Earnings Call: Q3 2020

Oct 28, 2020

Good morning, and welcome to the United Therapeutics Corporation Third Quarter 2020 Earnings Call. My name is Kenzie, and I will be your conference operator today. All participants will be in listen only mode until the question and answer portion of this earnings call. I will now turn the conference over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation Third Quarter 2020 Earnings Call. Accompanying me on today's call are Doctor. Martine Rothblatt, our Chairman and Chief Executive Officer Mr. Michael Bicklitz, 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 these forward looking statements. Today's remarks may also include financial measures that were not prepared in accordance with U. S. Generally Accepted Accounting Principles or GAAP. Reconciliations of non GAAP financial measures to the most directly comparable GAAP financial measures can be found on our earnings release available on our website at ir. Unithird.com. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our product. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for these products available on our website. Now I'll turn the call over to Doctor. Rothfach for an overview of the Q3 2020 financial results and business activities of United Therapeutics. Martin? Thank you, Dewey. Good morning, everybody, and welcome to our Q3 earnings call for 2020. I'm going to be joined on the call today by our President, Michael Benkowitz our Chief Financial Officer, James Edgemond and our Head of Product Development, Doctor. Lee Peterson. We really have all good news to report today, so it's going to be a very fun earnings call. Let me divide the good news into 2 categories: pulmonary hypertension and pulmonary fibrosis. Let's start with pulmonary hypertension. We had over the past quarter the highest number of patients on our treprostinil medicines ever. In addition to that, we've seen double digit growth in the number of our patients on Orenitram and a number of patients on Tyvaso. That's double digit growth year to year quarter to quarter. On top of that, we've also had solid Remodulin performance, and we expect this solid Remodulin performance to be even further enhanced with 2 planned launches for 2021. First, the RemUnity launch for the patients on subcutaneous forms of Remodulin and secondly, the ISR or implantable system for Remodulin launch for patients on the intravenous form of Remodulin. These new PABIC launches are important because most pulmonary hypertension patients declined Remodulin due to its great difficulty of delivery. Indeed, most pulmonary hypertension patients die without ever having access to Remodulin therapy. Speaking of our pipeline for pulmonary hypertension, also of great significance is our accelerating progress on ralinepag. We expect both the ralinepag outcomes and the ralinepag capacity Phase III trials to be half enrolled in 2021 and fully enrolled by the end of 2022. Let me now turn to some of the good news related to pulmonary fibrosis. We remain on schedule to launch our Tyvaso product for IPF associated pulmonary hypertension in April 'twenty one, subject to FDA approval on this PDUFA date. We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis associated pulmonary hypertension with the launch of our Dreamboat Trae T product by the end of 2021 or possibly early 2022. I'd like to remind everyone that systemic drugs for treating this type of pulmonary hypertension, the pulmonary fibrosis associated pulmonary hypertension are contraindicated, leaving Tyvaso as probably the only medicine approved by the FDA to treat this 30,000 patient population. We then expect to greatly expand our pulmonary fibrosis footprint with our TETON study in pure pulmonary fibrosis patients starting in the Q1 of 'twenty one. Indeed, we will be filing the IND for this TETON study next quarter. That 400 patient study should be completely enrolled by 'twenty two. So there's a lot of things that are happening both not only in our core historical franchise of pulmonary hypertension, but you can also see that the company is making a steady adjacent market expansion into the field of pulmonary fibrosis. 1st, by having kind of one leg in 2 camps with the Group 3 pulmonary pulmonary fibrosis and then with the other leg completely in the pulmonary fibrosis side of the fence with the TETON study. While I've been talking about our pipeline, let me also talk about things that are going on at the Phase 1 and what I would call the Phase 0.9 level of our pipeline. So to start Phase 1 in the in early 2021, we will begin clinical development of our once daily form of Orenitram based on an IND that will be going in shortly. This will be a much more convenient for patients than the 3 times daily form of Orenitram And I think we'll be instrumental in continuing the double digit growth that we're currently seeing year over year in Orenitram. Another exciting activity that I would say is at the Phase 0.9 level is RemoPro. This is the pain left form of subcutaneous remotulin designed ultimately to go into the RemUnity pump. We plan to file our IND in the Q4 of 'twenty one and then move into Phase I right after that in 'twenty two. Speaking of filing INDs in 'twenty one, another IND we plan to file in 'twenty one is for our Zeno Kidney project. This is a 10 gene modified porcine kidney designed specifically to avoid the types of rejection that are common in xenografting and instead to appear to the recipient as no different than another allograft. We expect to file the IND for the Xeno Kidney program in 'twenty one. And then due to the unique nature of that type of a product, move directly into a Phase II, III study in 'twenty two. Well, with that overview of our clinical development and pipeline activities, I'd like to next turn the microphone to our President, Michael Benkowitz, to give a review of other aspects of our operations, including commercialization. Michael? Great. Thanks, Martine. Good morning, everyone. As Martine said, overall, we're extremely pleased with our reported revenue performance in the 3rd quarter, highlighted by strong double digit year over year growth in our Renitaram, Tydeiso and Yintuxan. And when you adjust our revenue growth to account for the excess order that occurred by one of our distributors in the Q3 of 2019, that growth is even stronger. On this adjusted basis, U. S. Remodulin revenues grew year over year and 5% sequentially and Tyvaso and our retitarum revenues grew by approximately 30% each year over year. We periodically caution that our revenues represent sales to our distributors and may not reflect underlying demand for our products. Happily, we can report that revenue growth we saw in Q3 supported by growing demand in the U. S. As reflected by the following highlights during the quarter. First, after experiencing some COVID related softness in new patient starts earlier during the pandemic, total treprostinil starts returned to pre pandemic levels during the quarter. 2nd, as Martine noted, the number of patients utilizing 1 of our treprostinil products reach another all time high. This is the 4th quarter in a row that we've achieved in active patients since this record for our treprostinil products. We have a record number of patients benefiting from Orenitram, reflecting continuing and increasing adoption of this therapy by physicians following the Freedom UV label expansion last year. We have more patients benefiting from Tyvaso than we have had in approximately 5 years prior to the commercial availability of oral prostacyclin class medicines. And finally, we are just shy of a record number of patients utilizing Remodulin. In addition to those highlights, we're seeing increases in average dose levels and the length of time our patients stay on our medicines, both of which positively impact our revenues. So we're very pleased all the way around with the momentum and trending of our commercial products. Meanwhile, we are making very good progress towards our near term new product launches. We are building out our field based medical sales and nursing teams to support the expected Tyvaso label expansion in April of 21 to include patients with pulmonary hypertension associated with interstitial lung disease following our INCRED trial. We have started engaging with physicians that treat these patients, which by and large is a new prescriber base compared to those currently prescribing our products for PAH and appropriate forums such as investigator meetings, scientific presentations at healthcare conferences. The increased data is roundly considered overwhelmingly positive and the ILD treating community is looking forward to having Tyvaso in their treatment armamentarium for these very sick patients upon FDA approval. Between the momentum we're seeing with Tyvaso and its approved HUGRUP-1 indication and the excitement around the upcoming launch into WHO Group 3, we're well on our way to solidifying Tyvaso as our largest product in the very near term. Our 2 upcoming Remodulin pump launches are also progressing. In the case of RemUnity, our new subcu pump that was approved by the FDA earlier this year, We believe we have overcome the COVID related delays that impacted the July launch timing. Our partner Decker Research is building commercial inventory and once we have sufficient safety stock, which we expect soon, we'll begin making the RemUnity pumps commercially available. And finally, our partner Medtronic continues their discussions with the FDA to clear the outstanding conditions of approval for the ISR, which is our new IV pump. We believe we'll remain on track for a launch next year, we are already working with key PAH centers to get them ready for this launch. So with that, I'll turn the call back over to Martine. Thanks so much, Mike. Operator, I'm now happy to field the calls, and I'll direct them amongst Doctor. Peterson, James Edgemond and Mike Benkowitz as appropriate. Thank you. Our first Great. Thank you. And a really, really good quarter, Martine and team. So thank you. Just a quick question on Tyvaso. We're seeing a definite uptick in the trend growth over the last few quarters. Martine, as you mentioned, year on year double digit growth. And then also in our Q opinion leader calls, we've noticed that there's a lot of overlap between the physicians treating PH using Tyvaso there and physicians treating PH ILD. Do you expect a lot of this enthusiasm to be occurring in those patients and then also high base uptake in that group 3 patients currently there? Thank you. Thanks, Hartaj. Absolute question and good to hear your voice this morning. I think the best person on this call to field the question actually assigning different regional sales managers and their teams amongst the different types of physicians, those who treat patients with ILD that have never seen really pulmonary hypertension patient treatment options and those who are normal PAH treatment physicians that in addition to that also treat patients with PAH associated with their ILD. So Mike would really have the best answers for that. And Mike, if you could provide some color on Hartaj's question. Sure. Thanks, Hartaj, for the question. I think the short answer to the question is it's hard to tell when physicians are writing or submitting referrals or prescriptions for Tyvaso, they're not indicating whether it's a PHILV patient or a PAH patient. So it's a little hard to tell if there's some off label use in that group. What I can tell you though about the treating community is, and as I said in my opening remarks, we do see some differences in that group. I mean, we by our count, in terms of those physicians that are treating PAH and those that are treating ILD, there's maybe only about a 20% to 25% overlap. And there's sort of an inverse relationship between the number of PAH patients those doctors see and the number of those doctors see. Or in other words, if you've got a doctor that sees a lot of PAH patients are seeing very few ILD patients and vice versa. So what we can see on the reform are the doctors that are writing the prescriptions. And so what we haven't seen is a lot of new prescribers, which tells us obviously that all of the the vast, vast majority of these Tyvaso prescriptions are coming in, are being submitted by your typical PAH doctors. And given just sort of the, I think, the underlying data that we see, it would lead me to believe that the vast vast majority are for PAH patients. But again, we don't have the visibility to know exactly whether they're PAH or Thanks so much, Mike. That's a great response. I'll Harte first one little footnote I'd add to Mike's response is it's very interesting to me just having studied this field for quite a bit that there are this very substantial quantity of patients in the group 3, WHO group 3 type of pulmonary hypertension, over 30,000 patients that for those patients, the systemic drugs are contraindicated. So here in the field of Group 1 WHO, we have upwards of 12 different medicines available to treat pulmonary hypertension. And there are just about as many Group III patients as Group I patients, but there are 0, no approved medicines to treat those of Group III patients. So it's a screaming unmet medical need, and we are just crossing every finger we could cross that on in April, on the PDUFA date, that the FDA will give us clearance to translate the increased clinical trial results into an approved treatment for those 30,000 patients. It would be the only approved treatment for those patients. It was a great trial, the INCREASE trial. As you are well aware, Hartaj, we met all of our primary and secondary endpoints. So I think there is going to be a tremendous amount of excitement among the physicians that finally, they have something to treat those 30,000 patients with. Thanks so much again. Operator, next question please. Our next question comes from the line of Eun Yang with Jefferies. Please go ahead. Your line is open. Thank you. For Tyvaso in new indication PHILV, can you comment on your regulatory filing ex U. S? And then for TRY T, it's using PHILV. Do you expect you would need to run another switching study similar to Phase III brief? Thank you. Yes. Thank you, Ying, for those very interesting questions and exploring some kind of areas that a lot of people overlook. So I'm glad you've asked those questions. At this point in time, we haven't made a firm decision with regard to the European filing schedule, mostly because we're just like laser focused on gaining FDA approval to deal with this huge unmet medical 30,000 patients here. So we're kind of like a step by step strategy here. And first, we want to be able to successfully get approval into the U. S. And then we'll consider what is the best approach to go as to Europe. The second part of your question is also quite insightful because the Dreamboat Trade T device is a much easier to use device than the Optaneb nebulizer that we used in the INCREASE study and that we submitted for FDA approval on. And I think most people feel that whatever the captured market would be for this nebulizer, that, that dry powder Dreamboat device could give you 2, maybe 3 times larger a market because of its greater convenience. So as you mentioned, Yan, we did we do plan to file for approval of the Dreamboat device based on the current, BRIES study in April of 2021, and then that would take its normal FDA approval period. So as I mentioned in my opening remarks, hopefully, we can get that approved, if not by the end of '21, then at the very beginning of 'twenty two. Now whether or not that Dreamboat Trae T device is approved for just WHO Group 1 pulmonary hypertension, which is the population in which we did our BREATHE study or is also going to be approved for the WHO Group 3 population, that would be a decision which is, of course, up to the FDA. What we would do to support that decision and provide guidance is as soon as we wrap up the filing based on the BREES-one study in the WHO group 1 population, we will immediately begin a BREES-two 2 study in the ILD population or the WHO group 3 population. And that way, we will at least have that data available for the FDA. If they feel that they are not comfortable to approve green vote in Group 3 without some data. We should have that data by the time they would reach their PDUFA date for approving the BREED device in the Group 1 population. If for any reason things take a little longer, we'll have that data immediately available. I don't think it's really going to be as much consequence because, in fact, the desperation in the WHO group 3 population for any treatment is so large that the optinib based, the nebulizer based form of Tyvaso, I think, will be very rapidly taken up. But you always want to keep building on your momentum BREAS II data for the ILD population. We'll be right on that immediately after completing the BRES-one filing. Thanks for your question, Ian. Next question, operator? Our next question comes from the line of Marty Alsair with Credit Suisse. Please go ahead. Your line is open. Hey, everybody. Thanks for taking the question. Martine, will you indulge my 2 decade tender to let me ask 2 questions again? Yes, Doctor. Oster. One for being Marty and one for being doctor. Thank you kindly. So a couple of things I want to follow-up on. First on TRADE T, you reported that the healthy volunteer kind of part of that study was done. Can you comment at all on the what that data looked like in the equivalent to what you've seen with TABASO? And then can you also talk on TRYTEA about what the supply needs that you're anticipating would be and if you think you'll be able to kind of meet where the demand for that new device and that new system might be if you were approved on a first pass approval? The second question was on the Xeno Organ side. I think there's something like 20, 25,000 kidneys transplanted in the U. S. Each year. You probably know the number more specifically. But if you could comment maybe on what the overall big picture opportunity, I know there's a very long wait list and I know that there's a lot of people that don't get served. But what is the kind of addressable big picture market opportunity there? And when do you need to think about pulling the trigger to make decisions on expanding and building out your DPF capabilities to kind of start thinking about how to meet some of that long term demand? Okay. Thanks Marty. Fascinating questions. Kind of things we could like talk in a coffee house for hours over if we could talk in a coffee house. But with regard to the first question on Breeze, the PK data, the buildup of Trae T devices, Doctor. Peterson, if you could at least talk about the PK side and if you feel comfortable talking about the inventory side, roll into that. And if not, I'll talk about that at the front end of the Zeno stuff. Yes, sure. Hi, everyone. Thank you all for calling in. Great to speak with you. So you all know that the TRADE T study in healthy volunteers that was the primary objective of that was to show comparable PK between Tyvaso and Tri T. And that has been completed. And we're actually undergoing the data analysis right now. So I don't have the final, final output package to discuss with you. But I will tell you that, I mean, this was an open label study. And we're seeing consistent results between the two medications. We're actually seeing it appeared at least early on that the Tre T device actually seems to penetrate the lung a little bit better than Tyvasa with OptiNet. But that also might be because as you all might know, Tre T, you get your entire dose from like 1 to 2 breaths. And so you just need a tiny little cartridge and you breathe it in and then you get the full dose whereas with Tyvaso, you can take like 9 or 10 or it takes several different breasts to multiple breasts to get the full dose. And so that can explain the lung penetration. But again, the final data are being analyzed literally as I'm speaking. And we will be able to get that out to you very shortly, but we definitely do not expect any surprises there. Thanks, Doctor. Peterson. Thank you very much. So with regard to the inventory, Marty, I think we're going to be in good shape. In fact, just this week, at the request of our head of manufacturing, Pat Prossant, we allocated $5,000,000 for inventory buildup for the TRADE T launch during 2021. So he regularly visits the MannKind plant in Connecticut, where we do the manufacturing of everything. We'll have adequate supply to meet our needs. As you probably recall from reviewing our proxy, one of our company's 4 company wide objectives upon which everybody's bonus is based in the entire company is that we have to have a 2 year inventory of all commercially launched products at the rate of the product take up. So Mike Benkowitz and his commercial team, they provide a forecast to manufacturing in terms of how many Dreamboat Trae patients we expect to garner in the 1st 12 months after launch, which would be mostly a 2022 thing. And then so already in 2021, Pat Prasanth and our manufacturing team are making sure that we have 2x that amount of inventory built up for at the time of launch so that we can crush that manufacturing and inventory milestone as we actually always have every year for as far back as I can remember. With regard to the Zeno question, I think your numbers are quite accurate, Marty. There are 20,000 plus kidney transplants done there. If you get into what are called living related kidney transplants, where people designate a kidney to a relative or something like that, you get up into the 35,000 type of category. Then the next number that comes up a lot is 100,000 people are waiting for kidney transplants and are currently on dialysis. And then the next number that comes up is that there's something like 300,000 people in need of a kidney transplant, but for various and sundry reasons, they are not even able to access dialysis. So it it's probably one of the largest unmet medical needs in the United States. It's not unrelated to the very high levels of diabetes in the United States, but that's not the only reason for end stage renal disease. So kidney transplantation is a cure for end stage renal disease. And people such as ourselves have been working many years in order to have an unlimited supply of transplantable kidneys that would be well tolerated by the recipients. And I think that's what we are on the cusp of here. We've spent several years knocking out or knocking in gene after gene and then testing the results to make sure that we had really the ideal level and the ideal combination of genes that have been knocked in or knocked out. And then we've also constructed a pathogen free facility, which is the xeno equivalent of a good manufacturing product in Alabama. And it are it is those kidneys coming out of that DPS facility, which would be the first ones going into the clinic, which is why I mentioned that we expect to file an IND in 2021 based on kidneys coming out of that DPF. In terms of when we would pull the trigger on building a commercial scale DPF, the one I just referred to in Alabama is a clinical trial scale DPF. The commercial scale DPF will take a couple of years to build and bring into operation. So I think the right time to pull the trigger on that would be once we have a successful result in the first clinical xeno kidney transplants. And with the as mentioned at the beginning of the call, with the IND going in, in 'twenty one, so we will know in 'twenty two whether we have a successful Zeno Kidney product. And so that would be the time to pull the trigger. We have already completely designed the facility using our design architects at the Ewing Cole Company in Philadelphia. They specialize in bio agro type of manufacturing designs. So we have a well vetted design that's been reviewed by all of the experts in controlling viruses and microbes and whatnot in animal populations. So I think we're ready to like sign a contract pretty rapidly and proceed with the construction, and then that whole facility could be brought into operation sometime during 2024. Thanks for the question, Marty. And operator, we have time for one last question. Our last question comes from the line of Joseph Stone with Cowen and Co. Please go ahead. Your line is open. Hi there. Thank you for taking my question and congrats on the great quarter. Just a little bit on TyvasoVin in ILZ. Can you comment a little bit on how well these patients are identified currently given that as you mentioned there really aren't great treatment options for patients. Do you anticipate that the potential approval of Tyvaso in the indication will change this paradigm? And is it your expectation that there are some PHILB patients sort of built up and waiting for launch? Sure. Let me suggest like we give you a 2 part answer to that question. With the first part being given by Doctor. Petersen because she was ultimately in charge of the INCREASE study that produced the clinical result in the ILD patients. So she could speak most expertly about those results and which were reported at the abstract level at the ATS conference and I believe are imminently going to be appearing in a peer reviewed publication. So she could talk about kind of the medical thing of how well it worked in those patients. And then Mike Benkowitz, our President, who has spent a lot of time thinking about the market segmentation and the approach to the market, can speak more about the second part of your question. Doctor. Peterson? Yes, sure. So as you know, Tyvaso works quite well in the patient population, 3 population. And this was ILD plus pulmonary hypertension. And in this population, the for the INCREASE study, the patients actually did have data from a right heart test, okay? They didn't give the patients necessarily a right heart cath because even if they did discover PH, there was nothing to treat them. So why go through all of that invasive procedure in order to find that out? So we've heard several times that now that there is a treatment, they will be performing those right heart casts to see the degree of pulmonary hypertension because they do have they presumably will have an approved treatment relatively soon. So yes, the identification of this population will definitely be more robust since they have something to give them. And again, also with what Martine said about the publication, so we do expect to publish these results in a major medical journal very shortly prior to the PDUFA date of April. So that definitely will what we've also heard from the docs is that once we have that published, that gives them even additional confidence in looking for this for pulmonary hypertension in this patient population. And yes, we'll likely they have said they will either prescribe or certainly be waiting for the approval if they feel comfortable. So I hope that answers the question. Doctor. Peterson, that was great answer. And Mike, would you like to add some color on that, that we're getting from all of our medical sales teams? Sure. I agree with everything we said. I think there is a lot of pent up demand. There's also I think an under there has been I think an under diagnosis of of PHILB for the reasons that Doctor. Peterson stated, which is you have these physicians that may suspect pulmonary hypertension. That suspicion typically happens as the obviously as the symptoms become more severe and present themselves. But because there's no treatment out there, the doctors are putting the patients through the very invasive procedure of the right heart cath. All of our interactions with physicians, be it advisory boards, healthcare scientific presentations at healthcare conferences, interactions with our medical team suggest that now that there's a treatment available, these physicians suspect that significant percentages of their patient population have pulmonary hypertension and will start to really screen and diagnose those patients appropriately. So that's really a large part of what we're doing right now to prepare for the launch in April is we've got our medical teams out, Certainly, the key opinion leaders in the field understand the disease and understand the pulmonary hypertension piece related to interstitial lung disease. But as you get into some of the community physicians, we're spending a lot of time educating them on PHILD. How do you screen for these patients? What are the things that may lead you to suspect that, okay, this patient has pulmonary hypertension? And then how do you know about arranging for a right heart cap to confirm the diagnosis? Great. Thanks, Mike. Operator, there's time for one bonus question here. Do you have another person lined up? I do. Our next question comes from the line of Liana Moussatos with Wedbush Securities. Please go ahead. That's excellent. Okay. Hi, Liana. Good morning. Good morning. Thank you. Since COVID continues to be a problem and infection rates are going up and it's affecting our industry clinical trials and commercialization. Can you just give us a brief overview of what has to happen and when you think the timing of this could be resolved between now and maybe end of 'twenty one? Yes. It's like one of these kind of 30,000 foot questions that cover everything. In our company, Liana, we have a risk management group that reports into our Chief Financial Officer, James Edgemond. And this risk management group ultimately has group meetings that involve as many as like 50, 60, 70 people at United Therapeutics. And every week, they issue a report regarding COVID-nineteen and how it affects all the different parts of the company. So James, maybe if you could provide some color for Liana's question in terms of the overall impact of COVID-nineteen on United Therapeutics and when we see, based on inputs we're getting from our risk management group, when we see some of those effects perhaps ameliorating. Yes. Thank you, Martine. And Liana, good to hear your voice. So as Martine mentioned internally, way back to the beginning part of this year, we organized leadership a leadership team to make sure that across the organization we were communicating effectively and coordinating with each other with respect to risk management and the impacts around COVID-nineteen on all areas of the business, from human capital to clinical trials, product development, through specialty pharmaceutical distributors. And it's been a really effective tool for us to make sure that across the organization, everybody is in tune to what impacts there are to the organization as a whole. And I think broadly speaking, everybody has stepped up, all the Unitarians, as we call ourselves internally, has stepped up to make sure that we have understood the various risks and the impacts, not only internally, but to those of our patients and those, importantly, to the patients and individuals in the clinical trials, both that were enrolled, that continue to be enrolled as well as those that were back in our clinical trials that we may have shut down as we talked about and we've begun to reopen some of those based upon the opportunities and really the hotspots around the country or around the globe. So broadly speaking, I think Martine is right. It's been a coordinated effort to really veterinarians, our patients at large. From a standpoint of when we think things will get better, we hope for the best as everybody does in the near term. But we're going to need to stay vigilant around all aspects of the organization to make sure that we can continue to perform as an organization. And so I think as things unfold and we all continue to get better educated and educated on the multiple aspects. We'll certainly continue to communicate in our public filings and on conference calls with various questions. But it's something that we'll continue to take seriously as everybody is doing to make sure the business at whole and at large can continue to move forward. So back to you, Martine. Thanks so much, James. To wrap up, everybody on the earnings call, we've had a great quarter. I think this quarter and perhaps more generally this half of the year, will be looked at in retrospect as a key pivot point for United Therapeutics. This will be the time when we pivoted from being solely a pulmonary hypertension company to becoming both a pulmonary hypertension company as well as a pulmonary fibrosis and other forms of interstitial lung disease company. You can see this pivot in us moving into a group of pulmonary hypertension patients, WHO Group 3, as to whom pulmonary hypertension is not their primary problem. Their primary problem is interstitial lung disease. It's, of course, greatly worsened by the pulmonary hypertension, but the source of their pulmonary hypertension is ultimately interstitial lung disease. So for the first time, we're moving into a group of patients for whom pulmonary hypertension is not their number one problem, if you will. And secondly, for the first time, we're moving into a large Phase III study in which patients do not have pulmonary hypertension at all. They simply have this form of interstitial lung disease, pulmonary fibrosis. If you take a look at a diagram of all the species and subspecies of interstitial lung disease, you'll see it is a very large and diverse population. And we were really pleased to see in the outcome of our INCREASE study that we actually were able to modify the our in our forest vital capacity, but actually improved forest vital capacity in the patients with pulmonary fibrosis as well as a couple of other subsets of interstitial lung disease. So it's a very exciting time here at United Therapeutics. You always hope that you can be strong at your home base and then expand from that. And with this adjacency of interstitial lung disease and pulmonary hypertension, we have a very logical providing more and better health care to ever larger numbers of people. Thank you so much for your time and attention this morning. Look forward to seeing you at upcoming healthcare conferences. Operator, you can wrap up. Thank you for participating in today's United Therapeutics Corporation conference call. A rebroadcast will be available for replay for 1 week by dialing 1-eight hundred-five eighty five 8367 with the international caller dialing 1-four 16-six 21-four 1642 and using access code 8