Bristol-Myers Squibb (NYSE: BMY) reported fourth quarter earnings yesterday, but the company and investors alike are focused on the future -- specifically 2013, after Plavix, the company's $6.666 billion drug (hopefully that isn't an omen), starts to see generic competition.
The company is sticking to its post-Plavix 2013 adjusted earnings guidance of a minimum of $1.95 per share. That would put it just below 2010 earnings, but don't think that means 2011 and 2012 are wash years. Bristol needs to get drugs approved and pump up earnings over the next two years in order to cushion the fall.
There are three drugs that investors should be keeping their eye on: a blood clot preventer called apixaban, diabetes treatment dapagliflozin, and a treatment for melanoma called ipilimumab.
Apixaban, which Bristol-Myers is developing with Pfizer (NYSE: PFE), was shown to be superior to sanofi-aventis's (NYSE: SNY) Lovenox, but a second trial in another indication was stopped early because of an increased rate of bleeding in patients taking the drug. How those two balance out into a potential approval and sales remains to be seen.
Dapagliflozin is under review by EU and U.S. authorities. The drug, which will be sold with AstraZeneca (NYSE: AZN), works in a novel mechanism and should therefore sell better than the companies' Onglyza, which has had a hard time competing with Merck's (NYSE: MRK) Januvia.
Lastly, ipilimumab, which Bristol-Myers owns in entirety thanks to its acquisition of Medarex, is under review by the FDA and has a PDUFA date in March. I find the data a little confusing, and I'm rather surprised the FDA canceled the advisory panel to discuss the drug. But management seemed confident on the conference call that the company is on track to get a decision by March.
Unlike most other drugmakers facing patent cliffs, Bristol has a solid pipeline that should allow it so reaccelerate growth after the one-time decline. Of course, all of that is dependent on the new drugs being approved and hitting their sales potential, so Bristol is far from risk-free.
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