UPDATE 3-Amgen sees 2009 profit near low end of its view
* 2009 revenue to be at midpoint of forecast
* Still working with FDA on denosumab response - CEO
* Shares fall almost 2 pct (Adds denosumab background, updates share price)
By Deena Beasley
SAN FRANCISCO, Jan 12 (Reuters) - Biotechnology company Amgen Inc (AMGN.O) said 2009 earnings would come in close to the low end of its forecast, sending its shares down almost 2 percent.
Continued uncertainty about Amgen's experimental osteoporosis drug denosumab also weighed on the stock, as the company said it has not yet responded to a regulatory request for more information on the drug.
Denosumab is Amgen's most important experimental drug, and investors are anxiously awaiting its approval -- with hopes that big sales could rejuvenate the drugmaker's flagging earnings.
Speaking at the JP Morgan Healthcare conference on Tuesday, Chief Executive Officer Kevin Sharer said the company's full-year earnings would be close to the low end of its forecast of $4.90 to $5.05 per share. Analysts on average expected $5.04 per share, according to Thomson Reuters I/B/E/S.
Sharer also said 2009 revenue would be at the midpoint of the company's projection of $14.4 billion to $14.8 billion. Analysts were looking for $14.7 billion.
Sanford Bernstein analyst Geoff Porges said he was encouraged the revenue was "fairly consistent" with estimates.
"While the company's EPS results for 2009 are likely to come as a disappointment to investors, the company's in-line revenue result suggests that they may have pushed through additional expenses in (the fourth quarter) to allow for EPS growth in 2010," Porges said in a research note.
Amgen is counting on pending regulatory approval of experimental osteoporosis drug denosumab, a potential blockbuster and key to jump-starting growth at the company. The U.S. Food and Drug Administration in October delayed approval, seeking more information about a program to monitor the drug once on the market, as well as updated safety data.
Sharer said Amgen, based in Thousand Oaks, California, is still working with the FDA to answer the regulator's concerns about the drug, also known as Prolia, and will respond to the agency very soon.
Porges said a near-term response will still allow for a mid-year approval of the drug.
Amgen expects to announce during the current quarter results from a trial of denosumab as a treatment for bone problems in prostate cancer patients.
The company expects to eventually file a separate FDA application for use of the drug in cancer patients.
Despite reduced spending on denosumab, Sharer said he did not see "any dramatic change in philosophy" regarding research and development spending. Such costs are traditionally 18-20 percent of the company's revenue, he said.
Amgen has plenty of financial flexibility with $4 billion in cash at the end of the third quarter, the CEO said.
"We want to buy quality assets that have the potential to increase revenue growth," Sharer said.
Amgen shares fell 1.9 percent to $55.91 late Tuesday afternoon on Nasdaq. (Reporting by Deena Beasley; Writing by Lewis Krauskopf; Editing by Dave Zimmerman, Tim Dobbyn and Richard Chang)
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