Novavax Reports First Quarter 2015 Financial Results
May 07 2015 - 4:50PM
GAITHERSBURG, Md., May 7, 2015 (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 2015.
Corporate Highlights
First Quarter and Subsequent Achievements:
RSV
- Completed enrollment of two ongoing
clinical trials of its RSV F Vaccine, including a Phase 2 study in
elderly adults (60 years of age and older) and a Phase 2 trial to
protect infants via maternal immunization.
Ebola
- Initiated a randomized,
observer-blinded, dose-ranging Phase 1 clinical trial of our EBOV
GP Vaccine in Australia to evaluate the safety and immunogenicity
of the vaccine, with and without Matrix-MTM adjuvant,
in 230 healthy adults between 18 and 50 years of age.
Corporate Achievements
- Completed an underwritten public
offering of approximately 27.8 million shares, including shares
pursuant to the underwriters' option, at $7.25 per share resulting
in total gross proceeds from this offering of approximately $201
million before deducting the underwriters discount and offering
expenses; and
- Awarded 2015 Workplace Excellence
Seal of Approval from the Alliance of Workplace Excellence.
Companies awarded the Workplace Excellence Seal of Approval
demonstrate outstanding commitments to innovative corporate culture
and management practices, employee growth and learning
opportunities, diversity and inclusion practices and commitment to
corporate, social and civic responsibilities.
2015 Anticipated Events
- During the third quarter of 2015,
announce top-line clinical data from four of our ongoing clinical
trials, including:
- Phase 2 clinical trial of the RSV F
Vaccine in elderly adults;
- Phase 2 clinical trial of the RSV F
Vaccine in Phase 2 study to protect infants via maternal
immunization;
- Phase 2 clinical trial of the
Quadrivalent Seasonal Influenza VLP; and
- Phase 1 clinical trial of the EBOV
GP Vaccine in healthy adults.
"Novavax has now completed enrollment
of the elderly and maternal immunization RSV clinical trials. That
achievement, combined with our ongoing Quadrivalent Seasonal
Influenza VLP vaccine and Ebola GP Vaccine clinical trials, will
position us for significant clinical data readouts in the second
half of 2015," said Stanley C. Erck, President and Chief Executive
Officer of Novavax. "Our March 2015 financing provided us with the
resources to prepare for the next steps, with our key objective to
continue to execute our aggressive RSV F Vaccine development
plans."
Financial Results for the Three Months Ended March 31,
2015
Novavax reported a net loss of $24.4
million, or $0.10 per share, for the first quarter of 2015,
compared to a net loss of $13.8 million, or $0.07 per share, for
the first quarter of 2014.
Novavax revenue in the first quarter
of 2015 increased 32% to $9.9 million, compared to $7.5 million for
the same period in 2014. The increase results primarily from HHS
BARDA's approval of the reimbursement of the Company's prior Phase
2 Quadrivalent Seasonal Influenza VLP vaccine clinical trial (205
Trial) costs, resulting in an additional $3.1 million in revenue in
the quarter.
The cost of government contracts
revenue in the first quarter of 2015 decreased 19% to $2.5 million,
compared to $3.0 million for the same period in 2014. The decrease
in costs were associated with a lower level of activity in the
first quarter of 2015 associated with the Company's Phase 2
clinical trial of our quadrivalent seasonal influenza vaccine
candidate as compared to the Company's Phase 1/2 clinical trial of
our H7N9 pandemic influenza candidate with Matrix-M in the same
period in 2014; both programs are funded under our contract with
HHS BARDA.
Research and development expenses
increased 78% to $25.9 million in the first quarter of 2015,
compared to $14.5 million for the same period in 2014. The increase
in research and development expenses was driven by activities
relating to the ongoing RSV F Vaccine clinical trials, the
initiation of the Phase 1 clinical trial of our Ebola GP Vaccine
candidate program and higher employee-related expenses tied to the
continued growth of the Company.
General and administrative expenses
increased 36% to $5.8 million in the first quarter of 2015,
compared to $4.3 million for the same period in 2014. The increase
in general and administrative expenses resulted from increased
employee-related expenses tied to the continued growth of the
Company.
As of March 31, 2015, the Company had
$327.7 million in cash and cash equivalents and marketable
securities compared to $168.1 million as of December 31, 2014. Net
cash used in operating activities for the first quarter of 2015 was
$30.5 million, compared to $20.4 million for the same period in
2014. The factors contributing to the change in operating cash
usage were primarily due to increased research and development
costs relating to our vaccine candidates and higher
employee-related costs, as well as the timing of customer and
vendor payments.
Conference Call
Novavax management will host its
quarterly conference call today at 4:30 p.m. EDT. The dial-in
number for the conference call is (877) 212-6076 (Domestic) or
(707) 287-9331 (International). 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 7:30 p.m. on May 7, 2015 until midnight
May 14, 2015. To access the replay by telephone, dial (855)
859-2056 (Domestic) or (404) 537-3406 (International) and use
passcode 35660022. 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, 2014, 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 |
|
March 31, |
|
2015 |
2014 |
|
(unaudited) |
Revenue |
$ 9,877 |
$ 7,462 |
|
|
|
Costs and expenses: |
|
|
Cost of government contracts revenue |
2,459 |
3,021 |
Research and development |
25,888 |
14,518 |
General and administrative |
5,843 |
4,308 |
Total costs and expenses |
34,190 |
21,847 |
Loss from operations |
(24,313) |
(14,385) |
Interest income (expense), net |
85 |
(40) |
Other expense |
(142) |
-- |
Realized gains on marketable securities |
-- |
615 |
Net loss |
$ (24,370) |
$ (13,810) |
|
|
|
Basic and diluted net loss per share |
$ (0.10) |
$ (0.07) |
Basic and diluted weighted average |
|
|
number of common shares outstanding |
241,223 |
208,927 |
SELECTED
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
|
March 31,
2015 |
|
December 31, 2014 |
|
(unaudited) |
|
|
Cash and cash
equivalents |
$
215,050 |
|
$ 32,335 |
Marketable
securities |
112,685 |
|
135,721 |
Total current assets |
350,094 |
|
188,158 |
Working capital |
321,318 |
|
154,042 |
Total assets |
438,841 |
|
276,002 |
Total notes payable and capital
lease obligations |
990 |
|
1,173 |
Total stockholders' equity |
399,706 |
|
229,618 |
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, 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
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Novavax, Inc. via Globenewswire
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