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Edited Transcript of UTHR earnings conference call or presentation 30-Oct-19 1:00pm GMT

Q3 2019 United Therapeutics Corp Earnings Call

Silver Spring Nov 4, 2019 (Thomson StreetEvents) -- Edited Transcript of United Therapeutics Corp earnings conference call or presentation Wednesday, October 30, 2019 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* James C. Edgemond

United Therapeutics Corporation - CFO & Treasurer

* Martine A. Rothblatt

United Therapeutics Corporation - Founder, Chairman & CEO

* Michael I. Benkowitz

United Therapeutics Corporation - President & COO

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Conference Call Participants

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* Hartaj Singh

Oppenheimer & Co. Inc., Research Division - Research Analyst

* Jessica Macomber Fye

JP Morgan Chase & Co, Research Division - Analyst

* Martin Douglas Auster

Crédit Suisse AG, Research Division - Research Analyst

* Vasiliana Vireen Moussatos

Wedbush Securities Inc., Research Division - MD of Equity Research

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Presentation

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Operator [1]

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Good morning, and welcome to the United Therapeutics Corporation Third Quarter 2019 Earnings Call. My name is Justin, and I will be your conference operator today. (Operator Instructions)

I would now turn the call over to James Edgemond, Chief Financial Officer of United Therapeutics. Sir, you may begin.

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James C. Edgemond, United Therapeutics Corporation - CFO & Treasurer [2]

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Thank you, Justin. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation Third Quarter 2019 Earnings Call. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairman and Chief Executive Officer; and Mr. Michael Benkowitz, our President and Chief Operating Officer.

Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Form 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements.

Today's remarks may also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles. Reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release available on our website at www.unither.com.

Today's remarks may discuss the progress and results of clinical trials and other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for these products is available on our website.

Now I will turn the call over to Dr. Rothblatt for an overview of our third quarter 2019 financial results and business activities of United Therapeutics.

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Martine A. Rothblatt, United Therapeutics Corporation - Founder, Chairman & CEO [3]

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Thank you, James. Good morning, everybody. As James mentioned, I'm pleased to be joined today by our President and Chief Operating Officer, Mike Benkowitz, and he and James and I will answer questions after I give a brief business overview of United Therapeutics as well as the third quarter 2019.

We're pleased with our financial results over the past quarter, and I -- they're available in the press release. But on every metric, we're very pleased with how everything came out.

Let me give a bit of an overview now on some of the exciting business progress going on at United Therapeutics. Last month, my colleague, Dr. Peterson, reported the FDA approval of our new label for Orenitram. This was really a signal accomplishment for United Therapeutics. It's something that we worked on steadfastly for just about a decade. And for those of you who are kind of pulmonary hypertension geeks or are really into the deep history on the drugs used to treat pulmonary hypertension, it's interesting that even though the active pharmaceutical ingredient in Orenitram, treprostinil was discovered by the Nobel laureate, Sir John Vane. He himself did not believe that this API would be able to be successfully developed as an oral treatment that could reduce the rate of progression of pulmonary hypertension, much less reduce outright morbidity or mortality. And he was a great guy. Unfortunately, he passed, but it was, thanks to him, that we developed our parenteral form of treprostinil, which the brand name is Remodulin, and he was a spot on correct that, that would be a highly effective treatment for patients with pulmonary hypertension.

But it's kind of a little bit of like a pinch-me moment when you have a Nobel laureate thinking that this is just not going to be able to work as a PO. And you slug away for 10 years, and during the course of that 10 years, you're always thinking, "Geez, maybe Sir John was right, maybe Sir John was right," and then you end up with this absolutely beautifully executed FREEDOM-EV study with the excellent results that we shared with everybody last year, and then we're still crossing our fingers up until we get the final FDA stamp of approval on the results, which occurred just earlier this month. So that was really I think beyond the result -- beyond the doubt not only that signal result of -- since our last earnings call, but also of 2019.

I really personally believe that due to the great label that the FDA approved on Orenitram, that over the next 2 to 3 years, we're going to able to double the number of patients that we have on Orenitram and then actually be able to double that, again, in the following 2 to 3 years after that.

So it's a really good outlook for Orenitram, thanks to this accomplishment of our new greatly expanded label for that product.

Now there is some other really good things that are coming up in the approval category. During the next 12 months, and frankly, we've never had a greater perspective news flow for United Therapeutics than we do in the next 12 months.

In the next 12 months, we hope for and expect there to be no fewer than 3 new approvals for United Therapeutics out of the FDA. First, the one that we have also been working on for just about 10 years, the ISR, Implantable System for Remodulin. We hope to get the final approvals for that. As those of you who have been following us for a while know, actually it's -- United Therapeutics already got its approvals from the FDA, and we're waiting for the final Medtronic approvals before we could commercially launch that project.

Second up, we expect to get FDA approvals needed for the commercial launch of RemUnity. Also for those of you who've been following us, we actually did get an initial 510(k) approval on RemUnity, and we're just waiting for a final approval on a kind of special 510(k) or regulatory analog of that, that we would expect in the next 12 months, that would be truly transformative for the patients on subcutaneous Remodulin. And then third, we expect, within the next 12 months, to have an FDA approval for Trevyent. That's the project that we acquired along with the acquisition of SteadyMed.

This one is going to be transformative for a very large segment of the pulmonary hypertension population, especially that segment that suffers from connective tissue disease. And there's a whole spectrum of connective tissue disease state such as scleroderma and Raynaud's disease. And all of these kind of conditions, they make it very difficult for patients to activate the tiny buttons that we have on all of our devices.

So I think that, that one being so simple, no buttons involved for the patients to have to adjust the dosage or anything like that, truly just a plug-and-play system. I believe that Trevyent, together with RemUnity, is going to allow us to significantly expand the reach of subcutaneous Remodulin patients well beyond the number of patients that we have already been able to help and serve with that product.

Speaking of number of patients that we're helping and serving, I hope my colleague, Mike, won't be angry with me for stealing his thunder a little bit, but we are now serving more patients with treprostinil than we have ever served in the history of the company. So it's really a great launching point for 2020 because, here, we are serving more patients than we've ever served before. And we are on the cusp of launching in the next 12 months, not to mention the true launch of Orenitram with a new label, so really 4 new products, each of which have an ability to significantly expand the number of patients that can be served by the treprostinil family of products here at UT.

So on the FDA approval front, I think, things could not be going better. But let's take a look at what's going to come next after these approvals.

So we have also found ourselves in a very good position because of all the stage work and seed planting that we've done over the past few years to harvest 2 unblindings in the next -- coming quarter, by that mean -- by that, I mean the first quarter of 2020. We expect to unblind, first of all, our distinct study of Unituxin or dinutuximab for our small cell lung cancer. That's really exciting because right now, we've been able to serve, roughly speaking, about 1,000 patients with Unituxin. Those are the patients suffering from neuroblastoma. But the small cell lung cancer patient population is in the tens of thousands. It's really an order of magnitude more than we're able to serve with -- in neuroblastoma. So we're really, really hoping for a positive unblinding of Unituxin, dinutuximab in the first quarter. And then upwards set us on a course of FDA filings and then launch within a year after that to a tenfold larger population than we're able to serve with -- in neuroblastoma.

And then another very similar story, but different disease state. We will we unblinding our INCREASE study, and this is of Tyvaso in Group 3 pulmonary hypertension.

This is a group of patients characterized by interstitial lung disease and pulmonary fibrosis. A group of patients that payers will not approve the use of Tyvaso in this patient population today because they have very different characteristics. They are, for example, not cardiac catheterized, which is definitely a checkmark that payers require before reimbursement for the drugs in the Group 1 idiopathic or secondary pulmonary hypertension population.

So this population is also 10x larger than the number of patients that we're able to serve with Tyvaso today.

So it's a very analogous parallel situation with the cancer situation, where we've got a great drug, Tyvaso, similar to a great dug, Unituxin, able to serve single-digit thousands of patients, doing very well with those. And now we'll be able to unblind, in the next quarter, basically the same drug, so very much reduced risk in terms of the regulatory process, but for a patient population that's 10x larger than the one that we're already serving.

So again, very, very sweet situation with those 2 unblindings in the first quarter.

Let me just wrap up with kind of a flyover of the deeper pipeline just because we've got so much exciting stuff going on in the current 12-month pipeline. But there is upcoming a IND filing to begin the formal clinical development of our once-daily formulation of Orenitram.

There will be a movement right through the IND or just thereabouts for RemoPro. That will be the much less painful or painless form of Remodulin, again, certainly a game changer in subcutaneous treprostinil because of its ability to greatly mitigate, and for some patients, eliminate the site pain. The very exciting TreT program, which we've done in combination with Mannkind, where we're able to reduce the burden associated with Tyvaso to something that is truly de minimis, fits right in like a clutch purse or just a little -- even a jean pocket and really liberate thousands and thousands of patients from one of the burdens of dealing with drug delivery systems for pulmonary hypertension.

That program is going very well, also being managed by Dr. Peterson and patients already being dosed. The PERFECT trial of Tyvaso in COPD, this is a trial that we're very grateful to Dr. Waxman leading the way with his early proof of concept of the excellent results of Tyvaso in the very large and oftentimes difficult to treat COPD population. So that program is being run by our one biotechnology unit, and also proceeding straightforward with patients already being enrolled. Again, just to be clear, that's also a Phase III trial.

Our humanized form of dinutuximab, we're not resting on any laurels with the good results of Unituxin. And thanks to a great partnership we entered into with St. Jude Medical, we've been able to in-license the rights and now begin manufacturing a humanized form of dinutuximab. This might be delving a little bit into the uber geekiness, but I am personally very proud as I'm kind of a manufacturing geek myself, there were like multiple-fold improvements in the efficiency of our production of that humanized monoclonal. So hats off to our totally awesome biologics and manufacturing group.

And last, but not least, very, very exciting progress on the Xeno-Kidney front. We will open up, in the next quarter, the company's first designated pathogen-free facility for Xeno-Kidney. The acronym for that is called a D, delta; P, pafa; F, foxtrot; DPF. And what that means is that the kidney is being produced in a pig in that facility in a way that the FDA agrees the organs from that pig can be put into a person.

The FDA does not allow you, and thank goodness for that, just taking any former job pig's organs and put them into a person. They are very, very strict that you have to have a completely still environment just as you would have for any other drug or biologic that you're putting inside a person.

So a Xeno-Kidney is just a giant biologic, and there are very strict rules in terms of every aspect of infection testing and C-sectioning in of the genetically modified pigs for those organs to end up being tested in man.

So that facility will come online in 2020 and then pave the way for us to be able to actually, with FDA approval, accomplish the first-in-man of our xenograft in the 2021, 2022 time frame. So I've probably gone a little bit over my allotted time period, I guess, a bit by 5 minutes. But in any event, I'm so excited about all the stuff going on in UT.

So operator, if you can please open up the phone lines, and I will sort the questions to Mike and James.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question is going to come from Jessica Fye from JPMorgan.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [2]

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I was hoping you could elaborate on the earlier pump comments. I guess, specifically, can you help me understand the timing and order in which you expect those 3 different pumps to launch?

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Martine A. Rothblatt, United Therapeutics Corporation - Founder, Chairman & CEO [3]

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Yes. Thanks, Jessica. Everything's up to the FDA. So it's really difficult to be precise about that. You can be -- the Trevyent is one that I think you can follow from the PDUFA time line of the FDA. RemUnity, the FDA filing is actually not done by United Therapeutics, it's done by DEKA, who is our pump partner; and the ISR, as I mentioned in my opening remarks, it's also -- it's a Medtronic product.

So I wouldn't want to really fine tune it so much as to like line them up as 1, 2, 3 or 2, 3, 1, but we do feel quite confident that all 3 will launch in the next 12 months.

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Operator [4]

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Our next question is from Martin Auster from Crédit Suisse.

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Martin Douglas Auster, Crédit Suisse AG, Research Division - Research Analyst [5]

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On Remodulin, Martine, I'm curious, in the early days of generics, if you're seeing any sources of pressure at all, specific to kind of either Medicaid or Medicare or in commercial, if there is relatively any one area that you're seeing more pressure, more vulnerably for the franchise? And then also the ex-U. S. Remodulin sales, I noticed those were up pretty sharply from 2018 to 2019 year-to-date. Just curious if there was any color you guys can provide around that?

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Martine A. Rothblatt, United Therapeutics Corporation - Founder, Chairman & CEO [6]

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Sure, Marty. Nice to hear your voice this morning. I'm going to sort those questions, the first one to Mike as he has overall authority -- both questions to Mike, sorry, I'm going to sort both questions to Mike, as he's got overall authority on all commercialization matters at UT.

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Michael I. Benkowitz, United Therapeutics Corporation - President & COO [7]

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Yes. Thanks, Martine. So, Marty, we're now with -- I guess 2 full quarters in and facing competition and really have not seen a material impact to Remodulin business. For the second quarter in a row, we've achieved a record number of Remodulin patients on therapy. I think I mentioned in Q2 that we saw the highest number of new patients starts in almost 10 years. And Q3, we didn't quite hit that number, we came just by -- came a few prescriptions short.

So we're really pleased with how things have evolved in the face of generic competition.

We really have not seen any clear pressure of note. I mean there is -- there are one-off payers, I think, that these -- what they call dual-eligible Medicare-Medicaid patients, where we're seeing a little of pressure, but it's such a small part of the business that it's really not material in the grand scheme of things. And beyond that, there's really just, at this point no pressure -- no payer pressure of note. So that's actually, I think, where things sit with respect to the first question.

Second question, on the international business, we have -- similar to the U.S., we actually have seen nice uptick in demand, patient demand, prescriber demand for Remodulin outside the U.S. The other thing that's happened I think is the change in our relationship with Ferrer that happened over the last 12 to 18 months or so. So they've taken on more responsibility for labeling and packaging of our product. As a result of that, their orders are up because it takes them more time to go through that process. In the past, we were doing the labeling and the packaging and sending it to them. And so their orders were up relative to what they've been in the past because they need more time to get through our labeling and packaging process.

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Martine A. Rothblatt, United Therapeutics Corporation - Founder, Chairman & CEO [8]

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Great. Thanks, Mike. Thank you so much.

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Operator [9]

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Our next question comes from Liana Moussatos from Wedbush Securities.

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Vasiliana Vireen Moussatos, Wedbush Securities Inc., Research Division - MD of Equity Research [10]

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What would be clinically meaningful for overall survival in DISTINCT and for the 6-minute walk distance in INCREASE? And in INCREASE, why did you use 6-minute walk distance for a primary endpoint instead of morbidity, mortality?

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Martine A. Rothblatt, United Therapeutics Corporation - Founder, Chairman & CEO [11]

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Yes. Thank you, Liana. Nice to hear your voice this morning. With regard to DISTINCT, I'm actually not really qualified to answer that question. It's the -- our oncology programs run by the Dr. Golden, who's not on the conference call this morning. So I'm going to punt on the detailed answer to that question other than to say, it is a survival endpoint study.

So we are currently, within a handful of patients from having the survival endpoint and then we needed to unblind and see the difference between the non-dinutuximab-treated and the dinutuximab-treated group. All of those patients have, of course, had their conventional therapy treatment for their cancers.

But beyond just mere survival, I'm just not up to speed on maybe next level of details below that.

With regard to the 6-minute-walk endpoint for INCREASE, the reason for that is, I would say twofold. First of all, 6-minute-walk has long been the gold standard for measurement of whether or not somebody has obtained an improvement in their clinical status with pulmonary hypertension.

For those of us who are around pulmonary hypertension patients a lot, you hear all the time that their inability to do simple matters of exercise is the bellwether sign of a decline in their health status, whether it's like not being able to walk around Walmart or not being able to walk even to the mailbox and then not being able to walk up their stairs. So 6-minute-walk is definitely a good FDA multiple-time-left endpoint for pulmonary hypertension.

Secondly, because there are no other treatments available for the patients with interstitial lung disease and pulmonary fibrosis, there was no need to have a mortality or morbidity or combined mortality-morbidity endpoint as there is in Group 1 pulmonary hypertension, where there's upwards of a dozen different approved therapies and one wants to have the high mark in terms of -- the highest possible mark in terms of your data, which is what we were able to achieve with FREEDOM-EV.

So it's kind of a -- it's really 2 completely different markets. There is -- we've done a lot of research on this. There's very, very few patients with -- in the Group 3 who are treated with any of the drugs approved for Group 1 for the reasons that I said before. It's just not something that has been proven to work. In fact, it's something, if you're treating the patients in Group 3 with a systemic drug, like a parenteral drug or a oral drug, it's actually contraindicated in most people's points of view due to the occurrence of perfusion-ventilation mismatch. So it's something that can only be treated with an inhaled drug. And now you come down to just 2 inhaled drugs, iloprost and Tyvaso. And as good as United Therapeutics is at helping patients get reimbursement for their drugs, the payers say, this drug has not been approved for Group 3. And we're not going to pay for it.

So unfortunately, many, many patients in this category, today, have a foreshortened lives and foreshortened qualities of life due to the absence of any drug, at all, approved for the treatment of their condition. So as the first one, it's no real sense to like leap further than you have to go, and jump higher than you have to go. Getting Tyvaso approved for this population will be huge. And as I mentioned, there will be a tenfold increase in our addressable market population for Tyvaso.

So we want to do that as quickly as possible, with as lowest risk as possible and the 6-minute-walk distance was kind of the most logical way to achieve that.

Thanks, Liana.

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Operator [12]

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Our next question comes from Hartaj Singh from Oppenheimer & Co.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [13]

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Martine, I just wanted to ask you a little bit about Orenitram. I know that's on the commercial side. So maybe, Mike, you had indicated that now would be a -- the label expansion, you'll be able to get 2, 3x more patients. Can you just talk a little bit about what kind of patients would these be? More of the new patients, would be able to get some of the prevalent patients? Are there may be some patients that might not have qualified before Orenitram that can get on that? Or on Orenitram now? I would really appreciate it. And by the way, congratulations on not having that generics apocalypse that supposedly is going happen.

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Martine A. Rothblatt, United Therapeutics Corporation - Founder, Chairman & CEO [14]

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Thank you so much, Hartaj. Great hearing your voice this morning. Yes, we really -- we feel the love on that one so thank you so much. I'm going to bounce the Orenitram growth trajectory question over to Mike.

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Michael I. Benkowitz, United Therapeutics Corporation - President & COO [15]

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Yes. Thanks, Hartaj. So I think, Martine mentioned, I think, in his opening comments that this is really sort of the first true launch. This is really a true launch of Orenitram. And I think that's accurate and that's certainly how we're thinking about it. And if I think about the challenges that we've had in the marketplace with Orenitram prior to the EV label, it's -- I would say, the #1 challenge is doctors who are really trying to figure out where -- what's the right patient to use Orenitram.

And I think the nice thing about the EV study is it answered that question definitively. It's those early-stage patients, it's your functional Class 2 patients that are starting to be symptomatic and where you're going to have time to start them on a low dose, titrate them up slowly, help them manage their side effects and get to a therapeutic dose in a sort of a 4- to 6-month timeframe.

And then at that point, they sort of cross the -- they've crossed the side effects hurdle, so to speak. They're starting to see the benefit of the drug and then the doctors can titrate up accordingly, based on how their disease is progressing. And so I think in terms of the patient type, that's really, I think, the sort of the #1 thing that we've been able to answer with respect to the EV study.

And then part and parcel of that, as I mentioned is, we're -- the other issue has always been sort of the tolerability and upside effect. And so I think by starting the right patient, giving them time to titrate up, we're really solving 2 problems with the drug. And so I think because of that, we now have doctors understanding that "okay, now I understand where to use the drug, now I understand how to use the drug." It will take a little bit of time because doctors that have historically believed in the drug, and this really confirmed their belief in the drug and how they're using it, and hopefully, we'll see them put more patients on therapy.

Doctors that had maybe a poor experience with Orenitram in past, we know, are taking a look. I mean, I was at CHEST last week and talking to several doctors that have said either they have already taken another look at Orenitram based on the EV data or certainly are planning to. So I think, generally, they're impressed with the data, and it's bringing those doctors back to take a second look at the drug. I think the other place that we're going to use -- we're going to see this use, and we have seen this use, are patients that have been on Remodulin for some period of time, have started to stabilize and actually improve in functional class and the patients want to get off the pump. And so we have data from several years ago that talks about how patients can successfully transition from Remodulin to Orenitram. And they have done well over the long term, and we're looking at some other ways -- other studies that would further reinforce that. And so for patients that maybe aren't in that Functional Class -- Functional Class II category or maybe more Functional Class III, and they are sort of tweeners between, I'd say, do you start them on Orenitram, do you start them on Remodulin and maybe Tyvaso is not the right answer for them. You could potentially start them on Orenitram for, say, 30 to -- sorry, start them on Remodulin for 30 to 60 days, get them up to a dose and then quickly switch them over to Orenitram.

So again, I think what the EV label does, it really just kinds of open up -- really opens up the range of possibilities for where to use the drug. But I think to your original question, the main -- I think the main question to answer is, what's that early-stage patient look like that's the ideal candidate for Remodulin.

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Martine A. Rothblatt, United Therapeutics Corporation - Founder, Chairman & CEO [16]

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Mike, thanks. That is such a great explanation. Thank you for laying all of that out.

So to wrap up here, we're very excited to have now crossed 7,500 patients on treprostinil. This has been a goal for our company for quite a while. And I really want to salute Mike and the entire commercialization, compliance, medical affairs teams that have been absolutely essential to accomplishing that goal.

And I think it's now -- as I hope everybody can see from the explanations given during the call very much reasonable within our sites to next lock onto the goal of 10,000 patients on treprostinil. And this could be done; one, as Mike explained, with the growth sector for Orenitram, thanks to the EV label; secondly, as I mentioned in the introductory remarks, with the 3 new transformative treprostinil parenteral delivery systems, the ISR, RemUnity and Trevyent; and then finally, with the current BREEZE trial that we have going on with TreT and the MannKind product, you combine that with, hopefully, a successful unblinding increase and opening up a very small, easy-to-act, easy to -- drug-delivery device with a tenfold larger population of Group 3. And it seems to me that 10,000 patients on treprostinil is a very readily achievable, reasonable goal for our company to set out for ourselves, and we have done that.

So thanks so much for joining us this morning. And we look forward to seeing many of you certainly at J.P. Morgan in just a couple of months to come. Operator, you can wrap up the call.

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Operator [17]

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Thank you. Thank you for participating in today's United Therapeutics Corporation Conference Call. A rebroadcast will be available for replay for one week by dialing 1 (855) 859-2056, with international callers dialing in at 1 (404) 537-3406, using the access code 7462119. Thank you.