United Therapeutics Corporation (UTHR) Earnings Call Transcript & Summary

Good afternoon, everyone. My name is Jess Fye. I'm one of the biotech analysts at JPMorgan. We're continuing the 2020 Healthcare Conference today with United Therapeutics. Quick housekeeping note, we're going to do a Q&A session right after this just down the hall in the Sussex Room. You can follow me there. But with that, I'll turn it over to the company's CEO, Martine Rothblatt.

Thank you, Jess. Very glad to be here at the JPMorgan 2020 Healthcare Conference. I'm joined today by my colleagues, Michael Benkowitz, President and Chief Operating Officer, to my right; James Edgemond, our Chief Financial Officer, also to my right; Dr. Betsy Eades, our Head of Business Development, to my left; and also Dewey Steadman, our Head of Investor Relations, also to my left. All 5 of us will be available in the breakout room to answer questions afterwards. I'd like to start with the safe harbor statement. But since I think you've probably read this statement many times today already, I'll proceed without further ado. United Therapeutics develops therapies in 3 key areas: lung disease, oncology and organ manufacturing. Each of these 3 areas are characterized by significant unmet medical needs. We apply to them our mantra of identify the corridors of indifference and run like hell down them. We run like hell by following 5 guiding principles at United Therapeutics: first, to develop the best possible medicines from our intellectual property; second, to conduct the most insightful clinical trials; third, to take responsibility, in fact, a 100% responsibility for our entire chemistry, manufacturing and controls supply chain, the GMP supply chain; fourth, to effectively communicate our clinical trial results to regulators, prescribers, payers and patients; and fifth, to maintain a very high standard of ethics. These principles have enabled us to currently field 5 significant products. Remodulin, which is actually 2 products, an intravenous product and a subcutaneous product; Tyvaso, which is an inhaled product; Orenitram is a 3 times a day oral product; and Unituxin is an infusion for neuroblastoma. In addition to these commercialized products, we also have over 20 products in our pipeline. We expect no fewer than 3 and up to 5 of these pipeline products to be approved in the next 18 months. Meanwhile, our core already approved products continue to generate substantial revenue. Indeed, these products are now helping more total patients within United Therapeutics at the end of 2019 than ever before. The biggest of our current products is called Remodulin, both intravenous and subcutaneous. We expect Remodulin to continue to keep growing, notwithstanding the advent of generics about a year ago. This is likely because it is a very complex product in a very fragile patient population, which places a high premium on years of safety and supply chain reliability. Only United Therapeutics has this demonstrated capability as the sales figures demonstrate. Let me now share some thoughts about our pulmonary hypertension key markets. There are 2 main kinds of pulmonary hypertension in the United States. They are called WHO Group I and WHO Group III. All currently approved pulmonary arterial hypertension treatments are for WHO Group I. However, many more people have WHO Group III than have WHO Group I. Even within the WHO Group I, we expect to triple our captured patients over the next few years. This is because of the many innovative products that are in our pipeline as well as last year's successful launch of Orenitram for reduction of morbidity and mortality. Indeed, new prescriptions for Orenitram have been motivated by 61% reduction in risk. We now have hit our highest levels ever of patients on Orenitram. Let me now go into a little bit more detail about our pipeline. Over the next 18 months, as mentioned, we expect 3 and perhaps as many as 5 new FDA approvals. Three of these will help grow our Group I pulmonary hypertension. They are called RemUnity, Trevyent and ISR. One of these 5 increase will be the first product launched into Group III pulmonary hypertension. And one of these will expand our oncology franchise from neuroblastoma into small cell lung cancer. The small cell lung cancer prevalence in the United States is about 30,000 patients. This is much, much larger than our current neuroblastoma market. We expect to unblind our Phase III trial called DISTINCT for small cell lung cancer later this very month, probably just around the end of the month. Once we have a chance to analyze results, and hopefully, they will be successful, we'll then begin to -- we will then be able to file for regulatory approval in the June-July time frame and hopefully launch that product in the first half of 2021. Our first product for WHO Group III pulmonary hypertension will have its Phase III trial unblinded in just a few months. April is the current schedule. I'd like to emphasize that there is no competitive product for these 30,000 patients with Group III pulmonary hypertension. It will take us no more than 3 months to convert those unblinded results into an NDA supplement filing at the FDA and be able to launch that product into the market also in the first half of 2021. Our other near-term product launches are intended to grow our WHO Group I market from around 7,500 patients today to around 25,000 patients in the next few years. Each of them entail highly novel, first-of-kind and best-of-class drug device combination therapies. You can see some of them depicted on the screen here. In the upper left-hand corner, there's the ISR implantable system for Remodulin. Expect to launch that in the first half of 2021. In the lower left-hand corner, you see RemUnity, a disposable pump system ideally designed for the pulmonary hypertension patients' ease and convenience. We expect to launch that product in the first half of 2020, this year. In the upper right-hand corner, you see the product, Trevyent, which is a product ideally designed for patients that have conditions associated with Group I pulmonary hypertension, such as scleroderma, which causes a great deal of dexterity difficulty. This is a pump that there are no buttons that the patient has to push and everything is a fixed dose of Remodulin shipped directly to the patient from the pharmacy. And finally, in the lower right-hand corner is a product called RemoLife, a truly remarkable, so-called smart pump, a pump that will do for medical device pumps what our smartphones did for those of us who are old enough to remember the old flip phone, all that it could do was flip, and it's like all that pumps can do today is like pump, well the new smartphone will be able to do as many different things for pumps as our smartphones are able to do for phones. Beyond our near-term pipeline, we have over a dozen medium- and longer-term pipeline products queued up. Each of these meet our mantra of addressing unmet medical needs with the most awe-inspiring technology we can gather. For example, our Phase III gene therapy study for SAPPHIRE, shown on this screen, could render pulmonary hypertension manageable with just a once quarterly infusion of genetically engineered autologous stem cells from the patient. This trial is now in Phase III. We expect enrollment to be completed next year, and hopefully, we'll be able to launch this product in the first half of the 2020s. Another best-in-class potential in our pipeline is called ralinepag. We purchased this product a year ago for about $1 billion because our due diligence was persuasive that it could absolutely transform the care of WHO Group I pulmonary hypertension patients. Now I mentioned earlier that we like to identify the corridors of indifference and run like hell down them. Well, one of those corridors of indifference is the desperate need for more transplantable organs. Believe it or not, transplantable -- total transplantable organs in the United States annually have hardly changed in the past 20 years. Yet, during this time, thousands of patients have died every year waiting on the organ transplant list. We are developing 4 new technologies to create a literally unlimited supply of transplantable organs so that people dying on the organ transplant list can hopefully be something of the past. We've already been able to achieve quite a bit of success in this, what we call turning a moonshot into an earth shot. A moon shot is something that seems almost science fiction, almost impossible, but nevertheless is accomplished within a decade, like the Apollo moon program. An earth shot is a moonshot that helps people right here on Earth. And that's what we believe creating an unlimited supply of transplantable organs would do. It would help people right here on Earth. So our efforts are already showing steady progress. Our manufactured lungs have already saved over 100 people. Our manufactured kidneys are scheduled to go into clinical trials in the first half of this decade. And amazing as it seems, we've already been able to cellularize lung scaffolds, some of which are printed with 3D printers, fed by a bioink consisting of human collagen grown in recombinant DNA tobacco plants. I feel confident that these manufactured lungs, kidneys, hearts will transform the future medical care of patients suffering from end-stage organ disease. Organ manufacturing is a complex undertaking, involving trade-offs of immunology, technology and GMP scale up. Nevertheless, with 100,000 people on dialysis in the United States alone, 200,000 people dying each year of lung failure and over 0.5 million people dying each year of heart failure, we believe the benefits readily justify this challenge. We at United Therapeutics feel that we have achieved a balanced value-creating, growth-oriented model for biotechnology. You can see the balance in -- on the one hand, we have a number of FDA-approved products, producing several hundred millions of dollars a year in free cash flow. On the next hand, we have 5 different products that are queued up for FDA approval over the next 18 months, 2 of which depend upon Phase III trial unblindings over the next 3 or 4 months. And then finally, we have these transformative products like the gene therapy product for pulmonary hypertension; ralinepag; and finally, organ manufacturing that will really make a lasting difference in our health care system. At United Therapeutics, we like to say, biology is technology, and we humbly approach our responsibility to create the best possible biology we can with the technology and human resources at our company. Thank you for your attention this afternoon.

Okay. Welcome, everybody. Jess, you're going to make any more speeches?

All yours.

Okay. Welcome everybody to the United Therapeutics breakout. My name is Martine Rothblatt, the Chief Executive Officer. I am joined by Michael Benkowitz, our President and Chief Operating Officer; James Edgemond, our Chief Financial Officer; and standing at the door, we have Dewey Steadman, our Head of Investor Relations; and Betsy Eades, our Head of Business Development. So I think any question that you have between the 5 of us, 1 of us are going to have you covered. The floor is open to questions.

Remodulin has been very resilient after the first generic approvals. Can you talk about how you're thinking about the generic play out in 2020?

Yes, Jess has said that Remodulin has been very resilient after the generic approvals and she wants to know how do we expect that resilience to play out in 2020. How is that for repeating the question?

That's perfect.

That was badass. I'm going to ask Mike to answer that question.

Thank you. So -- yes, I think we've been certainly very pleased with how resilient it has been in the face of generics for coming up on a year now and multiple generics for about almost 6 months now. And we would expect that to play out similarly as we head into -- throughout the course of 2020. Our active patients on Remodulin are currently at an all-time high. We had the highest number of new patient starts in Q4 that we've had in about 10 years. Feedback we're receiving from physicians is that they continue to believe in the brand. They see a lot of value in the brand. They're not inclined to write for generic. The wildcard in all this, obviously, is the peer pressure. To date, there really has been no peer pressure to speak of. When the first generic launched, we did see some number of transitions really from the -- these are patients that are covered under the dual Medicare-Medicaid eligible patients. So we saw some sort of a bolus of those patients early on, but that really has waned over the last several months. And in fact, in December, we only had 1 transition from brand Remodulin over to generic. So we feel -- feeling very good about where things are right now and where we are positioned heading into 2020. I think a number of the new pump approvals of technologies that Martine talked about in her presentation with RemUnity, with Trevyent, with ISR coming in 2021 are really going to help us not only maintain the Remodulin patients but allow us to grow in the coming years.

Thanks, Mike. Excellent response. Next question, please. Next question in the back, right in front of the framed picture.

Can you comment on the timing for the Trevyent launch?

The question is, would we please comment on the timing for the Trevyent launch? I'd like to refer that question over to Mike Benkowitz.

I'm back. So the -- we filed for approval with the FDA last year. Our PDUFA date is -- I believe, it's April 27, I think, is the exact date. And so as things set right now, we believe we're on track. We're in sort of a back and forth with the FDA, answering their questions, addressing the needs that they have. So we're still optimistic that we'll get approval around that time frame and then we're positioned to launch that in 2020.

Thank you, President Benkowitz. Next question, please. Sir, question, the back row, middle section. Don't be shy. This is your time. Yes, thank you, hand up.

What is happening with Technosphere Treprostinil? What are the timelines on that front?

Question is what's happening with Technosphere Treprostinil? This is a product -- it goes by a few different names. So I'll just mention some of the names so people can all be on the same page. We also call it TreT in part because Technosphere Treprostinil is a mouthful. So TreT is easier to say. This is the replacement project -- product for our current Tyvaso brand name. It's a product that's a result of a partnership between us and MannKind in which we are using the MannKind inhaled insulin device to deliver treprostinil via a small palm-sized inhalation system. The palm-sized device is called Dreamboat. So -- and then finally, the name of the clinical trial to demonstrate that TreT works in Dreamboat for the treatment of pulmonary hypertension just as good as Tyvaso, we call that clinical trial BREEZE. So all those things kind of refer to the same thing. The timeline for that is that we will complete our clinical trial in May. It's currently being enrolled and everyone is confident that the trial will be enrolled by May. It is going on in parallel with production of our treprostinil in this new dry powder formulation that is used in the Dreamboat device from MannKind. And that product will complete its 12-month stability toward the end of this year. We'll then file for FDA approval by the end of the year and expect to have that approved by the end of 2021. So the product would probably be commercially launched anywhere between the fourth quarter of 2021 and the first half of 2022. Next question, please. You guys can't all just watch other people ask questions. You have to get outside your comfort zone, raise your hand.

Can you share anything about the rate of adoption of the new subcutaneous pumps for RemUnity and Trevyent?

Excellent. Jess asked, what do we think about the rate of adoption of the new pumps such as RemUnity and Trevyent? And for that question, I'd like to perhaps ask our excellent Head of Investor Relations, Dew -- Mr. Steadman.

So the -- for RemUnity, it's likely to be the 90-day period for the pharmacy fill. It's likely to be in the middle of February. So we'd launch shortly thereafter. We have ample or we're building ample supply to facilitate a launch. You've got to remember, this is a small market with a number of patients. So it doesn't require 1 million tablets that we're storing. It's a small number of devices that we have to have ready to go. Trevyent's PDUFA date is April 27. And if it gets approved April 27, we'd launch shortly thereafter as well. But the timeline isn't as set for that one as it is for RemUnity just because that one is coming up sooner.

Excellent answer. Thank you. Next up. Nobody has asked a question from the second row yet. Okay, quick question, standing up in the back.

Quick question on the pumps. Would you expect patients to switch from their current subcu pumps that they are on? Or would you be getting new starts with this when those pumps launch?

Very good question. Would we expect patients to switch from the current pumps that they are on to the new pumps? Or would we expect only the newly diagnosed patients, newly prescribed patients to go directly onto those pumps? And for that question, James, you haven't had a chance to answer a question. Would you like to answer one?

Yes, thank you. So I think, you'll see both. I think where there is a situation where we can transition existing patients over to the new pump technology, we certainly will. As Mike alluded to and Dewey talked about, the pumps, in general, have different opportunities for patients. So if you look at Trevyent, which is a fixed-dose pump, for example, that is -- could be convenient for somebody with scleroderma or dexterity issues. Where if you look at RemUnity, it's certainly an opportunity for somebody to use a titratable pump that's smaller than some of the existing pump technologies. So I think, overall, we'll see transitions from patients who are on pump technology into the new technology. Also, you could have new patients that are prescribed Remodulin, start on these new pumps right away depending upon the launch timeline. So I think it will be a mix of both.

Excellent. Thank you so much, James. Nobody has asked any questions about our cancer franchise with a major study being unblinded in just a -- in just like 2 weeks or so. Yes?

Tell us then.

Okay. Good question. Okay. Very good question was asked. Tell us about your study being unblinded in a couple of weeks. Fortunately, our Head of Business Development is also an expert in oncology, and Dr. Eades could you tell us about that?

You set me up for that question. So we do have that study unblinding soon. So this is a Phase II/III study, and it was in relapsed/refractory patients. So more second, third line therapy, and we have it in combination with irinotecan. We also compared it to a topotecan arm, where the dose is the same, max dose, that -- in neuroblastoma patients, but it follows the schedule with irinotecan. So it's every 3 weeks that the patients get dosed. The last event occurred in December. So we are very, very close to getting results on it. For those of you that are unfamiliar with Unituxin or small cell lung cancer, it's a neural crest derived tumor and these tumors typically express ganglioside 2, which is what Unituxin, dinutuximab or monoclonal antibody targets.

Thank you. Thank you very much, Betsy. Next question. Nobody in the second row has still asked a question.

What do you think is the size of the market opportunity for that small cell indication for Unituxin?

Okay. Jess has asked a question, what do we think is the size of the market opportunity for Unituxin in small cell lung cancer? Now that question, Mike, maybe if I could refer back to you?

Sure. So I think as Martine covered in her presentation, if you look at the small cell lung cancer population, it's about 30,000. Given that this is going to be second line therapy, you're going to have a fair amount of fallout after first line. So we estimate it at around 10,000 patients.

Excellent. Thank you, Mike.

What's the endpoint that you are going to report, indiscernible] survival or overall response rates or what's the endpoint to this?

So the question is, what is the endpoint for the DISTINCT study? Betsy, would you like to get back on that one?

It's overall survival for primary.

Okay. Can I add something to that?

Yes, please. Dewey Steadman, our Head of Investor Relations.

So we'll report that top line data. We'll do a deeper dive into the data as the year progresses. And we'll either give more information to investors or present it at scientific meeting when appropriate. But when we do report this data in the next couple of weeks, next several weeks, it will be top line data only.

I'd like everybody to know that this is the very first health care conference at which Dewey Steadman has been our Investor Relations Head. I think he's done a great job. A round of applause. Next question, please. Yes in the back.

What sort of overall survival in that study do you really need to show in order to sight positions in second line small cell given the administration requirements of Unituxin?

What sort of size -- did you say size of...?

Basically, the effect size that you can...

What effect size for survival do we have to show? For that, Dr. Eades.

So I don't think we have disclosed our full statistical plan, but I think we're expecting similar -- on a timeline similar to what you've seen with the other products. It's probably something in that 2 months' time range is what we're expecting to see there for it to have significance. Somewhere in that range so...

Great. Thank you. Next question. We have -- Dewey Steadman is going to ask himself a question.

Okay, I can't answer it, but ask it. Can you talk a bit about the mechanics of the ISR delay and sort of your expectations on how that's going to progress and how it moved into 2021 from 2020?

Yes. Dewey Steadman has asked about the ISR delay and how do we -- why do we think we have experienced that delay and what are we planning to do between now and when we expect to launch that product? President Benkowitz, can you take that one?

Sure. So if you kind of think about the history of the ISR program, there were -- it's a complex program, complex and complicated both. So the -- there's the device aspect, which is taking the pump that Medtronics already received approval for, for pain medication, specifically baclofen. And they designed a catheter that was -- which was a new component of the device to deliver Remodulin. So that catheter with the pump needed to receive FDA approval. And then there was a second approval, which is the use of Remodulin in the pump. And so the pump and catheter were approved by the FDA, I think it was December of '17, subject to 4 conditions of approval. The drug and the device was approved by the FDA in the middle of 2018. So what we've been doing over the last period of time is trying to address the 4 conditions of approval that the FDA flagged with the pump and the catheter. And so as we sit here today, 3 of those 4 conditions have been met. The last condition really relates to the pump life. So when the pump was approved for the use of baclofen, it was approved for the 7-year pump life. What happened in the clinical trial with Remodulin is there were a couple of cases where the pump motor stalled at 4 to 5 years. And so the FDA being very focused on patient safety, wanted to understand, okay, why did that happen? And then what does this mean for patients? So do they need to be reimplanted? What are the risks associated with reimplementation? What happens if for whatever reason the patient can't be reimplanted because their disease has progressed to a point where they are no longer candidates for the ISR? And so really, the back and forth over the latest period of time has been trying to educate the FDA around the engineering of the pump, why this is occurring and then the risk-benefit or the risk mitigation strategies we have in place to, one, alert patients and physicians if the pump is going to stall and then what are the implications of having to do a secondary implant. I will say that of the 60 patients that were in the original study, 40 are still alive and still on the pump and they're all actually on their second pump. So they've all gone through this re-implantation procedure. There have been no issues. The patients are all doing very well. So it's really just, at this point, a question of getting the FDA comfortable with where we are as it relates to this last issue. So we have some meetings coming up here in the spring with the FDA to have further dialogue around this, give them some additional information that they've requested. So there's no new clinical data -- clinical data per se that we have to generate. It's just really more data and more information about the workings of the pump. One of the things that they've at least said that they're probably going to want us to do is actually a patient preference survey on the ISR versus other pumps, which we're 100% confident that the patients will just like the ISR versus the other external pumps. But if we have to go through that process of doing the survey, we're going to have that survey approved by the FDA, which we expect to do here in the next couple of months. We'll have to do the survey, which will go very fast. And then -- but when -- and then turn it over to the FDA and then they have their, I think, a 6-month review period. So that's really why this is going to probably push into 2021.

Thanks, Mike. Excellent explanation. And great question, Dewey. Next question?

How do you feel about the potential for ralinepag in a generic Uptravi environment?

Okay. Jess Fye has asked the question, how do we feel about ralinepag in a generic Uptravi environment? And to answer that question, I think, I would refer to Dewey Steadman.

So obviously, it's a challenge when you've got 2 oral products and 1 of them goes generic. Just driven from my prior life in the generic industry, it definitely shakes up a market. But I think when you look at the 2 products together, we're likely to have an advantage over selexipag just given that we're shooting for once a day therapy and patient compliance is incredibly important in the docs that we've surveyed and the docs at some other sell-siders have surveyed, patient compliance is a big issue. So going from, what is it, 3 times a day or 4 times a day? Twice a day, BID.

Twice a day.

Going from twice a day to once a day is going to be a big advantage for patients. And then on top of that, because it's a once a day therapy, you're getting more consistent dosing levels. And we think that may translate into a better safety profile than selexipag over time.

Thank you.

Can I add...?

Sure. Absolutely.

The other thing to think about there is, I think, we have a decent analog. So if you think about Adcirca, right? And Adcirca versus Revatio. Revatio was multiple days. Adcirca was once daily. Revatio went generic I think it was 4 or 5 years ago. But I think we got a lot of the same questions at that time about what would happen to Adcirca in the face of another PD5 that was generic. And what we saw is that the doctors, the payers really looked at them differently. Adcirca continued to grow even in the face of having another PD5 that was generic. So again -- I think some of it'll depend on the data we get out of that ralinepag trial. But I think that -- that to us, gives us some confidence that we will be resilient in the face of a generic Uptravi.

Thanks, Mike. Next question, please. Anybody have any financial questions for James. He hasn't had too many questions asked for him. Yes. Excellent. Second row.

Do you have any plan for China? And what approach?

Can you repeat the question one more time?

Do you have any plan to expand into China? And what would be your approach?

Excellent. So the question is, do we have any plans to expand into China? And what would be our approach?

[Indiscernible]

Okay. And I'm going to answer part of the question and then turn it over to James Edgemond to continue the question. So first, we are approved in China for our Remodulin product. So we already have a good experience of being able to get one of our drugs approved in China. And we signed a licensing deal with a company called Lee's Pharma, which is currently selling Remodulin in China. Secondly, we have a -- we conduct clinical trials in China with Orenitram and ralinepag. So we have quite a bit of experience also with conducting clinical trials in China. In terms of the business development activity of how do we want to move into China in the future, the business development function at United Therapeutics reports in -- under our Chief Financial Officer. So I'd like to ask Mr. Edgemond on what is our approach for going into China forward?

Yes. Thanks, Martine. I think one of the things, just to give you an example, is around Orenitram with this new expanded label. And right now, it's only approved domestically. And when we think about executing that plan, there will be a point, and I know Michael Benkowitz is evaluating this currently, is there will be a point when we get to evaluate where we want to take Orenitram internationally, which could include China as well. So right now, just to give you 1 example of how we're thinking about it, Orenitram is something, just broadly speaking, we're going to look ex U.S. sometime over the next year or so, and we'll be giving more updates there, and that could include the expansion into China.

So any revenue from China?

Any revenue projections for China is the question, James.

Thanks, Martine. Not at this point. I think what we do is once we formulate the plan, we'll have a better opportunity to give you more specific guidance in that area.

Thank you very much, James. Next question row 3.

With the Orenitram sNDA approval, is it a fair assumption to expect that the growth rate would accelerate in 2020?

The question is, with the Orenitram sNDA approval, is it a fair expectation that the growth rate would accelerate in 2020? And I'd like to refer that question to President, Benkowitz.

That's certainly our expectation, and we believe that's true, and we're starting to see that. If you think about the label expansion or the label -- the approval on the label expansion was in middle of October. So really, it still quite early days. We've certainly seen a nice uptick in referrals and starts in the back -- kind of the last 1.5 months of the year. We expect that trend to continue as we move into 2020 and beyond. I think the physicians have been really impressed by the data that we're -- that came out of the EV study. And so you've got sort of the camp of physicians that have already used Orenitram, and I think this was just confirmatory in their belief. I think that will probably cause them to use it more than they already are. And then you've got physicians that were a little skeptical with the monotherapy label that are certainly taking a look and just in our conversations with them, they certainly have -- they're coming back and taking another look. So I think with them, the physicians tend to be cautious and getting them to change their behavior takes a little bit of time. And so it's really just getting them to identify potential patients come back, give Orenitram another shot. I think once they see that patients are benefiting from it, they'll start to use it more as well, but we certainly expect to see continued growth and at a faster rate in 2020.

Thanks, Mike. By the way, before our last question, the trivial question, who knows what Orenitram spells backwards? Martine. Just a little trivia. Okay. We have time for 1 last question in the back.

That was me. I was going to tell what's...

Okay. I didn't see your answer. Okay, you guessed. You're ahead of me. So it's a question about the incidence?

I said is that just a coincidence?

No. It isn't -- that will be like a point trivia [indiscernible]. In fact, the funny thing is after spending a lot of money with these companies to figure out your name and then the FDA saying no, it's like too close to some other name, we just like figured one out by ourselves and it like sailed right through the FDA. So we have time for 1 last question. Jess, you're always reliable for a question.

You haven't talked much about RemoPro? And what's the time line there?

Yes. So Jess says, we haven't talked much about RemoPro? And what's the timeline there? RemoPro is moving very well. For everybody to be on the same baseline, RemoPro is a pain-free form of Remodulin that can really redefine the entire area of subcutaneous treprostinil delivery. And the time frame is for the commencement of clinical trials in 2021, FDA filing in 2022 and approval and launch in 2023.

Thank you so much. Thank you all.

Our pleasure.