Novavax, Inc., (Nasdaq:NVAX) today provided a corporate update and
announced its financial results for the fourth quarter and twelve
months ended December 31, 2017.
“During this last quarter we collected our most
significant results to date from our two lead vaccine programs,”
said Stanley C. Erck, President and CEO, Novavax, Inc. “This
progress gives us enhanced focus and momentum to execute under
these programs for the remainder of 2018 and beyond.”
NanoFlu Program Update:
In late February 2018, the Company announced
positive top-line results from its Phase 1/2 clinical trial in 330
older adults of its NanoFlu recombinant influenza vaccine, which
includes its proprietary Matrix-M™ adjuvant, compared to the
leading licensed egg-based, high-dose influenza vaccine for older
adults (IIV3-HD). Key findings from the trial show that Novavax’
trivalent NanoFlu vaccine induced significantly higher
hemagglutination inhibition (HAI) antibody responses against
homologous A-type strains as well as against historic and
forward-drifted H3N2 strains. Based on the strength of these trial
results, the Company submitted a related manuscript to a
peer-reviewed medical journal and is planning to present the data
at the World Vaccine Congress meeting on April 4, 2018.
“This influenza season in the Northern
Hemisphere has resulted in a serious public health epidemic,
largely because of the H3N2 flu strain and the inability of current
vaccines to provide adequate protection, particularly to older
adults and other vulnerable populations,” said Gregory M. Glenn,
M.D., President of Research and Development. “Our NanoFlu vaccine’s
head-to-head performance against IIV3-HD demonstrated that it has
the potential to address two primary confounding factors related to
poor vaccine efficacy: virus drift and vaccine mutation resulting
from egg-based manufacturing. With these findings, we are able to
initiate manufacturing and clinical operations activities to
support our next step, a Phase 2 trial of a quadrivalent
formulation of our NanoFlu vaccine, scheduled to begin in the third
quarter of this year.”
RSV F Vaccine Maternal Immunization
Program Update:
In December 2017, the Company completed a
successful informational analysis of the Phase 3 Prepare™ clinical
trial of its RSV F Vaccine for infants via maternal immunization.
The analysis of data from 1,307 infants in the per-protocol
population indicate an observed vaccine efficacy in the range of
between 45% and 100%. The Company anticipates that it will reach
approximately 4,600 participants, including approximately 3,000
actively vaccinated mothers, in the second quarter of 2018, which
will enable an interim efficacy analysis with results reported in
early 2019. This program continues to be funded under an $89
million grant from the Bill and Melinda Gates Foundation (BMGF),
and has been granted Fast Track designation by the U.S. Food and
Drug Administration (FDA).
“The results of our informational analysis this December
significantly increased the likelihood of success of our RSV F
Vaccine program for infants via maternal immunization,” added Mr.
Erck. “With over 4,000 current participants, we are very close to
triggering the interim efficacy analysis, the positive results of
which would form the basis of our Biologics License Application
filing with the FDA. Providing protection to newborns from
respiratory syncytial virus, one of the most prevalent and damaging
diseases to which they are exposed during their first months of
life, has important global public health implications.”
Financial Results for the Three and
Twelve Months Ended December 31, 2017
Novavax reported a net loss of $50.8 million, or
$0.16 per share, for the fourth quarter of 2017, compared to a net
loss of $57.1 million, or $0.21 per share, for the fourth quarter
of 2016. For the twelve months ended December 31, 2017, the net
loss was $183.8 million, or $0.63 per share, compared to a net loss
of $280.0 million, or $1.03 per share, for the same period in
2016.
Novavax revenue in the fourth quarter of 2017
was $10.4 million, compared to $5.4 million in the same period in
2016. This 93% increase was driven by higher revenue recorded under
the BMGF grant of $89 million.
Research and development expenses decreased 3%
to $49.7 million in the fourth quarter of 2017, compared to $51.1
million for the same period in 2016. The decrease was primarily due
to reduced development activities of our RSV F Vaccine for older
adults, partially offset by increased developemtnt activities of
our RSV F Vaccine for infants via maternal immunization.
Interest income (expense), net for the fourth
quarter of 2017 and 2016 was ($3.1) million.
As of December 31, 2017, the company had $157.3
million in cash, cash equivalents and marketable securities,
compared to $235.5 million as of December 31, 2016. Net cash used
in operating activities for the full year 2017 was $138.7 million,
compared to $255.5 million for same period in 2016. The decrease in
cash usage was primarily due to decreased costs relating to our RSV
F Vaccine and lower overall employee-related costs.
Conference Call
Novavax management will host its quarterly
conference call today at 5:00 p.m. ET. The dial-in number for the
conference call is (877) 212-6076 (Domestic) or (707) 287-9331
(International), passcode 6472939. A replay of the conference call
will be available starting at 7:30 p.m. ET on March 14, 2018 until
8:30 pm ET on March 21, 2018. To access the replay by telephone,
dial (855) 859-2056 (Domestic) or (404) 537-3406 (International)
and use passcode 6472939.
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
14, 2018.
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.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 the Phase 1/2 Clinical Trial
Novavax conducted a randomized, observer-blind,
comparator-controlled trial of NanoFlu vaccine (in two trivalent
formulations: 45µg or 180µg total HA) against IIV3-HD in 330
healthy adults aged 60 years or older. Vaccine immunogenicity was
measured by HAI and neutralization antibody responses against a
panel of vaccine-homologous, and historically and forward-drifted,
influenza virus strains.
About NanoFlu™ and Matrix M™
NanoFlu vaccine is a recombinant hemagglutinin (HA) protein
nanoparticle influenza vaccine candidate produced by Novavax in its
SF9 insect cell baculovirus system. NanoFlu vaccine uses HA amino
acid protein sequences that are substantially the same as wild-type
circulating virus HA sequences. NanoFlu vaccine 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 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.3 In the US, RSV is the
leading cause of hospitalization of infants.4 Despite the induction
of post-infection immunity, repeat infection and lifelong
susceptibility to RSV is common.5 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 the U.S. Food and Drug
Administration’s (FDA) Fast Track Program
The Fast Track Drug Development Program was
established under the FDA Modernization Act of 1997. A Fast Track
designation is intended for products that treat serious or
life-threatening diseases or conditions, and that demonstrate the
potential to address unmet medical needs for such diseases or
conditions. The program is intended to facilitate development and
expedite review of drugs to treat serious and life-threatening
conditions so that an approved product can reach the market
expeditiously. Specifically, Fast Track designation facilitates
meetings to discuss all aspects of development to support licensure
and it provides the opportunity to submit sections of a BLA on a
rolling basis as data become available, which permits the FDA to
review modules of the BLA as they are received instead of waiting
for the entire BLA submission. In addition, priority review (six
month review versus standard ten month review) is a potential
benefit that may be available to Novavax’ RSV F vaccine in the
future.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
biotechnology company committed to delivering novel products to
prevent infectious diseases. Our RSV and influenza nanoparticle
vaccine candidates are Novavax’ most advanced clinical programs and
are at the forefront of the Company’s efforts to improve global
health. Additional information about Novavax is available on the
Company's website, 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.###
NOVAVAX, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except per share
information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ 10,412 |
|
$ 5,399 |
|
$ 31,176 |
|
$ 15,353 |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research
and development |
49,657 |
|
51,100 |
|
168,435 |
|
237,939 |
|
General and
administrative |
8,540 |
|
8,344 |
|
34,451 |
|
46,527 |
|
|
Total expenses |
58,197 |
|
59,444 |
|
202,886 |
|
284,466 |
Loss from
operations |
(47,785) |
|
(54,045) |
|
(171,710) |
|
(269,113) |
Interest
income (expense), net |
(3,105) |
|
(3,066) |
|
(12,126) |
|
(10,822) |
Other
income (expense) |
47 |
|
2 |
|
67 |
|
(31) |
Net
loss |
$ (50,843) |
|
$ (57,109) |
|
$ (183,769) |
|
$ (279,966) |
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
$ (0.16) |
|
$ (0.21) |
|
$ (0.63) |
|
$ (1.03) |
Basic and
diluted weighted average |
|
|
|
|
|
|
|
|
number of
common shares outstanding |
316,119 |
|
271,200 |
|
292,669 |
|
270,802 |
|
|
|
|
|
|
|
|
|
|
SELECTED CONSOLIDATED BALANCE SHEET
DATA |
(in thousands) |
|
December 31,
2017 |
|
December 31, 2016 |
|
|
|
|
Cash and cash
equivalents |
$ |
106,307 |
|
|
$ |
144,353 |
|
Marketable
securities |
|
50,996 |
|
|
|
91,126 |
|
Total current
assets |
|
203,311 |
|
|
|
287,830 |
|
Working capital |
|
129,636 |
|
|
|
221,424 |
|
Total assets |
|
302,493 |
|
|
|
394,301 |
|
Total notes payable and
capital lease obligation |
|
317,763 |
|
|
|
316,376 |
|
Total stockholders’
deficit |
|
(101,732 |
) |
|
|
(5,546 |
) |
Contact:
InvestorsWestwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaSam BrownMike Beyermikebeyer@sambrown.com312-961-2502
1 Resolution of the World Health Assembly (2003) WHA56.19.28
2 Influenza Vaccines Forecasts. Datamonitor (2013)
3
https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
4 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
5 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
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