Exhibit 99.1
Contact: Matthew M. Loar
Chief Financial Officer
650-562-1424
GENELABS TECHNOLOGIES REPORTS 2004 YEAR-END
AND FOURTH QUARTER FINANCIAL RESULTS
REDWOOD CITY, Calif., March 14, 2005 -- Genelabs Technologies, Inc.
(Nasdaq:GNLB) today reported financial results for the year ended December 31,
2004. Genelabs reported 2004 revenues of $5.6 million, compared to $2.9
million for 2003. Operating expenses were $21.6 million in 2004 compared to
$23.3 million in 2003. For 2004, the company reported a net loss of $13.5
million, or $0.15 per share, compared to a net loss of $19.8 million, or $0.31
per share, in 2003.
The company also reported financial results for the fourth quarter of 2004.
Revenues for the three months ended December 31, 2004 were $3.8 million,
compared to revenues of $0.7 million for the three months ended December 31,
2003. Operating expenses for the fourth quarter of 2004 were $5.4 million,
compared to $7.4 million for the fourth quarter of 2003. The net loss for the
three months ended December 31, 2004 was $1.5 million, or $0.02 per share,
compared to a net loss of $6.5 million, or $0.08 per share, for the three
months ended December 31, 2003.
Genelabs had $26.5 million in cash, cash equivalents and restricted cash at
December 31, 2004.
"2004 was marked by important advances in multiple aspects of our business,
particularly in our core hepatitis C virus drug discovery research programs,
the nucleoside portion of which we decided to partner through a worldwide
license and research collaboration with Gilead Sciences. In addition, we
signed a license agreement with Tanabe Seiyaku for Japanese rights to
Prestara(TM), completed the divestment of our diagnostics subsidiary, received
a milestone payment from GlaxoSmithKline relating to a clinical trial result
for an investigational hepatitis E vaccine, and further monetized our DNA
amplification technology in modifying a non-exclusive license previously
granted to Affymetrix. Unfortunately we also suffered a disappointing setback
for Prestara(TM) (prasterone), our investigational new drug for lupus, when
our Phase III clinical trial did not achieve its primary endpoint," stated
James A.D. Smith, President and Chief Executive Officer. "2005 has begun with
our research team further advancing our work on discovering new treatments for
HCV, targeting the RNA-dependent RNA polymerase, which is the enzyme
responsible for replication of the HCV genome. We are making progress in our
internally-sponsored programs as well as the nucleoside program that is being
conducted in collaboration with Gilead."
"Our Prestara development team is currently working closely with Genovate
Biotechnology Co. Ltd., our licensee that holds rights to Prestara in the
Asian countries other than Japan. Together the companies are completing a
standard review of the data from Genovate's Phase III clinical trial for
completeness and accuracy prior to unblinding the trial and announcing the
results, which we currently expect to occur before the end of the second
quarter of 2005," continued Mr. Smith. "The Genovate trial of prasterone is
being conducted in Taiwan, and is similar in design to our recently completed
U.S. trial, except that the treatment duration in the Genovate trial is longer
at nine months compared to six months for the U.S. trial that did not meet its
primary endpoint. If the result of the Taiwan trial is positive, we plan to
submit it to the U.S. Food and Drug Administration to support our Prestara New
Drug Application."
About Genelabs Technologies
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Genelabs Technologies, Inc. is a biopharmaceutical company focused on the
discovery and development of pharmaceutical products to improve human health.
We have built drug discovery and clinical development capabilities that can
support various research and development projects. Genelabs is currently
concentrating its capabilities on developing a late-stage product for lupus,
discovering novel compounds that selectively inhibit replication of the
hepatitis C virus and advancing preclinical development of compounds from this
hepatitis C virus drug discovery program. We believe that these high-risk,
potentially high reward programs focus our research and development expertise
in areas where we have the opportunity to generate either first-in-class or
best-in-class products that will address diseases for which current therapies
are inadequate. For more information, please visit www.genelabs.com.
Note: Genelabs(R) and the Genelabs logo are registered trademarks of Genelabs
Technologies, Inc.
NOTE ON FORWARD LOOKING STATEMENTS AND RISKS: This press release contains
forward-looking statements including statements regarding the progress of the
Company's HCV programs. Additional forward-looking statements include the
review of data from Genovate's clinical trial, the results of Genovate's
clinical trial, the timing for the results becoming available and our plans to
submit the results to the FDA. These forward-looking statements are based on
Genelabs' current expectations and are subject to uncertainties and risks that
could cause actual results to differ materially from the statements made.
Uncertainties and risks include, without limitation, errors, omissions or
adverse events in the recently completed Prestara(TM) clinical trial and
ongoing clinical trials; whether the results of Genelabs' or Genovate's
clinical trials and other supporting information will be sufficient to support
the approval of Prestara(TM) by the FDA, the European Agency for Evaluation of
Medicinal Products and other regulatory authorities; delays regarding the
regulatory approval process including the timing and scope of approval
received, if any; the possibility of delay, failure or additional expense in
our research programs; possible problems which may arise in our collaboration
with Gilead including decisions by Gilead to abandon, advance or delay
development of Genelabs' drug candidates; unexpected expenses and Genelabs'
capital requirements and history of operating losses. There can be no
assurance that Genelabs will continue development of Prestara(TM). The company
currently does not have regulatory applications submitted for review of
Prestara(TM) outside the U.S. In addition, neither U.S. nor other regulatory
authorities have made a determination as to the safety or efficacy of
Prestara(TM) for SLE. Please see the information appearing in the company's
filings with the Securities and Exchange Commission, including the Annual
Report on Form 10-K filed on March 11, 2005, under the captions "Risk Factors"
and "Forward-Looking Statements" for more discussion regarding these
uncertainties and risks and others associated with the company's research
programs, early stage of development and other risks which may affect the
company or cause actual results to differ from those included in the
forward-looking statements. Genelabs does not undertake any obligation to
update these forward-looking statements or risks to reflect events or
circumstances after the date of this release.
GENELABS TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31, December 31,
2004 2003
------------------ -------------------
ASSETS
Cash, cash equivalents and restricted cash $ 26,508 $ 26,530
Other current assets 824 1,456
Property and equipment, net 1,091 920
Long-term investments 960 960
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$ 29,383 $ 29,866
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LIABILITIES AND SHAREHOLDERS' EQUITY
Liabilities, including deferred revenue $ 16,436 $ 7,051
Shareholders' equity 12,947 22,815
-------------- ----------------
$ 29,383 $ 29,866
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Note: Balances are derived from the audited financial statements.
GENELABS TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
For the three months ended For the year ended
December 31, December 31,
------------------------------- -------------------------------
2004 2003 2004 2003
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(Unaudited) Note 1
Revenue $ 3,801 $ 715 $ 5,556 $ 2,916
--------------- -------------- -------------- --------------
Operating expenses:
Research and development 3,702 5,373 15,113 16,838
General and administrative 1,708 2,069 6,505 6,484
--------------- -------------- -------------- --------------
Total operating expenses 5,410 7,442 21,618 23,322
--------------- -------------- -------------- --------------
Operating loss (1,609) (6,727) (16,062) (20,406)
Interest income, net 106 49 269 84
--------------- -------------- -------------- --------------
Loss from continuing operations (1,503) (6,678) (15,793) (20,322)
Discontinued operations - income from
diagnostics business and gain on sale - 188 2,282 515
--------------- -------------- -------------- --------------
Net loss $ (1,503) $ (6,490) $(13,511) $(19,807)
=============== ============== ============== ==============
Loss per common share from continuing
operations $ (0.02) $ (0.08) $ (0.18) $ (0.32)
=============== ============== ============== ==============
Net loss per common share, basic and
diluted $ (0.02) $ (0.08) $ (0.15) $ (0.31)
=============== ============== ============== ==============
Weighted average shares outstanding to
calculate basic and diluted net loss per
common share 88,322 80,796 88,092 63,888
=============== ============== ============== ==============
Note 1: Derived from audited financial statements.