Novavax Reports First Quarter 2019 Financial Results
Novavax, Inc., (Nasdaq: NVAX) today announced its financial results
and operational highlights for the first quarter ended March 31,
2019.
First Quarter 2019 and Subsequent
Operational Highlights
ResVax™ Program
- In February 2019, Novavax announced top-line data from the
Prepare™ trial, which was designed to determine the efficacy of
ResVax™ against medically significant respiratory syncytial virus
(RSV)-positive lower respiratory tract infection (LRTI) in infants.
ResVax is the first RSV vaccine to demonstrate efficacy in
infants.
- In April 2019, Novavax presented additional results at the
World Vaccine Congress in Washington, D.C. from the Prepare trial
of ResVax. Although the Prepare trial results did not meet the
pre-specified primary efficacy endpoint, it demonstrated efficacy
against RSV LRTI hospitalizations, a pre-specified secondary
endpoint. RSV LRTI hospitalization is not only an important
indication of the severity of RSV disease in infants, it also
reflects a significant economic burden to global health
systems.
NanoFlu™ Program
- In January 2019, Novavax announced positive top-line results of
its Phase 2 clinical trial of NanoFlu comparing various
quadrivalent formulations, with or without Novavax’ Matrix-M™
adjuvant, with two U.S.-licensed influenza vaccines in older
adults. These results show that NanoFlu with Matrix-M generated
enhanced immune responses compared to the unadjuvanted formulation,
and importantly, showed superior hemagglutination inhibition
antibody (HAI) responses against wild-type A(H3N2) viruses,
including drifted strains, when compared to Fluzone® High-Dose, the
leading flu vaccine in older adults.
Key Upcoming Events
- Meet with the FDA, European regulatory agencies, and
potentially other national regulatory agencies during the second
and third quarters, to assess opportunities for submission of
marketing applications for ResVax.
- Reach agreement with the FDA during the third quarter of 2019
on a proposed Phase 3 clinical trial design for NanoFlu utilizing
accelerated approval criteria for licensure.
- Present ResVax Phase 3 clinical trial data at the 37th Annual
Meeting of the European Society for Paediatric Infectious Diseases
(ESPID) on May 7, 2019.
Financial Results for the First Quarter
Ended March 31, 2019
Novavax reported a net loss of $43.2 million, or
$0.11 per share, for the first quarter of 2019, compared to a net
loss of $46.4 million, or $0.14 per share, for the first quarter of
2018.
Novavax revenue in the first quarter of 2019 was
$4.0 million, compared to $9.7 million in the same period in 2018.
This 59% decrease was driven by the completion of enrollment of the
Prepare trial in the second quarter of 2018.
Research and development expenses decreased 20%
to $35.5 million in the first quarter of 2019, compared to $44.5
million for the same period in 2018. This decrease was primarily
due to decreased development activities, including lower clinical
trial costs, of ResVax.
General and administrative expenses were flat at
$8.7 million in the first quarter of 2019, compared to the same
period of 2018.
Interest income (expense), net was ($3.0)
million in the first quarter of 2019, compared to ($2.9) million
for the same period of 2018.
As of March 31, 2019, Novavax had $108.7 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 first quarter of 2019 was
$50.6 million, compared to $66.1 million for same period in
2018.
Conference Call
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 5394082. A replay of the conference call will be available
starting at 7:30 p.m. ET on May 2, 2019 until 7:30 p.m. ET on May
9, 2019. To access the replay by telephone, dial (855) 859-2056
(Domestic) or (404) 537-3406 (International) and use passcode
5394082.
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 2, 2019.
About RSV in Infants
Globally, RSV (respiratory syncytial virus) is
the leading viral cause of severe lower respiratory tract disease
in infants and young children. It is the second leading cause of
death in children under one year of age. 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. 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. Estimated annual hospitalizations are
up to 76,000. 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.
About ResVax™
ResVax 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).
About Influenza
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.
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.
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 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.
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 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.
About Novavax
Novavax, 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. 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.
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, 2018, and Quarterly Report on Form
10-Q for the period ended March 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 |
|
|
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
$ |
3,982 |
|
|
$ |
9,653 |
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
|
|
|
|
35,473 |
|
|
|
44,514 |
|
|
General and
administrative |
|
|
|
|
|
8,732 |
|
|
|
8,652 |
|
|
|
Total expenses |
|
|
|
|
|
44,205 |
|
|
|
53,166 |
|
Loss from
operations |
|
|
|
|
|
(40,223 |
) |
|
|
(43,513 |
) |
Interest income
(expense), net |
|
|
|
|
|
(2,983 |
) |
|
|
(2,872 |
) |
Other income
(expense) |
|
|
|
|
|
(12 |
) |
|
|
33 |
|
Net loss |
|
|
|
|
$ |
(43,218 |
) |
|
$ |
(46,352 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
|
|
|
$ |
(0.11 |
) |
|
$ |
(0.14 |
) |
Basic and diluted
weighted average |
|
|
|
|
|
|
|
|
number of common
shares outstanding |
|
|
|
|
|
408,843 |
|
|
|
336,972 |
|
SELECTED CONSOLIDATED BALANCE SHEET
DATA(in thousands)
|
March 31, 2019 |
|
December 31, 2018 |
|
(unaudited) |
|
|
|
|
|
|
Cash and cash equivalents |
97,711 |
|
|
70,154 |
|
Marketable securities |
2,484 |
|
|
21,980 |
|
Total restricted cash |
8,488 |
|
|
11,805 |
|
Total current assets |
123,394 |
|
|
119,276 |
|
Working capital |
91,898 |
|
|
73,737 |
|
Total assets |
221,319 |
|
|
207,978 |
|
Notes payable |
319,543 |
|
|
319,187 |
|
Total stockholders’ deficit |
(150,583 |
) |
|
(167,935 |
) |
Contacts:
InvestorsNovavax, Inc.Erika Trahanir@novavax.com240-268-2000
WestwickeJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
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