Novavax Reports First Quarter 2016 Financial Results
05 May 2016 - 6:05AM
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™, 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™, 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™ 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 |
|
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
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