Celgene Slips Further on Weak Outlook

Monday, Celgene forecast 2009 Revlimid sales in the range of $1.7 billion, slightly lower than consensus estimate of $1.8 billion. Celgene reported unaudited 2008 Revlimid sales of $1.3 billion, a 71% increase over 2007 sales.

While offering a cautious outlook for the coming year, Celgene management also expressed great optimism for Revlimid's growth, especially in Europe where the drug is still in the relatively early stages of a commercial launch.

The company sees growth in Revlimid revenue coming from increased market share and longer duration of therapy as well as opportunities to sell the drug in more countries around the world.

One thing that would help Revlimid would be an expansion of the drug's U.S. approval to include newly diagnosed multiple myeloma. Celgene said it plans to discuss this issue with the FDA in the first quarter using data from two studies conducted by cooperative research groups. While this data showed a compelling survival benefit for Revlimid in newly treated multiple myeloma patients, the quality of the data from the studies may not meet the standards required by the FDA for approval.

Celgene CEO Barer said FDA approval based on the cooperative group data was a "low probability," less than 50%. If that doesn't happen, Celgene will use data from a similar company-sponsored study that is ongoing, with results expected later this year.

While digesting the news from Celgene, investors were awaiting outlooks from Genentech (DNA Quote) and Gilead Sciences (GILD Quote), which also were expected to report Monday.