Martine A. Rothblatt
Analyst · JPMorgan
Thank you, operator. Thank you, everybody, for dialing in to United Therapeutics Third Quarter 2013 Financial Results. My name is Martine Rothblatt; and I'm joined today by our President, Dr. Roger Jeffs; our Chief Financial Officer, John Ferrari; and our Chief Strategy Officer, Andrew Fisher. Andy is particularly available to answer any questions with regard to intellectual property. I'm extremely pleased with the results of the third quarter. Our medicines are now prescribed for more PAH patients in the U.S.A. than any other company. Total net revenues for the quarter ended September 30 were $302.2 million, up from $242 million for the quarter ended September 30, 2012. Gross margin from sales was $269 million for the quarter ended September 30, compared to $212 million for the same quarter last year. I'd also like to draw attention to the fact that we now report non-GAAP earnings in lieu of earnings before noncash -- noncash charges. And this report of non-GAAP earnings is the result of helpful suggestions from our shareholders that this would bring our non-GAAP earnings reporting more in line with that of many of our other peers. The non-GAAP earnings were $2.98 per basic share or $2.78 per diluted share. As you can see from these numbers, United Therapeutics' revenues are clearly on an upward trajectory. And when I take a look at our, at our leading revenue generator, Remodulin, I'm kind of reminded of this quotation back from the 20th century. I believe it was Winston Churchill, World War II, but don't hold me to this and don't hold it against me if I didn't know for sure that it was Winston Churchill, for our English holders. But I believe he said something along the lines of, "This is not the beginning of the end, but the end of the beginning." And he was speaking with reference to World War II. But for me, I'm speaking with reference to Remodulin. It's kind of extraordinary for a drug that was launched in 2002 to 13 years -- 11 years later, still have striking revenue growth quarter-over-quarter, year after year. And somebody might say, "Well, is this the beginning of the end?" I mean, that's a long run for a drug, especially in an orphan market. But in fact, I feel very confident that it's actually only the end of the beginning and nowhere near the beginning of the end. And the reason it is just the end of the beginning is because we are now moving into an inflection period, where our Remodulin revenues are driven predominantly by parenteral delivery via subcutaneous or intravenous infusion attached to a pump that is carried outside of the patient's body. And among the patients and the doctors and the nurses in the pulmonary hypertension community, this is referred to as being on "the pump." And it's always said with kind of scary music in the background, that people are frightened that they have to go on "the pump." And it is, of course, something that any of us who are healthy enough not to need that, should really have a world of respect for those who do have to walk around 24 hours a day, 365 days a year with a catheter winding outside of their skin connected to a mechanical pump that is literally pumping medicine into their body with the full knowledge -- they all know that if that pump was to stop for any number of hours, they could face instant death. And people have died instantly from rebound hypertension due to an interference with parenteral prostacyclin delivery. So the pump is scary. Now despite that, as I just mentioned, we've grown revenues of Remodulin and are now -- actually have $0.5 billion a year revenue run rate within our eyesight. We're not there yet, but it's something that seems to be visible on the near horizon. But I really believe that this is just the end of the beginning because there is a revolutionary new product in our pipeline, which is the implantable Remodulin. And as I travel around the country and talk with physicians, I've not met one who is not tremendously excited and believes it will be transformative for their Remodulin class patients, these are New York Heart Association Class III or Class IV patients, to be able to have a pump implanted inside of their body in an outpatient procedure, likely perceived by most patients as being not that dissimilar from their friends or relatives who had a pacemaker implanted or who had various other things that get implanted into our bodies these days. And our implantable pump project is a unique partnership between us and Medtronic. And pursuant to this partnership, we paid for the development of the Synchromed II pump to deliver treprostinil, the active pharmaceutical ingredient in Remodulin, 24 hours a day via a pump which is built inside this device that is so small, the Synchromed II device that it's implanted inside the patient's abdomen and together with a very specially designed catheter. The FDA, when they first heard about this, they were also extremely thrilled, and saw this as -- from an efficacy standpoint, no different then the IV Remodulin drug that they had already approved, but said that they wanted to have a safety study conducted, which we call the Deliver study. Dr. Robert Bourge was the principal investigator of that study. And according to the study, we had to have patients on the implantable pump for a requisite number of patient years and have an event rate that would be no greater than 2.4, 2.5 events per thousand patient days while using the system. Well, that study accrued its necessary time faster than anybody had anticipated. And certainly, the first study that we've ever done at United Therapeutics -- and certainly, we would be in the top decile of the industry. That study was completed sooner than was expected because the results were so good. And in fact, we hit that endpoint, that primary endpoint with a P value better than 0.0001. A lot of zeros. That's good. We like a lot of zeros. And so there's absolutely no doubt that Synchromed II Remodulin delivery system, has demonstrated the primary endpoint to the satisfaction of where the FDA had wanted it to be set. What's now going on is there are a number of secondary endpoints that Medtronic is in the process of analyzing. And there are also additional checks and Is to be dotted, Ts to be crossed with respect to manufacturing, quality assurance, controls. So we all know and respect Medtronic for being a very deliberate and careful company, and that's certainly what we want from any company making things that go inside of our bodies. So we, here at UT, are really patient and waiting for our partner to complete its steps, and then, it will file its product marketing agreement -- product marketing application, PMA, for the Synchromed II. We will file a very minor change to our label to allow Remodulin to also be delivered via the Synchromed II with its associated specialized catheter. And the bottom line of all this, there's no scientific study, but I will say when -- as I talk to doctors, and I would welcome any of you to, most of them think that as many as the same number of patients that they already have on Remodulin will -- people who are resistant to go on Remodulin, will go on Remodulin because of the implantable pump. In other words, they would not walk around with the pump, but they would be willing to walk around with something that was implanted in their body. There was no sterile changing of their site. No prohibition against showering and swimming. No need to maintain a sterile section of their kitchen or their bathroom. No changing of the medicines every couple of days, so on and so forth. So that's why I say that I think this is really the end of the beginning, but nowhere near the beginning of the end because once Medtronic completes all of its efforts and once the FDA gives its approval, these terrific financial results that you've seen here today with regard to Remodulin should very well be double the level that you're seeing. And we find that to be tremendously, tremendously exciting and certainly, consistent with this being just the end of the beginning for Remodulin. Now with Tyvaso, things are just as exciting. You've seen in the financial results we released today, rapid uptake in Tyvaso. It's really in percentage terms. It's really striking how rapidly that's growing. And I simply would like to remind everybody that for Tyvaso -- Tyvaso as well, we are at -- no further along in the lifecycle than the end of the beginning because Tyvaso is the drug that most doctors like to use for their Functional Class III patients. They start off their patients generally on oral meds. That's kind of the least risk, most convenient thing to do. The patients progress, the great majority of the time, to become Functional Class III patients. And before going on the dreaded pump, there is the beautiful therapy we developed of Tyvaso. And there are about 10,000 to 12,000 patients in that demographic -- in that Functional Class III demographic, of which we just have, at the moment, we just have a minority -- a modest minority of those patients. So we have a lot of room to grow with Tyvaso. And I fully expect that the growth trajectory of Tyvaso is going to take it to at least 50% of all of the New York Heart Association Functional Class III patients. So I apologize if my introductory remarks have gone on a little bit longer than usual. But we have new shareholders, new holders coming into our stock all the time and it's always helpful, I think, to get everybody on a common baseline about what a tremendously exciting company United Therapeutics is, and how promising our existing products are, not to mention our pipeline. And hopefully, some of the questions from callers will elicit pipeline questions that Dr. Jeffs can address. So with that introduction behind us, operator, you may now open up the lines to any questions.