Q3 2019 Earnings Call

Operator: Good morning, and welcome to the United Therapeutics Corporation third quarter 2019 earnings call. My name is Justin, and I'll be your conference operator today. All participants will be in a listen-only mode until the question and answer portion of this earnings call.

Okay and welcome to the United Therapeutics Corporation third quarter 2019 earnings call. My name is Justin and I'll be your conference. Operator today, all participants will be you know listen only mode until the question to answer a portion of this earnings call. If you would like to ask a question during that time simply press Star then number one on your telephone keypad.

Operator: If you would like to ask a question during that time, simply press star and the number one on your telephone. If you would like to withdraw your question, press the pound on your telephone. I would now turn the call over to James Edgeman, Chief Financial Officer of United Therapeutics. Thank you, Justin. Good morning, everyone.

If you'd like to withdraw your question press the pound on your telephone keypad.

I would now turn the call over to James Edgemond, Chief Finance Officer of United Therapeutics, Sir you may begin.

Thank you Justin Good morning, everyone. It's my pleasure to welcome you to the United Therapeutics Corporation third quarter 2019 earnings call.

James C. Edgemond: It is my pleasure to welcome you to the United Therapeutics Corporation Third Quarter 2019 Earnings Call. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairman and Chief Executive Officer, and Mr. Michael Benkowitz, our President and Chief Operating Officer. My remarks today will include four 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 Form 10-K and 10-Q, contain additional information on these risks and uncertainties. However, we assume no obligation to update forward-looking statements.

Accompanying me on todays call are Dr. marketing rock Black, our chairman and Chief Executive Officer, Mr., Michael Benkowitz, Our President and Chief operating Officer 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 reserve results to differ materially.

Our latest FTC filings, including Form 10-K intend to contain additional information on these risks and uncertainty we assume no obligation to update forward looking statements.

Today's remarks May also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release available on our website at Www Dot unit there dot com.

James C. Edgemond: Today's remarks may also include financial measures that were not prepared in accordance with U.S. Generally Accepted Accounting Principles. Reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release, available on our website at www.unither.com. Today's remarks may discuss the progress and results of clinical trials and other developments with respect to our product. 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 use. Full prescribing information for these products is available on our website. Now, I will turn the call over to Dr. Rothblatt for an overview of our third quarter 2019 financial results and business activities of United Therapeutics. Thank you, James. Good morning, everybody.

Today's remarks may discuss the progress from results of clinical trial with another developments with respect to our products.

His remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision, making work to suggest that any products are safe and effective for any unapproved or investigational uses.

Oh prescribing information for these products is available on our website.

Now I will turn the call over to Dr. Rothblatt for an overview of our third quarter 2019 financial results and business business activities of United Therapeutics.

Thank you James good morning, everybody.

As James mentioned I'm pleased to be joined today by our President and Chief Operating Officer, Mike Bank with and he and James and I will answer questions. After I give a brief business overview of United Therapeutics as far as the third quarter.

Martine A. Rothblatt: As James mentioned, I'm pleased to be joined today by our President and Chief Operating Officer, Mike Benkowitz, and he and James and I will answer questions after I give a brief business overview of United Therapeutics for the third quarter of 2019. We're pleased with our financial results over the past quarter, and they're available in the press release, but on every metric, we're very pleased with how everything came out. Let me give a bit of an overview now of some of the exciting business progress going on at United Therapeutics. Last month, my colleague, Dr. Peterson, reported the FDA approval of our new label for Oronatram. This was really a major accomplishment for United Therapeutics. It's something that we have worked on steadfastly for just about a decade.

29 team.

We're pleased with our financial results over the past quarter and I. They were available in the press release, but on on every metric. We're we're very pleased with how everything came out.

Let me give up a bit up an overview now on some of the exciting business progress going on as United Therapeutics.

Last month or my colleague Dr., Peter soon reported the FDA approval of our new label for Orenitram.

This was really a signal accomplishment for United Therapeutics, It's something that we worked on steadfastly for just about a decade.

And for those of you who are kind of pulmonary hypertension, geeks or or really you know into the deep history on.

Martine A. Rothblatt: And for those of you who are kind of pulmonary hypertension geeks or are really, you know, into the deep history of the drugs used to treat pulmonary hypertension, it's interesting that even though the active pharmaceutical ingredient in Orenatram troprosinol was discovered by the Nobel laureate, Sir John Vane. He himself did not believe that this API would be able to be successfully developed as an oral treatment that could reduce the rate of progression of pulmonary hypertension, much less reduce outright morbidity or mortality. And he was a great guy.

On the drugs used to treat pulmonary hypertension, it's interesting that even though the active pharmaceutical ingredient in or rent a trend.

For profitable.

Was discovered by the Nobel Laureate, Sir John vein.

He himself did not believed that this a pie would be able to be successfully developed has an oral treatment that could reduce the a rate of progression of pulmonary hypertension.

Much less reduce outright morbidity or mortality.

And she was a great guy Unfortunately, he passed but it was thanks to him that we've developed our parenteral form of profit from all of which the brand name is remodulin and she was spot on correct that that would be a highly effective treatments for patients with pulmonary hypertension, but it.

Martine A. Rothblatt: Unfortunately, he passed, but it was thanks to him that we developed our parenteral form of troposomal, which the brand name is remodulin. And he was spot on correct in predicting that that would be a highly effective treatment for patients with pulmonary hypertension. But it's kind of a little bit of like a pinch me moment when you have a Nobel laureate thinking that this is just not gonna be able to work as a pill, and you slug away for 10 years. And during the course of that 10 years, you're always thinking, geez, maybe Sir John was right. And then you end up with this absolutely beautifully executed FREEDOM-EV study with the excellent results that we shared with everybody last year. And then we're still crossing our fingers until we get the final FDA stamp of approval on the results, which occurred just earlier this month. So that was really, I think, beyond a doubt, not only the signal result since our last earnings call but also of 2019.

Kind of a little bit of like a pinch me moment when you have a Nobel laureate thinking that this is just not going to be able to work has appeal and you slug away for 10 years and during the course of that 10 years, you're always thinking teeth may be Sir John was right maybe Sir John was right and then you end up with this.

Absolutely beautifully.

Freedom easy study.

With the excellent results that we shared with everybody last year and there were still crossing our fingers up until we get the final FDA stamp of approval on the results which occurred.

Just earlier this month, so that was really I think beyond the result, not and be able to Dallas not only the signal result of since our last.

Earnings call, but also up 29 team.

I really I personally believe that due to be great label that the FDA approved on Orenitram that over the next two to three years, we're going to be able to double the number of patients that we have on Orenitram and then actually be able to double that again in the following two to three years after about.

Martine A. Rothblatt: I really personally believe that, due to the great label that the FDA approved for Orenatram, that over the next two to three years, we're gonna be able to double the number of patients that we have on Orenatram and then actually be able to double that again in the following two to three years after that. So it's a really good outlook for Orenatram thanks to this accomplishment of our new, greatly expanded label for that product. Now there are some other really good things that are coming up in the approval category during the next 12 months.

So it's a really good outlook for Orenitram thinks that this accomplishment of our new.

Greatly expanded label for that product.

Now there's some other a really good things that are coming up in the approval category. During the next 12 months and Frac frankly, we have never had a greater our perspective news flow to the United Therapeutics than we do in the next 12 months in the next 12 months we hoped.

Martine A. Rothblatt: And frankly, we have never had a greater prospective news flow for United Therapeutics than we do in the next 12 months. In the next 12 months, we hope for and expect there to be no fewer than three new approvals for United Therapeutics from the FDA. First, the one that we have also been working on for just about 10 years, the ISR, the Implantable System for Remodulin. We hope to get the final approvals for that.

I wouldn't expect there to be no fewer than three new approvals for United Therapeutics, how that the FDA.

First the one that we have also been working on for just about 10 years.

The is our implantable system for Remodulin, we hope to get the final approvals for that as those of you who have been following us for a while no actually its United Therapeutics already got its approvals from the FDA and we're waiting for the final Medtronic approvals before we could commercially launched their project.

Martine A. Rothblatt: As those of you who have been following us for a while know, actually, United Therapeutics already got its approvals from the FDA, and we're waiting for the final Medtronic approvals before we could commercially launch that project. Second up, we expect to get FDA approvals needed for the commercial launch of Remunity. Also, for those of you who have been following us, we actually did get an initial 510K approval for Remunity, and we're just waiting for a final approval on a kind of a special 510K or regulatory analog of that that we would expect in the next 12 months that would be truly transformative for the patients on subcutaneous remodulin. And then third, we expect within the next 12 months to have an FDA approval for Trevian That's the product that we acquired along with the acquisition of Stedimed. This one is going to be transformative for a very large segment of the pulmonary hypertension population, especially that segment that suffers from connective tissue disease. And there is a whole spectrum of connective tissue disease states, such as scleroderma and Raynaud's disease.

Second up we expect together FDA approvals are needed for the commercial launch of Remunity I'm also for those of you've been following us we actually did get a and initial five 10-K approval on community and we're just waiting for final approval on I kind of a special five Ken.

Hey, or or regulatory catalog of that.

We would expect from the next 12 months that would be.

Truly transformative for the for the patients on subcutaneous Remodulin.

And then third we expect to know within the next 12 months to have an FDA approval for TREVYENT. That's the the project that we acquired along with the acquisition of steady Meds. This one is going to be transformative for a very large segment of the pulmonary hypertension population, especially that segment that suffers from.

Active tissues.

And there's a whole spectrum of connective tissue disease.

States, such as scleroderma and.

And Ray notes disease, and all of these kind of.

Martine A. Rothblatt: And all of these kinds of conditions make it very difficult for patients to activate the tiny buttons that we have on all of our devices. So I think that that one being so simple, no buttons involved for the patients to have to adjust the dosage or anything like that, truly just a plug and play system. I believe that Treviant, together with Remunity, is going to allow us to significantly expand the reach of subcutaneous remodulant patients well beyond the number of patients that we have already been able to help and serve with that product. Speaking of the number of patients that we're helping and serving, I hope my colleague Mike won't be angry at me for stealing his thunder a little bit, but we are now serving more patients with Proprosinol than we have ever served in the history of the company.

Conditions, they make it very difficult for patients to activate the tiny buttons that you know we help on all of our devices.

So I think that that's one being so simple no buttons involved so the patients to how to adjust the dosage or anything like that truly just plug and play system.

Believe TREVYENT aren't together with community on is going to allow us to significantly expand the reach of.

Subcutaneous remodulin patient well beyond the number of patients that we have already been able to health and serve that that product.

Speaking of a number of patients that were helping and serving.

I Hope my colleague Mike won't.

The Ingrid me for stealing his thunder, a little bit, but we are now serving more patients with for profitable than we have ever served.

Industry or the company. So it's a it's really.

Martine A. Rothblatt: So it's really a great launching point for 2020 because here we are serving more patients than we've ever served before, and we're on the cusp of launch in the next 12 months, not to mention the true launch of Orenotram with the new label. So really, four new products, each of which has the ability to significantly expand the number of patients that can be served by the Proprosinol family of products here at UT. So on the FDA approval front, I think things could not be going better. But let's take a look at what's going to come next after these approvals. So we have also found ourselves in a very good position because of all the spade work and seed planting that we've done over the past few years to harvest two unblindings in the next coming quarter. By that, I mean the first quarter of 2020.

A great launching point for 2020, because here, we are serving more patients and we've ever served before and we're on the cost of launching in the next 12 months not to mention the the true launch of Orenitram within the label, so really for new products each of which happened ability.

To significantly expand the number of patients that can be served.

The Treprostinil family of products here at U.T.. So on the FDA approval front, I think things could not be going better.

Let's take a look at what's going to come next after these approvals. So we have also found ourselves in a very good position on because of all the.

Spade work.

Flapping the up we've done over the past few years to harvest to Unblinding in the next coming quarter by definitely by that I mean, the first quarter of.

2020, we expect to Unblind first of all our distinct study of.

Martine A. Rothblatt: We expect to unblind, first of all, our distinct study of unitoxin or dinotoximab for small cell lung cancer. That's really exciting because right now we've been able to serve, roughly speaking, about 1000 patients with unitoxin. Those are patients suffering from neuroblastoma. But the small cell lung cancer patient population is in the tens of thousands.

Unituxin or gotten a tuck some app for small cell lung cancer.

That's really exciting because right now we've been able to serve roughly speaking about a thousand patients with unituxin those are the patients suffering from neuroblastoma.

But the small cell lung cancer patient population isn't the tens of thousands it. So it's really an order of magnitude more than we're able to serve with.

Martine A. Rothblatt: It's really an order of magnitude more than we're able to serve with in neuroblastoma. So we're really, really hoping for a positive unblinding of unitoxin dinotuximab in the first quarter, and then that would set us on a course of FDA filings and then launch within a year after that in a tenfold larger population than we're able to serve with in neuroblast And then, in another very similar story, but different disease state, we will be unblinding our increased study, and this is of tyvaso in group three pulmonary hypertension. This is a group of patients characterized by interstitial lung disease and pulmonary fibrosis, a group of patients that payers will not approve the use of tyvaso in this patient population today because they have very different characteristics. They are, for example, not cardiac catheterized, which is definitely a checkmark that payers require before reimbursement for the drugs in the group one idiopathic or secondary pulmonary hypertension population.

And neuroblastoma, so we're really really hoping for a positive unblinding of Unituxin diamond touch them out in the in the first quarter as end up with set us on a course of ft. A filings and then launch within a year after that to a tenfold larger population than we're able to serve.

With in Neuroblastoma, and then in another very similar story, but different disease States, we will be Unblinding. Our increased study and this is of Tyvaso in group three pulmonary hypertension. This is a group of patients.

Characterized by.

By interstitial lung disease, and pulmonary fibrosis, a group of patients that.

Payers will not approve the use of tyvaso in this patient population today, because they have very different characteristics. They are for example or not.

Cardiac half of Darius, which is definitely a checkmark downtown payers require before reimbursement for the drugs in the group one.

Idiopathic or secondary pulmonary hypertension population.

So this population is also 10 times larger than the number of patients if we're able to serve with tyvaso today. So it's a very analogous parallel situation with the.

Martine A. Rothblatt: So this population is also 10 times larger than the number of patients that we're able to serve with Tyvaso today. So it's a very analogous, parallel situation with the cancer situation where we've got a great drug, Tyvaso, similar to a great drug, Unituxin, able to serve single-digit thousands of patients, doing very well with those. And now we'll be able to unblind in the next quarter basically the same drug, so very, you know, much reduced risk in terms of the regulatory process, but for a patient population that's 10 times larger than the one that we're already serving. So again, a very, very sweet situation with those two blindings in the first quarter.

Cancers situation, where we've got a great drug tyvaso similar to a great drug unituxin.

Well to serve single digit thousands of patients.

Doing very well with those and now we'll be able to unblind into next quarter.

Basically the same drugs, so very much reduced risk in terms of the regulatory process, but for a patient population Thats 10 times larger than the ones that were already serving so again very very sweet situation with those two unblinding since the first quarter.

Let me just wrap up with kind of a fly over of the deeper pipeline just because we've got so much exciting stuff going on in the in the current 12 month pipeline, but there is upcoming a R&D filing.

Martine A. Rothblatt: Let me just wrap up with kind of a flyover of the deeper pipeline, just because we've got so much exciting stuff going on in the current 12-month pipeline. But there is an upcoming IND filing to begin the formal clinical development of our once-daily formulation of orenotram. There will be a movement right to the IND or just thereabouts for Remopro, which will be the much less painful or painless form of remodulin. Again, certainly a game-changer in subcutaneous troprosinol because of its ability to greatly mitigate and, for some patients, eliminate the sight pain.

To to begin the formal clinical development of our once daily oral formulation of around the trend.

There will be a.

Movement.

Right to the R&D or are just thereabouts for remote pro that will be the much less painful or paying less form of remodulin I guarantee.

Certainly a game changer in subcutaneous.

Professional because of its ability to.

Greatly mitigate and.

For some patients eliminate the site team.

The very exciting trade T program, which we've done in combination with mankind, where we'll be able to reduce the burden associated with tyvaso to something that is truly de minimis fits right in like a clutch purse.

Martine A. Rothblatt: The very exciting TRAIT-T program, which we did in combination with Mankind, where we'll be able to reduce the burden associated with Tivaso to something that is truly de minimis, fits right in like a clutch purse or just a little, even a jean pocket, and really liberates thousands and thousands of patients from a lot of the burdens of dealing with drug delivery systems for pulmonary hypertension. That program is going very well, and patients are already being dosed. The PERFECT trial of Tivaso in COPD, this is a trial that we're very grateful to Dr. Waksman for leading the way with his early proof of concept of the excellent results of Tivaso in the very large and oftentimes difficult-to-treat COPD population.

Or just a little.

Even gene pocket and really liberate thousands and thousands of patients from love the burdens of dealing with a drug delivery systems for pulmonary hypertension that program is going very well also being managed by Dr. Peterson and.

Patients already being being dosed.

The perfect trial of Tyvaso in CRPD. This is a trial that we're very grateful to Dr. waxman, leading the way with his.

Early proof of concept of the excellent results of Tyvaso in the in the very large and.

And oftentimes difficult to treat fuel PD population. So that program is being run by our one biotechnology unit and also proceeding straightforward with patients already being enrolled again just to be clear Thats also phase III trial.

Martine A. Rothblatt: That program is being run by one biotechnology unit and is also proceeding straightforward with patients already being enrolled. Again, just to be clear, that's also a Phase III trial. Our humanized form of dinatoxamab, we're not resting on any laurels with the good results of unitoxin, and thanks to a great partnership we entered into with St. Jude Medical, we've been able to in-license the rights to and now begin manufacturing a humanized form of dinatoxamab. This might be delving a little bit into the uber-geekiness, but So hats off to our totally awesome biologics and manufacturing group. And last but not least, very, very exciting progress on the xenokidney front. We will open up in the next quarter the company's first designated pathogen-free facility for xenokidney. The acronym for that is called D-Delta-P-Papa-F-Foxtrot-DPF.

Our humanized foremost have gotten the texel mab, we're not resting on any laurels with the good results of Unituxin and thanks to a great partnership we entered into with St. Jude Medical we've been able to and license the rights to now be good manufacturing humanized form of Diamond Tux Mab.

This might be dealt thing a little bit into the into the Super Geekiness, but I am personally very proud as to kind of our manufacturing keep myself that were like multiple fold improvements in the efficiency of our production of that humanized monoclonal. So hats off to are totally off some biologics and manufacturer.

In group and last but not least so very very exciting progress on the xeno kidney front, we will open up.

In the next quarter, the company's first death designated pathogen free facility for Xeno kidney.

The the after them for that lets call. The D Delta Papa AFE Foxtrot DPF and what that means is that the kidney is being produced in a pig in that facility in the way that the FDA agrees the organs from that pig can be put in.

Martine A. Rothblatt: And what that means is that the kidney is being produced in a pig in that facility in a way that the FDA agrees the organs from that pig can be put into a person. The FDA does not allow you, and thank goodness for that, just to take any farmer's John Pig's organs and put them into a person. They're very, very strict that you have to have a completely sterile environment just as you would have for any other drug or biologic that you are putting inside a person. So a xenokidney is just a giant biologic, and there are very strict rules in terms of every aspect of infection testing and C-sectioning of the genetically modified pigs for those organs to end up being tested in man.

To a person the FDA does not allow you. Thank goodness for that just to take you know any farmer, John pigs to organs and put them into a person they're very very strict that you have to have a a.

Completely sterile environment, just as you would have for any other drugs or biologic that you are putting inside a person. So xeno kidney is just a giant biologic and there are very strict rules in terms of every aspect of infection testing and see sectioning in as of the of the.

Genetically modified on pigs for those organs to end up being tested at man so.

That debt facility will come online in 2020, and then paves the way for us to be able to actually with the FDA approval accomplish the.

Martine A. Rothblatt: So that facility will come online in 2020 and then pave the way for us to be able to actually, with FDA approval, accomplish the first in man of our xenografts in the 2021-2022 timeframe. So I've probably gone a little bit over my allotted time here. I guess I'm dead by five minutes.

The first demand of our seen aircrafts in the 2021 2022.

Timeframe, so I, probably gone a little bit over my allow the time here I guess a bit by five minutes, but.

And then event I'm. So excited about all the stuff going on on duty. So operator, if you can see so open up the phone lines and I will sort the questions to Mike and James.

Martine A. Rothblatt: But in any event, I'm so excited about all the stuff going on at UT. So operators, you can please open up the phone lines, and I will sort the questions into Mike and Jason. Thank you, sir. As a reminder, to ask a question, you need to press star 1 on your telephone. To withdraw your question, press the pound key.

Thank you Sir.

As a reminder to ask a question you need to press star one on your telephone to withdraw your question press the pound Keith Please stand by only compiled acuity roster.

Operator: Please stand by while we compile the Q&A roster. Our first question... J.P. The line is now open. Hey there, good morning.

Once again that is starved one.

Our first question is going to come from justify JP Morgan.

Your line is now.

Jessica Fye: Thanks for taking my question. I was hoping you could elaborate on the earlier pump comments. I guess specifically, can you help me understand the timing and order in which you expect those three different pumps to launch?

Hi, there good morning. Thanks for taking my question I was hoping you could elaborate on the earlier comments I guess, specifically can you help me understand the timing in order in which you expect those three different pumps to launch.

Yes, Thanks Jessica.

Martine A. Rothblatt: Yeah, thanks, Jessica. You know, everything's up to the FDA, so it's really difficult to be precise about that.

You know everything's up to the FDA, so it's really difficult to be precise about that.

You can be TREVYENT is is one that I think you can you can follow from the PDUFA timeline of the FDA.

Martine A. Rothblatt: You can, the Treviant is one that I think you can follow from the PDUFA timeline of the FDA. Remunity, the FDA filing is actually not done by United Therapeutics. It's done by DECA, who is our pump partner. And the ISR, as I mentioned in my opening remarks, is also a Medtronic product. So I wouldn't want to really fine tune it so much as to line them up as, you know, one, two, three, or two, three, one.

Remunity the FDA filing is actually not done by United Therapeutics, It's done by Decca, who is our pump partner and the Iocs are as I mentioned in my opening remarks, it's also a to medtronic products. So I wouldn't want to really fine tune. It so much as to like line them up as you know 123 or 231.

But we do feel quite confident that all three will launch in the next 12 months.

Martine A. Rothblatt: But we do feel quite confident that all three will launch in the next 12 months. Next question, operator. Thank you. The next question is from Martin Oster from Credit Suisse. Thanks for taking the question. On remodeling, Martine, I'm curious, in the early days of generics, if you're seeing any sources of pressure at all specific to either Medicaid or Medicare or commercial, if there's relatively any one area where you're seeing more pressure, more vulnerability for the franchise, and then also the ex-US remodeling sales, I noticed those were up pretty sharply from 2018 to 2019 year-to-date. I was curious if there was any color you guys could provide around that.

Next question operator.

Thank you. Our next question is from margin Oscar from Credit Suisse.

Your line is now well thanks for taking my question. Thanks for taking the question.

On on Remodulin marching I'm curious in the early days of generics if you're if you're seeing any sources of pressured all specific to kind of either Medicaid or Medicare on commercial if theres relatively any one area, where you're seeing more more pressure more vulnerability for the franchise and also the ex us Remodulin sales I know.

Those are up pretty sharply from 2018 between 19 year to date just curious if there was any color you guys could provide around that thanks for taking the questions.

Martine A. Rothblatt: Thanks for taking the question. Sure, Marty. Nice to hear your voice this morning. I'm going to sort those questions. The first one goes to Mike, as he has overall authority.

Sure Mardi nice to hear your voice this morning, I'm going to sort those questions. The first one to Mike.

As he has overall authority.

Michael I. Benkowitz: Both questions to Mike. Sorry, I'm going to throw both questions at Mike as he's got overall authority on all commercialization matters at DUT. Yeah, thanks, Martine. So, Marty, you know, we're now, I guess, two full quarters in and facing current competition, and really have not seen a material impact on our module. For the second quarter in a row, we've achieved a record number of remodeling patients on therapy. I think I mentioned in Q2 that we saw the highest number of new patients start in almost 10 years. In Q3, we didn't quite hit that number; we came just a few prescriptions short. So, you know, we're really pleased with how things have evolved in the face of generic competition. We really have not seen any clear pressure of note.

Both questions to Mike, sorry, I'm going to sort of both questions to Mike.

As he's got overall authority on all commercialization another city, yes. Thanks 14.

So Marty.

We're not what to like a two full quarters and facing care competition.

And really have not seen a material impact to remodulin business.

For the second quarter in a row, we've achieved a record number of remodulin patients.

On therapy.

I think I mentioned in Q2 that we saw the highest number of new patient starts at almost 10 years in Q3, we didnt quite at that number we came into it but it just came a few prescription short so.

We're really pleased with how things have have evolved in the face of generic competition, we really have not seen any any clear pressure of note. I mean, there's there are one off payers I think that into the season with what they call dual eligible Medicare Medicaid patients where.

Michael I. Benkowitz: I mean, there are one-off payers, I think, that see what they call dual-eligible Medicare-Medicaid patients where we're seeing a little bit of pressure, but it's such a small part of the business that it's really not material in the grand scheme of things. And beyond that, there's really just, at this point, no pressure, no payer pressure of note. So that's really, I think, where things sit with respect to the first question. The second question concerns international business.

We're seeing a little bit of pressure, but at such a small part of the business that it's really not not material in the Grand scheme of things and beyond that there is really just at this at this point.

No pressure no payer pressure of note.

So thats really I think where things set with respect to first question on second question.

On the international business.

Michael I. Benkowitz: We have, you know, similar to the U.S., we actually have seen a nice uptick in demand, patient demand, prescriber demand, for remodeling outside the U.S. The other thing that's happened, I think, is a change in our relationship with Ferrer that happened over the last 12 to 18 months or so. So they've taken on more responsibility for labeling and packaging of our product. As a result of that, you know, their orders are up because it takes them more time to go through that process. And in the past, we were doing the labeling and packaging and sending them to them. And so, you know, their orders are up relative to what they did in the past, just because they need more time to go through that packaging process. Thanks, Mike. Thank you so much.

We have some are similar to you asked we actually have seen seen nice nice uptick in demand.

Patient demand prescriber demand.

For Remodulin outside the us.

The other thing that's happened I think as is the change in our relationship with four out of that happened over the last 12 to 18 months or so so they've they've taken on more responsibility for label and packaging of our product.

As a result of that their orders are up because it takes them more time to go through that process in the past we were doing a late in the packaging and sending it to them and so.

There their orders are up relative to what they've been in the past just because they need more time.

Pathogen process, great things, Mike. Thank you so much operator next question. Please.

Operator: Operator, next question, please. Our next question comes from Laiana Moussatos from Wedbush Security. Your line is now open.

Next question comes from Liana Moussatos from Wedbush Securities. Your line is now open.

Thank you for taking my question.

Laiana Moussatos: Thank you for taking my question. What would be clinically meaningful for overall survival in distinct and for the six-minute walk distance in increase? And in increase, why did you use the six-minute walk distance as the primary endpoint instead of morbidity and mortality? Yeah, thank you, Leanna. Nice to hear your voice this morning. With regard to DISTINCT, I'm actually not really qualified to answer that question.

We wouldn't be clinically meaningful for overall survival in distinct and for the six minute walk is increased and an increase why did you use six minute walk distance for primary endpoint incentive morbidity mortality.

Yes. Thank you all the on a nice to hear your voice this morning, our with regard to distinct.

I'm I'm actually not really qualified to answer that question. It's the our oncology programs run by Dr. Goldenberg Who's who's not on the conference call. This morning, so im going to punt on on the detail answer to that question other than to say it is a survival endpoints study so.

Martine A. Rothblatt: It's our oncology programs run by Dr. Golden, who's not on the conference call this morning. So I'm going to punt on the detailed answer to that question, other than to say it is a survival endpoint study. All of those patients have, of course, had their conventional therapy treatment for their cancers. But beyond just mere survival, I'm just not up to speed on any next level of details below that.

We are currently within a handful of patients from helping a the the survival endpoint and then do you need to Unblind and see the difference between the non diamond Tux Mem treated and the down a touch NAV are treated group all of those patients have of course had their consumption.

No.

Therapy treatment for for their cancers.

Beyond just mere survival I'm, just I'm, just not up to speed on on the next level of details below that.

With regard to be six minute walk endpoint for.

For increase the the reason for that is.

Martine A. Rothblatt: So the six-minute walk is definitely a good FDA multiple-time blessed endpoint for pulmonary hypertension. Secondly, because there are no other treatments available for patients with interstitial lung disease and pulmonary fibrosis, there was no need to have a mortality or morbidity or combined mortality-morbidity endpoint, as there is in Group 1 pulmonary hypertension, where there are upwards of a dozen different approved therapies. So it's kind of a, it's really two completely different markets.

I would say twofold first of all six minute walk has long been the gold standard for measurement of whether or not somebody has obtained a.

In improvement in their clinical status for pulmonary hypertension for those of US who are are around pulmonary hypertension patients. A lot you hear all the time that theyre in ability to do simple matters of exercise is the.

Is the bellwether sign of a decline in their health status, whether it's like not being able to walk around Walmart or not being able to walk even to the mailbox and and then not being able to walk up there. So six minute walk is definitely a good FDA multiple time.

Last endpoint for pulmonary hypertension.

Secondly, because there are no other treatments available for these patients with the interstitial lung disease and pulmonary fibrosis. There was no need to have a mortality or morbidity or combine mortality morbidity and point out there is in group one pulmonary hypertension with theirs.

Upwards of a dozen different approved therapies and one wants to have the high Mark in terms of highest possible Mark in terms of your data, which is what we were able to achieve with freedom theme.

Martine A. Rothblatt: We've done a lot of research on this. There are very, very few patients in group three who are treated with any of the drugs approved for group one. For the reasons that I said before, it's just not something that has been proven to work. In fact, if you're treating the patients in group three with a systemic drug, like a parental drug or an oral drug, it's actually contraindicated in most people's points of view due to the occurrence of perfusion and ventilation mismatch. So it's something that can only be treated with an inhaled drug. And now there are just two inhaled drugs, Iloprost and Tybaso. And as good as United Therapeutics is at helping patients get reimbursement for their drugs, the payers say, this drug has not been approved for group three, and we're not gonna pay for it. So unfortunately, many, many patients in this category today have foreshortened lives and foreshortened quality of life due to the absence of any drug at all approved for the treatment of their condition. So like the first one, it doesn't make any real sense to leap further than you have to go, jump higher than you have to go.

So it's kind of.

Really two completely different markets there's.

We've done a lot of research on this is very very few patients.

In the group three who are treated with any of the drugs approved for group one.

For the recent said I said before it's just not something that.

That has been proven to work in fact at something if you're treating the patient group three with a systemic drug like a parental drug or oral drug it's actually contra indicated in most people's points of view due to the occurrence of perfusion ventilation mismatch. So it's something that can only be treated.

With a button inhaled drug and now you come down to just to inhaled drugs idle cost.

And.

And Tyvaso and as good as United Therapeutics is add helping patients get.

Reimbursement.

For there for their drugs.

The payer say this drug has not been proof of group three and.

I'm not going to pay for it. So unfortunately, many many patients in this category today have a foreshortened lives and for short in quality supplies.

Due to the absence of any drug at all approved for the treatment of their condition. So as the first one it's no real sense to like leap further than you have to go jump higher than you have to go getting tyvaso approved for this population will be huge and as I mentioned will be a tenfold increase in our addressable.

Martine A. Rothblatt: Getting Tybaso approved for this population will be huge. And as I mentioned, it'll be a tenfold increase in our addressable market population for Tybaso. So we wanna do that as quickly as possible with the lowest risk as possible. And the six minute walk distance was kind of the most logical way to achieve it.

Our market population for Tyvaso. So we wanted to do that as quickly as possible with is lowest risk as possible and to six minute walk distance was kind of the most logical way to achieve that.

Martine A. Rothblatt: Thanks, Deanna. Operator, next question. Our next question comes from Hartaj Singh from Oppenheimer & Company. Your line is now: Great. Thank you, everyone. Thanks for the question. Martine, I just wanted to ask you a little bit about Ornatram. I know that's on the commercial side, so maybe, Mike, you had indicated that now with the label expansion, you'll be able to get 2, 3x more patients. Can you just talk a little bit about what kind of patients these would be? More of the new patients? Would you be able to get some of the existing patients? Are there maybe some patients that might not have qualified before Ornatram that can get on that, on Ornatram now, would really appreciate it? And, by the way, congratulations on not having that generic apocalypse that supposedly is going to happen.

Thanks, Operator next question.

Our next question comes from Hardy Singh from Oppenheimer and company. Your line is now open.

Great. Thank you everyone. Thanks for the question.

Marty I just wanted to ask you a little bit of orders from.

It's on the commercial sign so maybe Mike you had indicated that now with the.

The label expansion, you'll be able to began to three X more patients can you just talk a little bit about what kind of patients would these be more of a new patients would be able to get on the problem patients. Although maybe some patient might model qualifying before foreign trend I can get on that on on now would really appreciated and by the way.

Actuation, while not having that generics.

Hello ups that schools that was going to help thank you.

Hartaj Singh: Thank you. Thank you so much, Hartaj. It's great hearing your voices. Yeah, we really feel the love on that one, so thank you so much.

Thank you so much hartaj state hearing your voice.

Yeah, we really we feel the love them that one so thank you so much I'm going to bounce the orenitram.

Michael I. Benkowitz: I'm going to bounce the Renitram growth trajectory question over to Mike. Yeah, thanks, Hartaj. So I think, you know, Martine mentioned, in her opening comments, that this is really sort of the first true launch, or this is really the first real launch of a Renitram. And I think that's accurate, and that's certainly how we're thinking about it. If I think about the challenges that we've had in the marketplace with Renitram prior to the ED label, I would say the number one challenge is doctors were really trying to figure out where and who is the right patient to use Renitrem, and I think the nice thing about the study is it answered that question definitively. It's those early stage patients, it's your functional class two patients that are starting to be symptomatic, and where you're going to have time to start them on a low dose, titrate them up slowly, help them manage their side effects, and get to a therapeutic dose in a sort of a four to six month time frame.

Growth trajectory question over to Mike, Yes. Thanks.

Sorry.

Our team Thats, what I can are opening comments. If this is really sort of the first true launch.

This is it really a true launch of around trend I think thats, that's accurate and that's certainly how we're thinking about it I think about the challenges that we had in the marketplace with orenitram prior to the label.

Yes.

I'd say the number one challenges doctors were really trying to figure out where where what's the right patient to use orenitram and I think the nice thing about the study does that answer that question definitively. It's it's those early stage patient. That's your functional class two patients that are starting to be something static.

And where you're going to have time to start the model Lodos tripe tight trade up slowly help them manager there side effects and get to a third of therapeutic dose and sort of a four to six month timeframe and then at that point you other than that sort of cross the crossed of side effects hurdle so to speak Mr.

Michael I. Benkowitz: And then at that point, you know, they've sort of crossed the side effect hurdle, so to speak. They're starting to see the benefit of the drug, and then the doctors can titrate it up. Accordingly, based on how their disease is progressing. And so I think in terms of patient type, that's really, I think, the sort of the number one thing that we've been able to answer with respect to the EV study. And then part and parcel of that, as I mentioned, has always been sort of a tolerability and a side effect. And so I think by starting the right patient, giving them time to titrate up, we're really solving two problems with the drug. And so I think because of that, we now have doctors understanding that, okay, now I understand where to use the drug. Now I understand how to use the drug.

Turning to see the benefit of the drug Amendment and then the doctors can tie trade up.

Accordingly based on on how the how their disease is progressing and so I think in terms of the patient type that's really I think the sort of a number one thing that that weve.

Been able to answer.

With respect to the study and then part and parcel that as I mentioned his work. The other issue is always been sort of the tolerability and side effect and so I think by starting to write patient, giving them time to titrate up we're really solving to two problems.

What the drug and so I think because of that we now have doctors understanding that okay. Now I understand where do you use the drug now I understand how to use the drug.

Michael I. Benkowitz: It'll take a little bit of time because you've got doctors that have historically believed in the drug, and this really confirmed their belief in the drug and how they're using it. And hopefully, you know, we'll see them put more patients on therapy. Doctors that maybe had a poor experience with a random treatment in the past are taking a look. I was at CHESS last week, and I've been talking to several doctors that have said either they have already taken another look at Renatran based on the ED data or certainly are planning to.

It'll take a little bit of time because.

Got that you have got doctors that have historically believed in the drug and this really confirms our belief in the drug and how they're using it and hopefully we'll see them put more patients on therapy doctors that had maybe a poor experience with a current rent Tremont a pass we know are taking a look I mean.

I was at chest last week and talking to several doctors that have said.

You do they have already taking another look at renter trend based on the data or certainly are planning to so so I think generally they are impressed with the data and it is bringing those doctors backed.

Michael I. Benkowitz: So I think generally they're impressed with the data and it's bringing those doctors back, to take a second look at the drug. I think the other place that we're gonna see this used, and we have seen this used, are patients that have been on remodulin for some period of time, have started to stabilize and actually improve in functional class, and the patients wanna get off the pump. And so we have data from several years ago that talks about how patients can successfully transition from remodulin to remicron, that have done well over the long term and we're looking at some other ways, other studies that would.., that will further reinforce that. And so for patients that maybe aren't in that functional class two category, or maybe more functional class three, and they're sort of tweeners between, okay, do you start them on a renitrin, do you start them on remodulin, and maybe tybase is not the right answer for them, you could potentially start them on a renitrin for say 30 to 60, or sorry, start them on remodulin for 30 to 60 days, get them up to a dose, and then quickly switch them over to a renitrin.

Back to take the second look at.

At the drugs I think the other place that we're going to use.

We're going to see this use and we have seen this this use our patients that have been on remodulin for some period of time has started to stabilize it actually improve and functional class and at the patients want to get off I want to get off the pump and so we have data from several years ago that that talks about how how patients can successfully.

Transitioning from a module tourette accretive.

They've done level over the long term and we're looking at some other other waste other studies that would.

That will further reinforced at and so for patients that maybe aren't that functional class CAD functional class two category or maybe more functional class three and they're sort of tweeners between Acadia start them on a renter trend do you started on.

On a module and maybe tyvaso is not but not not the right right answer for them you could potentially start them on orenitram for say, 30% or sorry start them on Remodulin for 30 to 60 days get them up to a dose and then quickly switch them over over to a restaurant. So so again I think what the label is it really just kind of opens up really opens up the rate or possibility.

Michael I. Benkowitz: So again, I think what the EV label is, it really just kind of opens up the range of possibilities for where to use the drug, but I think to your original question, the main question and answer is, what does that early stage patient look like that's the ideal candidate for renitrin? Mike, thanks. That is such a great explanation.

As for where to use the drug, but but I think yes. Your original question.

The main I think the main question and answers is what's that early stage patients look like thats the ideal candidate for underground.

Mike. Thank said is such a great explanation.

Thanks for letting all of that out.

So to wrap up here, we're very excited to have now cross 7500 patients onto across and all this has been a goal for our company for quite awhile and I really want to.

Salute might can be entire.

Commercialization compliance.

Martine A. Rothblatt: Thank you for laying all of that out. So to wrap up here, we're very excited to have now crossed 7,500 patients onto Prosnol. This has been a goal for our company for quite some time, and I really want to salute Mike and the entire commercialization, compliance, and medical affairs teams that have been, you know, absolutely essential to accomplishing that goal. And I think it's now, as I hope everybody can see from the explanations given during the call, very much reasonable within our sites to next lock onto the goal of 10,000 patients on Triprosanol. And this can be done, one, as Mike explained, with the growth vector for Renitram thanks to the EV label.

Medical affairs teams that have been absolutely essential to.

To to accomplishing that goal and I think it's now as I hope everybody can conceive from the explanations given during the call very much a reasonable within our sites to next.

Lock onto the goal of 10000 patients onto a profitable and this can be done one as Mike explained.

With the growth vector for rent trends, thanks to the label Secondly, as I mentioned in the introductory remarks with the three new.

Transformative treprostinil parental delivery systems, the IR Saar review.

And then finally with the current on brief.

These trials that we have.

Going on with trade T. and the and the mankind product you combine that with hopefully a successful unblinding on increase and opening up a very small easy to act AC to DC.

Martine A. Rothblatt: Secondly, as I mentioned in the introductory remarks, with the three new transformative Triprosanol parenteral delivery systems, the ISR, Remedies, and Treviant. And then, finally, with the current BREEZE trial that we have going on with Trade T and the Mankind product, you combine that with, hopefully, a successful unblinding on increase and opening up a very small, easy to use drug delivery device with And it seems to me that 10,000 patients on Triprosanol is a very readily achievable, reasonable goal for our company to set out for itself. And we have done that.

Drug delivered device with a tenfold larger population of group.

And it seems to me that 10000 patients onto a profitable is a very readily achievable reasonable goal for our company to set out for ourselves and we have done that.

So thanks, so much for joining us this morning, and we look forward to seeing many of you certainly at JP Morgan in just a couple of months to come operator, you can wrap up the call.

Thank you.

You for participating in today's United Therapeutics Corporation Conference call.

Broadcast will be available for replay for one week Don in 18589, 2056 was international callers dialing in at 140, 45373 406, using the access code seven or six to one one night. Thank you.

Martine A. Rothblatt: So thanks so much for joining us this morning, and we look forward to seeing many of you, certainly at J.P. Morgan, in just a couple months. Operator, you can wrap up the call. Thank you. Thank you for participating in today's United Therapeutic Corporation conference call. A rebroadcast will be available for replay for one week by dialing 1-855-859-2056, with international callers dialing in at 1-404-537-3406 and using the access code 7462119. Thank you.

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