While Amgen Inc. recorded an 18 percent increase in revenues for 2005, the company's stock slid Thursday when it failed to release much-anticipated data for its colorectal cancer drug panitumumab.
Shares (NASDAQ:AMGN) fell $3.57 to end the day at $71.90, even though the company reported adjusted earnings per share for the fourth quarter of 75 cents - only a penny short of consensus.
Amgen reported GAAP net income and EPS in 2005 of $3.7 billion and $2.93, increases of 55 percent and 62 percent, respectively, from 2004's figures of $2.4 billion and $1.81. Revenues for the year were $12.4 billion.
Full-year adjusted net income was $4 billion, $3.20 EPS, compared with $3.1 billion, $2.40 EPS, for 2004.
"I think they did fine, just fine. The quarter came in, for all intents and purposes, in line," said Christopher Raymond, an analyst with Robert Baird & Co. in Chicago. "I think the stock action, though, is insane."
Wall Street had expected detailed interim data from an ongoing trial of panitumumab, a product for which Thousand Oaks, Calif.-based Amgen should complete a rolling new drug application this quarter. But the company declined to give the data in a conference call on Thursday. Raymond suspected the delay might be a strategic move to protect panitumumab from its largest potential competitor, New York-based ImClone Systems Inc.'s Erbitux. ImClone retained the investment bank Lazard earlier this week, essentially placing itself up for sale.
"I would say it would make sense for Amgen to decide they want to go a little radio-silent on their drug so they don't provide anybody with a glimpse of how this class of agents works in front-line data," Raymond told BioWorld Today. "Why give a potential acquirer, who would become a potential competitor, any ammunition for whether they want to buy this product or not?"
Another reason for the dip in Amgen's stock could be due to the company's adjusted EPS guidance for 2006 of between $3.55 and $3.70. The numbers in themselves are OK, Raymond said, but some investors might be disappointed that unlike last year, Amgen does not expect to raise the figures.
"Their commentary to not expect any upside from that spooked some folks," Raymond said, adding that "they do have a lot of clinical trials to fund."
The company plans to invest 30 percent to 40 percent more in research and development this year for various clinical studies, including one for denosumab in osteoporosis and metastatic bone disease, panitumumab and AMG 706 in several oncology indications, and morbidity/mortality studies with Aranesp in patients with chronic kidney disease and heart failure.
Amgen received positive data in the fourth quarter from a pivotal trial of panitumumab, and it announced plans to acquire Fremont, Calif.-based Abgenix Inc. for $2.2 billion, which would give it full ownership of panitumumab. It expects to close the deal in late March.
Assuming an approval this year, Raymond expects panitumumab to earn "a little over $1 billion" in peak sales by 2010. With data expected in 2007, Amgen's denosumab also could reach the market in the next few years. And some interesting Phase II oncology data could come this year for Amgen's oral VEGF-inhibitor, AMG-706.
"I think this company has sort of transformed itself in a two-to-three year period from being one with nothing to talk about in their pipeline to being in a position now where I think Genentech was three years ago," Raymond said. "Right now through 2007 should be a real exciting time to own Amgen because we're going to start to see some of those products hit."
Amgen posted fourth-quarter 2005 revenues of $3.3 billion. GAAP net income and EPS for the quarter were $824 million and 66 cents. Adjusted net income was $928 million, 75 cents EPS. The adjusted figures exclude expenses related to the acquisitions of Tularik Inc. in 2004, and Immunex Corp. in 2002, as well as other items.
Global product sales jumped 14 percent in the fourth quarter from $2.8 billion to $3.2 billion. For the full year, sales reached $12 billion, a 20 percent increase over the $10 billion recorded for 2004.
Individually, Aranesp (darbepoetin alfa) sold $3.3 billion last year, an increase of 32 percent; Epogen (Epoetin alfa) brought in $2.5 billion, a 6 percent decrease from 2004; Neulasta (pegfilgrastim) and Neupogen (Filgrastim) sold $3.5 billion, a 20 percent increase; and Enbrel (etanercept) helped the bottom line by $2.6 billion, a 35 percent jump over 2004.
"Aranesp worldwide missed our estimate - I think it missed consensus - but the U.S. figure was in line," Raymond said. Aranesp earned $579 million in U.S. sales in the fourth quarter, a 13 percent increase over the fourth quarter of 2004.
"Neupogen/Neulasta was up huge. I think they beat our estimate by almost $40 million," Raymond said, adding that the unexpected increase made up for the Aranesp "shortfall."
Aranesp and Enbrel sales were driven mainly by demand, while Neulasta sales benefited from a label extension for earlier use. Epogen's sales dipped due to lower patient demand.
"Epogen has been on sort of a long, extended decline due to Aranesp cannibalization," Raymond said.
Amgen's operating expenses for 2005 were $2 billion vs. $1.7 billion in 2004, an increase driven mainly by higher sales volumes. Research and development expenses totaled $2.3 billion, compared to $2 billion; and selling, general and administrative expenses rose to $2.8 billion, compared to $2.5 billion in 2004.
For 2006, Amgen expects revenue of $13.9 billion to $14.4 billion. As of Dec. 31, the company had $5.3 billion in cash and marketable securities.
In a separate release Thursday, Amgen said it gained access to a license from South San Francisco-based Genentech Inc. for multiple antibodies under the Cabilly patent family relating to methods of producing immunoglobulins.
Likewise, Genentech gained a license to Amgen's patents for the manufacture and use of antibodies and related technology.
Terms were not disclosed.