Q2 2020 United Therapeutics Corp Earnings Call

Your conference operator today.

Participants are in listen only mode until the question and answer portion of this earnings call.

Operator: All participants are in listen-only mode until the question and answer portion of this earnings call. If you'd like to ask a question during that time, simply press the star and the number 1 on your telephone. If you would like to withdraw your question, press the pound key on your telephone. I would now like to turn the call over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics. Good morning.

If you'd like to ask a question during that time simply press star and the number one on your telephone keypad.

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

I would now like to turn the call over to Mr., Dewey Steadman head of Investor Relations at United Therapeutics.

Good morning, it's my pleasure to walking into the United Therapeutics Corporation second quarter 2020, <unk> earnings call accompanied me on today's call our Dr. Martini <unk>, what our chairman and Chief Executive Officer, Mr., Michael Baker, what our President and Chief operating Officer, Mr., James Edgemond, Our Chief Financial Officer, and Treasurer and.

Dewey Steadman: It's my pleasure to welcome you to United Therapeutics Corporation's second 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 Treasurer, and Dr. Leigh 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. However, we assume no obligation to update our forward-looking statements.

I couldn't be 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 could differ materially our latest recipe filings, including form 10-K intend to contain a dish.

That makes and on the trip.

Certainty, we assume no obligation to update our forward looking statements.

Dewey Steadman: 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 these 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.unithird.com. Today's remarks may discuss the progress and results of our 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 or ineffective for any unapproved or investigational uses. Full prescribing information for these products is available on our website.

Todays remarks May also include financial matters measures that were not prepared in accordance with U.S. generally accepted accounting principles workout.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release available on our website that I are not you know third dot com.

Today's remarks made discuss the progress results of our clinical trials or other developments with respect to our products. These remarks intend them solely to educate investors and are not intending to it. So that's the basis for medical decision, making or to suggest that any products are safe and effective for any unapproved where investigations.

You said, hey, prescribing information for these products are available on our website now I'd like to turn the call over Dr. Rothblatt for an overview of our second quarter financial results and business activities.

Martine A. Rothblatt: Now I'd like to turn the call over to Dr. Rothblatt for an overview of our second quarter financial results and business activities of United Therapeutics. Dr. Rothblatt? Thank you, Dewey, and welcome everybody to our second quarter earnings call. I'll be pleased to coordinate the call, starting with a brief overview. I'll then turn the call over to our President and Chief Operating Officer, Mike Benkowitz, who will provide a more in-depth overview, and then he'll bounce the call back to me.

Therapeutic dropped but.

Thank you do we and welcome everybody to our second quarter earnings call.

I'll be pleased to coordinate the call starting with a brief overview I'll then turn the call over to our President Chief Operating Officer, Mike Benkowitz Who'll provide a more in depth overview, and then he'll bounce the call back to me and.

Martine A. Rothblatt: We'll open up the lines to questions and take the questions as they come, and I will forward them according to the topic, either if it's finance-related to James, our CFO, if it's science or clinical-related to our head of product development, Leigh Peterson, or if it's commercial-related or related to other areas of the company's operations to Mike Benkowitz. Well, I'm really pleased with the quarter because for the products that are material to us that really matter, namely U.S. sales of Remodulin, Tyvaso, Orenatram, and Unituxin, it's clear that we are poised to return to revenue growth as our patients are approaching the levels that we had pre-pandemic. We have previously stated that we believe these products will more than double current revenues for the following reasons.

Well open up the lunch question and Todd pick the question since the calm.

And I will afford them.

According to the topic, either if it's finance related to James our CFO, if it's a science or clinical related to our head of product development, We Peterson.

If its commercial Oh for later or related to other areas of the company's operations to Mike Bancorp.

Well I'm really pleased with the quarter because for the products that are material to us that really matter.

Namely U.S. sales of Remodulin, Tyvaso retina tram and you know toxin.

It's clear that though we are poised to return to revenue growth that was our patients are approaching now the oh levels that we had pre pandemic.

We have previously guided that we believe these products will more than double current revenues for the following reasons.

Martine A. Rothblatt: First, we expect net gains from remodulant patients each year once we launch the highly differentiated products Remunity and the implantable system for remodulants. These launches have been delayed for various supply chain reasons related to the pandemic for Remunity and for FDA Medtronic coordination reasons for the implantable system for remodulin, but we think these delays will not carry on for very much longer.

First we expect that gains fumble much when patients each year once we launched a highly differentiated products for immunity and the implantable system for Remodulin.

These launches have been delayed for various supply chain reasons related to the pandemic for immunity and for a F.D.A. Medtronic coordination reasons for the implantable system for Remodulin.

We think these delays will not carry on very much longer.

Also we expect to contribute to net gains didn't remodulin the pending approval of Trevor yet which is in front of the F.D.A.

Martine A. Rothblatt: Also, we expect to contribute to net gains in remodulin, the pending approval of Treviant, which is in front of the FDA, as a form of subcutaneous remodulin, and our R&D project with Smith's Medical of a very advanced... Smart Parenteral Pump Device for Remodulin that really, I think, will provide a great amount of convenience and greater certainty to patients, families, physicians, and payers. So for all of these differentiated products, we expect vermodulin to continue to gain popularity in patients year after year. We also expect net gains in Tyvaso patients from our new Dreamboat product, which is completing its final stage of clinical development, and a pending new market approval for Tyvaso in WHO Group 3 PAH patients, which is now pending before the FDA. We also have very exciting pipeline extensions for Tyvaso in the field of COPD with our PERFECT study and in a non-pulmonary hypertension field, interstitial lung disease, with our new Phase III Teton study.

As a form of subcutaneous remodulin.

And our R&D project of the with mess medical of a theory advanced smart parental pump device for Remodulin that I'm really I think for provided greater amount of convenience in graders.

Certainty to patients families physicians and payers.

So for all of these differentiated products, we expect remodulin to continue to gain in patients year after year.

Well, we also expect net gains in tyvaso patients from our new Dreamboat product, which is completing its its final stage of clinical development and they pending new market approval for Tyvaso and Whrrl group three P.H.

Patients that's one now pending in front of the F.D.A.

We also have very exciting pipeline extensions for type. They so in the field of C O P.D. with our perfect study and in a non pulmonary hypertension field.

Interstitial lung disease with our new phase three Teton study.

Martine A. Rothblatt: Third, we expect net gains in orenotram patients due to greater familiarity with its powerful new label and greater doctor confidence and appreciation of its unique titratability among oral treatments for pulmonary hypertension. Meanwhile, our pipeline is full of new opportunities. These include phase three programs such as RolenaPEG for pulmonary hypertension, Tyvaso for interstitial lung disease, Tyvaso for COPD, and endothelial nitric oxide synthase gene therapy or ENOS gene therapy for pulmonary hypertension.

Third we expect net gains into orenitram patients due to greater familiarity with its powerful new label and greater dr. confidence in appreciation of its unique tight trade ability among golf oral treatment for pulmonary hypertension.

Meanwhile, our pipeline is full of new opportunities. These include phase three programs such as <unk> peg for pulmonary hypertension type things so for interstitial lung disease Tyvek. So for C O P.D. and endothelial nitric oxide sent faced gene therapy or email.

Off gene therapy for pulmonary hypertension, and finally, a phase three trial relating to orkin manufacturing processes.

Martine A. Rothblatt: And finally, a phase three trial relating to organ manufacturing processes. Beyond these phase three programs, we have pipeline feeder projects, such as a less painful or painless form of remodulin, and regenerative medicine, sorry, Regenerative Medicine Exosome, which is a biological product that could be very helpful in a number of pulmonary and respiratory conditions. So when you take a look at the already existing products, which are being rejuvenated and relaunched with a differentiated drug delivery system, or being... advanced significantly due to label expansion, such as in the case of Orenatram, showing an ability to significantly reduce morbidity and mortality, or in the case of something like Tyvaso, move into a virgin market area such as Group 3 pulmonary hypertension with some 30,000 patients that have It's like three new companies.

The on these phase three programs, we have pipeline feeder projects such as they left painful or pay less form of Remodulin and regenerative regenerative medicine.

Sorry, regenerative medicine, Exosomes, which are a biological product that could be very helpful. In a number of pulmonary and respiratory conditions.

So when you take a look at the already existing projects, which are being read truven aided and had relaunched with differentiated drug delivery systems.

Or being.

Advance significantly due to label expansion such as in the case of Orenitram, showing an ability to significantly reduce morbidity and mortality.

All in the case of something like Tyvaso move into a Virgin a market area such as group three pulmonary hypertension with some 30000 patients that are yet been unable to benefit from prostacyclin therapy.

That's all that's that's a whole new company right. There those three areas like three new companies. So that's what you'd call super low hanging fruit, because it's a products, which have completed clinical development or virtually done or pending before the FDA and then you add on populates out the ER.

Martine A. Rothblatt: So that's what you'd call super low-hanging fruit because it's clinics that have completed clinical development or are virtually done, or are pending before the FDA. And then you add on top of that these opportunities that are currently in the midst of their Phase 3 strides, such as the Relenopag program for PAH, and the Tyvaso program for COPD. That, again, is like a whole new company worth of products. Then you've got these very exciting transformative opportunities such as gene therapy to actually cure or significantly reduce the need for treatment for pulmonary hypertension, and organ manufacturing with some 100,000 patients hanging out there on dialysis, waiting for a kidney transplant. This very month and next month, we move into the pivotal phase of our preclinical development of our xenokidneys with multiple transplants of our 10-gene xenokidney, which we hope will pave the way for the first clinical transplant sometime later in 2021.

Opportunities that are currently in the midst of their phase three strides such as the relenza pay like program for P. H. The on Tyvaso program for C. O P.D., the new Teton study in phase three.

That's again, it's like you know from New company Oh worth of products. Then you've got these very exciting a transformative opportunities such as gene therapy to actually cure horse significantly oh reduced the need of treatment for pulmonary hypertension.

And though organ manufacturing with 'em, some hundred thousand patients hanging out there on dialysis waiting for kidney transplant.

Martine A. Rothblatt: So it is the most exciting of times at United Therapeutics. This company is literally roaring on all cylinders and has the ability to do so for many years to come. With that 30,000-foot view of everything, I'd like to turn the line over to Mike Benkowitz, our President and Chief Operating Officer, to provide some additional color on where we're at. Thanks, Martine.

If this very much the next month, we move into the pivotal phase so far preclinical development of our Xeno kidneys with multiple transplants have our 10 chain.

Xeno kidney, which we hope will pave the way for the first.

Clinical transplants.

Michael I. Benkowitz: Yes, I'd like to provide some color around physician and patient demand in the second quarter and our commercial plans for PHI. As Martine said at the top, we're very pleased with our revenue performance in the second quarter, following the achievement of a record high number of U.S. patients on our tracostal therapy. We are happy that we're able to maintain relatively stable quarter-over-quarter active patient counts. On our first quarter earnings call, we mentioned that we were seeing some impact on proximal prescriptions and starts in the month of April attributable to the pandemic. However, as the quarter progressed, we saw the number of new patient prescriptions grow and reach close to pre-pandemic levels by the close of April. We're especially pleased with the 40% year-over-year growth of Orinotram in the second quarter, which we believe is driven by increased acceptance.

Sometime later in 2021.

So it is the most exciting of times that United Therapeutics. A this company is is literally roaring on the whole thrusters and has the ability to do so for many years to come.

With that 30000 foot few of everything I'd like to turned a line over to Mike Bank, What's our President Chief operating officer to provide some additional color on wherever at Mike.

Thanks, Mark will nothing I'd like to provide some color around position.

And the second quarter.

And our commercial plans for P and child.

All right Mark because we're very pleased with our revenue.

Quarter often considered.

Finally, we probably would you might have a record high number of directly on our call her.

Prior quarters.

Happy that were you able to move relatively stable quarter over quarter.

[laughter] concur and them it ever codependent it.

Our first quarter earnings call, we mentioned that we were supposed to come in Pat.

<unk> for the market April repeatable, who depend on it.

However, the quarter progress we saw the number of new concern prescriptions grow and reach close.

The knick level by the quarter over quarter.

We're definitely pleased with 40% year over year group of a record quarter, which we believe it's driven by increased acceptance pretty clear to me label by positions and two cents.

Michael I. Benkowitz: We continue to see growth in Oranatran prescribers, including them on KOLs at large PAH centers who have historically not written much. We also observed a decline in discontinuations and an increase in average dose per patient during the second phase. And we're excited that we've been able to improve formulary access to a rent-a-tram since the start of the year for plans that cover close to 11 million additional lives. According to our payer tracking data sources, Orinatran is now considered covered for around 76% of lives in the U.S. and a preferred or non-preferred formulary. This compares to under 72% of U.S. lives spent on a product.

I do this in growth on a winterkorn prescriber, including them on to your wells at large center historically not written much renter crown.

We also observed a decline and discuss discontinuation and an increase in average Bill who said during the second quarter.

And we're excited that we've been able to improve formulary access to a run a crown since the start of the year for plant that cover close to 11 million additional lives.

According to our care tracking data sources around kind of now consider covered for around 76% of lives in the U.S.

And upper preferred or non preferred formulary position.

This compares to under seven Cooper kind of New York Wise for a crowded.

So all in all we believe that physicians and payers and patients or understand and appreciate the value proposition Orenitram provides.

Michael I. Benkowitz: So, all in all, we believe that physicians, payers, and patients are understanding and appreciating the value proposition. We saw the biggest impact of COVID on our lives. progression during the quarter. Progression from oral therapies such as PD5s and ERAs to remodulin, which is typically an in-hospital procedure, had been delayed early on in the quarter, leading to an inadequate number of new patient prescriptions and starts to offset remodulin patient discontinuations that occurred during the quarter. However, as we closed out the quarter and clinics started opening back up, physicians became more comfortable starting therapy at home, and new prescriptions returned to almost normal.

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Progression during the quarter progression from oral therapy, such as PD, finding our is remodulin typically and hospital procedure.

I've been delayed early on in the quarter, leading to an adequate number you patient prescriptions and starts to offset remodulin consistent reasons that occurred during the quarter.

However, as we close out the quarter and clinic started opening backup and consistent became more and are positioned became more comfortable starting therapy at home new prescriptions return almost near normal levels.

Michael I. Benkowitz: In terms of generic competition in the U.S., the story remains the same as prior quarters. There's really been little to no interest on the part of physicians to write generic replacements and very little pay or pushback. In fact, we've seen zero transitions from remodeling to generics so far in the month of July.

In terms of generic competition in the U.S. story remains the same was prior quarters.

There's really been little to no interest on the part of <unk> right now Remodulin and very little paraphrased back in fact, we've seen you're kind of difference from remodulin generic so far them up in July.

Good how big are going during the quarter at more similar to the a renter Hampton or not we saw the quietly prescription early in the quarter, but historically strong rebound in June of continuing into July.

Michael I. Benkowitz: The Tydavis story during the quarter is more similar to the Orenocram story in that we saw it acquire new prescriptions early in the quarter but a historically strong rebound in June and continuing into July. Like Renatran, we observed fewer tidal ESO discontinuations during the quarter and an increase in new prescribers. As we mentioned on our last call, PAH is unfortunately a progressive disease that doesn't shut down for... There is a waiting list for patients that need or will need advanced PAH therapies, such as orenotram, tibasone, or modulin. So, we fully expect that we'll make up any ground we lost during Q2 in terms of adding new patients, as more hospitals and clinics open up to seeing them, or physicians become more comfortable prescribing via telemedicine. Finally, I want to spend a minute talking about our commercial launch plans for TAVISO and PHILT. The increased data was presented recently at the American Thoracic Society virtual session, and we're looking forward to a potential publication in a major medical journal.

Like Orenitram, we observed you were tied into discontinuations during the quarter and an increase in new prescribers.

As I mentioned on our last call.

Fortunately, a progressive disease that doesn't shutdown for kind of it there is a warehousing of patients that are well advanced gene therapy, such as a reference tyvaso and remodulin.

We fully expect that will make up any ground. We lost during Q2 in terms of added mutation as more hospitals and clinics opened up dislocation.

Well positioned to become more comfortable prescribing telematics.

Finally, I want to spend a minute talking about our commercial launch plans for today, So mph I already.

The increased data was presented recently at the American Thoracic Society worked with US and now we're looking for potential publication of the major medical girls.

We're very pleased with a positive reception of these important data by those positions able to attend gates, yet presentation, which is consistent with the feedback we've received from increase investigator physicians attending our advisory board and our market research.

Michael I. Benkowitz: We are very pleased with the positive reception of these important data by those physicians able to attend the ATS presentation, which is consistent with the feedback we've received from more investigators, physicians attending our advisory boards, and our market... The increased data is roundly considered overwhelmingly positive, and the ILB treating community is very much looking forward to having Tybaso in their treatment armamentarium for these very serious conditions. Following the supplemental NDA submission earlier this year, our launch preparations are well underway. As part of that effort, we're expanding our sales, marketing, and medical affairs team by around 30 to 35 people by the end of. Many of these new hires will focus their efforts on building relationships in the pulmonology community and beginning to share the increased data more broadly, subject, of course, to pharmacology. So with that, I'll turn the call back over to you. Thank you so much, Mike. That was a great color and insight into all the different areas of our activities.

Increased data as roundly considered overwhelmingly positive I opened three community and very much looking forward to having how they so at a treatment parliamentarian for these very sick patients.

Following the supplemental NDA submission earlier this year, our watch purposes launch preparations are well underway as part of that up or work then in our sales marketing and medical affairs team by about 30 to 35 people by the end the year.

Many of these new hires.

Look at their effort on building relationships than the Pulmonologists Committee and beginning to share the increased at a more broadly subject of course, the pharma compliance.

With that I'll turn the call back over to marketing.

Thank you so much my except with great color and insight and all the different areas of our activities and it's just.

Martine A. Rothblatt: It's just so beautiful to see us helping now over 7,000 patients, so thank you, Mike, so much for you and the entire large team of medical and pharmaceutical professionals that you have working with you. Operator, we can now accept questions that you may like to be directed to either myself, James, Leigh, or Michael. At this time, I'd like to remind everyone, in order to ask a question, please press star and the number one on your telephone keypad. Your first question comes from the line of Hartaj Singh from Oppenheimer. Your line is open.

It's it's it's just so beautiful to see us helping now over 7000 patients. So thank you Mike so much for your and the entire large team of medical and pharmaceutical professionals that you have worked with you.

Operating or we now can accept a question said me I'm like to be directed to either myself change so Lee or Michael.

[laughter], Tom could you remind everyone in order to ask the question. Please press star and the number one on your telephone keypad.

First question comes from a line of our James.

Your line is open.

Martine A. Rothblatt: Great, thank you for the question. A really nice quarter. Martine, the main question I have is that, you know, almost every other biopharmaceutical company reported decreases of 5 to 10% in revenue in the second quarter. You actually, I believe, had a slight increase over the first quarter. So can you just talk a little bit about the dynamics for the rest of the year, to the third and the fourth quarter, you know, with the same seasonality hold for United Therapeutics as historically with COVID-19? And then, and just talk a little bit about that in terms of also, as you expect, sort of near-term growth going forward. Thanks so much, Hartaj.

Great. Thank you for the question.

Really nice quarter Marty. The main question I have is that most almost every other biopharma company reported decreases of 5% to 10% in revenues in the second quarter, you actually I believe had a slight increase over the first quarter. So can you just talk a little bit about the dynamics to the rest of year, because I've heard of the fourth quarter.

You know what the same seasonality hold.

She has historically would cost 19 that and just talk a little bit about that in terms of also as you expect sort of near term great.

Thanks, So much hard times, great to hear your voice this morning, and I'm looking forward to the upcoming conference of your bank.

Michael I. Benkowitz: Great to hear your voice this morning and looking forward to the upcoming conference of your bank. Mike, I think you would be the best placed person on the call to respond to Hartaj's question. Sure. Thanks for the question, Hartaj. We haven't seen anything to suggest that the seasonality that we typically see in the second half of the year would change this year versus prior years.

Mike I think you would be the best place person on the call to respond to her touched his question.

Sure [noise] I'm kind of question her cause a yeah <unk> <unk>.

We haven't seen anything to suggest the seasonality.

That we typically see in in the second half a year would change this year versus a prior years. The big wildcard, obviously is what happens with code and.

Michael I. Benkowitz: The big wild card, obviously, is what happens with COVID. You know, if things continue to increase, if cases rise, and centers are having to shut down, do we get kind of this situation where new prescriptions and new starts kind of wax and wane, like we saw, you know, throughout the second quarter? But I think, you know, I think we're all learning how to cope and how to deal in this new environment, and I think physicians are no exception to that. And so, as I said in my opening statement, I think they're becoming more comfortable prescribing via telemedicine, and a lot of them are not allowing their patients to come back. So... at www.thevenusproject.com. Hopefully, it's not necessarily smooth sailing but certainly will continue kind of on an upward trajectory as we move into the second half of the year.

As things continue to increase its cases rise had centers are having to shut down do you guys kind of the situation where.

New Procrit, new prescriptions are new starts kind of wax and wane like we saw throughout the second quarter, but I think yes, yes, I think we're all learning how to how to go up and how to deal and this ER and this new environment at acquisitions or no exception to that so I think there as I said my my opening statement I think they're becoming.

We're comfortable.

Prescribing via Tele medicine, and a lot of these institutions all are allowing patients to come back at a different treatment they need so.

And <unk> plus we have this warehousing effect. So yes. So so unless we have another complete shutdown that we would expect that we.

Hopefully, but it's it's not.

Sorry through selling but certainly continue kind of on an upward trajectory as we move into the second half the year.

Thanks, Mike Thanks, again for touch for the question operator, you can lineup. The next question.

Next question comes from the line have two young from Jefferies. Your line is open.

Hi, Thanks, very much your question or a modular so you mentioned that the a reduction in the new patient starts I seem to have a more negatively impacting the margin in university baked in or Randy Chad. The question do you think you know.

Michael I. Benkowitz: Thanks, Mike. Thanks again, Hartaj, for the question. Operator, you can line up the next question. Your next question comes from the line of Eun Yang from Jefferies. Your line is open. Thanks very much.

And then they use a thing could that pay they may have a more impact. So why do you think that they need a greater impact on remodulin versus the others and then if he has a sale that decreased dramatically. So do you think of it if he has never been stabilized to from here. Thank you.

Eun Kyung Yang: A question on remodeling. So, you mentioned that the reduction in new patient starts seems to have a more negative impact on remodeling versus Tyvesin or Renitrab. The question to you is that, you know, during the pandemic, you think that Tyvesin may have had more impact. So, why do you think there is a greater impact on remodeling versus the others? And then, XCS sales decreased dramatically.

Oh, Thanks, a you know I'm going to again ask Mike to respond to that question since.

He is responsible for all those areas.

Sure So I think [noise].

In the case of.

Hi day, so versus robot going I won't talk there I think the main issue as you with with.

With remodeling you're talking about of kernel minerals therapies that some kids you, but most of the time is starting to huh.

Eun Kyung Yang: So, do you think that XCS sales have been stabilized from here? Thank you. Thanks, Eun.

With patients unable to come in during the first half ago second quarter get into the doctors get into the doctor get into hospitals because of a pandemic. That's that's it that's where we shot so the sharpest decline.

Michael I. Benkowitz: I'm going to again ask Mike to respond to that question since he's responsible for all those areas. Sure, so I think, you know, in the case of... Tidesa versus Verma going to the impact there. I think the main issue is with..., with a reminder that we are talking about parenteral therapy, most of the time starting, patients unable to come in.,,,,,, [inaudible] Unknown Attendee, Michael Benkowitz, Joseph John, Leigh Peterson, Patrick Poisson, Unknown, sort of historical precedents of starting much more regularly. Unknown Attendee.

In new prescriptions on new starts and then yes, we set a rebound towards put together the second quarter within you know what tyvaso.

Wow, I think positions with probably prefer to start that.

It is it it is more usable more easily started a in a home setting and so our specialty pharmacy margins are very well trained on how to use that have you lives or how to start fusions on on today. So.

Michael I. Benkowitz: As it relates to XUS, I think the situation there is that we always see some lumpiness in the orders. So it's really hard to kind of look at one quarter and project that out over subsequent quarters because there's not a regular ordering pattern at XUS as we see here in the U.S. But, you know, I think... What we've seen there is certainly the impact of generic entrants. A big, big reason for that is... The payer landscape outside the U.S., as you know, is very different than it is in the U.S. You have single-payer systems, and so what happens in a lot of these countries outside of the U.S. where Lomagilen is used is a generic entrant comes into the market, and they set their price, and there's mandatory price reductions by the government and Eric Price.

And that's much more common that that's how they so it's starting to the home. So that's the here that that's really I think the dynamic there it's just really familiarity.

Sort of historical precedent so starting today, so one though I'm much more regularly than what you would see with with what's with Remodulin. They've got I think we're starting to see a little bit about change jobs as people start to adjust to.

The current situation.

As it relates to.

Yeah, I think that since the situation. There is I mean, we always see some lumpiness of the ordering.

So it's really hard to kind of look at one quarter I forgot that out over over subsequent quarters, because there's just not if there's not a regular ordering patterns actually left as we seek or in the U.S.

But I think.

Uh huh.

You know what what we've seen there certainly the impact of generic entrants and a big big reason for that as.

The payer landscape outside the U.S., though is very different than it is in the U.S. you have got single payer systems and so what happens in a lot of these countries where outside of the glassware remodulin as use it as a generic entrant comes into the market and yeah. They set their price Anders mandatory price reductions by by the governments to meet the generic price them. So.

Michael I. Benkowitz: And so, you know, what we've done with our partner Ferrer, who's our distributor of a module outside the U.S. We've agreed to allow for adjustments in our transfer price of remodeling and Michael B. Farrar in order to allow them to compete with generics and retain as much share as they can, albeit at a lower price. So that's sort of the first piece of it. The second piece of it is you have two competitors that have been, I would say, successful in making En-ROADS in a couple of countries where we had a lot of... And so that's, you know, that's part of the dynamic there. On the flip side, you know, our partners are looking to expand into other countries and do a lot of the same things that we do.

So.

What we've done with our partner Ferraro, who who's our distributor module outside the U.S. is.

We have agreed to.

Allow for adjustments in our transfer price everybody wants you to forever and we're in order to allow them to compete with generics and retain as much or they can't albeit at lower price.

So that's sort of the first piece of it it's like a piece of it as you have to two competitors that have done I would say successful and making inroads in a couple of countries, where we had a lateral oxygen patients.

And so that's that's part of the dynamic there on the flip side your partner firms looking to expand into other countries or do a lot of things that were good and doing a lot at the same things that we're doing here in the last we promote the value of the brand over.

Michael I. Benkowitz: So, my takeaway there is I wouldn't necessarily intuit that the revenues in the second quarter you can project forward for every quarter going forward because it does vary a little bit based on the volatileness of the ordering patterns, but I think it's true that for all the reasons that Martine said in her beginning around, growth on Renitron, growth on Tybaso, you know, both in PEH and the newer indications, all of those, to the table for remodeling and everything else in our development pipeline that the rest of world remodeling rather, Increasingly an immaterial part of our overall revenue. Super.

Over generic so so I like take away, there's I wouldn't necessarily to it that the revenues in the second quarter you could project forward for every quarter going forward because.

It does it does vary a little bit based on the lumpiness the ordering patterns, but I think it's true that for all the reasons that Martinez said in her beginning around.

Gross on rent a track record today, so both in ph and the newer indications out all of the thing that we're bringing to the halo for Remodulin and everything else on our development pipeline that the rest of world Remodulin revenues are going to be increasingly an immaterial part of our overall revenue story.

Super Mike. Thank you so much.

Michael I. Benkowitz: Mike, thank you so much. Operator, if you could please queue up the next question. Your next question comes from the line of Marty Oster from Credit Suisse. Your line is open.

Operator, if you could please queue up the next question.

Your next question comes on line.

<unk> Osters from credit Suisse. Your line is open.

Thanks for taking my question or anybody, but the day before you see.

Martine A. Rothblatt: Thanks for taking the question. Hey Marty, good to hear your voice. I'm going to do a no-no and try to sneak in two questions, but I'll let you do that that way. You know what they say, for every ten years somebody has in the field, they're entitled to at least one question. So you're good for two and, soon, for three.

Oh man due in no I'm gonna do and no no and try to sneak into question, but I'll. Let you go once you do it that you know what they say for every 10 years somebody house in the field, they're entitled at least one question. So you're you're good for two and soon for Threeq.

[laughter] <unk> first party for Mike just thought you'd mentioned 30 to 35 kind of new sales marketing leads on reps that supports the ends up your child. The opportunity I was curious if you could kind of add a little more color to what's sort of percent increases I was at about 20, 30% increase to the upper and can we can we read into that that you expect to see kind of.

Martine A. Rothblatt: So the first part of me for Mike, just you'd mentioned 30 to 35 kind of new sales marketing liaison reps to support the PHILD opportunity. I was curious if you could kind of add a little more color to what sort of percent increases that are at about 20, 30% increase in the effort, and can we read into that that you expect to see kind of at least a commensurate type of revenue growth with that. The second question Martine asked you was, there's a competitor in Xenotransplantation that's out there that I noticed has been kind of hiring senior staff this year and had successful financing last year. I was curious if you could comment on the kind of competitive positioning for where UT is versus the competition in Xeno and any other kind of other competitive advantages you see you guys having.

At least a commensurate type of revenue growth with that the second question Martine was was for you.

There's a there's a competitor and do you know translocation that's out there that I noticed has been kind of hiring up senior staff. This year and had a successful financing last year I was curious if you could comment on kind of competitive positioning for where you can use versus versus the competition encino and any kind of other competitive advantages you see you guys, having and then secondly.

That company progressive because as United given any thought to potentially seeking to kind of capture value for that program through through spin out or sold or some other kind of effort just because we think it's something that gets overlooked within the a you know two possible. Another franchises that are commercial thats a great question. So a lot of good solid and teach those questions. Let me if it.

Okay I'll talk about the second one because the first one involves more metrics and give.

Martine A. Rothblatt: And then secondly, as that company progresses, has United given any thought to potentially seeking to kind of capture value for that program through a spin-out or some other kind of effort? Thanks. Great questions. A lot of good thought went into each of those questions. Let me, if it's okay, talk about the second one because the first one involves more metrics and give Mike a couple minutes to line up those metrics. So...

If I'm, Mike a couple of minutes to line up those metrics.

So.

There are there are more there are few competitors in the xeno space and there seem to be more creeping up all the time it probably has been inspired by the successful financing of of one of the company's and.

I don't Hum I'm going to I hope it doesn't break with anybody's protocol I believe you're referring to eat Genesis as has that company, but if not you know feel free to tell me afterwards, but each unassisted for one.

Martine A. Rothblatt: There are a few competitors in the Xeno space, and there seem to be more creeping up all the time. This probably has been inspired by the successful financing of one of the companies, and I hope it doesn't break anybody's protocol. I believe you're referring to eGenesis as that company, but if not, feel free to tell me afterwards. But eGenesis is the one that I'm aware of that's completed the financing, and they're a great company. They're spun out by George Church who's one of the geniuses and certainly biological geniuses of our time, and it's based on great genetic engineering work by Luhan Yang, who's an absolutely stellar molecular biologist and, now, I believe, running an arm of that company in China.

I'm aware of that's completed the financing and that there are great company. There is spun out by George Church, whose.

Who is one of the genius is certainly biological geniuses of our time and it's based on create genetic engineering work by a new hauling Yang who is oh, absolutely stellar molecular biologist.

And and now is I believe running an arm if that company in China. So that company has a lot of a lot going for it in a very good investors. We I tell you key are actually very happy to see the progress of each genesys because for a while it.

Martine A. Rothblatt: So that company has a lot going for it and very good investors. We at UT are actually very happy to see the progress of eGenesis because, for a while, it had been a little bit lonely for us in the xeno field, and we were wondering, like, why didn't other people see this opportunity? There are 100,000 people, over 100,000 people on kidney dialysis machines, and very few of them can survive past 10 years, and yet there are thousands and thousands, more than 10,000 that are out toward that number of years. So there's no other solution for these patients who are not gonna get an allograft other than something like xenotransplantation. So we think it's an amazing market. It's a place where we can do a great deal of good.

Had been a little bit Oh locally for us in this pheno field and we were wondering like you know why don't other people see this opportunity. There are 100000 people over 100000 people on kidney dialysis machines.

And very few of them can survive.

Past 10 years and yet there are there are thousands and thousands more than 10000 that are out toward that a number of years. So there's there's no. Other solution for these patients who are not going to get and allograft other than something like a casino transplantation. So we.

I think it's it's an amazing a market it's a place where we can do a great deal with good.

And as mentioned in the introductory remarks, we are now in the into pivotal phase of our preclinical development in another words conducting the last a non human studies that the FDA requires before going into the human studies.

Martine A. Rothblatt: And as mentioned in the introductory remarks, we are now in the pivotal phase of our pre-clinical development. In other words, conducting the last non-human studies that the FDA requires before going into the human studies. We've completed the construction of what's called a pathogen-free breeding facility for the xenokidneys. That's the GMP or good manufacturing practices equivalent that one needs for something like a xenok

We've completed construction of our hub and what's called a pathogen free.

Breeding facility for the casino kidneys, that's the G.M.P. or good manufacturing practices equivalent that's one needs for something like a casino kidney and again thats pursuant to an FDA guidance that we've received we have a tremendous collaboration with a university of Alabama, Birmingham, where.

Martine A. Rothblatt: And again, that's pursuant to FDA guidance that we've received. We have a tremendous collaboration with the University of Alabama-Birmingham, where a lot of this work is going on. And Dr. Jamie Locke there, she's our principal investigator.

Lots of just saw work is going on and Dr. Jamey lock their she's the our principal investigator Dr. walk for those of you who may not no is the principal person who is responsible for creating massive kidney chain transplant. You may have read how one person don't need to kidney to another.

Martine A. Rothblatt: Dr. Locke, for those of you who may not know, is the principal person who is responsible for creating massive kidney chain transplants. You may have read how one person donates a kidney to another unknown person to another unknown person, and ultimately, a friend or relative of theirs gets a kidney because of this huge chain of over 100 transplants. And that's all thanks to Dr. Jamie Locke. She's absolutely amazing, and we're so proud to have her as our PI.

I don't person to another another person that ultimately a friend or relative affairs getsy. It kidney because of this huge chain of over 100 transplant and that's all Dr. Jamey lock. She said absolutely amazing and were so proud to have her as her <unk>.

So we feel that we're in a really really sweet spot.

Martine A. Rothblatt: So we feel that we're in a really, really sweet spot, Marty, and at one time, we did explore concepts such as spinning this out because it wasn't getting enough attention. But when we looked more carefully at it, we realized that it wasn't getting more attention because it was just too premature; it was just too early. I think once people see that we have filed for clinical xenograft, which again, I'm hoping we'll be able to do in 2021, attention will start to surge very, very rapidly, and this organ manufacturing activity will become one of the multiple pillars that uphold United Therapeutics. So we're really not thinking about spinning it out at all right now.

Marty and it's at one time, we did explore concepts.

Such as spinning this out because it wasn't getting enough attention, but do you know when we looked more carefully how that we realized that it wasn't getting more attention because it was just too premature was just too early and I think once people see that we have a file.

For a clinical see no craft, which again is I'm, hoping we'll be able to do in a 2021 I think attention will spark up I'm very very rapidly and this decel organ manufacturing activity will become one of the.

Multiple pillars that help hold United Therapeutics, So we're really not thinking about spinning it out Tom had all right now we're very proud and excited to have it intrinsic to our company and we're really focused on.

Martine A. Rothblatt: We're very proud and excited to have it intrinsic to our company, and we're really focused on accomplishing enough with our xenokidney, with our 10 gene pig, that we'll be able to go into the clinic and, therefore, become a major contributor to UT's valuation. Mike, can you provide some of the metrics that Dr. Oster was requesting? Sure. So, yeah, Marty, I think the first part of your question was just around... 30 to 35 headcount ads. Yeah, currently, of the current group and those three functions that are principally focused on on PAH, the 30 to 35 is about a 25 to. I think it's hard to sort of draw, you know, sort of extend that out to expectations around revenue. We certainly...

Accomplishing enough with or Xeno kidney with our 10 gene pig that we'll be able to go into the clinic and therefore become a major contributor to you tease valuation.

Oh, Mike can you provide some of the metrics that are Dr. elster was requesting.

Sure. So yeah, Marty I think you first part of your question was just around.

30 to 35 headcount adds to sales marketing and medical and what does that look like as a percentage of the current staffing there. So if I think about the.

Currently the current group and those three functions that are principally focused on on on ph. The 30 to 35 is about a 25% to 30% increase.

Roughly in terms of headcount I think it's hard I think it's hard to sort of garage sort of extend that out to and expectations around revenue. We certainly think that the the rental opportunity with ideas.

Michael I. Benkowitz: Unknown Attendee, The Rebel Opportunity with I. L. is tremendous, certainly based on our excitement with the data and what we're hearing from others that have seen the data. I think the, you know, the challenge and trying to, The next question is, how do you draw a correlation between the headcount increase and revenue? There are a lot of variables in the air, and the variables tend to be where the patients are, at each physician or at each center. How many physicians and centers are there? And if I look at what PH looks like and what ILD looks like, those are different. What's are the other variables?

I was tremendous certainly based on our accident with the data and what we're hearing from positions that that has seen the data I think the.

The challenge and trying to.

To draw correlation between the headcount increased size to the revenue. It's just there's a lot of variables in the air So you know.

Ph it is the and the variable tend to be where the patients how concentrated or are they at the physician at each physician or at each set or.

How many physicians and centers are there any if I look at what ph looks like and what I'd looks like those those are different what's the other variables. What's the overlap between the docs that are treated eye LT and those that are treated ph and there's not a lot of overlap there. So I'm. So the the expansion of the Salesforce.

Michael I. Benkowitz: Overlap there. So, the expansion of the sales for the in the field sales force and medical will be really dedicated to IELTS, so it'll be as a dedicated team focusing on these ILD docs. And you're also talking about, as another variable, the fact that there's really not a lot of competition in ILD and these reps. Detailing one indication, one is on the PH side there. Carrying three products in a bag.

The in the field sales force and medical teams will be really dedicated to two I already.

So it'll be a.

Yes, a dedicated team detailing these these itll be docs and you're also talking about has another variable. The fact that there's really not a lot of not not a lot of competition and I'll be and these these reps and he said I sold.

Detailing one indication when those on the P.H. side, there they're carrying.

Carrying three products in the back so so there's a lot of variables that kind of go into salesforce sizing that that the it again, it's just really hard to kind of draw that correlation to what we think that revenue opportunity is and say, okay. Because we're increasing by 25% that we only thinks that the aisle de opportunity is 25%.

Michael I. Benkowitz: So there's a lot of variables that kind of go into sales force sizing. And again, it's just really hard to kind of draw that correlation to what we think the revenue opportunity is and say, okay, because we are. [inaudible] The opportunity is significantly greater just with the increased data and then certainly following it on with perfection with the TTOF study. Thanks, Mike. Excellent. Operator, we have time for the next two questions in the queue. The next question comes from the line of: "I'm Roanna Mostatos from Web Bush Securities." Your line is open.

Correct and as I think we all believe that given the decides the patient population and the unmet need the opportunity significantly greater just with the increased data and then certainly followed on with perfect analysts.

With the Tetons study, it's even even greater than that.

Thanks, Mike excellent operator, we have time for the next two questions in the Q.

Your next question comes from the line.

From Wedbush Securities. Your line is open.

Thank you for taking my question congratulations on the strong quarter of course beyond that.

Operator: Thank you for taking my question. Congratulations on the strong. Of course they are.

[laughter]. These two programs, which one is going to provide a cure first gene therapy for Oregon manufacturing.

Martine A. Rothblatt: Of these two programs, which one is going to provide a cure first? Wow, that is a very tough and challenging question. I'm not smart enough to know the answer to that question, because both of them are very promising. But they have kind of... come to their time.

Wow baddies fee that is a very tough and had a challenging question.

I'm not smart enough to know the answer to that question, because both of them or very promising and both of them have kind of.

Tom to their time, you know gene therapy has been something people have talked about for 20 years.

Martine A. Rothblatt: You know, gene therapy has been something people have talked about for 20 years. Organ manufacturing, especially xenotransplantation, has been something people have talked about for 20 years. And it's just, you know, both of them are finally coming into their own.

Organ manufacturing, especially as you know transplantation something people talked about for 20 years.

And it's just you know both of them, our finally coming into their own.

Martine A. Rothblatt: In all likelihood, there will be different solutions for different patients. I find that the thing that most people gloss over with disease generally and certainly with pulmonary disease is the tremendous heterogeneity of the patient population, and what works for some patients doesn't work for other patients. As you may know, Leanna, we've been conducting pharmacogenomic screening of patients coming into our studies, and we recently saw that there are significant pharmacogenomic differences among patients who respond to different types of medications for pulmonary hypertension.

In all likelihood there will be different solutions for different patients I find that the thing that <unk> most people gloss over.

With disease, generally and certainly with with pulmonary disease is a tremendous heterogeneity of the patient population and what works for some patients doesn't work for other patients has you may know the I know, we've been conducting pharmacogenomic screening of patients coming into.

Our studies and we've recently seen that there are significant pharmacogenomic differences among patients who respond to two different types of medications for the pulmonary hypertension.

Martine A. Rothblatt: Those differences we've seen are now correlative, so there are hypotheses that we'll test in future studies, but it indicates the heterogeneity of the patient population. I think, you know, for a patient who is... who pretty much looks like the... still has time on their lungs if one could reverse the remodeling process. Gene therapy would be a little bit more promising. However, I'd like to note that there is increasing data out there, Leanna, showing that aggressive upfront treatment with vermodulin with the goal of reducing pulmonary artery pressure below 40 millimeters of mercury is also associated with a much better long-term horizon. And more and more researchers are publishing articles where they dose to reduce pulmonary artery pressure rather than dosing to some symptomatic endpoints such as the six minute walk.

Those differences we've seen are now correlative. So there are hypotheses that will test and future studies, but it indicates the heterogeneity at the patient population I think you know for a patient who is.

Who who pretty much looks like.

He.

Still have time on their lungs, if one could refurbish the remodeling process gene therapy would be a little bit more promising.

Although I'd like to note that there is increasing data out there oh, liana showing that aggressive upfront treatment with remodulin.

With the goal of reducing pulmonary artery pressure below 40 millimeters of Mercury is also appears to be associated with a much better long term horizon and more and more researchers are our publishing articles where they dose to read.

Duesing pulmonary artery pressure rather than dosing to some symptomatic.

Endpoints, such as six minute walk Dr. Matsubara of Japan is one of the leaders of this area, but you T. south western.

Martine A. Rothblatt: Dr. Matsubara of Japan is one of the leaders in this area, but UT Southwestern, the University of Texas, United Therapeutics, and other researchers around the world are also beginning to see that you can effect remodeling. In other words, you can effect a disease modification of pulmonary hypertension by aggressive upfront treatment with vermodulin. Now that's very exciting because pressure is the kind of thing that you get into a well. And if you get into a well with very high pressure, it's hard to get out of that well.

University of Texas, Hi, Therapeutics and other researchers around the World are also beginning to see that you can effect from <unk> remodeling. Another word you can affect the disease modification appoint hypertension by aggressive upfront treatment with remodulin.

That's very exciting because you know pressure is they kind of thing that you get into a well and if you get into a well have a very high pressures, it's hard to get out of that well, but if you can get out of that high pressure well and dropped down to below 40 millimeters of Mercury you get back to a staple line.

Martine A. Rothblatt: But if you can get out of that high pressure well and drop down to below 40 millimeters of mercury, you get back to a stabilized situation, and the patient can have a much better long-term outlook. Now there are many patients who've been at super high pressures north of 60, 70, 80 millimeters of mercury for a couple years or more, and they've begun to experience serious fibrotic issues with their pulmonary And unfortunately, for these patients, the lungs are kind of shot. And that's the reason why, unfortunately, mean survival is reported as anywhere from five to ten years after diagnosis, depending on whether the person's diagnosis is functional class three, four, and what their condition is. So if a patient has already experienced essentially irreversible fibrotic processes in their pulmonary arteries and their pressures are supernormal, I think for them, the cure is going to be a lung transplant.

Stuff situation and the pace you can have a much better long term outlook now there will be many patients who've been at Super High pressures you know north of 60, 70, 80 millimeters from Mercury for a couple of years for more and they've begun to experience serious fight broderick issues with their pulmonary Vasco CERP.

And unfortunately for these patients the the ones who are kind of shot and and that's the reason why Unfortunately, I'm mean survival is reported as anywhere from five to 10 years after diagnosis, depending where the person's diagnosis functional class three for what there.

Condition is so if a patient has already experience you know essentially irreversible fight brother processes and their pulmonary arteries and there are pressures are super normal I think for them to cure is going to be a lung transplant and I would like to conclude on this question I'll leave.

Martine A. Rothblatt: And I would like to conclude this question, Lee, by pointing out that one thing I always hated about lung transplants was that they were trading one disease for another. They were trading the disease, whether it's pulmonary fibrosis, cystic fibrosis, whatever, that gave rise to the need for a lung transplant for chronic rejection, ultimately resulting in something like bronchiolitis obliterans that destroyed their graft.

Pointing out that's one thing I always hate is about lung transplants was that they were trading one disease for another they were trading to disease, whether its pulmonary fibrosis cystic fibrosis, whatever that gave rise to the need for lung transplant for chronic rejection ultimately, resulting in something like brought your largest split brands.

I had thought destroyed there they're graft. So whenever you get a transplant you are kind of trading a your previous condition for long term rejection, but we at United Therapeutics, There's been some enormous stride in the field of autologous manufactured organs in other words, we start.

Martine A. Rothblatt: So whenever you get a transplant, you are kind of trading your previous condition for long-term rejection. But we at United Therapeutics have made some enormous strides in the field of autologous manufactured organs. In other words, we start with a fibroblast of the intended patient and turn it into an iPSC cell, then re-differentiate it down into endothelial, epithelial, stromal, and basal cells, and then expand those cells to the 5 to 10 billion that are needed to cellularize a lung.

With a with fibroblast of the intended patient and turned it into an IPO CSL and then read differentiated down into the field go up a field stromal basal cells at doesn't expand those cells to the five to 10 billion to other needed to cellular rice alone.

Martine A. Rothblatt: So the patients that receive our autologous manufactured lungs will not have to take immunosuppressants, and it truly will be a cure for those patients rather than just a bridge to another disease. Thanks so much for those fascinating questions, Leanna and operator. Last question. Your last question comes from the line of Christopher Zoff from Cohen & Company. Your line is open. Thank you. Good morning. This is CJ on behalf of Chris Gibutani.

The patients that received our autologous manufactured lungs will not have to take immunosuppressants and a truly will be a cure for those patients rather than just a a bridge to another disease.

Thanks, so much for those cascading questions, a the and I don't operator last question.

Your next question comes from the line has christopher's off from Cowen and company. Your line is open.

Thank you. Good morning. This is CJ on for Chris Shibutani.

Operator: Given your interactions with the FDA on the Tyvaso SNDA, what sort of timeline are you expecting to add the PHILD indication to the label? Unknown Attendee.

Given your interactions with the FDA on the TV. So sndk, what sort of timeline are you expecting for being able to add the ph.

Indication.

And can you give us a sense what fraction of Q2, and maybe current TV subscriber might be seeing some off label use.

Martine A. Rothblatt: I just want to get a sense of what fraction of Q2 and maybe current type of... Off-label use fair is. Some transition from the remodeling. Yeah, I'm going to kind of cut off the second part of your question and ask Dr. Peterson, our Head of Product Development, and the one who, she's really the one that made the discovery or led the team that made the discovery in terms of efficacy of Tyvaso in chronic fibrosing interstitial lung disease. But Leigh, just before you go on, let me mention that, you know, I don't think that there is an off-label use of Tyvaso in that condition, and it's certainly something that we would never suggest, promote, encourage, or do any of the above.

Seeing some transition from Remodulin setting.

Surely kind of new piece.

Yeah, I'm going to kind of shop on the left second part of your question and ask a doctor Peterson, our head of product development and the one who she is really the one that made the discovery or let the team that's made the discovery.

In terms of of efficacy to confirm of Tyvaso and chronic pain approaching interstitial lung disease, but I'll lead just before you get on the let me mention that.

No I don't think that there is off label use of Taipei, So in that condition and it's certainly something that we would never suggest promote encourage or or any of the above. So we are we are your on label company and without introduction. The could you talk about the timeframe that you see.

Martine A. Rothblatt: So we are your on-label company, and with that introduction, Leigh, could you talk about, Yeah, I believe it was for the... increase the FDA submission timeline. Oh, the timeline for the FDA submission. Okay, sure. Yeah. Yeah.

For the Tetons study.

Yeah, I believe it lists or the.

Increase Sta, a submission timeline that timeline for the FDA submission, okay sure, but yeah. Yeah. So thank you I'd love to talk about increase because as you can imagine it's it's a really really excited but you're also unchartered asking so [laughter] [laughter] and.

Leigh Peterson: So, thank you. I'd love to talk about the increase because, as you can imagine, it is really, really exciting. But you were also in charge of that.

So we submitted that S. Andy.

Leigh Peterson: So we submitted that SNDA in June, and very, very soon, we will find out from FDA whether that gets priority review, which would be a six-month turn around, and if it doesn't, it would be 10. So that's the timeline for finding out about the approval of the increase and the ability to add it onto the label.

In June and we are any you know very very soon we will find out from SK <unk>, whether that receives priority review, which would be a six month turned around and if it doesn't it would be 10 minutes. So that's the timeline for for finding out.

The the approval process the approval of the increase in the ability to add it onto the label.

Assuming assuming if assuming positive response.

Leigh Peterson: Assuming positive. That's great. That's fantastic. And Leigh, while we have you on the line, would you give a rough estimate of when we would likely begin enrolling patients in the Teton study and about how long you think that study will be? Yes, so again, the TETON study is our study of using Tyvaso in inpatients that have not been diagnosed to also have pulmonary hypertension, as was the case in increase. So, we have actually submitted some questions and the protocol to FDA, and we're currently finalizing the study design with them, as well as with our steering committee. And once that happens, we will begin steady startup. It's approximately 250 to 300 patients we're imagining that we would need to enroll. So that would probably take about two years to enroll, depending on the follow-up period. It's either six months or one year for that. And then we would finish things up, submit, prepare that NDA, and submit that for, again, priority review, six month timeline, or if we didn't get that, it would be 10.

That's great that's fantastic and Oh, we well all we have you on the line would you give a sketch of when you think that we would likely begin enrolling patients in the Teton study and about how long do you think that study would take.

Yes, so again the Teton study is our study using type they so in in patients.

That have not been diagnosed with two also have pulmonary hypertension as was the case an increase so we have actually submitted on some questions and that the protocol to FDA and we're currently.

Finalizing the study design with them as well as with our steering Committee.

And once that happens we will begin study start up.

It's approximately.

250 to 300 patients, where imagining that we would need to enroll so that would probably take about two years to enrol depending on the follow up period, its either six months or one year or for that and then we would finish things that submit prepare that India and submit that for.

Again, I would submit for priority review six not timeline.

Or if we didn't get that it would be 10 month.

Leigh Peterson: Thanks so much, Leigh. There is so much exciting group activity going on in our product development group, and I'm really glad to share that with all of the shareholders on the call. Well, Operator, thank you so much for doing such a great job of coordinating all the questions today, and I will now turn the line back to you for your wrap-up statement. Thank you for participating in today's United Therapeutics Corporation conference call. Every broadcast will be for one week by dialing 1-800-585-8367. Conference, William and Mary. Thank you. Thank you.

Thanks, so much weight, so much exciting group activity going on in our product development group and really glad to shared that with all of the shareholders on the call.

Operator, thank you so much for doing such a great job of coordinating all the questions today and I will now turn the line back to you for your wrap up statement.

Thank you for participating in todays United Therapeutics Corporation Conference call everybody pass will be available for replay for one week by dialing one 800.

Hi.

Seven with international.

This concludes today's conference.

Yes.

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