DGAP-News: Novavax Reports Third-Quarter 2013 Financial Results
(firmenpresse) - Novavax, Inc.
08.11.2013 13:31
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ROCKVILLE, Md., 2013-11-08 13:31 CET (GLOBE NEWSWIRE) --
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused
on the discovery, development and commercialization of recombinant protein
nanoparticle vaccines and adjuvants, today announced its financial results for
the third quarter and nine months ended September 30, 2013.
Key Recent Corporate Highlights
-- In August, Novavax announced the closing of its public tender offer to
acquire Isconova AB, having purchased approximately 99.5% of the shares
during the Offer Period. Isconova AB, which manufactures a proprietary line
of saponin-based adjuvants including its lead Matrix-M(tm) adjuvant, has been
renamed Novavax AB.
-- In early September, Novavax presented clinical and pre-clinical data in two
posters at the 53rd Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) that provide insight into the potential application of
the company's RSV F vaccine strategy. The first poster, which provided
details from Novavax' RSV F vaccine Phase 1 clinical study of 220 healthy
elderly adults, demonstrated that the vaccine candidate was well-tolerated,
raised antibodies to potentially protective levels and was compatible with
co-administration of an influenza vaccine, supporting the development of a
combination respiratory vaccine. The second poster demonstrated that
palivizumab-competing antibodies induced by the RSV F vaccine could provide
passive protection in a relevant model, supporting our maternal
immunization strategy.
-- In late September, in conjunction with its Analyst and Investor Update Call
held on September 24, the company announced:
o That it had completed a $100 million public offering of approximately 32
million shares of common stock at $3.14 per share, resulting in net
proceeds to the company of approximately $94.7 million after deducting
underwriter's discounts and offering expenses.
o In addition, the company announced that it had reached agreement with
BARDA to initiate new seasonal and pandemic influenza clinical trials under
its contract. These new clinical trials include the planned initiations of
a quadrivalent seasonal influenza trial in the first quarter of 2014, and a
new pandemic (H7N9) influenza trial in the U.S. in the first half of 2014.
BARDA has also agreed to the use of our proprietary adjuvant, Matrix-M, in
the new pandemic vaccine clinical trial.
-- In early October, Novavax announced the initiation of a dose-confirmatory
Phase 2 trial of its RSV vaccine candidate in women of childbearing age.
This randomized, blinded, placebo-controlled Phase 2 study evaluates the
immunogenicity and safety of multiple formulations of Novavax' RSV-F
protein nanoparticle vaccine candidate with aluminum phosphate as an
adjuvant. The study enrolled 720 women of childbearing age who are
receiving either one or two intramuscular injections at each dose level of
vaccine or placebo at days 0 and 28. Immunogenicity and safety will be
evaluated over three month and six month periods, respectively.
'2013 has been a year of achievement for Novavax, starting with the
announcement of breakthrough data from two separate clinical studies of our
novel RSV vaccine candidate. These data validate the clinical and potential
commercial value of this novel vaccine candidate,' said Stanley C. Erck,
President and Chief Executive Officer of Novavax. 'In September, we followed
those positive clinical and scientific achievements with the completion of
important corporate objectives: a $100 million financing and an agreement with
BARDA to move forward with seasonal influenza and pandemic influenza clinical
trials. We also expect to announce top-line results before the end of the year
from our ongoing pandemic (H7N9) clinical trial that we initiated in the second
quarter of 2013. We are thus well positioned with the assets, agreements and
validated clinical candidates to deliver against our aggressive development
plans in 2014 and 2015.'
Financial Results for the Three and Nine Months Ended September 30, 2013
In connection with its acquisition on July 31, 2013, Novavax AB's operations
have been included in the company's consolidated results of operations and
financial position as of the acquisition date. The company reported a net loss
of $15.3 million, or $0.09 per share, for the third quarter of 2013, compared
to a net loss of $7.2 million, or $0.05 per share, for the third quarter of
2012. For the nine months ended September 30, 2013, the net loss was $37.9
million, or $0.24 per share, compared to a net loss of $20.5 million, or $0.16
per share, for the same period in 2012.
Novavax had revenue in the third quarter of 2013 of $4.8 million as compared to
$5.8 million for the same period in 2012. The decrease in revenue was primarily
a result of a lower level of BARDA-funded clinical trial activity associated
with the company's seasonal and pandemic influenza programs in the three months
ended September 30, 2013, as compared to the corresponding period in 2012. In
conjunction with the decrease in revenue, the cost of revenue was $2.3 million
in the third quarter of 2013 as compared to $3.8 million for the same period in
2012. This decrease was primarily related to lower levels of activity
associated with the company's previously mentioned influenza clinical trials.
Research and development expenses increased to $13.9 million in the third
quarter of 2013, compared to $6.6 million for the same period in 2012,
primarily a result of increased costs relating to the company's RSV and
pandemic (H7N9) influenza clinical trials and higher employee-related costs.
General and administrative expenses increased to $3.9 million in the third
quarter of 2013 as compared to $2.1 million for the same period in 2012,
resulting primarily from higher professional fees, including those associated
with the company's acquisition of Novavax AB.
As of September 30, 2013, the company had $146.4 million in cash and cash
equivalents and investments compared to $50.3 million as of December 31, 2012.
In September 2013, the company announced a public offering of its common stock
in which it raised $94.7 million in net proceeds. Net cash used in operating
activities for the nine months of 2013 was $33.1 million compared to $15.0
million for the same period in 2012. The increase in cash usage from the prior
year was primarily due to higher research and development spending, including
the company's RSV and pandemic (H7N9) influenza clinical trials, as well as
increased employee-related costs.
Conference Call
Novavax management will host its quarterly conference call today at 4:30 p.m.
EST. The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or
Canada) or 1 (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
November 7, 2013 until midnight December 7, 2013. To access the replay by
telephone, dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international)
and use passcode 93831495. 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 biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant protein
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Novavax is involved in several international partnerships, including
collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea
and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company
located in Sweden. Together, Novavax' network supports its global
commercialization strategy to create real and lasting change in the
biopharmaceutical and vaccinology fields. 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, 2012, and filed with the
Securities and Exchange Commission (SEC). Investors are cautioned not to place
considerable reliance on the forward-looking statements contained in this press
release. You are encouraged to read company 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 the company undertakes no obligation to update or revise any
of the statements. The company's 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 Nine Months Ended
September 30, September 30,
---------------------------------------------
2013 2012 2013 2012
---------------------------------------------
(unaudited) (unaudited)
Revenue $ 4,802 $ 5,765 $ 12,167 $ 17,510
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Costs and expenses:
Cost of revenue 2,276 3,838 5,619 12,740
Research and development 13,948 6,642 33,989 17,270
General and administrative 3,857 2,134 10,740 7,670
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Total costs and expenses 20,081 12,614 50,348 37,680---------------------------------------------
Loss from operations (15,279) (6,849) (38,181) (20,170)
Interest income (expense), net (11) 33 17 99
Other expense (10) ? (10) ?
Change in fair value of warrant ? (401) 267 (401)
liability
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Loss from operations before income (15,300) (7,217) (37,907) (20,472)
tax
Income tax expense ? ? 22 ?
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Net loss $ (15,300) $ (7,217) $(37,929) $ (20,472)
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Basic and diluted net loss per $ (0.09) $ (0.05) $ (0.24) $ (0.16)
share
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Basic and diluted weighted average 168,537 134,178 156,555 127,246
number of common shares
outstanding
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SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
September 30, December 31,
2013 2012
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(unaudited)
Cash and cash equivalents $122,493 $17,399
Investments 23,917 32,945
Total current assets 155,020 50,408
Working capital 140,760 38,733
Total assets 245,074 102,345
Total notes payable and capital lease obligations 2,587 1,205
Total stockholders' equity 216,574 80,240
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
News Source: NASDAQ OMX
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Language: English
Company: Novavax, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US6700021040
WKN:
End of Announcement DGAP News-Service
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