Q1 2020 Earnings Call

My name is Mariama and I'll be your conference operator today, all participants will be under listen only mode until the question and answer portion of this earnings call.

Operator: and I will be your conference operator today. All participants will be in a listen-only mode until the question and answer portion of this earnings call. If you would like to ask a question during that time, simply press the star and then the number one on your telephone keypad. If you would like to withdraw your question, press the pound key on your telephone keypad. I will now turn the conference call over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics.

He would like to ask a question during that time simply press Star then the number one on your telephone keypad. If he would like to withdraw your question press the pound key on your telephone keypad I will now turn the conference call over to Mr., Dewey Steadman head of Investor Relations of United Therapeutics.

Good morning, It's my pleasure to walk you me to the United Therapeutics Corporation first quarter 2020, earning call.

Dewey Steadman: Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation first quarter 2020 earnings call. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairman and Chief Executive Officer, Mr. Michael Benkowitz, our President and Chief Operating Officer, Mr. James Edgemond, our Chief Financial Officer, and Dr. Leigh Peterson, our Vice President, Product Developer. 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 Form 10-K and 10-Q, contain additional information on these risks and uncertainties, and we assume no obligation to update these forward-looking statements. Today's remarks may also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles or GAAP. Reconciliations 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.

Joining me on today's call, our Dr., Mark <unk>, our chairman and Chief Executive Officer.

Sure Michael Bank, one of our President and Chief operating Officer, Mr., James Edgemond, Our Chief Financial Officer, and Lee Dr., Lee Peterson, our vice President of product development.

Mark today will include forward looking statements, representing our expectations or beliefs regarding future adopt these statements involve risks and uncertainties that may cause actual results could differ materially.

<unk> SEC filings, including form 10-K and tend to contain additional information on these risks and uncertainties, we assume no obligation to update these forward looking statements.

Actually Mark May also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles her job.

Reconciliations 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 you know third dot com.

Today's results are today's remarks may discuss the progress on result, clinical trials or other developments with respect to our products. These remarks are intended so always educate investors are not intended to serve as the basis for medical decision, making or took adjusted any product from safe and effective for any unapproved or investigational use it.

Dewey Steadman: 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 users. Full prescribing information for the products is available on our website. Now, I'll turn the call over to Dr. Rothblatt for an overview of our first quarter 2020 financial results and business activities of United Therapeutics. Dr. Rothblatt

Oh prescribing information for the product is available on our website now turn the call over to Dr. Rothblatt for an overview of our first quarter 2020 financial results and business activity through the United Therapeutics Dr. Rothblatt.

Martine A. Rothblatt: Thank you, Dewey. Good morning, everybody. I'd like to start providing an overview of how we are at the beginning, more toward the end of the first month of the second quarter here, looking back on the past quarter. And then I'm going to turn the mic over to Michael Benkowitz, our President and Chief Operating Officer. He will continue to review the operating results of the company. Then we'll open up the call to questions, and they can be directed either to Mike or I, or to our Chief Financial Officer, James Edgemond, or to our Vice President for Product Development, Dr. Leigh Peterson. So looking back on the past quarter, I think that there were really three key themes that summarize what's gone on in the past quarter, and those three themes I would label as stable.

Thank you Julie good morning, everybody.

I'd like to start providing a overview.

Oh, we aren't there.

Beginning.

More toward the end of the first month of the second quarter here looking back on the past quarter.

And then I'm going to turn the Mike over to Michael Benkel Watch, our President Chief operating officer.

He will continue to over a few operating results of the company.

Then we'll open up the call two questions and they can be directed either to my cry or to our Chief Financial Officer, James Edgemond or to our vice President for product development Dr. Lee Peterson.

So looking back over the past corridor I think that there were really three key themes that summarizes what's going on to the pass corridor.

And those three themes I would label as stable.

Martine A. Rothblatt: So let me delve into each of stable, stronger, and sustainable for a moment and talk about what those words or concepts mean in the context of United Therapeutics right in the middle of this COVID pandemic. So with regard to stability, the first theme, I am really glad to share that our drug manufacturing, distribution, and reimbursement have been very stable during this past quarter, notwithstanding the COVID pandemic. Every one of United Therapeutics' offices and laboratories, from California to North Carolina, from Maryland to Florida, from Massachusetts to Virginia, and New Hampshire, have all remained open as essential biomedical research and production facilities. Our staff has continued to operate these facilities on a shift basis to reduce occupancy and to maintain physical separation in all regards.

Stronger.

And sustainable.

So let me delve into each of five stable stronger and sustainable for a moment and talk about what those words or concepts mean in the concept of in the context of United Therapeutics I'm right the middle of Descope It pandemic.

So with regard to stabilize the first theme I have really glad to share that our drug manufacturing distribution and reimbursement has been very stable. During this past quarter notwithstanding the co fed pandemic.

Everyone else fall, United Therapeutics offices, and laboratories from California to North Carolina from Maryland to Florida from Massachusetts to Virginia, and New Hampshire have remained open house, essentially biomedical research and production facilities.

Our staff has continued to operate these facilities on a shift basis to reduce occupancy and to maintain physical just didn't thing and already cards.

Martine A. Rothblatt: As a result, our production numbers this past quarter have enabled us to still maintain more than two years of finished drug inventory, even while shipping out a normal and customary amount of drug to our distributors. Indeed, I can report, and I'm very happy to report, that doctors, pharmacies, patients, they've all reported considerable relief in knowing that United Therapeutics has more than two years of finished drug in inventory. In addition to that, we also have, here in the U.S., at our sites, the chemical precursors on hand for making three additional years' worth of finished drug on top of the two years, all in our own laboratories here at United Therapeutics.

As a result, our production numbers this past quarter have enabled us to still maintained more than two years, just finished drug inventory, even while shipping out adorable and customary amounts of drug to our distributors.

Indeed, I can report then I'm very happy to report that doctors pharmacies patient they've all reported considerable relief and knowing that United Therapeutics has more than two years finished drug on inventory.

In addition to that we also help I hear the U.S. had our sites the chemical precursors on hand for making three additional years fitness drug on top of the two years all in the World laboratories here at United Therapeutics.

Martine A. Rothblatt: So, all told, we have been stable in drug production and distribution for five years, all based here in the USA. And I think that the reason it provides so much relief to everybody and the reason I start the review with the concept of stability is that when you get right down to the core purpose of United Therapeutics, its core purpose is to provide medicines for life, to provide medicines to our patients, to provide medicines even to patients in the context of our clinical trials. So all of that we've done, including the drug delivery devices that are part and parcel of them. So I'm happy to say that at the end of the first quarter, in the middle of the pandemic, UT is stable. The second main theme I'd like to talk about is stronger.

So all told we are stable and drug production distribution for five years, all based here in the U.S. say.

And I think that's the reason provides so much relief to everybody in the reason I start to review with the concept of stability is when you get right down to the core purpose of United Therapeutics. Its core purpose is to provide medicines.

For life to provide medicines to our patient to provide a medicine even to patients in the context of our clinical trials.

So all of that we've done including with the drug delivery devices that are part and parcel what's that.

So I'm happy to say that that the ended the first corridor and the middle of a pandemic a U T is stable.

Second the main theme I'd like to talk about it's stronger.

Martine A. Rothblatt: Here I'm referring to our pipeline. Our pipeline was very strong before this past quarter, and it's even stronger as of now. It was strong before because we had great phase three trials underway. One of them that I think is the most exciting is the Rolenapeg trial, a best-in-class prostacyclin agonist that is undergoing worldwide trials. And I should say, even during this pandemic, while we've not been able to enroll new patients in that trial, we have been able to keep the trial going and continue to provide clinical trial materials to the patients. So that's very exciting.

Here I'm, referring to our pipeline.

Our pipeline was very strong before this past quarter and it's even stronger assets now.

It was strong before because we had a great phase three trials underway one of them. That's I think you know most exciting is the relented peg trial, a best in class Prostacyclin agonist doubt is undergoing worldwide trials and.

I should say even during this a pandemic what we've not been able to enroll new patients in that trial, we have been able to keep the trial going in continued to provide clinical trial material to the patients. So that's very exciting. We had you know also we have also underway our phase three trials.

Martine A. Rothblatt: We had, you know, also underway our phase three trials of Tyvaso for COPD type of pulmonary hypertension. Same story, you know; we're not able to enroll new patients, but we're able to keep it going. That will open up a very, very large COPD pulmonary hypertension market for us based on the results of that phase three trial. Our phase three trial of gene therapy, the SAFIRE study, could really modify and perhaps, you know, turn back the course of pulmonary hypertension. So we had a super strong pipeline before this quarter.

Type based so first feel P D.

Type of pulmonary hypertension same story, you know, we're not able to enroll new patient, but we're able to keep it going that's well open up a very very large CR P.D. pulmonary hypertension market for us based on the results that phase three trial, our phase three trial of gene therapy. The Sapphire study.

That could really modifying and perhaps you know turn back the course of pulmonary hypertension. So you know super strong pipeline before this quarter that though one of the absolute most exciting things that came out of this quarter was the data that came out apart increase.

Martine A. Rothblatt: But one of the absolute most exciting things that came out of this quarter was the data that came out of our increased trial of Tyvaso in the context of interstitial lung disease. Now, as we reported, we hit all of our primary and secondary endpoints for that increased trial, and notwithstanding the COVID pandemic, our team has worked full speed, and we continue to be on schedule to file a supplemental NDA for the expansion of our label for Tyvaso into Group 3 pulmonary hypertension, specifically the interstitial lung disease variant. And just for some of you who may be new to the story here, this is a type of pulmonary hypertension that is larger than the group one types of pulmonary hypertension for which all the current pulmonary hypertension drugs are approved, but as to which, before our larger trial, no drug was proven successful in addressing this group three type of pulmonary hypertension, specifically the interstitial lung disease variant.

Hi trial of type they so in the context of a interstitial lung disease.

Now as we reported we hit all of our primary and secondary endpoints for that increased trial.

And notwithstanding the cobot pandemic. Our team is be worked a full speed and we continued to be on schedule to file a supplemental and D.A. for the expansion of our label of Tyvaso intra group three pulmonary hypertension specific.

Typically the interstitial lung disease a variant.

And just some of you who may be new to the to the story here.

This is a type of pulmonary hypertension that is larger than the group one types of pulmonary hypertension for which all the current pulmonary hypertension drugs her proof for but Oh asked which before or increase trial.

No drug was proven successful in addressing this group three type of pulmonary hypertension, specifically the interstitial lung disease variant.

Martine A. Rothblatt: And the reason for that is that this is a disease involving restriction or obstruction of the airways and the pulmonary vasculature, and so it's not really possible to treat this disease successfully with systemic drugs without giving rise to a very bad side effect called ventilation perfusion mismatch. So there are only two possibilities for treating this disease with this drug without triggering VQ mismatch. There's the Iloprost inhaled drug, which is not very practical, needing to be inhaled upwards of nine times a day for 15 minutes a shot, or Tyvaso, which is very practical, four times a day for just two minutes a inhalation.

And the reason for that is that the.

This is the oh disease involving restriction or obstruction of the airways and the pulmonary basket mature and so it's not really a possible to treat this disease successfully with systemic drugs without giving rise to a very bad.

Side effect comps required called ventilation perfusion mismatch.

So there are only really two possibilities for treating this drug without triggering CQ mismatch. There is the Oh <unk> I have a prost inhaled drug which is not very practical needing to be inhaled a upwards of nine times a day for 15 minutes a.

Shot or Tyvaso, which is very practical.

Four times a day, just two minutes say inhalation.

Martine A. Rothblatt: Well, we did that trial, and as reported, we had stellar results, and we'll file in early summer. And we expect approval and launch of that product in 2021. But what really made our pipeline stronger was one of the most spectacular results from that larger trial. And that was, about a quarter of the patients had a type of interstitial lung disease called pulmonary fibrosis.

Well, we did that trial and that's reported we had a stellar results and well filed in early summer and we expect a approval and launch of that product and 2021.

But what really made our pipelines stronger was one of the most spectacular results from that increase trial.

And that was about a corner of the patients had a type of interstitial lung disease called.

Cold pulmonary fibrosis.

Martine A. Rothblatt: And with this type of disease, the FDA has already, over the years, approved two drugs, and these two drugs, by the way, were not really potent in reversing IPF. What they were able to do was to slow the degradation in the patient's forced vital capacity better than the patients who were on placebo. So they didn't really improve the patient's condition; they just slowed the rate at which the patients were degrading.

And with this type of a disease. The F.D.A. has already over the years approved a two drugs.

And.

These two drugs by the way, we're not really a potent didn't reversing <unk> IP off what they were able to do was to slow the degradation in the patient forced vital capacity better than the patients who are on placebo.

So they didn't improve the patients condition. They just slowed the rate at which the patients were degrading.

Martine A. Rothblatt: Now, our team was prescient, I think, to have force vital capacity as a secondary endpoint in the larger trial. Impressions I say because this endpoint is not necessary for approval of a drug treating pulmonary hypertension, but it is the endpoint looked at by the FDA for a drug that would treat pulmonary fibrosis. And we were able to, in fact, improve the force vital capacity, or the FVC, of the patients with the pulmonary fibrosis type of interstitial lung disease by a greater amount than the other two approved drugs for pulmonary fibrosis, nitinamide and perfenadone, had done in their registration trials. And on top of that, our improvement in the patient's FDC was on top of those already approved background drugs because that's just a standard of care for patients with pulmonary fibrosis.

No. Our team was a precedent I think it too to have forced vital capacity has he secondary endpoint in the increase trial.

Restaurant I say, because this endpoint is not necessary for approval of a drug treating pulmonary hypertension.

But it is on the endpoint lucked out by the F.D.A. for a drug tests would be treating pulmonary fibrosis.

And we were able to in fact improve the forced vital capacity or the F. D. C. All the patients with the pulmonary fibrosis type of interstitial lung disease.

By a greater amount.

And the other two approved drugs for pulmonary fibrosis, and they tend to Midem Pirfenidone had done and their registration trials and on top of bad Ari our improvement of the patients FTC was on top of those already approved a background trucks.

Because that's just a standard of care for patients with pulmonary fibrosis.

Martine A. Rothblatt: So this is, for a clinical drug developer, this is like a best case scenario for sizing up a registration trial where you've already tested the hypothesis that you wanna confirm in a registration trial, and you see here, Tyvaso actually had a disease-modifying effect on these patients with pulmonary fibrosis by improving their FEC on top of the already approved background therapies, and those already approved background therapies had not even improved the patient' And then, like an icing on the cake, we were able to accomplish all of this in only eight weeks.

So this is for a clinical.

Drug developer. This is like a best case situation for sizing up a registration trial, where you've already tested the hypothesis that you want to confirm the registration trial and you see here today. They so actually had the disease model.

Buying effect on these patients with pulmonary fibrosis by improving their FCC on top of the already approved a background therapies and those already approved background therapies have not even approved improve the patients FTC. They just slowed the rate of degradation.

And then if there was like an icing on the cake, we were able to accomplish all of this is only eight weeks. So eight weeks. After the patients were randomized we already saw this marked improvement in FCC and that improvement was maintained until the end of the clinical trial. This is a much faster Uh huh.

Martine A. Rothblatt: So eight weeks after the patients were randomized, we already saw this marked improvement in FVC, and that improvement was maintained until the end of the clinical trial. This was a much faster onset of improvement than was demonstrated in the nintenamide and perfenadone studies, which, in fact, as mentioned, didn't actually show much of an improvement at all. So based on this, we have now been able to design and specify and begin the process of opening up a new phase three trial that will be in pulmonary fibrosis, and it'll be in a specific type of it known as chronic fibrosing interstitial lung disease. I just call that C-FILD for short, C-F-I-L-D, cause it's a mouthful.

Fair enough improvement then was demonstrated in the Nintendo mind and for net adult Pirfenidone studies, which which in fact as mentioned didn't actually show much of an improvement at all.

So based on the US we have now been able to design and specifying begin the process of opening up a new phase three trial.

That will be in pulmonary fibrosis, and it'll be in a specific type of it a known as chronic fibrocell interstitial lung disease I, just called that see field Oh for short see a file D. That's a mouthful.

Martine A. Rothblatt: So we call this new phase three trial the Teton trial. And in parallel with our work in putting together the SNDA for increase. We are also putting together the IND for Seafield, and our plan is to get the IFD, the IND, for this Phase 3 trial in Seafield that goes by the name Teton, that we will get that in the latter half of the summer, really right on the tails of the SNDA for increase, and then achieve our IRB approvals during the third and fourth quarters of this year and begin enrolling patients in that registration trial in the Let me mention one other thing why I'm so excited about this.

So we call this new phase three trial, the Teton trial.

And in parallel with our work you know putting together the S. In D.A. for increase a we're also putting together the hi, Andy for see field and our plan is to get the I ft. The I indeed.

For for this phase three trial in Seafield there'll be goes by the name Teton.

That we will get bad then in the latter half of the summer really right on the tales of the Essen D.A. for increase and then achieve our higher be approvals during the third and fourth quarter.

Of this year and begin enrolling patients in that a registration trial in the first quarter of a plenty 20 watt.

Let me mention one other thing why I'm. So I'm excited about this this is really the other than our activities in cancer. This is the first time that a United Therapeutics has undertaken and expansion of its franchise.

Martine A. Rothblatt: This is really, other than our activities in cancer, this is the first time that United Therapeutics has undertaken an expansion of its franchise beyond pulmonary hypertension. Just so I didn't confuse anybody here, this C-field indication, this fibrosis indication, will be in patients who don't have pulmonary hypertension. Now I mentioned about a quarter of the patients in the increase had pulmonary hypertension with pulmonary fibrosis, but in fact, the number of patients who have pulmonary fibrosis without pulmonary hypertension is about four times larger, well over 100,000 patients. So this Teton study that we'll embark upon in the first quarter of 2021 will be United Therapeutics' first non-cancer phase three study outside of the field of pulmonary hypertension, and in a patient population that is several times larger than the pulmonary hypertension population, and finally, with a mechanism of action that appears to us to actually be disease-modifying based on the positive improvement in the FEC shown in those patients.

Beyond pulmonary hypertension, or just so I didn't like you know confuse anybody here just to see filled indication this of fibrosis syndication well be in patients who don't have pulmonary hypertension.

Mentioned about a quarter of the patients and increased had the pulmonary hypertension with the pulmonary fibrosis.

But in fact, the number of patients who have the pulmonary fibrosis with out the pulmonary hypertension is about four times larger oh, well over 100000 patients.

So this teton study that will embark upon in the first quarter.

2021 will be United Therapeutics first on non cancer, a phase three study outside of the field of pulmonary hypertension.

And then a patient population that is several times larger than the pulmonary hypertension population and finally with a mechanism of action that appears to us to actually be disease modifying based on the positive improvement in the FCC showing that though.

These patients so all told by expanding beyond pulmonary hypertension and doing so with that solidly data back hypothesis, and then a patient population several times larger than we're addressing in pulmonary hypertension I think that there really is no doubt that we have a emerge.

Martine A. Rothblatt: So all told, by expanding beyond pulmonary hypertension and doing so with a solidly data-backed hypothesis and in a patient population several times larger than we're addressing in pulmonary hypertension, I think that there really is no doubt that we have emerged from the first quarter of 2020 with a stronger pipeline than we had even before. The third theme that I want to talk about before turning things over to Michael is sustainability. It's very fortunate, and I'd say that our entire pulmonary hypertension community has been blessed, that COVID has not disproportionately impacted the pulmonary hypertension population. There are various hypotheses of why this is.

From the first quarter of plenty plenty with a stronger pipeline than we had even before.

Oh, the third theme that I want to talk about before turning things over to Michael is sustainable.

It's very fortunate and I I'd say that our entire pulmonary hypertension community has been blessed that co bid has not a disproportionately impacted the pulmonary hypertension population.

They're very various hypotheses of why a this is I think you know they kind of the outcomes race or answer is it's due to the extraordinary care and caution of this population with respect to physical distance, saying Oh, the patients realize that they have you know heart lung condition.

Martine A. Rothblatt: I think, you know, the kind of Occam's razor answer is that it's due to the extraordinary care and caution of this population with respect to physical distancing. The patients realize that they have, you know, a heart-lung condition, and so they are probably, you know, much more careful than other people in maintaining the necessary distancing. But in any event, there is already a published article showing that COVID has not adversely impacted the PH population statistically compared to any other population. So I do believe that we will be able to sustainably continue to help our pulmonary hypertension population as we go through what remains of the COVID pandemic. Another aspect of sustainability is that, in our quarterly financials that we released today, our revenues and profit margins are as good as they've been in the past. And for all that we can see, they are quite sustainable. As our chief financial officer, who I know has talked about many times, we maintain an algorithm to ensure profitability by setting our maximum budget at 50% of the previous year's revenues.

And so they are probably you know much more careful Dan then other people in maintaining the distancing necessary, but in any event. There are some already about published articles shown that cope it has not.

Adversely impacted the P.H. population statistically compared to any other populations.

So I do believe that we will be able to sustainably continued to help our pulmonary hypertension population as we go through you know what remains of the co fit pandemic.

Another aspect of sustainability effects, you'll see an hour quarterly financials for you released today, our revenues and profit margins are as good as they've been in the past and for all that we can see they are quite sustainable has our chief financial Officer, I know has talked about many.

Times, we maintain a algorithm to ensure our profitability by setting our maximum budget that 50% to the previous year revenues.

Martine A. Rothblatt: And within this budget, we are able to continue to invest in all of the transformative technologies that mark our pipeline, such as transformative technologies for Remodulin such as the Remunity pump, which remains on schedule to launch in July. The manufacturing folks have continued manufacturing those pumps all during the pandemic, again coming in in shifts, spacing themselves out, everybody's doing the right and proper and safe thing. The implantable system for remodulin, the ISR system, our RemoPro painless analogs of triprosanol to completely get rid of the issue of sight pain.

And within this budget, a we're able to continue to invest in all of the transformative technologies that I'm, Mark our pipeline transformative technologies for Remodulin such as the.

The remunity pump, which.

Remains on schedule to launch in July the manufacturing folks have continued manufacturing those pumps all during the pandemic again coming and then shifts spacing themselves out everybody's doing the right and improper unsafe thing the implantable system for Remodulin, the highest Saar assessed.

Our remote pro Oh, painless analogs of Treprostinil to completely get rid of the issue of site pain.

Martine A. Rothblatt: All of this we're able to do sustainably because of the maintenance of the profit margin against the constant level of revenues. We also continue to fund market-expanding products for pulmonary hypertension, like for LENIPEG, as I mentioned at the beginning. We have this perfect Phase III study of COPD-related pulmonary hypertension.

All of this we're able to do sustainably because of the maintenance of the profit margin against the constant level of revenues were also continued to fund the market expanding products for pulmonary hypertension like for Atlanta, Pegas I mentioned at the beginning we have filed this perfect phase three study of field.

Martine A. Rothblatt: The gene therapy work I mentioned previously. We have a once-daily form of orenotram that will enable us to continue to build on the excellent revenue growth that you've seen in the past quarter. And then these sustainable cash flow margins that we're fortunate to have also enable us to take on new R&D challenges, such as several efforts that we're now directing against COVID using an exosome product, which is the outcome of our region med research on lung manufacturing to treat the ARDS sequelae of worst-case COVID situations, as well as upright organ manufacturing to produce an unlimited supply of transplantable kidneys, for example, I am absolutely full of pride in how well United Therapeutics has demonstrated its nimbleness and adaptiveness to a once-in-a-lifetime changing environment that we're all experiencing. Well, with that introduction, I'd like to now turn the mic over to Mike Benkowitz, our President and Chief Operating Officer. Michael?

He de related pulmonary hypertension, the gene therapy work I mentioned previously a.

They a once daily a form of of Orenitram.

That will enable us to continue to build on the excellent revenue growth that you've seen in the past corridor.

And then these sustainable cash flow margins that are that we're fortunate to have also enable us to take on new R&D challenges such as several efforts that for now directing against a co fed using an extra some product, which is an outcome of our reach and med research lung Manny.

Factoring to treat the ards sequelae of a worst case covitz situations as well as though quite organ manufacturing to produce an unlimited supply of Transplantable kidneys. For example that would create literally a new paradigm.

Organ transplantation.

So stable stronger sustainable I am absolutely you know full of pride and how well United Therapeutics has demonstrated its nimbleness and adaptive yes.

Michael I. Benkowitz: Thanks, Martine. I wanted to spend a few minutes just talking about the commercial side of the business. Overall, we were very pleased with our revenue performance in the first quarter. As we have mentioned quite often, our revenues reflect sales of our triposyl-based products to specialty pharmacy distributors, who typically place monthly orders based on current patient utilization trends and contractual inventory requirements. Therefore, our sales do not always track the volumes our distributors are dispensing to patients in a given time period.

To a once in a lifetime.

Changed environment that for all experiencing.

Well without overview I'd like to now turned the Mike over to Mike Banquets, our President and Chief operating Officer Michael.

Thanks, Martine I wanted to spend a few minutes just talking about the commercial side of the business. Overall, we were very pleased with our revenue performance in the first quarter.

As we mentioned quite often our revenues reflects sales of our capacity based products to specialty pharmacy distributors, who typically place monthly orders based on current patient utilization trends and contractual inventory requirements.

Michael I. Benkowitz: So I'd like to provide some color around physician and patient demand for our products in the first quarter. And then, in addition, I'll touch on some early Q2 data we're seeing as a result of COVID-19. So in the first quarter, we did not experience a material impact on our commercial business as a result of COVID-19, either in terms of distributor ordering patterns, which are represented by our revenues, or as measured by active patients on our therapies, new patient starts, and drug dispensed to patients. In fact, Q1 saw us build on the momentum from last year, as we once again reached an all-time high number of patients using one of our trapros Our U.S. remodulin business remains resilient in the face of generic competition.

Therefore, our sales do not always track the volumes our distributors are dispensing to patients in a given time period. So I'd like to provide some color around physician and patient demand for our products in the first quarter.

And then an additional kuch I'm on some early Q2 data we're seeing as a result, though that's kind of 18.

So in the first quarter [noise].

We did not experience a material impact to our commercial business as a result to come in 19, either in terms of distributor ordering patterns, which are represented by our revenues or as measured by active patients are therapies, new patient starts and drug dispensed to patients in fact Q1 sauce build on the momentum from last year as once again.

First of all time high number of patients using one of our krasnow medicines.

Are you asked Remodulin doesn't that's remains resilient in the face of generic competition.

Michael I. Benkowitz: In Q1, new patients started to remain strong. Our active patients were at an all-time high once again, and remodulin drug dispensed to patients grew year over year. Transitions from remodulin to generic troposomal remain negligible and are primarily limited to the dual eligible Medicare and Medicaid patients we've mentioned on prior earnings calls. And to date, we estimate that 15% of those transitions have come back to remodulin

In Q1, new patient starts remained strong our active patients red and all high all time high once again and Remodulin drug dispensed to patients grew year over year.

Transitions from remodulin to generic or possible to across all remain negligible.

And our primary limited to the dual eligible Medicare Medicaid patients we'd mentioned on prior earnings calls.

And today, we estimate that 15% of those transitions have come back to Remodulin.

Michael I. Benkowitz: In addition, we're continuing our immunity launch preparations and remain on track for a July launch. Meanwhile, our Tybaso business remains solid with year-over-year growth in Q1 and active patients, new patient starts, and product distributed to patients and hospitals. We are especially pleased with a renter trans 18% year over year revenue growth in Q1, which in this case correlates fairly well with what we're seeing at the patient level. We were very excited to issue the press release last week announcing additional results from a FREEDOM-EV substudy, specifically that a renter term significantly improved key hemodynamic parameters and improved a patient's risk status, which are important indicators of long-term outcomes in PA Additionally, we recently published an analysis showing that PAH-related health care costs for patients taking CelexaPag were 67% higher than those taking Orenatram, despite similar adherence, persistence, and rate of PAH-related hospitalizations between the two groups. We believe the oranitarian value proposition is clear and distinct, and that physicians are starting to recognize it. And we look forward to continuing to share these data with physicians, which should help the rent-a-tram reach its market potential. Finally, Unituxin continues to hum along through Q1.

In addition, we're continuing our remunity launch preparations and remain on track for July launch.

Our <unk> business remained solid with year over year growth in Q1, and active patients new patient starts and product distributed to patients and hospitals.

We're especially pleased with a renter srams, 18% year over year revenue growth in Q1, which in this case correlates fairly well with what we're seeing at the patient level.

We were very excited to issued a press release last week announcing additional results from a freedom easy sub study.

Specifically that orenitram significantly improved.

Chemo Dammit hee hee hemodynamic parameters and improved occasions risk status, which are important indicators of long term outcomes and ph patients.

Additionally, we recently published and analysis showing that P.H. related health care costs for patients, taking selexipag were 67% higher than those taking orenitram. Despite similar adherence persistence and rate a p. age related hospitalizations between the two groups.

We believe the orenitram value proposition is clear and distinct and that physicians are starting to recognize us and we look forward to continuing to share. These data with physicians, which should help orenitram reach its market potential.

Finally, a unituxin continues to hum along through through Q1, a year over year revenues grew 7% in Q1, but actual dispenses of unituxin into hospitals increased in the 15% to 20% range. So we're pleased with how this product is performing and are looking forward to filing our supplements and to expand the label.

Michael I. Benkowitz: Year-over-year revenues grew 7% in Q1, but actual dispenses of Unituxin to hospitals increased in the 15 to 20% range. So we're pleased with how this product is performing and are looking forward to filing our supplement soon to expand the label to include relapse-refractory neuroblastoma. Now, in terms of potential COVID-19 impact in the second quarter, it's a bit of a mixed bag thus far. On the one hand, one of our specialty pharmacy distributors placed a larger-than-normal order for our troposomal-based products during April to increase its inventory beyond typical levels. And this was done for three reasons.

To include relapse refractory neuroblastoma.

Now in terms of potential Coburn 19 impact in the second quarter, it's a bit of a mixed bag. Thus far on one hand, one of our specialty pharmacy distributors placed a larger than normal order for Prostone based products during April to increase its inventory beyond typical levels and this was done for three reasons first they want us to account for potential increase.

Michael I. Benkowitz: First, they wanted to account for potential increased investigational use of Tyaso for acute respiratory distress syndrome resulting from COVID-19, which is a major cause of patient morbidity and mortality. Second, they wanted to prepare for an anticipated increase in patient requests for 60 to 90-day refills as compared to their typical 30-day supply. And third, they wanted to increase their inventory levels across various locations to ensure uninterrupted business continuity during the pandemic.

Occasional use of <unk>, so for acute respiratory distress syndrome, resulting from Cowen 19, which is a major cause a patient morbidity and mortality.

Second they wanted to prepare for anticipated increase in patient request for 60 to 90 day rebuilds as compared to their typical 30 day supply.

And third they wanted to increase or inventory levels across various locations to ensure uninterrupted business continuity during the pandemic.

On the other had we have seen some softening a new patient prescriptions throughout the month.

Michael I. Benkowitz: On the other hand, we have seen some softening in new patient prescriptions throughout the month and also a softening and new patient starts in the last couple of weeks. We believe this is due to the inability of patients to visit their physician's office to determine whether our medicines may be appropriate. However, we are starting to hear that some institutions in various parts of the country are gearing up to start allowing patients to come back in for visits very soon, and we are aware of the increased use of telemedicine with PAH physicians. However, how this impacts revenues over the balance of the quarter remains unclear. We don't know how long the reduction in new patient prescriptions and new patient starts will last, but we certainly expect some pent-up demand that should come through in later months once things start to normalize.

It also a softening in new patient starts in the last couple of weeks. We believe this is due to the inability of patients to visit their physicians office to determine what our medicines maybe appropriate.

However, we are starting to hear that some institutions in various parts of the country are gearing up to start allowing patients to come back in for visits very soon and we are aware of the increased use of tele medicine with ph positions.

How this impacts revenues over the balance of the quarter or the year remains unclear.

We don't know how long the reduction in new patient prescriptions and new patient starts will last but we certainly expect some pent up demand that should can come through in later months once things start to normalize.

Michael I. Benkowitz: It's also unclear whether these events will even materially impact orders from specialty pharmacy distributors since they place orders based on current utilization trends and contractual inventory requirements. And so, you know, I think just kind of coming back to Martine's theme around sustainability; we certainly think that the commercial side of the business remains sustainable. The patients are there. They will continue to need our medicines. When they're able to access them is a little bit unclear given the current dynamics of the pandemic, but we expect that, you know, once things start to normalize, as I said, there'll be a pent-up demand, and we'll get those patients started on our medicines appropriately. And so with that, I'll turn the call back over to Martine.

Also on car weather events will even materially impact orders from specialty pharmacy distributor since they place orders based on current utilization trends and contractual inventory requirements and so you know I I think you just just kind of coming back to Martine martines theme around sustainability, we certainly think that the commercial side the business remain sustainable.

The patients are there they will continue to need they will continue to meet our medicines when they're able to access those is a little bit unclear given a but the current dynamics of the pandemic Oh, we expect that you know once things start to normalize as I said it'll be a pent up demand and Oh, we will get.

Those patients on started on her on medicines appropriately.

And so with that I'll turn the call back over to our team.

Martine A. Rothblatt: Thanks so much, Mike. Operator, if you could now open up the lines and have on Dewey Steadman. I think, Dewey, did you want to take the call?

Thanks, So much Mike operator, if you could now open up the lines all men have Uh Huh Dewey Steadman I think do we did you want to take that calls for you.

Dewey Steadman: I know you can already go ahead and

Well you want me to.

I know you can Oh go ahead and okay, given a range I always like this pay high there.

Dewey Steadman: and opening Q&A for our audience. Thanks. I always like to say hi there. Operator, you can open up the calls.

People I know on the line thanks doing.

Okay, operator can open up the on calls.

Thank you as a reminder to ask a question you'll need to press star one on your telephone to withdraw your question press the pound or hash key please standby only compiled the culinary roster.

Operator: As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Your first question comes from Chris Shibutani on Cohen. Your line is open. Thank you.

Your first question comes from Christian Bhutan eat with Cowen Your line is open.

Thank you very much. Good morning, you commented that you're seeing an estimated 15% of patients who had been on generic switch back to Remodulin can you help us understand better what's going on there is that somehow one of the dynamics is related to supply.

Chris Shibutani: Thank you very much, good morning. You commented that you're seeing an estimated 15% of patients who had been on generics switched back to remodulin. Can you help us understand better what's going on there? Is that somehow, what are the dynamics? Is it related to supply, is it payers? Just what is driving the switchbacks from generics?

Errors, just what is driving the switch back from thinner and thanks, Chris interesting question.

Chris Shibutani: Thank you.

Michael I. Benkowitz: Thanks, Chris. Interesting question. I'm going to ask Mike if he could please respond to you.

Ask 'em, Mike if he could please respond to you.

Yes, so we we get some visibility into the reasons for the switched back we don't get we don't get total visibility, but anecdotally, what we hear from physicians and through that channel is that patients are experiencing either.

Michael I. Benkowitz: Yeah, so we get some visibility into the reasons for the switchback. We don't get total visibility, but anecdotally, what we hear from physicians and through the channel is that patients are experiencing either adverse events, worsening of the symptoms, and in some cases, hospitalizations when they make the switch over to generic troposinol. I think we all know that while the FDA considers the generic version to be the same as the brand version, they do allow for some variances, and because these are very, very sick and very, very fragile patients, I think we can hypothesize that those differences become magnified in a very fragile patient population. And so, as a result, we've seen an increase in the number of patients that have transitioned back to brand new molding.

Adverse events worsening of the symptoms in some cases hospitalizations when they make the switch over to over two generic across at all I think we all know that one of the FDA considers the generic version to be the same as a brand birds and they do allow for some variances and because these are very very second very very fragile patients.

I think we got hypothesize that you know those those differences because magnified in a in a very fragile patient population and so.

As a result, we've we've.

We've we've seen the actually increasing the number of patients that have transition back to Randy when modeling.

Michael I. Benkowitz: Thanks, Mike. Thanks, Chris. Operator, next question.

Thanks, Mike Thanks, Chris Operator next question.

Your next question comes from Yin Yang with Jefferies. Your line is open.

Operator: Your next question comes from Eun Yang with Jeffries. Your line is open. Thank you.

Thank you so because of the up closer to 19 impact I Dare I say General study [laughter] College, having paused for a new patient enrollment. So one I would then he's the.

Eun Kyung Yang: So, because of the COVID-19 impact, there are several studies, clinical trials that have been paused for new patient enrollment. So, one of them is the dry powder inhaler, dry blood plasma in the technosphere. So, with that, I guess we are not expanding, and we are expecting the data by mid-this year. The question is, when does the study have to resume in order for us to see the data this year? Thank you.

Dry powder inhaler.

Pascal Chimbonda skier I'm so.

With that I guess, we are not expanding backing the data I need to do you see here in question need to buy when this study has to read.

In all fairness to see the data. This year. Thank you sure very very interesting question and I'm going to ask Dr. Peterson who's in charge of that study to answer it but just so I'm just so I want to keep everything and perspective, while she's compiling her answer.

Martine A. Rothblatt: Very, very interesting question. And I'm going to ask Dr. Peterson, who's in charge of that study, to answer it. But just so I want to keep everything in perspective while she's compiling her answer. You know, when the COVID pandemic began to fall down upon us, the first thing that we were concerned with, of course, was to make sure that all of the distribution channels and everybody were set up and were solid so everybody could get their medicine. And as I mentioned in my opening remarks, we have done that very, very well. Now, our clinical trials presented an interesting situation in that the default situation would be that you might have to just stop the clinical trial and then restart it all over again, which would be unfortunate.

You know when the coated pandemic began to fall down upon us. The the first thing that we were concerned with of course was to make sure that all of the distribution channels and everybody could was where SAP and were solid so everybody could get their medicine.

And as I mentioned in my opening remarks, a we have done that fared very well.

Now our clinical trials the they.

Presented they interesting situation in that the default.

Situation would be that you might have to just like stop the clinical trial and.

Then you know restart that all over again, which would be you know unfortunate. So we worked very very hard and to make sure that our clinical trials Oh, we're not stopped but that chest that the into Weldment 10 them of new patients was suspended so that.

Martine A. Rothblatt: So we worked very, very hard to make sure that our clinical trials were not stopped, but just that the enrollment in them of new patients was suspended so that as hospitals are opening up, and you heard Mike Benkowitz mention previously that some of these centers are now beginning to open up and see patients again, we could, you know, without really missing a beat, continue the enrollment of the patients. So even though we've suspended new enrollment, the patients who are already in the BREEZE trial that you were referring to, the PERFECT trial that I mentioned for our COPD, and the ROLENIPEG trial, which involves patients all over the world, we have to get them their clinical trial materials. We have been doing all of that throughout the entire COVID situation without missing a beat. So speaking of beats, Dr. Peterson, she's a drummer.

As hospitals are opening up and you heard the I'm, Mike Banquets mentioned previously that some of these centers are now beginning to open up in C. Patients again that we could you know without really missing a beat continue with the enrollment into the patients. So even though we suspended new enrollment the patients who are ready into breezed.

Trial that you are referring to the perfect trial that I mentioned of how far CR P.D. The relented pick trial, which involves patients all over the world that we have to get them their clinical trial material. We have been doing all of that throughout the entire co fed situation without missing a beat.

So.

Taking a beat a doctor Peterson.

[laughter], She said trauma with you or would you like to provide a little more insight on the timeframe, it's around breeze right now.

Leigh Peterson: Would you like to provide a little more insight on the timeframes around Breeze right now?

Sure. Okay, Oh, so this study.

Leigh Peterson: Yes, sure. Thank you.

Leigh Peterson: So, this brief study, as you may already know, is a study where patients who are on Tyveso are transitioned over to our Trade T formulation with the dry powder and the device that we have with Mankind. And so we had, this study was actually a 45 patient study, it's not very big, FDA has agreed to this, and we were about a third of the way through enrollment. In fact, the study's primary endpoint is taken at three weeks after the patient starts, and so we were lucky enough to have had all of the patients who are currently enrolled complete that period, so we won't have missing data on the ongoing patients. And as far as timing due to the pause is concerned, we have again, about two-thirds of the 17 sites open for enrollment in this study.

<unk> already know is a study where patient.

Who are on tight base, so a transition over to our.

Trade T a formulation with the dry powder and.

The device that we have with a with mankind.

And so.

We had so this study was actually a 45 patients study. It's it's not very big has agreed to this and we were were about a third of the way through enrollments.

The study a primary endpoint is taking at three weeks.

The patient starts and so we were lucky enough to have.

Had all the patients who are currently enrolled to complete that period. So we won't have missing data on the ongoing on the ongoing patient and as far as climbing due to the pause.

We have again, we have about two thirds of the patients to enroll and we had about I'm not quite but about.

17 site.

Opened for enrollment in this study and so what we've done it's we've taken the time.

Leigh Peterson: And so what we've done is we've taken the time to do the paperwork and to prepare additional sites to conduct this study. So when we do open, we can, the plan is to make up for lost time and finish that study actually close to the original timeline. So we hope not to have a big, really a big delay there. We've already started the additional phase, the one, the second phase study that FDA has agreed to conduct for this product. We started that.

Do you the paperwork and to create additional sites to conduct the study. So when we do open we can the plan is to make up for last time and and finish that study actually close to the.

Well timeline. So we don't we hope not well have a big really a big delay there. We are we already started.

The additional phase the one.

The second phase study, but at the edge agreed that we conduct for this so this product.

With that.

Leigh Peterson: That is about halfway finished. That's in healthy volunteers, the bioequivalence study. And again, those patients have already completed, so we won't lose any data there, and we'll be able to finish that one up quickly as well. Again, it's easier to enroll with healthy volunteers. So, overall, we're hoping to not expect a big delay due to the halting of enrollment in that study.

Let's finish that's in healthy volunteers the Bioequivalent study.

And again those patients had completed so we won't lose any David there and we'll be able to finish that went up quickly as well again, it's it's easier to enroll at healthy volunteers. So.

Overall, we're hoping to not stuff.

A big Big delay.

Due to the halting of of enrollments in that study.

Leigh Peterson: Thanks so much, Dr. Peterson. Thank you, Liam. Operator, next call, please.

Thanks, So much Dr. Peter sent thank you very Oh then.

Operator: Your next question comes from Hartaj Singh with Oppenheimer & Co. Your line is open.

Operator next call. Please.

Your next question come comes from Hartaj Singh with Oppenheimer and company. Your line is open.

Hartaj Singh: Great, thank you, and thank you for all the work that United Therapeutics is doing on behalf of its patients.

Oh, great. Thank you and thank you for all the work I'm not therapeutics is doing on hofh patients much even though they see I said one question on time, you had I think a 20% growth in the fourth quarter, 18%. This quarter I'm can you just given some color on where that's coming from is it new patients are getting maybe a little bit market.

Hartaj Singh: Patients Smart Team, and stay safe. I just have one question on Orangetram. You know, you had, I think, 20% growth in the fourth quarter, 18% this quarter. Can you just give us some color on where that's coming from? Is it new patients? Are you getting maybe a little bit of market share from Oktravi? Any color there would be really appreciated. And again, thank you for all the work.

Share from Uptravi or any color there would really appreciate and again. Thank you for all work.

Martine A. Rothblatt: Thank you so much, Hartaj, and thank you for acknowledging our efforts on COVID. We have, just very briefly before I segue over to Mike to address the question of where the orenotram growth is coming from, we have a cell therapy product for patients with COVID and two parallel ARDS initiatives for patients who are suffering the worst consequences of COVID, as well as an advanced form of our total artificial lung device to be an alternative to the intubation and sedation that's necessary with Current Ventilators. So we have quite a bit of activity going on directly in COVID and, most importantly, taking care of everybody and making sure everybody's safe. So thanks for that recognition, Hartaj. Mike, can you talk about where the Renatram growth is coming from?

Thank you so much hard times and Doug. Thank you for acknowledging our efforts on co bid we have I'm just very briefly before I secondly over to Mike to address the question on where the Orenitram growth is coming from.

We have a.

Cell therapy product in a in patients with a co bid and to parallel all arts initiatives for patients who are.

Suffering a the the worst consequences of co fit as well has had an advanced form of heart total artificial one device to be an alternative to the intubation and sedation that's necessary with with with current ventilator. So we have gone quite a bit of activity.

Going on directly in Cove, it and most importantly, taking care of everybody and making sure pretty safe. So think say recognition hard times I'm, Mike can you talk about where where they run the trend growth is coming from.

Michael I. Benkowitz: Sure. Thanks, Hartaj.

Michael I. Benkowitz: It's kind of, well, let me just sort of, you know, step back and, you know, obviously point out the obvious, which is that we had the label expansion for Oranatram come through in October, reflecting the FreedomEV data. And so we've had about a quarter and a half now of being able to promote the new data from a sales and marketing standpoint. So that has certainly, I think, helped because, you know, as we've said on these calls and as we talked about in the press release last week, the data really, when you look at it in its totality, is pretty compelling. And so I think that message is getting through to physicians. And so, you know, when we look at where the growth is coming from, as I said, it's really three areas.

Sure.

Thanks Archives it it's kind of well, let me just sort of step back and you know obviously plant the obvious which is that a we had though the label expansion.

For Orenitram come through in October, reflecting the freedom meaty data and so we've had about a.

Really about quarter, and a half now or be able to promote from a sales and marketing standpoint on the on the new data so that that is certainly.

I think health because I'm, you know as I think and as we've said on these calls and as we've talked about in the press sort of press released last week and a debate I really when you look at in its totality is pretty compelling and so I think that message is getting three with getting through the physicians and and so when you look at where where the growth is coming from as I said, it's really three areas. It's hard for me it I guess.

Michael I. Benkowitz: It's hard for me, I guess, at this point to say how much is attributed to each. But I would say, you know, first, it's coming from patients staying on therapy and increasing their doses. So that's, you know, that's one piece of it. The second piece of it is just new patient growth, generally. I mean, that's obviously a big part of it.

At this point to say how much is attributed to each but I would say you know first it's coming from patients stay on therapy, increasing their dose.

So that's that's one piece of that the second piece of it is.

Just new patient growth generally I mean that that's obviously a big part of it we're continuing to see you know really nice really nice trends in terms of patients on therapy, and then underlying that is a new prescribers. So prescribers that either had never use orenitram or or had you know used in early on act.

Michael I. Benkowitz: We're continuing to see really nice, really nice trends in terms of patients on therapy, and then underlying that is new prescribers. So prescribers that either have never used Renatram or had, you know, used it early on after the Freedom N trial and, for whatever reason, stopped using it. I kind of define a new prescriber as somebody that has not used it at all or has not prescribed within, say, the 12 months prior to writing. So we're, you know, certainly seeing some increases there. And particularly among, I think, the KOLs, the more experienced PAH physicians that maybe used them initially, went away from them. I think the ED data has really compelled them to come back and take another look. And they're giving it another try.

For the freedom and trial and for whatever reason.

Ah, yes stopped using that I got kind of define it as new prescribers somebody that has not used in at all or has not not prescribed within say 12 months. Prior prior to lighting. So were certainly see some increases there and I'm, particularly among I think the K a wells the more experience ph physicians that maybe they use it initially when it.

From at I think the EDI data has really down I think compel them to come back and take another look and they're getting into another trial.

Michael I. Benkowitz: Thanks so much, Mike. All righty, operator, next call, please.

Thanks, so much Mike.

Oh by the operator next call. Please.

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

Operator: Your next question comes from Jessica Fye with J.P. Morgan. Your line is open.

Great. Good morning. Thanks for taking my question can you. Please walk through the plan development program and regulatory strategy for your pro candidate.

Jessica Fye: Great. Good morning.

Jessica Fye: Thanks for taking my question. Can you please walk through the planned development program and regulatory strategy for your REMA Pro candidate, the IND, which I believe cleared in the first quarter? Do you need to run efficacy trials there or just show site pain and safety compared to remodulin? And could I just follow up on Hartaj's question? I'm curious about the potential interplay between the new starts on Orenatram and the slight year-over-year decline in Tyvaso. Do you think any of the Orenatram growth came at the expense of new Tyvaso starts?

For which I believe you heard the first quarter do you need to an efficacy trials, there or just show like pain and safety compared to Remodulin and if I could just following up on her child. His question I'm curious about the potential interplay between the new starts on Orenitram and a slight year over year decline in TV. So do you think any of your rent growth.

Keen expensive you TV so starts.

Michael I. Benkowitz: Sure, so why don't we have Mike, since we're already on the Orenatram theme, answer your second question, and then Mike, if you could pass the call to Dr. Peterson for her to talk a little bit about the anticipated timeline for RemoPro?

Sure. So why don't we have Mike since we already on their run a tram same answer your second question and then Mike If you could pass the call to Dr. Peterson for her to talk a little bit about the anticipated timeline on dream a pro.

Sure.

Michael I. Benkowitz: Sure, yeah, so I don't really, at some level, it's hard to know exactly, but what I can tell you in terms of looking at whether a doctor is saying, okay, I want to use Renitram instead of where I would otherwise use Tyvaso. So that's a little harder to get insight into, but at a patient trend level, in terms of active patients, our active patients on Tyvaso are up about 10% year over year. So we are continuing to add to our Tyvaso active patient count as we add to our Renitram count. So I don't, I mean, I'm sure those trade-offs are being made on the margins, but in general, and we're modular too, the franchise as a whole continues to grow across the three products. So it's hard to say that one's cannibalizing the other, but again, I think at an individual physician level, that may be entering into their calculus, but at a macro level, we're seeing growth across the board.

So I don't really.

The adjusted <unk> at some level of it's hard to know it's hard to know exactly but what I can tell you in terms of looking at just sort of in terms of what our dr., saying, okay, I want to use or winner tram instead of.

Well, what otherwise used today so.

So that's a that that's a little harder to get insight to that at a patient trend level in terms of active patients.

You know our active patients on Friday, so are up about 10% year over year. So we're we're continuing to add to our TV. So after patient count as we're adding to our.

Try orenitram count so I don't I mean, so I'm sure those trade offs are being made on the margins but in general.

And you had remodulin to the franchise as a whole continues to grow across across the three products. So it's its hard it's hard to say that one's cannibalizing. The other but you know again I I think on an individual physician level, there that may be entering into their into the calculus, but at a macro level, we're seeing growth across the board.

Absolutely sustainable love it.

Michael I. Benkowitz: Absolutely sustainable. I love it.

Lee.

Yeah, Yeah filter agreement Pro [laughter] I will say.

Leigh Peterson: Yes, yes. So for REMA Pro, I will say, I'll give you the answer that our statistician always tells me when I ask questions like this: It depends.

The answer what are.

Isn't always tells me when I ask questions like that's it depends on [laughter].

[laughter] and as you probably already know we are in phase one looking at these.

Leigh Peterson: And as you probably already know, we are in phase one looking at these remaproproducts, the prodrugs of troprosinol with regard to pain and also the pharmacokinetics. And the pharmacokinetics we're looking at are not only of the prodrug itself, so in that case it's the parent molecule, but also of troprosinol, which is... really the metabolite, As far as the development program goes, it depends on what we see in the PK results, and so on, but what we're... The drug that we're shooting for, and we're looking for the compounds that best show this, is a prodrug that is injected and very quickly converts to triprostanol, and has a high proprostanol level relative to the control, which would be basically injecting troprostanol, the parent compound as remodeling. So, if we have good...

Remember pro product the pro drug.

Across to know with regard to pain.

And also than pharmacokinetics and the pharmacokinetic. We're looking at are not only the pro drug itself. So in that case, it's the parents molecule, but Oh, Oh, <unk>, which is.

Really the metabolite if you will have the prodrug.

And so.

With is for the development program goes.

It depends on what we see in in the PK results and so but what were.

Shooting for and we're looking for the compound that that best.

<unk>.

Yeah, Hey.

But.

Injected and very quickly convert to treprostinil.

And have the high level.

Level.

Relative to.

The the control, which would be basically injecting treprostinil.

The parent compound as Remodulin. So yes, if we have good.

Right.

Leigh Peterson: Conversion of the prodrug, and we've reached proprosinol levels comparable to that of the parent drug. We can, FDA has said that we don't need to do an efficacy study because we've already shown that troposinol works, and so if we have a good conversion to troposinol, we're good. And then, what we do have to do is a safety study, and again, that also depends on conversion. If there's a lot of the prodrug in the patients, we will do a safety study. We have asked for about a 45 patient safety study for this. And again, this would be to show that the prodrug that's in the system prior to conversion is safe. That's, you know, that's the plan so we don't have to do an efficacy study. We have feedback from FDA on that. But again, it's, it's, provided that we do get what we're expecting, which is a high conversion of the prodrug to proprosinol and blood levels comparable to proprosinol blood levels from that prodrug.

Conversion of the pro drug and professional level.

Trouble.

With the parents.

Doug.

We can.

Yes, but we don't do an efficacy studies because we've already shown that your personal berkson. So if we have good convergence that to cross now well get.

And then.

You have to do you.

Safety study and again that also depends on conversion.

If there's a lot of the per job in the patients we will do a safety study it we have asked.

About a 45 patient safety study.

For the and and again this would be to show that the pro drug that's in the system prior to conversion yes.

And and so.

That's you know that's the plan that we don't have to do an escalation study we have feedback from FDA on that.

But again.

<unk>.

Providing that you get what we're but we're expecting which is a high conversion of the contract to treprostinil and showing comparable across you know blood levels from that fragile.

Leigh Peterson: Excellent. Thank you so much, Dr. Peterson. Operator, next question.

Excellent. Thank you so much Dr. Peterson operator next question.

Your next question comes from Liana Moussatos with Wedbush Security Your line is open.

Operator: Your next question comes from Leanna Moussatos with Wedbush Security. Your line is open. Thank you.

Thank you.

Roanna Ruiz: What percent of tripostenil prescriptions are new versus refills?

Were sent a true passino prescriptions are new versus refill.

Hi, Good morning Leanna. Thank you for the question what percent showed professional <unk> prescription starting new versus refill I think once again I don't like banker, which would be the best person on the call to answer that question.

Roanna Ruiz: Good morning, Leanna. Thank you for the question. What percentage of caprocinol prescriptions are new versus refills? I think, once again, Mike Benkowitz would be the best...

Michael I. Benkowitz: Yeah, Leigh, that's a good point. I don't know if I have that off the top of my head. Let me, well, actually, let me think about that for a second.

Yeah. That's a good color I don't know if I have that off the top of my had.

Well I actually think about that first I guess it's.

Yeah.

It has more than half less than <unk>, new it's less than it has a newcomer new prescriptions. Each yeah I think about it each month, that's it's it's definitely less than half.

Michael I. Benkowitz: It's less than, in terms of new prescriptions, if I think about it each month, it's definitely less than half. It's probably on the order of about 5 to 10 percent.

Its probably on the order of about 5% to 10%.

Michael I. Benkowitz: Thanks, Mike. Thanks, Leanna. Next call, and this will have to be, I believe, the last one, operator.

Okay. Thanks, Mike Thanks Deanna.

Our next call and this will have to be I believe the last one operator.

Your next question comes from the line of Marty I'll start with credit Suisse. Your line is open.

Operator: Your next question comes from the line of Marty Oster with Credit Suisse. Your line is open.

Yeah. Thanks for taking my question.

Unknown Attendee: Hey y'all, thanks for taking the question.

Unknown Attendee: Hey Marty, good morning!

Good morning, one but.

Unknown Attendee: Hey Martine, how are you? Really, really excited to hear the progress with Teveso and the Teton study you're planning. And so to that effect, I'm super pumped to see the increased data. I know that you're working with ATS on a virtual presentation, but I guess from the website and ATS, it's not clear they're going to have that format available. If that is not available by mid May, are you planning to just make a separate kind of company-sponsored presentation of the data? And then, the second one, would you just do a quick follow up for Leigh on Jess's question on Remapro? Is phase one currently enrolling volunteers? And when do you think we might get some data on the PK and the accountability profile of our product? Thanks.

Hey, Marty and where you I'm really really excited to hear the progress with today. So in the teatime for your planning so to that effect I'm Super pumped it to see the increased data I know that you're working with him. He has done a virtual presentation, but I guess from the website and you'd get it's not clear they're going to have that for amount available if that is not available.

In mid May or are you planning to just make a separate kinda company sponsored presentation of the data and then the second one would you just a quick follow up for really Justin's question on remote pro.

Is that pays one currently ruling volunteers and when do you think we might get some data on the PK and become Tolerability profile that product thing yeah. Thanks, I'm already for both questions. I think both are pretty much in a lease Bailey work. So we can you talk about what you're thinking.

Martine A. Rothblatt: Thanks Marty for both questions. I think both are pretty much in Leigh's bailiwick. Leigh, can you talk about what you think in terms of Teton and the ATS and the latest information that we have in terms of what kind of data presentation would be possible there?

This is in terms of Teton and the ATM send the latest information would be half in terms of what kind of data presentation, we could pop spoke there.

Yeah.

Leigh Peterson: Yes, so we are planning, and we've been accepted to APS for our presentation. It will be a virtual presentation for the increased results, the full results, but we don't know the timing on that. So I'm sorry I can't give you a specific date. They haven't given us one. We assumed this summer, and we've also got The Journal, and it's under review right now, and we expect to hear their comments any time now and to publish that. Full publication this summer as well. So one way or another, we'll have the results to you very soon, and we two are very, very excited. So thank you. Thank you for saying that it's really a blessing to have those types of results come in our lifetime.

We are planning, we've been accepted to Oh, yeah, or our presentation will be a virtual presentation.

Chris results the whole results and.

But the timing.

Oh I'm, sorry specific date, they haven't given us one <unk>. That's some of this summer and we've also submitted those results to.

General and it's under review right now and we expect this year anytime now.

They're comment.

HM two published that's.

For publication this summer as well, so one way or another.

Do you very soon.

And we too are very very excited so thank you. Thank you for saying that it's.

Really a blessing to have those types of results come in you know lifetime.

Leigh Peterson: Thanks so much, Leigh. James, we have our Chief Financial Officer on the phone, and it's really important, I think, for everybody on the call to appreciate what an amazing job and difficult job it is in the midst of a pandemic to be able to close out a year, complete your year-end audits, gather all the necessary financial information for a 10-Q Not to mention the processing of, you know, well over a million dollars a day in account payable It's a tremendous testament to the strength and stability of United Therapeutics as a business organization to move so smoothly through this pandemic without missing a beat. So since nobody asked a question specifically for James, I would like to ask him to say a word or two on the topic of our quarterly earnings. James?

Thanks, so much leap.

James If you [noise].

We have far Chief financial officer on the phone and it's really important I think for everybody on the call to appreciate I wasn't amazing a job and difficult chop. It is in the midst of of a pandemic to be able to go ahead and close out the a year complete here.

Year end audits.

To gather all the necessary financial information for a 10-Q.

I'm not to mention the processing of you know well over a million dollars a day and account payables to go to all of the right places and none of the wrong places and to do all of this remotely it's a tremendous a testament to the to the we need to stay.

Length of stability of the United Therapeutics as they as a business organization to how moves so smoothly through this pandemic without missing a beat so since nobody ask a question specifically for James I would like to ask him to say award or to Hum the topic of how far.

Quarterly earnings James.

Yep, marking thank you very much worse the opportunity a couple of things come to mind, a you mentioned on into the process is the whole organization has in place really.

Martine A. Rothblatt: Yes, Martine, thank you very much for the opportunity. A couple of things come to mind, as you mentioned, the processes the whole organization has in place, really, to execute, whether it's year-end or the quarter, as we all tend to work remotely. So it's certainly within all the groups that we've talked about, from the R&D, the manufacturing, the finance teams, and all the administrative functions, that I think is a real testament. The other thing that's very important is the realization of the strength around the balance sheet. You know, as we entered COVID-19 and as we continue during this pandemic, from a financial stability perspective, we are well capitalized to be able to continue to execute on our research and development programs.

To execute whether it's your and your support or as we all tend to work remotely. So it's certainly within all the groups that we've talked about from the R&D the manufacturing.

The funding needs and all the administrative functions that I think because your real Testament. The other thing that's very important.

The realization of the strength around the balance sheet as we entered.

Koby 19, and as we continue during this pandemic.

From a financial stability perspective, we are well capitalized.

To be able to continue to execute on our research and development program.

James C. Edgemond: as we make sure we take care of our patients as well as our fellow Unitarians. And it's really important for people to realize, you know, that strength as we continue during this time that we are able to function as an organization, which should be reassuring to many, both listeners on this call and again patients and people in the organization. So I just thought those were two things that I think are very important to mention, and I appreciate the opportunity to allow me to do that. So, back to you.

As we make sure we take care of our patients as well as our fellow unit area.

And it's really important for people to realize you know that strength as we continue during this time a than we are able to execute as an organization, which you'd be rare reassuring to many both listeners on this call.

And again piece and some people in the organization. So I just thought those two things I think are very important to mention and I. Appreciate the opportunity to allow me to do that so back to you.

James C. Edgemond: Thanks so much, James. Well, Operator, we've had a great chance to address most of the people in queue on the line, and thank you so much for organizing the call. Everybody on the phones, thank you for your continued support for United Therapeutics. Our hearts go out to those of you who have loved ones or friends that are suffering directly from the COVID pandemic, health-wise, for sure, but economically-wise, otherwise. And for those of you who are related to frontline healthcare workers, our complete admiration and respect for everybody who's out there fighting on the front lines. Operator, you can wrap up the call.

Thanks, so much shames well operator, all we've had a great chance to address as most of the people in Q on the line and thank you so much for organizing the called everybody on the phones. Thank you for your continued support for United Therapeutics. Our Hearts go out to those of you who have fall loved ones are friends that are.

Suffering a directly from the covert pandemic.

Health wise for sure economic wise otherwise.

And for those of you who are all related to frontline health care, a workers are complete admiration and respect for everybody who's out there fighting on the front lines operator, you can wrap the call.

Thank you for participating in today's United Therapeutics Corporation Conference call every broadcast will be available for replay for one week by dialing one 800 585, Athree six seven with international callers dialing one for one 661 for six or too [laughter] when nine eight.

Operator: Thank you for participating in today's United Therapeutics Corporation conference call. A rebroadcast will be available for replay for one week by dialing 1-800-585-8367, with international callers dialing 1-416-621-4642 and using access code 1984097.

For your own nine seven.

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Operator: ???