United Therapeutics Earnings Call Insights: Refiling Oral Trepostinil NDA and Sandoz Patent Case

United Therapeutics Corporation (NASDAQ:UTHR) recently reported its fourth quarter earnings and discussed the following topics in its earnings conference call.

Refiling Oral Trepostinil NDA

Mark Schoenebaum – ISI Group: Could you just maybe explain to us, why you made a decision to refile the oral treprostinil NDA if that’s possible to comment on that?

Martine A. Rothblatt, Ph.D. – Chairman and CEO: That to me is a favorite topic. I think really that to not refile would be the absolute worst decision I might have ever made as CEO of the company. We are talking Mark, about a molecule that has been a life saver for thousands of patients. It’s the key pharmaceutical ingredient in Remodulin it’s the API in Tyvaso. In all of its clinical trials it resulted in P values which were either statistically significant in the case of the FREEDOM-M trial or very close to statistical significance in the case of the FREEDOM-C(1) and C(2) trials. As I know you know very well Mark when you are very statistical significance 0.05 is not some kind of like you know magic marker in the sense that a drug definitely positively works if it’s less than 0.05 and definitely positively it does not work if its above 0.05, its instead of regulatory sort of line in sand, and can be somewhat of a shaded line in the sand depending on compelling factors to take into account, especially for patient welfare. So the p-values for the C-1 and C-2 studies were so close to statistical significance, nobody doubted that the drug works. Nobody thinks that the drug is a placebo, and in fact, when you begin to look at subsets of the patients, it has a dramatic benefit for many of the patients. With regard to the FREEDOM-M data, this drug had a, oral treprostinil, had a better demonstration of efficacy with high statistical significance than Remodulin or Tyvaso did. Again, just what I’m talking about here is the 6-Minute Walk outcomes which were greater for oral treprostinil than for Tyvaso or Remodulin. As you see from our financial results today, Mark, Remodulin is far and away the first choice of physicians for prostacyclin therapy delivered parenterally. Tyvaso is far in a way the choice of physicians for prostacyclin therapy delivered via inhalation, both of them continue to be prescribed by physicians to ever greater numbers of patients. So, of course, we are going to refile oral treprostinil, and of course, we’re going to be relentless in getting this drug approved because sooner or later, it will get approved and it will be a great blessing to the patients who have it.

Mark Schoenebaum – ISI Group: What’s your level of confidence it will approve. Then I’ll drop-off?

Martine A. Rothblatt, Ph.D. – Chairman and CEO: I think that I personally, I’m a believer in the right things and the right outcomes resulting, so long as one doesn’t quit and give up first. So my personal belief is that, as long as we persistently do everything which is right and necessary, oral treprostinil definitely will get approved, and I know it sounds kind of silly to say quitters never win and winners never quit, but we are winners here and we’re not going to quit on oral treprostinil.