Turnaround Time for CVT

Nothing's more fun to watch than a pharma turnaround story ... well, except maybe a biotech train wreck. Yesterday, Motley Fool Rule Breakers pick CV Therapeutics (Nasdaq: CVTX) announced its third-quarter financial results, signaling it may bounce back in 2008.

CVT experienced more solid sales growth with second-line angina treatment Ranexa. Third-quarter sales of the drug were $18.4 million -- up 20% over last quarter. While its overall market penetration hasn't been spectacular, the double-digit gains are pleasing to see, since they come before the possible expansion of Ranexa to a first-line angina treatment. They also occurred following a very welcome cost-cutting move to reduce the size of the company's sales force.

CVT burned through $24.2 million in cash in the quarter, but this burn rate is down significantly from the $43.4 million in cash it used last quarter, thanks to reduced clinical trial expenses and the aforementioned cost-cutting. CVT ended the quarter with a little less than $200 million of cash and investments on its balance sheet.

On the conference call, CVT gave preliminary (and likely conservative) guidance for some of next year's numbers. It expects a cash burn rate of less than $100 million next year, with projected Ranexa sales of less than $100 million as well. If Ranexa gets the front-line angina label expansion sometime in next year's second quarter, CVT could see revenues far exceed these estimates.  

Speaking of label expansions, there's renewed excitement over Ranexa after CVT's presentations at the American Heart Association medical conference yesterday. A secondary endpoint of a new phase 3 study, which is pivotal in Ranexa's attempt to secure the label expansion, measured the drug's effectiveness in helping control blood glucose levels for the subset of patients with diabetes.

The results presented yesterday showed that Ranexa was, in the intermediate term, as effective as Merck's (NYSE: MRK) future blockbuster diabetes treatment Januvia (for example) in helping diabetics control their blood glucose levels. There's not enough room to parse the details here; we'll do that on our Rule Breakers message boards.

Based on the strong diabetes data, CVT filed a separate marketing application with the FDA to expand the Ranexa label to treat type 2 diabetics with coronary artery disease. This patient population would cover a substantial number of the millions of type 2 diabetics. Needless to say, this is another huge opportunity for Ranexa.

If the FDA accepts CVT's marketing application for this indication, a decision should come roughly 10 months from the September filing date. So instead of one shot on goal to substantially grow Ranexa sales, with the front-line angina label expansion, CVT now has two coming up in the next year.