All right. Welcome, everyone, to Jefferies 2026 Global Healthcare Conference. My name is Roger Song, Senior Analyst covers mid-cap biotech. It's my great pleasure to have the fireside chat with our next company, United Therapeutics. We have James, CFO, and then Harry from IR. Good to see you, gentlemen. Great, Roger. Thank you. Thanks for inviting Harry and I, and we appreciate the time. We've had great meetings this morning, so thank you. Excellent. Yeah. Excellent to hear. I'm very happy to have you here as well. Maybe, James, if you want to do a quick state of IR for United Therapeutics, because you just gave us fantastic data at the ATS and then from TETON and then the ralinepag. I think United Therapeutics is in a very good position for the next stage of the growth and then, yeah, give us some high level and then we can have a conversation. Yeah, you bet, Roger. Thanks. Harry's going to do real quickly our forward-looking statements. Okay as always. Yeah. Then I'll do an overview. Yeah. Thanks for having us, Roger. Thanks for everybody in the room and online listening in as well. Today we may make some forward-looking statements, and for any risks and uncertainties associated with those statements, would encourage you to look at our latest SEC filings on forms 10-K and 10-Q. Great. Thanks, Harry. Thanks again, Roger. For a quick overview, it's hard to imagine really another mid-cap biotech that has as many growth prospects kind of in its quiver as we do. As an example, we just read out, as Roger alluded to, two clinical trials that were incredibly successful with two therapeutics, so in two different diseases that have significant growth prospects. Both of those trials had clinical results that were outstanding. They had p values of less than 0.0003 and those two trials, one was nebulized Tyvaso in idiopathic pulmonary fibrosis, and it was the second of two trials they read out that had great clinical results. I'm sure we're going to get into some of those discussions soon. The other clinical trial was called ADVANCE OUTCOMES, and it was a therapy called ralinepag, so an oral, once a day, very efficacious therapeutic in pulmonary arterial hypertension. These are two different therapeutic areas, we believe significant growth prospects. As we'll talk about, we're on track to file both of those with the FDA by the end of the summer. With ralinepag, it will be an NDA, so a new drug application, new chemical entity. For Tyvaso nebulized in idiopathic pulmonary fibrosis, that'll be an sNDA. We are beyond excited. The product development teams, the site management teams, and everybody that supports these clinical trials did an outstanding job and it yielded great results that we're incredibly excited about. Excellent. All right. I think, James, you said it well. As a mid-cap company, you do have your very solid foundation commercial business, and then you have a next-level growth from those pipeline products. Maybe we focus on the commercial for a minute. Maybe you've been the soft guidance in terms of the growth for the year, and then towards the end of next year, 2027, $4 billion run rate and then double-digit growth. When I look at our model and then also the other consensus from the sales model, seems lower than that. Maybe it's a good thing because people want to be conservative and can surprise people in a positive way. How confident is the United Therapeutics management team about that guidance and then why you think the street is missing, and then you can give us the positive? Yeah, thanks, Roger. Good question. As we've talked about recently on our last quarterly earnings calls, we still have the expectation, broadly speaking, to exit 2027 with a quarterly billion-dollar run rate. We've made this assertion previously, and we still expect coming out of 2027, so next year, and that's the growth of our commercial business when we made this assertion, so it's the currently approved commercial products. Now, as we just talked about, Roger, we had two clinical trials we're going to file with the FDA later or by the end of the summer. Our assertions were really based upon our expectation of growing the commercial business. Where that growth is going to come from is in the Tyvaso franchise, specifically in Tyvaso DPI and looking at growth within the PH- ILD disease state. We feel very confident with the investments that we've made, the investments we're making, so that when we end 2027, we will be on that billion-dollar run rate going forward. Great. The interesting thing is Tyvaso has been entrenched as a great product and a franchise for PH and PH- ILD. You'd have other products in a similar class, they're also launching pretty well. Within that dynamic, how you think about your scenario, base case scenario can continue to support the growth projection that you are making? Yeah. Thanks, Roger. From a Tyvaso, I think it's a Tyvaso DPI kind of perspective you're thinking about. As an organization, we continue to feel very comfortable about the growth prospects in Tyvaso DPI and specifically in PH-ILD going forward. If you think about the product, the partnership that we have with MannKind, the success we've had, the product profile, the delivery of the drug deep into the lungs, we've continued to feel very confident about our own growth prospects as we look forward. We've had many successful and thousands of patients combined with prescribers, and we feel very confident in continuing that success going forward in Tyvaso DPI, and frankly, when we look across the commercial business. We're pretty excited. We have conviction. The other thing that we're doing, and this may come into play, Roger, when we talk about IPF, we're actually investing in the sales force and Michael Benkowitz. He's the President and Chief Operating Officer, runs sales and marketing. We've accelerated the hiring of sales teams for IPF and ralinepag, those are not approved products. We're going to deploy those sales teams within the PAH and PH-ILD franchises. We're going to have more individuals, so feet on the street talking about our commercial business as we onboard those new sales teams members who will pivot going forward into the new disease states. Excellent. Okay, great. I like the confidence and the conviction there. Street want to be our particular outlook, so want to be a little bit conservative, but on the other side is we look forward to the growth, as you mentioned, can amongst all the competition. Let's move on to the IPF because this is very exciting for everybody. I think you also mentioned on the last earnings call is thinking about with the new product, new indication across different formulation and presentation, you can double for the $4 billion run rate by 2027 in the coming years. How much we should think about the contribution from IPF or maybe from other new product like a soft mist and then some new indications? Yeah, Roger, we're pretty excited, one, about the results of the clinical trial really for the patients that are dealing with idiopathic pulmonary fibrosis. From the standpoint of currently approved therapies, we feel that the clinical trial results, and it was pretty clear actually, that it'll be a superior product and an inhaled product, which is different than the current orals that are approved on the market. We think based upon the clinical results and ultimately, the FDA will determine the label, but we have a lot of conviction that this will be a pretty big revenue opportunity for us and run ramp. We haven't actually talked about, Roger, what the run ramp will be. In time, we'll actually give more information on that. Based upon the currently approved therapies and where we currently price Tyvaso, and just the opportunity of having a therapy on the market that has a different profile from the current adverse events profile or what patients are dealing with, that we think this is going to be very successful. We have an outline what that growth ramp looks like, but we feel very confident that we will be able to at least double the revenue size from where we're currently at going forward. Exiting 2027, as I talked about earlier, which would be the billion-dollar run rate, we've actually talked about doubling that revenue size going forward based upon the contributions primarily of nebulized Tyvaso and idiopathic pulmonary fibrosis. There will also be contribution, and we'll talk about ralinepag too a little bit later going forward. Excellent. Okay. Maybe quickly circle up to the ATS data for the IPF TETON-1, TETON-2. I think the top line efficacy looks fantastic. 100 plus and then pooled analysis and cross different subgroup, everything seems very impressive. I have to say, you must ask about it, and then it's AE driven, the discontinuation a little bit higher. How you think about that? Also I think in the comment from the paper and then talk about the nebulizer fatigue because it's four times a day. How you will respond to that and then how this will feed into the real-world adoption for nebulized Tyvaso? Yeah, sure, Roger. It's a good question. Look, when you think about prostacyclin-related adverse events, cough is a known AE there. I think what's important to note when you look at the trial, the amount of discontinuations due to cough overall, especially severe cough, were quite low. Severe cough was a single-digit percentage, or maybe even a single-digit N. As doctors and patients have experience with using the nebulizer and doctors help coach patients through using the nebulizer, you kind of tend to see that improve over time. You had the dosing schedule, and you can see in the graphs the separation of the FVC. Up to about 8 to 16 weeks, patients are titrating and once you kind of get past that and you can tolerate the cough and get to the higher effective dose, you really see that separation and the benefit of the therapy. In the real-world setting, these things really can improve over time when doctors have experience using the product. You have patient support programs like our own. That's even evident in the trial itself at ATS. Dr. Nathan spoke to his own practice and his experience with the drug in the trial, and he actually had a much lower overall discontinuation rate relative to the overall trial because he's somebody that knows how to coach patients through using the nebulizer due to his familiarity with the product. Yeah, some education is needed. Just like PAH, PH-ILD. I think, when you launch Tyvaso, you also see early on discontinuation due to different reasons, but with more education, then the patient will be able to stay on treatment a little bit longer, and then with the education from the physician. Okay, got it. In terms of the pricing, I know PAH, PH-ILD, the epidemiology or the prevalence are a bit lower than the IPF, and then you price a little bit premium. The current standard of care for IPF with, not considered generic, but the brand of the drug is about $100,000 per year. How you think about the pricing for Tyvaso in this population for IPF if you launch it? Yeah. Thanks, Roger. Tyvaso, as we know now, is an approved therapy, and we don't anticipate modifying the current price by adding IPF to the label for nebulized Tyvaso, just in summary. As I mentioned earlier, at some point, we'll be talking from our perspective more about the market size. Obviously, that would play into the pricing aspect. At this point, we don't anticipate changing by adding Tyvaso to the label. Mm-hmm. Yeah. Honestly, when I look at the data you presented for the TETON-1, TETON-2, you definitely can see the differentiation, even a lot of the advantage compared to the standard of care. I understand, you probably will justify the price, either the current price or slightly closer to the standard of care, but we'll stay tuned on that one. Stay tuned. Yeah. Okay, good. Then, I think, James, you alluded earlier, you're hiring new sales rep and then maybe expanding the current indication, PAH, PH-ILD, and then IPF is some synergy with the current market. Also you probably want to increase further the sales force, given you want to doubling the market size. How should we think about the cadence of the sales expansion? Thanks, Roger. The cadence of expanding the sales team, some of that is actually underway and has been completed. When we think about the opportunity in the IPF market is pretty significant, as we talked about. There's a lot of activities going on in the background all across United Therapeutics to make sure once it's approved, we can actually hit the ground running. As Roger mentioned, one of the items was the sales teams that I talked about previously. Roger, that hiring is actually ongoing right now. We expect them to be in place, trained, and up and running specifically for the PAH right now and the PH-ILD market, so this summer. You'll see that kind of cost increase on a going forward basis. Whether Michael looks at opportunities and resizes things and shifts things based upon actually how that pans out over time, that'll be a decision later on, and that'll be what Michael sees as investment opportunities, et cetera. That cadence and those hirings are happening right now, have been happening. Folks internally have been pretty busy. Beyond that, what we're doing is looking at what are the things that we can do now to prepare for the launch. We've had questions around nebulizers, inventory builds, things of that nature. Across United Therapeutics, because we want to make sure we can serve and support those patients right out of the gate, we're doing anything and everything we can to get things in place. Great. All right. Maybe we stay on Tyvaso before we move on to the ralinepag, considering the pipeline. You have another pivotal program for PPF for Tyvaso is ongoing. Where's the status right now? How you think about the TETON-1 translation to PPF? Understand it's a different disease, but they have some synergy in the underlying pathology, particular for the magnitude of the treatment effect you see for the IPF, TETON-1, TETON-2. How confident you are regarding the PPF at this point. Yeah. We're certainly not going to speculate on what the magnitude of the FVC delta might be in that trial. You're right, we are highly confident. As you said, the sort of underlying fibroses and progression of disease are pretty similar between IPF and PPF. When you think about the success of what we saw in the TETON trials, combined with what you already see in the space where nerandomilast and nintedanib are approved for both indications, we're pretty confident that we can also see a similar treatment effect in PPF with inhaled treprostinil. Can I add on one thing? Yeah, sure. Harry nailed it. I think just a couple other things. The PPF trial is another clinical trial that the product development team is actually working on, and we've seen a little bit of a halo effect where with the positive results of nebulized Tyvaso in idiopathic pulmonary fibrosis. In the PPF trial going very well. As Harry's mentioned in some prior discussions, it was 75% enrolled at this point. There's a lot of great attention on it. Folks are working very hard. The opportunity size as we provided, and you see some of the disclosures in the 10-Q that we filed, it's twice as big as the IPF market when you look at the PPF market. We just think there's a tremendous opportunity. The team is focused on the clinical trial and to get things done right, and we just think going forward, that's just another one to add to the quiver, Roger, of prospects for us for continued growth on a going-forward basis. Excellent. Okay, great. Maybe another question related to the Tyvaso pipeline is the Tyvaso SMI. You announced Soft Mist two quarters ago, that's very interesting because you see some dramatic reduction on the cough, which is maybe the only drawback for the current kind of formulation. Where are you in terms of the clinical and the regulatory status? I believe you say something like you complete a pivotal study, you are filing later this year, how much you can tell us about the results? Yeah, that's right. We'll be filing for the indications for which Tyvaso is currently approved. That's PAH and PH-ILD, filing later this year. Again, that's based on some healthy volunteer PK work that we've done. As for branching out into the other diseases, IPF and PPF, we're still working on what that clinical development path looks like. Got it. Have you completed the study and then ready for the filing, or you are continuing to do the trial and then waiting for data before you can file? We completed a first cohort of healthy volunteers in the second half of last year, the second cohort is either nearly complete or still going on right now. We're still on track for a later this year filing. Yeah, I think the important part, Roger, that we're still committing to filing by the end of the year. Yes. I think these underlying activities that we're doing will continue. We're just focused on meeting that deadline that we've committed to. Got it. Okay. ralinepag. That's super prostacyclin, as Martine say. How should we think about the data will support early use and then even take over the current drug? We know we have some drug and going generic pretty soon. I think how you're going to position this once daily, oral, and then in the PH-ILD first? Yeah. Look, we're really excited about the potential for ralinepag. The ADVANCE OUTCOMES data was a clear home run, really what this company has been working to from its beginning in terms of a highly convenient, really efficacious product. The data, it's clear that ralinepag, it's QD and really has a high potent receptor affinity. That's what led to what you saw in the trial with really strong ability to delay the progression of the disease. We think these factors position it really strongly in the prostacyclin class and could potentially shift it to earlier usage in terms of time since diagnosis, still following an ERA and PDE5, but potentially capturing earlier usage from prostacyclin PH patients. Roger, you've seen the clinical results. They was really a home run, as Harry talked about. This was something that Martine was really focused on when she started the company, which is once a day therapy. It's hard to imagine why a patient wouldn't be prescribed ralinepag after frontline therapy because of the once a day, very efficacious formulation. We just think in addition to what we've talked about in the IPF, which is a tremendous opportunity, we also think in the PH opportunity that this is going to be a new chemical entity that will have far-reaching benefits to patients that are dealing with PH. We think a huge opportunity from a revenue standpoint as well. Yep. Got it. In terms of the indication expansion, I think you want to make this super prostacyclin across broader than the PH. What's the biology or mechanistic rationale support that? Because so far the receptor seems to be more focused on the PAH versus treprostinil is broader into the other indications. Yeah. It's very clear from the ADVANCE OUTCOMES trial that ralinepag is a highly potent member of the class of drugs that treprostinil is in. It's clear from the TETON trials that treprostinil is very effective in managing the progression of IPF. Thereby we expect that ralinepag could also see the same effects. To your point, we're planning on developing it in a DPI formulation. Mm-hmm. Yeah. Okay, for DPI, it's interesting you choose DPI as the inhaled formulation for ralinepag rather than other formulation. What's the rationale behind that? Yeah, it's kind of right now the path of least resistance in terms of the formulation work as well as if the DPI may better support once daily dosing. Got it. Okay. One new indication that you raised at the last earnings call, COPD. It is a massive population, but on the other side you may not address the entire COPD, like a more kind of enriched population. How much we know about that? I know last time I asked the question, and you said stay tuned and that you will give us more updates. Any latest thoughts about this? Yeah. We've disclosed that we're seeking a PH-COPD indication expansion for inhaled treprostinil. In this trial, we're actually using the SMI relative to the last time that we pursued this indication. We really learned a lot in the first time that we ran a full clinical trial to pursue this indication, and we have a lot of learnings that we're applying in terms of design and patient selection. Then, of course, you layer in the SMI, we're confident that we can hopefully see a successful outcome this time. Got it. Okay. Very good. This is in the treprostinil and the prostacyclin kind of franchise for PH-ILD, and the related disease. You have another transformative angle of the story is the xenotransplantation transplant. It is in clinical right now. You are transplanting people, patients now. How should we know the strategy disclosing data, how we're going to win, and we're going to see the data? Yeah, thanks, Roger. This is kind of another one from a longer-term growth opportunity for United Therapeutics, where we're actually doing clinical trials, for those new to the story, in kidney using xeno organs, so genetically modified organs. We have three clinical trials right now going on. One is in UKidney, which is a 10-gene genetically modified kidney that we've kicked off. We've had transplants in. The second one is UThymoKidney, which is using the thymus of a one gene-edited kidney or pig with using the kidney. We announced a couple of Fridays ago that the FDA released EXPRESS, which is using a heart, so a genetically modified heart. Those clinical trials, as you mentioned, Roger, are ongoing, and we think ultimately this will be an opportunity to really put a huge dent in the enormous shortage of transplantable organs that exist today. If you think about it, we're sitting here, and there's 500,000 people that are currently on dialysis in need of an organ. We're pursuing these opportunities to supply kidneys and hearts through these clinical trials if they're successful. From a disclosure standpoint, Roger, the approach we're probably going to take is in some of the protocols for the trials, we're required to finish six transplants and provide data back to the FDA if I'm talking about the UKidney. We'll have to see what kind of disclosure comes from that. We can't today commit to a disclosure plan. We think once we talk with the FDA and we potentially resize the trials, right now it's up to 50 patients, that we will be able to communicate more about those clinical trials that are currently ongoing. Excellent. Okay. All right. Well, time's up, and then thank you so much for