Earnings Call: Q2 2020

Jul 29, 2020

Good morning, and welcome to the United Therapeutics Corporation Second Quarter 2020 Earnings Call. My name is Marcella, 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. 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 welcome you to the United Therapeutics Corporation's Q2 2020 earnings call. Accompanying me on today's call are Doctor. Martine Rothblatt, our Chairman and Chief Executive Officer Mr. Michael Bakowitz, our President and Chief Operating Officer Mr. James Edgemond, our Chief Financial Officer and Treasurer and Doctor. Lee Peterson, our Vice President of Product Development. Remarks today will include forward looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Form 10 ks 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 website at ir. Dot 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 are available on our website. Now I'd like to turn the call over to Doctor. Rothblatt for an overview of our Q2 financial results and business activities of United Therapeutics. Doctor. Rothblatt? Thank you, Dewey, and welcome everybody to our Q2 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'll 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 a science or clinical related to our Head of Product Development, Lee 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, Orenitram and Unituxan, 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 launch the highly differentiated products 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 and D project of the with Smiths 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 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 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. 3rd, 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 titratability 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 ENOS 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 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 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 are yet been unable to benefit from prostacyclin therapy. I mean, that's a whole new company right there, those three areas. It's like 3 new companies. So that's what you'd call super low hanging fruit because it's 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 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 Xeno kidneys with multiple transplants of our 10 gene, xeno kidney, which we hope will pave the way for the 1st 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? 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 2nd quarter offerings considered. Following the achievement of a record high number of U. S. Patients on our treprostinil therapies 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 a COVID pandemic. On our Q1 earnings call, we mentioned that we were seeing some impact to Prostinol prescriptions and starts for 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 the quarter. We're especially pleased with the 40% year over year growth of Orenitram in the 2nd quarter, which we believe is driven by increased acceptance of the Freedom ED label by physicians and patients. We continue to see growth in Orenitram prescribers, including among KOLs at large PAH centers who have historically not written much Orenitram. We also observed a decline in discontinuations and an increase in average dose per patient during the Q2. 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 11,000,000 additional lives. According to our payer tracking data sources, Orenitram is now considered covered for around 76% of lives in the U. S. And a preferred or non preferred formulary physician. This compares to under 72% of U. S. Lives for AKROVI. So all in all, we believe that physicians and payers and patients are understanding and appreciating the value proposition orenitram provides. We saw the biggest impact of COVID through our Remodulin business. Progression during the quarter, progression from oral therapies such as PD-five 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 and physicians became more and physicians became more comfortable starting therapy at home, new prescriptions returned 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 to no interest on the part of physicians to write generic Remodulin and very little payer pushback. In fact, we've seen 0 transitions from Remodulin to generics so far in the month of July. The Tyvaso story during the quarter is more similar to the orenitram story and that we saw a decline of new prescriptions early in the quarter, but a historically strong rebound in June and continuing into July. Like Orenitram, we observed fewer TIDESO 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 PTH therapies such as Orenitram, Tyvaso and 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 to seeing patients or physicians become more comfortable prescribing via telemedicine. Finally, I want to spend a minute talking about our commercial launch plans for Tyvaso in PAH ILD. 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 soon. We are very pleased with the positive reception for these important data by those physicians able to attend the ATS presentation, which is consistent with the feedback we've received from increased 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 in a treatment armamentarium 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. 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 just so beautiful to see us helping now over 7,000 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 questions that may like to be directed to either myself, James, Lee or Michael. Your first question comes from the line of Harjit Singh from Oppenheimer. Your line is open. 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 Q2. You actually, I believe, had a slight increase over the Q1. So can you just talk a little bit about the dynamics through the rest of the year, the 3rd and the 4th quarter, with the same seasonality hold for United Therapeutics as historically with COVID-nineteen? And then and just talk a little bit about that in terms of also as you expect sort of near term growth going forward? Thank you. 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. Sure. Thanks for the question, Hartaj. Yes, I mean, I'd say we haven't seen anything to suggest the seasonality that we typically see in the second half of the year would 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, do we get kind of the situation where new prescriptions and new starts kind of wax and wane like we saw throughout the Q2. But 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 I think they're as I said in 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 through sailing, but certainly continued kind of on an upward trajectory as we move into the second half of the year. Thanks, Mike. Thanks again Hartaj for the question. Operator, you can line up the next question. Your next question comes from the line of Ew Yang from Jefferies. Your line is open. Thanks very much. A question on Remodulin. So you mentioned that the reduction in the new patient starts seem to have a more negative impact on Remodulin versus the Tyvaso and Orenitram. So question to you is that during the pandemic, you would think that Tyvaso may have more impact. So why do you think there is a greater impact on Remodulin versus the others? And then XES' sales decreased dramatically. So do you think that XES' sales have been stabilized from here? Thank you. Thanks, Eun. I'm going to again ask Mike to respond to that question since he's responsible for all those areas. 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 peritoneal therapies that in some cases, most of the time it started in the hospital. And so if patients are unable to come in during the first half of the second quarter, get into the doctor, get into the doctor, get into hospitals because of the pandemic, that's where we saw the sharpest decline in new prescriptions and new starts. And then as we said, a rebound towards the end of the second quarter. With an inhaler with Tyvaso, while I think physicians would probably prefer to start 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 the nebulizer and how to start patients on Tyvaso. And it's much more common that, 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 precedence of 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 ex U. S, I think that the situation there is that we always see some lumpiness in the ordering. So it's really hard to kind of look at 1 quarter and project that out over subsequent quarters because there's just not a there's not a regular ordering pattern ex U. S. As we see here in the U. S. But I think what we've seen there is certainly the impact of generic entrants. And a 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 where outside of the U. S. Where Remodulin is used, there's 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 Ferrera, who's our distributor of Remodulin outside the U. S. Is, we've agreed to allow for adjustments in our transfer price of Remodulin to Ferrer, 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, is you have 2 competitors that have been, I would say, successful in making inroads in a couple of countries where we had a lot of relaunch lymphoma patients. And so that's part of the dynamic there. On the flip side, our partner for us looking to expand into other countries and do a lot of the same things that we're doing 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 Q2 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 her beginning around growth on Orenitram, growth in TIVASO, both in PAH and the newer indications, all of the things that we're bringing to the table for Remodulin and everything else in 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. Operator, if you could please queue up the next question. Your next question comes from the line of Marty Auster from Credit Suisse. Your line is open. Hey, thanks for taking the question. Hey, Marty. Good to hear you for asking. Yes, all good. I'm going to do a no no and try to sneak in 2 questions. But I'll let you do that. That way you will. 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 2 and soon for 3. Okay. So the first part of me for Mike, just you mentioned 30 to 35 new sales marketing liaison reps that support the PHILD opportunity. I was curious if you could add a little more color to what percent increase is that? Is that about 20%, 30% in the guide 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 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 UT is versus the competition in Zeno and any kind of other competitive advantages you see you guys having? 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 just because I think it's something that gets overlooked within the treprostinil and other franchises that are commercial? Thanks. Great questions. A lot of good thought into each of those questions. Let me, if it's okay, I'll talk about the second one because the first one involves more metrics and give Mike a couple of minutes to line up those metrics. So there are more there are few competitors in the Zeno space and there seem to be more creeping up all the time. It probably has been inspired by the successful financing of 1 of the companies. And I don't I'm going to I hope it doesn't break with 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, 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 Zeno 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 1,000 and 1,000 more than 10,000 that are out toward that number of years. So there's no other solution for these patients who are not going to 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. 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 that we've received. We have a tremendous collaboration with University of Alabama, Birmingham, where a lot of this work is going on and Doctor. Jamie Locke there. She's the, our principal investigator. Doctor. 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, then ultimately a friend or relative of theirs gets a kidney because of this huge chain of over 100 transplants. And that's all Doctor. Jamie 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, Marty. 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 looked more carefully at it, 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 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 Zeno Kidney, 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 Doctor. Alster was requesting? Sure. So Marty, I think your first part of your question was just around the kind of the 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 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 tremendous, certainly based on our excitement with the data and what we're hearing from physicians that have seen the data. I think the challenge in 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, it's the I mean and the variable tend to be 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 variables? What's the overlap between the docs that are treating ILD and those that are treating PAH and there's not a lot of overlap there. So the expansion of the sales force the in the field sales force and medical teams will be really dedicated to ILD. So it will be a dedicated team detailing 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 and these MSLs will really only be detailing one indication, whereas on the PAH side, they're carrying 3 products in the bag. 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% 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 and with the TETON study, it's even greater than that. Thanks, Mike. Excellent. Operator, we have time for the next two questions in the queue. Your next question comes from the line of Biena Moszatos from Wedbush Securities. Your line is open. Thank you for taking my question. Congratulations on the strong quarter. Of these two programs, which one is going to provide a cure first, gene therapy or organ manufacturing? 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 talked about for 20 years, organ manufacturing, especially xenotransplantation, something people have 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 the 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 pharmacogenomic screening of patients coming into our studies. And we've recently seen that there are significant pharmacogenomic differences among patients who respond to different types of medications for their pulmonary hypertension. 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 for a patient who pretty much looks like they still have time on their lungs if one could reverse 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, 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 6 minute block. Doctor. Matsubara of Japan is one the leaders of this area, but UT Southwestern, University of Texas, not Thymei Therapeutics and other researchers around the world are also beginning to see that you can effect remodeling. In other words, you can effect the disease modification of pulmonary hypertension by aggressive upfront treatment with Remodulin. Now 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 of years or more and they've begun 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 anywhere from 5 to 10 years after diagnosis, depending on whether the person's diagnosis is functional Class III, IV 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, 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. 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, with a cyber blast of the intended patient and turned it into an iPSC cell and then redifferentiated down into epithelial, epithelial, stromal, basal cells and then expand those cells to the 5,000,000,000 to 10,000,000,000 that are needed to cellularize the lung. 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, Liana. And then operator, last question. Your last question comes from the line of Christopher Zaff from Cowen and Company. Your line is open. Thank you. Good morning. 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 to the label? And can you give us a sense what fraction of Q2 and maybe current Tyvaso scripts might be seeing some off label use there? Are we seeing some transition from their modulin setting? Or is this purely kind of new patient growth? Yes. I'm going to kind of chop on the second part of your question and ask Doctor. 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 fibrosis and interstitial lung disease. But Lee, just before you get on, let me mention 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? Yes. I believe it was for the increased FDA submission timeline. The timeline for the FDA submission. Okay, sure. No problem. Yes. So thank you. I'd love to talk about INCREASE because as you can imagine, it's a really, really exciting But you were also in charge of that team. And so we submitted that sNDA in June and we are very, very soon we will find out from FDA whether that receives priority review, which would be a 6 month turnaround. And if it doesn't, it would be 10 months. So that's the timeline for finding out the approval process, the approval of the increase and the ability to add it onto the label, assuming positive response. That's great. That's fantastic. And Lee, 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 you think that study would take? Yes. So again, the TETON study is our study of using Tyvaso in patients that have not been diagnosed with 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 study start up. It's approximately 250 to 300 patients we're imagining that we would need to enroll. So that would probably take about 2 years to enroll depending on the follow-up period. It's either 6 months or 1 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, 6 month timeline or if we didn't get that, it would be 10 months. Thanks so much, Lee. 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. Thank you for participating in today's United Therapeutics Corporation Conference Call. Every broadcast will be available for replay for 1 week by dialing 1-eight hundred- 585-eight thousand three hundred and sixty seven with International. Thank you. This concludes today's conference call. You may now disconnect.