Tuesday, Jan 10, 2006
South San Francisco, Calif. -- January 10, 2006 --Genentech, Inc. (NYSE: DNA) today announced financial results for the full year and fourth quarter 2005. Key results for the full year 2005 included:
Key results for the fourth quarter of 2005 included:
¿Looking back over 2005, Genentech had a year of unprecedented success in clinical trial results and FDA filings for potential therapeutics to treat cancer, blindness and rheumatoid arthritis,"said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. ¿We completed the last year of our 5x5 plan and are pleased with our average annual non-GAAP EPS growth of 33 percent between 1999 and 2005. We continue to build on our strong scientific foundation and to focus on research and development to fuel our long-term growth."
The company announced it expects approximately 35 to 45 percent growth in non-GAAP earnings per share for the full year 2006.
Note: The compound annual GAAP earnings per share growth rate was 31 percent from 1999 through 2005. (Given negative GAAP earnings per share in 1999 and 2000, a directly comparable calculation of the average annual growth rate for 1999 through 2005 is not available and compound annual growth rate instead of average annual growth rate is provided.) Genentech's 2005 non-GAAP net income and non-GAAP earnings per share exclude the after-tax impacts of recurring charges related to the 1999 Roche redemption of Genentech's stock and litigation-related special items. Genentech's forecasted 2006 non-GAAP earnings per share excludes the after-tax impacts of recurring charges related to the 1999 Roche redemption of Genentech's stock, litigation-related special items, and stock compensation expense associated with Genentech's adoption of SFAS No. 123R on January 1, 2006. The differences in non-GAAP and GAAP numbers are reconciled in the tables provided and on www.gene.com.
Product Sales ¿Genentech set record sales across its product portfolio in 2005,"said Ian T. Clark, executive vice president, Commercial Operations. ¿Total U.S. product sales were more than $5 billion for the full year 2005, an increase of 45 percent compared to 2004.¿
For 2005, including the three months ended December 31, 2005:
Royalty and Contract Revenues
Total Costs and Expenses
Clinical Development ¿Moving toward our Horizon 2010 goals, Genentech added 13 new projects into the pipeline in 2005, including three new molecular entities in oncology,"said Susan D. Hellmann, M.D., M.P.H., president of Product Development. ¿Genentech received positive data from eight important Phase III clinical trials of Herceptin, Avastin, Rituxan and Lucentis. We also filed five submissions for product approval with the FDA, an unmatched accomplishment for Genentech.¿
Genentech anticipates filing multiple supplemental Biologics License Applications (sBLAs) in 2006, starting with Herceptin in the adjuvant setting in the first quarter of 2006. The company also expects to file two sBLAs for Avastin in the second quarter of 2006 ¿ one in first-line non-squamous, non-small cell lung cancer, and another in first-line metastatic breast cancer. Genentech also announced that in February 2006 it expects U.S. Food and Drug Administration (FDA) action on two Rituxan filings, one for front-line intermediate grade or aggressive front-line non-Hodgkin's lymphoma (NHL) and one for rheumatoid arthritis for patients who have an inadequate response to anti-TNF therapy. In the fourth quarter of 2005, Genentech completed enrollment in the Phase III study of Rituxan in primary progressive multiple sclerosis, as well as in the Phase II combination study of Avastin and Tarceva in non-small cell lung cancer.
Other Company Events On December 23, 2005, the U.S. Patent Office received from another third party an additional request for reexamination of the Cabilly, et al. U.S. Patent No. 6,331,415 (Cabilly patent). The Patent Office has not yet acted upon this request.
On October 31, 2005, the U.S. Food and Drug Administration granted approval for the production of Avastin bulk drug substance for commercial use from two 10,000-liter bioreactors at Genentech's Porriño, Spain manufacturing facility.
Webcast: Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Tuesday, January 10, 2006, 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 January 24, 2006. A telephonic audio replay of the webcast will be available beginning at 5:15 p.m. PT on January 10, 2006 through 5:15 p.m. PT on January 17, 2006. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-9291 (international); conference ID number is 3689902.
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 and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed 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 the expected time frame for the Herceptin and Avastin sBLA filings and long-term growth, including 2006 non-GAAP EPS growth. Such statements are just predictions and involve risks and uncertainties such that actual results may differ materially. Among other things, the time frame for the sBLA filings could be affected by unexpected safety, efficacy or manufacturing issues, delays in receiving study data from third parties, additional time requirements for data analysis and BLA preparation, or FDA actions or delays; and our long-term growth, including 2006 non-GAAP EPS growth, could be affected by all of the foregoing and by failure to receive FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals, new product approvals and launches, achieving product sales revenue consistent with internal forecasts, 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. Please also refer to Genentech's periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise the forward-looking statements in this press release.