United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation second quarter 2026 corporate update. My name is JL and I'll be a 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 the earnings call. If you'd like to ask a question during this time, simply press star then the number one on your telephone keypad. If you'd like to withdraw your question, simply press star one again.

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 8th in Boston, the Cancer Fitzgerald Global Healthcare Conference in New York on September 9th. Pat Poisson will join us for the Morgan Stanley Healthcare Conference in New York on September 14th. And then lastly, the Bernstein Third Annual Healthcare Forum in New York on September 23rd. Our scientific, commercial, and medical affairs teams will be present at the European Respiratory Society Congress in Barcelona September 5th through 9th and the American College of CHESS Physicians CHESS 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 advanced outcome study, demonstrating Relinapag's potential to become a major new oral therapy for patients with PAH. Then, we unblinded TETON1, which surpassed the impressive TETON2 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 high vaso 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 tyveso in IPF and the NDA for rilinopag in PAH. We are not stopping there. Additional filings planned later this year, including an IND for rilinopag DPI and an NDA for Tuprastenil 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 Nebula Tyveso in IPF, for Linapag in PAH and the SMI device in PAH and PHILD. These are not incremental opportunities. We believe they are multi-billion 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 TETON1 and TETON2 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 PPF would open the door to an even larger opportunity, at least double that of IPF. and position nebulized Tyveso 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 U Kidney 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 euthymokidney 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 two additional commercial scale DPFs in Minnesota and Texas. With three 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 lifesaving 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 timelines. 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 Thymune 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 Thymune 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 Tyveso, total revenue for the quarter was $453 million. Nebulized Tyveso remained pressured by competitive dynamics within the inhaled prostacycin category, as patients and providers evaluated 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. Tyveso 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 reach 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 enter the field in early July, and are already increasing our recent frequency of engagement with physicians across both PAH and PHILD. 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 a combination of record patient metrics, increased commercial reach, the strength of our differentiated portfolio and growing physician awareness positions as 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 two potentially transformative opportunities in front of us. First, Nebulized Tyveso and IPF. Second, Rolunopeg and PAH. Both represent areas of substantial unmet need. Both have the potential to become multi-billion dollar opportunities. and both have the potential to further strengthen our leadership position in respiratory and cardiopulmonary disease. For Tyveso and 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 Rilettapag, 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 is certainly narrowed. Factoring some of the revenue from our anticipated IPF and Rolanda PEG 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 two 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 Tyveso and IPF and Rolanda FEG 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 Unitarians 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 yourself to one question with respect to the long queue that we have. JL, you can go ahead.

Thank you. Again, if you have a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you wish to remove yourself from the queue, simply press star 1 again.

One moment, please, for your first question.

Your first question comes from the line of Joseph Tome of TD Cowan.

Your line is open.

Hi there, good morning, and thank you for taking my question. Maybe just as we're thinking about some of the other offerings, either Relinopag in PAH or the TRES-ME in PAH and PHLD, 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? Yeah, just kind of your thoughts around that.

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

Yeah, so I think in terms of Rolena PEG, as I think both Martine and I said in our opening remarks, we look at that as a multibillion-dollar opportunity. We talked about the notion that this is a super-processed cycling. We think that the data that we saw in the announced outcome studies certainly support that. I think the initial reactions and feedback we're getting from physicians is very positive, and I think the combination, 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, you know, eventually all of our indications. And so I think, you know, when we believe that that's going to be, you know, I think very well received by both the physician 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.

Next question, Operator.

Thank you.

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

Great. Thanks for taking the question. 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 Nebulizer IPF, Tyration IPF, and then Renanopak, and then Tresmai. Thank you.

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

Sure, Roger. Thanks for the question. You know, 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, early 2027. I think, you know, we're working through that now. You know, as we said, I think we certainly look at both as being multi-billion 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, you know, when we're able to launch. You know, 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 a launch directory. We'll have more information to share later this year, as I said.

Operator, next question.

Your next question comes from the line of Jessica Fye of JP Morgan. Your line is open.

Hey guys, good morning. Thanks for taking my question. I guess this one's for Michael and 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 Tyveso consensus is for about a billion and 47 million of revenue. Is that achievable based on kind of the, you know, larger Salesforce 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.

Yeah, so just 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 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.

Operator, next question.

Your next question comes from the line of Rowana Ruiz of Lyrinc Partners. Your line is open.

Hey, guys. You have Ryan on for Rowana. Thanks for taking our question. Maybe pivoting over to IPF, you know, coming out of ATS and your conversations with physicians, can you kind of talk about your expectations for where you think Tyveso is going to be positioned in the IPF treatment landscape? You know, in between Nebulizer, DPI, and SMI, what do you think is really the main driver of future prescribing for this franchise? Thanks.

Hey, Ryan. Good morning. Thanks for the question. We got Michael again for you.

Yeah, so just to make sure everybody's clear, when we launch into IPF next year, we're just not launching with the Nebulize type ASO. We still have some engagement to do with the FDA to understand exactly what we're going to need to do to get approval and that indication for both DPI and SMI. So the launch next year will slowly be nebulized in IPF. And I think 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, you know, as we've kind of talked to some of the top KOLs, they said, you know, 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, you know, ultimately 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 Tyveso 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.

Great. JL, you can take the next one.

Thank you. Your next question comes from the line of Ben Burnett of Wells Fargo. Your line is open.

Hi. Thank you very much. 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 to generate any more efficacy data?

Hey, 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 type A to DPI.

Yeah, you want me to start, Harry? Yeah.

Yeah, I mean, we're engaged with FDA to have those discussions to understand what they need to see for Tyveso 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.

Yeah, 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. And that goes for both SMI and DPI.

Great, thank you both. JL, next question.

Your next question comes from the line of Ash Reverma of UBS. Your line is open.

Hi, yeah, thanks for taking our question. Can you talk about the Salesforce expansion heading into the IPF and run and effect potential approval? How much of the Salesforce 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 tie-based indications? Thanks.

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

Sure, Ash. Yes, so we 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 Rolenapec indications. And we've done that. So we accelerated that process, made that decision earlier this year to accelerate that process and get those Get those sales reps out in the field by July 1st, which we've essentially done. I mean, just look at maybe one or two openings that we have to fill. But essentially, we've expanded the sales force. Now, of course, Relenopec 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 or a little bit greater reach and frequency to providers in our approved indications of PAH and PHILD. And so that, like I said, we got them out in early July and so they're out and starting to call on those physicians. I think your point on the call point is it's a little bit different in the sense that with IPS, those patients are much more in the community than the academic centers and that was really sort of the rationale behind Expanding the Salesforce and 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 position. It's just a question of getting deeper into the community than we currently have.

That's a great overview. Thank you. Operator, next question.

Thank you. Your next question comes from the line of Olivia Saunders of Kantor. Your line is open.

Hey, good morning, guys. Thank you for the question. 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 Jaskade'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 Jaskade and Tyveso. I also did want to see if there's anything you can say around baseline characteristics of the 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. Thank you.

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.

Yeah, so I think, Olivia, on your first question, I went to the 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 Yeah, JASCADE has had, I think, a very strong launch. I mean, there's no question. And so, you know, we're certainly looking at that. We're looking at what OFEP and ASBRIET did. And, you know, all of those things factor into kind of how we're thinking about the Tyveso trajectory. But like I said, we'll have a lot more details to share on that as we get to kind of later part of this year, early 2027.

Lee, do you want to take that PPF question?

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

Perfect. Thank you both. Operator, next one.

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

Oh, good morning. Thanks for taking our question. Just a quick one on the IPF SNDA filing. I 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 so much.

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

Yeah, 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.

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.unitedver.com. That is at ir.unither.com. You may now disconnect.