What: Shares of Orexigen Therapeutics (NASDAQ: OREX), a biopharmaceutical company focused on developing drugs to treat obesity, put on some serious heft and gained 43% during the month of November, data courtesy of S&P Capital IQ, after reporting better-than-expected third-quarter results and updating the progress of its Contrave program in Europe.
So what: Between the two stories, clearly none was bigger than the update on the company's weight control management drug Contrave in Europe. Contrave was recently approved in the U.S., but no competitor in the space -- VIVUS with Qsymia nor Arena Pharmaceuticals with Belviq -- has been able to crack to the code to get its weight control drugs approved in Europe. Orexigen notes that it recently met with EU regulators and believes the remaining issues pointed out by the Committee for Medicinal Products for Human Use (i.e., the EU's version of a Food and Drug Administration advisory panel) are easily addressable. In other words, investors are excited about Contrave possibly being approved in Europe where drug accessibility and sales could be stronger than in the U.S.
Taking a backseat to the Contrave update, but nonetheless boosting Orexigen in November, was its third-quarter earnings results. Overall revenue for the quarter of $30.9 million was boosted by two milestone payments from Contrave licensing partner Takeda Pharmaceuticals totaling $30 million. These one-time payments resulted in the company reporting a profit of $0.09 per share. Comparably speaking Wall Street expected only $9 million in revenue and a $0.13 per share loss!
Now what: With respect to Orexigen's quarterly profit, investors should enjoy it while it lasts because it was essentially made up of non-recurring payments from Takeda. Moving forward Orexigen will rightly be judged by how well Contrave performs rather than what milestone payments it receives.
The differentiating factor here is Orexigen's Light Study, a close to 8,900-person cardiovascular outcomes study that in an interim analysis demonstrated that Contrave led to no more serious adverse events than the current standard of care. This long-term and broad-scope study could place Contrave at the head of its class ahead of the likes of Belviq and Qsymia because of its favorable safety profile.
Of course, investors would be wise to note that hopes were high for Qsymia and Belviq when they were approved by the FDA, and neither has lived up to the hype. Unless Contrave can get physician and insurer support and get consumers excited about the product, it could be another notoriously slow start. Among the three weight control management drugs that have been approved over the past two years, Contrave looks as if it has the most potential, but after a stunning run higher in November I'm personally not willing to take that bet as of yet.
