GAITHERSBURG, Md., May 04, 2016 (GLOBE NEWSWIRE)
-- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company
focused on the discovery, development and commercialization of
recombinant nanoparticle vaccines and adjuvants, today announced
its financial results for the first quarter ended March 31,
2016.
Novavax
First Quarter Achievements:
- Continued execution of Resolve(TM),
a pivotal Phase 3 trial of our RSV F Vaccine in older adults (60
years of age and older). Resolve 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. Prepare 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. Prepare is supported by a grant of up to $89
million from the Bill & Melinda Gates Foundation
(BMGF).
- Issued a total of $325 million
Convertible Senior Notes, resulting in net proceeds of $276.5
million. The Notes' initial conversion price of approximately $6.81
per common share represents a 22.5% premium to Novavax' common
stock on January 25, 2016, the day the Notes were issued. In
conjunction with the issuance of the Notes, the Company entered
into capped call transactions with an initial cap price of $9.73
per share. The capped call will serve to reduce dilution from
issuance of shares upon conversion at prices greater than the
Notes' conversion price of $6.81.
- Appointed Bob Darius to Senior Vice
President, Quality Operations and promoted Gregory M. Glenn, M.D.,
to President, Research & Development, Amy B. Fix to Senior Vice
President, Regulatory Affairs, Louis F. Fries III, M.D., to Senior
Vice President and Chief Medical Officer, and Iksung Cho to Vice
President, Biostatistics.
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 in the second
half of 2016.
Summary
"During the first quarter, we
continued to successfully execute on our two ongoing pivotal Phase
3 trials of our RSV F Vaccine. We also raised $325 million in a
successful Convertible Senior Notes offering, which strengthens
Novavax' balance sheet ahead of data from the pivotal Phase 3
Resolve clinical trial," said Stanley C. Erck, President and CEO.
"We are pleased 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. We remain well positioned to
announce value creating data from the Resolve trial and the Phase 2
rollover trial in older adults in 2016."
Financial
Results for the Three Months Ended March 31, 2016
Novavax reported a net loss of
$77.3 million, or $0.29 per share, for the first quarter of 2016,
compared to a net loss of $24.4 million, or $0.10 per share, for
the first quarter of 2015.
Novavax revenue in the first
quarter of 2016 decreased 57% to $4.2 million, compared to $9.9
million for the same period in 2015. Lower revenue under the HHS
BARDA contract of $7.3 million is the primary driver of this
decrease. The lower HHS BARDA revenue is the result of a lower
level of activity in the three months ended March 31, 2016, as
compared to the same period in 2015, along with a one-time revenue
recognition of $3.1 million in the first quarter of 2015. This
decrease in HHS BARDA revenue was partially offset by $1.6 million
in revenue recorded under the BMGF grant relating to our ongoing
Prepare clinical trial.
Research and development expenses
increased 143% to $69.0 million in the first quarter of 2016,
compared to $28.3 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 80% to $10.5 million in the first quarter of
2016, compared to $5.8 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 first quarter of 2016 includes $2.1 million of interest expense
relating the Company's Convertible Senior Notes offering.
As of March 31, 2016, the company
had $433.9 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 quarter of 2016 was
$69.8 million, compared to $30.5 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. As previously mentioned, Novavax
completed a $325 million Convertible Senior Notes offering in the
first quarter of 2016.
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 95870834. 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 May 4, 2016 until
midnight May 11, 2016. To access the replay by telephone, dial
(855) 859-2056 (Domestic) or (404) 537-3406 (International) and use
passcode 95870834. 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.
|
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(in thousands, except per share information) |
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
|
2016 |
|
|
2015 |
|
|
|
(unaudited) |
|
Revenue |
$ |
4,218 |
|
$ |
9,877 |
|
|
|
|
|
|
Expenses: |
|
|
|
Research and development |
|
68,952 |
|
|
28,347 |
|
|
General and administrative |
|
10,528 |
|
|
5,843 |
|
|
Total expenses |
|
79,480 |
|
|
34,190 |
|
|
Loss from operations |
|
(75,262 |
) |
|
(24,313 |
) |
|
Interest income (expense),
net |
|
(1,957 |
) |
|
85 |
|
|
Other expense |
|
(33 |
) |
|
(142 |
) |
|
Net loss |
$ |
(77,252 |
) |
$ |
(24,370 |
) |
|
|
|
|
|
Basic and diluted net loss per
share |
$ |
(0.29 |
) |
$ |
(0.10 |
) |
|
Basic and diluted weighted
average |
|
|
|
number of common shares outstanding |
|
270,179 |
|
|
241,223 |
|
|
|
|
|
|
SELECTED CONSOLIDATED BALANCE SHEET DATA |
(in thousands) |
|
|
|
March 31, |
December
31, |
|
|
2016 |
|
2015 |
|
(unaudited) |
|
Cash and cash equivalents |
$ |
132,225 |
|
$ |
93,108 |
|
Marketable securities |
|
301,642 |
|
|
137,548 |
|
Total current assets |
|
484,595 |
|
|
287,257 |
|
Working capital |
|
413,544 |
|
|
210,763 |
|
Total assets |
|
592,507 |
|
|
386,038 |
|
Total notes payable and
capital lease obligation |
|
315,614 |
|
|
503 |
|
Total stockholders'
equity |
|
185,433 |
|
|
292,669 |
|