Exhibit 99.1
VICAL ANNOUNCES FOURTH-QUARTER AND YEAR-END 2004 FINANCIAL RESULTS
SAN DIEGO, Feb. 15 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq:
VICL) today reported revenues of $5.0 million for the fourth quarter of 2004,
compared with revenues of $1.7 million for the fourth quarter of the prior year.
The increase in revenues was primarily the result of the timing of contract
manufacturing shipments.
Revenues for the full year 2004 were $14.5 million compared with $8.1
million for the full year 2003. Results for the year reflected higher contract
revenues for DNA vaccine supplies, a milestone payment under the company's
agreement with Centelion SAS, formerly Gencell SAS, a wholly-owned subsidiary of
Aventis Pharma SA, and increased grant funding for the company's cytomegalovirus
(CMV) vaccine program.
The net loss for the fourth quarter of 2004 was $4.5 million or $0.19 per
share, compared with a net loss of $6.9 million or $0.35 per share for the
fourth quarter of 2003. For the full year 2004, the company reported a net loss
of $23.7 million or $1.05 per share compared with a net loss of $24.5 million or
$1.22 per share for 2003. The decreases in net loss per share for the fourth
quarter and the full year 2004 reflected higher revenues and the increased
weighted average numbers of shares outstanding for those periods as a result of
the registered direct placement of approximately 3.4 million shares of common
stock during the first quarter of 2004. The company maintained a strong balance
sheet at the end of the year with cash, cash equivalents and marketable
securities of $74.0 million compared with $84.5 million at December 31, 2003.
Vijay B. Samant, Vical's President and Chief Executive Officer, said,
"Vical made significant progress in its development programs during 2004 with
the initiation of clinical trials in our CMV and anthrax programs and the
completion of Phase 2 testing in our high-dose Allovectin-7(R) melanoma
immunotherapy program. Our net loss of $23.7 million for 2004 was lower than our
forecast range of $26 million to $29 million as a result of strong
fourth-quarter revenues. We expect continued fiscal strength in the coming year,
and we are projecting a net loss for 2005 of between $23 million and $26
million."
Allovectin-7(R)
The company announced last week that it has completed a Special Protocol
Assessment with the U.S. Food and Drug Administration (FDA) for a Phase 3 trial
of high-dose (2 mg) Allovectin-7(R) for patients with recurrent metastatic
melanoma. Additional information on the Allovectin-7(R) program will be included
in today's conference call on financial results.
Infectious Disease Vaccine Programs
During 2004, the company began separate Phase 1 trials with two-component
(bivalent) and three-component (trivalent) immunotherapeutic vaccine candidates
for CMV. Initial safety data from the bivalent vaccine trial, presented at the
44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy,
showed the vaccine to be safe and well-tolerated. Safety and immunogenicity data
from both trials are expected to be presented in an appropriate scientific forum
in 2005, and to support the selection of one vaccine candidate to advance into
Phase 2 testing in transplant patients.
With the support of a three-year, $5.8 million Small Business Innovation
Research (SBIR) grant awarded in July 2003 from the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH), the company is continuing non-clinical development of its anthrax
vaccine candidate. Additionally, in July 2004, the company began a Phase 1
clinical trial of its anthrax vaccine candidate at two NIAID-funded Vaccine and
Treatment Evaluation Units. Safety and immunogenicity data from this trial are
expected in the first half of 2005, however, the additional outside funding
needed to support further clinical development is unlikely under current federal
government biodefense program priorities.
The Vaccine Research Center (VRC) at the NIAID is developing DNA vaccines
for HIV, Ebola, Severe Acute Respiratory Syndrome (SARS), and West Nile Virus,
based on Vical's patented gene delivery technology. Human safety and
immunogenicity studies of investigational vaccines for HIV and Ebola are
ongoing. A Phase 1 human study of the SARS vaccine began in December 2004.
Initial human studies of the West Nile Virus vaccine are planned for early 2005,
subject to review and allowance by the FDA.
Outlook
The company expects to achieve the following milestones in 2005:
* Completion of discussions with potential partners for
Allovectin-7(R),
* Evaluation of data from the Phase 1 CMV vaccine trials and
initiation of Phase 2 testing in transplant patients,
* Data from the Phase 1 anthrax vaccine trial,
* Initiation of a Phase 1 trial with a novel IL-2 treatment for
metastatic melanoma,
* Continued revenue strength based on existing and potential new
agreements, and
* Potential announcements by collaborators related to developments in
the angiogenesis, HIV, Ebola, West Nile Virus, and animal health
programs.
Conference Call
Vical will conduct a conference call and webcast to discuss the financial
results with invited analysts and institutional investors today, February 15, at
noon Eastern Time. The call and webcast are open on a listen-only basis to any
interested parties. The company will provide additional details on independent
and partnered development programs in the conference call and webcast.
To listen to the conference call, dial (888) 224-3260, or (913) 905-1086
for international participants. A replay of the call will be available for 48
hours beginning about two hours after the call. To listen to the replay, dial
(888) 203-1112, or (719) 457-0820 for international participants, and enter
conference identification number 1541913. The call also will be available live
and archived through the webcast center at www.vical.com. For further
information, contact Vical's Investor Relations department by phone at (858)
646-1127 or by e-mail at info@vical.com.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of serious
or life-threatening diseases. Potential applications of the company's DNA
delivery technology include DNA vaccines for infectious diseases or cancer, in
which the expressed protein is an immunogen; cancer immunotherapeutics, in which
the expressed protein is an immune system stimulant; and cardiovascular
therapies, in which the expressed protein is an angiogenic growth factor. The
company has retained all rights to its internally developed product candidates.
In addition, the company collaborates with major pharmaceutical companies and
biotechnology companies that give it access to complementary technologies or
greater resources. These strategic partnerships provide the company with
mutually beneficial opportunities to expand its product pipeline and serve
significant unmet medical needs. Additional information on Vical is available at
www.vical.com.
This press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from those
projected. Forward-looking statements include statements about the company's
projected financial performance; advancement of the company's research and
development activities; expectations regarding the company's high-dose
Allovectin-7(R) program, including plans for a Phase 3 trial and potential
partnerships for further development and commercialization of Allovectin-7(R);
the company's infectious disease vaccine development programs including results
from ongoing clinical trials for these vaccine candidates and expectations
regarding future trials; the potential revenues and other
benefits of contract services agreements and grants; the scope of coverage of
and potential applications for the company's issued and pending patents; as well
as potential applications of the company's technology and arrangements with
collaborative partners, including current and future clinical trials for product
candidates covered by these arrangements. Risks and uncertainties that could
cause actual results to differ materially from those projected include: whether
the company will achieve the levels of revenues and be able to control expenses
to meet projected financial performance; whether the company will identify and
reach agreement with a potential partner for the further development and
commercialization of Allovectin-7(R); whether the company, alone or with a
potential partner, will conduct a Phase 3 trial of Allovectin-7(R); whether
endpoints in such a trial will be achieved; whether achievement of such
endpoints will establish sufficient safety and efficacy to support product
approval; whether the ongoing Phase 1 CMV vaccine trials will be completed as
scheduled, if at all, and lead to further development; whether the ongoing Phase
1 anthrax vaccine trial and ongoing non-clinical development will be completed
as scheduled, if at all; whether additional government funding will be available
to support further clinical development of the company's anthrax vaccine
candidate; whether the NIH will begin human testing of a West Nile Virus vaccine
in early 2005, if at all; whether the company will begin Phase 1 safety testing
of a novel IL-2 treatment for melanoma in 2005, if at all; whether the company's
revenues will continue at comparable levels to those achieved in 2004; whether
new agreements will provide revenues; whether the company's collaborators will
achieve development milestones and, if so, whether they will announce any such
developments; whether the company's independent or partnered research and
development efforts will lead to viable product candidates; the scope and
enforceability of the company's intellectual property; whether any product
candidates will be shown to be safe and efficacious in clinical trials; the
timing of clinical trials; and additional risks set forth in the company's
filings with the Securities and Exchange Commission. These forward-looking
statements represent the company's judgment as of the date of this release. The
company disclaims, however, any intent or obligation to update these
forward-looking statements.
For further information, please contact: Alan R. Engbring, Executive
Director, Investor Relations, or Jill M. Church, Vice President and Chief
Financial Officer, both of Vical Incorporated, +1-858-646-1127.
VICAL INCORPORATED
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except per share amounts)
Three Months Ended Twelve Months Ended
---------------------- ----------------------
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
2004 2003 2004 2003
--------- --------- --------- ---------
Revenues:
Contract and grant revenue $ 4,651 $ 1,163 $ 11,168 $ 6,012
License and royalty revenue 352 532 3,377 2,066
Total revenues 5,003 1,695 14,545 8,078
Operating expenses:
Research and development 7,557 6,952 31,178 26,777
General and administrative 2,194 1,894 8,510 6,923
Write-down of investment -- -- -- 482
Total operating expenses 9,751 8,846 39,688 34,182
Loss from operations (4,748) (7,151) (25,143) (26,104)
Net investment income 281 205 1,410 1,654
Net loss $ (4,467) $ (6,946) $ (23,733) $ (24,450)
Basic and diluted
net loss per share $ (0.19) $ (0.35) $ (1.05) $ (1.22)
Shares used to calculate
basic and diluted net
loss per share 23,493 20,092 22,695 20,091
VICAL INCORPORATED
CONDENSED BALANCE SHEETS
(Unaudited)
(in thousands)
December 31,
---------------------
2004 2003
--------- ---------
Assets:
Cash, cash equivalents and marketable securities $ 73,996 $ 84,517
Other current assets 3,412 4,688
Total current assets 77,408 89,205
Property and equipment, net 16,277 15,034
Other assets 7,541 6,468
Total assets $ 101,226 $ 110,707
Liabilities and stockholders' equity:
Current liabilities $ 10,108 $ 12,223
Long-term obligations 8,209 8,662
Stockholders' equity 82,909 89,822
Total liabilities and stockholders' equity $ 101,226 $ 110,707
SOURCE Vical Incorporated
-0- 02/15/2005
/CONTACT: Alan R. Engbring, Executive Director, Investor Relations, or
Jill M. Church, Vice President and Chief Financial Officer, both of Vical
Incorporated, +1-858-646-1127/
/Web site: http://www.vical.com /