0.63 )
Basic and diluted weighted average
number of common shares outstanding 383,171 316,119 369,757 292,669
SELECTED CONSOLIDATED BALANCE SHEET DATA
December 31, 2018 December 31, 2017
Cash and cash equivalents $ 70,154 $ 106,307
Marketable securities 21,980 50,996
Total restricted cash 11,805 29,124
Total current assets 119,276 203,311
Working capital 73,737 129,636
Total assets 207,978 302,493
Notes payable 319,187 317,763
Total stockholders' deficit (167,935 ) (101,732 )
Last updated: Mar 18, 2019