Q3 2020 United Therapeutics Corp Earnings Call

Good morning, and welcome to the United Therapeutics Corporation third quarter Twentytwenty earnings call. My name is Ken and I will be your conference operator today.

All participants will be in listen only mode until the question and answer portion of this earnings call.

Operator: Participants will be in listen-only mode until the question-and-answer portion of this earnings call. If you would like to ask a question during that time, simply press the star, then the number 1 on your telephone keypad.

If you would like to lock they question during that time simply press Star then the number one on your telephone keypad.

Operator: If you would like to withdraw your question, press pound on your telephone keypad. I will now turn the conference over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics. Good morning.

If he would like to withdraw your question press pound on your telephone keypad.

I will now turn the conference over to Mr. or do we start men head of Investor Relations at United Therapeutics.

Good morning. It is my pleasure to walk you made to the United Therapeutics Corporation third quarter 2020 earnings call accompany me on today's call are Dr. Martine Rothblatt, our chairman and Chief Executive Officer, Mr., Michael Vick Whats, our President and Chief operating Officer, Mr., James Edgemond, Our Chief Financial Officer and Treasurer.

Dewey Steadman: It is my pleasure to welcome you to the United Therapeutics Corporation third quarter 2020 earnings call. Accompanying me on today's call are Dr. Martine Rothblatt, Executive Officer, Mr. Michael Benkowitz, our President and Chief Operating Officer, Mr. James Edgemond, our Chief Financial Officer and Treasurer, and Dr. Leigh Peterson, our Vice President of Product Development. Remarks today will include forward-looking statements representing our expectations or beliefs regarding the future... These statements involve risks and uncertainties that may cause actual results to differ materially.

Dr. Lee Peterson, our vice president of product development.

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 we assumed no.

Dewey Steadman: Our latest SEC filings, including Form 10-K and 10-Q, contain additional information on these risks and uncertainties. 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 on our earnings release available on our website at IR.gov. Additionally, today's remarks may discuss the progress and results of clinical trials or 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 investigation. Full prescribing information for the products is available on our website.

Obligation to update these forward looking statements.

Today's remarks May also include financial measures that were not prepared in accordance with the U.S. generally accepted accounting principles workout a.

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 IR thought units our dot com.

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 now and are not intended to serve as the basis for medical decision, making or to suggest that any products are safe and effective for any unapproved or investigational uses.

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

Dewey Steadman: Now I'll turn the call over to Dr. Rothblatt. 3rd Quarter 2020 Financial Results and Business Activities of United Therapeutics. Martine.

Now I'll turn the call over to Dr. Rothblatt for an overview of the third quarter 2020 financial results and business activities have United Therapeutics Marty.

Martine A. Rothblatt: Thank you, Dewey. Good morning, everybody. And welcome to our third quarter earnings call for 2020. I'm going to be joined on the call today by our President, Michael Benkowitz, our Chief Financial Officer, James Edgemond, and our Head of Product Development, Dr. Leigh Peterson. We really have only good news to report today, so it's going to be a very fun earnings call.

Thank you do a good morning, everybody and welcome to our third quarter earnings call for 2020.

I'm gonna be joined on the call today by our President Michael Benkowitz, Our Chief Financial Officer, James Edgemond, and our head of product development Dr. Lee Peterson.

We really have good news to report today, so it's going to be a very fun earnings call let.

Martine A. Rothblatt: Let me divide the good news into two categories, pulmonary hypertension and pulmonary fibrosis. Let's start with pulmonary hypertension. We had the highest number of patients on our traprosnal medicines ever in the past quarter. In addition to that, we've seen double-digit growth in the number of our patients on Orenatram and the number of patients on Tyvaso. That's double-digit growth year-to-year, quarter

Let me divide the good news into two categories pulmonary hypertension, and pulmonary fibrosis, let's start with pulmonary hypertension.

We had over the past quarter, the highest number of patients on their treprostinil medicines.

Yeah.

In addition to that we've seen double digit growth in the number of our patients are kinda orenitram and the number of patients on tyvaso, that's double digit growth year to year quarter to quarter.

Martine A. Rothblatt: On top of that, we've also had solid remodeling performance, and we expect this solid remodeling performance to be even further enhanced with two planned launches for 2021. First, the remunity launch for patients on subcutaneous forms of remodulin. And secondly, the ISR, or implantable system for remodulin, launched for patients on the intravenous form of remodulin. These new product launches are important because most pulmonary hypertension patients decline remodulin due to its grave difficulty of delivery. Indeed, most pulmonary hypertension patients die without ever having access to remodulin therapy.

[laughter]. We've also had solid remodulin performance and we expect a solid remodulin performance to be even further enhanced with two planned launches for 2021.

First the Remunity launch to the patient on subcutaneous form set for March one and secondly, the highest Saar for implantable system for Remodulin watch for patients on the intravenous form of Remodulin.

These new product launches are important because most pulmonary hypertension patients declined remodulin due to its great difficulty of delivery. Indeed, most pulmonary hypertension patients die without ever having access to Remodulin therapy.

Martine A. Rothblatt: Speaking of our pipeline for pulmonary hypertension, also of great significance is our accelerating progress on Relenopag. We expect both the Relenopeg outcomes trials and the Relenopeg capacity phase 3 trials to be half enrolled in 2021 and fully enrolled by the end of 2022. Let me now turn to some of the good news related to pulmonary fibrosis. We remain on schedule to launch our Tyvaso product for IPF-associated pulmonary hypertension on April 21, subject to FDA approval on its PDUFA date. We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis associated with pulmonary hypertension with the launch of our DreamBoat Tray-T product by the end of 2021 or possibly early 2022. I'd like to remind everyone that systemic drugs for treating this type of pulmonary hypertension, the pulmonary fibrosis associated pulmonary hypertension, are contraindicated, leaving Tyvaso as probably the only medicine approved by the FDA to treat this 30,000 patient population.

Speaking of our pipeline for pulmonary hypertension.

Great significance since our accelerating progress onto the lender Patrick.

We expect both the banana peg outcomes and when you have a pet capacity phase three trials to be half enrolled in 2021 and fully enrolled by the end of 2022.

Let me now turn to some of the good news related to pulmonary fibrosis.

We remain on schedule to launch our Tyvaso product for I.P.F. associated pulmonary hypertension in April 21 subject to FDA approval on its PDUFA date.

We expect to further penetrate that 30000 patient market for patients with pulmonary fibrosis associated pulmonary hypertension with the launch of our Dream boat trade T product by the end of 2021 or possibly early 2022.

I'd like to remind everyone that systemic drugs for treating this type of pulmonary hypertension, the pulmonary fibrosis associated pulmonary hypertension, our country indicated leaving type base. So as probably the only medicine approved by the FDA to treat this 30000 patient population.

Martine A. Rothblatt: We then expect to greatly expand our pulmonary fibrosis footprint with our Teton study in pure pulmonary fibrosis patients starting in the first quarter of 2021. Indeed, we will be filing the IND for this Teton study next quarter. That 400 patient study should be completely enrolled by 22. So there are a lot of things that are happening, both not only in our core historical franchise of pulmonary hypertension, but you can also see that the company is making a steady adjacent market expansion into the field of pulmonary fibrosis. First, by having kind of one leg in two camps with group three pulmonary hypertension associated with pulmonary fibrosis, and then with the other leg completely on the pulmonary fibrosis side of the fence with the Teton study.

We then expect to greatly expand our pulmonary fibrosis footprint with 30 ton study in pure pulmonary fibrosis patients starting in the first quarter of 21, Indeed, we will be filing the I.M.D. for this Teton study next quarter.

400 patient study should be completely enrolled by 22.

So there's a lot of things that are happening both not only in our Payor historical franchise, Oh pulmonary hypertension, but you can also see that the company is making a steady adjacent market expansion into the field of pulmonary fibrosis first by having kind of a one leg into.

Two camps with the group three pulmonary hypertension associated with pulmonary fibrosis, and then with the other leg completely in the pulp pulmonary fibrosis side of the fence with the T. tone study.

Martine A. Rothblatt: While I've been talking about our pipeline, let me also talk about things that are going on at the phase one and what I would call the phase 0.9 level of our pipeline. So with regard to phase one, in early 2021, we will begin clinical development of our once-daily form of Orenatram based on an IND that'll be going in shortly. This will be much more convenient for patients than the three-times-daily form of Orenatram and I think it will be instrumental in continuing the double-digit growth that we're currently seeing year-over-year in Orenatram. Another exciting activity that I would say is at the phase 0.9 level is RemoPro. This is the painless form of subcutaneous remodulin designed ultimately to go into the rimmunity pump.

Well I've been talking about our pipeline. Let me also talk about things that are going on at the phase one and what I would call the phase 0.9 level up our pipeline.

So it's got to phase one in the Oh in early twenties 21, we will begin clinical development of our once daily form of Orenitram based on an i. Indeed thatll be going in shortly this will be a much more convenient for patients tend to three times daily form up around a tree.

And I think will be instrumental in continuing the double digit growth that we're currently seeing year over year in orenitram.

Another exciting activity that I would say is that the phase 0.9 level is remote pro this is the pain less form of subcutaneous remodulin designed to ultimately to go into the Remunity pump.

Martine A. Rothblatt: We plan to file our IND in the fourth quarter of 21 and then move into phase one right after that in 22. Speaking of filing INDs in 21, another IND we plan to file in 21 is for our XenoKidney Project. This is a 10-gene modified porcine kidney designed specifically to avoid the types of rejection that are common in xenografting and instead to appear to the recipient as no different than another allograft

We plan to file our idea in the fourth quarter of 21, and then move into phase one right after that in 22.

Speaking of filing I am decent 21, another I'm D., we plan to file in 21 as far as you know kidney project. This is a 10 gene modified a poor sign kidney designed specifically to avoid the types of rejection that are common.

Encino crafting and instead to appear to the recipient as no different than another allograft, we expect to file the R&D for this you know kidney program at 21, and then due to the unique nature of that type of a product move directly into a phase two three study in 22.

Martine A. Rothblatt: We expect to file the IND for the XenoKidney Program in 21 and then, due to the unique nature of that type of product, move directly into a Phase II-III study in 22. Well, with that overview of our clinical development and pipeline activities, I'd like to next turn the microphone to our president, Michael Benkowitz, to give a review of other aspects of our operations, including commercialization.

[noise] well with that overview of our clinical.

Clinical development and pipeline activities [noise].

I'd like to next turn the microphone to our President Michael Baker, which to give a review of other aspects of our operations, including commercialization Michael Great. Thanks, Marty and good morning, everyone.

Michael I. Benkowitz: Thanks, Martine. Good morning, everyone. As Martine said, overall, we're extremely pleased with our reported revenue performance in the third quarter, highlighted by strong double-digit year-over-year growth and a Renitram-Tyveso annual. And when you adjust our revenue growth to account for the excess order that occurred by one of our distributors in the third quarter of 2019, that growth is even stronger. On this adjusted basis, US remodeling revenues grew year over year and 5% sequentially, and Tyvaso and Orinatron revenues grew by approximately 30% each year over year. However, we periodically caution that our revenues represent sales to our distributors and may not reflect underlying demand for our products.

As Martine said overall, we are extremely pleased with our reported revenue performance the third quarter highlighted by strong double digit year over year growth and Orenitram Tyvaso and toxin.

When you adjust our revenue growth to account for the excess order that occurred by one of our distributors and the third quarter of 2019 that growth is even stronger.

This adjusted basis, U.S. Remodulin revenues grew year over year, and 5% sequentially and Tyvaso and Orenitram or revenues grew by approximately 30% each year over year.

We periodically caution that our revenues represent sales to our distributors and may not reflect underlying demand for our products happily. We can report that revenue growth. We saw in Q3 is supported by growing demand in the U.S. as reflected by the following highlights during the quarter.

Michael I. Benkowitz: Happily, we can report that revenue growth we saw in Q3 is supported by growing demand in the U.S., as reflected by the following highlights during the quarter. First, after experiencing some COVID-related softness, a new patient starts earlier during the pandemic, and total professional starts return to pre-pandemic levels during the quarter. Second, as Martine noted, the number of patients utilizing one of our traprosonal products reached another all-time high. This is the fourth quarter in a row that we've achieved an active patient census record for our traprosonal products. We have a record number of patients benefiting from Orenatram, reflecting continuing and increasing adoption of this therapy by physicians following the FreedomEV label expansion last year. We have more patients benefiting from Tyvaso than we have had in approximately five years prior to the commercial availability of oral prostacyclin class. And finally, we are just shy of a record number of patients utilizing remote. In addition to those highlights, we're seeing increases in average dose levels and the length of time our patients stay on our medicines, both of which positively impact our... So we're very pleased all the way around with the momentum and direction of our commercial product.

First after experiencing some kobin related softness in new patient starts earlier during the pandemic total treprostinil starch returned to pre tax pre pandemic levels during the quarter.

Second as Martine noted the number of patients utilizing one of our cross sell products reached another all time high. This is the fourth quarter in a row that we've achieved in fact, if patient census record for our Treprostinil products.

We have a record number of patients benefiting from a raghuram, reflecting continuing and increasing adoption of this therapy by physicians following a freedom easy label expansion last year.

We have more patients benefiting from Friday. So then we have had an approximately five years prior to the commercial availability of oral prostacyclin class medicines.

Finally, we are just shy of a record number of patients utilizing remodulin.

In addition to those highlights were seeing increases in average dose levels and the length of time, our patients stay on our medicines, both of which positively impact our revenues.

So we're very pleased all the way around what the momentum and trending of our commercial products.

Meanwhile, we are making very good progress towards our near term new product launches. We are building out our field based medical sales and nursing teams to support the expected Tyvaso label expansion in April 2021 to include patients with pulmonary hypertension associated with interstitial lung disease following our increase trial.

We have started engaging with physicians that treat these patients which by and large is a new prescriber base compared to those currently prescribing our products for P. H at appropriate forums, such as investigator meetings scientific presentations at healthcare conferences advisory boards market research and one on one interactions.

Michael I. Benkowitz: Meanwhile, we are making very good progress towards our near-term new product. We are building out our field-based medical sales and nursing teams to support the expected Tybaso label expansion in April of 2021 to include patients with pulmonary hypertension associated with interstitial lung disease, following our We have started engaging with physicians that treat these patients. This, by and large, is a new prescriber base compared to those currently prescribing our products for PAH, and appropriate forums, such as investigator meetings and scientific presentations at healthcare conferences. Advisory Boards, Market Research, and one-on-one interaction.

The increased data is roundly considered overwhelmingly positive and the I'll do you treat community is looking forward to having tyvaso and their treatment parliamentarian for these very sick patients upon FDA approval.

Between the momentum, we're seeing with Tyvaso and its approved group one indication and the excitement around the upcoming launch into who group three we're well on our way to solidify anti body. So it was our largest product in the very near term.

Our two upcoming Remodulin pump boxes are also progressing in the case of reality, our new subs Subcu pump that was approved by the FDA earlier. This year. We believe we have overcome the corporate related delays that impacted the July launch timing our.

Michael I. Benkowitz: The increased data is roundly considered overwhelmingly positive, and the ILD treating community is looking forward to having Tybaso in their treatment armamentarium for these very sick patients upon FDA approval. Between the momentum we're seeing with Tyvaso and its approved WHO Group 1 indication, and the excitement around the upcoming launch into WHO Group 3, we're well on our way to solidifying Tyvaso as our largest product in the very near future. Our two upcoming remodeling pump launches are also progressing. In the case of Immunity, our new sub-q pump that was approved by the FDA earlier this year, we believe we have overcome the COVID-related delays that impacted the July launch timing. Our partner, Decker Research, is building commercial inventory, and once we have sufficient safety stock...

Our partner Decker research is building commercial inventory and once we have sufficient safety stock, which we expect soon will be again, making the remunity pumps commercially available.

And finally, our partner Medtronic continues their discussions with the FDA to clear the outstanding conditions of approval for the for the I.S., our which is our new IB pump. We believe we remain on track for a launch next year and we are already working with key ph centers to get them ready for this launch.

So with that I will turn the call back over to marketing.

Thanks, so much Mike.

Operator, I am now happy to field, the calls and I'll direct them amongst Dr. Peterson, James Edgemond, and Mike Benkowitz as appropriate.

Thank you at this.

This time I would like to remind everyone in order to ask a question. Please press Star then the number one on your telephone keypad again that is star then the number one on your telephone keypad. If you wish to withdraw your question you May press the pound cool.

Our first question comes from the line of Hartaj Singh from Oppenheimer. Please go ahead. Your line is open.

Great. Thank you and a really really good quarter Martine and team. So thank you.

Martine A. Rothblatt: If we expect it soon, we'll begin making the room unity pumps commercially available. And finally, our partner Medtronic continues its discussions with the FDA to clear the outstanding conditions of approval for the ISR, which is our new IV. We believe we remain on track for a launch next year, and we are already working with key PAH centers to get them ready. So with that, I'll turn the call back over to you. Thanks so much, Mike.

Just a quick question on Tyvaso.

So we've seen a definite uptick in the trend growth over the last few quarters Martinez you mentioned youre near double digit growth and then also in our Q can you meter calls we've noticed that there's a lot of overlap between the physicians treating ph using TV so their positions to treating ph file d.

Do you expect.

Operator: Operator, I'm now happy to field the calls, and I'll direct them amongst Dr. Peterson, James Edgeman, and Mike Benkowitz as appropriate. Thank you. At this time, I would like to remind everyone, in order to ask a question, please press star, then the number one on your telephone keypad. Again, that is star, then the number one on your telephone keypad. If you wish to withdraw your question, you may press the pound key. Our first question comes from the line of Hartaj Singh from Oppenheimer.

A lot of this enthusiasm to be occurring in those patients and then also maybe some uptick not that good treat patients going there. Thank you.

Thanks for telling US excellent question and good to hear your voice. This morning, I think the best person on this call to field. The question would be Mike because he is.

He is right in the middle of all of the details right now of actually assigning different our regional sales managers and their teams.

Among the different types of physicians, those who treat pain.

Patients with the aisle D data that.

Never seen Oh, really pulmonary hypertension patient treatment options and those who.

Hartaj Singh: Please go ahead. Your line is open. Great. Thank you. And a really, really good quarter, Martine, and team.

Our normal ph treatment physicians that debt. In addition to that also treat patients with hum ph associated with their ionkey. So Mike we'd really have the best answers for that and Mike. If you could provide some color on hard times. His question sure. Okay. Thanks Archives quick question.

Martine A. Rothblatt: So thank you. Just a quick question on Tyvaso. You know, we're seeing a definite uptick in trend growth over the last few quarters. Martine, as you mentioned, you're on double-digit growth. And then also, in our QPENY leader calls, we've noticed that there is a lot of overlap between the physicians treating PH using Tyvaso there and physicians treating PH, ILD. Do you expect a lot of this enthusiasm to be occurring in those patients and then also Tyvaso uptake in that group of three patients? Thanks, Hartaj.

The short answer to the question is it's it's hard to tell.

When physicians are writing are submitting referrals are prescriptions for tyvaso, they're not indicating whether it's a PK trial, the patient or a ph patients.

So its a little little hard to tell if there's.

Some off label use in that group, what I can tell you, though about the treating community is and as I said in my opening remarks, we.

Michael I. Benkowitz: Excellent question, and it's good to hear your voice this morning. I think the best person on this call to field the question would be Mike because he is right in the middle of all of the details right now of actually assigning different regional sales managers and their teams among the different types of physicians, those who treat patients with ILD that have never seen real pulmonary hypertension patient treatment options, and those who are normal pH treatment physicians that, in addition to that, also treat patients with a pH associated with their ILD. So Mike would really have the best answers for that, and Mike, if you could provide some color on Hartaj's question. Sure. Thanks, Hartaj, for the question. So it's a little hard to tell if there's any... I'm off the label.

We do see some differences in that group I mean, we have by our count in terms of the physicians that are treating P.H. and those that are treating.

Ill be there's maybe only about a 20% to 25% overlap.

And there's sort of an inverse relationship between the number of ph patients those doctors see and the number of idle DP should patients those doctors see or in other words, if you've got a doctor that sees a lot of a lot of ph patients are seeing very few I, all the patients and vice versa. So.

Yes, what we can see on the reform are the doctors that are writing prescriptions and so what we haven't seen it a lot of new prescribers, which tells US obviously that that all of the time.

The vast majority of these type types of prescriptions are coming in.

Michael I. Benkowitz: Group. What I can tell you, though, about the treating community is, as I said in my opening remark, we do see some differences in that group. I mean, by our count, in terms of the physicians that are treating PAH and those that are ILB, there's, you know, maybe only about a 20 to 25% overlap, and there's sort of an inverse relationship between the number of PH patients those doctors see and the number of ILDs. [inaudible] And so what we haven't is a lot of new prescribers, which tells us, you know And given the, you know, just sort of the underlying data that we see, it would lead me to believe that the vast, vast majority are.

Our being a submitted by your typical ph doctors.

And given just sort of the I think the underlying data that we see it would lead me to believe that the vast majority are for ph patients, but again, we don't we don't have the visibility to know exactly whether they're pediatric LT.

Thanks, So much Mike Oh, Thats, Great response, I'll start times, one little one.

Footnote I'd add to Mike's.

Response is.

It's very interesting.

To me just having studied this field for quite a bit that there are this very.

Very substantial quantity of patients in the group three WH group three type of pulmonary hypertension over 30000 patients that oh for those patients. The systemic drugs are contra indicated so here in the field of group one.

Great show, we have upwards of 12 different medicines.

Available to treat pulmonary hypertension.

And there are just about as many group three patients has group one patient, but there are zero no approved medicines to crude to treat those hub group three patients. So it's a it's a screaming unmet medical need.

Martine A. Rothblatt: But again, we don't have the visibility. Thanks so much, Mike. That's a great response. Hartaj, one little footnote I'd add to Mike's response is that it's very interesting to me, just having studied this field for quite a bit, that there are this very substantial number of patients in the group 3, WHO group 3 type of pulmonary hypertension, over 30,000 patients, that for those patients, systemic drugs are

And we are just you know crossing every finger we could cross that Oh on in April on the PDUFA date that the FDA will give us clearance to translate the increase of clinical trial results into an approved treatment for those 30000 patients who would be the only approved treatment.

For those patients.

It was a great.

Trial. The increased trial is as you are well aware of our times, we met all of our primary and secondary endpoints. So I think there is going to be a tremendous amount of excitement among the physicians. That's finally, they have something to treat those 30000 patients with.

Martine A. Rothblatt: So here in the field of Group 1 WHO, we have upwards of 12 different medicines available to treat pulmonary hypertension. And there are just about as many Group 3 patients as Group 1 patients, but there are zero, no approved medicines to treat those Group 3 patients. So it's a screaming, unmet medical need.

Thanks, So much again operator next question please.

Our next question comes from the line of Yun Yang with Jefferies. Please go ahead. Your line is open.

Thank you Tybee hi in your mind.

PJM PJM.

Operator: And we are just crossing every finger we can cross that in April, on the PDUFA date, the FDA will give us clearance to translate the increased clinical trial results into an approved treatment for those 30,000 patients that would be the only approved treatment for those patients. It was a great trial; the increased trial, as you are well aware, Hartaj; we met all of our primary and secondary endpoints. So I think there is gonna be a tremendous amount of excitement among the physicians that finally they have something to treat those 30,000 patients with. Thanks so much again.

Can you comment on your other.

Today's filing.

The U.S. and then a follow trade key eat see using P. giant E. G that you needed to run well another suites studies.

Thank you, yes. Thank you for those very interesting questions and exploring some kind of areas that a lot of people overlook. So I'm glad you asked those questions. At this point in time, we haven't made a firm decision with regard to the European filing schedule.

Mostly because we're just like laser focused on gaining FDIC approval to deal with this huge unmet medical need that I just talked about the 30000 patients here. So we are kind of like a you know step by step strategy here and first.

Eun Kyung Yang: Operator, next question, please. Our next question comes from the line of Eun Yang with Jeffreys. Please go ahead, your line is open. Thank you. For Taipei, so in the new indication, PHIR. Can you comment on your regulatory filing for XeUS, and then for TREAD-T, it's used in PHILD.

We want to be able to successfully get approval into the U.S.

And then we'll consider what is the best approach to go has to Europe.

Martine A. Rothblatt: Do you expect you will need to run another switching study similar to phage three? Thank you. Yes.

The second part of your question is also quite insightful.

Because the dreamboat trade key device is a much easier to use device stand the opt to Nab nebulizer that.

Martine A. Rothblatt: Thank you, Eun, for those very interesting questions and exploring some areas that a lot of people overlook, so I'm glad you asked those questions. At this point in time, we haven't made a firm decision with regard to the European filing schedule, mostly because we're just, like, laser-focused on gaining FDA approval to deal with this huge unmet medical need that I just talked about, the 30,000 patients here. So we're kind of like a, you know, step-by-step strategy here, and first, we want to be able to successfully get approval in the U.S., and then we'll consider what is the best approach to go as to Europe.

That we used in the increased study and that we submitted for FDA approval on and I think most people feel that whatever the the captured market would be for this nebulizer that that dry powder dreamboat device could give you two maybe three times.

Larger a market because if it's a greater convenience.

So as you mentioned I mean again, we did Oh, we do plan to file for approval of the Dreamboat device based on the current briefs study in the April in April.

2021, and then that would take its normal FTC approval period. So as I mentioned in my opening remarks. So hopefully we can get that approved if not by the end of October.

Martine A. Rothblatt: The second part of your question is also quite insightful because the Dreamboat Trade T device is a much easier to use device than the Optineb nebulizer that we used in the INCREASE study and that we submitted for FDA approval on. And I think most people feel that whatever the captured market would be for this nebulizer, that the dry powder dreamboat device could give you two, maybe three times the larger market because of its greater convenience. So, as you mentioned, again, we do plan to file for approval of the Dreamboat device based on the current BREE study in April of 2021, and then that would take its normal FDA approval period. So, as I mentioned in my opening remarks, hopefully, we can get that approved. If not by the end of 21, then at the very beginning of 22.

The one that at the very beginning of 22.

Now whether or not that dreamboat trade key device is approved for Jess I want WH group, one pulmonary hypertension, which is the population in which we did our our.

Our brief study or is also going to be approved for the WH group three population that would be a decision which is of course up to the FDA. All what we will do to support that decision and provide guidance is as soon as we wrap up.

The filing based on the Breeze, one study in the WD choke group one population. We will immediately begin a brief to study in the Ionkey population or the WH group three population and that way.

We will at least have that data available for the FDA. If they feel that they are not comfortable to approve dreamboat in group three without some data we should have that data by the time they would reach their PDUFA date for approving the.

Martine A. Rothblatt: Now, whether or not that Dreamboat TRAIT-T device is approved for just WHO Group 1 pulmonary hypertension, which is the population in which we did our BREE study, or is also going to be approved for the WHO Group 3 population, that would be a decision that is, of course, up to the FDA. What we will do to support that decision and provide guidance is, as soon as we wrap up the filing based on the BREEZE-1 study in the WHO Group 1 population, we will immediately begin a BREEZE-2 study in the ILD population or the WHO Group 3 population. And that way, we will at least have that data available for the FDA. If they feel that they are not comfortable to approve Dreamboat in Group 3 without some data, we should have that data by the time they reach their PDUFA date for approving the BREEZE device in the Group 1 population. If, for any reason, things take a little longer, we'll have that data immediately available. I don't think it's really gonna be of much consequence because, in fact, the desperation in the WHO Group 3 population for any treatment is so great that the Optinib-based, the nebulizer-based form of Tyvaso, I think, will be very rapidly taken up.

The breeze device in the group one population if for any reason things take a little longer will help that data immediately available I don't think it's really going to be as much on a consequence.

Because in fact, the desperation in the W. choke group three population for any treatment is so large that the that the opt to NAV based the Nebulae nebulizer based form of TV. So I think we'll be very rapidly taken up but you always want to you know.

Building on your momentum and making it easier for larger and larger patient populations to avail themselves of Tyvaso. So we will be right on with breeze to data for.

For the Io D. population will be right on that immediately after completing the priest one filing thanks for your question.

Next question operator.

Our next question comes from the line of Marty I'll start with Credit Suisse. Please go ahead. Your line is open.

Hey, everybody. Thanks for taking the question Martine will you indulge my two decades lender to let me ask two questions again.

Oh, Yes, Dr Officer, one one.

For being Bharti and one for being Doctor.

Thank you kindly.

Martine A. Rothblatt: But, you know, you always want to keep building on your momentum and making it easier for larger and larger patient populations to avail themselves of Tyvaso. So, we will be right on with BREEZE 2 data for the IOD population. We'll be right on that immediately after completing the BREEZE 1 filing. Thanks for your question, Ian. Next question, operator. Our next question comes from the line of Marty Oster with Credit Suisse. Please go ahead; your line is open.

So a couple of things on a follow up on first on Treaty you reported healthy volunteer kind of part of that study was done can you comment at all on the what that data looks like in the equivalent to what you seem to be so and then can you also talk on treaty about what the.

Supplied needs that you're anticipating would be and if you think you'll be able to kind of meet where they did.

Demand for that but new device and that new system might be if you were approved on a first pass approval. The second question was on the casino, Oregon side, there's something like 20, 25000 kidneys transplanted in the U.S. each year, you probably know the number more specifically, but if you could comment maybe on what the overall.

Operator: Hey everybody, thanks for taking the question. Martine, will you indulge my two-decade tenure to let me ask two questions again? Yes, Dr. Oster, one for being Marty and one for being a doctor.

Martine A. Rothblatt: Thank you kindly. So, a couple things I want to follow up on. First, on TRAIT-T, you reported that the healthy volunteer part of that study was done. Can you comment at all on the, you know, what that data looked like in terms of equivalence to what you've seen with Tobaso?

So big picture opportunity I know there was a very long wait list and I know that you see a lot of people that don't get served but what is the kind of addressable big picture market opportunity there and when do you need to think about pulling the trigger to make decisions on expanding and building out your GPS capabilities to kind of start thinking about how to meet some of that long term demand. Thanks.

Leigh Peterson: And then can you also talk on TRAIT-T about what the, you know, supply needs that you're anticipating would be? And if you think you'll be able to kind of meet the demand for that new device and that new system might be if you were approved on a first pass approval? The second question was on the XenoOrgan side.

Okay. Thanks, Thanks Marty.

Fastening questions.

Kind of things, we could like talking a coffee house for hours over if we if we could talk in a coffeehouse.

But with regard to the first question on a breeze the PK data the.

The build up of two.

Great key devices, Oh, Dr., Peter said, if you could at least talk about the the PK side and if you feel comfortable talking about the inventory side roll into that and if not I'll talk about that at the front end of the CNO stuff.

Martine A. Rothblatt: I think there's something like 20-25,000 kidneys transplanted in the US each year. You probably know the number more specifically, but if you could comment maybe on the overall big picture opportunity, I know there's a very long wait list, and I know that there's a lot of people that don't get served, but what is the kind of addressable big picture market opportunity there? And when do you need to think about pulling the trigger to make decisions on expanding and building out your DPF capabilities to kind of start thinking about how to meet some of that long-term demand?

Yeah, sure Hi, everyone and thank you all for calling in great to speak with you. So you all know that the the treaties study in healthy volunteers.

That was that.

Primary objective was to show.

Comparable PK between Tyvaso and straight tea and that has been completed and we're actually undergoing the data analysis right now.

So I.

Hi.

Don't have the final final output package to to discuss with you.

Martine A. Rothblatt: Thank you. Okay. Thanks, Marty. Fascinating questions, the kind of things we could talk about in a coffee house for hours if we could talk in a coffee house.

But I will tell you that I mean this was an open label study and we're seeing consistent results between the two medications, we're actually seeing.

Leigh Peterson: But with regard to the first question on BREEZE, the PK data, and the buildup of TRAIT-T devices, Dr. Peterson, if you could at least talk about the PK side and if you feel comfortable talking about the inventory side, go ahead and do that, and if not, I'll talk about that at the front end of the Zeno. Yeah, sure. Hi, everyone. Thank you all for calling in.

It it appeared at least getting in at.

Early on that the trade T device actually seems to penetrate the lung.

A little bit better than then tyvaso with up to now but that also might be because as you all might know trade Ti you get you get your entire dose from like one to two grass and so you just need a tiny little cartridge and read it in and then you get the full the full dose.

Leigh Peterson: Tratee Study in Healthy Volunteers, the primary objective of that was to show comparable PK between Taiveso and Treity, and that has been completed, and we're actually undergoing the data analysis right now. I, you know, don't have the final, final output package to discuss. But I will tell you that, I mean, this was an open-label study, and... We're seeing consistent results between the two medications.

Whereas with Tyvaso. It you can take like nine or 10 or you know it takes several different breasts too multiple breasts too do you get the full dose and so you know that that can explain the lung penetration, but again, that's the final data are being analyzed literally.

As I'm speaking and we will be able to get that up to you very shortly but we definitely do not expect any surprises there.

Leigh Peterson: It appeared at least early on that the TRAIT-E device actually seems to penetrate the lung, Unknown Attendee. Thank you. As you all might know, TRA-T, you get your entire dose from like one to two breaths. And so you just need a tiny little cartridge, and you breathe it in, and then you get the full dose.

Thanks, Dr. Peter said, thank you very much.

So with regard to the inventory Marty I think we're going to be in good shape. In fact, just this week at the at the request of our head of manufacturing pepper spot, we allocated on a $5 million for inventory buildup for.

Martine A. Rothblatt: Whereas with Tyvaso, you can take like nine or 10 breaths to get the full dose. And so, you know, that can explain lung penetration, literally as we will be able to get that out to you very shortly, but we definitely will. Do not expect any surprises there. Thanks, Dr. Peterson. Thank you very much. So with regard to the inventory, Marty, I think we're going to be in good shape. In fact, just this week, at the request of our head of manufacturing, Pat Poisson, we allocated $5 million for inventory buildup for the traitee launch during 2021. So he regularly visits the Mankind plant in Connecticut, where we do the manufacturing of everything.

The trade TV launch during 2021, so he regularly basis, it's the mankind plant in Connecticut, where we where we do the manufacturing of everything and I feel confident that our wells how far will.

Adequate supply to meet our needs as you probably recall from reviewing our proxy or one of our companies for companywide objectives upon which everybody's a bonus is based in the entire company.

Is that we have to have a two year inventory of all commercially launch products at the.

The rate of the product take up so Mike banquets and his commercial team they would provide a forecast.

To manufacturing in terms of how many dreamboat trade key how patients we expect to garner in the first 12 months after launch.

Martine A. Rothblatt: And I feel confident that we'll have an adequate supply to meet our needs. As you probably recall from reviewing our proxy, one of our company's four company-wide objectives, upon which everybody's bonus is based in the entire company, is that we have to have a two-year inventory of all commercially-launched products at the rate of product take-up. So Mike Benkowitz and his commercial team would provide a forecast to manufacturing in terms of, you know, how many Dreamboat trachea patients we expect to garner in the first 12 months after launch, which would be mostly a 2022 thing. And then, already in 2021, Pat Poisson and our manufacturing team are making sure that we have two times that amount of inventory built up for at the time of launch so that we can crush that manufacturing and inventory milestone With regard to the Zeno question...

Which would be mostly a 2022 things and then so already in 2021.

Pat Prosoft, our manufacturing team are making sure that we have two times that amount of inventory built up for at the time of launch.

Thats weekend crush that manufacturing and inventory milestone as we actually always have every year for as far back as I can remember.

With regard to the XE no question.

Yeah, I think you know your numbers are quite quite accurate Marty there are.

You know 20000 plus.

The transplants done there if you get into what are called you know living related kidney transplant, where people you know designate a kidney to a relative for something like that you get up into the 35000.

Martine A. Rothblatt: I think, you know, your numbers are quite accurate, Marty, 20,000 plus kidney transplants done. But if you get into what are called living-related kidney transplants, where people designate a kidney to a relative or something like that, you get up into the 35,000 type of category. Then the next number that comes up often is 100,000 people are waiting for kidney transplants and are currently on dialysis. And then the next number that comes up is that there are something like 300,000 people in need of a kidney transplant, but for various and sundry reasons, they are not even able to access dialysis. So it is probably one of the largest unmet medical needs in the United States. It's not unrelated to the, you know, very high levels of diabetes in the United States, but that's not the only reason for end-stage renal disease.

Type of category then the next number that comes up a lot is 100000 people are waiting for kidney transplant and are currently on dialysis and then the next number that comes up.

That there's something like 300000 people home in need of kidney transplant, but for various and sundry reasons. They are not equal even able to access dialysis.

So it is so.

It's probably one of the largest unmet medical needs in the United States, It's not unrelated to the you know very high levels of diabetes in the United States, but that's not the only reason for end stage renal disease.

So kidney transplantation is a is a cure for end stage renal disease and people such as ourselves had been working many years in order to have an unlimited supply of transplantable kidneys that would be well tolerated by the recipients.

Martine A. Rothblatt: So kidney transplantation is a cure for end-stage renal disease, and people such as ourselves have been working for many years in order to have an unlimited supply of transplantable kidneys that would be well-tolerated by the recipient. And I think that's what we are on the cusp of here. We've spent several years knocking out or knocking in gene after gene and then testing the results to make sure that we have really the ideal level and the ideal combination of genes that have been knocked in or knocked out.

And I think that's what we are on the cusp of here we've spent several years.

Knocking out or knocking in gene after Jean and then testing the results to make sure that we had really the.

The ideal level and the ideal combination of genes that.

They have been knocked in Howard.

Martine A. Rothblatt: And then we've also constructed a pathogen-free facility, which is the Zeno equivalent of a good manufacturing product in Alabama. And it is those kidneys coming out of that DPF facility that would be the first ones going into the clinic, which is why I mentioned that we expect to file an IND in 2021 based on kidneys coming out of that DPF. In terms of when we would pull the trigger on building a commercial-scale DPF, the one I just referred to in Alabama is a clinical trial-scale DPF. A commercial-scale DPF will take a couple of years to build and bring into operation.

Or knocked out and then Weve also constructed a pathogen free facility, which is the see no equivalent of a good manufacturing product.

In Alabama, and the board are it is those kidneys coming out of that DPF facility, which would be the first one's going into the clinic, which is why I mentioned that we expect to file an hi, Andy in 2021.

Based on kidney is coming out of that DPF.

In terms of when we would pull the trigger on building a commercial scale DPF. The one I just referred to in Alabama is a clinical trial scale DPF. The commercial scale DPF will take a couple of years to build and bring into operation. So I think the right time to pull the trigger on that would be.

Martine A. Rothblatt: So I think the right time to pull the trigger on that would be once we have a successful result in the first clinical xenokidney transplants and, as mentioned at the beginning of the call, with the IND going in in 21. So we will know in 22 whether we have a successful xenokidney product. And so that would be the time to pull the trigger. We have already completely designed the facility using our design architects at the Ewing Coal Company in Philadelphia.

The once we have a successful result in the first clinical seen.

I see no kidney transplant.

And with the as mentioned the beginning it Mike the call with the R&D going in and 21. So we will know in 22, whether we have a successful xeno kidney.

Hum product.

Product and so that would be the time to pull the trigger we have already completely designed the facility using our design architect set the Ewing coal company and in Philadelphia, They specialize in bio ad growth.

Martine A. Rothblatt: They specialize in bio-agro types of manufacturing designs. So we have a well-vetted design that's been reviewed by all of the experts in controlling viruses and microbes and whatnot in animal populations. So, I think we're ready to, you know, sign a contract pretty rapidly and proceed with the construction, and then that whole facility could be brought into operation sometime during 2024. Thanks for the question, Marty and Operator. We have time for one last question. The last question comes from the line of Joseph Stone with Cohen & Co. Please go ahead; your line is open.

Type of manufacturing designs. So we have a well validated design that's been reviewed by all of the experts in in controlling viruses in and microbes and whatnot in animal populations.

So I think we're ready to like you know signed a contract pretty rapidly and proceed with the construction and then das whole facility could be brought into operation.

Sometime during 2024, thanks for the question Marty and operator, we have time for one last question.

Our last question comes from the line of Joseph Baum with Cowen and co. Please go ahead. Your line is open.

Operator: Hi there, thank you for taking my question and congrats on a great quarter. Just a little bit on cybazo in ILD, can you comment a little bit on how well these patients are identified currently, given that, as you mentioned, there really aren't great treatment options? Do you anticipate that the potential approval of Tevezo for this indication will change this paradigm? And is it your expectation that there will be some PHILD patients? You know, built up and waiting.

Hi, there. Thank you for taking my question and congrats on the great quarter.

Just a little bit on Tyvaso in I'll do you can you comment a little bit on how well these patients are identified.

Currently given that as you mentioned, there really aren't great treatment options for patients.

Do you anticipate that the potential approval of today's when the indication will change. This this paradigm and is it your expectation that there are some ph aldi patients sort of built up and waiting for lunch. Thanks sure. Let me suggest like we give you a two part answer to that question with.

Unknown Attendee: Sure. Let me suggest, like, we give you a two-part answer to that question, with the first part being given by Dr. Peterson because she was ultimately in charge of the larger study that produced the clinical result in the ILD patients. So she could speak most expertly about those results, which were reported at the abstract level at the ATS conference and, I believe, are imminently going to be appearing in a peer-reviewed publication. So she could talk about kind of the medical thing about how well it worked in those patients, and then Mike Benkowitz, our president, who has spent a lot of time thinking about the market segmentation and the approach to the market, can speak more about the second Dr. Peterson? Yeah, sure.

The first part being given by Dr. Peter soon because she was ultimately in charge of the increased studied that produce the.

The clinical result in the Io d. patients. So she could speak most expertly how about those results and which.

Were reported at.

At our at the abstract level at the Ats Conference and I believe our imminently going to be appearing in a peer reviewed publication. So she could talk about kind of the medical thing of of how well it worked in those patients.

Then Mike.

Mike Benkowitz, our president who has spent a lot of time thinking about the market segmentation and the approach to the market can speak more about the second part of your question.

Dr Peterson.

Yeah sure so as as you know.

Leigh Peterson: So, as you know, Taivesa works quite well in the patient population, and this was ILD plus pulmonary hypertension, and in this population... For the larger study, the patients actually did have data from a right heart cast. So they had documented pulmonary hypertension, but up until now, since there was no medication for this, the doctors didn't really, if they suspected IPS, or even suspected pulmonary hypertension in this population, they didn't necessarily give the patients necessarily a right heart cath because even if they did discover pH, there was nothing to treat them.

Okay. So words.

Quite well in the patient population three population and this is this was I L D plus plus pulmonary hypertension and in this population the for the increased study the patients actually did have data from a REIT her cas okay. So that they had.

Accumulated pulmonary hypertension and up.

Up until now since there was no medication for this group.

The doctors didn't really if they suspected IP, yes, they will.

Or even suspected pulmonary hypertension in this population they didnt they didnt give the patients necessarily right heart cast because even if they did discover ph there was nothing to treat them. So why go through all of that that invasive procedure.

Leigh Peterson: So I go through all of that invasive procedure in order to find that out. So we've heard several times that now that there is a treatment, they will perform those Reithardt casts because they do have, presumably will have an approved treatment relatively soon. So yes, the identification of this population will definitely be more robust, something to give them. And again, also with what Martine said about the publication. So we do expect to publish these results in a major medical journal very shortly prior to the PDUFA date of April. So that's definitely will.

Order to <unk> to find that out so weve heard several times that now that there is a treatment they will be.

Performing those right heart Cas to see the degree of pulmonary hypertension, because they do have you know they presumably will have an approved treatment.

Relatively soon so yes, the identification of this population will definitely.

Be more robust since.

Since they have something something to give them and again also with what Martina said about the publication. So we do expect to publication publish these results in a major medical journal a very shortly prior to the.

Producer date of April so that's definitely will.

Leigh Peterson: What we've also heard from the docs is that once we have that published, that gives them even more... Confidence in looking for this, for Pulmonary Hypertension, in this patient population. And yes, we'll likely. They have said they will either prescribe it or certainly be waiting for approval if they feel it is appropriate. So, I hope that answers the question. Thanks, Dr. Peterson, that was a great answer, and Mike, would you like to add some color on that that we're getting from, you know, all of our medical sales teams? Sure, I agree with everything Leigh said. There is a lot of pent-up demand.

What we've also heard some the docs is that once we have that published that gives them even additional.

Confidence in in looking for this for pulmonary hypertension in this patient population and yes will likely.

They have said they will either prescriber certainly be waiting for the approval if they feel comfortable so I hope that answers the question.

So thanks.

Pietersen that was great answer and all Mike would you like to add some color on that that we're getting from you know all of our medical sales.

Sure.

I agree with everything he said I think the.

There that there is a lot of pent up.

Demand.

Michael I. Benkowitz: There's also, I think, an under-diagnosis of PHILD for the reasons that Dr. Peterson stated, which is that you have these physicians that may suspect pulmonary hypertension. That suspicion typically happens, you know, as the symptoms become more severe and present themselves. But because there's no treatment out there, doctors aren't putting the patients through the variant. All of our interactions with physicians, be it advisory boards, healthcare, scientific presentations at health care conferences, and interactions with our medical team suggest that now that there's a treatment available, these physicians suspect that significant percentages of their patient population have pulmonary hypertension and will start to So, you know, and that's really a large part of what we're doing right now to prepare for the launch. We've got our medical teams out. Certainly, the key opinion leaders in the field understand, some of the community. We're spending a lot of time educating them on PHILB. How do you...

There's also I think in under died there has been I think it under diagnosed and say appear trial will be for the reasons that that that Dr. Peterson Peterson stated which is.

You'd have these physicians that may suspect pulmonary hypertension that suspicion typically happens as good obviously as the symptoms become more severe and present themselves, but because there is no treatment out there the doctors are putting through putting the patients through the the varian base.

As a procedure of of the REIT hard cath.

All of our interactions with physicians the advisory boards health care, a scientific presentations that healthcare conferences.

Interactions with our medical team suggests that now that Theres a treatment available these positions suspect that significant percentages of their patient population.

Have you had already hypertension, and well start to really screening and diagnosis patients appropriately. So you know that.

And that's really a large part of what we're doing right now to prepare for the launch in April is we've got our medical teams out educate you know certainly the key opinion leaders in the field I understand the disease and understand that the pulmonary hypertension piece related to attend our social lung disease, but again as you get into.

Some of the community physicians.

We are spending a lot of time educating them on P. a child the how do you screen for these patients how do you know what it what are the things that you know may lead you to suspected okay. This patient has.

Michael I. Benkowitz: Okay, this patient has, has pulmonary, then how do you go about arranging for a Reinhardt cap? Great. Thanks, Mike. Operator, there's time for one bonus question here. Do you have another person lined up? I do. Our next question comes from the line of Leanna Moussatos with Web Flash Security.

Summary, hypertension, and then how do you know about arranging for right right her cat to confirm the diagnosis.

Great. Thanks, Mike.

Operator at this time for one bonus question here do you have another person lined up.

I do our next question comes from the line of Liana Moussatos with Wedbush Securities. Please.

Operator: That's excellent. Okay. Hi Leanna. Good morning. Good morning.

That's excellent Okay, Hi, Leon and good morning.

Good morning, Thank you Cobiz.

I hope it continues to be a problem and infection rates are going up and it seems that it's affecting our industry clinical trials and commercialization can you just give us a brief overview of what has to happen and when you think the timing of this could be resolved between now and maybe end of 21.

Roanna Ruiz: Thank you. Since COVID continues to be a problem and infection rates are going up, can you just give us a brief overview of what's going on, Unknown Attendee? Yeah, it's like one of these kind of 30,000-foot questions that cover everything.

Yeah. It's a it's like one of these kind of 30000 foot questions that cover everything in our in our company. We I know we have a risk management group that reports into our Chief Financial Officer James Edgemond.

Martine A. Rothblatt: In our company, Leanna, we have a risk management group that reports to our chief financial officer, James Edgeman, and this risk management group ultimately has group meetings that involve as many as 50, 60, and 70 people at United Therapeutics. And every week, they issue a report regarding COVID-19 and how it affects all the different parts of the company. So, James, maybe you could provide some color for Leanna's question in terms of, you know, the overall impact of COVID-19 on United Therapeutics and when we see, based on inputs we're getting from our risk management group, when we see some of those effects perhaps diminishing. Yeah, thank you, Martine and Liana. It's good to hear your voice. So, as Martine mentioned internally, way back to the beginning part of this year, we organized... leadership. Transcripts provided by Transcription Outsourcing, LLC. COVID-19 on all areas, from Human Capital.

And this risk management group ultimately has group meetings that involve as many as like 50 60 70.

People at United Therapeutics, and every week they issue a report regarding Cove, It 19, and how it affects all the different parts of the company. So James maybe if you could provide some color for the end of his question in terms of you know the overall impact.

Active of co fit nine keen on United Therapeutics, and when we see based on inputs were getting from our risk management group when we see some of those effects perhaps ameliorating.

Yep, Thank you Martine and Liana good to hear your voice.

Martine mentioned internally way back to the beginning part of this year, we work and I.

Leadership, a leadership team to make sure that across the organization we were communicating.

Effectively in coordinating with each other with respect to risk management and the impacts around.

James C. Edgemond: Manufacturing, Clinical Trials, Product Development, Specialty Pharmaceutical, and it's been a really effective tool for us to make sure that everybody's in tune to what impacts there are, as a whole, and I can broadly speak. Everybody gets stepped up, all the Unitarians.

COVID-19 on all areas of the business.

From a human capital to manufacturing clinical trial is product development.

You know food specialty pharmaceutical distributors and it's been a really effective tool for us to make sure that occur.

James C. Edgemond: Assistant Director, National Cancer Institute, Dr. Robert A. Levey, A. H. H. M. S. P. A. A. P. K. M. D. M. N. M. T. K. N. M. P. K. M. P. K. M. M. P. K. M. P. K. N. M. P. K. N. M. P. K. N. M. N. P. K. M. P. K. N, understood the various risks and the Unknown Speaker Not only internally, but to those of our, and individuals in the clinical trials, both that were enrolled, that continued to be enrolled as well as those that were about to enter clinical trials that we may have shut down, as we talked about, and we've begun to reopen some of those based upon the opportunities, and really the hotspots around the country or around. So broadly speaking, I think Martine is right.

Across the organization everybody in tune to what impacts the arc of the organization as a whole and I think broadly speaking everybody had stepped up all the Unitarian. This we call ourselves internally has stepped up to make sure that we have understood the various rent and the impact.

Not only internally, but those of our patients and those importantly to the patients.

And individuals in their clinical trials, both that were enrolled.

They continue to be enrolled as well as those that we're about to enter clinical trials that we may have shutdown as we talked about only begun to reopen some of those based upon the opportunities.

And really the hot spots around the country or around the globe are so broadly speaking I think Martina is right. It's been a coordinated effort to really understand and prepare and execute to make sure as an organization. We can continue.

James C. Edgemond: It's been a coordinated effort to really understand and prepare to make sure as an organization we can continue. Again, for the Unitherians, our patients at large, things will get better. We hope for the best, like everybody. But we're around all that.

Again for the Unitarians, our patients and large.

From a standpoint of when we think things will get better we hope for the best as everybody does in the near term but.

James C. Edgemond: Unknown Attendee, Ashwani Verma, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, We'll certainly continue to communicate in our public filings and on conference calls with various questions. But it's something that Transcription by Transcription Outsourcing, LLC. So, back to you, Martine.

But we're going to need to see vigilant around all aspects of the organization to make sure that we can continue to perform.

As an organization and so I think things unfold and we all continue to get better educated and educated on the multiple aspects and we'll certainly continue to communicate in our public filings and on conference calls it varies questions.

But it's something that we'll continue to take seriously is everybody's doing to make sure the business that hole in it large can't continue to move forward. So back to you Martine. Thanks, So much change to wrap up everybody on the earnings call. We've had a great quarter I think this quarter and perhaps I'm more generally.

Martine A. Rothblatt: Thanks so much, James. To wrap up everybody on the earnings call, we've had a great quarter. I think this quarter and, more generally, this half of the year will be looked at in retrospect as a key pivot point for United Therapeutics. This will be the time when we pivot from being solely a pulmonary hypertension company to becoming both a pulmonary hypertension company as well as a pulmonary fibrosis and other forms of interstitial lung disease company. You can see this pivot in us moving into a group of pulmonary hypertension patients, WHO Group 3, for whom pulmonary hypertension is not their primary problem. Instead, their primary problem is interstitial lung disease. It's, of course, gravely worsened by pulmonary hypertension, but the source of their pulmonary hypertension is ultimately interstitial lung disease.

This half of the year.

Will be looked at in retrospect as a key pivot point for United Therapeutics. This will be the time, when we pivoted from being solely a pulmonary hypertension company to becoming both a pulmonary hypertension company as well as a pulmonary fibrosis.

And other forms of interstitial lung disease company you can see this pivot in us moving into a group of pulmonary hypertension patients Whr group three as to whom pulmonary hypertension is not their primary problem. Their primary problem is interstitial lung disease itself.

Course, gratefully worsened by the pulmonary hypertension, but their source of their pulmonary hypertension is ultimately interstitial lung disease. So for the first time, we're moving into a group of patients for whom pulmonary hypertension is not their number one problem. If you will and secondly for the first time, we're moving into a lot.

Martine A. Rothblatt: For the first time, we're moving into a group of patients for whom pulmonary hypertension is not their number one problem, if you will. Secondly, for the first time, we're moving into a large phase three study in which patients do not have pulmonary hypertension at all. They simply have this form of interstitial lung disease, pulmonary fibrosis. In other words, they not only slow the rate of decline in forced vital capacity but actually improve forced vital capacity in patients with pulmonary fibrosis, as well as a couple of other subsets of interstitial lung disease. It's a very exciting time here at United Therapeutics. You always hope that you can be strong at your home base and then expand from that.

<unk> phase three study in which patients do not have pulmonary hypertension that all they simply have the us form of interstitial lung disease pulmonary fibrosis. If you take a look at a diagram of all of the species and subspecies I'll finish tissues lung disease, you'll see it is a.

Very large and diverse population and we were really pleased to see in the outcome of our increased study that we actually were able to modify the disease in other words, not only slow the rate of decline and a forced vital capacity, but actually.

The improved forced vital capacity in the patients with pulmonary fibrosis as well as a couple of other subsets of interstitial lung disease. So let's say, it's a very exciting time here at United Therapeutics, you always hope that you could be.

Martine A. Rothblatt: With this adjacency of interstitial lung disease and pulmonary hypertension, we have a very logical and solid basis from which to expand our footprint in providing more and better healthcare to ever larger numbers of people. Thank you so much for your time and attention this morning. I look forward to seeing you at upcoming healthcare conferences. Operator, you can wrap up. 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 878-625-6262. 2637. The University of Georgia College of Agricultural and Environmental Sciences, BF-WATCH TV 2021

The strongest your home base, and then expand from that and with this Ah Jason C of interstitial lung disease in pulmonary hypertension, we have a very logical and solid basis from which to expand our footprint in providing more and better health care to ever larger numbers of people. Thank you.

So much for your time and attention. This morning look forward to seeing you at upcoming healthcare conferences, operator, you can wrap up.

Thank you for participating in today's United Therapeutics Corporation Conference call, a rebroadcast will be available for replay for one week by dialing 180 05858367 with the international callers dialing 14166 to one.

For sex 14, and using access code 878.

2637.

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