Biopharmaceutical company CV Therapeutics
It was a fairly quiet quarter for CVT, as investors await the clinical trial results from the company's large phase 3 Merlin study testing its marketed angina drug, Ranexa, as a potential treatment for acute coronary syndrome (ACS).
Investors are eagerly waiting for these trial results, which will be released in the first quarter of next year, because as a second-line treatment for angina, Ranexa sales have been anemic. Revenues from Ranexa were $8 million in the third quarter, but $5 million of that was due to the delayed recognition of some of the drug's sales at launch. Compare this to the just more than $1 million in sales achieved in the second quarter, and it's plain to see that the drug is not exactly catching on with cardiologists with its current form.
Luckily, the Merlin trial provides CVT several opportunities to give Ranexa sales a booster shot. One of three scenarios will occur with the trial: 1) Ranexa will succeed in its primary endpoints and the drug will be approved to treat ACS, which would be a home run for CVT; 2) Ranexa will fail in its primary endpoints as a treatment for ACS but show no significant safety issues compared to placebo, and the drug will remain eligible for a label expansion to treat front-line angina; or 3) Ranexa will fail as a treatment for ACS and will be associated with an increased level of significant adverse events over placebo, which will then ensure that the drug is destined to become a commercial failure.
The other mildly interesting news for the quarter is that CVT stopped using its more than 200-person sales force to co-market Solvay's ACE inhibitor, Aceon. This makes sense from a business perspective because it enables the company to focus its sales force on Ranexa. Aceon only brought in $1 million to CVT in the second quarter, and I'm sure these paltry revenues and costs associated with the marketing of it won't be missed if Ranexa is successful in the Merlin trial.
CVT currently has more than $350 million in cash and equivalents on its balance sheet after engaging in another dilutive financing to stem the $76 million in costs incurred during the quarter. CVT is going to need to do another financing of some sort next year, but I doubt investors will mind at all, assuming the Merlin clinical trial results are favorable, so we'll have to wait and see.
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