Q3 2025 United Therapeutics Corp Earnings Call

It depends on the call portion of this webcast will be in a listen only mode until the question and answer portion of this earnings call.

If you'd like to ask a question during that time. Please press Star then the number one on your telephone keypad, if you'd like to withdraw your questions. You May press star and the number two on your telephone keypads.

As a note todays event is being recorded.

At this time I'd like to turn the floor over to Harry Silvers Investor Relations manager at United Therapeutics.

Thank you Jamie Good morning, It's my pleasure to welcome you to the United Therapeutics Corporation third quarter 2025, corporate update webcast.

Remarks today will include forward looking statements, representing our expectations or beliefs regarding future events.

These statements involve risks and uncertainties that may cause actual results to differ materially.

Our latest SEC filings, including forms 10-K, and 10-Q contain additional information on these risks and uncertainties, we assume no obligation to update forward looking statements.

Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision, making or to suggest that any products are safe and effective for any unapproved or investigational uses.

Full prescribing information for the products is available on our website.

Accompanying me on today's call are Dr. Martine Rothblatt, our chairperson and Chief Executive Officer, Michael <unk>, Our President and Chief operating Officer.

James Edwin our Chief Financial Officer, and Treasurer, Dr. Leigh Peterson, our executive Vice President of product development, and as you know transplantation and Pat points on our executive Vice President of strategic development.

Note that pathway son, and I will participate in a fireside chat and one on one meetings at the UBS Global Healthcare conference in Palm Beach on November 10th.

Additionally, James and I will be at the Jefferies Global Healthcare conference in London on November 18th for a fireside chat and one on one meetings and finally Martine Rothblatt will present at the 44th annual J P. Morgan Healthcare conference in San Francisco in January of next year.

Our scientific commercial and medical affairs teams will be present at phenomenal hope 2025 on December 5th in Boston and that the pulmonary vascular Research Institute annual Congress in Dublin in late January next year.

Speaker #1: Good morning everyone , and welcome to the United Therapeutics Corporation . Third quarter 2025 Corporate Update . My name is Jamie and I will be your conference operator today .

Operator: Good morning everyone and welcome to the United Therapeutics Corporation Third Quarter 2025 Corporate Update. My name is Jamie and I will be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question and answer portion of this earnings call. If you'd like to ask a question during that time, please press STAR and the number one on your telephone keypads. If you'd like to withdraw your questions, you may press STAR and the number two on your telephone keypads. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Harry Silvers, Investor Relations Manager at United Therapeutics.

Speaker #1: participants on the call portion of this webcast will be in a listen only mode until the question and answer portion of this earnings call .

Now I will turn the webcast over to Martina for an overview of our development pipeline and business activities Martine.

Thank you Harry and.

Good morning, everyone.

<unk> therapeutics had a great corner.

Helping more patients and earning more revenues than ever before.

In addition, this past quarter, our pipeline made more progress than ever before.

Michael Benkowitz: Thank you, Jamie. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation Third Quarter 2025 Corporate Update Webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website. Accompanying me on today's call are Dr.

We fully enrolled three phase III trials, and we shared the unblinded results for pulmonary fibrosis in fact, the best results for that condition ever reported by anyone anywhere anytime.

We feel confident we'll be able to help tens.

Of IPF patients live better lives.

United Therapeutics is a public benefit company and I'm, sometimes asked what exactly does that mean.

Well one thing that it means is to defy the odds and invest millions of dollars over several years to develop a historically unmatched product portfolio for pulmonary fibrosis.

Being a public benefit company means providing a framework of trust for patients doctors payers and employees.

Michael Benkowitz: Martine Rothblatt, our Chairperson and Chief Executive Officer; Michael Benkowitz, our President and Chief Operating Officer; James Edgemond, our Chief Financial Officer and Treasurer; Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation; and Pat Poisson, our Executive Vice President of Strategic Development. Note that Pat Poisson and I will participate in a fireside chat and one-on-one meetings at the UBS Global Healthcare Conference in Palm Beach on November 10th. Additionally, James and I will be at the Jefferies Global Healthcare Conference in London on November 18th for a fireside chat and one-on-one meetings. Finally, Dr. Martine Rothblatt will present at the 44th annual J.P. Morgan Healthcare Conference in San Francisco in January of next year.

Being a public benefit company also means having shareholder interest as the.

Our hands on the helm.

For example, we've repurchased millions of our shares including quite a few this quarter at a bargain price.

For example, we are now guiding that we'll be at a 4 billion dollar revenue run rate not later than 2027.

And finally I'll point out because we are actively engaged in all manner of business development.

In fact.

I can predict and great companies, such as Merck J&J with Novartis with strong pulmonary disease franchises will be very keen to partner with us given our best in class data released for IPF This quarter with.

Michael Benkowitz: Our scientific, commercial, and medical affairs teams will be present at Phenomenal Hope 2025 on December 5th in Boston and at the Pulmonary Vascular Research Institute Annual Congress in Dublin in late January next year. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine.

With long lived IP and also given the very near term results of Rwanda Peg with its 24, the patent life and.

Indeed, I'd love to see a trial of relented peg combined with women repair and I bet It would be Super Super assistant.

Let's now give Mike tanker with a chance at the microphone. So he can give us a deep dive into our grade and better than ever numbers this quarter Michael.

Martine Rothblatt: Thank you, Harry, and good morning everyone. United Therapeutics had a great quarter helping more patients and earning more revenues than ever before. In addition, this past quarter our pipeline made more progress than ever before. We fully enrolled three Phase 3 trials, and we've shared the unblinded results for pulmonary fibrosis. In fact, the best results for that condition ever reported by anyone, anywhere, anytime. We feel confident we'll be able to help tens of thousands of IPF patients live better lives. United Therapeutics is a public benefit company, and I'm sometimes asked what exactly does that mean? One thing that it means is to defy the odds and invest millions of dollars over several years to develop a historically unmatched product portfolio for pulmonary fibrosis. Being a public benefit company means providing a framework of trust for patients, doctors, payers, and employees.

Yeah.

Thank you Martina and good morning, everyone.

Today, we are pleased to report another quarter of record total revenues of $800 million.

Representing 7% growth from the third quarter of 2020 for.

This quarters performance was driven by continued year over year growth in total Taipei, so at a rent of trim sales, reflecting patient demand and the resilience of our commercial strategy and execution.

Continued double digit revenue growth for total debt total highway so demonstrates that we are realizing no material impact from the launch of your trip yeah.

Our continued revenue growth also reinforces our belief that competition drives additional disease awareness, which in turn increases the overall opportunity in the large addressable pulmonary hypertension market.

We remain confident that <unk> is the best position in held for possible product and can sustain long term growth to the convenience of our DPI device, it's unlimited dosing potential.

Thousands of prescribers and many thousands of patients who've experienced hydro so DPI since launch and the fact that there are no payer incentives to prefer an alternative product.

On dosing inconvenience archiving, so DPI platform is driving a meaningful shift intra possible dosing behavior.

Martine Rothblatt: Being a public benefit company also means having shareholder interest as the hands on the helm. For example, we've repurchased millions of our shares, including quite a few this quarter at a bargain price. For example, we are now guiding that we'll be at a $4 billion revenue run rate not later than 2027. Finally, I'll point out that we are actively engaged in all manner of business development. In fact, I can predict that great companies such as Merck, Johnson & Johnson, or Novartis with strong pulmonary disease franchises will be very keen to partner with us given our best-in-class data released for IPF this quarter with long-lived IP, and also given the very near-term results of ralinepag with its 2040 patent life. Indeed, I'd love to see a trial of ralinepag combined with Wingovir, and I bet it would be super synergistic.

Historically patients averaged nine breaths per treatment using W lifestyle based on delivery with.

With Televisa DPI that average has increased to a 12 breath equivalent or 64 micrograms I'm pleased to announce that we will soon be launching Taipei. So DPI 80, micro micro gram cartridges to provide added convenience for patients being treated at higher doses. This new cartridge will allow patients to reach that.

Equivalent of 15, <unk> breath with one single breath as compared to four breast for you Tom for your trip you up.

This is the highest dose ever delivered in one breath via one cartridge offering a clear competitive edge and dosing flexibility and reinforcing the clinical and commercial value of higher dose <unk>.

This innovation positions us to provide greater patient benefit capture greater market share and unlock new revenue potential and the growing pulmonary hypertension space.

At the same time, we launched the 80 microgram cartridge. We will also be launching 96, and 112 micro crown combination kits, which we believe will facilitate access and affordability for patients requiring even higher doses of <unk>.

Martine Rothblatt: Let's now give Michael Benkowitz a chance at the microphone so he can give us a deep dive into our great and better than ever numbers this quarter. Michael.

On Tolerability top excuse me on Tolerability.

Looking forward to sharing abstracts at the <unk> annual Congress in January that compare our real world data from United Therapeutics Safety database to clinical trial evidence from your trip years inspire study.

James Edgemond: Thank you, Martine, and good morning, everyone. Today we are pleased to report another quarter of record total revenues at $800 million, representing 7% growth from the third quarter of 2024. This quarter's performance was driven by continued year-over-year growth in total Tyvaso and Orenitram sales, reflecting patient demand and the resilience of our commercial strategy and execution. Continued double-digit revenue growth for total Tyvaso demonstrates that we are realizing no material impact from the launch of Eutrepis. Our continued revenue growth also reinforces our belief that competition drives additional disease awareness, which in turn increases the overall opportunity in the large addressable pulmonary hypertension market. We remain confident that Tyvaso DPI is the best positioned inhaled treprostinil product and can sustain long-term growth.

These analyses show among other things a lower incidence of cost in both Taipei, So anti VSO DPI.

Finally on access we have secured multiple favorable coverage decisions with major payors supporting a clear validation that <unk> is well positioned in the marketplace.

Our confidence in the growth profile of <unk> is further supported by the recent two type two study.

Which is more teams demonstrated an unprecedented treatment benefit for inhaled for possible in patients with idiopathic pulmonary fibrosis. We are excited about the <unk> two data, which have the potential to significantly broaden our therapeutic reach and to respiratory disease and further accelerate our growth.

Lastly, turning to remodeling, we're pleased to have launched our new immunity pro pumped during the third quarter, which we designed based on feedback from health care providers and patients to enhance the overall experience of our parental therapy.

James Edgemond: Due to the convenience of our DPI device, its unlimited dosing potential, the thousands of prescribers and many thousands of patients who have experienced Tyvaso DPI since launch, and the fact that there are no payer incentives to prefer an alternative product on dosing and convenience, our Tyvaso DPI platform is driving a meaningful shift in treprostinil dosing behavior. Historically, patients averaged nine breaths per treatment using nebulized Tyvaso delivery. With Tyvaso DPI, that average has increased to a 12-breath equivalent or 64 micrograms. I'm pleased to announce that we will soon be launching Tyvaso DPI 80 microgram cartridges to provide added convenience for patients being treated at higher doses. This new cartridge will allow patients to reach the equivalent of 15 nebulized breaths with one single breath as compared to four breaths for Eutrepis.

Ah Remunerative pro pump is small in discrete and features a user friendly remote with guided instructions automated finding an easy selling additionally at slower flow rates may enable more patients to initiate remodel and therapy at home instead of requiring a hospital stay.

In closing we are extremely proud of our team's steadfast dedication, which has driven these remarkable innovations on our results and enables us to offer a critical therapies for patients who rely on them. We are confident that our strong foundation positions us to maintain our momentum and continue delivering success for many years to come with that I'll turn things back to our team.

Michael that was an amazing overview. Thank you so much for sharing all that information and for all of your leadership operator, you may now open the lines to any questions.

James Edgemond: This is the highest dose ever delivered in one breath via one cartridge, offering a clear competitive edge in dosing flexibility and reinforcing the clinical and commercial value of higher dose treprostinil. This innovation positions us to provide greater patient benefit, capture greater market share, and unlock new revenue potential in the growing pulmonary hypertension space. At the same time we launch the 80 microgram cartridge, we will also be launching 96 and 112 microgram combination kits, which we believe will facilitate access and affordability for patients requiring even higher doses of Tyvaso DPI. On tolerability, we're looking forward to sharing abstracts at the PBRI Annual Congress in January that compare real world data from United Therapeutics Safety Database to clinical trial evidence from Eutrepis' Inspire study. These analyses show, among other things, a lower incidence of cough in both Tyvaso and Tyvaso DPI.

Ladies and gentlemen at this time, we'll begin the question and answer session to ask a question you May Press Star and then one using a touch tone telephone.

If you are using a speaker phone, we do ask that you. Please pickup your handset prior to pressing the keys.

So withdraw your question you May press Star two.

At this time, we will pause momentarily to assemble the roster.

And our first question today comes from Lisa Walter from RBC. Please go ahead with your question.

Oh, great. Thanks, so much for taking our questions and congrats on the quarter.

I'm just curious given the time to results and Ikea.

Are you, perhaps seeing an uptick and diagnoses of IPF patients with ph.

And if so do you think this could positively impact high basis sales over the next few quarters any color here would be helpful. Thanks.

James Edgemond: Finally, on access, we have secured multiple favorable coverage decisions with major payers supporting a clear validation that Tyvaso DPI is well positioned in the marketplace. Our confidence in the growth profile of Tyvaso is further supported by the recent TETON 2 study which, as Martine said, demonstrated an unprecedented treatment benefit for inhaled treprostinil in patients with idiopathic pulmonary fibrosis. We are excited about the TETON 2 data which have the potential to significantly broaden our therapeutic reach into respiratory disease and further accelerate our growth. Lastly, turning to Remodulin, we're pleased to have launched our new Remunity Pro pump during the third quarter, which we designed based on feedback from healthcare providers and patients to enhance the overall experience of our parenteral therapy. Our Remunity Pro pump is small and discreet and features a user-friendly remote with guided instructions, automated priming, and easy filling.

Thanks for the question, Lisa I'm going to refer that to Michael.

Under his overall leadership include some <unk>.

All of the different parts of U T that are interacting with physicians and patients such as global Medical Affairs, and our commercialization teams are regional nurse specialists. So Mike would have a lot of input on that Michael.

Sure. Thanks for the question, Yes, it's an interesting question, it's actually one.

The opportunity to attend both the European respiratory Society, where we unblinded the Teton two data as well as the chest conference last week in Chicago, and it's I've actually every physician I talked to I asked them that exact question just to try and get a sense of.

Whether whether that data would.

Maybe create an incentive or proppant to be more aggressive in screening for for pulmonary hypertension.

James Edgemond: Additionally, its lower flow rates may enable more patients to initiate Remodulin therapy at home instead of requiring a hospital stay. In closing, we are extremely proud of our team's steadfast dedication which has driven these remarkable innovations and results and enables us to offer critical therapies to our patients who rely on them. We are confident that our strong foundation positions us to maintain our momentum and continue delivering success for many years to come. With that, I'll turn things back to Martine.

And their IPF patients and so.

Yeah.

They all said, yes, yes, whether that plays out yet I think it's still too early because we don't normally unblinded. The data just a few weeks ago, So I can't point to.

Directly towards that.

Directly towards towards the T cells to study, but it's certainly something I think that we're chatting with physicians about and monitoring.

Monitoring very closely so I.

Martine Rothblatt: Michael, that was an amazing overview. Thank you so much for sharing all that information and for all of your leadership. Operator, you may now open the lines to any questions.

I think I think I think its logical that that this will play out over time.

Whether it does when it does to what degree I think remains to be seen.

Operator: Ladies and gentlemen, at this time we'll begin the question and answer session. To ask a question, you may press star and then one using a touch tone telephone. If you are using a speakerphone, we do ask that you please pick up your handset prior to pressing the keys. To withdraw your questions, you may press star and two. At this time, we'll pause momentarily to assemble the roster. Our first question today comes from Lisa Walter from RBC. Please go ahead with your question.

Perfect. Thank you Michael Operator next question please.

Our next question comes from Andreas <unk> from Oppenheimer. Please go ahead with your question.

Good morning, and thanks for taking the question and congrats on another solid quarter here.

You mentioned in your remarks.

Relented pegged and potential for combination can you just give us a sense of where you see the market opportunity.

[Analyst]: Oh great. Thanks so much for taking our questions and congrats on the quarter. I'm just curious, given the TETON 2 results in IPF, are you perhaps seeing an uptick in diagnoses of IPF patients and if so, do you think this could positively impact Tyvaso sales over the next few quarters? Any color here would be helpful. Thanks.

For Atlanta, pegged and expectations.

Advance outcomes.

Next year I appreciate it thank you.

Sure absolutely.

Let a peg is.

Yes.

Just blowing the doors off of expectations in everywhere, we look.

First of all the enrollment of the outcomes trial, which is just.

Martine Rothblatt: Thanks for the question, Lisa. I'm going to refer that to Michael, under his overall leadership, which includes all of the different parts of United Therapeutics that are interacting with physicians and patients, such as Global Medical Affairs and our commercialization teams, our regional nurse specialists. Mike would have a lot of input on that. Michael, sure.

Just a trial enrolled the pulmonary hypertension has gone extraordinarily well and even the some of the open label.

Hum results have been announced by some doctors that for patients who have already exited the trial and the six minute walk distances that are maintained even a year. After these patients have left the trial are best in class six minute walk distances.

James Edgemond: Thanks for the question. Yeah, it's an interesting question. It's actually one the opportunity to attend both the European Respiratory Society where we unblinded the TETON 2 data, as well as the CHEST conference last week in Chicago. I've actually, every physician I talk to, I ask them that exact question just to try and get a sense of whether that data would maybe create an incentive or prompt them to be more aggressive in screening for pulmonary hypertension in their IPF patients. They all said yes. Whether that plays out yet, I think it's still too early because we only unblinded the data just a few weeks ago. I can't point to an uptick directly towards that or directly towards the TETON 2 study. It's certainly something I think that we're chatting with physicians about and monitoring very closely.

Then as I mentioned.

The long patent life for Lennar Peg is a it's a very significant factor as well from a business standpoint with the patent I'm not the expert on all the data, but it's roughly 2040. So it has a very very long patent life. As you know it's a pill that you just take once a day.

Hey.

It seems to be the most potent.

Prostacyclin type of drug that has been identified yet so patients have an opportunity to just take one pill once a day and.

And be able to keep their pulmonary hypertension managed as well as it could be the case with any other prostacyclin type therapy now on top of all of that.

We were very impressed with the synergy that was shown in the.

James Edgemond: I think it's logical that this will play out over time. Whether it does, when it does, to what degree, I think remains to be seen.

And the data released by Merck between for tab cel.

And Coprostanol.

Martine Rothblatt: Thank you, Michael. Operator, next question, please.

And we've continued to see that synergy in the marketplace subsequent to the Teva CEP launch.

Operator: Our next question comes from Andreas Agarides from Oppenheimer. Please go ahead with your question.

Our sales have just continued to grow so there seems to be like a really nice synergy between those two drugs and if one could leverage that synergy with a once a day pill wow that would be like even better.

Martine Rothblatt: Good morning and thanks for taking our question and congrats on another solid quarter here. Martine, you mentioned in your remarks ralinepag and potential for combination.

Operator: Can you just give us a sense of where you see the market opportunity?

And to that their turns out to be a tremendous formulation flexibility with rollout of peg, which opens up a number of opportunities that are more in our <unk>.

Martine Rothblatt: For ralinepag and expectations for advanced outcomes next year? Appreciate it. Thank you. Sure. Absolutely. Ralinepag is just, you know, just blowing the doors off of expectations in everywhere we look. It's first of all, the enrollment of the outcomes trial, which is just about the largest trial ever enrolled in pulmonary hypertension, has gone extraordinarily well. Even some of the open label results have been announced by some doctors that for patients who have already exited the trial and the six minute walk distances that are maintained even a year after these patients have left the trial are best in class.

<unk> catalog.

Things such as combination all treatment and so on so.

Well it wasn't peg is.

While IPF is the disease is something forward for us.

A N C E a relapse.

<unk> is our number one.

Next question operator.

Our next question comes from Joseph <unk>.

Tony from TD Cowen. Please go ahead with your question.

Hi, there good morning, Congrats on the progress and thank you for taking my question Martijn in addition to that.

Or combination partnership potential it sounds like you also mentioned some large pharma partnership.

Two are in light of the recent 10 days of IPF data. So maybe if you could go a little bit more into maybe what you were what are you thinking about there what would an ideal kind of partner look like her partnership and is this related to you know kind of European Reits or.

Martine Rothblatt: Six minute walk distances then as I mentioned, the long patent life for ralinepag is a very significant factor as well from a business standpoint with the patent, I'm not to be the expert on all the dates, but it's roughly 2040, so it has a very, very long patent life. As you know, it's a pill that you just take once a day. It seems to be the most potent prostacyclin type of drug that has been identified yet. Patients have an opportunity to just take one pill once a day and be able to keep their pulmonary hypertension managed as well as, you know, could be the case with any other prostacyclin type therapy. Now, on top of all of that, you know, we were very impressed with the synergy that was shown in the data released by Merck between sotatercept and treprostinil.

Everywhere. We've looked it's, um, first of all the, um, enrollment of the outcomes trial, which is, um, just not the largest, uh, trial diploma or hypertension has gone extraordinarily well and, um, even the, uh, some of the open label, um, um, results have been uh, announced by some doctors, you know, that for patients, who have already exited the trial and the 6-minute walk distance, is that are maintained even a year after these patients have left. The trial are are best in class. Uh, 6 minute, walk distances,

Just any additional clarity around that because it does seem like they're a little bit of an update from the prior quarter, obviously given the recent data. Thank you.

Yeah, well, it's only it's so funny that you say that because before we release this data I would say that.

These are just terrific numbers, but like 90% of people seems like they didn't really believe that our drug would work in pulmonary fibrosis, which which seemed odd to us we have a computational biology lab, which has an extraordinary.

Digital model of the lung and all of the key diseases that we focus on in the lung.

Um, then, um, as I mentioned, um, the long patents life for l'nip is a, is a very significant factor as well from a business standpoint with the, uh, patent. But I'm, I'm not thinking the expert on all the dates, but it's it's roughly 240. So it has a very, very long pattern size. As you know, it's a pill that you just take once a day, um, it seems to be the most potent, um, prostate cycle. Uh, type of drug that has uh been identified yet. So patients have an opportunity to just take 1 pill once a day and um and be able to keep their pulmonary hypertension managed as well as you know, could be the case with any other across the cycle and type therapy. Now, on top of

We use.

Largely learning model based on all of the previous.

Studies that have been done in pulmonary fibrosis and pulmonary hypertension to develop this digital one model and then we are able to run a new NCS need drugs through this model to get the results of.

Martine Rothblatt: We've continued to see that synergy in the marketplace subsequent to the sotatercept launch. Our sales have just continued to grow. There seems to be like a really nice synergy between those two drugs. If one could leverage that synergy with a once a day pill, wow, that would be like, you know, even better. In addition to that, there turns out to be tremendous formulation flexibility with ralinepag, which opens up a number of opportunities that are more in our stealth catalog, things such as combination oral treatment and so on. So ralinepag is while IPF as a disease is front and forward for us as a nce, ralinepag is our number one push. Next question, Operator.

Of standard endpoint measurements. So for example.

We ran the <unk> two study.

The entire like 100 clinical trials model as the tea time to study 100 clinical trials.

The two hours.

And what.

Compare that to the years and years that it takes like slugging around the world.

Enrolling these trials and the results of that.

Followed that. Um, you know, we were very impressed with the Synergy that was shown in the, um, in the data released by, uh, MK between satisfaction and, uh, Toro and, uh, We've continued to see that Synergy in the marketplace, uh, subsequent to the sort of tatter set launch, uh, our sales have just continued to grow. So, there seems to be like a really nice, uh, Synergy between those 2 drugs, and if 1 could, uh, leverage that, uh, Synergy with a, once a day pill, uh, wow, that would be like, you know, even better. Um, in addition to that there turns out to be, uh, tremendous, uh, formulation flexibility with relena PEG, which opens up, uh, a number of opportunities that are more in our, um, stealth catalog, um, things such as combination.

Of that digital clear clean trial.

That Mike.

By comparison to the roughly 95 milliliters.

Proof meant over baseline that we showed with the clinical trial.

All treatments and so on. So um, well what a peg is uh, while ipf is a disease is front and forward for us as a uh, nce relative is our number 1 Force.

We had estimated our median estimate of these hundred trials was like a $130 million, which is fascinating because the the difference between the digital trial and the physical trial was closer than the.

Next question, operator.

Operator: Our next question comes from Joseph Tomi from TD Cowen. Please go ahead with your question.

Martine Rothblatt: Hi there.

[Analyst]: Good morning. Congrats on the progress and thank you for taking my question. Martine, in addition to that combination partnership potential, it sounds like you also mentioned some large pharma partnership related to or in light of the recent Tyvaso IPF data. If you could go a little bit more into what you were thinking about there, what would an ideal kind of partner look like or partnership? Is this related to European rights or just any additional clarity around that? That seemed like a little bit of an update from the prior quarter, obviously, given the recent data. Thank you.

Our next question comes from Joseph. Tommy from TD. Callum, please. Go ahead with your question.

And then the effect size from the Pirfenidone and <unk> trials. So what that tells you is that the additional trial very closely.

Model, but it seems like we know what we're doing here.

And.

And.

So.

Think that that augurs really really well for some companies that might have been a bit skeptical.

About the anti fibrotic effects of true cross Nolan pulmonary fibrosis, I'm kind of waking up and.

Martine Rothblatt: Yeah, it was only. You know, it's so funny that you say that because before we released this data, I would say that, I don't know, these are just heuristic numbers. Like 90% of people seems like they didn't really believe that our drug would work in pulmonary fibrosis, which seemed odd to us. We have a computational biology lab which has an extraordinary digital model of the lung and all of the key diseases that we focus on in the lung. We use a large learning model based on all of the previous studies that have been done in pulmonary fibrosis and pulmonary hypertension to develop this digital lung model. We are able to run new NCEs, new drugs, through this model to get the results of standard endpoint measurements.

Hi there, good morning. Congrats on the progress and thank you for taking my question. Um, Martine in addition to that, um uh, combination partnership uh potential. It sound like you also mentioned some large Pharma partnership, um, related to area in light of the recent High baso ipf data. So maybe if you could go a little bit more into, maybe what you were what you're thinking about their, what would I do? Kind of partner look like or partnership and um, is this related to, you know, kind of European rights or, um, just any additional Clarity around that because that seemed like a, a little bit of an update, um, from the prior quarter, obviously given the recent data, thank you.

And paying a little bit of attention now.

I did therapeutics is very much of a United States company.

Not that we don't do things in other countries in the world.

We do in fact, the <unk> T trial was enrolled.

Throughout all of the rest of the world, but if you look at our financials, you'll see that the overwhelming.

A portion of our revenues.

Are derived from the United States.

All of our medicines are manufactured in the United States.

All of our devices for delivering our medicines are manufactured in the United States, So with better partners in other parts of the world that wanted to help bring the amazing benefits.

Yeah, it was only, you know, it's so funny that you say that because before we released this data, I would say that um, I don't know, these are just eurest numbers, but like 90% of people seems like they didn't really believe that our drug would work in pulmonary fibrosis which, which seems odd to us. Um, we have a computational biology lab, which has an extraordinary, uh, Digital model of the lung, and all of the key diseases that we focus on in the lungs. Um, we use, um, you know, a large L learning model based on all of the previous, uh, studies that

<unk> to patients in those other parts of the World I think that would be a good thing for everybody concerned.

Thanks for the Great question Operator next question.

Martine Rothblatt: For example, we ran the TETON 2 study, the entire like 100 clinical trials modeled as the TETON 2 study. 100 clinical trials in 62 hours. Compare that to the years and years that it takes, like slugging around the world enrolling these trials. The results of that digital clean trial were that by comparison to the roughly 95 mL improvement over baseline that we showed with the clinical trial, we had estimated our median estimate of these 100 trials was like 130 mL, which is fascinating because the difference between the digital trial and the physical trial was closer than the effect size from the pirfenidone and nintedanib trials. What that tells you is that the digital trial very closely modeled the disease, like we know what we're doing here.

That have been done in uh pulmonary fibrosis and um pulmonary hypertension to uh develop this digital uh lung model and then we're able to run a new NC's new drugs through this model to get the results of um of standard endpoint me measurements.

Our next question comes from Olivia Prior from Cantor. Please go ahead with your question.

Hi, Good morning. Thank you for the question can you talk through some of the commercial dynamics, you're seeing for Tvs show over these last few months and maybe even into October.

Really I'm curious, whether most of the share gains for DPI or in ph verse verse ph ILD and then.

like,

I have to ask the obvious question, but whether you're seeing any competitive impact in either indication or if you are maybe it's made it weighted more towards one versus the other and then sorry to sneak this in but Martina I did just want to ask for a quick point of clarification, you're now guiding to a $4 billion run rate by 2027, which I think is.

you know, compare that to the years and years that it takes like, you know, slugging around the world, um, enrolling these trials and the results of that, um, of that, um, digital clear, um, clean trial,

Well ahead of where some numbers are today does that mean, you expect to hit $1 billion in a quarter sometime in 2027, just to kind of clarify and I assume that's in light of the very strong IPF results. Thank you so much.

Yes, so we do expect to hit 1 billion in the quarter and 2027 and <unk>.

We're very happy for you poking around all the different whys and Wherefores of our revenue growth growth. So no problems, there and Michael will take it away on that question.

Martine Rothblatt: I think that augurs really, really well for some companies that might have been a bit skeptical about the antifibrotic effects of treprostinil in pulmonary fibrosis, kind of, you know, waking up and paying a little bit of attention. Now, United Therapeutics is very much a United States company. It's not that we don't do things in other countries in the world. We do. In fact, the TETON 2 trial was enrolled throughout all of the rest of the world. If you look at our financials, you'll see that the overwhelming portion of our revenues are derived from the United States. All of our medicines are manufactured in the United States. All of our devices for delivering our medicines are manufactured in the United States.

Yes. So thanks for the question. So I think in terms of what we're seeing.

Over the course of the third quarter and then even early into the into the fourth quarter.

As I said I think we're confident and that there's really no material impact from the launch of <unk> and in fact, what we what we see and we see we've seen this in the past with other competitors launches actually it really kind of grows of Hyatt addressed.

Were that um, by comparison to the roughly 95 milliliters, um, improvement over Baseline that we showed with the clinical trial. We uh, we had estimated our median estimate of these 100 trials was like 130 milliliters, which is fascinating, because the, the difference between the digital trial, and the physical trial was closer than the, uh, than the effect size from the percentage, Don, and antenna, my trials. So, what that tells you is that the digital trial very closely, uh, modeled the disease. Like, we know what we're doing here. And, um, and um, so I, I think that, that augur is really, really well, for some companies that might have been a bit skeptical, um, about the anti- fibrotic effects of tropos and Pulmonary Fibrosis, um, kind of, you know, waking up

Addressable patient population because you now have like another sales force out there talking about these diseases.

You've got doctors thinking about.

Arterial hypertension, groupon as well as ph ILD.

In group three and so.

That's a great thing for patients and then it's a great thing for for the companies that are that are providing these drugs and variably. What happens is I think what we saw this even with the city.

<unk> as Mark alluded to in her opening remarks, we continue to grow through that.

And that's what we expect to happen here.

As we move into.

Martine Rothblatt: There were partners in other parts of the world that wanted to help bring the amazing benefits of Tyvaso to patients in those other parts of the world. I think that would be a good thing for everybody concerned. Thanks for the great question, Operator. Next question.

Into 2026 is continued growth in Taipei, So both PAA Jen and.

And ph ILD and so when I look at.

For.

Let's say beginning of September through halfway through October and then I think I got it.

The things I look at the underlying metrics patient shipments.

Happened and and and, and paying a little bit of attention. Now, um, United Therapeutics is very much of a United States company. It's not that we don't do things in other countries in the world. Uh, we do in fact, the Teton 2 trial was enrolled, um, throughout all of the rest of the world. But if you look at our financials, you'll see that the overwhelming, um, portion of our revenues. Um, are derived from the United States. Um, all of our medicines are manufactured in the United States, um, all of our devices for delivering, our medicines our manufactured in the United States. So if there are, you know, Partners in other parts of the world that wanted to help, bring the amazing benefits of um, paeso to patients in in those other parts of the world. I think that would be a good thing for everybody who's concerned.

Scriber breadth and depth referrals and starts and I think on the on the patient shipments Super strong and really heading into October like exceptionally strong so far couple of weeks and.

Operator: Our next question comes from Olivia Breyer from United Therapeutics. Please go ahead with your question.

Thanks for the great question. Operator. Next question.

Olivia Breyer: Hi, good morning. Thank you for the question. Can you talk through some of the commercial dynamics you're seeing for Tyvaso over these last few months and maybe even into October? I'm curious whether most of the share gains for Tyvaso DPI are in PAH versus PH-ILD. I have to ask the obvious question, whether you're seeing any competitive impacts in either indication, or if you are, maybe it's weighted more towards one versus the other. Sorry to sneak this in, but, Martine, I did just want to ask for a quick point of clarification. You're now guiding to a $4 billion run rate by 2027, which I think is well ahead of where some numbers are today. Does that mean you expect to hit $1 billion in a quarter sometime in 2027? Just to kind of clarify, and I assume that's in light of the very strong IPF results.

Our next question comes from Olivia, Pryor from caner, please go ahead with your question.

Prescriber, the prescribed number of prescribers grew quarter over quarter, and we're still maintaining depth in those three to three plus.

Writers.

Which is sort of our key key metric on that and then referrals and starts kind of bounced around a little bit in the quarter, but really again since September are pretty consistent upward trend and were almost back at where we were pretty choppy along so.

Hi, good morning, thank you for the question. Um, can you talk through some of the commercial Dynamics, you're seeing for tyvaso over these last few months and and maybe even into October, uh, really I'm curious whether most of the share gains for DPI or in Paw versus versus pH ald and then

This is I think played out about like we expected there has been some trialing with their with their products.

You know we've had some some patients transition a lot of those have come back.

And as I said in my mind, I think as we look out into <unk>.

2026, and beyond we think we're really positioned positioned well for continued growth in both PIH N ph ILD.

Perfect Michael Thank you so much Rob that's a great covering of all three months of.

Olivia Breyer: Thank you so much.

Martine Rothblatt: Yes, we do expect to hit $1 billion in the quarter in 2027, and we're very happy for you poking around all the different whys and wherefores of our revenue growth. No problems there, and Michael will take it away on that question.

I have to ask the obvious question, but, but whether you're seeing any competitive impacts in either indication or, or if you are, maybe it's made it weighted more towards 1 versus the other and then sorry to sneak this in but Martine, I I did just want to ask for a quick point of clarification. You're now guiding to a 4 billion, run rate by 2027, which I think is is, well ahead of of where some numbers are today. Does that mean you expect to hit 1 billion in a quarter sometime in 2027, just to kind of clarify, and I assume that in light of of the very strong ipf results. Thank you so much.

That question. Thanks.

Operator next question please.

Our next question comes from Roger song from Jefferies. Please go ahead with your question.

Oh great.

That's for that record quarter again, and thank you for the question a quick ones. One is on the PPS. So just curious about that data timing on the enrollment and then more a more interesting question could be the given that you don't.

James Edgemond: Yeah, thanks for the question. I think in terms of what we're seeing over the course of the third quarter and even early into the fourth quarter, as I said, I think we're confident that there's really no material impact from the launch of Eutrepis. In fact, what we see, and we've seen this in the past with other competitors' launches, is that it really kind of grows the pie through addressable patient population because you now have another sales force out there talking about these diseases. You've got doctors thinking about pulmonary arterial hypertension group one, as well as PH-ILD in group three. That's a great thing for patients and it's a great thing for the companies that are providing these drugs.

Yeah, so we do expect to hit a billion in the quarter in 2027 and, uh, and we're we're very happy for you poking around all the different lines and wherefores of, um, our, our Revenue growth growth, so no problems there, and Michael will will take it away on that question.

<unk> data.

There <unk> any new updated thoughts from physician and scientist regarding that.

And then also quickly on Ips and the phase two meeting believe youre, having a meeting with the FDA.

Around year end and then just curious about the potential outcome scenario any upside case, you have to have already approval. Thank you.

Yeah, so uh, thanks for the question. So I think, you know, in terms of what we're seeing, um, over the course of the third quarter and then even early into the 4 into the fourth quarter. Um, as as I said, I think we're, we're confident in that there's really no material impact from from the launch of your trip. Yet, in fact, what we, what we see and we see we've seen this in the past with other competitors, launches it actually, it really kind of grows the pie but the the addressable patient population because you now have like another sales force out there talking about these diseases. Uh so you've got doctors, you know, thinking about homework, or 2 hypertension Group 1 as well as Phile and uh and

Okay. So that's a whole lot that's a whole pancakes back of questions you've got there.

James Edgemond: Invariably, what happens is, I think we saw this even with the sotatercept launch, as Dr. Martine Rothblatt alluded to in her opening remarks, we continue to grow through that and that's what we expect to happen here as we move into 2026: continued growth in Tyvaso in both PAH and PH-ILD. When I look at really from, let's say, beginning of September through halfway through October, the things I look at are the underlying metrics: patient shipments, prescriber breadth and depth, referrals, and starts. On the patient shipments, super strong and really heading into October, exceptionally strong so far, a couple weeks in. The number of prescribers grew quarter over quarter and we're still maintaining depth in those three, the three-plus writers, which is sort of our key metric on depth.

So basically I'm going to refer all three of those questions and hopefully she has been taking notes to Dr. Peterson, who would be the best person to opine.

And then.

On the enrollment progress with the.

The Pts for maybe we could call it key town III trial.

And then.

And then.

Walk through the mechanism of action, that's increasingly being understood as she has attended all of the major.

Jeff pulmonary respiratory conferences and she is talk with them all of the major kols.

She is also right in the loop on the.

Major top tier top of the top tier type of public peer reviewed.

Publication Thats about to come out and there's a lot of you know.

Interest in the MLA question, there and then finally, she works very closely with our regulatory group and to give you some insight.

James Edgemond: Referrals and starts kind of bounced around a little bit in the quarter, but really again since September, a pretty consistent upward trend. We're almost back at where we were pre-Eutrepis launch. This has played out about like we expected. There has been some trialing with their products. We've had some patients transition. A lot of those have come back. As I said in my remark, as we look out into 2026 and beyond, we think we're really positioned well for continued growth in both PAH and PH-ILD. Perfect.

On the kind of.

The cadence of what we can expect in terms of filing so Dr. Peterson could you take all those questions away and that will probably make you the last answer.

That was a lot of questions.

Thank you.

Yes, they did take notes bed.

Yeah sure so regarding Teton PPS.

We're about halfway through in on that a little bit more and Ah that study in design as you well know is it's very similar to <unk>.

Martine Rothblatt: Michael, thank you so much. Wow, that's a great covering of all 360 degrees of that question. Thanks, operator. Next question please.

Referrals and stars. And I think on the, on the patient shipments, super strong, and really heavy in October, like exceptionally strong, so far, a couple weeks in, uh, prescriber the prescribed, number of prescribers grew quarter over quarter. Uh, and we're still maintaining depth in those 3. The 3 plus, uh, uh, writers, uh, which is sort of our key. Uh, key metric on that and then referrals and starts. Kind of bounced around a little bit in the quarter, but really again, since September, um, a pretty consistent upward Trend and we're almost back at where we were pretty Utopia a lot so, um, you know, it's it's so, so this is, I think played out about like, we expected. There has been some trialing with their, with their products. Um, you know, we've had some, some patients transition, a lot of those have come back. Um, and as I said in my mind, I think, as we look out into, um, you know, 2026 and Beyond, we think we're really, uh, positioned, uh, positioned well for continued growth, in both paw and pH ild.

For the <unk> in that there is a.

Operator: Our next question comes from Roger Song from Jefferies. Please go ahead with your question.

Perfect. Michael. Thank you so much. Wow, that's a great covering of all 3, Associates degrees of that question. Thanks! Um, operator. Next question, please.

52 week follow up period and so.

Martine Rothblatt: Oh great.

Our next question comes from Roger song from Jeffrey's, please go ahead with your question.

[Analyst]: Congrats for the record quarter again and thank you for taking your question. Quick ones. One is on the IPF. Just curious about the data timing on the enrollment, and then more interesting question could be given the TETON 2 data, how's the read through to the IPF? Any new updated thoughts from physicians and scientists regarding the MOA, and then also quickly on IPF and the Phase 2 meeting. Believe you are having meeting with the FDA around year end, and then just curious about the potential outcome scenario, any upside case you can have earlier approval. Thank you.

So again we.

Can't really speak in detail about you know when we would expect on blinding, but that gives you an idea.

And you all know that that's being run in a basically U S, Canada as well as rest of the world. So.

And again, most importantly, really based on the similarities of the underlying fibrosis and disease progression between the IPF and P. P F.

I mean these results suggest that inhaled surprises no.

Martine Rothblatt: Okay, that's a whole pancake stack of questions you got there. Basically, I'm going to refer all three of those questions, and hopefully she's been taking notes, to Dr. Peterson, who would be the best person to opine in the instance on the enrollment progress with the PPF, or maybe we could call it TETON 2 trial, and then walk through the mechanism of action that's increasingly being understood as she's attended all of the major chest pulmonary respiratory conferences and she's talked with all of the major KOLs. She's also right in the loop on the major top tier, top of the top tier type of peer-reviewed publication that's about to come out. There's a lot of interest in the MOA question there.

<unk>.

Oh great. Uh, congrats for the record holder again, and thank you for taking your question. Uh, quick ones. Uh, 1 is on the ppf, so just, uh, curious about the data timing on the enrollment and then, more more interesting question could be the, uh, given the key down to data. Uh, how's the, the re through to the ipf? Any new updated thoughts from physician and scientists regarding the M, uh, the Moa. And then also, uh, quickly on ipf and the phase 2 meeting believe. You are having meeting with the FDA, uh, around year end and then just curious about the potential outcome scenario. Or any upside case you can have a earlier approval. Thank you.

Would potentially offer.

Treatment option for these patients with P. P F.

With regard to the mechanism of action specific mechanism of action again with the similarities and the underlying fibrosis.

And as we've as we've discussed.

The both the in vitro results preclinical results.

Demonstrating an anti fibrotic effect.

Of two process and I'll ask it.

<unk>.

As it works through the various receptors FGF receptor two D. D. All of that in addition to having these a dilation effect and we expect that to play out in both of these indications.

Okay. So that's a whole uh, that's a whole pancake, stack of questions, you got there. So um, basically I'm going to refer all 3 of those questions. And hopefully, she's been taking notes to Dr. Peterson, who would be the best person to opine? Um, in the first on the enrollment progress with, um, the ppf, or maybe we could call a ketone 3 trial and then, uh, and and then, um, walk through the mechanism of action that, um, increasingly being understood as she's attended all of the major, uh, chess pulmonary respiratory conferences, and she's talked with, um, all of the major Ko's. Um, she's also write in the loop on the

Hum.

And as far as the regulatory path. So we Havent had agreed with FDA that we will we're using both the data from Teton to U N T timeline.

Martine Rothblatt: Finally, she works very closely with our regulatory group to give you some insight on the kind of cadence of what we can expect in terms of filing. Dr. Peterson, could you take all those questions away? That'll probably make you the last answer because that was a lot of questions.

And I don't know.

Know that we are expected to.

Have the Teton when results we report those in the first half of 2026.

And.

So in fact, we are meeting.

With the FDA before the end of this year and to discuss ways to potentially expedite that regulatory review process. When the Teton one results there are available so.

[Analyst]: Thank you. Yes, I did take notes. Regarding TETON PPF, we're about halfway through enrollment, a little bit more. That study in design, as you well know, is very similar to those for the TETON 1 and TETON 2 in that there's a 52-week follow-up period. We can't really speak in detail about when we would expect unblinding, but that gives you an idea and you all know that that's being run in basically the U.S., Canada, as well as rest of the world. Most importantly, really based on the similarities of the underlying fibrosis and disease progression between IPF and PPF, these results suggest that inhaled treprostinil would potentially offer a treatment option for these patients with PPF.

Um, major top tier top of the top, tier type of top peer reviewed. Um, um, publication, that's about to come out. And there's a lot of, you know, um interest in the Moa question there. And then finally um she works very closely with our regulatory group and um to give you some insight um, on the kind of um Cadence of what we can expect in terms of filing. So uh, Dr. Peterson, could you take all those questions away? And that'll probably make you the last, uh, answer. Uh, because that was a lot of questions.

All of that is is really positive really really exciting and and definitely pointing in the right direction of of you know.

Consistent results among these these various teton trial.

Thank you so much Dr Peterson.

Responses and you've collapsed that so hello can lead that we have time for one last question operator.

Yes.

Alright, alright.

Yes, I did take notes, uh, good, good. So yeah, for, for regarding Teton PPS, um, we're about, uh, halfway through enrollment a little bit more, um, and, uh, that study in in design as you, well, know, is is very similar to um, those for the Teton 1 and Teton 2 in that there's a, you know, fear 52 week, uh, follow-up period. And so um, and so again we um you know, we we

Next question comes from Rowenta Ruiz from Leerink. Please go ahead with your question.

Great morning, everyone. So I wanted to ask about the 80 microgram cartridge for DPI could you give a little bit more color on the launch plans for that any strategies to drive more durable patient use possible switching from the prior cartridge et cetera.

Sure, Let me turn that question.

Initially and perhaps comprehensively to Pat <unk>, who is our executive Vice President for technical operations and.

Kent really speak, uh, in detail about, you know, when we would expect on blinding, but that gives you an idea. Um, and you all know that that's being, uh, runs in, uh, basically US Canada, as well as the rest of the world. Um, so, uh, and, and again, most importantly, um, really based on the similarities of the, underlying fibrosis and disease progression between the ipf and ppf.

We, I mean, these results suggest that inhale to prostal, um,

Has been keen in the design of that incredible tie VSO.

[Analyst]: With regard to the mechanism of action, the specific mechanism of action, again with the similarities in the underlying fibrosis, and as we've discussed, both the in vitro results, the preclinical results demonstrating an anti-fibrotic effect of treprostinil as it works through the various receptors, the IP receptor, all of that in addition to having a vasodilation effect, we expect that to play out in both of these indications. As far as the regulatory path, we had agreed with FDA that we are using both the data from TETON 2 and TETON 1. You all know that we are expected to have the TETON 1 results and report those in the first half of 2026. In fact, we are meeting with the FDA before the end of this year to discuss ways to potentially expedite that regulatory review process when the TETON 1 results are available.

From the very beginning.

Pat.

Yeah happy to think smart team.

I didn't.

Catch the whole question could you just repeat it for me just to make sure I answer it correctly.

would, uh, potentially offer a a treatment option for these patients with ppf, um, with regard to the mechanism of action, the specific mechanism of action again with the similarities in the underlying fibrosis, and as we've as we've discussed

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

Demonstrating an anti-fibrotic effect.

Sure sure so.

of proximal as it, um,

With PPI we've seen.

Patients are able to titrate higher and.

Really for their convenience.

Develop this 80 microgram cartridge.

To allow them to take 15 brass in one single dose.

So that'll be added convenience, whereas to get there before they had to combine two cartridges.

as it, it works through the various receptors the IP receptor. If you to DB all of that, um, in addition to having a a vasodilation effect, um, we, we, we expect that to, um, play out in in both of these, um, indications. So, um,

So we're anticipating launching that very soon.

Certainly in the next say three.

30 to 60 days that'll be out there.

So we're really just looking to add convenience and easier dosing for patients.

Yeah.

Excellent.

So much.

And it's far as uh, the regulatory path. So we, uh, have had agreed with FDA that we will. We're using both the data from Teton 2 and Teton 1, and you all know that, uh, we are expected to, uh, have the Teton, 1 results report those at the first half of 2026,

and um,

I'm going to wrap up the call now we reached our a lot of time, but I wanted to thank everybody for the congratulations that they've offered us on this our best quarter that we've ever had.

Commercially clinically.

[Analyst]: All of that is really positive, really exciting and definitely pointing in the right direction of consistent results among these various TETON trials.

Really across the board.

We're super excited about the U T product portfolio just off if there is some newbies under call just to remember that the opportunity in pulmonary fibrosis is more than twice the size of the opportunity in pulmonary hypertension, and we're still continuing to go and grow like game.

So, in fact, we are meeting, uh, with the FDA before the end of this year and to discuss, uh, ways to potentially expedite that regulatory review process, um, when the Teton 1 results are are available. So, um, all of that is, is really positive, really, really exciting, um, and and definitely pointing in the right direction of of, you know,

Martine Rothblatt: Thank you so much, Dr. Peterson. Great responses. You collapsed that so elegantly that we have time for one last question. Operator.

Consistent results. Among these these various Teton trials?

Buster's in pulmonary hypertension itself. So it's truly best of times that United Therapeutics. Thank you for your interest and operator, you can wrap up the call.

Thank you so much. Uh, Dr. Peterson uh, great responses and you collapse that. So um, elegantly that we have time for 1 last question, operator.

Operator: All right, our next question comes from Roanna Ruiz from Leigh Peterson. Please go ahead with your question.

[Analyst]: Great morning, everyone. I wanted to ask about the 80 microgram cartridge for Tyvaso DPI. Could you give a little bit more color on the launch plans for that? Any strategies to drive more durable patient use, possible switching from the prior cartridge, et cetera? Sure.

All right. Uh, our next question comes from Rowena Ruiz from Leerink. Please go ahead with your question.

Thank you for participating in today's United Therapeutics Corporation earnings webcast.

Broadcast of this webcast will be available for replay for one week by visiting the events and presentations section of these United Therapeutics Investor Relations website at IR Dot.

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

Great morning, everyone. So, uh, I wanted to ask about the 80 microgram cartridge for Deipi. Could you give a little bit more color on the launch plans for that, any strategies to drive more durable patient use, possible switching from the prior cartridge, etc.

Unit their dot com again, Thats IR Dot U N.

H E R Dot com.

We thank you for participating you may now disconnect your lines.

James Edgemond: Yeah, happy to.

Sure, let me um, turn that question. Um, initially and perhaps comprehensively to uh, path, who's our Executive Vice President, for uh, technical cooperation and um, has been Keen in the design of of that incredible Tao, uh, product from the very beginning. Um,

Martine Rothblatt: Thanks, Martine. I didn't catch the whole question. Could you just repeat it for me to make sure I answer it correctly?

Pat.

Yeah, happy to Thanks Martin. Um I didn't

Catch the whole question. Could you just repeat it for me? Just make sure I answer it correctly.

[Analyst]: Sure. For the new 80 microgram cartridge, just curious about launch plans for that, strategies to drive patient use, switching, et cetera.

Martine Rothblatt: Sure, sure. With DPI, we've seen patients able to titrate higher and, you know, really for their convenience, we've developed this 80 microgram cartridge to allow them to take 15 breaths in one single dose. That will be added convenience, whereas to get there before, they had to combine two cartridges. We're anticipating launching that very soon, certainly in the next, say, 30 to 60 days that'll be out there. We're really just looking to add convenience and easier dosing for patients. Excellent, Pat. Thank you so much. I'm going to wrap up the call now. We've reached our allotted time, but I want to thank everybody for the congratulations that they've offered us on this best quarter that we've ever had commercially, clinically, really across the board. We're super excited about the UT product portfolio.

Sure, so for the new 80 microgram cartridge, just curious about launch plans for that, strategies to drive patient use, switching, etc.

Sure, sure. So with DPI, we've seen patients able to titrate higher and,

You know, really for their convenience, uh, We've developed this 80 microgram cartridge uh, to allow them to take 50 breaths uh in 1 single dose. Uh, so that would be added convenience, whereas to get there before they had to combine 2 cartridges.

So we're anticipating launching that very soon. Um, certainly, uh, in the next say, uh, 30 to 60 days, uh, that'll be out there and uh, so. So we're really just looking to add convenience and easier dosing for patients.

Excellent. Uh Pat. Thank you so much.

Um,

Martine Rothblatt: Just if there's some newbies on the call, just to remember that the opportunity in pulmonary fibrosis is more than twice the size of the opportunity in pulmonary hypertension, and we're still continuing to go and grow like gangbusters in pulmonary hypertension itself. It's truly best of times at United Therapeutics. Thank you for your interest and operator, you can wrap up the call.

I'm going to wrap up the call. Now we've uh, reached our a lot of time, but I want to thank everybody for the congratulations that they've offered us on this uh, best quarter that we've ever had um, commercially clinically, um, really across the board. We're super excited about the UT product portfolio. Just off. If there's some newbies on the call, just to remember that the opportunity.

In pulmonary fibrosis is more than twice the size of the opportunity in pulmonary hypertension and we're still continuing to go and grow like Gang Busters in pulmonary hypertension itself. So it's truly best of times that the United Therapeutics thank you for your interest and operator. You can wrap up 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 Presentation section of the United Therapeutics investor relations website at ir.unither.com. Again, that's ir.unither.com. We thank you for participating. You may now disconnect your lines.

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.

Dot unit there.com. Again, that's ir.com.

We thank you for participating. You may now disconnect your lines.

Martine Rothblatt: Sam.

Q3 2025 United Therapeutics Corp Earnings Call

Demo

United Therapeutics

Earnings

Q3 2025 United Therapeutics Corp Earnings Call

UTHR

Wednesday, October 29th, 2025 at 1:00 PM

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