United Therapeutics (UTHR) Q1 2012 Earnings Call April 26, 2012 9:00 am ET Executives Martine A. Rothblatt - Founder, Chairman and Chief Executive Officer Andrew Fisher - John M. Ferrari - Chief Financial Officer, Principal Accounting Officer and Treasurer Roger A. Jeffs - President, Chief Operating Officer and Director Analysts Unknown Analyst Roz Sweeney - RBC Capital Markets, LLC, Research Division Joseph P. Schwartz - Leerink Swann LLC, Research Division Liana Moussatos - Wedbush Securities Inc., Research Division Mike Schmidt Presentation Operator
Any questions that you may have relating to passing the IP issues could be directed to Mr. Fisher. Questions with regard to distributor, distribution, finance issues could be directed to Mr. Ferrari, and questions with regard to clinical development, sales marketing, and company-wide operations to Dr. Jeffs. And otherwise, I'm pleased to answer any questions you may have.We've had a really great first quarter and we're announcing today's revenues of $204 million for the quarter. Earnings per share of $1.32 per basic share, $1.29 per diluted share. And then the main metrics that we used to gauge our business operations, the earnings before non-cash charges, Baird we're really pleased to report $2.13 per basic share, $2.08 per diluted share. These really good financial results, on the part is a stepping stone for our revenue guidance, which is plus or minus 5%, $875 million for this calendar year of 2012 and $1 billion for the next calendar year of 2013. So the big pictures here is that product revenues are growing, earnings are growing and we remain on track for the guidance that we've provided for 2012 and 2013. Operator, if you could please now open up the lines for any questions that people might have. Question-and-Answer Session Operator [Operator Instructions] We have a question from Mark Schoenebaum of ICI Group (sic) [ISI Group]. Unknown Analyst This is West sitting in for Mark. I had couple of questions about IP and also use of cash. My first question was around Tyvaso. Could you let us what the earliest potential date for a potential Paragraph IV filing for that product? And your expectations of any filing? And then also, I'd like to know if you have any updates on use of cash around share buybacks, as well as business development for the remainder of the year? Any additional details around that would be very helpful.
Martine A. RothblattOkay, thank you very much. We're going to spend more through our time on your first question and you feel free to get back in the queue on the second question. Just to give you a quick answer, there is no change in our previously announced use of cash fund plans. Andy, can can you expand, provide some color on the IP questions asked? Andrew Fisher Sure. Thanks, Martine. So the situation with Tyvaso is that it has orphan drug exclusivity until July of 2016, and it has a range of Orange Book listed patents expiring from 2014 until 2018. So those are the things you need to be mindful of when you consider Tyvaso's exclusivity position with respect to generic filers. I would also remind our listeners that Tyvaso is approved as a drug device combination. So I think the situation presents slightly differently with Tyvaso, than with respect to the current pending Paragraph IV and the filing for a module. Martine A. Rothblatt Excellent observations Andy hopefully, that we're responses to Mark's question. I'd like to add just a little top off color, on top of that what Andy said. On the concept to the drug device combination because it's kind of an unusual concept in the biotechnology space. When we were originally getting the Remodulin approved the -- what was somewhat different is that the drug was improved with, sort of a generic step of infusion flow parameters that applied through the Medtronic, and formerly called MiniMed device, that infused it such that one could in fact, provide Remodulin with an -- the equivalent infusion device from another manufacturer. And there are in fact, a couple or maybe even more than 2 different infusion pumps that are used in combination with Remodulin. But as Andy pointed out, it's quite a different situation with Tyvaso being approved as a drug device combination. We ourselves tried more than once to reproduce the dispersal pattern within the bronchi that is associated with our device. It was in fact, not possible. Oftentimes other insulation devices will provide something that was deeper than the Optineb, perhaps some people could argue "better" than the Optineb, in terms of it's dispersal pattern within bronchi. But what was incontestable is that all of the any other device, it was always very, very different from the Optineb. And therefore, it would not in any way, shape or form come within the approval that was granted for Tyvaso and the Optineb device, as the drug device combination. So it would be -- it's going to be a hoarse of another color for there to be an introduction of a substitute for Tyvaso because of this unique drug device combination approval. And of course, as many of you are aware, this is a device that we own all rights to, the manufacture, so on and so forth. Thanks for the question from Mark's Group. And operator, if you can please take the next question. Read the rest of this transcript for free on seekingalpha.com