GAITHERSBURG, Md., Aug. 09, 2016 (GLOBE NEWSWIRE)
-- Novavax, Inc., (Nasdaq:NVAX) today announced its financial
results for the second quarter and six months ended June 30,
2016.
Novavax
Second Quarter Achievements:
- Announced a new seasonal combination
respiratory vaccine program. Novavax demonstrated the ability to
combine the RSV F and influenza nanoparticle vaccines, bringing
together a vaccine approach that induces broadly neutralizing
antibodies against both influenza and RSV. Novavax' program was
unveiled at the New Approaches to Vaccines for Human and Veterinary
Tropical Diseases Keystone Symposia in Cape Town, South Africa in
June 2016.
- Continued execution of Resolve(TM),
a pivotal Phase 3 trial of our RSV F Vaccine in older adults (60
years of age and older). The Resolve trial is a randomized,
observer-blinded, placebo-controlled trial in 11,850 older adults
at 60 sites in the United States. The primary efficacy objective is
the prevention of moderate-severe RSV-associated lower respiratory
tract disease, as defined by the presence of multiple lower
respiratory tract symptoms. Enrollment was completed in the fourth
quarter of 2015.
- Ongoing execution of a Phase 2
rollover clinical trial of our RSV F Vaccine in 1,330 older adults.
The trial is a randomized, observer-blinded, placebo-controlled
rollover trial designed to enroll from the population of older
adults who participated in the prior Phase 2 trial. The primary
endpoints of the trial will evaluate safety and serum anti-F IgG
antibody concentrations in response to immunization with our RSV F
Vaccine. Enrollment was completed in the fourth quarter of
2015.
- Expanded enrollment of Prepare(TM),
a pivotal Phase 3 trial of our RSV F Vaccine in healthy pregnant
women, to multiple international sites to take advantage of the RSV
season in the southern hemisphere. The Prepare trial is a
randomized, observer-blinded, placebo-controlled trial. The primary
objective is to determine the efficacy of maternal immunization
with our RSV F Vaccine against symptomatic RSV lower respiratory
tract infection with hypoxemia in infants through the first 90 days
of life. The Prepare trial is supported by a grant of up
to $89 million from the Bill & Melinda Gates
Foundation (BMGF).
2016
Anticipated Events:
- Announce top-line data from Resolve,
the Phase 3 pivotal RSV F Vaccine trial in older adults in the
third quarter of 2016; and
- Announce top-line data from the
Phase 2 RSV F Vaccine rollover trial in older adults between now
and year end.
Summary
"This is an incredibly exciting
time for Novavax, as we near the announcement of Phase 3 data for
our RSV F Vaccine in older adults. Our regulatory expertise,
manufacturing operations, and strong balance sheet, in conjunction
with the pre-commercialization activities we have initiated, leave
us very well-positioned to execute on this opportunity," said
Stanley C. Erck, President and CEO. "We also continue to see
significant interest from a number of multinational, world-class
vaccine companies seeking potential partnership and
commercialization rights to our RSV F Vaccine franchise outside of
North America."
Financial
Results for the Three and Six Months Ended June 30,
2016
Novavax reported a net loss of
$79.4 million, or $0.29 per share, for the second quarter of 2016,
compared to a net loss of $20.6 million, or $0.08 per share, for
the second quarter of 2015. For the six months ended June 30, 2016,
the net loss was $156.6 million, or $0.58 per share, compared to a
net loss of $45.0 million, or $0.18 per share, for the same period
in 2015.
Novavax revenue in the second
quarter of 2016 decreased 82% to $2.5 million, compared to $14.0
million for the same period in 2015. Lower revenue under the BARDA
contract of $13.6 million is the primary driver of this decrease.
The decline in BARDA revenue in the second quarter of 2016 is the
result of the one-time recognition of $7.7 million in revenue in
the second quarter of 2015, and the recent advances in the
Company's seasonal influenza nanoparticle program which resulted in
the wind-down of VLP influenza activities under the BARDA contract.
This decrease in BARDA revenue was partially offset by $1.7 million
in revenue recorded under the BMGF grant relating to our ongoing
Prepare clinical trial.
Research and development expenses
increased 134% to $64.9 million in the second quarter of 2016,
compared to $27.7 million for the same period in 2015. The increase
in research and development expenses was primarily due to increased
costs associated with the clinical trials and development
activities of our RSV F Vaccine and higher employee-related costs,
including non-cash stock-based compensation.
General and administrative
expenses increased 99% to $14.1 million in the second quarter of
2016, compared to $7.1 million for the same period in 2015. The
increase was primarily due to higher employee-related costs,
including non-cash stock-based compensation expense, and
professional fees for pre-commercialization activities, as compared
to the same period in 2015.
Interest income (expense), net for
the second quarter of 2016 includes $3.0 million of interest
expense relating to the Company's Convertible Senior Notes.
As of June 30, 2016, the Company
had $366.4 million in cash and cash equivalents and marketable
securities compared to $230.7 million as of December 31, 2015. Net
cash used in operating activities for the first six months of 2016
was $131.9 million, compared to $42.8 million for same period in
2015. The increase in cash usage was primarily due to increased
costs relating to our RSV F Vaccine, higher employee-related costs
and timing of vendor payments.
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 59901631. 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 conference call
will be available starting at 7:00 p.m. on August 9, 2016 until
midnight August 16, 2016. To access the replay by telephone, dial
(855) 859-2056 (Domestic) or (404) 537-3406 (International) and use
passcode 59901631. The replay will also be available as a webcast
and can be found on the "Investor Info"/"Events" on the Novavax
website.
About
Novavax
Novavax, Inc. (Nasdaq:NVAX) is a
clinical-stage vaccine company committed to delivering novel
products to prevent a broad range of infectious diseases. Our
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are
the foundation for groundbreaking innovation that improves global
health through safe and effective vaccines. 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, 2015 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) |
| |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| |
|
For the
Three Months |
|
For the
Six Months |
| |
|
Ended June 30, |
|
Ended June 30, |
| |
|
2016
|
|
2015
|
|
2016 |
|
2015 |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
(unaudited) |
|
(unaudited) |
| Revenue |
|
$ |
2,505 |
|
|
$ |
13,996 |
|
|
$ |
6,723 |
|
|
$ |
23,872 |
|
| |
|
|
|
|
|
|
|
|
| Expenses: |
|
|
|
|
|
|
|
|
| Research and development |
|
|
64,904 |
|
|
|
27,729 |
|
|
|
133,856 |
|
|
|
56,076 |
|
| General and administrative |
|
|
14,099 |
|
|
|
7,088 |
|
|
|
24,627 |
|
|
|
12,931 |
|
| Total expenses |
|
|
79,003 |
|
|
|
34,817 |
|
|
|
158,483 |
|
|
|
69,007 |
|
| Loss from operations |
|
|
(76,498 |
) |
|
|
(20,821 |
) |
|
|
(151,760 |
) |
|
|
(45,135 |
) |
| Interest income (expense),
net |
|
|
(2,842 |
) |
|
|
108 |
|
|
|
(4,799 |
) |
|
|
194 |
|
| Other income (expense) |
|
|
(11 |
) |
|
|
72 |
|
|
|
(44 |
) |
|
|
(70 |
) |
| Net loss |
|
$ |
(79,351 |
) |
|
$ |
(20,641 |
) |
|
$ |
(156,603 |
) |
|
$ |
(45,011 |
) |
| |
|
|
|
|
|
|
|
|
| Basic and diluted net loss per
share |
|
$ |
(0.29 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.18 |
) |
| Basic and diluted weighted
average |
|
|
|
|
|
|
|
|
| number of common shares outstanding |
|
|
270,760 |
|
|
|
268,083 |
|
|
|
270,469 |
|
|
|
254,727 |
|
| |
|
|
|
|
|
|
|
|
| SELECTED
CONSOLIDATED BALANCE SHEET DATA |
| (in
thousands) |
| |
|
|
|
|
| |
|
June
30,
2016 |
|
December 31,
2015 |
| |
|
(unaudited) |
|
|
| Cash and cash equivalents |
|
$ |
89,395 |
|
|
$ |
93,108 |
|
| Marketable securities |
|
|
276,967 |
|
|
|
137,548 |
|
| Total current assets |
|
|
419,981 |
|
|
|
287,257 |
|
| Working capital |
|
|
338,103 |
|
|
|
210,763 |
|
| Total assets |
|
|
525,004 |
|
|
|
386,038 |
|
| Total notes payable and capital lease obligations |
|
|
315,849 |
|
|
|
503 |
|
| Total stockholders' equity |
|
|
110,117 |
|
|
|
292,669 |
|
| |
|
|
|
|
|
|
|
|