Genentech, Inc. has performed well during the year ended December 2008 and its net profit increased by 23.8 per cent to US$3,427 million from $2,769 million in the previous year. Its product sales increased by 11.5 per cent to $10,531 million from $9443 million and its US product sales reached at $9,503 million as against $8,540 million in 2007, an increase of 11 per cent.
Arthur D. Levinson, chairman and CEO of Genentech, said "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. 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's R&D expenditure increased by 14.5 per cent to $2,800 million from $2,446 million in the 2007. Its marketing, general and administrative spending went up to $2,405 million from $2,256 million. The operating profit increased by 26 per cent to $5,329 million from $4,229 million.
The company expecting non-GAAP earnings to be in the range of $3.55 to $3.90 for the full-year 2009, recognizing that there are a large number of business uncertainties that make it a difficult year to forecast.
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 US 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.