GenVec Reports Third Quarter 2012 Financial Results
GAITHERSBURG, Md., Nov. 9, 2012 /PRNewswire via COMTEX/ -- Today GenVec, Inc.
(GNVC) announced financial results for the three months and nine months ended
September 30, 2012.
GenVec reported a net loss of $4.0 million, or $0.31 per share for the three
months ended September 30, 2012, compared with a net loss of $1.5 million, or
$0.11 per share, in the comparable quarter of 2011. For the nine months ended
September 30, 2012, GenVec's net loss was $10.9 million, or $0.84 per share,
compared to a net loss of $4.9 million, or $0.38 per share, for the nine months
ended September 30, 2011.
"The third quarter was very productive for GenVec as we made important
advancements in our vaccine programs as well as our collaboration with Novartis
to develop treatments for hearing loss utilizing our core technology," commented
Cynthia Collins, GenVec's President and CEO. "Specifically, we presented
important data on our RSV program, entered into a new collaboration for our
malaria program, and aligned our cost structure with our business strategy. We
are encouraged by emerging data and new contracts that will leverage GenVec's
proprietary adenoviruses that are capable of generating a broad immune response
while avoiding the problems of vector specific immunity that have hampered other
vectored vaccines."
Recent Highlights
Promising data were presented on GenVec's respiratory syncytial virus (RSV)
vaccine program at the 8th Annual International Respiratory Syncytial Virus
Symposium, demonstrating that GenVec's pre-clinical, universal RSV vaccine
candidate is highly immunogenic and produces durable and broad protection from a
single intramuscular administration. Protection in cotton rat and mouse models
was characterized by functional RSV neutralizing antibodies and no disease
potentiation was observed.
GenVec completed a pre-IND meeting with the U.S. Food and Drug Administration
(FDA) to obtain guidance on the development plan for its vaccine against RSV. The
goal of the pre-IND meeting was to obtain clarification on the nonclinical,
clinical, and chemistry, manufacturing, and control (CMC) requirements that need
to be met in order to submit an acceptable IND.
GenVec signed an agreement worth approximately $3.5 million with the Naval
Medical Research Center (NMRC) to support malaria vaccine development. Under the
terms of the agreement, GenVec is responsible for producing clinical supplies of
its malaria vaccine, which utilizes its novel, proprietary technology. The NMRC
plans to use this clinical material to assess the safety and efficacy of these
next-generation vectored vaccines using the clinical challenge model developed by
the NMRC and the Walter Reed Army Institute of Research (WRAIR) malaria vaccine
programs, which now are unified as the U.S. Military Malaria Vaccine Program
(USMMVP). GenVec retains the right to commercialize this novel technology.
GenVec lowered its operating costs to conserve capital including eliminating 23
positions, or approximately 30% of its workforce.
Financial Results for the Three and Nine Months Ended September 30, 2012
Revenues for the three-month and nine-month periods ended September 30, 2012,
were $2.1 million and $7.8 million, respectively, as compared to $4.3 million and
$14.4 million in the comparable prior year periods.
The decrease for the three-month and nine-month periods ended September 30, 2012
is primarily due to lower revenue associated with our hearing program which was
$1.4 million and $4.1 million, respectively. The lower revenue for our hearing
program is due mainly to reduced work scope associated with research and
manufacturing activities in preparation of clinical studies under our Novartis
agreements in 2012 as compared to the 2011 periods. Also, revenue associated with
our hearing program was lower because of the recognition of the up-front payment
in the 2011 periods, as recognition of the upfront payment was completed in
January 2012.
There was also a decrease in revenue associated with our HIV program of $0.4
million and $1.5 million, for the three-month and nine-month periods ended
September 30, 2012, respectively, due to reduced work scope from the NIH. The
revenue for our animal health program, FMD vaccine, also decreased by $0.4
million during the three-month period ended September 30, 2012 and $1.0 million
in the nine-month period ended September 30, 2012 compared to the comparable 2011
periods due mainly to the successful completion of field safety studies in early
2012.
Operating expenses were $6.2 million and $18.8 million for the three-month and
nine-month periods ended September 30, 2012, respectively, as compared to $5.8
million and $19.3 million in the comparable prior year periods. The increase in
the three-month period ended September 30, 2012, as compared to the comparable
prior year period is due mainly to higher personnel costs associated with the
elimination of 23 positions. These increases are partially offset by lower
personnel costs in our research and development areas and manufacturing costs
associated with our animal health program, FMD vaccine, and, to a lesser extent,
lower supply costs. The decrease in the nine-month period ended September 30,
2012, as compared to the comparable prior year period is due mainly to reduced
manufacturing and testing costs associated with our hearing program, partially
offset by higher personnel costs associated with the elimination of 23 positions
and the CEO transition. In each of the three-month and nine-month periods ended
September 30, 2012, we experienced reduced costs associated with the closure of
our TNFerade trial.
GenVec ended the third quarter of 2012 with $18.2 million in cash, cash
equivalents, and short-term investments. "Based on our current operations, we
anticipate that we will have sufficient capital to fund our operations through
the third quarter of 2014," commented GenVec's Senior Vice President and Chief
Financial Officer, Douglas J. Swirsky. "That runway could be extended to the
middle of 2015, subject to the achievement of certain milestones under our
collaboration agreements."
Conference Call Information
GenVec will hold a conference call today at 10:00 a.m. EST to discuss the
Company's third quarter financial results. To listen to the live conference call,
please dial 877-558-0567 (U.S. or Canada) or 706-643-4980 (international) and use
the following Conference ID: 47688439. An audio replay of the conference call
will be available starting at 1:00 p.m. EST on November 9, 2012, through November
16, 2012. To listen to the audio replay, dial 855-859-2056 (U.S. or Canada) or
404-537-3406 (international) and use Conference Replay ID: 47688439.
To access the webcast or the replay, go to genvec.com, click on
"Investors and Media," and click on "Events and Presentations."
About GenVec
GenVec is a biopharmaceutical company using differentiated, proprietary
technologies to create superior therapeutics and vaccines. A key component of our
strategy is to develop and commercialize our product candidates through
collaborations. GenVec is working with leading companies and organizations such
as Novartis, Merial, and the U.S. Government to support a portfolio of product
programs that address the prevention and treatment of a number of significant
human and animal health concerns. GenVec's development programs address
therapeutic areas such as hearing loss and balance disorders; as well as vaccines
against infectious diseases including respiratory syncytial virus (RSV), herpes
simplex virus (HSV), dengue fever, malaria, and human immunodeficiency virus
(HIV). In the area of animal health, we are developing vaccines against
foot-and-mouth disease (FMD). Additional information about GenVec is available at
genvec.com and in the Company's various filings with the Securities
and Exchange Commission.
Statements herein relating to future financial or business performance,
conditions or strategies and other financial and business matters, including
expectations regarding funding, grants, collaborations, revenues, cash burn
rates, the development of products and the success of the Company's
collaborations, including with Novartis and Merial, are forward-looking
statements within the meaning of the Private Securities Litigation Reform Act.
GenVec cautions that these forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time. Factors that may
cause actual results to differ materially from the results discussed in the
forward-looking statements or historical experience include risks and
uncertainties, including the failure by GenVec to secure and maintain
relationships with collaborators; risks relating to the early stage of GenVec's
product candidates under development; uncertainties relating to research and
development activities; risks relating to the commercialization, if any, of
GenVec's proposed product candidates; dependence on the efforts of collaborators
and third parties; dependence on intellectual property; currently unanticipated
expenses, and risks that we may lack the financial resources and access to
capital to fund our operations. Further information on the factors and risks that
could affect GenVec's business, financial conditions and results of operations,
are contained in GenVec's filings with the U.S. Securities and Exchange
Commission (SEC), which are available at sec.gov. These
forward-looking statements speak only as of the date of this press release, and
GenVec assumes no duty to update forward-looking statements.
(Tables to follow)
GenVec, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
(Unaudited)
Three Months EndedNine Months Ended
September 30,September 30,
2012201120122011
Revenues$2,128$4,332$7,832$14,355
Operating expenses:
Research and development3,3803,81911,28413,538
General and administrative2,7992,0057,4755,787
Total operating expenses6,1795,82418,75919,325
Loss from Operations(4,051)(1,492)(10,927)(4,970)
Other income:1293133
Net loss$(4,039)$(1,483)$(10,896)$(4,937)
Basic and diluted net loss$(0.31)$(0.11)$(0.84)$(0.38)
per share
Shares used in computation of12,93812,91812,93812,917
basic and diluted net loss per
share
GenVec, Inc.
Selected Balance Sheet Information
(in thousands)
September 30, 2012December 31, 2011
(unaudited)
Cash, cash equivalents and $18,195$26,446
short-term investments
Working capital15,64325,739
Total assets20,44529,866
Stockholders' equity16,59126,538
Retail Investor and Media Contact: Institutional Investor Contact:
GenVec, Inc.S.A. Noonan Communications
Douglas J. SwirskySusan A. Noonan
(240) 632-5510(212) 966-3650
dswirsky@genvec.comsusan@sanoonan.com |
