Good morning, and welcome to the United Therapeutics Corporation First Quarter 2022 Earnings Webcast. My name is Abby, and I will be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question and answer portion of this earnings call. If you would like to ask a question during that time, simply press star and the number one on your telephone keypad. If you would like to withdraw your question, simply press star, then the number one again on your telephone keypad. I will now turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Thanks, Abby, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation First Quarter 2022 Earnings Webcast. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, and Pat Poisson, our Executive Vice President of Technical Operations, and Dr. Leigh Peterson, Senior Vice President of Product Development. 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 Forms 10-K and 10-Q, contain additional information on these risks and uncertainties, and we assume no obligation to update these forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products, and 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 the products are available on our website. Now I'll turn the broadcast over to Dr. Rothblatt for an overview of the first quarter of 2022 financial results and business activities of United Therapeutics. Dr. Rothblatt. Thank you, Dewey, and good morning, everyone. Welcome to our first quarter of 2022 financial results call. In my opinion, this is the best quarter we have ever reported, considering not only profits, patients, and our contributions to our planetary community. At $462 million in revenues, we are now on the cusp of a $2 billion revenue run rate. This is a major milestone achievement for us. This $2 billion revenue run rate is what we expect based on the strong trends that are evidenced in this quarter as well as what we expect in coming quarters. Importantly, we see strength across our entire product portfolio. As a public benefit company, we focus on three P's, profitable cash flow, patient care, and planetary community. With respect to profits, that approximately $2 billion revenue run rate was accompanied by nearly $0.25 billion in quarterly profits. We are making more money than we spend, which is one of our key financial metrics. With respect to patient care, we are spending a lot. Seven phase III studies are underway. A new phase I study in RemoPro is just starting. An exciting phase IV study called ARTISAN, designed to prove that strong dosing on Remodulin followed by a rapid switch to Orenitram allows patients long-term good results for their treatment of pulmonary hypertension. They will be able to live with pulmonary hypertension more than die from pulmonary hypertension. Finally, with respect to our planetary community, we continue to lead by example with zero- carbon healthcare facilities that are among the best in our entire industry. For example, our clinical development operations work in the world's largest site zero carbon building in Silver Spring, Maryland. We are now building a first of its kind, zero carbon footprint pharmaceutical inventory warehouse in North Carolina to store our ever-expanding production of pharmaceutical intermediates and pharmaceutical products. Speaking of products, I think that is a good opportunity for me to pass the baton to our President and Chief Operating Officer, Michael Benkowitz. Thanks, Martine, and good morning, everyone. In the first quarter, we continued our trend of year-over-year revenue growth, and we saw the highest quarterly revenue for Tyvaso as well as our overall treprostinil business. I'd like to dive into the underlying performance of our three treprostinil products: Tyvaso, Remodulin, and Orenitram. As usual, I'm gonna focus more on our patient metrics, and I'll remind everyone that our quarterly treprostinil revenue does not always track exactly with quarterly underlying patient demand due to specialty pharmacy ordering patterns. Starting with Tyvaso, we increased our active patients to about 4,400 as of the end of the first quarter, putting us approximately halfway toward the goal we set last year of doubling the number of Tyvaso patients from 3,000 to 6,000 by the end of this year. As I do in every setting like this, I wanna remind everyone that achieving this goal assumes no COVID-related impact to healthcare practitioner access and patient initiation of therapy, and the path to doubling will not be linear. Uptake in January and February was a little more gradual than in prior months. This is not atypical for a serious chronic life-threatening condition where doctors want to be extra cautious about adding therapies. Having said that, in March, we saw a nice acceleration of patient additions with historically strong referrals and new starts along the lines of what we saw in Q2 and Q3 of last year, and this momentum has continued into April. Our continued path to 6,000 patients will be aided by three factors. First, assuming approval later this month, the launch of Tyvaso DPI, which we believe will expand Tyvaso's use in both Groups One and Group Three pulmonary hypertension for the reasons I mentioned earlier. The recent CMS coverage update to include Tyvaso for PH-ILD, that's our second factor. Despite the availability of our patient access programs for Medicare patients before a coverage decision, we are aware that many physicians were waiting for a CMS coverage decision before referring their PH-ILD patients on Medicare for Tyvaso therapy. Third, continued growth in the Tyvaso prescriber base, particularly among ILD treaters. As I've mentioned on prior calls, many of these physicians have been on the front lines treating COVID patients. Now that COVID cases and hospitalizations hopefully seem to be on the decline, and with Tyvaso DPI and a CMS coverage decision, we expect to see more growth in prescriptions from these physicians over the next few quarters and beyond. Moving to Orenitram, we saw yet another quarter of record patient counts as of the end of the first quarter. As we've discussed before, we believe this uptick is driven by the FREEDOM-EV label expansion now that we're able to have more robust interactions with prescribers about the data. Finally, moving on to Remodulin. In the first quarter, we saw the highest level of Remodulin referrals since 2014 and relative resilience and stability in the business despite the launch of a subcutaneous form of generic treprostinil last year. The relaunch of the Remunity pump is proceeding well, and we're accepting referrals for starting patients on Remunity, and we've been doing that since about mid-March. We expect Remunity starts to pick up through the balance of the year and into 2023. To wrap up, we're pleased with the continued momentum in the Orenitram and Remodulin business and progress with Tyvaso and PH-ILD. Expected second quarter events such as CMS coverage in PH-ILD, the Tyvaso DPI launch and approval, not to mention the INCREASE buzz around PH-ILD we're seeing at HCP conferences, particularly now that these are in person again, have us well positioned to achieve our 6,000 patient goal by the end of the year. With that, I'll turn the call over to Martine to quarterback answers to your questions. Thanks so much, Mike. That was perfect. Operator, you may open the lines. Thank you. At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad, and we'll pause for just a moment to compile the Q&A roster. We will take our first question from Eun Yang with Jefferies. Your line is open. Thank you very much. Yeah, great quarter. Question on Tyvaso DPI. As we await FDA approval, once approved on time, what do you think the conversion rate to DPI from Tyvaso would be? Whether you think that it's gonna just help to expand into new patients. Thank you. Thanks so much, Eun. Nice to hear your voice after it's been a while since we've been able to see each other face-to-face, so thanks for dialing in. That question is something that I think on this call, Mike would have the most details and ability to address. Mike, can you give us a response on that one? Sure. Happy to. Yeah, I think what you'll see is you'll see this play out over a little bit of time. As I said in my opening remarks, you know, we're dealing with chronic life-threatening diseases here, and I think patients or, I'm sorry, physicians and patients can be a little bit cautious in terms of switching therapy, switching delivery devices, what have you. We do see and we hear a lot of excitement among both physicians and patients for the Tyvaso DPI. So we do believe that there will be a lot of interest in switching over to Tyvaso DPI. I think as this plays out, as we expand the use of Tyvaso into Group One and Group Three, over time, you know, my estimate is that we'll probably see somewhere around 60% of the patients on Tyvaso DPI and about 40% on the nebulizer. I'd say that's. I think that's a pretty good estimate for Group One. I think Group Three may be a little bit more 50/50 just because of the disease we're talking about and the severity and some patients, for whatever reason, may decide that the nebulizer is a better option for them than the DPI. Thanks, Mike. You know, Eun, just to give you a little bit more color. As you know, my daughter has pulmonary hypertension, so I meet with a lot of parents and even their adult children with pulmonary hypertension. I'm astonished actually that when I have a lunch or something with them, one of them will tell me that their daughter or their son is still taking Flolan from the old legacy pump, you know, which weighs as much as, you know, maybe a small brick. You know, not a fat brick, but a small brick. You know, we're just talking and I'm obviously not selling, I'm just talking, you know, parent to parent. I say, like, you know, there are much smaller devices available and ones that can go subcutaneously and you know, I'm just, you know, I know you're aware of this, you know, I'm just curious, you know, why your daughter or son has never transitioned. They always give the same answer, which is very resonant with what Mike just said. They said, "You know, this has kept our child alive. This, you know, legacy Flolan, you know, brick, if you will, you know, has kept our daughter alive or kept our son alive, and we just don't, you know, if it's not broken, we don't wanna fix it." So that just gives you a little bit more color on what Mike was saying, that when patients have this type of condition, if the nebulizer is, you know, I don't wanna say keeping them alive 'cause I don't think that's in the label, but if the nebulizer is what they feel has, you know, made their pulmonary hypertension livable, it's just human nature to be very cautious about, you know, flipping that to a different therapeutic modality. Now, for new patients, totally different story. If you tell somebody you want a big thing or a small thing, almost everybody will take the small thing. Next question, please. Our next question comes from Joseph Thome with Cowen and Company. Your line is open. Hi there. Good morning. Thank you for taking my question, and congratulations on the quarter. It was interesting that you mentioned there was an uptick in PH-ILD, either patient starts or referrals, I forget what you mentioned in March and continuing into April. Just a little bit of color in terms of, you know, why do you think maybe this was the case? Are you seeing an increasing number of conventional ILD physicians using the therapy? Thank you. Thanks, Joseph. Mike, hand off to you. Sure. Yeah, great question. I think there's a number of factors at play, Joe. I mean, one is, yes, we are continuing to, you know, day by day, week by week, continuing to grow our Tyvaso prescriber base in the ILD community, and that will just continue to play out over really, I think, years, this year into next year and beyond. We're really focused on, you know, the breadth of the prescribing community, and so that is certainly a contributing factor to that. I think the other things that, you know, have kind of played into that are, you know, I know Martine talked a little bit about the impact of COVID on clinical trial enrollment in the market generally. I think, you know, in hindsight, looking at Omicron and the impact, I think, you know, it had an impact more than maybe we realized at the time, just in terms of us being able to get in and talk to physicians and physicians willing to really take the time to understand PH-ILD, think about Tyvaso, think about their patients and move them to Tyvaso. I think what we've seen really in the last, I would say six-eight weeks is, as I said, with the cases coming down, hospitalizations coming down, there's just I think the physicians have a lot more time to really, you know, dig into this. We're starting to. Yeah, I think that's what's contributing to the increase in the referral and the starts that we've seen in the last two months. I think the third factor too is, I mentioned this in my opening remarks about the conferences. I think again, none of these are just, you know, by themselves, I think, driving it. It's a combination of a number of things. I was at the ISHLT conference last week, which was very well attended in person. I think just the fact that physicians were there, they were able to attend presentations live in person. There were, you know, a lot of really nice discussions around PH-ILD, around the use of Tyvaso in PH-ILD. We were able to have those hallway or coffee conversations. We were able to get out in front of these physicians and have really, I think, detailed conversations with them about the use case and the drug, I think, helps. I think the peer-to-peer interactions, our interactions that will continue into the balance of the spring and the summer. I think ATS is, from what I understand, gonna be even better attended at ISHLT, and we've got a lot of, I think, great presentations going on there. I think it's just really a combination of all of those things have led to, you know, kind of the return to where we, you know, kind of strong referral and start patterns that we saw in the middle of last year. You layer on top the factors that I mentioned in my opening remarks, particularly the CMS coverage, which, you know, everybody I talked to said that that's really important and is gonna increase their use of Tyvaso along with the DPI, as I said, I think have us really well positioned, to hit our goal by the end of the year. Thanks so much, Mike. Excellent. Operator, next questioner. Our next question comes from Jessica Fye with JP Morgan. Your line is open. Hey, good morning. Thanks for taking my question. I have a backup if you can't answer this. With the Tyvaso DPI PDUFA approaching, can you say if you've seen an updated draft label at this point? What's your backup so we have them all queued up? What are your latest expectations for enrollment completion and data for the PERFECT and TETON trials? Okay. First, Jess, good morning, and nice to hear your voice again. I'm excited speaking further about what Mike mentioned on the in-person presence. I'm excited to hear that JPMorgan will be, you know, fully in person this year. Congratulations on leading our industry back to face-to-face healthcare conferences. We really, you know, try to stay away from talking about decisions within the FDA and even decisions which are imminent. We'll just, you know, we'll just leave it at that, and we'll issue the press release as soon as we get the good news. We are successfully enrolling all of our different clinical trials. It's really not possible to predict, you know, when any given trial will be completely enrolled. They are all enrolling, as we mentioned in the beginning of the remarks. Maybe just to provide a little bit of color around your question of what kind of factors are affecting enrollment in our clinical trials, I'd like to turn the microphone over to our Head of Product Development, Dr. Leigh Peterson. Leigh? Hi, everyone. Thank you for the question. We do have. Actually, we're able to progress. As Michael said, we were probably impacted by COVID for enrollment of the trials a little bit more than we had realized, as we learn more and more about sites were closing due to the pandemic. They're opening now. We're getting more and more. We're getting boluses of patients coming in that we hadn't had before. We're really looking forward to completing the enrollment. Again, we can't really give you a specific timeline. We're really we haven't been inhibited to following our patients either. I mean, once we get the patients in the study, it's obviously critical that we continue to watch what happens, follow, and make sure that the sites are open, have access to the medicine and everything. We've actually had no problems with that. We even have a site in the Ukraine that has active patients that we're able to continue to follow and get medicine to in our study. I hope that's the type of color you're looking for. Again, apologies, we can't really give you the specific enrollment dates as is impossible for any clinical study, really. Thanks so much, Dr. Peterson. Just to, you know, provide a little more color to your question, Jess, I think it is been proven over and over that clinical trial enrollment is a core competency at United Therapeutics. It's something that we do very, very well. Two examples that are out of many I could give, I myself am blown away at how our team successfully during COVID's early days delivered our medicines to patients in Wuhan, China, the, you know, ground zero of of COVID, yet we continued delivering medicines. We were able to have local clinical trial monitors continue to take all the measurements like Dr. Peterson said. Then a more recent example, as Dr. Peterson just said, you know, we have this center in the Ukraine, and it's part of our outcome study. Fortunately, they are not in the part that's actively under, you know, bombardment from the Russians, but it's not far from there. It's just, you know, amazing to me that our team is able to work to conduct these studies even in places of very, very difficult circumstances. Of course, here in the U.S., we're able to do much better. Things are peaceful. We've even worked out backup measures with the FDA, for example, in PERFECT, where we can take endpoint measurements using things like I can't remember the exact word, like actigraphy. It's a kind of thing that measures how much you're walking, and it's an analogy to six-minute walk endpoint studies. We have, you know, adapted to doing clinical trials during COVID, and I think we've adapted very, very well, as you could see from, for example, the outcomes of the INCREASE trial and the FDA approval of INCREASE and all seven of our ongoing phase III trials are enrolling. As I mentioned, we're now beginning to enroll a new phase I trial for RemoPro. We're enrolling a phase IV trial, ARTISAN. It's a core competency of our company to carry these things out even during difficult times. Next question, please. Our next question comes from Andreas Argyrides with Wedbush Securities. Your line is open. Good morning, and thanks for taking our question. Assuming approval, can you elaborate on the initial launch dynamics for DPI, given that it'll be a first-to-market product? Also, what the timeframe is to achieving the previously described breakdown between DPI and nebulizer. Lastly, just an update on the Xeno programs. Thanks. Thanks, Andreas. While Mike is queuing up some answers to the first two questions that you asked, I'd like to have the Xeno question addressed by Dr. Peterson because she is now also in charge of our UHeart and UKidney clinical development, so she can give you a general overview of the type of things that we're doing on Xeno. Before I leave the introductory part of your answer, please give our best to Liana. All righty. Leigh, would you while you're thinking about the Xeno response, Mike, do you wanna start with the first two questions he asked? Sure. I think in terms of launch dynamics or launch timing Our expectation is that if we receive an approval this month in accordance with our action date, we'll be able to commence promotional activities immediately. We have all of our promotional materials cued up and ready to go and our sales reps trained. They'll be able to go out and start talking to physicians immediately. There'll be, you know, a little bit of a lag just in terms of getting product to specialty pharmacy and be able to start patients, but we would expect that patients will be able to start out therapy sometime in June. You're just talking about a few weeks lag there, which is actually faster than normal between an approval and a launch. For us, it's you know, doing what we do from a sales and marketing standpoint, going out and you know, communicating with physicians and communicating with patients and getting them to understand the benefits of DPI and helping physicians and patients identify the appropriate patient to either start de novo or transition over to the DPI. In terms of the timing, for the breakdowns that I mentioned earlier, sort of like the clinical trial question. I hesitate to put a timeline on that because it always seems to move a little bit slower than what we think for the reasons that Martine, you know, the example that Martine gave, and because of the types of patients we're dealing with. I am optimistic that this will happen maybe quicker than what we typically see in this space just because of all of the, you know, the pre-launch or pre-approval buzz and excitement there is around this product. Awesome, Mike. Totally awesome. All right, Leigh, people are interested about what we can expect next on Xeno. Yeah. As everyone knows, the world is very, very excited about what's going on here. We have reports of institutions doing work in humans. One case that's coming out where the xenoheart was placed into a human patient. The case study of that is coming out in a major medical journal. Please look for those details in that report. We're excited for that to come out soon. What we do is we are really interested in doing the clinical studies that prove if a product is efficacious as we expect. In order to do the more formal phase I sponsored clinical studies, we're required to continue to do some pre-clinical work and, per FDA, we're working with FDA to understand specifically what we should do in order to prepare ourselves for the IND and prepare them. As everyone knows, this is an entirely new field, and we're working really closely together to make sure that we do this right. We're spending time now working with our academic partners and doing the non-clinical work and making sure everything is in order for our phase one and everything being the specific immunosuppression regimen that will be used, the specific product, and all of the procedures that are associated with that. Once we have that completed, we will be submitting our IND to start the phase I studies with the xeno organs. Excellent. Thank you so much, Leigh. You know, I'm gonna call on one more person, Patrick Poisson, who's our Executive Vice President for Technical Operations. Those of you who know me know that I kind of geek out on pharma biologic manufacturing things. I just, you know, I just really love it. It's amazing, you know, to manufacture a xeno kidney and a xeno heart. That is a biologic, obviously. But it requires manufacturing facilities, you know, really the likes of which, you know, have not existed before. It is under Patrick Poisson as our EVP Technical Operations that we are building the manufacturing facility for the clinical trials that Dr. Peterson just referred to. Because, you know, for a clinical trial, whether it's a small molecule, a biologic or a whole organ, you have to have a higher level of attention and care to GMP type of processes. Pat, we just have, like, about a minute left in the call, but if you could kind of give us an overview of the kind of stuff that you're overseeing in terms of preparing a clinical trial, if I could say material or, you know, organ for Dr. Peterson's trial. Yeah. Thanks, Martine. Certainly us in operations are very excited about the prospects of Xeno. We are undertaking building a clinical, call it manufacturing facility that will produce organs, for the trials that Dr. Peterson will run. This is gonna be a first in kind, greenfield facility in western Virginia, and it'll be state-of-the-art as we do with all of our facilities, working closely with FDA. We are kicking that program off. It's underway and design work is happening as we speak. We will be prepared to supply organs, when these trials start. Thank you so much, Pat. Operator, it's been a wonderful call. Like I said at the beginning, in my opinion, the best quarter we've ever had the pleasure to share with everybody, considering revenues, pipeline, even these amazing manufacturing activities. Operator, you may now wrap up the call. Thank you. Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir.unither.com.