EXHIBIT 99.1 - PRESS RELEASE GENELABS TECHNOLOGIES, INC. REPORTS FINANCIAL RESULTS FOR THE SECOND QUARTER AND FIRST HALF OF 2004 REDWOOD CITY, Calif. - August 3, 2004 - Genelabs Technologies, Inc. (Nasdaq:GNLB) today reported contract revenues of $0.7 million and a net loss of $2.9 million, or $0.03 per share, for the second quarter 2004. This compares to revenues of $0.8 million and a net loss of $4.3 million, or $0.07 per share, for the second quarter 2003. Revenues for the six month period ended June 30, 2004 were $1.4 million and the net loss was $7.6 million, or $0.09 per share, compared to revenues of $1.5 million and a net loss of $8.5 million, or $0.15 per share, for the same period in 2003. During the second quarter of 2004, the company recorded a gain of $2.0 million upon completion of the sale of its diagnostics business, which had been accounted for as a discontinued operation. This gain reduced the net loss for the second quarter of 2004 and the six months ended June 30, 2004 by $2.0 million. At June 30, 2004, Genelabs had $24.0 million in cash and cash equivalents. "I am very pleased with the continued progress in all key areas of our business," stated James A.D. Smith, president and chief executive officer. "The last patients enrolled into our confirmatory clinical trial of Prestara(TM) for lupus are scheduled to complete their final visits this month. Our drug development team is working hard to complete this study and we are on track to report data in the fourth quarter this year, as previously indicated. Separately, our research team continues to make significant progress in our programs to discover new treatments for hepatitis C virus infections. I am as excited as I have ever been about the prospects for each of these important programs." Outlook for third quarter of 2004 Contract revenues for the third quarter of 2004 are currently estimated to be approximately $0.6 million. Operating expenses are estimated to be approximately $5.6 million to $6.1 million, with approximately 70% of the operating expenses related to research and development. The third quarter net loss is estimated to be approximately $5.0 million to $5.5 million, or $0.06 per share. We estimate our cash and cash equivalents at September 30, 2004 to be approximately $19.5 million. About Genelabs Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the discovery and development of novel pharmaceutical products to improve human health. We are concentrating our clinical development capabilities on Prestara(TM), an investigational drug for women with systemic lupus erythematosus and have received an approvable letter for our Prestara New Drug Application from the U.S. Food and Drug Administration. We are concentrating our drug discovery capabilities on novel antiviral compounds for treatment of hepatitis C virus infections. NOTE: This press release contains forward-looking statements including statements regarding the prospects of our Prestara and hepatitis C virus drug discovery programs and the outlook for the third quarter of 2004. 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, the company's capital requirements and history of operating losses; errors, omissions or adverse events in the current Prestara(TM) clinical trials; whether the results of the company's clinical trials of Prestara(TM) 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; uncertainties and risks regarding market acceptance of Prestara(TM) as a treatment for SLE; uncertainties and risks regarding the company's ability to consummate strategic or corporate partner transactions on favorable terms or at all; the early stage of Genelabs' research programs and uncertainties associated with the preclinical development of compounds, including whether a compound will advance to preclinical testing, clinical trials, or ultimately become a product, and the uncertainty of the timing of any of these; and the validity, scope and enforceability of patents related to the company's technologies. The active ingredient in Prestara(TM) is prasterone, the synthetic equivalent of the androgenic hormone dehydroepiandrosterone (DHEA). Products containing DHEA are currently being marketed by others as dietary supplements. 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 most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K, under the captions "Risk Factors," "Business Risks" 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) June 30, December 31, 2004 2003 ------------ ------------ (Unaudited) Note 1 ASSETS Cash and cash equivalents $ 24,013 $ 26,530 Other current assets 747 1,456 Property and equipment, net 980 920 Long-term investments 960 960 ------------ ------------ $ 26,700 $ 29,866 ============ ============ LIABILITIES AND SHAREHOLDERS' EQUITY Total liabilities $ 8,101 $ 7,051 Shareholders' equity 18,599 22,815 ------------ ------------ $ 26,700 $ 29,866 ============ ============ Note 1: Derived from audited financial statements GENELABS TECHNOLOGIES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) (UNAUDITED) For the three months ended For the six months ended June 30, June 30, -------------------------- -------------------------- 2004 2003 2004 2003 ---------- ---------- ---------- ---------- Contract revenue $ 667 $ 776 $ 1,356 $ 1,503 ---------- ---------- ---------- ---------- Operating expenses: Research and development 3,923 3,645 8,127 7,037 General and administrative 1,669 1,615 3,252 3,171 ---------- ---------- ---------- ---------- Total operating expenses 5,592 5,260 11,379 10,208 ---------- ---------- ---------- ---------- Operating loss (4,925) (4,484) (10,023) (8,705) Interest income, net 51 10 104 31 ---------- ---------- ---------- ---------- Loss from continuing operations (4,874) (4,474) (9,919) (8,674) Discontinued operations: Income from diagnostics business -- 194 262 194 Gain on sale of diagnostics business 2,020 -- 2,020 -- ---------- ---------- ---------- ---------- Net loss $ (2,854) $ (4,280) $ (7,637) $ (8,480) ========== ========== ========== ========== Loss per share from continuing operations $ (0.06) $ (0.08) $ (0.11) $ (0.15) ========== ========== ========== ========== Net loss per share - basic and diluted $ (0.03) $ (0.07) $ (0.09) $ (0.15) ========== ========== ========== ========== Weighted average shares outstanding 88,018 58,617 87,854 56,005 ========== ========== ========== ==========