Good morning and welcome to the United Therapeutics Corporation First Quarter 2013 Earnings Call. My name is Ashley, and I will be your conference operator today. All participants will be in a listen-only mode until the question-and-answer session of this earnings call. After the company's remarks, there will be a question-and-answer session. I would now like to turn the conference over to James Edgemond, Chief Financial Officer of United Therapeutics.

Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation first quarter 2018 earnings call. Accompanying me today on the 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 are 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 on our earnings release available on our website at www.unither.com. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended to solely educate investors and are not intended to serve as the basis for medical decision making or to suggest that the products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website. Now, I want to turn the call over to Dr. Rothblatt for an overview of the first quarter 2018 business activities of United Therapeutics.

Thank you, James. Good morning, everyone. As James mentioned, I'm glad to also be joined on this earnings call for the first time, Mike Benkowitz, our President and Chief Operating Officer. After my introductory remarks, we'll open up the call to any questions. And if there are questions of a financial nature, I will ask that they'd be answered by James, our CFO. If there are questions of a commercial nature, I'll ask that they'd be answered by Mike Benkowitz as our President, and if there are questions of a clinical development type of nature, then I will handle those myself. Starting with our top line financial results for the first quarter of 2018, our quarterly revenues totaled $389 million, an increase of 5% year-over-year. Orenitram posted a fourth consecutive quarter of greater than 20% revenue growth on a year-over-year basis. In addition, we continue to treat an increasing number of pulmonary arterial hypertension patients with our prostacyclin product franchise, which consists of Orenitram, Remodulin, and Tyvaso, confirming our belief in the organic growth opportunity for these proven therapies. The sequential drop in our total revenues from the fourth quarter of 2017 reflects consistent historical patterns as our first quarter revenues tend to be either down or virtually flat when compared to the prior-year fourth quarter. This pattern reflects distributor purchases that are typically placed once a month based on current utilization trends and contractual minimum inventory requirements. As a result, quarterly sales of Remodulin, Tyvaso, and Orenitram can vary depending on the timing and magnitude of these orders and do not precisely reflect changes in underlying patient demand. Let's now transition to our pipeline, which currently has over 20 investigational programs, including therapies for PAH and other forms of pulmonary hypertension, drug delivery devices, gene therapy, oncology, and technologies…

Thank you. Our first question comes from Terence Flynn of Goldman Sachs. Your line is open. Terence Flynn - Goldman Sachs & Co. LLC: Hi. Thanks for taking the question. Martine, I think there was some new commentary in the Q about potential launch dynamics of the implantable pump. I think your – it sounds like Medtronic is limited to do about 100 pumps out of the gates and then maybe making some improvements upon that. Can you give us a little bit more details about kind of the process next steps and how to think about that ramp, as we look into 2019 and beyond? Thanks a lot.

Yeah. Terence, good to actually hear you on the phone. So, that's amazing. As far as the implantable pump program, I don't – I wouldn't get hung up on any limits or I can't give any credence to the numbers that you mentioned at all. What is the situation with the Medtronic pump is that we are awaiting approval of the second half of the NDA from the FDA and we expect that we should hear from the FDA by the end of July. Once that happens, Medtronic and us intend to rollout these pumps to every pulmonary hypertension patient that can benefit from it. And I do believe that that number is in the thousands and in the high thousands. The reason for that, Terence, is that the pump allows the treatment of the disease to be all but forgettable for the patients. There's nothing they have to do to prepare their infusions. They have no open wounds or painful marks on their skin, and the drug can automatically be delivered systemically providing them an ideal sort of PK-PD situation on treprostinil. The physicians are very, very happy with the drug. The patients are very, very happy with the drug. Now, there is a fair amount of intriguing research, although nothing that has ever been approved on a label to show that the earlier you start treating patients with a true prostacyclin, the longer the patient is going to live and this data has been presented at medical conferences like the American Heart, American Thoracic Society, going back to the early 2000s. The problem, Terence, is that it's been so difficult to provide a patient continuously bioavailables, in other words, zero-order delivery true prostacyclin that patients instead of starting on it at the very beginning of their disease, they…

Our next question comes from Geoff Meacham of Barclays. Your line is open.

Good morning. Thanks for taking the question, Martine. Good to hear your voice.

Thank you, Geoff, great hearing your voice as well.

So, let me ask you a question on Orenitram. When you look at the FREEDOM-EV study, it sounds like you may have data by year end. What would you characterize as the incremental PH patient that could go on assuming you have positive data? And is there a hurdle you think you have to hit in terms of time to worsening? Is it comparative to Actelion, or is it just a stat sig benefit? Thanks.

Yeah. Thanks, Geoff. Great question. You know because that really is kind of the commercial operations question in terms of who would be the patients that would most likely form the growing number Orenitram patients, as you heard, we're doing quarter after quarter after quarter after quarter of strong revenue growth on that, over 20% up every time year-over-year. But all that is great tribute to the med affairs and the reimbursement, there's global supply chain management, and last but not least the sales and marketing forces under Mike Benkowitz. So, Mike, could you answer Geoff's question for me?

Sure. Yeah. Thanks, Martine, and thanks for the question. Yeah, I think the – what we're seeing in the marketplace right now is the typical Orenitram patient tend to be your earlier diagnosed patients or patients that are early on in their disease state because they need the time to start on therapy, titrate up. And what we have found is starting those patients earlier when they have time to titrate up on therapy, they're able to manage the side effects better and just have – and just generally have better experience with the drug. And I think even without the clinical worsening label, we feel like we're getting a good share of those patients in relation to what J&J is seeing with Uptravi. I think the label – the benefit of the clinical worsening label will put us on par with Uptravi and I think will allow us to capture even a greater portion of those patients because we'll now have the same clinical worsening benefit in our label in addition to being really a true prostacyclin, and then having the ability to put patients on that prostacyclin earlier, titrate them up, and then as Martine about in her comments, as the disease progresses, easily transition them over to Tyvaso or Remodulin as they continue in their disease.

Excellent, Mike. Excellent. Excellent. Thank you, Geoff. And, operator, we're ready for the next question.

Great. Thank you.

Our next question comes from Hartaj Singh of Oppenheimer. Your line is open. Hartaj Singh - Oppenheimer & Co., Inc.: Yeah. Hi. Thanks for the question. I just want to see, Martine, if you could dig a little bit deeper into the scientific rationale going in Tyvaso and ILD, and then also in COPD and Orenitram in the heart failure, the Phase III studies. I mean what's the thought, the scientifics or rationale behind the mechanism of action of using treprostinil to go after these disorders? Thank you.

Thank you, Hartaj. Great, great question. So let's talk about the science between the – behind the INCREASE and the PERFECT studies, which are the ILD and COPD studies respectively and the science behind the SOUTHPAW study, which is the left heart failure study. So, given the limitations on the time on the call, let me in a sense drop to one kind of bottom line starting with the COPD and ILD. Treprostinil, Tyvaso is not on label for patients with these indications. And as you would expect, it's not an inexpensive therapy, and payers don't just like blindly push the pay button on Tyvaso. Every patient is carefully assessed by payers in ensuring that it's an appropriate patient that they're obligated to pay for and not being an experimental patient. Having said that, both through the efforts of our medical affairs group over the years in supporting investigator-sponsored studies and through the kindness and generosity of certain payers around the country who have gone ahead upon the initiative of their physicians were able to enable some WHO Group III patients to benefit, there were unmistakable signals to some of the leading physicians in this field. Mike called out one of them on the call, Dr. Waxman, but there are many others Who said to UT, this drug works. This, in fact – they believe that this drug works even better in that indication than in the Group I indication in terms of at least the exercisability that they saw in their patients, discounting any placebo effects that might be involved. So, with that kind of data, some of which has been presented in posters and maybe even publications, I don't know, but I've definitely seen posters, we went ahead and then had the statistics to power the study for…

Thank you. I'm being told that we have time for one more question.

Our last question comes from Liana Moussatos of Wedbush. Your line is open.

Thank you for taking my question and congratulations on your progress. You mentioned that the DEKA pump has been accepted by the FDA, a 510(k). And when do you think you can get it approved? Last call you said early 2019, is it on track for that?

Thanks, Hartaj – I mean, thanks, Liana. Sorry about that. Yes – so, let me, like, back up. I – whatever I said in the last call, I still think it is good. So, I'm not changing anything from the last call. The pump is a really fascinating piece of machinery, Liana. And the more I see it in operations, the more just kind of completely blown away I am by it. It's got virtually no moving parts, in fact, actually the pump itself has no moving parts. And I think of it kind of like a Tesla of pumps, like a regular car has something like thousands of moving parts, and a Tesla, I think they advertised it as 20 or 25 moving parts. So, of course, regular infusion pumps don't have thousands of parts, but they got a lot of parts. And just ask the poor patients who have to put all the pieces together every day or two on their table, take stuff like half a dining room table. But with the DEKA Unity pump, there are no moving parts due to the inventive geniuses of those folks. So, this is going to be a super cool device. Of course, we will ship it to the patients. We have the drug already supplied to eliminate the need for the patients to have any errors in the process of drug fill and also to buy back for the patient very, very valuable hours of their time which is, otherwise, spent on refilling these pumps. We also have the rights, Liana, to use this pump technology for additional drugs for other orphan diseases. And we have now begun a program in Parkinson's disease based on using the same pump technology, the same pumps actually. So, it's really a super exciting program. Of course, and as I mentioned in my introductory remarks, nobody can predict the FDA exactly and the FDA is going to make the decision. And I've been right sometimes. I've been wrong sometimes. So I'm not going to – like I don't make any more bets on these things. But I will say this, that you are looking at a sponsor, DEKA, that has successfully obtained FDA approval for every product that they have taken through the FDA, including some truly revolutionary products such as bioelectronics, prosthetic arms, class 3 medical devices. I mean very, very challenging approvals, dialysis machines for Baxter, multiple generations of those. So, this is an organization that definitely has, to my knowledge, a 100% success record at the FDA. I'm confident that they will take this through, and wow, believe it or not, United Therapeutics also has a 100% success record at the FDA because Remodulin, Tyvaso, Orenitram, Unituxin. So, I believe between the two of us I could not be more confident, Liana, that we'll be able to successfully launch this RemUnity pump. Exactly which month, who know, it's up to the FDA. But I stand by everything I've said before.

Thank you.

Thanks again, Liana. And operator, if you could please do your wrap-up comments.

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 1-404-537-3406 and using access code 5778455.