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. All participants will be in a listen-only mode until the question-and-answer portion of this earnings call. [Operator Instructions]. I will now turn the call over to James Edgemond, Chief Financial Officer of United Therapeutics. Sir, you may begin.

Thank you, Justin, and 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. Reconciliations 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 usage. 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.

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 the United Therapeutics as of the third quarter 2019. We're pleased with our financial results over the past quarter and 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. Petersen 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 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 perennial form of treprostinil which the brand name is Remodulin. And he was 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 pill…

Thank you sir. [Operator Instructions]. Our first question is going to come from Jessica Fye from JP Morgan. Your line is now open.

Hey there, good morning. Thanks for taking my question. 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 three different pumps to launch?

Yeah, thanks Jessica. You know everything is 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 timeline of the FDA. RemUnity the FDA filing is actually not done by United Therapeutics, it's done by Decca who is our pump partner, and the ISRs 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 one, two, three or two, three, one. But we do feel quite confident that all three will launch in the next 12 months. Next question operator.

Thank you our next question is from Martin Auster from Credit Suisse. Your line is now open.

Thanks for taking the question. Thanks for taking the question. On Remodulin Martine I'm curious in the early days of generics if you're seeing any sources of pressure all specific to kind of either Medicaid or Medicare or in commercial if there's relatively any one area where you're seeing more pressure more vulnerability for the franchise? And 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 could provide around that? Thanks for taking the question.

Sure Martin, 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. So I'm going to sort both questions to Mike as he has got overall authority on all commercialization…

Yeah, thanks Martine. So Marty when I went two full quarters out facing current competition and really have not seen a material impact to Remodulin business. For the second quarter in a row we achieved a record number of Remodulin patients on therapy. I think I mentioned in Q2 that we saw the highest number of new patient starts in almost 10 years and Q3 we didn't quite get that number. We came with it but just 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 peer pressure of note. I mean there's -- there are one off payers I think that with what they call dual Medicare Medicaid patients where we're seeing a little bit of pressure but it is such a small part of the business that it is 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 it's definitely I think where things sit with respect to your 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 get through that process. In the past we were doing the labeling and the packaging and sending it to them and so yeah, their orders are up relative to what they've been in the past just because they need more time for the labeling and packaging process.

Great, thanks Mike. Thank you so much. Operator next question please.

Our next question comes from Liana Moussatos from Wedbush Securities. Your line is now open.

Thank you for taking my question. What would be clinically meaningful for overall survival in DISTINCT for the six minute walk in increase and in increase why did you use six minute walk distance for primary endpoint instead of morbidity mortality?

Yeah, 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 -- oncology programs run by Dr. Golden who's is 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 end point study. So we are currently within a handful of patients from having a hard day at the survival end point and then being able 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 the next level of details below that.With regard to the six minute walk end point 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 for 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 other decline in their health status whether it's like not being able to walk around Wal-Mart or not being able to walk even to the mailbox and then not being able to walk up the stairs. So six minute walk is definitely a good FDA multiple time 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…

Our next question comes from Hartaj Singh from Oppenheimer and Company. Your line is now open.

Great, thank you everyone. Thanks for the question. Martine, I just want to ask you a little bit about Orenitram. I know it's on the commercial side so you and Mike you had indicated that now via the label expansion you'll be able to get 2X to 3X more patients. Can you just talk a little bit about what kind of patients would be more of the new patients, would be able to get from the prevalent patients although maybe some patients that might not have qualified before that can get on Orenitram would really appreciate it? And by the way congratulations on not having that generics apocalypse that supposedly was going to happen. Thank you.

Thank you so much Hartaj. Great hearing your voice this morning. Yeah, 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.

Yeah, thanks Hartaj. So I think -- Martine I think made in his opening comments that this is really sort of the first true launch. This is a really a true launch of Orenitram and I think that's accurate and that's certainly how we are thinking about it. If I think about the challenges that we've had in the marketplace with Orenitram prior to the EV label it's -- I think the number one challenge is doctors were 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 that answering that question definitively. If those early stage patients that'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 four to six month timeframe. And then at that point they sort of crossed the side effects hurdle so to speak. I'm starting to see the benefit of the drug and the doctors can titrate up accordingly based on how the disease is progressing.So I think in terms of the patient type that's really I think the sort of the number one 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, the other issue has always been sort of tolerability than side effect. And so I think by starting the right patient, giving them time to titrate up we're really solving two problems with the drug. And so I think because of that we now have doctors understanding that okay, now I understand where to…

Mike, thanks. That is such a great explanation. Thank you for letting all of that out. So to wrap up here we're very excited to have now crossed 7500 patients. Once you cross 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 is now as I hope everybody can see from the explanations given during the call very much reasonable within our sites to next walk on to the goal of 10,000 patients on treprostinil. And this can be done, one is Mike explained with the growth objectives for Orenitram thanks to the EV label. Secondly, as I mentioned in the introductory remarks, with a three new look transformative to proximal prudential delivery systems, 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 use drug deliver device with a ten fold larger population and it seems to me that 10,000 patients on treprostinil is a very readily achievable, reasonable growth 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 the JP Morgan in just a couple of months to come. Operator you can wrap up the call.

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.