Earnings Call Transcript - UTHR Q3 2025

Operator, Operator

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. 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.

Harrison Silvers, Investor Relations Manager

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 Edgemond, our Chief Financial Officer and Treasurer; Dr. Leigh 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 10. Additionally, James and I will be at the Jefferies Global Healthcare Conference in London on November 18, for a fireside chat and one-on-one meetings. And finally, Martine Rothblatt 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 5, 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 Rothblatt, CEO

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 fully enrolled three Phase III 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, 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 result of ralinepag with its 2040 patent life. Indeed, I'd love to see a trial of ralinepag combined with Winrevair, and I bet it would be super synergistic. Let's now give Mike Benkowitz a chance at the microphone so he can give us a deep dive into our great and better-than-ever numbers this quarter.

Michael Benkowitz, President and COO

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 Tyvaso and Orenitram sales, reflecting patient demand and the resilience of our commercial strategy and execution. Continued double-digit revenue growth for total Tyvaso demonstrates that we are realizing no material impact from the launch of YUTREPIA. 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 Tyvaso DPI is the best positioned inhaled treprostinil 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 Tyvaso DPI since launch, and the fact that there are no payer incentives to prefer an alternative product. On dosing and convenience, our Tyvaso DPI platform is driving a meaningful shift in treprostinil dosing behavior. Historically, patients averaged 9 breaths per treatment using nebulized Tyvaso delivery. With Tyvaso DPI, that average has increased to a 12-breath equivalent or 64 micrograms. I'm pleased to announce that we will soon be launching Tyvaso 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 YUTREPIA. 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 treprostinil. 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 launched 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 Tyvaso DPI. On tolerability, we're looking forward to sharing abstracts at the PVRI Annual Congress in January that compare real-world data from United Therapeutics’ safety database to clinical trial evidence from YUTREPIA's INSPIRE study. These analyses show, among other things, a lower incidence of cough in both Tyvaso and Tyvaso DPI. Finally, on access, we have secured multiple favorable coverage decisions with major payers, supporting a clear validation that Tyvaso DPI is well-positioned in the marketplace. Our confidence in the growth profile of Tyvaso is further supported by the recent TETON 2 study, which, as Martine said, demonstrated an unprecedented treatment of benefit for inhaled treprostinil in patients with idiopathic pulmonary fibrosis. We are excited about the TETON 2 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 RemunityPRO 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 RemunityPRO 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.

Martine Rothblatt, CEO

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.

Operator, Operator

Our first question today comes from Lisa Walter from RBC.

Lisa Walter, Analyst

Congrats on the quarter. I'm just curious, given the TETON 2 results in IPF, are you perhaps seeing an uptick in diagnoses of IPF patients with PH? And if so, do you think this could positively impact Tyvaso sales over the next few quarters? Any color here would be helpful.

Martine Rothblatt, CEO

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, our regional nurse specialists. So Mike would have a lot of input on that. Michael?

Michael Benkowitz, President and COO

Thank you for the question. It's an interesting one. I attended both the European Respiratory Society and the CHEST conference last week in Chicago. Every physician I spoke with, I asked if the TETON 2 data would encourage them to be more proactive in screening for pulmonary hypertension in their IPF patients. They all responded positively. However, since we only just unblinded the data a few weeks ago, it's too early to see any direct increase in that regard or in relation to the TETON 2 study. Nonetheless, we are actively discussing this with physicians and watching it closely. It makes sense that this will unfold over time, but the extent and timing of that effect remain uncertain.

Operator, Operator

Our next question comes from Andreas Argyrides from Oppenheimer.

Andreas Argyrides, Analyst

Congrats on another solid quarter here. Martine, you mentioned in your remarks ralinepag and potential for combination. Can you just give us a sense of where you see the market opportunity for ralinepag and expectations for advanced outcomes next year? Appreciate it.

Martine Rothblatt, CEO

Ralinepag is exceeding expectations across all fronts. The enrollment for the outcomes trial, which is the largest ever for pulmonary hypertension, has gone exceptionally well. Additionally, some doctors have reported that patients who have completed the trial are maintaining best-in-class 6-minute walk distances even a year after leaving the trial. The long patent life for ralinepag, expected to last until around 2040, is a major advantage from a business perspective. This pill, which is taken once daily, appears to be the most potent prostacyclin therapy identified so far, allowing patients to manage their pulmonary hypertension effectively with one dose a day. Moreover, we are pleased with the synergy demonstrated in the data from Merck between sotatercept and treprostinil, which we continue to observe in the market. Following the launch of sotatercept, our sales have steadily increased, indicating a strong synergy between these two medications. Leveraging that synergy alongside a once-daily pill could enhance treatment even further. Additionally, ralinepag offers significant formulation flexibility, presenting various opportunities for combination oral treatments and more. While idiopathic pulmonary fibrosis is a focus for us, ralinepag remains our top priority as a new chemical entity.

Operator, Operator

Our next question comes from Joseph Thome from TD Cowen.

Joseph Thome, Analyst

Congratulations on the progress. Martine, you mentioned the potential for a combination partnership, and it seems like there is also a large pharmaceutical partnership concerning the recent Tyvaso IPF data. Could you elaborate on your thoughts regarding that? What would an ideal partner or partnership look like? Is this related to European rights, or could you provide any additional clarity on that since it seems like an update from the prior quarter, especially given the recent data?

Martine Rothblatt, CEO

Yes, it's interesting you mention that. Prior to releasing this data, it felt like around 90% of people were skeptical about the effectiveness of our drug for pulmonary fibrosis, which we found surprising. Our computational biology lab has developed an impressive digital model of the lung that encompasses all the major diseases we target. We utilize a large learning model based on prior studies in pulmonary fibrosis and pulmonary hypertension to create this digital lung model. This allows us to evaluate new drugs through the model to produce results based on established endpoint measurements. For instance, we modeled the entire TETON 2 study with all 100 clinical trials in a matter of hours, compared to the years it usually takes to enroll in such trials globally. The digital trial indicated a median improvement estimate of around 130 milliliters, which is notable given that our clinical trial showed a roughly 95 milliliters improvement over baseline. The close alignment between the digital and physical trials suggests that we have a strong grasp of the disease dynamics. This could encourage companies previously skeptical about the antifibrotic effects of treprostinil in pulmonary fibrosis to rethink their stance. While United Therapeutics is primarily a U.S.-based company, we do operate internationally, as seen with the enrollment for the TETON 2 trial across various countries. However, the majority of our revenue comes from the U.S., and all our medicines and delivery devices are produced here. If there are global partners interested in helping to provide the benefits of Tyvaso to patients worldwide, that would be beneficial for everyone involved. Thank you for the great question.

Operator, Operator

Our next question comes from Olivia Brayer from Cantor.

Olivia Brayer, Analyst

Can you talk through some of the commercial dynamics you're seeing for Tyvaso 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 PH-ILD. 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 Martine, 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.

Martine Rothblatt, CEO

Yes. So we do expect to hit $1.5 billion in 2027. And we're very happy for you poking around all the different lines and workflows of our revenue growth. So no problems there. And Michael will take it away on that question.

Michael Benkowitz, President and COO

Thank you for the question. Regarding what we are experiencing throughout the third quarter and into the early fourth quarter, we are confident that the launch of YUTREPIA has not caused any significant impact. In fact, similar to past competitor launches, it actually expands the pool of addressable patients because there is now another sales team discussing these diseases. This brings attention to pulmonary arterial hypertension Group 1 and PH-ILD in Group 3, which is beneficial for patients and also advantageous for the companies offering these medications. Historically, we have seen similar outcomes, such as with the sotatercept launch. As noted in the opening comments, we continue to see growth, and we anticipate this trend will continue into 2026, with ongoing growth for Tyvaso in both PAH and PH-ILD. From the start of September through mid-October, the metrics I monitor, including patient shipments, prescriber engagement, referrals, and starts, show strong performance. Patient shipments have been robust and have continued to be strong as we entered October. The number of prescribers has increased quarter-over-quarter, and we are retaining depth among our key prescribers. Although referrals and starts fluctuated a bit during the quarter, we have observed a steady upward trend since September, nearly returning to pre-YUTREPIA launch levels. Overall, this has unfolded largely as anticipated. Some patients have trialed competitive products, but many have returned. As we look towards 2026 and beyond, we believe we are well-positioned for sustained growth in both PAH and PH-ILD.

Martine Rothblatt, CEO

Perfect, Michael. Thank you so much. Wow, that's a great covering of all of that question.

Operator, Operator

Our next question comes from Roger Song from Jefferies.

Jiale Song, Analyst

Congratulations on another record quarter. I have a couple of quick questions. First, regarding the PPF, could you provide some insight on the timing of the enrollment data? Also, considering the TETON-2 data, how does it relate to the IPF? Have there been any new updates from physicians and scientists about the mechanism of action? Lastly, I believe you have a Phase II meeting with the FDA planned for around the end of the year. I'm curious about the potential outcomes; is there a possibility for earlier approval?

Martine Rothblatt, CEO

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 first instance on the enrollment progress with the PPF or maybe we could call it TETON 3 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 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 and 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 will probably make you the last answer because that was a lot of questions.

Leigh Peterson, EVP of Product Development and Xenotransplantation

Thank you. Yes, I did take notes. Regarding TETON-PPF, we're about halfway through enrollment, slightly more. The study design is very similar to TETON 1 and TETON 2, including a 52-week follow-up period. We can't provide specific details about when we expect unblinding, but that should give you some context. This study is being conducted in the U.S., Canada, and other parts of the world. Importantly, the similarities in underlying fibrosis and disease progression between IPF and PPF suggest that inhaled treprostinil could offer a treatment option for patients with PPF. Concerning the mechanism of action, the similarities in fibrosis, along with our in vitro and preclinical results, indicate an antifibrotic effect of treprostinil through various receptors, including the IP receptor, along with a vasodilation effect. We expect these effects to hold true for both indications. Regarding the regulatory path, we have agreed with the FDA to utilize data from both TETON 2 and TETON 1. We anticipate reporting TETON 1 results in the first half of 2026. We are also meeting with the FDA before the end of this year to discuss ways to potentially expedite the regulatory review process once TETON 1 results are available. Overall, this is promising and exciting, and it indicates consistent results among the various TETON trials.

Martine Rothblatt, CEO

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

Operator, Operator

Our next question comes from Roanna Ruiz from Leerink.

Roanna Clarissa Ruiz, Analyst

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?

Martine Rothblatt, CEO

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

Patrick Poisson, EVP of Strategic Development

Yes, 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?

Roanna Clarissa Ruiz, Analyst

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

Patrick Poisson, EVP of Strategic Development

Sure, sure. So 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 will be out there. And so we're really just looking to add convenience and easier dosing for patients.

Martine Rothblatt, CEO

Excellent, Pat. Thank you so much. I'm going to wrap up the call now. We've reached our allotted 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. Just 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.

Operator, Operator

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 Presentations 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.