Monday, Jul 11, 2005
South San Francisco, Calif. -- July 11, 2005 --Genentech, Inc. (NYSE: DNA) today announced financial results for the second quarter of 2005. Key results for the second quarter of 2005 included:
"Our recent clinical and financial successes are built on decades of rigorous efforts to continuously follow the science and focus on the patient. We have demonstrated continued strong growth this past quarter, achieving significant increases in product sales, revenues and earnings per share," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "Moving forward, we remain focused on strong execution that will allow us to pursue breakthrough therapies and the achievement of our Horizon 2010 goals."
"We are currently expecting year-over-year non-GAAP earnings per share for 2005 to increase by greater than 35 percent, relative to 2004," said David Ebersman, senior vice president and chief financial officer.
Note: Genentech's non-GAAP net income and non-GAAP earnings per share exclude recurring charges related to the 1999 Roche redemption of Genentech's stock and litigation-related special items. The differences in non-GAAP and GAAP numbers are reconciled in the tables below and on www.gene.com. All share and per share amounts reflect the May 2004 two-for-one split of Genentech common stock.
For the three months ended June 30, 2005:
Royalties and Contract Revenues
Total Costs and Expenses
"I am tremendously pleased that our efforts to discover and develop potential therapies may change clinical practice and improve the lives of patients. We are actively working with the FDA to prioritize the nine potential filings relating to our significant Phase III trial results, while we continue to develop more than 30 projects in the pipeline primarily in our oncology and immunology focus areas,"said Susan D. Hellmann, M.D., M.P.H., president of Product Development. We currently anticipate filing Herceptin for adjuvant breast cancer in the first quarter of 2006 and expect to provide updates on filing timelines for Avastin data upon the completion of preliminary discussions with the FDA."
Genentech is preparing for potential U.S. Food and Drug Administration (FDA) filings for Avastin for second-line metastatic colorectal cancer; Avastin for first-line non-squamous non-small cell lung cancer; Avastin for metastatic breast cancer; Herceptin for adjuvant breast cancer; Herceptin in combination with Taxotere for first-line metastatic breast cancer; Lucentis in wet age-related macular degeneration; Rituxan for front-line aggressive non-Hodgkins lymphoma (NHL); Rituxan for front-line indolent/maintenance NHL*; and Rituxan for rheumatoid arthritis in inadequate anti-TNF responders.
Genentech announced that in the second quarter of 2005 it began enrolling patients in several Phase III studies, including Rituxan in systemic lupus erythematosus, Avastin in prostate cancer, and combination Avastin and Tarceva in second-line non-small cell lung cancer. It also began enrollment in a Phase I study of a small molecule hedgehog antagonist in basal cell carcinoma in collaboration with Curis.
The company also announced that it removed from the development pipeline Omnitarg as a single agent in breast and lung cancer. It continues to enroll the Phase II study of Omnitarg in combination with chemotherapy for ovarian cancer.
Genentech and Boehringer Ingelheim announced that they stopped early the ASSENT 4 PCI trial, a randomized, open-label Phase IIIb/IV clinical study of the single-bolus thrombolytic TNKase/Metalyse® (tenecteplase) in combination with a planned percutaneous coronary intervention (PCI, also known as primary angioplasty/stenting) versus PCI alone in patients with large acute myocardial infarctions. The trial was stopped after an analysis of the 30-day data showed that the mortality rates in those treated with tenecteplase plus PCI were higher than in the PCI alone arm. Additional results from the study will be presented at the annual meeting of the European Society of Cardiology in Stockholm, Sweden in September 2005.
Patrick Y. Yang, Ph.D., senior vice president of Product Operations, will become a member of Genentech's Executive Committee. Yang will continue to report to Levinson and will continue to be responsible for Manufacturing, Facilities, Engineering, Process Development and Supply Chain Management functions. He joined Genentech in 2003 as vice president, South San Francisco Manufacturing and Engineering.
Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Monday, July 11, 2005, at 2:15 p.m. Pacific Time (PT). The live webcast may be accessed on Genentech's website at http://www.gene.com. This webcast will be available via the website until 5:00 p.m. PT on July 25, 2005. An audio replay of the webcast will be available beginning at 5:15 p.m. PT on July 11, 2005 through 5:15 p.m. PT on July 18, 2005. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-9291 (international); conference ID number is 7086252.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
For information on Genentech's latest business and product development events please refer to http://www.gene.com/gene/news/press-releases/index.jsp.
This press release contains forward-looking statements regarding nine potential FDA filings, the FDA filing timeframe for Herceptin in adjuvant breast cancer, achievement of Horizon 2010 goals and expected growth in non-GAAP EPS for 2005, and actual results could differ materially. Among other things, potential FDA filings, including the Herceptin filing timeframe, and our Horizon 2010 goals of adding programs into research and clinical development could be affected by product safety, efficacy or manufacturing issues, additional time requirements to achieve study endpoints or for data analysis or filing preparation, need for additional clinical studies, and FDA actions or delays; our Horizon 2010 goal of bringing potential new products or indications to market could be affected by all of the foregoing and failure to receive FDA approval; our Horizon 2010 goals of becoming number one in U.S. oncology sales and building a leading immunology business could be affected by all of the foregoing and by competition, pricing, reimbursement, the ability to supply product, product withdrawals, new product approvals and launches and achieving sales revenue consistent with internal forecasts; and non-GAAP EPS growth, including our Horizon 2010 goal of non-GAAP EPS growth, could be affected by all of the foregoing and by unanticipated expenses such as litigation or legal settlement expenses or equity securities write-downs, costs of sales, R&D expenses, fluctuations in royalties and contract revenues, and fluctuations in tax and interest rates. Genentech disclaims, and does not undertake, any obligation to update or revise any forward-looking statements in this press release.
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*One area of concern for the FDA is the use of the term "maintenance." Genentech will be working toward a nomenclature that the FDA feels better describes this approach to treating patients with Rituxan.