Sometimes, a drugmaker just has one of those quarters where everything goes right. With big successes on the regulatory and financial fronts, there's no other way to describe CV Therapeutics' (Nasdaq: CVTX ) second quarter. Better yet, the good times may be just beginning.
CV Therapeutics started the second quarter off with a bang, after the Food and Drug Administration approved its heart-imaging diagnostic aid Lexiscan in April. CVT wasted no time in trading half of the royalty stream it will receive from Lexiscan for $185 million, which it will use to partly pay down its debt.
The regulatory successes kept rolling in for CVT in April, as its lead drug, angina treatment Ranexa, also essentially gained marketing approval in the European Union. In the conference call accompanying its earnings release yesterday, management said that it should have a European marketing partner for Ranexa "in time to launch [Ranexa] in Europe in the first part of next year."
That search could produce some very interesting game-changing results for the company. CVT hasn't ruled out doing a deal for more than just the European rights to Ranexa. If it can snag a partner with a deep and experienced sales force, like AstraZeneca (NYSE: AZN ) , GlaxoSmithKline (NYSE: GSK ) , or Sanofi-Aventis (NYSE: SNY ) , then Ranexa's future prospects in Europe will be bright indeed.
Based on similar deals in the past, I expect CVT to negotiate a double-digit royalty on all European sales of Ranexa, plus an up-front payment potentially topping $100 million, depending on the scope of the marketing deal that it inks.
Ranexa's prospects in the U.S. have also been shining lately. Though CVT smartly slashed its Ranexa sales force last year to conserve cash, the drug's sales still rose 66% year over year in the second quarter, to more than $25 million.
CVT also announced that Lexiscan sales by marketing partner Astellas started strongly, raking in $13 million after only a couple of weeks of active marketing in June. Especially given the strong competition from King Pharmaceuticals (NYSE: KG ) and Astellas' similar imaging agent, Adenoscan, these swift and lucrative Lexiscan sales could portend bright royalty prospects, assuming demand hasn't been distorted by wholesalers stocking up on the drug.
None of this success was enough to stem the tide of red ink at CVT, but things there are nonetheless improving. Once you take out amortized royalty revenue and one-time milestone payments, CVT turned in an approximately $30 million operating loss this quarter. That's still far better than the more than $62 million operating loss it turned in last year, stripping out license revenue and restructuring charges.
Unfortunately, CVT didn't get the FDA regulatory decisions on Ranexa that it was waiting for this week. There's a silver lining from the FDA delays, though; approval to grant at least the front-line angina labeling claim sounds highly likely, after CVT announced that the FDA is working on "draft labeling" for the drug. Investors shouldn't have to wait much longer to better know what Ranexa's future potential is, and whether CVT's shares are as undervalued as I think they may be.
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