Novavax Reports Fourth Quarter and Year-End 2018 Financial
Results
Novavax, Inc. (Nasdaq: NVAX) today announced its financial results
and operational highlights for the fourth quarter and twelve months
ended December 31, 2018.
“In 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.”
Fourth Quarter 2018 and Subsequent
Operational Highlights
ResVax™ Program
- In February 2019, Novavax announced
top-line data from the Prepare trial, which was initiated in
December 2015 to determine the efficacy of ResVax against medically
significant RSV-positive lower respiratory tract infection (LRTI)
in infants. Although the Prepare trial results did not meet the
pre-specified primary efficacy endpoint, they demonstrate efficacy
against a secondary objective (RSV LRTI hospitalizations). In
addition, other pre-specified exploratory endpoints and post-hoc
analyses highlight ResVax’ potential to improve global health
against serious RSV disease.
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
- Continue ongoing discussions with
the FDA, European regulatory agencies, and potentially other
national regulatory agencies, to assess opportunities for
submission of marketing license applications for ResVax.
- Reach agreement with the FDA during
the second quarter of 2019 on a proposed Phase 3 study design for
NanoFlu utilizing accelerated approval criteria.
- Present ResVax Phase 3 trial data
at the 37th Annual Meeting of the European Society for Paediatric
Infectious Diseases (ESPID) on May 7, 2019.
Financial Results for the Three and
Twelve Months Ended December 31, 2018
Novavax 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.
Novavax 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.
Research 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.
General 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.
Interest income (expense), net for the fourth
quarter of 2018 was ($2.8) million, compared to ($3.1) million for
the same period of 2017.
As 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.
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 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.
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 18, 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.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.
In 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.
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.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
_______________1 Nair, H., et al. (2010) Lancet. 375:1545-15552
Losano R., et al. (2012/Dec15) Lancet. 380: 20953 Ting S/Nair
H. Lancet. 2017/Sep2;390:9464 Leader S., et al. (2003) J
Pediatr. 143: S1275 Hall CB. N Engl J Med 2009;360:5886
CDC-Stockman LJ. Pediatr Infect Dis J 2012;31:57 Resolution of the
World Health Assembly. (2003) WHA56.19.288 Influenza Vaccines
Forecasts. Datamonitor (2013)
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 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 |
|
|
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(in thousands)
|
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 |
) |
|
|
|
|
|
|
|
|
Contacts:
InvestorsNovavax, Inc.Erika Trahanir@novavax.com240-268-2000
WestwickeJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaSam BrownAndrea
Cohenandreacohen@sambrown.com917-209-7163
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