Good day, everybody. Welcome to UBS Healthcare Conference. Next company on the podium here, with me, United Therapeutics, and I'm really, really excited. We have Patrick Poisson, who is the EVP for Strategic Development, and Harrison Rose, who is with IR. Guys, thank you so much for joining us. Yeah, thanks for having us, Ash. Good to be back. I just wanted to remind everybody that during our discussion today, I may be making some forward-looking statements, and I would refer you to our SEC filings for any risk and uncertainties associated with our business. Great. With that out of the way, maybe if you can just give us a, like, a little bit of a high-level sense on where we are in the story. I mean, you just reported third-quarter earnings, so if you can hit a couple of highlights, then we can go into that. Yeah, for sure. We were very pleased with our third-quarter earnings. We showed double-digit year-over-year growth again in our Tyvaso franchise, so we were very excited about that. Of course, we had the big announcement with our TETON-2 clinical trial with IPF, which ended up being the best IPF study ever conducted as far as data goes. We announced that in September. Of course, just recently, last week, we announced the first transplant of our U-Kidney under our clinical trial. A lot of exciting news coming from UT. We're excited about our pipeline. The first half of next year, we're looking at two big trial outcomes in the outcomes study with ralinepag and, of course, TETON-1 with IPF. Right. Yeah. I think one thing that people got surprised by was just this call for partnerships on your third-quarter earnings call with the potential, you know, pharma companies. Is that something that, like, what sort of drove that, and have you heard back from any of them? Like, where, what shape can this take in the future? Yeah, I should clarify that that was a general comment made by Martine, that right now, there's no active partnership discussions. However, with the outcome of the TETON-2 trial, we're really looking at global markets, and the infrastructure required to support those markets with those patient populations really has ignited our interest in considering potential partnerships. I think she was just commenting on that, the dynamic has changed a little bit for us and that, you know, we're still a small company. As we look at supporting a global market, it's a big leap for us. I think she was just really commenting on that the interest is there, and if we could find the right partnership, we'd certainly have those discussions. Great. There was a comment also just around, like, the $4 billion revenue by 2027. I do think that there is a lot of potential that you have to get there. What I wanted to understand, is this kind of like a formal guidance? I know this is something that has been talked about before as well. I mean, I wouldn't call it a formal guidance. We now have clarity into what the IPF, with TETON-2, we have clarity in IPF now. I think that's given us the confidence that we can hit that $4 billion run rate by the end of 2027 with that market size. Great. Okay. Perfect. Yeah, I think just in terms of where the third quarter and some of the recent prints that we've seen from Tyvaso, can you talk to us about, like, what is driving the volume strength for DPI and nebulizer? Like, is it PH, PH-ILD, sort of what are the different dynamics at play for? Yeah, sure. As I said earlier, you know, again, double-digit growth year over year. We're continuing really to make inroads in that space, really with PH-ILD. That market is still growing, and there's still a pretty big run rate, in our opinion. As far as the breakdowns between nebulizer and DPI, we tend to look at it as a total franchise, and we're pleased to offer two ways to dose treprostinil, either through dry powder or through nebulizer. You know, certainly, the DPI has a real convenience play for the patients, but we believe the nebulizer still has its place. It's a very flexible platform. It allows really dosing down to the breath, a lot of convenience without having to get a different SKU. We believe it's always gonna have a place in that market. Some physicians like to use it for titration, and then transfer over to DPI. There are some techniques there that make it attractive. Really, you know, there's again a lot of running room with PH-ILD, and we're confident we're gonna continue to see the same results for years to come. Great. I know this is the first time, like, on the third-quarter earnings that you also started to talk about some of these higher-dose cartridges, right? The 80, 80 microgram and the 96 and 112. Yeah, I know in the past, dosing higher with Tyvaso, like, the challenge there has been that, kind of the side effect profile that came in the way. With these, like, new formats that you've talked about, is that, like, how do you sort of overcome that challenge? Yeah. I mean, you know, with the AEs, cough is the most predominant, and it's very subjective to the patient. There are some people that tolerate higher doses better than others. We do have a significant amount of people on the highest DPI dose that we have available right now. There's been a lot of interest in having a higher-dose cartridge, which has driven the 80 microgram cartridge. None of these things can happen very quickly. We have to interact with the FDA. We have to do a lot of work to build a higher dose. That's all been done, and we're very close to launching the 80 microgram. We know there's some excitement from the HCPs and the patients to have that convenience of being able to dose in a single cartridge, 15 breaths equivalent to the nebulizer. We're going to offer some higher-dose packaging SKUs that'll have two cartridges in them so the patient does not have to buy two separate kits. That'll go up to 96 micrograms and 112. Those are gonna get introduced over the next couple of months. Really, it's about patient convenience. I think we'll see a lot of people go to the 80, honestly. These would primarily be focused for patients who might be at a high dose to begin with to transition to an even higher dose? That's correct. That's correct. Like I said earlier, we have a significant population of patients that are taking 64 micrograms or even more. This will, again, allow them the convenience of a single cartridge. We expect a lot of people to move to the 80 once it's available. Does that make a difference between the indication, like PAH or PAH-ILD, or is it sort of the same from either direction? I think it's probably when you get to those higher doses, these are people who have built up tolerance to treprostinil, so it probably is somewhat agnostic at that point as to whether it's PAH or PAH-ILD. Yeah. Okay. All right. And then, there is a competitor update that we've seen from Liquidia that have recently launched. And I know you guys have said that there is no material impact that you're seeing on Tyvaso. I'm just trying to understand, like, as their launch progresses more, what is your sense on, like, where they might be taking share from and if that has, like, a sort of a downstream impact on Tyvaso? Yeah. If you look at our third-quarter results, you know, double-digit year-over-year growth. We sustained that despite the launch of Yutrepia. I believe they stated in their quarterly earnings call that approximately 75% of their starts were de novo patients, so these are patients new to treprostinil. Secondary to that, there were some conversions from oral therapies. I think what's happening is that by having another sales force out there, they're really expanding the PAH and PAH-ILD markets. The data suggests that. We've seen that happen before with prior products. That, and we've always said, you know, throughout the years that PAH is underdiagnosed. In a way, this is more products helps expand the market. With, especially with PAH ILD, we think there is certainly space for more than one product to be successful. You know, I think the data really kind of supports what our intuition was earlier. Yeah. Yeah. I remember, like, Winrevair launch was the same type of dynamic that, yeah, a lot of investors were kind of worried that, Winrevair is gonna have a meaningful impact on Tyvaso, but it did not necessarily pan out that way. Is it sort of a similar dynamic that you think that, because of just how underpenetrated these markets are, particularly PH-ILD, that it does not necessarily impact Tyvaso growth, but more sort of expands the market opportunity for the patients? Yeah. I think with Winrevair, their most really compelling clinical data was with treprostinil as a background therapy. In a way, we're hoping Winrevair actually increases use of treprostinil. We've been through this before, and, you know, it's kind of the same old story, where we hear headwinds and a launch happens, and then we see the continued growth. Treprostinil, in our view, is the gold standard. We're the innovators of treprostinil. We've been on the market for 23-plus years, so we know this market very well, better than really anybody. You know, we continue to be successful. You know, as this plays out, we do believe that PAH will get better diagnosed. It's tough to diagnose. You have to do a right heart cath. That is somewhat a big deal for a patient to go through. But as more products come out there, somehow the patient population just keeps expanding. Right. Yeah. And then there is a pretty imminent update on a legal case. To the extent that you can comment on this, I, like, I either way would understand, but just what are you assuming on, like, what is your base case assumption, basically, on the PAH-ILD parent outcome? As a policy, we do not comment on ongoing litigation. All we can say right now, it is in the judge's hands. Yeah. We expect to hear an outcome any day. Got it. Okay. Let's talk about IPF. Very impressive data, like you mentioned. I think it's hard to find any, poke any holes in it. You know, it was just pretty remarkable, like, the efficacy and, on the safety side as well. What I wanted to ask on that is that there is a little bit of a focus on, like, the discontinuation rate for Tyvaso, in, like, the data that you showed from TETON-2. One of the things was the 74 patients that discontinued in the Tyvaso arm. Is that, like, the core discontinuation for that clinical trial, or were there also some, like, immaturely discontinued patients? Does that get factored into the overall discontinuation rate when you think about that? Yeah. I mean, we have to accept that there's gonna be discontinuations. And, I think our kind of conclusion from that is that the discontinuations from our trial really weren't that much different than the discontinuations from previous IPF trials. There was also discontinuations, with people taking placebo. I wouldn't overemphasize that. I would say that it was within expectations. The really what we wanna emphasize is, the decline in, you know, preventing the decline in FVC. And, really, that was a great outcome along with the secondary endpoints, you know, really, like I said earlier, the best IPF trial that's ever been conducted. We're excited, to see the TETON-1 results sometime in the first half of 2026. Yeah. And really to get this product to market so that it can start helping some of these IPF patients. Yeah. Yeah. That's great. I think on the forced vital capacity, so the endpoint that you're studying, I mean, you have pretty remarkable effect size, like you said. I think the way that the trend of forced vital capacity sort of panned out in TETON-2, there was more of a efficacy accumulation, I wanna say, from like week 24 onwards. Right. Yeah, can you talk about that a little bit? Like, what might be driving that? Is it that, like, persistently providing treprostinil to the patient is what sort of accumulates the benefit over time? Did it sort of, is it happening faster or slower versus what you had originally assumed? Yeah. I mean, let's, let's keep in mind it's a, it's a progressive disease. Okay? Yeah. The other piece is that it takes some time to titrate up to a clinically effective dose. There's gonna be a bit of a lag as a result of that. When you look at that data, you need to understand, as people titrate up, they'll start to see greater benefits from the product. We believe that's an explanation for that. Really, at the end of the trial, the FVC data is extremely compelling. We're very pleased with that. Really, I think any doubters of it, with that data, it's hard to argue how good this product will be for IPF. Right. Yeah. I mean, just like the comparative, looking at the comparative profile, we don't really have good therapeutic agents available. So just looking at how good the data has come out to be, it can have a pretty differentiated launch from that standpoint. Is that sort of aligned with your? Yeah. I think one of the great things about it is that it's not gonna require a change in background therapy, and it doesn't require a right heart cath. So patients can start very quickly on it. You know, unlike PAH and PAH ILD, where there's some hoops that patients have to jump through to get on the product, with IPF, those hurdles really aren't there. Right. They'll should be able to start very quickly, once it's approved. Got it. Okay. And then there was a, there was a fair bit of focus on the secondary endpoint of the study as well, which I think you had pretty good data across the board there. One of the things that was the, like, the exacerbations and the survival, you know, endpoint, which I, I know, like, the survival endpoint kind of narrowly missed in this, this trial. As you think about TETON-1, any, any reason to believe that it can, you know, potentially meet the survival endpoint in that study? I mean, we'll only find out when the study's done. But the demographics are very similar. Yeah. The patient population's very similar. We're expecting to see very similar results from that. We'll analyze those individually when they come out. We'll also analyze TETON-1 and TETON-2 together as a whole. If you look at that patient population and you look at demographics, there's some slight differences in background therapy approaches in North America versus the rest of the world. Really, I think we're anticipating a very, very similar result. Right. Yeah. Can you remind us just the timeline of what you've talked about publicly on when are you expecting that data? Yeah. It'll be certainly the first half of 2026. You know, it depends on a lot of things, but, you know, I would say on or before June 30, 2026. Yeah. I think it was enrolled, like, January of 2025, right? So, like, if we track from that perspective, I think the. Yeah. I mean, you could use that as kind of a marker. You know, is there a guarantee there? No. But that, you know, certainly is an indicator of what it will take to get that data and unblind. Yeah. Yeah. There isn't necessarily much of a difference in the baseline characteristics amongst the patient. Yeah, just like the U.S. versus ex-U.S. dynamic, does that make any difference in your mind on, like, a potential trial outcome? I mean, there are certainly gonna be some slight differences. Will they be enough to really affect the trial outcome? I really can't speculate. Like I said, though, there's enough similarities that gives us the confidence that we're gonna see a very similar outcome. Yeah. Got it. Okay. Let's talk about ralinepag. So, yeah, this is another data readout that you're expecting in first half of 2026, just with the advanced outcome. Yeah, how should we think about that? There's a lot of investors that focus on whether it can show sort of a similar outcome compared to Opsumit. That's the, you know, the J&J drug. I wanted to understand from your standpoint, what are the pushing and pulls with that? Yeah. I mean, I think, you know, the phase two data gave us the confidence to go forward and design the advanced outcomes trial. There's, I think, a couple of compelling things with Ralinepag first. It's versus Opsumit, it's a once-daily dose. Right. It's also titratable, which Optravi's not. If we can show an improvement in six-minute walk distance that's improved over what Optravi has shown, we think that it's gonna end up being a great product for us. Right. And just going back to the phase two data, it's a smaller sample size, obviously. So there was a 20% PVR improvement, which is pretty impressive. But, like, when you think about the six-minute walk distance, it wasn't able to show a benefit over the placebo. So that, yeah, like, is it like a function of, like, smaller N that drove that, or do you think? Yeah. I mean, that study wasn't really powered for that endpoint. Right. I would be careful to draw too many conclusions from that. The design of the advanced outcomes is powered for that. You know, again, we're hopeful that we can show a much improved six-minute walk distance when that study ends. If you combine that with some of the conveniences of dosing ralinepag, we think, again, it's a very powerful product for the PAH community. Right. But your objective would be to try to show differentiation both on PVR and six-minute walk distance? Yeah. Both of those are critical for physicians and patients. Yeah. I mean, certainly, six-minute walk distance is the one that everyone's, you know, looks at. Certainly, yeah. Got it. Okay. And then, yeah, on the xenotransplantation, so, good to see the progress on that front. And you got the first patient transplanted, you said last week, I think. So, talk to us about just, you know, what is the overall plan for this study and when do we start to see the follow-ups from this? Yeah. Certainly. I think anybody who's followed our xeno program is aware of the compassionate use transplants that we've done in the past, with both heart and kidney. We've now progressed. Late last year, we filed an IND, our own IND, for the 10-gene kidney. That was approved by the agency. A week and a half ago, we did our first transplant under that IND. That was a big milestone for us. It's the first clinical IND for a xeno organ was done. The agreement with the agency, and this has been publicly shared, is that really the focus is gonna be on a two-cohort program, where the first cohort is six patients. Mm-hmm. When those six patients are done, there'll be a review with the agency on that data. A decision will be made to go forth with the second cohort, which will consist of 44 or more patients that will get transplanted. Now, as far as how, what's the, you know, how quickly that's gonna get done, I really can't say. This is a very complicated study to conduct. There's not a great playbook for this, so we're kind of plowing our own path. The logistics are daunting. Yes. You're doing an organ transplant. It's a big procedure. Coordinating with NYU, who's doing the first six cohorts, there's a lot that goes into preparing for this. Now that we've done the first one, we believe we have some momentum. How quick it's gonna get done, you know, we really can't say. I think, unlike traditional drug studies, the disclosures are going to be, you know, not routine. I think probably the next public statement we'll make is when the first cohort is done. There's patient privacy that we have to respect and things like that. I would expect that, you know, we'll make some sort of announcement when we're complete with cohort one. When that will be, I can't tell you right now. Got it. Okay. So, like, the first cohort, you mean, like, the six patients, when they are, like, the follow-up is completed, is when we will publicly hear the first time. Mm-hmm. About this. Likely. Got it. Okay. I think for the compassionate use, I saw that some of these patients that have been sort of followed for, like, three to four months' timeframe, right? It can vary in a trial setting, obviously. Is that a, is like, yeah, can the timeline be very different compared to the compassionate use? You have to keep in mind that with the compassionate use, it's really a one-off IND that was filed by the hospital. Our role in that was to supply the organ, and the hospital took the lead with communicating with the agency. There was a lot more public disclosure over that, so I don't expect to have the same from us. Right. Those patients, the criteria that was used to allow those patients is different than what we're using for our IND. You know, I wouldn't use that as a baseline. It's more of a reference point, if anything. Again, you know, this is all new. It's exciting, and we're excited about it. We're excited we got our first transplant done, and then we're excited to do more. How quickly that will happen, you know, it's tough to estimate. Yeah. Got it. Okay. Just quickly, as a reminder for the audience who are in the room, if you want to submit any questions through the QR code, feel free to do that, and we can take them over. Just, yeah, like, I think just, on the xenotransplantation, and you guys are pretty far ahead of competition, but I see there are some developments starting to happen in this. The way that you are approaching it with the 10-gene editing effectively versus there are a few other companies that are pursuing, like, sort of a totally different approach. Can you talk to us about, like, what is the differentiation that your platform has that might increase the chances of success here? Yeah. I mean, the philosophies are similar. They've, you know, the one competitor that, that's out there that has done some work, eGenesis, has focused many of their gene edits on eliminating PERV, which is a virus. We also have some edits for that, just not as many. And, you know, the reality is, as you look at this market, where there's 500,000 people in the U.S. on dialysis, there's no one company that will be able to serve that whole market with a xeno organ. So there's plenty of room for companies to operate in that market in a profitable manner. The capital investment, and we've talked about this, is big to do this. I mean, we almost kind of need more companies to do this. Now we're paving the way. And we've made a lot of progress. If you look at the history of our involvement in this, it goes back many, many years. The investment we've made has been significant to do the R&D work to get to the point we are. The market is large. You know, I think it's our belief that multiple companies can be successful, serving that market. There's certainly a need. The cost to the Medicare system alone is massive, for dialysis. The opportunity to give people a better life and to reduce costs to the citizens of our country is really a great outcome. Yeah. Great. Great. Awesome. With that, we are out of time. Thank you so much for this. Yeah, looking forward to learning more about.