Sometimes getting a drug compound approved for marketing is only half the battle. For instance, sales can be handicapped if the FDA grants too narrow a product label, thus restricting the types of patients that the compound can actively be marketed to. Rule Breakers pick CV Therapeutics (NASDAQ:CVTX) has been dealing with just such a problem for its angina treatment, Ranexa, ever since the drug was approved last year. With last week's announcement that Ranexa trial results that could expand the drug's label will be announced in late March, CVT may finally be able to boost Ranexa's sales growth.
Ranexa has been on the market since March of last year. Sales of heart treatments in the fourth quarter accounted for more than $9 million of the drug's sales for the year. This represented quarter-over-quarter net sales growth of 180%. Still, the $18 million in sales that Ranexa brought in seems paltry considering that CVT blasted through $315 million in expenses for the year.
The good news is that some of these expenditures are expected to decrease in the coming months. 2007 operating expenses are expected to be about $30 million lower than last year, in the $275 million to $285 million range. And wrapping up the Regadenoson and Ranexa clinical trials next year will help rein in R&D spending, since those two drugs account for nearly 50% of the roughly $100 million in estimated R&D costs for the year.
Speaking of Regadenoson, CVT mentioned in its fourth-quarter conference call last week that it was expecting to file a new drug application for the drug sometime in the middle of 2007. Assuming a 10-month FDA product review, this puts potential approval in the second quarter of next year.
CVT ended 2006 with cash and equivalents of $337 million, down from the $482 million that it started the year with -- even after a dilutive financing in August that brought in more than $90 million.
So what investors are getting with CVT today is a specialty pharma that is rapidly burning the cash on its balance sheet. On the other hand, the company owns a product that's facing a potential label expansion to a much larger patient group. Investors also have a possible Ranexa approval in Europe to look forward to this year, since CVT filed a marketing application in the European Union in December. As management has stated, though, the upcoming clinical trial results for the Ranexa study are still blinded and unknown. And this trial is a big question mark, since the study is for a mostly different patient group than previous studies; its odds for success are tough to predict at best.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
