Press Releases |
Press Release Archive |
Gilead Sciences Announces First Quarter 2002 Financial ResultsProduct Revenues Include $27.2 Million in Viread SalesFoster City, CA -- April 30, 2002 Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter ended March 31, 2002. For the first quarter, Gilead recorded revenues from net product sales of $70.7 million, royalty revenues of $5.4 million and contract revenues of $2.3 million. Total revenues for the first quarter ended March 31, 2002, were $78.4 million, compared to total revenues of $57.8 million for the first quarter of 2001. Revenues for the first quarter of 2001 included net product sales of $45.1 million, royalty revenues of $6.2 million and contract revenues of $6.6 million. The net loss for the first quarter of 2002 was $3.8 million, or $0.02 per share. This compares to a net loss in the first quarter of 2001 of $21.7 million, or $0.11 per share, including the cumulative effect of a change in accounting principle related to the company's adoption of Statement of Financial Accounting Standards Nos. 133 and 138. Net revenues from product sales were primarily derived from sales of AmBisome® (amphotericin B) liposome for injection, accounting for 56 percent of product sales for the first quarter of 2002. AmBisome sales for the first quarter of 2002 were $39.8 million, a decrease of 5 percent compared to the first quarter of 2001. Excluding the impact of the decline in foreign currencies relative to the U.S. Dollar, AmBisome sales decreased by 1 percent for the first quarter of 2002 over the comparable quarter of 2001. Sales of VireadTM (tenofovir disoproxil fumarate) for human immunodeficiency virus (HIV) were $27.2 million in the first quarter of 2002, or 38 percent of product sales. In addition, Gilead recorded other product sales of $3.8 million during the first quarter of 2002, compared to $3.2 million in the first quarter of 2001. "We are very pleased with Viread sales results during the quarter," said John C. Martin, Ph.D., president and chief executive officer of Gilead Sciences. "In its first full quarter on the market, prescription trends for Viread were strong, reflecting the successful launch in the United States, bolstered by the rapid approval and initial launches in the European Union. Based on NDC Health prescription data, over the first 25 weeks of launch, the uptake for Viread in the United States is tracking better than or equal to recent launches of other HIV antiviral drugs in the nucleoside reverse transcriptase inhibitor class." For the first quarter of 2002, royalty and contract revenues resulting from collaborations with corporate partners totaled $7.7 million. These revenues include contract revenues for the manufacturing agreement with OSI Pharmaceuticals, Inc., royalties on sales of AmBisome in the United States by Gilead's co-promotion partner Fujisawa Healthcare, royalties on sales of Tamiflu® (oseltamivir phosphate) by Hoffmann-La Roche and royalties on product sales of Vistide® (cidofovir injection) outside the United States by Pharmacia Corporation. Research and development (R&D) expenses for the first quarter of 2002 were $33.6 million, compared to $51.1 million for the same quarter in 2001. The substantially lower spending during the first quarter of 2002 was attributable in part to the recognition in the first quarter 2001 of $10.6 million of a $13.0 million up-front payment to Cubist Pharmaceuticals related to the European licensing agreement for daptomycin signed in January 2001. In addition, Gilead's expenses associated with the Viread clinical program have decreased, and oncology expenses have been largely eliminated due to the divestiture of this program to OSI Pharmaceuticals in December 2001. Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2002, were $39.8 million, compared to $21.9 million for the same quarter of 2001. The significant increase in expenses is primarily due to Gilead's increased global marketing efforts and the expansion of Gilead's U.S. and European sales forces to support the commercial launch of Viread for HIV. Net interest income for the first quarter of 2002 was $2.1 million, compared to $3.8 million for the same quarter in 2001. This decrease is attributable to the significant decline in interest rates over the past year. The income tax benefit for the first quarter of 2002 was $1.0 million, compared to income tax expense of $0.5 million for the first quarter 2001. The benefit reported in 2002 is due to a $1.3 million credit recognized because of recently enacted tax law changes. As of March 31, 2002, the company had cash, cash equivalents and marketable securities of $564.7 million, compared to $582.9 million at December 31, 2001. Corporate Highlights On March 29, the company announced that Dr. John Milligan was promoted to senior vice president and chief financial officer. In his new post, Dr. Milligan will be responsible for corporate development, communications, information technology and finance. Former chief financial officer Sharon Surrey-Barbari will remain with the company through the middle of the year to assist in the transition. On April 29, Gilead and GlaxoSmithKline (GSK) announced the signing of a licensing agreement for the rights to commercialize adefovir dipivoxil for the treatment of chronic hepatitis B in Asia, Latin America and other territories. Under the agreement, Gilead will retain rights to adefovir dipivoxil in the United States, Canada, Eastern and Western Europe, Australia and New Zealand. GSK will receive exclusive rights to adefovir dipivoxil solely for the treatment of hepatitis B in all countries outside of the Gilead territories, the most significant of which are China, Korea, Japan and Taiwan. GSK paid Gilead an up-front licensing fee of $10 million, and Gilead is entitled to receive additional cash payments of up to $30 million upon achievement of certain milestones. GSK will be responsible for all development and commercialization activities in these territories and will pay Gilead an undisclosed royalty on net sales of adefovir dipivoxil. Products and Pipeline Highlights Viread™ (tenofovir disoproxil fumarate) for HIV At the 9th Conference on Retroviruses and Opportunistic Infections in Seattle in late February, Gilead released promising data from several studies of Viread, including:
In clinical studies of Viread to date, the most common adverse events in patients receiving Viread were mild to moderate gastrointestinal events, such as nausea, diarrhea, vomiting and flatulence. Tamiflu® (oseltamivir phosphate) for Influenza A and B Adefovir Dipivoxil for Chronic Hepatitis B In late March, Gilead announced the submission of a New Drug Application (NDA) to the U.S. FDA for marketing approval of adefovir dipivoxil for the treatment of patients with chronic hepatitis B, including treatment-naive and treatment-experienced patients. Gilead submitted a request for a priority, or six-month, review of the adefovir dipivoxil NDA. Also in late March, Gilead announced the submission of a Marketing Authorisation Application (MAA) to the EMEA for adefovir dipivoxil. The MAA will be reviewed under the centralized licensing procedure, which, if approval is granted, provides a marketing license valid in the 15 member states of the European Community. In April, Gilead took part in the 37th Annual Meeting of the European Association for the Study of the Liver (EASL) in Madrid, Spain. During this meeting, twenty abstracts were presented describing the antiviral activity, safety and resistance profile of adefovir dipivoxil in a variety of chronic hepatitis B patient populations. Highlights from the conference included:
In the studies described above, the most common adverse events reported were pharyngitis, headache, asthenia and abdominal pain. GS 7340 for HIV Conference Call About Gilead Forward-looking Statements # # #
AmBisome and Vistide are registered trademarks, and Viread is a trademark of Gilead Sciences, Inc.
Tamiflu is a trademark of F. Hoffmann-La Roche Ltd.
For more information on Gilead Sciences, please visit www.gilead.com or call the Gilead Corporate Communications Department at 1-800-GILEAD-5 (1-800-445-3235). ![]() ![]() |