United Therapeutics Corporation

Good morning, everyone, and welcome to the United Therapeutics Corporation third quarter 2025 corporate update. My name is Jamie, and I will be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question and answer portion of this earnings call. If you'd like to ask a question during that time, please press star and the number one on your telephone keypads. If you'd like to withdraw your questions, you may press star and the number two on your telephone keypads. Please also note today's event is being recorded. At this time, I'd like to turn the floor 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 third 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 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 Pat Poisson and I will participate in a fireside chat and one-on-one meetings at the UBS Global Healthcare Conference in Palm Beach on November 10th. Additionally, James and I will be at the Jeffries Global Healthcare Conference in London on November 18th for a fireside chat and one-on-one meetings. And finally, Martine Rocklatt will present at the 44th Annual JPMorgan Healthcare Conference in San Francisco in January of next year. Our scientific, commercial, and medical affairs teams will be present at Phenomenal Hope 2025 on December 5th in Boston and at the Pulmonary Vascular Research Institute Annual Congress in Dublin in late January next year. Now, I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?

Thank you, Harry, and good morning, everyone. United Therapeutics had a great quarter, helping more patients and earning more revenues than ever before. In addition, this past quarter, our pipeline made more progress than ever before. We've fully enrolled three phase three trials, and we've shared the unblinded results for pulmonary fibrosis. In fact, the best results for that condition ever reported by anyone, anywhere, anytime. We feel confident we'll be able to help tens of thousands of IPF patients live better lives. United Therapeutics is a public benefit company. And I'm sometimes asked, what exactly does that mean? Well, one thing that it means is to defy the odds and invest millions of dollars over several years to develop a historically unmatched product portfolio for pulmonary fibrosis. Being a public benefit company means providing a framework of trust for patients, doctors, payers, and employees. Being a public benefit company also means having shareholder interest as the hands on the helm. For example, we've repurchased millions of our shares, including quite a few this quarter at a bargain price. For example, we are now guiding that we'll be at a $4 billion revenue run rate not later than 2027. And finally, I'll point out that we are actively engaged in all manner of business development. In fact, I can predict that great companies such as Merck, J&J, or Novartis with strong pulmonary disease franchises will be very keen to partner with us given our best-in-class data released for IPF this quarter with long-lived IP, and also given the very near-term results of Relenopeg with its 2040 patent life. Indeed, I'd love to see a trial of Relenopeg combined with Wingovir, and I bet it would be super synergistic. Let's now give Mike Henkiewicz a chance at the microphone so he can give us a deep dive into our great and better-than-ever numbers this quarter. Michael?

Thank you, Martine, and good morning, everyone. Today, we are pleased to report another quarter of record total revenues of $800 million, representing 7% growth from the third quarter of 2024. This quarter's performance was driven by continued year-over-year growth in total Tyveso and Arenatram sales, reflecting patient demand and the resilience of our commercial strategy and execution. Continued double-digit revenue growth for total Tyveso demonstrates that we are realizing no material impact from the launch of eutropia. Our continued revenue growth also reinforces our belief that competition drives additional disease awareness, which in turn increases the overall opportunity in the large addressable pulmonary hypertension market. We remain confident that Tyveso DPI is the best position inhaled for possible product and can sustain long-term growth due to the convenience of our DPI device, its unlimited dosing potential, the thousands of prescribers and many thousands of patients who have experienced Tyveso DPI since launch, and the fact that there are no payer incentives to prefer an alternative product. On dosing inconvenience, our Tyveso DPI platform is driving a meaningful shift in troposomal dosing behavior. Historically, patients averaged nine breaths per treatment using nebulized Tyveso delivery. With Tyveso DPI, that average has increased to a 12-breath equivalent, or 64% micrograms. I'm pleased to announce that we will soon be launching Tyveso DPI 80 microgram cartridges to provide added convenience for patients being treated at higher doses. This new cartridge will allow patients to reach the equivalent of 15 nebulized breaths with one single breath, as compared to four breaths for Eutrepia. This is the highest dose ever delivered in one breath via one cartridge, offering a clear competitive edge in dosing flexibility and reinforcing the clinical and commercial value of higher dose tryprosinol. This innovation positions us to provide greater patient benefit, capture greater market share, and unlock new revenue potential in the growing pulmonary hypertension space. At the same time we launch the 80 microgram cartridge, we will also be launching 96 and 112 microgram combination kits, which we believe will facilitate access and affordability for patients requiring even higher doses of Tyveso DPI. On tolerability, we're looking forward to sharing abstracts at the PVRI Annual Congress in January that compare real-world data from United Therapeutic Safety Database to clinical trial evidence from Eutropia's INSPIRE study. These analyses show, among other things, a lower incidence of cough in both Tyveso and Tyveso DPI. Finally, on access, we have secured multiple favorable coverage decisions with major payers supporting a clear validation that Tyveso DPI is well positioned in the marketplace. Our confidence in the growth profile of Tyveso is further supported by the recent TITAN2 study, which, as Martine said, demonstrated an unprecedented treatment benefit for inhaled troposomal in patients with idiopathic pulmonary fibrosis. We are excited about the TITAN2 data, which have the potential to significantly broaden our therapeutic reach into respiratory disease and further accelerate our growth. Lastly, turning to Remodulin, we're pleased to have launched our new Remunity Pro Pump during the third quarter, which we designed based on feedback from healthcare providers and patients to enhance the overall experience of our parenteral therapy. Our Remunity Pro Pump is small and discreet and features a user-friendly remote with guided instructions, automated priming, and easy filling. Additionally, its lower flow rates may enable more patients to initiate Remodulin therapy at home instead of requiring a hospital stay. In closing, we are extremely proud of our team's steadfast dedication, which has driven these remarkable innovations and results and enables us to offer critical therapies to our patients who rely on them. We are confident that our strong foundation positions us to maintain our momentum and continue delivering success for many years to come. With that, I'll turn things back to Martine.

Michael, that was an amazing overview. Thank you so much for sharing all that information and for all of your leadership. Operator, you may now open the lines to any questions.

Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one using a touch-tone telephone. If you are using a speakerphone, we do ask that you please pick up your handset prior to pressing the keys. To withdraw your questions, you may press star and two. At this time, we'll pause momentarily to assemble the roster. And our first question today comes from Lisa Walter from RBC. Please go ahead with your question.

Oh, great. Thanks so much for taking our questions, and congrats on the quarter. I'm just curious. Given the TTON2 results in IPF, are you perhaps seeing an uptick in diagnoses of IPF patients with PTSD? And if so, do you think this could positively impact Tyveso sales over the next few quarters? Any color here would be helpful. Thanks.

Thanks for the question, Lisa. I'm going to refer that to Michael. Under his overall leadership includes all of the different parts of UT that are interacting with physicians and patients, such as global medical affairs and our commercialization teams. a regional nurse specialist. So Mike would have a lot of input on that. Michael?

Sure. Thanks for the question. Yeah, it's an interesting question. It's actually one of the opportunities to attend both the European Respiratory Society, where we unblinded the TITAN-2 data, as well as the CHESS conference last week in Chicago. And actually, every physician I talk to, I ask them that exact question, just to try and get a sense of whether that data would maybe create an incentive or prompt them to be more aggressive in screening for pulmonary hypertension in their IPS patients. And so, you know, they all said yes, yes. Whether that plays out yet, I think it's still too early because, you know, we only unblinded the data just a few weeks ago. So I can't point to – It upticked directly towards that or directly towards the TITAN-2 study, but it's certainly something I think that we're chatting with physicians about and monitoring very closely. So, you know, I think it's logical that this will play out over time. Whether it does, when it does, to what degree, I think remains to be seen.

Perfect. Thank you, Michael. Operator, next question, please.

Our next question comes from Andreas Aggerides from Oppenheimer. Please go ahead with your question.

Good morning, and thanks for taking our question, and congrats on another solid quarter here. Martin, you mentioned in your remarks Relenopeg and potential for combination. Can you just give us a sense of where you see the market opportunity for Relenopeg and expectations for advanced outcomes next year? Appreciate it. Thank you.

Sure, absolutely. RELENOPEG is just, you know, just blowing the doors off of expectations everywhere we look. First of all, the enrollment of the outcomes trial, which is just a trial that enrolled in pulmonary hypertension, has gone extraordinarily well. And even some of the open-label trials results have been announced by some doctors, you know, that for patients who have already exited the trial and the six-minute walk distances that are maintained even a year after these patients have left the trial are best in class, six-minute walk distances. Then, as I mentioned, The long patent life for Lenapeg is a very significant factor as well from a business standpoint. With the patent, I'm not going to be expert on all the dates, but it's roughly 2040. So it has a very, very long patent life. As you know, it's a pill that you just take once a day. It seems to be the most potent prostacyclin type of drug that has been identified yet. So patients have an opportunity to just take one pill once a day and be able to keep their pulmonary hypertension managed, as well as, you know, could be the case with any other prostacyclin-type therapy. Now, on top of all of that, you know, we were very impressed with the synergy that was shown in the data released by Merck between cetatriceps and tryprosinol, and we've continued to see that synergy in the marketplace. Subsequent to the Taterstep launch, our sales have just continued to grow. So there seems to be like a really nice synergy between those two drugs, and if one could leverage that synergy with a once-a-day pill, wow, that would be like, you know, even better. In addition to that, there turns out to be tremendous formulation flexibility with Relenopeg, which opens up a number of opportunities that are more in our stealth catalog, things such as combination, oral treatment, and so on. So Relenopeg is, while IPF is a disease, is front and forward for us, as a MCE relentless is our number one course. Next question operator.

Our next question comes from Joseph Tomey from TD Calum. Please go ahead with your question.

Hi there, good morning. Congrats on the progress and thank you for taking my question. Martine, in addition to that combination partnership potential, it sounds like you also mentioned some large pharma partnership related to, or in light of the recent Taibeso IPF data. So maybe if you could go a little bit more into maybe what you were thinking about there, what would an ideal kind of partner look like or partnership and is this related to kind of European rights or Just any additional clarity on that because that seemed like a little bit of an update from the prior quarter, obviously, given the recent data. Thank you.

Yeah, it was only, you know, it's so funny that you say that because before we released this data, I would say that, I don't know, these are just heuristic numbers, but like 90% of people seems like they didn't really believe that our drug would work in pulmonary fibrosis. Which seems odd to us. We have a computational biology lab which has an extraordinary digital model of the lung and all of the key diseases that we focus on in the lung. We use, you know, a large learning model based on all of the previous studies that have been done in pulmonary fibrosis and pulmonary hypertension. to develop this digital lung model. And then we were able to run new NCEs, new drugs through this model to get the results of standard endpoint measurements. So, for example, we ran the TITAN-2 study, the entire, like, you know, 100 clinical trials modeled as the TITAN-2 study. You know, compare that to the years and years that it takes, like, you know, slugging around the world enrolling these trials. And the results of that digital CLEAR, CLEAN trial were that, you know, By comparison to the roughly 95 milliliters improvement over baseline that we showed with the clinical trial, we had estimated our median estimate of these 100 trials was like 130 milliliters, which is fascinating because the difference between the digital trial and the physical trial was closer than the effect size from the Profanadone and Intanamide trials. So what that tells you is that the digital trial very closely modeled the disease, like we know what we're doing here. And so I think that augers really, really well for some companies that might have been a bit skeptical about the anti-fibrotic effects of trypanosomal and pulmonary fibrosis, I'm kind of, you know, waking up and paying a little bit of attention. Now, United Therapeutics is very much of a United States company. It's not that we don't do things in other countries in the world. We do. In fact, the TETON2 trial was enrolled throughout all of the rest of the world. But if you look at our financials, you'll see that the overwhelming portion of our revenues are derived from the United States. All of our medicines are manufactured in the United States. All of our devices for delivering our medicines are manufactured in the United States. So there are, you know, partners in other parts of the world that wanted to help bring the amazing benefits of Tyveso to patients in those other parts of the world, I think that would be a good thing for everybody concerned. Thanks for the great question. Operator, next question.

Our next question comes from Olivia Breyer from Cantor. Please go ahead with your question.

Hi, good morning. Thank you for the question. Can you talk through some of the commercial dynamics you're seeing for Tyveso over these last few months and maybe even into October? Really, I'm curious whether most of the share gains for DPI are in PAH versus PHILD. And then I have to ask the obvious question, but whether you're seeing any competitive impacts in either indication, or if you are, maybe it's weighted more towards one versus the other And then, sorry to sneak this in, but Martin, I did just want to ask for a quick point of clarification. You're now guiding to a $4 billion run rate by 2027, which I think is well ahead of where some numbers are today. Does that mean you expect to hit $1 billion in a quarter sometime in 2027, just to kind of clarify? And I assume that's in light of the very strong IPF results. Thank you so much.

Yes. So we do expect to hit $1 billion in a quarter in 2027. And we're very happy for you poking around all the different whys and wherefores of our revenue growth, so no problems there. And, Michael, we'll take it away on that question.

Yeah, so thanks for the question. So I think, you know, in terms of what we're seeing over the course of the third quarter and then even early into the fourth quarter, as I said, I think we're confident in that there's really no material impact from the launch of Utrepi. And, in fact, what we see, and we've seen this in the past with other competitors' launches, it actually, it really kind of grows the pie of the addressable patient population, because you now have, like, another sales force out there talking about these diseases. So you've got doctors, you know, thinking about pulmonary artery hypertension, group one, as well as PHILD in group three. And so, you know, so that's a great thing for patients, and then it's a great thing for, for the companies that are providing these drugs. And invariably what happens is I think, you know, we saw this even with the Cetatercept launch, as Martine alluded to in her opening remarks, we continue to grow through that. And that's what we expect to happen here as we move into 2026 is continued growth in Tyveso and both PAH and PHILD. And so when I look at, you know, really from, you know, let's say beginning of September through halfway through October. And I think the things I look at, the underlying metrics, patient shipments, prescriber breadth and depth, referrals and starts. And I think on the patient shipments, super strong and really headed into October, like exceptionally strong so far, a couple weeks in. The number of prescribers grew quarter over quarter. And we're still maintaining depth in the three plus riders. which is sort of our key metric on depth. And then referrals and starts kind of bounced around a little bit in the quarter, but really, again, since September, a pretty consistent upward trend, and we're almost back at where we were pre-eutropia launch. So, you know, so this has, I think, played out about like we expected. There has been some trialing with their products. You know, we've had some patients transition. A lot of those have come back. And as I said in my remark, I think as we look out into – you know, 2026 and beyond, we think we're really positioned well for continued growth in both PAH and PHILD.

Perfect, Michael. Thank you so much. Wow, that's a great covering of all three necessities of that question. Thanks. Operator, next question, please.

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

Oh, great. Congrats for the record holder again. And thank you for taking our question. Quick ones. One is on the PPF. So just curious about the data timing on the enrollment. And then more interesting question could be, given the T-DON2 data, how's the research to the IPF? Any new updated thoughts from physician and scientists regarding the MOA? And then also, quickly, on IPF and the Phase II meeting, I believe you are having meeting with the FDA. around year end, and then just curious about the potential outcome scenario, any upside case you can have earlier approval. Thank you.

Okay. So that's a whole pancake stack of questions you got there. So basically I'm going to refer all three of those questions, and hopefully she's been taking notes, to Dr. Peterson, who would be the best person to opine. in the third instance on the enrollment progress with the PPF or maybe we could call it ketone-free trial and then walk through the mechanism of action that's increasingly being understood as she's attended all of the major chest pulmonary respiratory conferences and she's talked with all of the major KOLs. She's also right in the loop on the major top-tier, top of the top-tier type of peer-reviewed publication that's about to come out, and there's a lot of interest in the MOA question there. And then finally, she works very closely with our regulatory group to give you some insight on the kind of cadence of what we can expect in terms of filing. So, Dr. Peterson, could you take all those questions away? And that'll probably make you the last answerer because that was a lot of questions.

Thank you. Yes, I did take notes. Good, good. So, yeah, regarding Teton PPS, we're about halfway through enrollment, a little bit more. And that study in design, as you well know, is very similar to those for the Teton I and Teton II in that there's a 52-week follow-up period. And so, again, we can't really speak in detail about, you know, when we would expect unblinding, but that gives you an idea. And you all know that that's being run in basically U.S., Canada, as well as the rest of the world. So, and again, most importantly, really based on the similarities of the underlying fibrosis and disease progression between IPF and PPF, I mean, these results suggest that inhaled tropostinol would potentially offer a treatment option for these patients with PPF. With regard to the mechanism of action, the specific mechanism of action, again, with the similarities in the underlying fibrosis and as we've discussed, both the in vitro results, the preclinical results, demonstrating an anti-fibrotic effect of proprostenol as it works through the various receptors, the IP receptor, IP2, DP, all of that, in addition to having a vasodilation effect. We expect that to play out in both of these indications. and as far as uh the regulatory path so we uh have had agreed with fda that we will we're using both the data from teton 2 and teton 1 and you all know that we are expected to have the teton 1 results report those at first half of 2026 and um so in fact we are meeting with the FDA before the end of this year and to discuss ways to potentially expedite that regulatory review process when the TETON1 results are available. So all of that is really positive, really, really exciting, and definitely pointing in the right direction of, you know, consistent results among these various TETON trials.

Thank you so much, Dr. Peterson. Great responses, and you collapsed that so elegantly that we have time for one last question, operator.

All right. Our next question comes from Rowana Ruiz from LeRinc. Please go ahead with your question.

Great. Morning, everyone. So I wanted to ask about the 80-microgram cartridge for DPI. Could you give a little bit more color on the launch plans for that? Any strategies to drive more durable patient use, possible switching from the prior cartridge, et cetera?

Sure. Let me turn that question initially and perhaps comprehensively to Pat Plassant, who is our Executive Vice President for Technical Operations. has been keen in the design of that incredible Tyveso product from the very beginning. Pat?

Yeah, happy to. Thanks, Martine. I didn't catch the whole question. Could you just repeat it for me, just to make sure I answer it correctly?

Sure. So for the new 80-microgram cartridge, just curious about launch plans for that, strategies to drive patient use, switching, et cetera?

Sure, sure. With DPI, we've seen patients able to titrate higher. And really for their convenience, we've developed this 80 microgram cartridge to allow them to take 15 breaths in one single dose. So that will be added convenience, whereas to get there before, they had to combine two cartridges. So we're anticipating launching that very soon. certainly in the next, say, 30 to 60 days, that'll be out there. And so we're really just looking to add convenience and easier dosing for patients.

Excellent, Pat. Thank you so much. I'm going to wrap up the call now. We've reached a lot of time, but I want to thank everybody for the congratulations that they've offered us on this best quarter that we've ever had. commercially, clinically, really across the board. We're super excited about the UT product portfolio. If there are some newbies on the call, just to remember that the opportunity in pulmonary fibrosis is more than twice the size of the opportunity in pulmonary hypertension, and we're still continuing to go and grow like gangbusters in pulmonary hypertension itself. So it's truly best of times at United Therapeutics. Thank you for your interest, and operator, you can wrap up the call.

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. Again, that's ir.unither.com. We thank you for participating. You may now disconnect your lines.