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Weekly UpdatesGenentech, Inc. (NYSE:DNA), South San Francisco, has announced financial results for the full year and fourth quarter of 2008. Key results for the full year 2008 include:
U.S. product sales of $9,503 million, an 11 percent increase from $8,540 million in 2007.
Non-GAAP operating revenue of $13,403 million, a 14 percent increase from $11,718 million in 20071; GAAP operating revenue of $13,418 million, a 14 percent increase from $11,724 million in 2007. Non-GAAP net income of $3,643 million, a 16 percent increase from $3,142 million in 20071; GAAP net income of $3,427 million, a 24 percent increase from $2,769 million in 2007.
Non-GAAP earnings per share of $3.42, a 16 percent increase from $2.94 in 20071; GAAP earnings per share of $3.21, a 24 percent increase from $2.59 in 2007.
We are pleased that 2008 was another year of solid financial growth for Genentech. In addition, our late-stage and early-stage development efforts progressed well across our focus areas with four sBLA filings submitted for serious diseases in oncology and immunology, and Phase I clinical trials initiated for eight new molecular entities, including in neuroscience," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "In 2009, we have the potential to receive four FDA approvals and we anticipate filing more than ten regulatory applications for new indications." The company announced it is currently forecasting full-year 2009 non-GAAP earnings to be in the range of $3.55 to $3.90 per share1, recognizing that there are a large number of business uncertainties that make it a difficult year to forecast. Other Financial Results
Key results for the fourth quarter of 2008 include:
U.S. product sales of $2,495 million, a 13 percent increase from $2,199 million in the fourth quarter of 2007. Non-GAAP operating revenue of $3,703 million, a 25 percent increase from $2,966 million in the fourth quarter of 20071; GAAP operating revenue of $3,707 million, a 25 percent increase from $2,970 million in the fourth quarter of 2007.
Non-GAAP net income of $1,014 million, a 38 percent increase from $737 million in the fourth quarter of 20071; GAAP net income of $931 million, a 47 percent increase from $632 million in the fourth quarter of 2007. Non-GAAP earnings per share of $0.95, a 38 percent increase from $0.69 in the fourth quarter of 20071; GAAP earnings per share of $0.87, a 47 percent increase from $0.59 in the fourth quarter of 2007.
Reconciliations between non-GAAP and GAAP earnings per share for the full years 2008 and 2007 and the fourth quarters of 2008 and 2007 are provided in the following table:
Clinical Development
In the fourth quarter of 2008, Genentech completed enrollment in three Phase III Lucentis (ranibizumab injection) trials, including for the treatment of retinal vein occlusion (BRAVO and CRUISE studies) and diabetic macular edema (RISE study).
In December of 2008, Genentech submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Xolair (Omalizumab) to extend its current asthma indication to the pediatric setting for children 6 and older.
The company also received dates for Prescription Drug User Fee Act (PDUFA) reviews of its two sBLA submissions for Avastin (bevacizumab) in relapsed glioblastoma (May 5, 2009) and Avastin in combination with interferon alfa-2a therapy for patients with first-line metastatic renal cell carcinoma (August 1, 2009).
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA.
For more information, 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 $1.3 billion in free medicine to uninsured patients through the Genentech[R] Access to Care Foundation (GATCF) and other product donation programs. Since 2005, Genentech has also donated approximately $250 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.
For information on Genentech's latest business and product development events
Full-year 2008 results include a net favorable adjustment of $0.16 per share related to the COH contract dispute and litigation settlement, offset by intangibles amortization related to the 1999 redemption of Genentech's stock by Roche and the 2007 acquisition of Tanox, Roche Proposal-related fees incurred on behalf of the Special Committee, and other items related to the acquisition of Tanox, including recognition of deferred royalty revenue and asset impairment charges, totaling $0.12 per share. Full-year 2007 results include accrued interest and bond costs related to the COH trial judgment, intangibles amortization related to the 1999 redemption of Genentech's stock by Roche and the 2007 acquisition of Tanox, partially offset by recognition of deferred royalty revenue related to the acquisition of Tanox.
Genentech's full-year 2008 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $82 million, $152 million, and $165 million, respectively, and MG&A expense also excludes asset impairment charges of $15 million related to the acquisition of Tanox and charges of $14 million associated with supporting the Special Committee in connection with the Roche Proposal. Full-year 2007 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $71 million, $153 million, and $179 million, respectively. Genentech's fourth quarter 2008 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $20 million, $33 million, and $35 million, respectively, and MG&A expense also excludes charges of $8 million associated with supporting the Special Committee in connection with the Roche Proposal. Fourth quarter 2007 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $22 million, $39 million, and $42 million, respectively.
For more information, http://www.gene.com or call 650/467-6800.
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