Transcript: United Therapeutics Q1 2026 Earnings Conference Call

United Therapeutics Corporation

United Therapeutics Corporation

UTHR

0.00

United Therapeutics (NASDAQ:UTHR) reported first-quarter financial results on Wednesday. The transcript from the company's first-quarter earnings call has been provided below.

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The full earnings call is available at https://app.webinar.net/4yJGk8ngNEA

Summary

United Therapeutics Corp reported a first-quarter 2026 revenue of $782 million, with Tyvaso contributing $458 million despite some operational issues.

The company announced significant progress and promising results from clinical trials for Ralinepag in PAH and Tyvaso in IPF, projecting these to significantly boost revenue.

Strategic initiatives include multiple product formulations and regulatory filings, aiming to expand their market presence in PAH and IPF with a forecast of doubling revenues.

Management highlighted the success of their 'multiple shots on goal' strategy and the potential of their new chemical entity, Ralpi, for inhalation across various indications.

Future outlook remains positive with expectations for FDA approvals and market expansions, emphasizing relentless innovation and patient-focused strategies.

Full Transcript

JL (Operator)

4 3. 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 the number one on your telephone keypad. If you would like to withdraw your questions, simply press STAR and the number 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.

Harry Silvers (Investor Relations)

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 10K and 10Q, 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 Edgeman, our Chief Financial officer and treasurer Dr. Lee Peterson, our Executive Vice President of Product Development and Xenotransplantation and and Pat Poisson, our Executive Vice President of Strategic Development. Note that James Edgeman and I will participate in a fireside chat and one on one meetings at the RBC Global Healthcare Conference in New York 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 Rothblatt

Martine thank you Harry. Okay folks, it's going to be a great and exciting call today. UT is doing so frickin 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 three 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. 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 PH 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 force vital capacity far more than the three existing drugs it and only. It boosted Forced Vital Capacity to over 100 milliliters of oxygen. And. And it did so quickly, and it did so durably. With tens of thousands of PH 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. And coming right behind Tyvaso for IPF will be Tyvaso DPI for IPF and right behind that, Tyvaso 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 on blinding. We were ahead of schedule on Teton on blinding. And today I am excited to announce another ahead of schedule, the next blockbuster product to emerge from stealth mode. In our Skunk Works division and inhaled formulation of our new chemical entity Ralenopag called Ralpi R A L D P I in stealth mode. A few months ago we activated our exclusive option with Mankind for a second dpi. We now feel confident based on subsequent PK computational biology via our proven climb 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 raw pie 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 Mankind production plant and all the capacity of the new United Therapeutics NC DPI facility to keep up with the Tyvaso DPI and Ralpi demand.

Martine Rothblatt

Now let's delve into the science to better appreciate what a generational product Ralpi will be for IPF. Ralenopag is the most potent member of the class of drugs that includes Treprostanol. This is super clear from the extraordinary results of the outcome 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 Ralpi to show after further clinical trials that it is the best in class treatment for IPF and pps. The scientific reason lies in the chemical differences between the new ralinepag molecule and the old treprostanol molecule, both of which are digitally mirrored in our climb predictive computational biology model. Ralenopeg has 8 fewer hydrogen atoms than triprostanol but instead has a key nitrogen and a key chlorine atom that treprostenol lacks. These changes in molecular chemistry make all the difference in the world for pharmacodynamics and pharmacokinetics.

Martine Rothblatt

Now troprostanol is a very very good molecule delivering very very good results. But not R Tryprostanol, not not insmeds, not liquidious treprostanol. None of these can ever be the super prostacycline that is Ralenopeg. It is just not in their chemistry, but it is in ralenapeg's chemistry. It is this change in chemistry that makes Ralenapeg a generational product for IPF. In summary, UT's long standing multiple shots on goal strategy has now yielded its greatest reward.

Martine Rothblatt

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. And 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 Tres MI 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.

Martine Rothblatt

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. And now I'll turn to Michael to describe how the demand for our existing products from doctors and patients is strong as ever.

Michael Benkowitz

thank you Martine. That's a tough act to follow, but I'm going to 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, but it did impact our sales in the quarter, particularly in February.

Michael Benkowitz

As discussed on our last earnings call, we expect to return to sequential growth

Michael Benkowitz

in the near term. Turning to Tibaso, 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 processed cyclins is attractive and growing. We built and lead this market and expect our proven expertise to continue to win in the long term.

Michael Benkowitz

We see this competitive dynamic as fuel for sharper execution across the organization and 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 Uptrevia launched. Patient shipments have grown for the last five months. Prescriber breadth and depth continue to grow, and we've seen a steady increase in patients graduating to higher doses of Tyvaso DPI with the launch of the 80 microgram single capsule and the 96 microgram and 112 microgram combination kits. Going forward, we're doubling down on what has always driven our success relentless innovation, proven experience and patient obsession. Additionally, the salesforce investments we're making in anticipation of the relentpeg 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

Michael Benkowitz

share in pah. With our existing commercial portfolio, we've built a durable, high performing commercial engine and we're confident in our ability to expand our core business while driving the next wave of growth in Treprostinil, Ralinepag, PEG and IPF to once again quickly recap as Martine mentioned, both the Teton1 and Teton2 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. And in parallel, we have already embarked on preparations for a product launch following IPF approval. We'll 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're fully prepared to seize it. Coming back to Advanced Outcomes the unprecedented top line results suggest relentpag has the potential to revolutionize the treatment of pulmonary arterial hypertension. As the first true once a day oral prostacycline agonist, we believe this advancement could fundamentally shift the treatment paradigm, potentially positioning prostacyclines for earlier lying usage in conjunction with ERAs and PD5s. With a differentiated clinical profile combined with its convenient once daily dosing, we foresee a multibillion dollar opportunity in the market for oral orlanipag 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 prostacycline, and after anticipated FDA approvals for Ralenopag to become the most prescribed prostacycline for PAH and for nebulized Tyvaso to become the most prescribed therapy for IPF to Close. I want to 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 and A session.

Harry Silvers (Investor Relations)

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

Operator

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 and for today's session we do ask that you restrict yourself to one question. Your first question comes from the line of Ash Verma of ubs. Your line is open.

Ash Verma (Equity Analyst at UBS)

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? And do you think that by the time that you launch the IPF you would have the DPI format available? And just as a quick follow up I wanted to understand just your thoughts on the Jascade Orange last launch metrics that are looking particularly strong. So do you think that is kind of like indication of the pent up demand in this market given there isn't much of good options available? And how does Tyvaso get positioned compared to Jascade when you launch it? Thanks.

Harry Silvers (Investor Relations)

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

Lee Peterson (Executive Vice President of Product Development and Xenotransplantation)

Yep. Thanks. So for to we're actually working with FDA to come up with our bridge bridging bridging strategy for IPF with the Tyvasa dpi. I think we've been discussing that before. We will likely do healthy volunteer PK compatibility studies, comparability studies and as well as patient studies to demonstrate safety and efficacy. And as far as the sample size and duration of those studies again we're still working with FDA to, to come up with a clinical development plan.

Michael Benkowitz

Yeah, thanks. On the Jascade. Wait, let me. I think I'm going to address the question that the. Yeah. So yeah Ash, we've been, I mean obviously we're following that very closely. I do think, I do think that's a good, a good proxy or a good analog and does suggest that there is a lot of pin up demand for, for new therapies and IPF given what's currently on the market. So, I mean, yeah, I guess the short answer is we agree with you. And that's really kind of 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 because we were somewhat embargoed in what we could talk about with the New England Journal publication. But now that that's behind us, we're able to have those conversations. And 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. And we were asking a question around, you know, where are you going to use Tyvasa? Are you going to use it first line or use it after Jazcade? How do you about this? And you know, they all said it's going to be patient dependent. Some cases they do use Tyvaso first. In some cases they may start Jazcade. But at the end of the day it doesn't matter because they fully expect that this disease is going to look a lot like what we see in PAH where it's combination therapy. So even if they're starting Jascade first, they're going to add Tyvaso on very quickly thereafter. So, yeah, we think the potential is, as Martine's said in the beginning, just enormous in ipf.

Harry Silvers (Investor Relations)

All right, operator, next question.

Operator

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

Roanna Ruiz (Equity Analyst at Leering Partners)

Great morning, everyone. So 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 DPI and also thinking about the smi.

Harry Silvers (Investor Relations)

Thanks, Ryanna, for the question. Good to hear your voice this morning, Michael, you want to take that one? Sure.

Michael Benkowitz

Anna? Yeah, 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. But I think, I think high level what Martine said in her opening remarks is right. I mean, if we're, you know, we're trending towards 4 billion by next $4 billion run rate by next year, we think certainly with just Relent Peg 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 our models.

Harry Silvers (Investor Relations)

All right operator, next question.

Operator

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

Jessica Fye (Equity Analyst at JP Morgan)

Hey guys, good morning. Thanks for taking my question. I wanted to focus on Ralena Peg dpi. Can you just confirm this product coming out of stealth mode? Is that the 1staling inhaled product you've been alluding to in prior quarters? When should we expect that? Phase 1 Healthy Volunteer PKPD data comparing that product to oral Ralanpeg. And what led you to decide for DPI over SMI for ralinepeg's new formulation? Thank you.

Harry Silvers (Investor Relations)

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

Pat Poisson (Executive Vice President of Strategic Development)

Thanks Harry and thanks for the question. So first, first let me say we are excited to work with the Mankind development team again. What we were able to do with together with Tibaso 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 even better encore with Ralphie. So as mentioned in the in the Mannkind press release this morning, we began work on Ralphie 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 by an IND and a phase one study which we will we believe will be completed before the end of the year. We believe the half life of Ralena Peg along with some other characteristics we are investigating are very promising for this to be a once a day product. And 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. So I'll finish with as they say in IndyCar racing, we are staying with hard tires and not making any pit stops.

Harry Silvers (Investor Relations)

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

Operator

Your next question comes from the mind of Joseph Thorne of TD Cowan. Your line is open.

Joseph Thorne (Equity Analyst at TD Cowan)

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 rhel. Hi, maybe how quickly can this move. Is the availability of the data for oral rallynopag helpful at all? Maybe specifically for pah? Could you go right into registration? Just trying to think about timelines relative to some competitors in the space. Thank you.

Harry Silvers (Investor Relations)

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

Pat Poisson (Executive Vice President of Strategic Development)

Yeah, another great question. You know, of course the advanced outcomes data was off the charts incredible. So that's very encouraging that Ralphie will be very effective to treat pah, phild and IPF and ppf. So as far as the timing, I think long term we're going to be able to move into PH fairly quickly relative to our world in pharma as we'll be pursuing that approval with the solid dose. And 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 Roundpi. So I anticipate, you know, will complete the initial phase one study by the end of the year and we'll be rapidly be able to kick off studies for PAH efficacy as well as pH, ILD, IPF and PPF. So each of those will progress at different paces. But initially PAH will be the first approval.

Harry Silvers (Investor Relations)

Thanks again Pat Operator. You can go ahead.

Operator

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

Lisa Walter (Equity Analyst at RBC Capital Markets)

Oh, good morning. Thanks for taking our question on the 1x daily Rolanopeg DPI. Just wondering if you can share more color on the formulation. Should we think of this as a ronapeg prodrug or another formulation with the lung targeting ligand or or are relatively little additional flourishes needed to make relanopeg inhalable? Any color here would be helpful. Thanks so much.

Harry Silvers (Investor Relations)

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

Pat Poisson (Executive Vice President of Strategic Development)

All right, thanks, Harry. So we'll be leveraging mankind's crystal carrier IP for Rolanopec, very similar to what we have for Treprostino. It is not going to be a pro drug. Now perhaps we investigate other polymorphs of Ralenapeg in the future, but initially it's going to be the Ronin PEG molecule that we investigated for solid dose. So again, very similar formulation to the current Treprostino in using mankind's crystal carrier ip.

Harry Silvers (Investor Relations)

All right, thanks Pat Operator. You can move to the next question.

Operator

Your next Question comes from the line of Olivia Breyer of Cantor. Your line is open.

Olivia Breyer (Equity Analyst at Cantor)

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. And, and 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 for getting some of these next formulation to patients? I mean it sounds like a bridging study for dpi, but what about the SMI formulation? And then when could you realistically start those ralinepag studies in IPF and ppf?

Harry Silvers (Investor Relations)

Thank you.

Michael Benkowitz

Thanks, Olivia. Perhaps from a broader strategic standpoint, Michael can take that question and then maybe Lee could follow up on the regulatory side. Yeah, I think from a strategic standpoint, our approach to IPF is very similar to what you see seen us over the last 30 years do in PAH, which is taking multiple shots on goal approach. And you know, we started with Remodulin iv. We thought Remodulin sub Q could be a better version of Remodulin just in terms of, you know, dealing with the potential for infections. And then we progressed to Tyvaso, we progressed to Orenitram. Now we're. Then we looked at Tyvaso dpi, we looked at, look at and now we're a lot of peg. And 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, all respond to the same drug delivery approach. And so there's a role for all of these products in pah and I think that's what we're going to see in IPA 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. And we think they're all going to have a role. Right. I think there's going to be some patients that like, you know, for that are going to respond well to dpi. I mean, you look over in Ph I L D, I mean I think you still have a significant number of patients that are still on nebulizer even though you have the convenience of a dpi. So patients are. They're unique. They all respond to different drugs and different delivery devices in different ways. And so 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. And then 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.

Lee Peterson (Executive Vice President of Product Development and Xenotransplantation)

So strategically, that's how we think about these different devices and different NCEs and IPF. So, Lee, I don't know if you want to. Or pat. You guys want to talk about the regulatory path? Yeah, actually, I just wanted to add on a little bit of color to what you said. And with the patients or people are snowflakes. Just keep in mind that with, you know, 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, ID or IPS, given the potential for worsening ventilation, perfusion, mismatch, VQ mismatch. And so that kind of, you know, separates that right there as to, you know, we imagine the inhaled would be more for this other population. And 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. And so that's, you know, where that might fall out. And then as far as, you know, this is something we haven't really talked about too much. But, you know, even though treprostamil 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, and as such, they. They bind their receptors differently. Ralanpag is a really, really potent IP receptor agonist, whereas treprostenol binds multiple receptors, IP, EB2, and DPI. And so there may be some differences with regard to efficacy there based on patient genetics. And so all of these things, again, just to reiterate that they really give us. This really allows individual patients to get the absolute best treatment possible. And 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. And so, and this is, if you want to really get into the molecules and the pathway, it's versus this June P53 pathway. And so I mean there's coming out more and more evidence for these things and these type, this class of molecules versus different mechanisms of action in these indications, whether it's PAH or HILD or ILD or IPF or PPF or through all of them. So anyway, just wanted to add a little bit more there and then maybe Pat would want to talk about the regulatory aspect.

Pat Poisson (Executive Vice President of Strategic Development)

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

Harry Silvers (Investor Relations)

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

Operator

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

Roger Song (Equity Analyst at Jefferies)

Congrats for the call and thank you for squeezing for the last question. Maybe I think in the, in the updates you also have the PHCOPD phase two about to start later this year. So 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 drug. Thank you.

Harry Silvers (Investor Relations)

Thanks. Roger Lee, perhaps you want to share a little bit of color on the phcopd study.

Lee Peterson (Executive Vice President of Product Development and Xenotransplantation)

Yeah. So as far as the formulation, we're planning to use treprostinol sma, SMI for this and for phcopd. And we're planning on doing it the study in a couple of phases. We obviously have our phase one where that's already ongoing with the treprostomal SMI and healthy volunteers. And then we're planning a phase two study with PHCOPD patients and that'll be followed by a phase 3 Phcopd study. And we have several learnings through over the years that are being considered here with regard to patient populations. And we're really looking forward to starting these studies with these sort of enriched patient population eligibility criteria.

Harry Silvers (Investor Relations)

Thank you, Lee. Operator, you can go ahead and close the call.

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. This concludes today's conference call. You may now disconnect.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.