Good morning. My name is Latoya, and I will be the conference operator today. At this time, I would like to welcome everyone to United Therapeutics Corporation Third Quarter 2011 Conference Call. [Operator Instructions]
Remarks today concerning United Therapeutics will include forward-looking statements, which represent United Therapeutics' expectations or beliefs regarding future events based on current assumptions. United Therapeutics cautions that statements involve risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Consequently, all such forward-looking statements are qualified by cautionary language and risk factors set forth in United Therapeutics' periodic and other reports filed with the SEC. There can be no assurance that these actual results, events or developments referenced in such forward-looking statements will occur or be realized. United Therapeutics assumes no obligation to update these forward-looking statements to reflect actual results, changes and assumptions or changes in factors affecting such forward-looking statements. Thank you.
Dr. Rothblatt, you may begin your conference.
Thank you. Good morning, everybody. I am pleased to be joined on the call this morning by our illustrious Chief Financial Officer, John Ferrari; and our dynamic President and Chief Operating Officer, Roger Jeffs. I’ll make [ph] a few introductory remarks, and then we would open up the phone lines and welcome all of your questions.
We achieved over $200 million in revenue this quarter, which reflects the continued strength of our core business. I'm also pleased to report that our board of directors recently authorized a $300 million share repurchase program, which has already begun to return additional value to our shareholders. The combination of these 2 main points from our quarterly release is that the United Therapeutics growth story remains very strong, and we remain committed to sharing that value with our shareholders on a regular basis.
I'd like to point out a couple of things that are, perhaps, not quite so clear from the black and white letters of the press release. The GAAP profitability has almost doubled from the third quarter of 2010 to the third quarter 2011 and, also, for the 9 months of 2010 to 9 months of 2011. So that, certainly, is a very exciting dynamic indication of the strength of the core business.
Now I think when you take a look at the reasons behind the growth, one has to take a look primarily at the fact that United Therapeutics is a company that is committed to doing the absolute best that can be done for the pulmonary hypertension community. In fact, with now over 6,000 patients on Adcirca, over 3,000 patients on Flolan -- I'm sorry, on Remodulin, excuse that slip, and over 2,000 patients on Tyvaso, United Therapeutics actually helps more American patients with pulmonary hypertension than any other company in the world. And that's something we're really excited about because we formed our company 15 years ago specifically to help patients with pulmonary hypertension.
Certainly, Adcirca has been a big part of our ability to reach out to more and more patients. Yet, even with the 6,000 patients we're helping on Adcirca, that's only about 20% of the diagnosed U.S. patients with pulmonary hypertension. And all of the data out there really supports the fact that there should be no patient with pulmonary hypertension who is not on a PDE-5 background therapy of which Adcirca is the most convenient, as efficacious as any, as safe as any and the least expensive. So you really get 4 of a kind with Adcirca, and we certainly expect that growth to continue from its current 6,000 level up until we are hitting something close to the 30,000 patients in the U.S. with PAH who could all benefit with it.
Let's take a look at Tyvaso. Over 2,000 patients benefiting from that now, a true revolution in prostacyclin therapy. And that’s what patients used to have to endure 24 hours a day, 365 days a year. They now just have 4 brief 1- to 2-minute inhalation sessions and achieve significant therapeutic benefit.
We're really excited with the growth in Tyvaso revenues, which we've been sharing with you for the past few quarters, but the fact of the matter is, is that in terms of Class III patients, which is the label for Tyvaso, we are serving maybe about 20% of the patients. So we still have 4/5 of the way to go to achieve the peak revenue potential of Tyvaso among the pulmonary hypertension community. So again, a very, very exciting growth trajectory on Tyvaso.
And finally, let's talk about Remodulin. Notwithstanding the fact that it has been on the market for 9 years, as the numbers for this quarter demonstrate, Remodulin continues to be a strong growth story. The reason for that is simply that physicians have achieved great comfort with Remodulin. And we, as a company, have gone to every possible length possible to make Remodulin as convenient and tolerable for the patients as possible.
For example, originally, when we were delivering Remodulin subcutaneously, over 90% of the patients were reporting severe site pain subcutaneously. We delivered and obtained FDA approval for the intravenous route of delivery, which just about doubled the number of patients on Remodulin. Well, we don't want to count any chickens before they're hatched, but all signs are looking very positive that we will be able to achieve European authorization -- we're certainly optimistic about this -- by the end of this year for intravenous Remodulin in Europe. And our hope and expectation is that we can also double our number of European patients on Remodulin by having the intravenous route of delivery available as well as the subcutaneous.
Let me mention another point which is not often appreciated. Through years of careful work with the great physicians in this field, the physicians have learned that if the patients leave their subcutaneous Remodulin system in place for about 30 days, they only experience the site pain for the first 2 to 3 days, and most of the patients do not experience site pain for the rest of the month. As a result, more and more patients are saying, "Okay, I will step up to Remodulin. I understand that there'll be some site pain for a couple of days. But as long as I don't have to experience that for the rest of the month, I want this therapy," and the physicians want to give it to them. So a real hats off there to the physicians throughout the U.S. who have figured out a way to greatly extend the power, reach and convenience of subcutaneous Remodulin.
And when I said that we are leaving no stone unturned in making Remodulin available to more and more patients, we're now at over 50 patients between the U.S. and Europe who are actually using Remodulin through an implanted micropump that only has to be refilled once a month or, in some cases, once every 2 months by a visit to their doctor. All the rest of the days of the month, the patients do nothing with regard to their therapy, and the Remodulin pump works automatically.
Just one anecdote I cannot resist sharing is of the patient who could not go swimming, could not even go to the beach for years on Remodulin because she rightly feared getting a septic infection from having exposure to the seawater or to the sand. And after she got a Remodulin implanted inside her, after a week, she went down to the Gulf Coast and enjoyed time there at the beach and said she got her life back. And it’s just a wonderful therapy.
So here too, in the Class IV category of patients who are the natural users of Remodulin, I think there, too, we have a long way to go in terms of reaching peak revenue. Probably, we're only about half the way to peak revenue in that patient population. So Adcirca, Tyvaso, Remodulin, all tremendous growth stories, and the results of this quarter, I think, evidence that we are right on that growth trajectory.
Well, thank you for giving me a few moments to share with you some color behind the numbers. And let me now open up the phone lines to any questions.
[Operator Instructions] Our first question is from Geoff Meacham of JPMorgan.
Anupam Rama - JP Morgan Chase & Co, Research Division
This is Anupam Rama in for Geoff Meacham. I was just wondering if you could give us a quick update on the duration of therapy for Tyvaso.
Yes, great question. Because that is a clinical question, I'm just going to give you a brief one liner then ask Dr. Jeffs to provide you a little more color. But the one liner is that the duration of therapy on Tyvaso continues to increase quarter-over-quarter, which certainly is something else that augurs well for us growing up toward that 10,000-patient peak revenue potential for it. Roger, would you like to maybe give some specific kind of month count from the last data you may have available?
Roger A. Jeffs
Sure, Martine. Thanks for the question, Geoff. The last time we've tracked, we were approximating just north of 16 months. So really, Geoff, our goal is to continue to increase that number over time, and a couple of things will do that. One is proper selection of patients. We certainly want to make sure physicians are selecting patients for the drug that are appropriate. The second is management of any adverse events that could be dose limiting, such as cough. So some of that relates to dosing administration, particularly the initiation, going with a fewer number of breaths at the start of therapy. And then finally, it's about helping the patient manage the therapy and increase the dose over time and the number of breaths within the label as appropriate. So we spend a lot of time with continued education on patient selection and then dose initiation and then dose escalation over time, even for Tyvaso, just as we do for subcutaneous and intravenous Remodulin. And I think from those efforts, we've seen a very handsome increase in the average duration of patients on therapy, and we expect to see that continue over the next year. Our goal would be obviously to try to get that in the multiyear timeframe. And the other thing that would help that would be the earlier we could start Tyvaso therapy then the longer the duration of therapy would be. So that's a coincident effort that the sales and marketing team is making, and I think they're making tremendously good strides based on the data that I've just given you.
Thanks, Roger. Great answer. A little bit of further color, just to add to that, that John Ferrari just shared with me is that -- keep in mind that Tyvaso has only been on the market about 2 years. And yet, despite that fact, well something in excess of 500 patients have already been managed on it for over 2 years. So if it all augurs well for what Roger said that mean numbers are continuing to tick up.
Our next question is from Liana Moussatos of Wedbush Securities.
Liana Moussatos - Wedbush Securities Inc., Research Division
Can you give us the split between U.S. and Europe for Remodulin sales?
Sure. I'm going to just again mention kind of a highlight, kind of a broad-brush statement on that and then ask John to give a little bit more color on it in just a moment, but thank you for the congratulations, Liana. And the European business reflects Remodulin alone. Unfortunately that, as mentioned in my introductory remarks, reflects only subcutaneous Remodulin plus a little bit of the implantable Remodulin. And this is because our agreement with, Lilly [ph], for Adcirca, unfortunately, did not include the European Union. And with regard to Tyvaso, the European Medicines Agency requires us to do a second study. We were able to get approved on a single study in the U.S. We'll have to do a second study to get approved in Europe. Dr. Jeffs and his team, together with our German partner, NEBU-TEC, are working together to move forward on that second study to obtain European approval. I would like to -- I know you're very well aware of this, Liana, but just so everybody else knows, we do have 10-year orphan drug exclusivity for Tyvaso in Europe. It is a wonderful therapy. I mean, the differences between it and the only other alternative that one can even conceive of, which is inhaled iloprost, are like night and day, and that's just a black and white fact. Inhales iloprost has to be inhaled 6 to 8 times per day for 15 minutes duration. Maybe that can be cut down to 10 minutes, but unfortunately, the mean duration of people on that therapy is less and less the less they breathe it. So it's -- it really is a first-generation inhalation drug, Tyvaso being the second generation. So we're confident that Dr. Jeffs' team will be able to execute that study to the satisfaction of the EMA, and then we will be able to add all the Tyvaso revenues in Europe. And then as mentioned, we've been working for many years to satisfy the European concerns with regard to intravenous Remodulin in Europe. And again, just to refresh some people's deep history on this, we never did an actual full-blown clinical study for intravenous Remodulin. We were able to obtain approval in the U.S. by bioequivalence of intravenous Remodulin to subcutaneous Remodulin. In Europe, we never filed for approval for subcutaneous Remodulin with the European Medicines Agency. Instead, we went through the older country-by-country approach. Hence, the Europeans have some very reasonable bases for asking us to go this kind of slow and steady approach to get intravenous Remodulin approved there. However, we do feel that we are rounding the last lap and that, hopefully, that will be approved by December. And then our excellent teams over in Europe are excited about the prospect of being able to start marketing intravenous Remodulin there very soon. So let me -- with that kind of high level color, let me ask John to give you a quantitative answer to your question, Liana.
John M. Ferrari
Core sales for Remodulin still remain pretty consistent of 13% to 15% total Remodulin sales. So I mean, it's -- they're growing almost as nicely as the U.S. base and have been for last several years.
Thanks, John. That's great. And if I could just add a coda to that, John, we also have been diligently working in the past several years, the Japanese and the Chinese markets. With regard to the Japanese market, the best market information we have is that Flolan is about $100 million a year business over there. It’s had a protected market. It hasn't seen the shadow of Remodulin, but usually, where Remodulin does come in, the other prostacyclin drugs tend to kind of shrink away. And we're quite hopeful that within the next 18 to 24 months, we should have approval in Japan through our superb partner, Mochida Pharmaceuticals, over there in Japan. Mochida is the leader in orphan drugs such as Remodulin, and we could not ask for a better partner to introduce this. So I think there's definitely a solid $100 million a year potential for Remodulin over in Japan. In China, we have an agreement with Lee's Pharmaceuticals, which is a major force in drug distribution in China. Our application for approval in China has actually been accepted since our last conference call by the Chinese FDA or the SFDA. And the way things work in China, that actually is the more important step. So we may very well have approval in China even before we end up getting approval in Japan. And hence, Asia is a very important part of the company's future growth story. Thanks, Liana.
Our next question is from Robyn Karnauskas of Deutsche Bank.
Navdeep Singh - Deutsche Bank AG, Research Division
Navdeep in for Robyn. Just wondering, the Remodulin's quarter-over-quarter sales were pretty impressive, and I was just wondering what drove that growth and if there were any inventory fluctuations.
Well, thanks for your question. Thanks for the congratulations. As Chief Financial Officer and also head of all distributor operations, John Ferrari keeps a close eye on inventory issues, and I'll ask John to please address that.
John M. Ferrari
The inventory just went up by patient days just slightly, nothing unusual from what we've seen in the up and down fluctuation every quarter. So nothing material, nothing significant, nothing that would -- has given us any rising concern.
Navdeep Singh - Deutsche Bank AG, Research Division
Okay. Also, I just had a quick follow-up. You mentioned the Chinese market, and I was wondering if you could give some color around that, like what's the real opportunity? You gave some color on Japan. Just if you could elaborate a little bit more on China.
Yes. I think the opportunity is certainly no less than the Japanese opportunity in quantitative terms. Pulmonary hypertension has no demographic preferences. It afflicts all demographic groups equally. One of the most interesting cases in the pulmonary hypertension literature is when members of the Chinese People's Liberation Army will be repositioned up to Tibet at its high altitudes back in the '70s or '80s or so, there would be a striking increase in incidence of pulmonary hypertension. And that rings true to me, because when my own daughter -- what triggered her pulmonary hypertension was time spent up at around 7,000, 8,000 feet in Colorado. So for people who do have an underlying predisposition of pulmonary hypertension, high altitudes can trigger it, and that's certainly -- the Chinese was one of the first case studies of that. We know from our expert clinical investigators in China that there is a huge, unmet need for therapy for pulmonary hypertension. As I believe Dr. Jeffs shared with people during our FREEDOM conference call results, a significant number of patients in our FREEDOM trial were enrolled in China. And if you just take the basic demographics, if you've got, say, 30,000 diagnosed patients in the U.S., that's going to translate to a diagnosable 150,000 patients in China. Nowhere near 150,000 patients would need to be treated to have a revenue potential comparable to Japan. In fact, at U.S. pace -- at U.S. prices, only 1% of that number of patients would have to be treated to have the revenue potential equivalent to that of Japan. So I think that, that's a very solid revenue goal there.
Our next question is from Terence Flynn of Goldman Sachs.
Terence C. Flynn - Goldman Sachs Group Inc., Research Division
I just had 2 quick ones. The first was wondering if you could comment on your view of any potential impact that the introduction of GLEEVEC might have on Tyvaso. And then the second question, I was just wondering if you can give us an update on beraprost and your plans there.
Sure. Let me -- I'll take the beraprost question and ask Roger if you could take the GLEEVEC question, because that's more of a clinical trial interpretation based on their recently announced clinical trial results. So while Roger is gathering his thoughts on that, let me share with you where we are on beraprost. We are just now finishing up the second Phase II study for beraprost and, at the same time, preparing to enroll the first patient in the Phase III trial. One of our internal company goals is to enroll the first Phase III patient before the end of this calendar year. So the entire team is working pretty diligently to do that. We have all of the clinical trial material set forth. We've met with our steering committee. We've met with the FDA. Everybody is on board with what's called the time to clinical worsening endpoint. This would make beraprost the second-generation prostacyclin analog, one that carried a label of time to clinical worsening, improvement in time to clinical worsening rather than just improvement in exercise ability. So that does, on the other hand, mean that it's going to be a little bit of a longer study, somewhat similar to the Actelion studies of selexipag, I believe, is also a time to clinical worsening study. These tend to be larger studies and take longer. I believe we will end up having to enroll upwards of 500 patients, and so it's going to take upwards of 5 years to complete that study. In the meanwhile, though, since you got me on the subject of oral prostacyclin analogs, we are also working very hard -- a whole separate team of people in the company led actually by Dr. Jeffs is working very hard on our NDA for oral treprostinil. And that NDA is on schedule right now for first quarter 2012 submission, and we would hope to have a 10-month PDUFA date on that with the prospect for almost a full year of 2013 revenues on that. Dr. Rubin just presented the results of the FREEDOM study at the CHEST meeting being held with all the major pulmonary hypertension experts in Hawaii. I believe the presentation was very well received, and I think the consensus of physician opinion is probably that the prostacyclin drugs tend to get used a whole lot more in practice than the clinical trial results might imply, and we certainly saw that with Remodulin that was seen earlier with Flolan back in the earlier part of the last decade. So because with oral treprostinil, you have an opportunity for a -- to get the prostacyclin plant [ph] into a patient at the very beginning of their disease process -- we're pretty excited about that -- long before beraprost becomes available. So with that mini review of the oral prostanoids, both beraprost and treprostinil, Roger, can I turn it to you for giving us some insight and wisdom about the prospects of any impact that GLEEVEC might have on Tyvaso?
Roger A. Jeffs
Yes, certainly, Martine. So I think there was some noise around a GLEEVEC presentation in Europe in early September, where they showed use of GLEEVEC as second- or even third- or fourth-line therapy, I believe, was beneficial in terms of 6-minute walk distance. However, in that same study, the patients on active drug, those who received GLEEVEC, actually had a more prevalent chance of having time to clinical worsening. So you have a real paradox or a contradiction within the data set in that some patients may have walked further, but other patients actually worsened. And then I think, subsequent to that, there's another tyrosine kinase inhibitor I think from Bristol-Myers or some other company that actually has had the possibility of causing pulmonary arterial hypertension added as a risk factor. So from what I've heard, I don't think Novartis is going to file GLEEVEC as an indication that they've done the study. So the rumor is they're not going to do a subsequent study. And then if physicians choose to use it because it's already available on the market, then they can do -- they can so choose. Whether or not it's reimbursed, I don't know. My sense is, given the contradiction in the data set, that physicians will be very, very cautious about adding GLEEVEC to patients, and it will be limited to patients who are in extreme condition and in absolute right heart failure and refractory to all therapies, including Remodulin. So it's my sense or our sense that it will have very little if any impact on the prostacyclin franchise.
Thanks, Roger. Great answer.
And our next question is from Joseph Schwartz of Leerink Swann.
Joseph P. Schwartz - Leerink Swann LLC, Research Division
I was wondering if you could give us your thoughts on how much your prior experience getting subcutaneous Remodulin approved on the basis of pooled data for 2 studies, which did not hit pre-specified p-values, how much is that a precedent for oral Remodulin once as you head into that filing? And as a follow-up, do you expect to have orphan drug status any time soon, which could help make the case for approvability there?
Joe, thanks for those questions. I'm going to ask Roger to maybe provide you some thoughts about those 2 points.
Roger A. Jeffs
Sure. It's a great question, Joe. So there's 2 arms to the response to that question. So in the U.S., we don't think the subcutaneous precedent, which we're proud of, 2 studies with p-values slightly greater than 0.05, which is certainly what we've with our FREEDOM-C and C2 study. We actually don't think a combined analysis in the U.S. is needed to get oral treprostinil approved. And the reason is we feel that we're very closely near and, in fact, absolutely meet the guidance document, the 1998 guidance document on product approval for efficacy. And that's principally these 3 things, that it's an alternative dosage form to treprostinil. So once it's in solution, treprostinil diethanolamine, which is the oral salt form that's in the oral Remodulin, oral treprostinil, becomes treprostinil. So it's just -- the body sees the active pharmaceutical ingredient to be treprostinil, and we have, as Martine talked in terms of patient numbers, over 10,000 patients have been exposed to treprostinil. So we have a tremendous experience with treprostinil as an active pharmaceutical ingredient. Further, the labeling is in related use. We're not seeking labeling for a cancer indication, for example. This is for the same indication that Tyvaso and Remodulin are approved. That is in patients with pulmonary arterial hypertension, and then those other routes that certainly substantiate the use of oral treprostinil. And then finally, with intravenous, as Martine said, we did a bioequivalence study, and we actually didn't do a patient trial. Now oral treprostinil is not exactly bioequivalent, so we have conducted a clinical trial, which is the FREEDOM-M, and we have highly significant and clinically meaningful results which we think warrant labeling for frontline use, particularly as it meets all the 3 tenets of the guidance document. So I think we're in very good stead without the need to combine FREEDOM-C and C2. Now having said that, those studies are supportive. They do provide sufficient evidence that we cause no harm, and they have additional safety information. So that's the first arm, which is the U.S. In Europe, we actually are contemplating doing a combined analysis on C and C2 and presenting that to the Europeans because, as we sat down with Tyvaso, single-study approvals are a little bit more difficult because they don't have this guidance document that we can point to and lean on for precedence. So it may require exactly what you're suggesting, Joe, which is insightful, that we do combined analysis, C and C2. We're obviously doing that, and then we'll combine it with the favorable results we've seen in FREEDOM-M and ask for approval. And whether or not they approve it, we'll have to see, and then they may suggest that we do additional studies or not, but that's the approach we're going to take: one in the U.S., which I think is cut and dry, and one in Europe, which is a little bit more ambiguous.
Thanks, Roger. Thank you, Joe.
Joseph P. Schwartz - Leerink Swann LLC, Research Division
I'm sorry. Just as far as the -- it seems like orphan drug exclusively, that designation might give the FDA some more license for a flexible interpretation of the data. Is that in line with your thinking? Or -- and do you think that you'll have orphan drug status any time soon for oral Remodulin?
Roger A. Jeffs
Yes. So let me just answer that 2 ways. So I don't think we need orphan designation because we meet the tenets of the guidance documents. So I don't think it's required. Having said that, we are going to file an orphan application. It needs to be filed before we submit the NDA. So we will do that. That's being worked on concurrently. And will it help? Certainly, I think it emphasizes that this is an orphan disease. There remains unmet needs, and any incremental benefit is a positive one and one that would warrant approval. So it certainly won't hurt, and that's the approach we're taking. And it gives us other protections as well from an IP standpoint.
Thank you. Thank you very much. Roger, thanks for that great response, and operator, thank you for conducting the call. We will be attending several healthcare conferences over the coming months, and we look forward to seeing as many of you as possible in breakout sessions, one-on-ones and in the group session. Thank you very much.
Thank you for participating in today's United Therapeutics Corporation Third Quarter Earnings Conference Call. This call will be available for replay beginning at 11:35 today through 11:59 on November 10, 2011. This conference ID number for the replay is 16451381. The number to dial in for the replay is 1 (855) 859-2056 or (404) 537-3406. Thank you.
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