Healthcare Industry News: glioblastoma
News Release - March 14, 2008
Genentech Provides Business Update at Annual Investment Community MeetingSOUTH SAN FRANCISCO, Calif.--(HSMN NewsFeed)--Genentech, Inc. (NYSE:DNA ) is providing investors today with an overview of recent developments in its business, including highlights from the research, development and commercial areas.
“We remain focused on conducting excellent science and translating our scientific understanding into important new medicines that may benefit patients with serious diseases,” said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. “We are pleased with the progress of our pipeline. We currently have 13 new molecular entities in Phase I, six of which are in immunology or tissue growth and repair. Additionally, we have six new molecular entities in Phase II studies in oncology.”
Genentech is announcing the following today:
- The company now expects full-year 2008 non-GAAP earnings to be in the range of $3.35 to $3.45 per share, revised from $3.30 to $3.45 per share.1
- Based on encouraging Phase II results, the company expects to submit in 2008 a supplemental biologics license application to the U.S. Food and Drug Administration for accelerated approval of Avastin® (bevacizumab) for the treatment of relapsed glioblastoma multiforme (GBM). The company also expects to initiate a Phase III study of Avastin for first-line metastatic GBM.
- Genentech and its collaborator Curis plan to study a systemic hedgehog antagonist molecule in Phase II studies in 2008 as a treatment for metastatic colorectal cancer, advanced basal cell carcinoma and another undisclosed advanced solid tumor.
- The research organization has initiated early efforts in two new therapeutic areas: neuroscience and infectious disease.
- The company believes it is making good progress against all five of its Horizon 2010 goals that were communicated in March of 2006: achieving a compound annual non-GAAP earnings per share growth rate of at least 25 percent2 through 2010; attaining cumulative free cash flow of greater than $12 billion3 through 2010; bringing 20 or more new molecules into clinical development; bringing at least 15 major new products or indications onto the market; and being the number one U.S. oncology company as measured by sales.
A live webcast of the investment community meeting will begin today at 9:00 a.m. Eastern Time. The meeting is expected to last approximately four hours, including a short break. The webcast can be accessed on Genentech's website at http://www.gene.com. The webcast will be archived and available for replay until 8:00 p.m. Eastern Time on April 4, 2008.
Founded more than 30 years ago, 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.
About Genentech’s Commitment to Patient Access
Genentech is committed to patients having access to our therapies. Through its Genentech Access Solutions program, the company provides patients and healthcare providers with coverage and reimbursement support, patient assistance and informational resources. Patient assistance support is for those eligible patients in the United States who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs. Since 1985, when its first product was approved, Genentech has donated approximately $1 billion in free medicine to uninsured patients through the Genentech® Access to Care Foundation (GATCF) and other product donation programs. Since 2005, Genentech has also donated more than $140 million to various independent, non-profit organizations that provide financial assistance to eligible patients who cannot access needed medical treatment due to co-pay costs.
This press release contains forward-looking statements regarding expected growth in non-GAAP earnings per share (EPS) for 2008; the timeframe for a regulatory submission for Avastin and the initiation of clinical trials for Avastin and a systemic hedgehog antagonist molecule; growth in non-GAAP EPS through 2010; achieving cumulative free cash flow of greater than $12 billion; adding new molecules into development; bringing new products or indications onto the market; and being the number one U.S. oncology company as measured by sales. Such statements are predictions and involve risks and uncertainties such that actual results may differ materially. Such risks and uncertainties include, but are not limited to, difficulty in enrolling patients in clinical trials; the need for additional data, data analysis or clinical studies; the results of clinical trials; BLA preparation and decision making; FDA actions or delays; failure to obtain or maintain FDA approval; difficulty in obtaining materials from suppliers; unexpected safety, efficacy or manufacturing issues for us or our contract/collaborator manufacturers; our ability to meet demand for our products; product withdrawals; competition; efficacy data concerning any of our products which shows or is perceived to show similar or improved treatment benefit at a lower dose or shorter duration of therapy; pricing decisions by us or our competitors; our ability to protect our proprietary rights; the outcome of, and expenses associated with, litigation or legal settlements; our cost of sales, other expenses and indebtedness; variations in collaborator sales and expenses; fluctuations in contract revenues and royalties; actions by Roche that are adverse to our interests; decreases in third party reimbursement rates; and changes in tax laws or the application or interpretation of such laws. 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 forward-looking statements in this press release.
1 Our 2008 non-GAAP EPS estimate excludes the effects of: (i) recurring amortization charges related to the 1999 redemption of our common stock by Roche Holdings, Inc. and our acquisition of Tanox, Inc., which are estimated to be approximately $172 million on a pretax basis in 2008, (ii) litigation-related and similar special items for accrued interest and associated bond costs on the City of Hope judgment which are currently estimated to be in the range of $9 million to $18 million on a pretax basis in 2008, (iii) recognition of deferred royalty revenue of approximately $15 million on a pretax basis in 2008, (iv) income tax effect of $65 million to $68 million on recurring charges related to the redemption of our common stock and our acquisition of Tanox, Inc., litigation-related and similar special items, and recognition of deferred royalty revenue, and (v) employee stock-based compensation expense, which we expect the net of tax diluted EPS impact to be in the range of $0.25 to $0.27 per share for 2008. Our 2008 GAAP EPS would include the items listed above as well as any other potential special charges related to existing or future litigation or its resolution, or changes in or adoption of accounting principles, any of which may be significant.
2 The non-GAAP EPS goal for 2006 through 2010 excludes the effects of charges related to the 1999 redemption of our common stock by Roche Holdings, Inc., litigation-related and similar special items, employee stock-based compensation expense, and certain items associated with the acquisition of Tanox, Inc., including an in-process research and development charge (a non-recurring charge in the third quarter of 2007), recurring recognition of deferred royalty revenue, recurring amortization of intangible assets, and a gain on acquisition pursuant to Emerging Issues Task Force (EITF) Issue No. 04-1 (a non-recurring item in the third quarter of 2007), together with the related tax effects of excluding such items, as well as potential and similar special items related to existing or future litigation or its resolution, and changes in or adoption of accounting principles, any of which may be significant. GAAP EPS for 2006 through 2010 would include the items described above.
3 Our free cash flow measure is defined as cash from ongoing operations less capital expenditures. Cash from ongoing operations is derived from the “net cash provided by operating activities” line in our consolidated statements of cash flows excluding the effect of changes in the trading portfolio, but this number could be adjusted for items that would allow the measure to better reflect our operational performance. These adjustments may include, for example, cash receipts or payments related to litigation settlements, and other potential items, any of which may be significant.
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