Full Press Release Details
Novavax Reports Second Quarter 2018 Financial
Novavax Delivers on Key Milestones Supporting
Company to Host Conference Call Today
MD, August 8, 2018 - Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for
the second quarter and six months ended June 30, 2018.
keeping with our stated 2018 objectives, Novavax reached two important milestones in the second quarter for our lead ResVaxTM
and NanoFluTM programs," said Stanley C. Erck, Novavax President and CEO. "With ResVax, we achieved a critical
enrollment goal in the PrepareTM trial, enabling us to reach agreement with the FDA to initiate a final efficacy analysis
in the first quarter of 2019. This analysis will be used to support the future BLA and MAA in the U.S. and Europe, respectively."
the NanoFlu front," Mr. Erck continued, "the data published in The New England Journal of Medicine demonstrated
that NanoFlu induced significantly improved immune respones compared to the current leading high-dose influenza vaccine. We are
on track to initiate a Phase 2 clinical trial of quadrivalent formulations of NanoFlu in the third quarter of this year. Pending
successful Phase 2 data, based on discussions with the FDA, we anticipate initiating a Phase 3 immunogenicity clinical trial that
may provide the basis of licensure via the FDA's accelerated approval pathway."
Results for the Three and Six Months Ended June 30, 2018
reported a net loss of $44.5 million, or $0.12 per share, for the second quarter of 2018, compared to a net loss of $44.5 million,
or $0.16 per share, for the second quarter of 2017. For the six months ended June 30, 2018, the net loss was $90.8 million, or
$0.25 per share, compared to a net loss of $88.3 million, or $0.32 per share, for the same period in 2017.
revenue in the second quarter of 2018 was $10.8 million, compared to $6.7 million in the same period in 2017. This 60% increase
was driven by higher revenue recorded under the Bill & Melinda Gates Foundation (BMGF) grant of $89 million as a result of
increased enrollment in the Prepare trial and increased activities of Novavax AB, a wholly owned subsidiary of Novavax.
and development expenses increased 13% to $44.5 million in the second quarter of 2018, compared to $39.3 million for the same period
in 2017. The increase was primarily due to increased development activities of ResVax.
and administrative expenses decreased 8% to $8.2 million in the second quarter of 2018, compared to $8.9 million for the same period
in 2017. The decrease was primarily due to lower employee-related costs.
income (expense), net for the second quarter of 2018 was ($2.6) million, compared to ($3.0) million for the same period of 2017.
of June 30, 2018, Novavax had $178.2 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 second quarter of 2018 was $40.0 million,
compared to $12.4 million for same period in 2017. The increase in cash usage was primarily due to the receipt of a $25 million
payment under the BMGF grant in the six months ended June 30, 2017, whereas no payment was received in the same period of 2018
(however, we expect to receive a $15 million payment in the third quarter of 2018).
will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 212-6076
(Domestic) or (707) 287-9331 (International),
passcode 5886748. A replay of the conference call will be available starting at 7:30
p.m. ET on August 8, 2018 until 7:30 pm ET on August 15, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic)
or (404) 537-3406 (International) and use passcode 5886748.
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 November 8, 2018.
About RSV in infants
RSV (respiratory syncytial virus) is the
leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. Estimated annual infections
of 64 million and an estimated 160,000 deaths make it the second leading cause of death in children under one year of age. RSV
results in a total global economic burden of $6.2 billion annually. In the U.S., RSV is the leading cause of hospitalization of
infants. 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.
ResVax is an RSV fusion (F) protein recombinant
nanoparticle vaccine with aluminum phosphate. It is being developed to protect infants from RSV disease via maternal immunization
and is the only RSV vaccine in a Phase 3 clinical trial for this indication. Protecting infants via maternal immunization has been
shown to be effective against influenza, another respiratory virus, in prospective clinical studies. In addition, maternal immunization
with tetanus and pertussis vaccines has been shown to be effective in preventing these diseases in infants. Maternal immunization
may offer the best method of protection from RSV disease in infants through the first months of life.
Currently, ResVax is being evaluated in
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).
Influenza 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.1 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 2015 to $5.3 billion by 2025.2
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. Novavax expects to begin
a Phase 2 for its quadrivalent NanoFlu clinical trial in the third quarter of 2018.
About Accelerated Approval
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 BLA 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.
1 Resolution of the World Health Assembly (2003)
2 Influenza Vaccines Forecasts. Datamonitor (2013)
Novavax, Inc. (Nasdaq:NVAX)
is a late-stage biotechnology company that drives improved health globally through the discovery and development of innovative
vaccines to prevent serious respiratory diseases. ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine
in a Phase 3 clinical program and is poised to help prevent the second leading cause of death in children under one year of age
worldwide. Novavax is also advancing the clinical study of our influenza nanoparticle vaccine, which addresses key factors that
lead to poor efficacy by currently approved flu vaccines. 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 particles addressing urgent global health needs.
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 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, 2017 and the Quarterly Report on Form
10-Q for the period ended June 30, 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