Novavax, Inc., (Nasdaq:NVAX) today announced its financial results
for the first quarter ended March 31, 2018.
First Quarter and Subsequent
Achievements:
RSV F Vaccine
- In May 2018, Novavax reached enrollment of approximately 4,600
pregnant women in its Prepare™ Phase 3 clinical trial of its RSV F
Vaccine for infants via maternal immunization. This milestone
enables Novavax to initiate a prespecified interim efficacy
analysis after approximately six months of follow-up of the last
infant born to the approximately 4,600 women enrolled (including
3,000 actively vaccinated women). Completion of this analysis is
expected in the first quarter of 2019. Since 2015, the Prepare
trial is supported by an $89 million grant from the Bill &
Melinda Gates Foundation (BMGF).
- In April 2018, Novavax presented at the World Vaccine Congress
on the status of its Phase 3 clinical trial of its RSV F
Vaccine.
NanoFlu™
- In April 2018, Novavax presented clinical data at the World
Vaccine Congress from the Phase 1/2 clinical trial in older adults
comparing trivalent formulations of NanoFlu to the market-leading
licensed egg-based, high-dose influenza vaccine for older
adults.
- In February 2018, Novavax reported positive top-line results
from its Phase 1/2 clinical trial of its trivalent NanoFlu.
Corporate
- In April 2018, Novavax completed an underwritten public
offering of approximately 34.8 million shares of its common stock,
including 4.5 million shares pursuant to the underwriters’ option
to purchase additional shares. The shares resulted in net proceeds
of $54 million.
- Effective on March 14, 2018, John J. Trizzino, former Senior
Vice President, Commercial Operations since 2014, was promoted to
Senior Vice President, Chief Business Officer and Chief Financial
Officer.
Anticipated Events:
- Initiation of the Phase 2 clinical trial of quadrivalent
formulations of NanoFlu scheduled to begin in the third quarter of
2018.
- Top-line data from the Phase 2 NanoFlu trial and End of Phase 2
meeting with the FDA expected in the first quarter of
2019.
- Results of the Prepare Phase 3 interim efficacy analysis for
our RSV F Vaccine expected in the first quarter of
2019.
Summary
“We had an extremely productive first quarter,
including making important advances in our two lead clinical
vaccine programs. We are pleased to have reached the enrollment
target for our Prepare Phase 3 RSV F Vaccine trial, which
clears the path for following these most recent participants and
their babies, and subsequently announcing top-line results of our
planned interim efficacy analysis in the first quarter of 2019,”
said Stanley C. Erck, President and CEO of Novavax, Inc. “We also
continue to make significant progress on NanoFlu and plan to
initiate a Phase 2 clinical trial in the third quarter of
2018.”
Financial Results for the First Quarter
Ended March 31, 2018
Novavax reported a net loss of $46.4 million, or
$0.14 per share, for the first quarter of 2018, compared to a net
loss of $43.9 million, or $0.16 per share, for the first quarter of
2017.
Novavax revenue in the first quarter of 2018 was
$9.7 million, compared to $5.7 million in the same period in 2017.
This 70% increase was driven by higher revenue recorded under the
BMGF grant corresponding to the increased enrollment in the Prepare
trial.
Research and development expenses increased 18%
to $44.5 million in the first quarter of 2018, compared to $37.7
million for the same period in 2017. The increase was primarily due
to increased development activities of the RSV F Vaccine for
infants via maternal immunization.
Interest income (expense), net for the first
quarter of 2018 was ($2.9) million, compared to ($3.0) million for
the same period of 2017.
As of March 31, 2018, Novavax had $164.2 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 first quarter of 2018 was
$66.1 million, compared to $44.5 million for same period in 2017.
The increase in cash usage was primarily due to approximately $16
million of one-time payments, as well as the adoption of a new
accounting standard that requires restricted cash to be included in
the beginning and ending balances on the statements of cash flows,
thus increasing Novavax’ cash usage in the first quarter of 2018
and 2017 by approximately $9 million and $6 million, respectively.
We expect our cash used in operating activities to significantly
decrease for the subsequent quarters of 2018 as compared to the
first quarter of 2018.
Conference Call
Novavax management 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 3687883. A replay of the conference call
will be available starting at 7:30 p.m. ET on May 9, 2018 until
7:30 p.m. ET on May 16, 2018. To access the replay by telephone,
dial (855) 859-2056 (Domestic) or (404) 537-3406 (International)
and use passcode 3687883.
A webcast of the conference call can also be
accessed via a link on the home page of the Novavax website at
www.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 9, 2018.
About RSV
RSV is the most common cause of lower
respiratory tract infections and the leading viral cause of severe
lower respiratory tract disease in infants and young children
worldwide, with estimated annual infection and mortality rates of
64 million and 160,000, respectively.1 In the U.S., RSV is the
leading cause of hospitalization of infants.2 Despite the induction
of post-infection immunity, repeat infection and lifelong
susceptibility to RSV is common.3 Currently, there is no approved
RSV vaccine available.
About RSV F Vaccine for Infants via
Maternal Immunization
Novavax is developing a vaccine that targets the
fusion protein, or F protein, of the RSV virus. The F protein has
highly conserved amino acid sequences, called antigenic sites,
which are the target of neutralizing antibodies and are believed to
be ideal vaccine targets. Novavax’ genetically engineered novel F
protein antigen exposes a range of these antigenic sites, and can
evoke immune responses to them in human vaccine recipients. In a
previous Phase 2 clinical trial of the RSV F Vaccine, which
assessed the transplacental transfer of maternal antibodies induced
by the vaccine, immunized women demonstrated meaningful fold rises
in anti-F IgG, palivizumab-competing antibodies and
microneutralization titers. In addition, infants’ antibody levels
at delivery averaged 90-100% of the mothers’ levels, indicating
efficient transplacental transfer of antibodies from mother to
infant.
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 each year are attributed to influenza.4 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 2025.5
About NanoFlu™
NanoFlu is a recombinant hemagglutinin (HA)
protein nanoparticle influenza vaccine candidate 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.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
biotechnology company committed to delivering novel products to
prevent infectious diseases. Its RSV and influenza nanoparticle
vaccine candidates are Novavax’ most advanced clinical programs and
are at the forefront of Novavax’ efforts to improve global health.
For more information, please visit www.novavax.com.
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 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.
1
https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
2 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
3 PLOS. “How immunity to respiratory syncytial virus develops in
childhood, deteriorates in adults.” ScienceDaily. 21 April 2016.
https://www.sciencedaily.com/releases/2016/04/160421145747.htm
4 Resolution of the World Health Assembly (2003) WHA56.19.28
5 Influenza Vaccines Forecasts. Datamonitor (2013)
|
|
NOVAVAX, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except per share
information) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
$ |
9,653 |
|
|
$ |
5,680 |
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
|
|
|
44,514 |
|
|
|
37,654 |
|
|
General and
administrative |
|
|
|
|
|
8,652 |
|
|
|
8,852 |
|
|
|
Total expenses |
|
|
|
|
|
53,166 |
|
|
|
46,506 |
|
Loss from
operations |
|
|
|
|
|
(43,513 |
) |
|
|
(40,826 |
) |
Interest
income (expense), net |
|
|
|
|
|
(2,872 |
) |
|
|
(3,039 |
) |
Other
income (expense) |
|
|
|
|
|
33 |
|
|
|
11 |
|
Net
loss |
|
|
|
|
$ |
(46,352 |
) |
|
$ |
(43,854 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
|
|
|
|
$ |
(0.14 |
) |
|
$ |
(0.16 |
) |
Basic and
diluted weighted average |
|
|
|
|
|
|
|
|
number of
common shares outstanding |
|
|
|
|
|
336,972 |
|
|
|
274,178 |
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED CONSOLIDATED BALANCE SHEET
DATA |
(in thousands) |
|
|
March 31,
2018 |
|
December 31,2017 |
|
(unaudited) |
|
|
Cash and cash
equivalents |
$ |
113,402 |
|
|
$ |
106,307 |
|
Marketable
securities |
|
30,358 |
|
|
|
50,996 |
|
Total restricted
cash |
|
20,439 |
|
|
|
29,124 |
|
Total current
assets |
|
181,034 |
|
|
|
203,311 |
|
Working capital |
|
136,130 |
|
|
|
129,636 |
|
Total assets |
|
276,067 |
|
|
|
302,493 |
|
Notes payable |
|
318,119 |
|
|
|
317,763 |
|
Total stockholders’
deficit |
|
(99,369 |
) |
|
|
(101,732 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:
InvestorsNovavax, Inc.Erika Trahanir@novavax.com240-268-2000
Westwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaSam BrownMike Beyermikebeyer@sambrown.com312-961-2502
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