United Therapeutics Corporation

Good morning, everyone, and welcome to the United Therapeutics Corporation fourth quarter 2025 corporate update conference call. My name is Jamie, and I'll 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, please simply press star and then the number one on your telephone keypads. If you would like to withdraw your questions, you may simply press star and the number two on your telephone keypads. We do ask that you please limit yourselves to one question. Please also note today's event is being recorded. At this time, I'd like to turn the webcast over to Harry Silvers, Investor Relations Manager at United Therapeutics.

Thank you, Jamie. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation fourth quarter 2025 corporate update webcast. 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. We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or 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 uses. Full prescribing information for the products is available on our website. Accompanying me on today's call are Dr. Martine Rothblatt, our chairperson and chief executive officer, Michael Bankiewicz, our president and chief operating officer, James Edgman, our chief financial officer and treasurer, Dr. Lee Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Pat Poisson, our Executive Vice President of Strategic Development. Note that Michael Benkowitz, James Edgman, and I will participate in a fireside chat and one-on-one meetings at the TD Cowan 46th Annual Healthcare Conference in Boston on March 2nd. Additionally, Martine Rothblatt, James, and I will be at the Lee Rink Global Healthcare Conference in Miami on March 9th. for a fireside chat and one-on-one meetings. Finally, James and I will also participate in one-on-one meetings at the UBS Biotech Summit in Miami on March 10th. Our scientific, commercial, and medical affairs teams will be present at the 21st Annual John Vane Memorial Symposia in London, March 13th and 14th, and at the International Society for Heart and Lung Transplantation in Toronto, April 22nd to 25th. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?

Thank you, Harry. Good morning, everyone. Today I'm going to share with you news that transforms the fields of pulmonary hypertension and IPF. This news is our unsheathing of a category killer product called Tresmi, T-R-E-S-M-I. This product is a revolutionary product proprietary drug device formulation of troprostanol into a soft mist inhaler. It will reduce the number one side effect of dry powder inhalers, which is coughing, by up to 90% based on the human studies we've done so far. And we intend to file for its approval in PAH and ILD this year and commercially launch it next year. The days of people discontinuing their PAH or ILD therapy due to cough will be over. Anyone would rather have soft mist than dry powder. Also transformative for our markets will be the unblinding of our outcome study next week. We are optimistic that this unblinding will usher in a new era of once-a-day treatments for pulmonary hypertension. The reason we can promise once-a-day treatment is because the new medicine is a superprostacyclin. It is a superprostacyclin because it lasts much longer and binds molecules much more efficiently than all other approved forms of prostacyclin. Hence, between our superprostacyclin once-daily pill and our coughless soft mist inhaler, or SMI, We have solved the two biggest problems in our diseases, cough and dose frequency. Also very exciting is our unblinding next month of our second pivotal trial of Tyveso for IPF. You'll recall from last quarter that our first pivotal trial showed Tyveso to be much better than any other IPF drug the FDA has ever approved. with confirmation of those results next month, will quickly file for approval and commercially launch into IPF not later than June of 2027. In summary, for 2027, we should have three disease-transformative paradigm-shattering commercial launches. One, a once-daily superprostacycline for PAH, Two, a category-crushing Tresmite coughless inhaler for ILD. And three, a better-than-everything new treatment for IPF. Hell, yeah, we are pumped. Now, let me review some of the other major management areas that I track as CEO. We are religious about revenue growth at UT.

Thanks, Martin, and good morning, everyone. 2025 marked another year of record-breaking revenue, driven by double-digit percent revenue growth from Tideso and Orinatram, leading to 11% total revenue growth over a full year of 2024 and surpassing $3 billion in total revenue for the first time in our history. For the fourth quarter, we recorded $790 million in total revenue, representing 7% growth from the fourth quarter of 2024. We have pointed out in the past and continue to remind investors of our historical seasonal revenue trends where the first quarter and fourth quarter tend to be lighter ordering quarters, while the second quarter and third quarter tend to be heavier ordering quarters. As such, sales in the short term can vary depending on the timing and magnitude of orders from our specialty pharmaceutical distributors and may not precisely reflect patient demand or changes in patient census. Turning to Tyveso, total revenue for the fourth quarter was $464 million, a 12% increase over the previous year. underpinned by robust 24% year-over-year growth in Tyveso DPI. This impressive trajectory reflects our strategic positioning in a large and growing addressable but uncaptured market in PAH and PHILD, where we are steadily increasing our share of voice and expect to continue delivering double-digit growth. Through mid-February of this year, our rate of referrals for total Tyveso was at its highest level in two years. Notably, the referral rate in three of the last four months was at or above where we were heading into a competitive launch early summer of last year. This continued strength and the underlying fundamentals reflects the disciplined execution of our teams who continue to reinforce our message. And we expect this momentum to continue throughout the year as the many attributes of Tyveso DPI position the device for sustainable long-term growth. We are constantly striving to enhance our Tyveso DPI platform, which we believe will help us solidify and grow our position as the preferred inhaled prostacyclin therapy. We recently introduced 80-microgram cartridges, which enable delivery of the equivalent of 15 nebulized tropostinal breaths in a single DPI breath, as well as 96 and 112-microgram combination kits. This advancement strengthens Tyveso DPI's differentiation in the pulmonary hypertension market by improving convenience and expanding dosing flexibility. which we believe can support broader adoption and longer-term growth while streamlining access and affordability for patients with more advanced dosing needs. Moreover, we believe the consistency of flow rate and delivery with our DPI device and its low inspiratory flow requirements further differentiates our platform. Turning to our Renitram and Remodulin, last month at the Pulmonary Vascular Research Institute Annual Congress in Dublin, Our medical affairs teams presented data from the ongoing artisan study examining the effect of early and rapid tropostomal therapy on mean pulmonary arterial pressure, or MPAP, and the reduction to improve right ventricular function in PAH. Preliminary data suggests that early initiation of high-dose tropostomal therapy represents a feasible strategy for reducing MPAP and improving right ventricular structure and function. These data further reinforce the significant benefits that can be achieved from a Renatram and Remodulin, which remain backbones to proprostinol-based therapy in treating pulmonary hypertension and are strong foundational pieces to our commercial business. To close, we are proud of the exceptional drive and relentless focus of our teams who remain deeply committed to making a real difference for the patients we serve. Building on the strength of this past year, we expect this foundation will continue to support durable double-digit growth and ongoing success over the long term. With that, I'll turn things back to Martin to run the Q&A.

Michael, thanks so much for that great review of our religious dedication to strong revenue growth.

Operator, maybe we could go to the first question in the queue.

Hello? Hello? Hello? Hello?

Yes, Martin, you can be heard. And ladies and gentlemen, at this time, we'll start the question and answer session. Operator? Operator? At this time, we'll begin the question and answer session. In order to ask a question, please press star and then one using a touchstone telephone. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality. Once again, that is star and then one to join the question queue. We'll pause momentarily to assemble the roster. Our first question today comes from Ash Varma from UBS. Please go ahead with your question.

Oh, yeah. Hi. Good morning. Thanks for taking our question. So just on TETON1 data coming up, wanted to understand your level of confidence here in a positive study for IPF. I know you're very confident ahead of the TETON2 study, but just in terms of how you're thinking about for this second study, would love to get your thoughts. And then secondly, it seems like this question keeps coming up, just the impact from eutrapia. I know previously we talked about that there was a give it a try dynamic, but just what are you seeing latest in terms of the patient ads for DPI or nebulizer and if there is any impact from the competitor? Thanks.

Yeah, I'll go ahead. This is Lee Peterson, and I will go ahead and answer the first question about expectations for Teton1. And yeah, just to reinforce that we're extremely encouraged by the Teton2 results, and we're really optimistic that we can show a treatment effect in the Teton1 study as well, particularly since we did see such a robust effect in Teton2. and that the TETON1 and TETON2 study population are relatively similar with regards to the baseline characteristics. So, we're confident that the TETON2 results will translate to a second successful study.

Operator, it seems like we lost Martine and Michael. We're here now.

And we actually have Martine rejoining.

I got cut off by the system. Martine, you've been rejoined. Yeah, when did I get – I got cut off in the middle of my talking. Hello?

Yep, we hear you, Martine. Michael, can you hear us?

I hear Harry, I hear Mike, but I'm trying to understand when I got cut off because it just went dead on my end.

Martin, this is the conference operator. We're going into the live conference.

Your line just dropped here recently. We've rejoined you back in. Your line is live.

Okay. I'm sorry, everybody. The conference operator... messed up the conference call, and I think, Mike, were you able to get your entire presentation through before you got dropped?

I think so. I'm not sure if anybody heard me, though.

Okay, well, why don't we start back up? We'll go over 9.30, and why don't we go start back up around the time I think I was dropped? And then, Mike, if you don't mind redoing your presentation after I continue. Is that okay?

Okay. Yeah, well, I just think, Martin, I think we just confirmed that everybody heard my presentation.

Oh, okay, good. Well, I'll pick up from when I was dropped then. Thanks. So everyone has just heard Mike's presentation, and I think it confirms what we've been saying to everybody is our commitment to double-digit revenue growth. I'm going to continue from the point that I got dropped by the call. to say in addition to all of the, you know, fantastic success that Mike and his team have delivered in terms of revenues, that we at UT are also fanatical about new product development, because we never like to rest on laurels. And Dr. Peterson, who is also on this call, is doing a superb job of product development, including the amazing new superprostacyclin and IPF medicines that I mentioned at the start. Before I dive into these new products, let me just take a moment due to the conference call earlier just to double check with Harry and Michael that my remarks are coming through. Are they coming through?

Yep, we got you, Martin.

Okay. Sorry for the interruption, but, you know, like trust but verify kind of thing. All righty. So other areas that I focus on in addition to new product development are investor relations and business development. With regard to business development, we are now in fruitful discussions with three great pharmaceutical companies. And this is really driven by their keen interest in the proven predictive power of our AI-enabled digital lung model. Our model can run hundreds of accurate in silico phase three trials in way less time than it takes for a single in vivo trial. No one else has this advanced and lung-specific computational biology technology. It is great to know that the outcome of a pulmonary trial can be known before spending hundreds of millions of dollars to run it, not to mention the many years saved or gained. Transplantation is another major management focus for me, and it too is firing on all thrusters. I'm just going to, before I go into transplantation, just let me take a moment to check again with Harry and Mike and make sure the line remains active.

Yes, we have it.

Okay, great. The first thruster is Zeno. which has now two patients transplanted and doing well in our FDA-approved phased-less clinical trial. We are on schedule to fully enroll the full six-patient cohort by this summer. Then we'll enroll the full balance of the trial needed for registration as decided by the FDA in 2027. At this rate, we should have a commercial Xeno product on the market in 2030. The second transplant thruster is Mural Matrix. We've now fully enrolled and successfully completed the first manufactured liver clinical trial ever. We expect FDA guidance on how to take this liver failure recovery product and also our mural kidney implanted product to regulatory approval during the course of this year. Instead of me going through all of our multiple other transplant thrusters, such as, for example, 3D bioprinting of kidneys and lungs, let me simply say that I felt honored to be chosen by Forbes team of experts and AIs as the eighth most innovative person in America. I feel an obligation to live up to that, and there is no company in the world manufacturing as many transplantable organs in as many different ways with as many, or for that matter, any in the human clinical trials as my teams at United Therapeutics. This is life-saving innovation with very, very large. A final area of major management focus for me is our strategic clinical development group, also known as our Skunk Works or Stealth Division. It is in this group that the revolutionary new TRES-My product was birthed as described at the start of the call. This is the product that will totally transform our markets by all but eliminating Triprostenol's number one reason for patient discontinuation, harsh coughing. We are unsheathing this product today because it will be filed this year for commercial launch next year. The immense power of this product is summarized in its name. Few will want to continue inhaling a dry powder when instead they can breathe a soft mist. Other products that you'll soon see emerging from our Skunk Works division include, one, a once-daily inhaler, two, PRN inhalers, three, even better pills than the once-daily Relenopeg, And four, more IPF and pH products than I can really discuss in a mass call like this because they are deeper in stealth mode. But all of these products have long IP. In summary, UT is committed to using relentless innovation and our AI-enabled digital lung model to keep producing the best, most convenient, most effective, and safest products in the PAH and IPF space. Operator, you can now open up the line for additional questions.

And once again, at this time, if you would like to ask questions, please press star and then 1. To withdraw your questions, you may press star and 2. If you are using a speakerphone, we do ask that you please pick up the handset to ensure the best sound quality. Once again, that is star and then 1. Our first question, once again, will be from Ash Verma from UBS. Please go ahead with your question.

Oh, great. Yeah, thanks. Sorry about what happened earlier. Just on like the TITAN-1 data coming up, I wanted to get an understanding of the level of confidence you have in the IPF study outcome versus how you were feeling about TITAN-2 data. And secondly, just wanted to get the latest on impact from Utopia if you're starting to see any type of patient ad or competitive dynamic on the DPI or the nebulizer.

Thanks. Okay. Thank you, Ash. Thanks for the question. So the first part of your question about TETON1, we will have answered by Dr. Lee Peterson. She's in charge of product development and in charge of the team that's running the TETON trials. And then after she finishes answering your question, then the second part of your question will be answered by Mike Bankowitz relating to marketplace dynamics between us and EUTREPIA. Dr. Peterson, could you please start?

Yeah, sure. So I don't know if you all heard me the first time I said this, but I'll add a little bit more detail this time. Just to reiterate, we're extremely enthusiastic about the TITAN-2 results, and we have great confidence that these results are going to be translated to a second successful study, in particular TITAN-1. The baseline characteristics of both studies are similar, relatively similar, so the possibility of the translation is really high. And again, the robust results that we saw in Teton II also give us confidence. I mean, we not only saw a very, you know, a very good, very positive, statistically significant, basically, primary endpoint with regard to FBC. We saw, as everyone knows, we saw an improvement in absolute force biocapacity of 95.6 milliliters. And we also saw significant improvements in our secondary endpoints. And so, again, given these really good results, we expect similar results from Teton1.

Perfect, Dr. Peterson. Thank you so much. Mike, I'm not sure how much they heard of your earlier discussion, so if you could just respond to Ash's question as you think best.

Yeah, so Ash, I think you were asking about just kind of the competitive dynamics between us and Liquidia. And so what I would say is Tyveso remains the well-entrenched market leader for inhaled therapy and pulmonary hypertension. The healthcare providers consistently affirm UT's leadership position in this space. As we said, there was initial curiosity to evaluate a new market entrant, but the doctors are recognizing that the advantages of Tyveso DPI's easy and importantly consistent delivery in just one breath is important. Our primary market research insights and underlying demand trends support this. What we're hearing and seeing is that the belief in liquidity is unsubstantiated claims of higher dosing, less cough, better lung deposition, lower effort is definitely waning. Our referrals have been at pre-liquidity launch levels in three of the last four months. Our prescriber breadth and depth and patient retention is at or better to where it was before Liquidia launched. Now, what we have seen is the patient starts have lagged these trends a little bit. I think that's primarily due to the typical Q4 seasonality we see, as well as just kind of the cross-country severe weather we experienced in January. However, that logjam really seems to have broken in February, based on what we've seen in the last three or four weeks. And I would say if these trends continue, you'd expect to see us return to sequential revenue growth no later than Q2.

Thank you, Mike. Operator, next question.

Our next question comes from Orlando Ruiz from LeeRank Partners. Please go ahead with your question.

Great. Morning, everyone. So I thought it was a really interesting update on the soft mist inhaler product and was curious if you could talk a bit more about the human-based studies you've done so far and what additional features you've been optimizing for this product and how you think physicians will react in terms of prescribing it if it's fully available and commercialized.

Yeah, thanks for your question. I think physicians will be super happy about it. It is, as it says right in the name, it's soft mist versus dry powder. So I think physicians will be happy about it because patients will be happy about it. I think it will be equivalently effective. So why not have something that works just as good but is, you know, easier for the patient to tolerate? We have just brought this out of self mode today. on this call, so this is totally really exciting news. And so many of the details we are not going to share openly, but I did want everybody to know that it was going to be filed for approval this year and then launched next year. So given the proximity of all of that, it was important for us to unsheathe the product But all of the various competitive advantages of this product will remain undisclosed until we end up seeing the FDA approval. Next question, operator.

Our next question comes from Roger Song from Jefferies. Please go ahead with your question.

Great. Congrats for the progress and exciting to see those three launches. Maybe the team, so I think you confirmed the double-digit growth this year. I think, Martine, you mentioned the 4 billion run rate by 2027, the end of 2027. Can you also comment on that kind of soft guidance? And also, given those three new product launch next year, so how much contribution from those launches will contribute to the long-term growth, including the $4 billion run rate? Thank you.

Yeah, it's a really insightful question. So first of all, we can clearly double down on our commitment to hit that $4 billion revenue run rate next year. So it will, you know, be in the back half of the year. But if you just take our double-digit revenue growth and you roll it forward from the levels that we are at right now, you'll see that we would be hitting that billion-dollar quarter by the tail end of next year. So we're doubling down on that. It does not require the contribution of these three new product launches. So all of that is, you could say, you know, gravy, whipped cream, whatever is your favorite metaphor. But definitely these three product launches are going to bend the curve upwards in terms of our revenue levels beyond the $4 billion annualized rate because we were growing double-digit with the great products that we currently have, the Tyveso DPI, Orenatram, Ramodulin, you know, all of these, Unitoxin, all of these products. So above and beyond that, we've now got three more products, and these aren't just like Me Too products. These are fricking category crusher products. The first one that can like, you know, slash way down the cough, a coughless inhaler. That's amazing. A once a day super prostacyclin. That's amazing. And an IPF treatment that's better than anything the FDA has ever approved for IPF since the beginning of IPF. It does not get better than that. So like I said, we're super pumped. And I think the $4 billion revenue run rate, it's It's just to be the point at which the revenue curve bends even more sharply upwards. Next question.

Our next question comes from Joseph Tomei from TD Cowan & Company. Please go ahead with your questions.

Hi there. Good morning. Thank you for taking my question, and congrats on the progress. Maybe, given your excitement for Rolinapag, what are the most important outcomes that we should be looking at when we see those data? Is it on PBR, six-minute walk, time to worsening event? Kind of what do you think will resonate most with physicians in addition to the dosing benefit to drive adoption there? Thank you.

Yeah, we love these kind of scientific questions. Dr. Peterson, the head of product development, she has lived this trial for seven years because this trial started before COVID and persevered through COVID. So I don't think anybody knows the whole panorama of positive therapeutic benefits from this superprostacyclin than she does. Lee, if you could, you know, give kind of your stream of consciousness on what we can expect from this super-processed cycling and what you think physicians will appreciate.

Yeah, sure, happy to. So, obviously, what Martine said is the most important with regard to this being a very, very potent activity. It binds the receptors, the IP receptor, very tightly and has a really long half-life. And so this translates to the once-a-day dosing and potentially more tolerability. So that's definitely a bonus. But also we're looking to see the statistically significant and clinical meaningful benefit on top of that in clinical worsening versus placebo. And as you all know from our other studies as well as this one, clinical worsening is defined with specific parameters. And seeing a benefit in the number of hospitalizations as well as mortality would be a super positive. no pun, a super effect to see in this product. So as Martine says, we are unblinding next week, and we are really, really looking forward to that and happy to put those results out there.

Thank you so much, Leigh. Really appreciate it. Operator, I'm getting input that other people are being dropped on the call, so we can close the call at this time.

Ladies and gentlemen, at this time, we will close today's conference call. We 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 presentation section of the United Therapeutics Investor Relations website at ir.unither.com. That's ir.unither.com. We thank you for joining. You may now disconnect your lines.