United Therapeutics - Q4 2025

Transcript

Operator (participant)

Please also know today's event is being recorded. At this time, I'd like to turn the webcast over to Dewey Steadman, Investor Relations Manager at United Therapeutics.

Dewey Steadman (Head of Investor Relations)

Thank you, Jamie. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation 4th 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 Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Patrick Poisson, our Executive Vice President of Strategic Development. Note that Michael Benkowitz, James Edgemond, and I will participate in a fireside chat and one-on-one meetings at the TD Cowen 46th Annual Health Care Conference in Boston on March 2nd. Additionally, Martine Rothblatt, James, and I will be at the Leerink Partners Global Biopharma 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?

Martine Rothblatt (Chairperson and CEO)

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 proprietary drug device formulation of treprostinil 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. 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 super prostacyclin. It is a super prostacyclin because it lasts much longer and binds molecules much more efficiently than all other approved forms of prostacyclin. Hence, between our super prostacyclin once-daily pill and our cough-less soft mist inhaler, or SMI, we have solved the two biggest problems in our diseases: cough and dose frequency. Very exciting is our unblinding next month of our second pivotal trial of Tyvaso for IPF. You'll recall from last quarter that our first pivotal trial showed Tyvaso to be much better than any other IPF drug the FDA has ever approved.

With confirmation of those results next month, we'll quickly file for approval and commercially launch into IPF not later than June 2027. In summary, for 2027, we should have three disease transformative, paradigm-shattering commercial launches. One, a once-daily super prostacyclin for PAH, two, a category-crushing Tresmi cough-less inhaler for ILD, and three, a better-than-everything new treatment for IPF. Hell, yeah, we are pumped! Let me review some of the other major management areas that I track as CEO. We are religious about revenue growth at UT, and Michael Benkowitz-

Michael Benkowitz (President and COO)

Thanks, Martine, and good morning, everyone. 2025 marked another year of record-breaking revenue, driven by double-digit percent revenue growth from Tyvaso and Orenitram, leading to 11% total revenue growth over full year 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 Tyvaso, 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 Tyvaso DPI. This impressive trajectory reflects our strategic positioning in a large and growing addressable but uncaptured market in PAH and PH-ILD, where we are steadily increasing our share voice and expect to continue delivering double-digit growth.

Through mid-February of this year, our rate of referrals for total Tyvaso 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 in the underlying fundamentals reflects the disciplined execution of our teams, who continue to reinforce our message. We expect this momentum to continue throughout the year as the many attributes of Tyvaso DPI position the device for sustainable long-term growth. We are constantly striving to enhance our Tyvaso 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 treprostinil breaths in a single DPI breath, as well as 96 and 112 microgram combination kits. This advancement strengthens Tyvaso 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 Orenitram and Remodulin, last month at the Pulmonary Vascular Research Institute Annual Congress in Dublin, our medical affairs teams presented data from the ongoing ARTS study examining the effect of early and rapid treprostinil 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 treprostinil 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 Orenitram and Remodulin, which remain backbones to treprostinil-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 Martine to run the Q&A.

Martine Rothblatt (Chairperson and CEO)

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

Michael Benkowitz (President and COO)

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

Martine Rothblatt (Chairperson and CEO)

You're up. Hello?

Operator (participant)

Yes, Martine, you can be heard. Ladies and gentlemen, at this time we'll start the question and answer session. Operator? Are you able. 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 touchtone 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 Ashish Varma from UBS. Please go ahead with your question.

Ashish Varma (Group Internal Audit - AI Initiatives Manager)

Oh, yeah. Hi, good morning. Thanks for taking our question. Just on TETON-1 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 TETON-2 study, just in terms of how you're thinking about for this second study, would love to get your thoughts. Secondly, seems like this question keeps coming up, just the impact from Yutrepia. I know previously you talked about that there was a give it a try dynamic, 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.

Leigh Peterson (EVP of Product Development and Xenotransplantation)

Yeah, I'll go ahead. This is Leigh Peterson, and I will go ahead and answer the first question about expectations for TETON-1. Yeah, just to reinforce that we're extremely encouraged by the TETON-2 results.

... we're really optimistic that we can show a treatment effect in the TETON-1 study as well, particularly since we did see such a robust effect in TETON-2, and that the TETON-1 and TETON-2 study population are relatively similar with regards to the baseline characteristics. We're confident that the TETON-2 results will translate to a second successful study.

Michael Benkowitz (President and COO)

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

Operator (participant)

We actually have Martine rejoining.

Martine Rothblatt (Chairperson and CEO)

I got cut off by the system.

Operator (participant)

Martine, you've been rejoined in.

Martine Rothblatt (Chairperson and CEO)

I got cut off by the system. Yeah, when did I got cut off in the middle of my talking? Hello?

Michael Benkowitz (President and COO)

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

Martine Rothblatt (Chairperson and CEO)

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

Operator (participant)

Martine, 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.

Martine Rothblatt (Chairperson and CEO)

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?

Michael Benkowitz (President and COO)

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

Martine Rothblatt (Chairperson and CEO)

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. Mike, if you don't mind redoing your presentation after I continue. Is that okay?

Michael Benkowitz (President and COO)

Okay. I just... Yeah, well, I just-

Martine Rothblatt (Chairperson and CEO)

Okay.

Michael Benkowitz (President and COO)

Martine, I think we just confirmed that everybody heard my presentation.

Martine Rothblatt (Chairperson and CEO)

Okay, good. I'll pick up from when I was dropped then. Thanks. Everyone has just heard Mike's presentation. 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. Dr. Peterson, who is also on this call, is doing a superb job of product development, including the amazing new super prostacyclin 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 error earlier, just to double-check with Harry and Michael that my remarks are coming through. Are they coming through?

Operator (participant)

Yep, we got you, Martine.

Martine Rothblatt (Chairperson and CEO)

Okay. Sorry for the interruption, but, you know, like, trust but verify kind of thing. All righty. 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, 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 III 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. 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.

Operator (participant)

Yes, we have you.

Martine Rothblatt (Chairperson and CEO)

Okay, great. The first thruster is Zeno, which has now two patients transplanted and doing well in our FDA-approved phase Less clinical trial. We are on schedule to fully enroll the full six-patient cohort by this summer. 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 Zeno product on the market in 2030. The second transplant thruster is Miromatrix. 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 mirokidney 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. 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 human clinical trials as my teams at United Therapeutics. This is life-saving innovation writ 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 Tresmi 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 treprostinil'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 Ralinepag. Four, more IPF and PH products than I can really discuss in a mass call like this because they are deeper in stealth mode. 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.

Operator (participant)

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

Ashish Varma (Group Internal Audit - AI Initiatives Manager)

Oh, great. Yeah, thanks. Sorry about what happened earlier. Just on, like, the TETON-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 TETON-2. Secondly, just wanted to get the latest on impact from Uptravi, if you're starting to see any type of patient ad or competitive dynamic on the DPI or the nebulizer. Thanks.

Martine Rothblatt (Chairperson and CEO)

Okay, thank you, Ash. Thanks for the question. The first part of your question about TETON-1, we will have answered by Dr. Leigh Peterson. She's in charge of product development and in charge of the team that's running the TETON trials. After she finishes answering your question, then the second part of your question will be answered by Michael Benkowitz, relating to marketplace dynamics between us and Uptravi. Dr. Leigh Peterson, could you please start?

Leigh Peterson (EVP of Product Development and Xenotransplantation)

Yeah, sure. I don't know if y'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 TETON-2 results, and we have great confidence that these results are going to be translated to a second successful study, in particular, TETON-1. The baseline characteristics of both studies are similar, relatively similar. The possibility of the translation is really high. Again, the robust results that we saw in TETON-2 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 FVC.

We saw the, as everyone know, we saw an improvement in absolute forced vital capacity of 95.6 milliliters. And we also saw significant improvements in our secondary endpoints. Again, given these really good results, we expect similar results from TETON-1.

Martine Rothblatt (Chairperson and CEO)

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.

Michael Benkowitz (President and COO)

Yeah. Ash, I think you were asking about just kind of the competitive dynamics between us and Liquidia. What I'd say is Tyvaso 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 Tyvaso DPI's easy and importantly, consistent delivery, in just one breath, is important. Our primary market research insights and underlying demand trends support this. You know, what we're hearing and seeing is that the belief in Liquidia's unsubstantiated claims of higher dosing, less cough, better lung deposition, lower effort is definitely waning.

Our referrals have been at pre-Liquidia launch level, been at pre-Liquidia 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 that 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, you know, the just kind of the, you know, 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, you know, three to four weeks. I would say if these trends continue, you'd expect to see us return to sequential revenue growth no later than Q2.

Martine Rothblatt (Chairperson and CEO)

Thank you, Mike. Operator, next question.

Operator (participant)

Our next question comes from Roanna Ruiz from Leerink Partners. Please go ahead with your question.

Roanna Ruiz (Senior Research Analyst)

Great. Morning, everyone. 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?

Martine Rothblatt (Chairperson and CEO)

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. 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 stealth mode today on this call, so this is totally really exciting news. 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.

Given the proximity of all of that, it was important for us to unsheathe the product. But the all of the various competitive advantages of this product will remain undisclosed until, you know, we end up seeing the FDA approval. Next question, operator.

Operator (participant)

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

Roger Song (Senior Equity Research Analyst)

Great. Congrats for the progress, and exciting to see those three launches. Maybe the team, I think you confirmed the double-digit growth this year. I think, Martine, you mentioned the $4 billion run rate in by 2027, the end of 2027. Can you also comment on that kind of soft guidance? 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.

Martine Rothblatt (Chairperson and CEO)

Yeah, it's a really insightful question. First of all, we can clearly double down on our commitment to hit that $4 billion revenue run rate next year. 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 $1 billion a quarter by the tail end of next year. We're doubling down on that. It does not require the contribution of these three new product launches. All of that is, you could say, you know, you know, gravy, whipped cream, whatever is your favorite metaphor.

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 Tyvaso DPI, Orenitram, Remodulin, you know, all of these, you know, Unituxin, all of these products. Above and beyond that, we've now got three more products, and these aren't just like me-too products. These are freaking category crusher products. I mean, the first one that can, like, you know, slash way down the cough, a cough-less inhaler. That's amazing. A once-a-day super prostacyclin, that's amazing. 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.

Like I said, we're super pumped and, I think the $4 billion revenue run rate, it's just to be the point at which the revenue curve bends even more sharply upwards. Next question.

Operator (participant)

Our next question comes from Joseph Thome from TD Cowen & Company. Please go ahead with your question.

Joseph Thome (Managing Director and Senior Research Analyst)

Hi there. Good morning. Thank you for taking my question. Congrats on the progress. Maybe, given your excitement for Ralinepag, what are the most important outcomes that we should be looking at when we see those data? Is it on PVR, 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.

Martine Rothblatt (Chairperson and CEO)

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, like, started before COVID and, you know, persevered through COVID. I don't think anybody knows the whole, you know, panorama of positive therapeutic benefits from this super prostacyclin than she does. Leigh, if you could, you know, give kind of your stream of consciousness on what we could expect from this super prostacyclin and what you think physicians will appreciate.

Leigh Peterson (EVP of Product Development and Xenotransplantation)

Yeah, sure. Happy to. Obviously the what Martine said is the most important with regard to this being a very potent drug. It binds the receptors, the IP receptor, very tightly and has a really long half-life. This translates to the once-a-day dosing and potentially more tolerability. That's definitely a bonus. Also we're looking to, I mean, we're looking to see the statistically significant and clinical meaningful benefit on top of that in clinical worsening versus placebo. As you all know from our other studies as well as this one, clinical worsening is defined with specific parameters.

Seeing a benefit in the number of hospitalizations as well as mortality, would be a super, no pun, a super fact to see in this product. As Martine says, we are unblinding next week, and we are really looking forward to that and happy to put those results out there.

Martine Rothblatt (Chairperson and CEO)

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

Operator (participant)

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 line.