United Therapeutics Corporation (UTHR) Q2 2026 Earnings Report, Transcript and Summary

Good morning, and welcome to the United Therapeutics Corporation Second Quarter 2026 Corporate Update. My name is JL, and I'll be your conference operator today. [Operator Instructions] Please note that this call is being recorded. I'll now turn the webcast over to Harry Silvers, Investor Relations at United Therapeutics.

Thank you, JL. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation's Second Quarter 2026 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 Martine Rothblatt, James Edgemond and I will participate in a fireside chat and one-on-one meetings at the Wells Fargo Healthcare Conference, September 8 in Boston; the Cantor Fitzgerald Global Healthcare Conference in New York on September 9. Pat Poisson will join us for the Morgan Stanley Healthcare Conference in New York on September 14. And then lastly, the Bernstein Third Annual Healthcare Forum in New York on September 23. Our scientific, commercial and medical affairs teams will be present at the European Respiratory Society Congress in Barcelona, September 5 through 9, and the American College of Chest Physicians CHEST 2026 Annual Meeting in Phoenix, October 18 through 21. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?

We have slides available for reference, and I encourage you to review those at your leisure. I'm not going to speak directly to the slides. The first half of 2026 has been one of the most consequential periods in United Therapeutics' history. First, we delivered exceptional clinical results from our ADVANCE OUTCOMES study, demonstrating ralinepag's potential to become a major new oral therapy for patients with PAH. Then we unblinded TETON-1, which surpassed the impressive TETON-2 results we reported last September. Together, these results put us in an extraordinary position, a new molecule advancing toward the PAH market and a potential new indication for nebulized Tyvaso in IPF, representing an opportunity meaningfully larger than our currently approved markets and a new option for patients. With these highly statistically significant clinical results, we recently submitted to the FDA what we believe are two of the most important new drug applications in rare pulmonary disease: the sNDA for nebulized Tyvaso in IPF and the NDA for ralinepag in PAH. And we are not stopping there with additional filings planned later this year, including an IND for ralinepag DPI and an NDA for treprostinil SMI. We are moving with urgency toward what we believe will be a pivotal change in our growth trajectory as we plan to bring pioneering advanced inhalation technologies to patients. We expect potential approvals in 2027 for nebulized Tyvaso in IPF, ralinepag in PAH and the SMI device in PAH and PH-ILD. These are not incremental opportunities. We believe they are multibillion-dollar catalysts with the potential to redefine patient treatment paradigms, improve outcomes for patients and fundamentally transform our growth profile and competitive position. Looking further ahead, enrollment in our TETON-PPF trial is nearly complete, paving the way for another substantial Phase III readout in the back half of 2027. Based on the successful TETON-1 and TETON-2 studies as well as the similarities in underlying fibrosis and disease progression between IPF and PPF, we have a high degree of confidence in our ability to report another positive outcome. If successful, TETON-TPF would open the door to an even larger opportunity, at least double that of IPF, and position nebulized Tyvaso to become a leading therapy for patients with pulmonary fibrosis. Turning to our organ pipeline, we continue to make strong progress toward our goal of expanding the availability of transplantable organs. The UKidney EXPAND study continues to make great progress with completion of the initial six-patient cohort expected later this year. In parallel, we soon anticipate initiating the UThymoKidney EXTEND registration-enabling study. Lastly, with recent clearance from the FDA, we are working to commence our EXPRESS-UHeart study. Moreover, by the end of this year, we will complete construction of our 2 additional commercial-scale DPFs in Minnesota and Texas. With 3 authorized clinical trials, United Therapeutics is not just participating in the future of xenotransplantation; we are leading it. We believe this work can redefine organ transplantation, save countless lives and create one of the most significant growth opportunities in our company's history. Our deep organ pipeline represents a bold and differentiated extension of United Therapeutics' mission with the potential to transform how patients access life-saving organs and how United Therapeutics will create substantial value over the long term. We will be sharing with you more details about these programs as each moves through their development time lines. Our ability to pursue these opportunities is supported by a disciplined approach to capital allocation through our budget algorithm, which has positioned us near the top of our industry in operating efficiency. We have also been thoughtful in deploying capital toward internal growth objectives while remaining mindful of returning capital to shareholders. As an example, we recently deployed capital to acquire Thymmune Therapeutics, adding a promising thymus-based regenerative medicine platform that fits squarely within our mission. This acquisition broadens our organ alternative strategy and strengthens our ability to pursue therapies that could restore immune function for patients with serious diseases. We see tremendous potential ahead, and we're excited to welcome the Thymmune team to United Therapeutics. To close, we believe United Therapeutics is entering a defining era, one shaped by scientific ambition, innovative platforms and a pipeline with the potential to transform care across some of the most challenging areas of medicine. As these opportunities advance, we see a future in which our impact on patients, our industry and our growth trajectory can reach an entirely new level, making United Therapeutics a growth story unlike any other in biotech. And with that, I'll turn the call over to our President, Michael Benkowitz, who will provide an overview of our commercial performance for the quarter. Mike?

Thank you, Martine, and good morning, everyone. For the second quarter of 2026, we generated approximately $783 million in total revenue, essentially flat with the first quarter. While these results were below our expectations, they do not change our confidence in the strength of our business, the opportunities in front of us or our ability to create substantial value over the coming years. I want to start by acknowledging something directly. Over the last several quarters, we understand investors have been looking for a faster acceleration in growth, and we recognize that confidence is earned through execution, not projections. So our focus is on improving results. As we evaluate the current state of the business, we believe the underlying fundamentals are strong, and we believe we are positioned to deliver improved performance in the second half of the year. Simply put, we exited the second quarter with considerably more momentum than the reported revenue line alone would suggest. Based on the trends we're seeing today, we expect the second half of 2026 to be stronger than the first half of 2026, and we remain focused on accelerating revenue growth as we move through the balance of the year. That said, we are not reaffirming or updating any prior revenue growth expectations for 2026 today. Turning to Tyvaso, total revenue for the quarter was $453 million. Nebulized Tyvaso remained pressured by competitive dynamics within the inhaled prostacyclin category as patients and providers evaluate an increasing number of treatment options. We expected this market to become more competitive over time, and that's precisely what we are seeing today. Tyvaso DPI, meanwhile, continued to demonstrate growth and, more importantly, exited the quarter with what we view as significant underlying momentum. As we have discussed previously, quarterly sales are not always the best measure of underlying demand. Starts, referrals, total patients and commercial patients all reached record levels exiting the quarter. Those metrics give us confidence not only in the durability of the franchise but also in our ability to translate that momentum into stronger commercial performance over the second half of the year. So we remain confident in the strength and long-term value of our existing commercial portfolio. Our conviction is grounded in what we believe are highly differentiated therapies that offer meaningful advantages in efficacy, convenience, dosing and long-term tolerability. We continue to believe these characteristics matter deeply to patients and providers and position us well for sustained growth. Recognition of these benefits, particularly in a highly competitive environment, are taking time to crystallize with physicians. However, we believe our commercial strategy has us well positioned to accelerate that process, and the underlying trends we are seeing reinforce our belief that we are moving in the right direction. As we discussed last quarter, we significantly expanded, that is roughly doubled, our sales force. Those representatives entered the field in early July and are already increasing our reach and frequency of engagement with physicians across both PAH and PH-ILD. We recruited an exceptionally strong team with deep, relevant experience, and we expect their efforts to meaningfully enhance awareness of our therapies, accelerate adoption and support stronger commercial performance over time. To round out this section, we believe the combination of record patient metrics, increased commercial reach, the strength of our differentiated portfolio and growing physician awareness positions us well to accelerate performance in the second half of the year. At the same time, it's important to recognize that our story is not solely about the next quarter or the next year. We continue to believe that we have 2 potentially transformative opportunities in front of us. First, nebulized Tyvaso and IPF; second, ralinepag in PAH. Both represent areas of substantial unmet need, both have the potential to become multibillion-dollar opportunities and both have the potential to further strengthen our leadership position in respiratory and cardiopulmonary disease. For Tyvaso in IPF, we continue to see strong interest from physicians following the TETON results, and we remain excited about the potential impact this therapy could have for patients with limited treatment options today. For ralinepag, we believe the opportunity to introduce the first once-daily oral prostacyclin could represent a meaningful advancement for patients and providers seeking a differentiated treatment option. We have previously projected a $4 billion revenue run rate by the end of 2027 with our existing commercial portfolio. We still see a path to achieve this, although it has certainly narrowed. Factoring in some of the revenue from our anticipated IPF and ralinepag launches next year should get us there and beyond. Our strategy is straightforward. We are focused on executing and growing the business we have today while simultaneously preparing the organization for what we believe could be 2 important future launches. We do not view these future opportunities as replacing our current growth story. Rather, we view our current commercial portfolio as providing a strong, durable and growing foundation, while Tyvaso and IPF and ralinepag offer meaningful upside beyond that foundation. That combination gives us confidence not only in the long-term potential of United Therapeutics but also in our ability to accelerate growth in the near term and create value across multiple time horizons. Before I close, I want to share with our investors something that is an important part of our culture and how we work. Across the company, we have a rallying cry called LTFI, which stands for Lock The F In. While there are certainly exciting opportunities on the horizon in 2027 and beyond, LTFI is a reminder that our responsibility is not to focus on future possibilities at the expense of present execution. We have patients, providers, shareholders and fellow Unitherians counting on us today. LTFI is our commitment to all of those stakeholders. It's a reminder that, while we are excited about what may come next, our focus remains on what we must deliver now. And we believe the trends we are seeing today position us to do exactly that. We are focused; we are accountable. We are committed to accelerating performance in the second half of the year. And we will continue to be LTFI as we deliver for patients, providers, our colleagues and our shareholders. With that, I'll pass the call back to Harry to start our Q&A session. Harry?

Great. Thank you, Michael, and thank you, Martine, for the excellent overviews this morning. Before I give this over to JL to start the Q&A session, I would just like to remind those on the call asking questions, please try to limit yourselves to one question with respect to the long queue that we have.

[Operator Instructions] Your first question comes from the line of Joseph Thome of TD Cowen.

Maybe just as we're thinking about some of the other offerings, either ralinepag in PAH or the Tresmi in PAH and PH-ILD, I guess, how much do you think you're going to be able to kind of recapture maybe some of the momentum that you did lose by increased competition in the space? Yes, just kind of your thoughts around that.

Thanks, Joe. I'm going to pass it to Michael to answer that question.

Yes. So I think in terms of ralinepag, as I think both Martine and I said in our opening remarks, we look at that as a multibillion-dollar opportunity. We've talked about the notion that this is a super-prostacyclin. We think the data that we saw in the ADVANCE OUTCOMES study certainly support that. I think the initial reactions and feedback we're getting from physicians is very positive. And I think the combination of -- it's not just it being a once-daily oral prostacyclin, which we think is differentiated in and of itself. But more importantly, actually, the clinical benefit that we saw in the trial, I think, is really going to position us well for an exciting launch and, like we said, a multibillion-dollar opportunity. I think -- similarly with SMI, I think we look at SMI as really being a really differentiated way to deliver inhaled therapies across eventually all of our indications. And so I think when -- we believe that it's going to be, I think, very well received by both the physicians and the patients. We think there could be potentially some tolerability benefits. And so we look at that as really being, again, another way to kind of differentiate ourselves relative to competition.

Your next question comes from the line of Roger Song of Jefferies.

Great. Also along the line, in terms of those new product launch, appreciating the 2027 guidance reaffirmation. How should we think about the launch ramp-up for those new products, including the nebulized IPF, Tyvaso IPF and then ralinepag and Tresmi?

Thanks, Roger. Michael will answer that question for you.

Sure, Roger. Thanks for the question. I think we're going to have more information to share on launch trajectory or launch ramps as we get to the back half of the year or early 2027. I think we're working through that now. As we said, I think we certainly look at both as being multibillion-dollar opportunities. I don't think that's really in question. How quickly we get there? I think we're kind of working through that. And then obviously, a lot of that's going to depend on when we're able to launch. Do we get priority review or not? So I think as we get a little bit more information on the status of our regulatory filings and the timing of when we could see an approval and just kind of continue doing kind of our work on the commercial side to prepare our launch trajectory, we'll have more information to share later this year, as I said.

Your next question comes from the line of Jessica Fye of JPMorgan.

I guess this one is for Michael, and I appreciate the comments on how you see the business set up for a stronger back half than first half. I guess just in the interest of getting consensus numbers in the right place for this sort of period prior to the IPF launch, I think back half Tyvaso consensus is for about $1.047 billion of revenue. Is that achievable based on kind of the larger sales force and the other dynamics you mentioned? Or should the Street be thinking about that number a little bit differently? Just want to make sure expectations are in the right place for the next couple of quarters.

Thanks for the question, Jess. Good to hear from you this morning. We got Michael to answer that.

Yes. So Jess, as we said, we're not really kind of reaffirming or updating anything at this point. As I said in my opening remarks, we expect it to be -- we expect the second half to be stronger than the first half. And I think we're just going to kind of leave it at that for right now.

Your next question comes from the line of Roanna Ruiz of Leerink Partners.

You have Ryan on for Roanna. Maybe pivoting over to IPF. Coming out of ATS and your conversations with physicians, can you kind of talk about your expectations for where you think Tyvaso is going to be positioned in the IPF treatment landscape? And between nebulizer, DPI and SMI, what do you think is really the main driver of future prescribing for this franchise?

Ryan, thanks for the question. We got Michael again for you.

Yes. So just to make sure everybody is clear, when we launch into IPF next year, we're just not launching with the nebulized Tyvaso -- we still have -- have some engagement to do with the FDA to understand exactly what we're going to need to do to get an approval in that indication for both DPI and SMI. So the launch next year will solely be nebulized in IPF. And I think it's -- the feedback we're getting is, as I said in my remarks, really, I think, a lot of excitement around IPF, around the data, around the treatment option. And so I think as we've kind of talked to some of the top KOLs, they said whether they use it first line or whether they add it on, it's really going to be patient-dependent. But I think they all said ultimately, it doesn't -- it probably doesn't really even matter because I think what they're saying is IPF is moving towards what we're seeing in PAH in terms of a polytherapy approach to treating these patients. And so I think the vast, vast majority of the docs we're talking about have said they're going to use Tyvaso in combination with other products. And so whether it's sequenced first or second, it kind of doesn't matter, but they're going to quickly get to polytherapy.

Your next question comes from the line of Ben Burnett of Wells Fargo.

I just wanted to follow up just on IPF. And just what's your expectation for the type of data that you would need to generate to get the DPI and the SMI into IPF? Like would this just be bridging data? Or would you anticipate you need to generate any more efficacy data?

Ben, thanks. I think for part of the question with the SMI, perhaps Pat can address that. And maybe, Leigh, if you want to add any commentary on bridging to the Tyvaso DPI.

Yes, you want me to start, Harry?

Yes.

Yes. I mean we're engaged with FDA to have those discussions to understand what they need to see for Tyvaso DPI. So it's yet to be determined. And I'll pass it over to Leigh to maybe add some color to the clinical approach.

Yes. So as Pat said, we're engaging with FDA. We have some good ideas for bridging, and with regard to our current population that's enrolled as far as potentially new starts, we have a proposed strategy that we'll be presenting to them, and we look forward to seeing what they have to say, similar to what we've done in the past with regard to bridging. So -- and that goes for both SMI and DPI.

Your next question comes from the line of Ashwani Verma of UBS.

Can you talk about the sales force expansion heading into the IPF and ralinepag potential approval? How much of the sales force is already deployed? And I'm assuming the physician calling point is a little bit different. So how much does that help with the current Tyvaso indications?

Thanks for the question, Ash. Good to hear from you this morning. Michael can take that one for you.

Sure, Ash. Yes. So we -- what we've talked about in the past and what I mentioned in my opening remarks is our plan has always been to roughly double the size of the sales force to support both the IPF and ralinepag indications. And we've done that. So we accelerated that process, made that decision earlier this year to accelerate that process and get those sales reps out in the field by July 1, which we've essentially done. I mean we still got maybe one or two openings that we have to fill. But essentially, we've expanded the sales force. Now of course, ralinepag and IPF are not approved indications. So they're not out detailing those two products or indications, but we're using them, I think, to really kind of get a little bit more leverage and a little bit greater reach and frequency to providers in our approved indications of PAH and PH-ILD. And so that -- like I said, we have them out in early July, and so they're out and starting to call on those physicians. I think the -- your point on the call point is it's a little bit different in the sense that with IPF, those patients are much more in the community than the academic centers, and that was really sort of the rationale behind expanding the sales force in IPF is because we knew we were going to have to go deeper into the community than we previously have had to because that's where those patients reside. So it's not necessarily a different physician. It's just a question of getting deeper into the community than we currently have.

Your next question comes from the line of Olivia Saunders of Cantor.

Are you able to put some numbers around how big of a revenue opportunity you see IPF being, maybe, kind of, overall franchise at peak? And just given how impressive JASCAYD's uptake has been so far, how does that impact the way that you guys are thinking about your own launch just given some of the differences between JASCAYD and Tyvaso? I also did want to see if there's anything you can say around baseline characteristics of the TETON PPF patients enrolled so far, just given that you're hitting that 95% plus and whether you guys plan to publish those details after enrollment wraps.

Thanks, Olivia, for your questions. I think Michael will address the commercial expectations side of it, and then maybe Leigh can answer the part on PPF patient characteristics.

Yes. So I think, Olivia, on your first question in terms of opportunity, as I said, I think to an earlier question, I think we'll start to provide more information on kind of all of that peak potential and ramp and trajectory and all of that as we get to the second half -- deeper into the second half of the year. The -- yes, JASCAYD has had, I think, a very strong launch. I mean there's no question. And so we're certainly -- we're certainly looking at that. We're looking at what OFEV and Esbriet and all those things factor into kind of how we're thinking about the Tyvaso trajectory. But like I said, we'll have more details to share on that as we get to kind of later part of this year, early 2027.

Leigh, do you want to take the PPF question?

Yes. So as we mentioned, our PPF study enrollment is actually quite a bit ahead of schedule, finishing up very, very shortly. And yes, we will present the baseline characteristics of those -- that patient population in upcoming conferences. And so basically, that's your answer. Yes, you will be seeing those. We look forward to sharing.

Your next question comes from the line of Lisa Walter of RBC Capital Markets.

Just a quick one on the IPF sNDA filing. Wonder if you could share the date when it was filed and when we could hear about acceptance of the filing and whether you think there is potential for priority review? Any color here would be helpful.

Thanks, Lisa. Always happy to take your questions. I think Leigh can answer that one.

Yes. So we submitted late June, and we will be learning shortly if we're able to receive priority review, probably -- well, I can't really give a specific date on that. But again, that would be a six-month review period if that is received and 10 months otherwise. So that's basically what I can say right now.

I think that was perfect, Leigh. Operator, you can go ahead and 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 Presentations section of the United Therapeutics Investor Relations website at ir.unither.com -- that is -- sorry, that is at ir.unither.com. You may now disconnect.