United Therapeutics Corp

NASDAQ:UTHR

Earnings Call Transcript 2020-Q2

[Operator]

Good morning and welcome to the United Therapeutics Corporation Second Quarter 2020 Earnings Call. My name is Marcela and I will be your conference operator today. All participants are in listen-only mode until the question-and-answer portion of this earnings call. [Operator Instructions]

I'd now like to turn the call over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics.

[Dewey Steadman, Head, Investor Relations]

Good morning.

It's my pleasure to welcome you to the United Therapeutics Corporation 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. We assume no obligation to update our 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 these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release available on our Web site at ir.unither.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 and effective for any unapproved or investigational uses. All prescribing information for the products is available on our Web site.

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?

[Martine Rothblatt, Chairman and Chief Operating Officer]

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, Chief Operating Officer, Mike Benkowitz, who provide a more in depth overview, and then he'll bounce the call back to me and 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.

While 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, Orenitram and Unituxin. It's clear that we are poised to return to revenue growth as our patients are approaching now the 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.

First, we expect net gains from Remodulin patients each year, once we launched the highly differentiated products for Remunity and the implantable system for Remodulin. 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 very much longer.

Also, we expect to contribute to net gains in Remodulin the pending approval of Trevyent, which is in front of the FDA, as a form of subcutaneous Remodulin and our R&D project of the -- with Smiths medical of have a very advanced, smart, 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 Remodulin to continue to gain 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. That's one now pending in front of 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 3 TETON study.

Third, we expect net gains in Orenitram patients due to greater familiarity with its powerful new label and greater doctor confidence and appreciation of its unique titrate ability among oral treatments for pulmonary hypertension. Meanwhile, our pipeline is full of new opportunities. These include Phase 3 programs such as Ralinepag for pulmonary hypertension, Tyvaso for interstitial lung disease, Tyvaso for COPD and endothelial nitric oxide synthase gene therapy or heNOS gene therapy for pulmonary hypertension and finally a Phase 3 trial relating to organ manufacturing processes.

Beyond these Phase 3 programs, we have pipeline feeder projects, such as a less painful or painless form of Remodulin and regenerative medicine Exosomes, which are a biological product and 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 differentiated drug delivery systems, or being advanced significantly due to label expansion, such as in the case of Orenitram, showing 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 are yet then unable to benefit from prostacyclin therapy. I mean, that's a whole new company right there, those three areas, it's like three new companies. So that's what you'd call super low hanging fruit because products which have completed clinical development or virtually done or 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 Ralinepag program for PAH, the Tyvaso program for COPD, the new TETON study in Phase 3, 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 of treatment for pulmonary hypertension, and organ manufacturing with some hundred thousand 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 xeno kidneys with multiple transplants of our 10-gene xeno kidney, which we hope will pave the way for the first clinical transplants sometime later in 2021. So it is the most exciting of times at United Therapeutics. This company is literally roaring on all thrusters 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. Mike?

[Mike Benkowitz, President and Chief Operating Officer]

Thanks, Martine.

Yes, I'd like to provide some color around physician and patient demand in the second quarter and our commercial plans for PH ILD. As Martine said at the top, we're very pleased with our revenue performance in the second quarter often considered following the achievement of a record high number of U.S. patients on our treprostinil therapy in each of the prior three quarters. We're happy that we're able to maintain relatively stable quarter-over-quarter active patient census in the midst of the COVID pandemic.

Our first quarter earnings call, we mentioned that we were seeing some impact of treprostinil prescriptions and starts for the month of April attributable through the pandemic. However, the quarter progressed we saw the number of new patient prescriptions grow and reach close to pre-pandemic levels by the close of the quarter.

We're especially pleased with the 40% year-over-year growth of Orenitram in the second quarter which we believe is driven by increased acceptance of FREEDOM-EV label by physicians and patients. We continue to see growth at Orenitram prescribers, including among KOLs at large PAH candidates who have historically not written much for Orenitram.

We also observed a decline in discontinuation and an increase in average dose per patient during the second quarter. And we're excited that we've been able to improve formulary access to Orenitram since the start of the year for plans that cover close to 11 million additional lives. According to our payer tracking data sources, Orenitram is now considered covered for around 76% of lives in the U.S. and preferred or non-preferred formulary physicians. This compares to under 72% of the U.S. lives for [indiscernible].

So all-in-all, we believe that physicians and payers and patients are understanding and appreciating the value proposition Orenitram provides. We thought the biggest impact of COVID to Remodulin business, progression during the quarter -- progression from oral therapies such as PDE-5 and ERA with 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 discontinuation that occurred during the quarter. However, as we close out the quarter and clinics started opening back up and physicians became more comfortable starting therapy at home, new prescriptions return to almost near normal levels.

In terms of generic competition in the U.S., the story remains the same as prior quarters. There's really been little or no interest on the part of physicians to write generic Remodulin and very little pair of push back. In fact, we've seen zero transitions from Remodulin to generic so far in the month of July.

The Tyvaso story during the quarter is more similar to the Orenitram story and that we saw decline in prescriptions early in the quarter, but historically strong rebound in June are getting lean into July. Like Orenitram, we observed newer Tyvaso 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 COVID. There is a warehousing of patients that need or will need advanced PAH therapy such as Orenitram, Tyvaso or Remodulin, 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 between patients or physicians become more comfortable prescribing via telemedicine.

Finally, I want to spend a minute talking about our commercial launch plans for Tyvaso and PH ILD. The increased data which was added recently at the American Thoracic Society virtual session and we're looking forward to a potential publication in a major medical journal soon. We're 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 increasing investigators, physicians attending our advisory board and our market research. The increased data is roundly considered overwhelmingly positive. And the ILD treating community is very much looking forward to having Tyvaso and treatment [indiscernible] interim for these very sick patients.

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 the year, 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 pharma compliance restrictions.

So with that, I'll turn the call back over to Martine.

[Martine Rothblatt, Chairman and Chief Operating Officer]

Thank you so much, Mike. That was a great color and insight on all the different areas of our activities and it's just -- it's so beautiful to see us helping our over 7000 patients so thank you, Mike, so much for your and the entire large team of medical and pharmaceutical professionals that you have working with you.

Operator, we now can accept the questions that may like to be directed to either myself, James, Leigh or Michael.

[Operator]

[Operator Instructions] Your first question comes from the line of Hartaj Singh from Oppenheimer. Your line is open.

[Hartaj Singh, Oppenheimer]

Really nice quarter. Martine, 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 through the rest of the year into the third and the fourth quarter, with the same seasonality hold the United Therapeutics has 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.

[Martine Rothblatt, Chairman and Chief Operating Officer]

Thanks so much Hartaj. 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.

[Mike Benkowitz, President and Chief Operating Officer]

Sure. Thanks for the question Hartaj. Yes, I mean, I think we haven't seen anything to suggest the seasonality that we typically see in the second half of the year, which change this year versus prior years. The big wild card obviously, is what happens with COVID. And, if things continue to increase, if cases rise and centers are having to shut down, we get as kind of a situation where new prescriptions and new starts kind of wax and wane like we saw throughout the second quarter, but I think we're all learning had a growth and had a deal in this new environment. And I think physicians are no exception to that. So I think, as I said my opening statement, I think they're becoming more comfortable prescribing via telemedicine and a lot of these institutions are allowing their patients to come back in and get the treatment they need.

So and plus we have this warehousing effect. So, unless we have another complete shutdown, I think we would expect that we hopefully -- it's not necessarily smooth sailing, but certainly continue to kind of on an upward trajectory as we move into the second half of the year.

[Operator]

Your next question comes from the line of Eun Yang from Jefferies. Your line is open.

[Eun Yang, Jefferies]

A question on Remodulin. So you mentioned that the reduction in the new patient start assume to have a more negative impact on Remodulin versus a Tyvaso or Orenitram. So question to you that during the pandemic, you think that Tyvaso may have a more impact. So why do you think there is a greater impact on Remodulin versus the others? And then, x-U.S. sales decreased dramatically. So do you think that x-U.S. sales will be stabilized from here? Thank you.

[Martine Rothblatt, Chairman and Chief Operating Officer]

Thanks, Eun. I'm going to again ask Mike to respond to that question since he's responsible for all those areas.

[Mike Benkowitz, President and Chief Operating Officer]

Sure. So I think, in the case of Tyvaso versus Remodulin and the impact there, I think the main issue is, with Remodulin, you're talking about a perennial therapy that some cases --most of the time is starting in a hospital. So patients aren't able to come in during the first half of those second quarter, get into the doctor, get into hospitals because of the pandemic that's what we saw the sharpest decline in new prescriptions and new starts. And then, as we set a rebound towards the end of the second quarter with an inhaler with Tyvaso, while I think physicians would probably prefer to start with that in their clinic. It is more easily started in a home setting. And so our specialty pharmacy nurses are very well trained on how to use a nebulizer and how to start patients on Tyvaso. And it's much more common that Tyvaso is starting to the home. So that's really I think the dynamic there. It's just really I think the familiarity and sort of historical precedents are starting Tyvaso in the home much more regularly than what you would see with Remodulin. But again, I think we're starting to see a little bit of that change as people start to adjust to the current situation.

As it relates to x-U.S. yeah, I think that the situation there is that we always see some lumpiness of the ordering. 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 in x-U.S., as we see here in the U.S.

But, I think what we've seen there, certainly, the impact of generic entrants and a big reason for that is the payer landscape outside of the U.S., as you know is very different than it is in the U.S. You have a single payer system. And so what happens in a lot of these countries were outside of the U.S. where Remodulin is used is a generic entrant comes into the market and they set their price and there's mandatory price reductions by the governments to meet the generic price.

And so, what we've done with our partner Sorrento who's our distributor of a Remodulin outside the U.S. is we've agreed to allow for adjustment, our transfer price of Remodulin to Sorrento. And in order to allow them to compete with generics and retain as much sure they can all be at a lower price. So that's sort of the first piece of it.

The second piece of it is since you have two competitors that have been, I would say, successful and making inroads in a couple countries where we had a lot of Remodulin patients. And so that's part of the dynamic there. On the flip side, partner firms looking to expand into other countries and do a lot of the same things that we're doing and doing a lot of the same things that we're doing here in the U.S. to promote the value of the brand over generic.

So, my takeaway there is, I wouldn't necessarily intuit that the revenues in the second quarter, you could project forward, for every quarter going forward, because it does vary a little bit based on the lumpiness of the ordering patterns, but I think it's true, that for all the reasons that Martine said in the beginning around growth of Orenitram versus Tyvaso. So both in PAH and the newer indications, all other things that we're bringing to the table for Remodulin and everything else that our development pipeline, that the rest of world Remodulin revenues are going to be increasingly an immaterial part of our overall revenue story.

[Operator]

Next question comes from the line of Martin Auster from Credit Suisse. Your line is open.

[Martin Auster, Credit Suisse]

I'm going to do a no, no and try to sneak in two questions but let…

[Martine Rothblatt, Chairman and Chief Operating Officer]

You know what they say for every 10 years somebody has in the field they're entitled at least one question. So you're good for two and soon for three.

[Martin Auster, Credit Suisse]

So the first probably for Mike, you mentioned 30 to 35, kind of new sales marketing liaison reps that support the PH ILD opportunity. I was curious if you could kind of add a little more color to what sort of percent increases as at about 20%, 30% increase to 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 was for you. There's a competitor in transportation 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 see versus the competition in Dino? And any kind of other competitive advantages, you see you guys having?

And then secondly, is that company progressive as United giving any thought to potentially seeking to kind of capture value for that program through a spin out or some other kind of effort just because they think it's something that gets overlooked within the [indiscernible] other franchises that are commercial. Thanks.

[Martine Rothblatt, Chairman and Chief Operating Officer]

Great questions. A lot of good thought into each of those questions, let me, if it's okay, I will talk about the second one because the first one involves more metrics and give Mike a couple minutes to line up those metrics. So there are a few competitors in the xeno space and there seemed to be more creeping up all the time. It probably has been inspired by the successful financing of one of the companies. And I don't -- I'm going to, I hope it doesn't break with anybody's protocols. I believe you're referring to eGenesis has that company. But if not, feel free to tell me afterwards. But eGenesis is the one that I'm aware of that's completed a financing. And they're a great company. They're spun out by George Church who's one of the geniuses, certainly biological geniuses of our time. And it's based on great genetic engineering work by Luhan Yang, who's absolutely stellar molecular biologist. And now is, I believe running an arm of that company in China. So that company has a lot of -- 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 don'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 the number of years So there's no other solution for these patients who are not going to get allograft other than something like xeno transplantation. So we think it's an amazing market. It's a place where we can do a great deal of good.

And as mentioned in the introductory remarks, we are now in the pivotal phase of our preclinical development. In other words, conducting the last non-human studies that the FDA requires before going into the human studies. We've completed construction of our what's called a pathogen free breeding facility for the xeno kidneys. That's the GMP or Good Manufacturing Practices equivalent that one needs for something like a xeno kidney. And again, that's pursuant to FDA guidance, if we perceived.

We have a tremendous collaboration with the University of Alabama, Birmingham where a lot of this work is going on and Dr. Jayme Locke there she's the principal investigator. 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 Dr. Jayme Locke, she's absolutely amazing. And we're so proud to have her as our PI.

So we feel that we're in a really, really sweet spot, Martin. And it's, at one time we did explore concepts, such as spinning this out because it wasn't getting enough attention. But when we look more carefully at it we realized that it wasn't getting more attention because it was just too premature. It was just too early. And I think once people see that we have filed for clinical xenograft which, again, is I'm hoping we'll be able to do in 2021. I think attention will spark up very, very rapidly. And this organ manufacturing activity will become one of the multiple pillars that upholds United Therapeutics. So we're really not thinking about spitting it out at all right now, we're very proud and excited to have it intrinsic to our company. And we're really focused on accomplishing enough with our xeno kidney with our 10-Gene gig 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. Auster was requesting?

[Mike Benkowitz, President and Chief Operating Officer]

Sure. So, yes, Martin, I think that your first part of your question was just around the kind of 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 current -- of the current group and those three functions that are principally focused on PAH, the 30 to 35, is about a 25% to 30% increase, roughly in terms of headcount.

I think it's hard to sort of draw -- sort of extend that out to an expectations around revenue. We certainly think that the revenue opportunity with ILD is tremendous, certainly based on [indiscernible] with the data and what we're hearing from physicians that have seen the data. I think the challenge and trying to draw a correlation between the headcount increase size to the revenue is just there's a lot of variables in the air. So, in PAH, I mean in the variable entity, where are the patients? How concentrated are they at the physician -- at each physician or at each center? How many physicians and centers are there? And if I look at what PAH looks like and what ILD looks like those are different. What's the other variable? What's the overlap between the [indiscernible] in ILD and those that are treating PAH and there's not a lot of overlap there. So, the expansion of the -- in the field sales force and medical teams will be really dedicated to ILD. So it'll be a dedicated team detailing these ILD doc's.

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 and these MSOs will only be detailing one indication, while those on the PAH either they're carrying three products in the back. 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're increasing by 25%, that we only think that the ILD opportunity is 25% of our current revenues. I think we all believe that given the size of the patient population, the unmet need, the opportunity is significantly greater just with the increased data and then certainly following it all with perfect with the TETON study, it's even greater than that.

[Operator]

The next question comes from the line of Liana Moussatos from Wedbush Securities. Your line is open.

[Liana Moussatos, Wedbush Securities]

Congratulations on the strong quarter. Of these two programs, which one is going to provide a cure first, gene therapy or organ manufacturing?

[Martine Rothblatt, Chairman and Chief Operating Officer]

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 and both of them have kind of come to their time. Gene therapy has been something people have talked about for 20 years. Organ manufacturing, especially xenotransplantation, something people talked about for 20 years. And it's just both of them are finally coming into their own.

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 a tremendous heterogeneity of the patient population. And what works for some patients doesn't work for other patients. As you may know, Liana, we've been conducting pharmacogenomics 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 pulmonary hypertension. Those differences we've seen are now correlative. So there are hypotheses that will test in future studies, but it indicates the heterogeneity of the patient population.

I think for a patient who pretty much looks like they still have time on their lungs if one could reverse the remodelling process, gene therapy would be a little bit more promising. Although I'd like to note that there is increasing data out there, 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 publishing articles, where they dose to reducing 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 UT Southwestern, University of Texas [indiscernible] therapeutics and other researchers around the world are also beginning to see that you can effect from remodeling.

In other words, you can affect a disease modification, applying hypertension by aggressive upfront treatments with remodulin. That's very exciting because pressure is a kind of thing that you get into a well. And if you get into a well, of very high pressures, it's hard to get out of that well, 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 will be 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 began to experience serious fibrotic issues with their pulmonary vasculature. And unfortunately for these patients, the lungs are kind of shot and that's the reason why unfortunately, mean survival is reported as any where from five to 10 years after diagnosis, depending whether the person's diagnosis, 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 super normal, I think for them, the cure is going to be a lung transplant. And I would like to conclude on this question 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.

So whenever you get a transplant, you are kind of trading your previous condition for long-term rejection. But we at United Therapeutics could face some enormous strides in the field of autologous manufactured organs. In other words, we start a with cyber blast of the intended patient and turned it into an IPSC cell and then read differentiated down into endothelial epithelial stroma basal cells and then expand those cells to the five to 10 billion that are needed to pulverize the lungs.

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 testing questions Liana. And operator last question.

[Operator]

Your last question comes from the line of Christopher Zopf from Cowen and Company. Your line is open.

[Christopher Zopf, Cowen and Company]

This is CJ on for Chris Shibutani. Given your interactions with the FDA on the Tyvaso SNDA, what sort of timeline are you expecting for being able to add the PH ILD indication label? And can you give us a sense what fraction of Q2 and maybe current Tyvaso groups might be seeing some off label use there? Are we seeing some transition from their modeling setting or is this purely kind of new patient group?

[Martine Rothblatt, Chairman and Chief Operating Officer]

Yes. I'm going to kind of chop on the last 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 to confirm of Tyvaso in chronic fibrosing interstitial lung disease. But we just before you get on a let me mentioned that, I don't think that there is off label use of Tyvaso in that condition and it's certainly something that we would never suggest, promote, encourage or any of the above. So we are your on label company and with that introduction, Leigh, could you talk about the timeframe that you see for the TETON study?

[Leigh Peterson, Vice President, Product Development]

Yes. I believe it was for the increase FDA submission timeline.

[Martine Rothblatt, Chairman and Chief Operating Officer]

The timeline for the FDA submission. Okay, sure.

[Leigh Peterson, Vice President, Product Development]

Yes. So, thank you, I love to talk about increase because as you can imagine, it's a really, really exciting --

[Martine Rothblatt, Chairman and Chief Operating Officer]

Are you also in-charge to that team?

[Leigh Peterson, Vice President, Product Development]

And so we submitted that SNDA in June and we are any -- very, very soon we will find out from FDA, whether that receives priority review, which would be a six month turnaround and if it doesn't, it would be 10 months. So that's the timeline for finding out the approval of the increase in the ability to add it onto the label assuming positive response.

[Martine Rothblatt, Chairman and Chief Operating Officer]

That's great. That's fantastic. And while 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 will take?

[Leigh Peterson, Vice President, Product Development]

Yes. So again, the TETON study is our study of using Tyvaso in patients that have not been diagnosed with -- 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 study startup. It's approximately 250 to 300 patients were 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, we would submit for priority review, six month timeline, or if we didn't get that it would be 10 months.

[Martine Rothblatt, Chairman and Chief Operating Officer]

Thanks so much, Leigh. So much exciting group activity going on in our product development group and 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.

[Operator]

Thank you for participating in today's United Therapeutics Corporation Conference Call. A rebroadcast will be available for replay for one week by calling 1-800-585-8367 with international. Thank you. This concludes today's conference call. You may now disconnect.