UTHR

Good morning, and welcome to the United Therapeutics Corporation First Quarter 2026 Corporate Update. My name is JL, and I will be your operator today. All participants on the call portion of this webcast will be in listen-only mode until the question-and-answer portion of this earnings call. If you would like to ask a question during that time, simply press star then one on your telephone keypad. If you would like to withdraw your question, simply press star and one again on your telephone keypad. Please note that this call is being recorded. I'll now turn the webcast over to Harry Silvers, Investor Relations at United.

Thank you, JL. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation First 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 Patrick Poisson, our Executive Vice President of Strategic Development. Note that James Edgemond and I will participate in a fireside chat and one-on-one meetings at the RBC Global Healthcare Conference in N.Y. on May 19th, as well as the Jefferies Global Healthcare Conference in New York on June 3rd. Our scientific, commercial, and medical affairs teams will be present at the American Thoracic Society International Conference in Orlando, May 15th to the 21st. Now, I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine.

Thank you, Harry. Okay, folks, it's going to be a great and exciting call today. UT is doing so freaking amazing that it is hard to imagine any other mid-cap biotech right now with prospects as good as ours. Here's what I mean. We just proved beyond a shadow of a doubt with a P value of less than 0.0001 that we have two different therapeutics in two different diseases of substantial size, each of which has been shown to produce better clinical outcomes than any other drug ever approved for either indication. Wow, that's got to sink in. I personally have not seen anything like that from a single pharma company all accomplished within six months. The two diseases we will be the best therapeutic for based on the completed phase III trials are IPF with TYVASO and PAH with Ralinepag.

Each of the two products will exceed our total revenues of today, a revenue run rate of $3 billion going to $4 billion by the end of 2027. Let's take Ralinepag first. Every patient with PAH should be prescribed that once-daily pill because it actually gives them their best shot at clinical improvement. Specifically, we showed a threefold reduction in disease progression compared to background therapy, where Ralinepag hit this and all other primary endpoints with better hazard ratios than selexipag and durably through four years. Frankly, this is the drug I dreamed of in starting United Therapeutics. This is why we've been calling Ralinepag a super prostacyclin. There is simply no reason that virtually every PAH patient shouldn't be on it. Hence, I fully expect within two years of launch, it will double our number of PAH patients to over 30,000 total.

Next, let's look at TYVASO for IPF. I said this will become the most prescribed drug for IPF because it improves forced vital capacity far more than the three existing drugs. It, and only it, boosted FVC to over 100 mL of oxygen, and it did so quickly, and it did so durably. With tens of thousands of PAH patients and tens of thousands of IPF patients, it is nearly certain that these two drugs, once approved, will lap our 2027 $4 billion revenue run rate twice over. Coming right behind TYVASO for IPF will Tyvaso DPI for IPF, and right behind that, Treprostinil SMI for IPF. Our goal is to leave no IPF patient behind, regardless of how their particular body best absorbs TYVASO. Now let's take a breath and reflect back on United Therapeutics. UT has been ahead of schedule as a habit.

We were ahead of schedule on OUTCOMES unblinding. We were ahead of schedule on TETON unblinding. Today I'm excited to announce another ahead of schedule. The next blockbuster product to emerge from stealth mode in our Skunk Works division, an inhaled formulation of our new chemical entity, Ralinepag, called raldpi, R-A-L-D-P-I. In stealth mode a few months ago, we activated our exclusive option with MannKind for a second DPI. We now feel confident based on subsequent PK, computational biology via our proven Klein digital lung model, and the results of the OUTCOMES and TETON studies that this will be our biggest product ever. As you can see in the distributed market capture graph, we foresee our raldpi product rising to tens of thousands of treated patients through PAH, ILD, IPF, and PPF.

Indeed, we will need all the capacity of the Danbury, Connecticut MannKind production plant and all the capacity of the new United Therapeutics North Carolina DPI facility to keep up with the Tyvaso DPI and Ralinepag demand. Let's delve into the science to better appreciate what a generational product raldpi will be for IPF. Ralinepag is the most potent member of the class of drugs that includes Treprostinil. This is super clear from the extraordinary results of the OUTCOMES study. Second, it is now indisputable that this class of drugs via inhalation has significant anti-fibrotic effects as we proved in the two TETON trials. Ergo, we very reasonably and scientifically expect raldpi to show after further clinical trials that it is the best-in-class treatment for IPF and PPF.

The scientific reason lies in the chemical differences between the new Ralinepag molecule and the old Treprostinil molecule, both of which are digitally mirrored in our Klein predictive computational biology model. Ralinepag has eight fewer hydrogen atoms than Treprostinil, instead has a key nitrogen and a key chlorine atom that Treprostinil lacks. These changes in molecular chemistry make all the difference in the world for pharmacodynamics and pharmacokinetics. Treprostinil is a very, very good molecule delivering very, very good results. Not our Treprostinil, not Insmed's, not Liquidia's Treprostinil, none of these can ever be the super prostacyclin that is Ralinepag. It is just not in their chemistry, but it is in Ralinepag's chemistry. It is this change in chemistry that makes Ralinepag a generational product for IPF.

In summary, UT's longstanding multiple shots on goal strategy has now yielded its greatest reward, a proven once-daily NCE in PAH formulated to use a proven DPI drug device for the best in disease treatment of the largest indications to which we aim. As we march to this summit, we are rising through a series of great product stages that give us ever greater reach into the PAH and IPF communities. Namely, we are rising through TYVASO for ILD and IPF, Tyvaso DPI for ILD and IPF open label extension, TYVASO SMI or Tresmi for PAH, ILD and IPF, and many more such combinations of products and diseases to treat which are still in stealth mode in our Skunk Works division.

Each incremental product indication platform that I just mentioned, each of these we are now aggressively developing for new and existing markets, and each of these brings UT ever closer to the ultimate goal depicted in the forecast chart released today. Thanks for listening and digesting all of this great science and great clinical development work. Now I'll turn to Michael to describe how the demand for our existing products from doctors and patients is strong as ever. Mike?

Thank you, Martine. That's a tough act to follow, but I'm gonna do my best. Good morning, everyone. For the first quarter of 2026, we recorded $782 million in total revenue. Typical historical seasonality trends persisted in the first quarter, in addition to severe winter weather and pharmacy operations issues that slowed starts during the quarter. These have since been rectified, it did impact our sales in the quarter, particularly in February. As discussed on our last earnings call, we expect to return to sequential growth in the near term. Turning to TYVASO, total revenue for the first quarter was $458 million. While sales of nebulized TYVASO lagged a little bit over the quarter, Tyvaso DPI contributed 9% year-over-year growth, driven by an increase in patient demand.

Looking at the competitive landscape, it's clear the market for inhaled prostacyclins is attractive and growing. We built and lead this market and expect our proven expertise to continue to win in the long term. We see this competitive dynamic as fuel for sharper execution across the organization, enhancing our strategic focus while operating with greater tactical intensity as we continue to shift momentum back in our favor. Speaking of momentum, we are seeing favorable trends in our underlying demand metrics. Coming out of the quarter, TYVASO referrals or prescriptions rates are at approximately the same level they were before Yutrepia launched. Patient shipments have grown for the last five months.

Prescriber breadth and depth continue to grow. We've seen a steady increase in patients graduating to higher doses of Tyvaso DPI with the launch of the 80 mcg single capsule and the 96 mcg and 112 mcg combination kits. Going forward, we're doubling down on what has always driven our success. Relentless innovation, proven experience, and patient obsession. Additionally, the sales force investments we're making in anticipation of the Ralinepag and IPF approvals will be deployed in the middle of this year to focus on expanding our reach and capturing more of the large addressable but yet uncaptured market in PH-ILD and expanding share in PAH with our existing commercial portfolio. We've built a durable, high-performing commercial engine. We're confident in our ability to expand our core business while driving the next wave of growth in Tresmi, Ralinepag and IPF.

To once again quickly recap, as Martine mentioned, both the TETON-1 and TETON-2 trials of nebulized TYVASO and IPF were a resounding success and exceeded our highest expectations. We look forward to filing a supplemental new drug application by the end of the summer and believe the highly compelling body of evidence across both the TETON studies could warrant an expedited approval through priority review to bring this therapy to those patients in need as quickly as possible. If we receive a standard review timeline, we would expect to launch by Q2 of next year. In parallel, we have already embarked on preparations for a product launch. Following IPF approval, we will work with payers to secure coverage for the new indication as soon as possible. We recognize the substantial market opportunity that lies ahead, and we are fully prepared to seize it.

Coming back to advent OUTCOMES, the unprecedented top-line results suggest Ralinepag has the potential to revolutionize the treatment of pulmonary arterial hypertension as the first true once-a-day oral prostacyclin agonist. We believe this advancement could fundamentally shift the treatment paradigm, potentially positioning prostacyclins for earlier line usage in conjunction with ERAs and PDE5s. With a differentiated clinical profile combined with its convenient once-daily dosing, we foresee a multi-billion dollar opportunity in the market for oral Ralinepag, where we expect to launch mid-next year, assuming a smooth FDA approval on a standard review timeline. In summary, our goals over the near to medium term are to drive further growth in TYVASO, the most prescribed inhaled prostacyclin, and after anticipated FDA approvals for Ralinepag to become the most prescribed prostacyclin for PAH and for nebulized TYVASO to become the most prescribed therapy for IPF.

To close, I wanna recognize the intensity, discipline, and patient-first commitment our commercial and medical affairs teams bring every day. We remain confident that our business is positioned to deliver sustained double-digit long-term growth. With that, I'll pass the call back over to Harry to start the Q&A session.

Thanks, Michael. Operator, if you want to assemble the roster and start with the first question.

Thank you. If you have a question, please press star one on your telephone keypad. If you wish to remove yourself from the queue, simply press star one again. One moment please for your first question. For today's session, we do ask that you restrict yourself to one question. Your first question comes from line of Ash Verma of UBS. Your line is open.

Hi, thanks a lot for taking our question and congrats on all the progress. Maybe just on the IPF regulatory filing and how you're positioning yourself in the market. I know you had previously mentioned that you would do bridging study for the DPI and where are we on that? Do you think that by the time that you launch the IPF, you would have the DPI format available? Just as a quick follow-up, I wanted to understand just your thoughts on the JASCAYD or nerandomilast launch metrics that are looking particularly strong. Do you think that is kinda like indication of the pent-up demand in this market, given there isn't much of good options available? How does TYVASO get positioned compared to JASCAYD when you launch it? Thanks.

All right, thanks, Ash. Everybody please try to keep it to one question. Lee, if you wanna take the DPI to IPF component, and then maybe Michael can follow up on JASCAYD.

Yep. Thanks. We're actually working with FDA to come up with our bridging strategy for IPF with the Tyvaso DPI. I think we've been discussing that before. We will likely do a healthy volunteer PK compatibility studies, comparability studies, and as well as patient studies to demonstrate safety and efficacy. As far as the sample size and duration of those studies, again, we're still working with FDA to come up with a Clinical Development Plan.

Yeah. Thanks, Leigh. [crosstalk]

Just on the JASCAYD front. Do it. Wait, let me I think I'm gonna address the question that.

Yep, go ahead.

Ash had on JASCAYD. Yeah. Yeah, Ash, I mean, obviously we're following that very closely. I do think that's a good, a good proxy or a good analog and does suggest that there is a lot of pent-up demand for new therapies in IPF given what's currently on the market. Yeah, I mean, yeah, I guess the short answer is I, we agree with you, and that's really kinda how we're starting to think about potential launch curve. We're starting to have conversations with physicians now. It's still a little bit on the early side 'cause we were somewhat embargoed in what we could talk about with The New England Journal publication.

Now that that's behind us, we're able to have those conversations. I think we're hearing from the physicians that they're very impressed by the data, very excited about bringing TYVASO to market. I think we had a, you know, we had an advisory board about a month or so ago where we had, you know, some of the, like, the top 15, I think, IPF treaters in the country. We were asking a question around, you know, what, where are you gonna use TYVASO? Are you gonna use it first line? Are you gonna use it after JASCAYD? How do you think about this? You know, they all said, it's gonna be patient-dependent. Some cases they do use TYVASO first.

In some cases, they may start JASCAYD. At the end of the day, it doesn't matter 'cause they fully expect that this disease is gonna look a lot like what we see in PAH, where it's combination therapy. Even if they're starting JASCAYD first, they're gonna add TYVASO on very quickly thereafter. Yeah, we think the potential is, as Martine said in the beginning, just enormous in IPF.

All right. Operator, next question.

Thank you. Your next question comes from the line of Roanna Ruiz of Leerink Partners. Your line is open.

Great. Morning, everyone. I was curious, how does your overall commercial strategy and peak sales and timing expectations change now that you're focusing on, you know, a few different levers, like the triple combo pill for Ralinepag, a DPI for Ralinepag, and also thinking about the SMI?

Thanks, Roanna, for the question. good to hear your voice this morning. Michael, you wanna take that one?

Sure. I think we'll provide some more granularity as we start to kind of, you know, build out our forecast. We start to have more conversations with physicians about the different products and where they expect to use them. I, you know, I think high level, what Martine said in her opening remarks is right. I mean, if we're, you know, we're turning towards $4 billion dollar run rate by next year. We think certainly with just Ralinepag and the IPF indication, regardless of the delivery device, you know, that puts us on a path to more than double revenues over the next few years. That's what we're building for and aiming for.

How that breaks out between the different indications, different devices, like I said, I think we'll provide some more granularity on that as we get later in the year and build out our models.

All right, Operator, next question.

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

Hey, guys. Good morning. Thanks for taking my question. I wanted to focus on Ralinepag DPI. Can you just confirm this product coming out of stealth mode, is that the once-daily inhaled product you've been alluding to in prior quarters? When should we expect that phase I healthy volunteer PK/PD data comparing that product to oral Ralinepag? What led you to decide for DPI over SMI for Ralinepag's new formulation? Thank you.

Thanks, Jess. Good to hear from you. Welcome back. We'll kick that over to Pat to answer on Ralinepag DPI plans.

Yeah. Thanks, Harry, and thanks for the question. First, let me say we are excited to work with the MannKind development team again. What we were able to do with, together with Tyvaso DPI, which was approved in less than four years from our engagement while contending with the pandemic, was really nothing short of incredible, and we expect a even better encore with raldpi . As mentioned in the MannKind press release this morning, we began work on raldpi about six months ago, and we've made great progress with the completion of formulation development and the transition into manufacturing tox study supplies.

We've had a very positive pre-IND engagement with FDA and we'll shortly be moving into some minimal non-clinical testing, which will be quickly followed by an IND and a phase I study. Which we will, we believe will be completed before the end of the year. We believe the half-life of Ralinepag, along with some other characteristics we are investigating, are very promising for this to be a once-a-day product. Important to note that this will be without the addition of any release controlling materials, which need to be carefully studied for safety when used chronically. I'll finish with, as they say in IndyCar racing, we are staying with hard tires and not making any pit stops.

Thank you, Pat. That was a great answer. Operator, next question, please.

Your next question comes from the line of Joseph Thome of TD Cowen. Your line is open.

Hi there. Good morning. Congrats on progress, and thanks for taking my question. Maybe just to extend a little bit on the development program for raldpi. Maybe how quickly can this move? Is the availability of the data for oral Ralinepag helpful at all, maybe specifically for PAH? Could you go right into registration? Just trying to think about timelines relative to some competitors in this space. Thank you.

Hey, Joe. Thanks for the question this morning. I think we'll kick that back over to Pat again.

Yeah, another great question. You know, of course, the ADVANCE OUTCOMES data was off the charts incredible. That's very encouraging that raldpi will be very effective to treat PAH, PH-ILD, and IPF and PPF. As far as the timing, I think long term, we're gonna be able to move into PAH fairly quickly relative to our world in pharma, as we'll be pursuing that approval with the solid dose.

Certainly, the solid dose has been a big contributor to our engagement with FDA and really, you know, the minimal amount of pre-IND work that we have to do for raldpi. I anticipate, you know, we'll complete the initial phase I study by the end of the year. We'll rapidly be able to kick off studies for PAH efficacy as well as PH-ILD, IPF, and PPF. Each of those will progress at different paces, and initially, PAH will be the first approval.

Thanks again, Pat. Operator, you can go ahead.

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

Good morning. Thanks for taking our question. On the once daily Ralinepag DPI, just wondering if you can share more color on the formulation. Should we think of this as a Ralinepag prodrug or another formulation with a lung-targeting ligand? Are relatively little additional flourishes needed to make Ralinepag inhalable? Any color here would be helpful. Thanks so much.

Thanks, Lisa. Good to hear from you. Pat, you're the star of the show today.

All right. Thanks, Harry. We'll be leveraging MannKind's Crystal Carrier IP for Ralinepag, very similar to what we have for Treprostinil. It is not going to be a pro drug. Now, perhaps we investigate other polymorphs of Ralinepag in the future, but initially it's going to be the Ralinepag molecule that we investigated for solid dose. Again, very similar formulation to the current Treprostinil, in using MannKind's Crystal Carrier IP.

All right. Thanks, Pat. Operator, you can move to the next question.

Your next question comes from line of Olivia Brayer of Cantor. Your line is open.

Hey. Good morning, guys, and thank you for the question. Now that you are committing to developing a number of different formulations in IPF going forward, can you maybe just talk about which you think have the highest chances for success and how you're thinking about nebulized versus DPI versus SMI and then also TYVASO versus Ralinepag for IPF patients specifically? Just kind of following up on that from a regulatory strategy perspective, anything you can say yet in terms of what that strategy is for getting some of these next formulations to patients? I mean, it sounds like a bridging study for DPI, but what about the SMI formulation? Then when could you realistically start those Ralinepag studies in IPF and PPF? Thank you.

Thanks, Olivia. Perhaps from a broader strategic standpoint, Michael can take that question and then maybe Leigh could follow up on the regulatory side.

Yeah. I think from a strategic standpoint, our approach to IPF is very similar to what you've seen us over the last 30 years do in PAH, which is take a multiple shots on goal approach. You know, we started with Remodulin IV. We thought Remodulin subQ could be a better version of Remodulin just in terms of, you know, dealing with the potential for infections. You know, we progressed to Tyvaso, we progressed to Orenitram. Now we're, you know, we looked at Tyvaso DPI. We look at, and now Ralinepag.

I think the point of all that is that I think what we've uncovered in PAH, and we think this is true in IPF, is that patients are like snowflakes, right? They're not this homogenous group of people that all respond to the same drug delivery approach. There's a role for all of these products in PAH, and I think that's what we're gonna see in IPF is, we take multiple shots on goal and, you know, I think we're very optimistic and confident in our ability to bring all of these products to market. We think they're all going to have a role, right?

I think, you know, there's gonna be some patients that like, you know, that are gonna respond well to DPI. I mean, you look over in PH-ILD, I mean, I think, you know, you still have a significant number of patients that are still on nebulizer even though you have the convenience of a DPI. So, you know, patients are, you know, they're unique. They all respond to different drugs and different delivery devices in different ways. You know, the approach has always been multiple shots on goal. We give patients options, give patients options in terms of the way they can receive the drug.

From our standpoint, we're really kind of agnostic as to which one they choose as long as they're choosing one of our products. Strategically, that's how we think about these different devices and different NCEs in IPF. If Leigh, I don't know if you wanna, or Patrick, you guys wanna talk about the regulatory path.

Yeah. Actually, I just wanted to add on a little bit to, a little bit of color to what you said and with the patients or people are snowflakes. Just keep in mind that with so we have different, the different sort of categories. We have the inhaled route versus the oral route. Now, we know that oral for patients, especially if it's once a day, tends to be more convenient, but we also know that systemic vasodilators are generally contraindicated in patients with like PH-ILD or IPF given the potential for worsening ventilation perfusion mismatch, VQ mismatch. That kind of separates that right there as to we imagine the inhaled would be more for this other population.

Then as far as the powder versus the SMI, some patients, it could be a convenience thing or a cough. You know, some patients might be more sensitive to the powder versus the nebulizer. That's, you know, where that might fall out. Then as far as, you know, this is something we haven't really talked about too much, but, you know, even though Treprostinil and Ralinepag are both in the same class of drugs, they do bind, you know. Martine went through the chemistry of the actual molecular structure between the two. As such, they bind their receptors, you know, differently. Ralinepag is a really potent IP receptor agonist, whereas Treprostinil binds multiple receptors, IP, EP2, and DPI.

There may be some differences with regard to efficacy there based on, you know, patient genetics. You know, all of these things, again, just to reiterate that they really give us, you know, this really allows individual patient to get the absolute best treatment possible. As far as the IP receptor goes, there's some recent data that recent preclinical data that IP receptor activation promotes alveolar regeneration during lung repair. This is if you want to really get into the molecules and the pathways versus this Jun/p53 pathway.

I mean, there's coming out more and more evidence for these things and this class of molecules versus different mechanisms of action in these indications, whether it's PAH or PH-ILD or ILD or IPF or PPF or all of them. Anyway, just wanted to add a little bit more there, and then maybe Pat would wanna talk about the regulatory aspect.

Yeah. I mean, I think the regulatory, you know, strategy would proceed kind of as expected. We'll have nebulized approved in IPF, and we'll conduct whatever agreed upon bridging study is necessary and then proceed directly with a filing from there. I don't anticipate anything unusual.

Thank you, Pat, Leigh, Michael. Three really wonderful answers. Operator, I think one more question we have time for.

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

Great. Congrats for the call and thank you for squeezing me in for the last question. Maybe, I think, in the in the updates, you also have the PH-COPD phase II about to start later this year. Curious about how should we think about the market opportunity and then also what the product formulation potential sequence for that indication, given we haven't talked about a lot of the combination device and the drug? Thank you.

Thanks, Roger. Leigh, perhaps you wanna share a little bit of color on the PH-COPD study?

As far as the formulation, we're planning to use Treprostinil SMI, excuse me, for this and for PH-COPD. We're planning on doing the study in a couple of phases. We obviously have our phase I where that's already ongoing with the Treprostinil SMI in healthy volunteers. We're planning a phase II study with PH-COPD patients, and that'll be followed by a phase III PH-COPD study. We've have several learnings over the years that are being considered here with regard to patient populations. We're really looking forward to starting these studies with these sort of enriched patient population eligibility criteria.

Thank you, Leigh. Operator, you can go ahead and close 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. That is ir.unither.com. This concludes today's conference call.