United Therapeutics Corp (UTHR) 2022 Q3 法說會逐字稿

Good morning, and welcome to the United Therapeutics Corporation Third Quarter 2022 Earnings Webcast. My name is Chantel, and I will be your conference operator today. (Operator Instructions)

I will now turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation Third Quarter 2022 Earnings Webcast. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer; Michael Benkowitz, our President and Chief Operating Officer; James Edgemond, our Chief Financial Officer and Treasurer; and Pat Poisson, our Executive Vice President of Technical Operations; and Dr. Leigh Peterson, our Senior 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 Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update these forward-looking statements.

Also, today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products are available on our website.

Now I'll turn the webcast over to Dr. Rothblatt for an overview of our third quarter 2022 financial results and business activities of United Therapeutics. Martine?

Thanks, Dewey. Good morning, everyone. Currently, we are helping about 12,000 patients, including over 10,000 treprostinil patients, a high mark for our company. And we are making great progress on our goal of 25 by '25, meaning helping 25,000 patients by the year 2025.

Now achieving that goal will require annual growth in patient adds per quarter. Over the past year, we have increased our patient adds per quarter by about 66% from our historic rate of around 300 per quarter in 2021 to around 500 per quarter in 2022. Of course, there are monthly ups and downs and quarterly variability. But maintaining even half our current growth rate for the next 3 years seems evenly doable and will allow us to nail 25,000 patients by 2025.

Further supporting the achievability of continued growth in quarterly patient add rate is that we have really just begun with multiple new products and new product information. For example, we have just started our Remunity relaunch. We have just released our expedite top line results for Orenitram, and we have just commenced our WHO Group III penetration of ILD with Tyvaso. Then on top of all of this, we are at the very beginning stages of a truly warm embrace by physicians, patients and payers of Tyvaso DPI.

Hence, with 3 years to go to 2025 and a 30,000-patient Group III market waiting to be penetrated with Tyvaso, we feel confident that year after year, we can increase our quarterly patient adds at the rate needed to meet our announced goals.

Now upon getting even close to 25 by 25, we expect our revenues will be about double what they are now since right now, we have about half that number of patients. I believe that level of double PAH revenues will be sustainable well into the 2030s due to our expected launch of once-daily ralinepag and continued patient-focused improvements in delivery systems and in protocols for Remunity, Tyvaso and Orenitram.

Now on top of all of that, we expect soon after 2025 a successful outcome of our 2 TETON Phase III trials in pulmonary fibrosis, also known as IPF. That new indication for us with about 100,000 U.S. patients will enable our revenues to grow so rapidly that by the end of this decade, I expect our IPF revenues will actually be even greater than our PAH revenues. In other words, by around 2030, I'd expect to see something like a 60-40 split of $10 billion in revenues between IPF and PAH.

Meanwhile, I believe this past year, we have proven that genetically modified xenografts and lab cellularized organ scaffolds are practically doable. These achievements are the technology from which we plan to produce an unlimited supply of heart, lungs and kidneys. We will use the next few years of rapid growth in PAH and IPF revenues to flesh out the numerous aspects of turning our technological accomplishments into the preclinical, clinical and commercial manufacturing precursors of an exciting new transplant business.

As our PAH revenues start to plateau in the 2030s, we should be ready to ship thousands of life-saving manufactured organs each year. In summary, UT has a pragmatic step-by-step business plan of ever more unique and important products that produce ever more value for patients, physicians and payers. Furthermore, this business is resilient against generic products due to our unique drug delivery technologies, and it is resilient against NCEs such as sotatercept or existing drugs such as nintetimeb or pirfenidone due to our additive or therapy stacking approach to treatment.

We all feel extraordinarily fortunate to work at UT for multiyear goals, as is evidenced by our industry-leading retention rates and multiple Best Places to Work awards.

With that high-level overview, let me now turn things over to our President, Mike Benkowitz, for a whole raft of really great news. Mike?

Thanks, Martine, and good morning, everyone. Overall, we're extremely pleased with our third quarter commercial performance. We set a number of records on an overall and product-by-product basis during the quarter. But I want to highlight 3 of these milestones that we're particularly excited about.

First, for the last couple of quarters, we have been saying that we're effectively at a $2 billion revenue run rate. In the third quarter, our total revenues crossed $500 million for the first time in our history, which puts us, in fact, on a $2 billion run rate.

Second, as Martine mentioned, we exceeded 10,000 U.S. patients and approached 12,000 patients worldwide on one of our treprostinil therapies, Tyvaso, Tyvaso DPI, Remodulin and Orenitram.

Finally, Tyvaso revenues exceeded $250 million for the quarter, which puts that product on a $1 billion annual revenue run rate. As many of you know, a drug that generates $1 billion in annual sales is widely considered to be a "blockbuster" product. So the first -- for the first time in United Therapeutics history, we have a product that has reached blockbuster status, at least on a run rate basis.

These results are due to the efforts of our commercial and medical affairs teams who have been working hard all year, but have been particularly effective the last 2 quarters to help get us to this point.

Now I'll provide a little bit of color at the product level, starting with Tyvaso. As I said, we reported a really strong quarter for Tyvaso, which was driven by a number of factors. First, the third quarter was our first full quarter with CMS or Medicare coverage for patients with PH-ILD, so that prescribing obstacle has been removed.

Second, our continuing efforts to educate prescribers, particularly those ILD specialists to screen their ILD patients for PAH as having an impact.

Third, we continue to grow our prescriber base. Since the beginning of 2021, the number of Tyvaso prescribers has grown by approximately 50%. And finally, the big driver was the launch of Tyvaso DPI. As a result of these things, we added 500 Tyvaso patients during the quarter.

Regarding the Tyvaso DPI launch, physician engagement and enthusiasm around this new product is extremely high. Often, in the PH space, we see and hear enthusiasm around a new product launch but it takes some time for that to translate into referrals, which is our term for prescriptions, and then patient starts.

Fortunately, the Tyvaso DPI launch has bucked that trend as referral activity has been very strong from the beginning. For some context, we said in the past that we expect the patient mix between Tyvaso DPI and Tyvaso delivered via the TD 300 nebulizer to eventually settle out at around 50-50 over time, while our Tyvaso new patient referral mix is already at around 50-50.

Meanwhile, transitions from the TD 300 to DPI are occurring as expected. Also, while still very early, we're really encouraged by the low discontinuation rate of patients using Tyvaso DPI as compared to other prostacyclin class therapies.

Turning to Remodulin. In the third quarter, we saw a continuation of the strong referral patterns we've seen throughout 2022 and relative resilience and stability in the business despite the availability of generic competitors. The relaunch of the Remunity Pump is proceeding well, and we expect Remunity starts and total patients on our immunity to grow over the balance of the year and into 2023.

In September, we launched a patient fill version of a Remunity Pump that complements our prefilled pharmacy distribution option. The patient-filled option is being introduced for patients who prefer to fill their own cassettes and receive Remodulin shipments on a monthly basis rather than weekly shipments of prefilled cassettes. Offering both prefilled and patient-filled options is expected to broaden and accelerate uptake for the Remunity Pump.

Continued adoption of the Remunity Pump is becoming increasingly important to ensure that PAH patients do not experience a delay or disruption in the Remodulin therapy. One of the prior pumps used for subcutaneous Remodulin delivery, the Smiths Medical CADD-MS 3 Pump, was discontinued by the manufacturer in 2015. At that time, United Therapeutics funded the manufacture of several thousand additional pumps and, in parallel, pursued development of the Remunity Pump to ensure Remodulin patients would have a pump for their therapy.

Earlier this year, we sold our remaining inventory of CADD-MS 3 pumps to our specialty pharmacy partners and hospitals. And it is our understanding that the available inventory of MS3 pumps at those specialty pharmacy partners and in hospitals for both the pumps that we funded as well as other MS3 pumps that may have been on the market is winding down. Fortunately, the Remunity Pump is on the market and available as an alternative for subcutaneous Remodulin patients.

Moving to Orenitram. We released top line data from the recent Phase IV expedite study investigating the rapid titration and transition of functional Class II and III PAH patients from Remodulin to Orenitram. This study demonstrated that with this treatment approach, a patient can reach a therapeutic dose of Orenitram faster and with fewer side effects than starting de novo.

Over the long term, we expect Orenitram will continue to be an important part of our product portfolio and the PAH treatment armamentarium in patients that either prefer oral medications have failed on Tyvaso or want to transition from Remodulin after the right ventricular function has normalized. The expedite protocol provides physicians with our road map to effectively use Orenitram in these patients.

To wrap up, as many of you know, we established a goal last year to double the number of Tyvaso patients from 3,000 to around 6,000 by the end of 2022. We established this goal to address questions around and to frame the existence of: one, a PH-ILD market; two, the size of that market; and three, how quickly we could tap into it.

As of the end of October, we have around 5,600 patients on Tyvaso. We added more than 250 patients in October alone. Specialty pharmacy has around 500 pending referrals for new patients that are making their way through the insurance approval process and then can be scheduled for patient start. Those 500 referrals exclude referrals to transition from the TD-300 Tyvaso DPI. Our average monthly Tyvaso referrals in east of the last 3 months are around 75% greater than the average monthly referrals pre DPI launch. I'm sure that may drop in November and December with holidays, but they should remain above the pre-DPI average.

So I think it's fair to say today, we're demonstrating that there is a PH-ILD market, and we've tapped into it relatively quickly. Thus, the objective of setting the 6,000 patient goal have been accomplished. Typically, the fourth quarter can be a little challenging for us because of the holidays, which reduces selling days, clinician days and shipping days, not to mention that new patients, especially once we get between Thanksgiving and Christmas, sometimes choose to delay therapy initiation until after the holidays.

Having said that, and based on the stats that I just provided, we're well positioned as it relates to our goal of around 6,000 patients -- 6,000 Tyvaso patients by the end of the year, and we're continuing to build really good momentum heading into next year.

So with that, I'll turn the call over to Martine to lead the Q&A section.

Mike, that was a raft of really great news. So I was totally accurate in that up, I'll say. Operator, would you please open up the phone lines for any questions?

(Operator Instructions) Our first question comes from Eun Yang with Jefferies.

Great quarter. So if I heard you correctly, you added additional 500 patients to Tyvaso this quarter. That's the same number as in the second quarter, but sales were a lot higher because I guess it's -- according to your comments, the PI patients got on pretty early on. But at the same time, given the tremendous sales growth quarter-over-quarter, is it fair to assume that patients to get on Tyvaso that DPI, would that be more from the new patients instead of a feature from nebulizer?

Thank you, Eun. We appreciate your question. And Mike, I think you've got the most context answer.

Sure. I think on the revenue, I think the other thing to keep in mind in terms of comparing the number of patient adds versus the revenue growth is that in the third quarter, the vast, vast majority of those patients were commercial patients. Whereas in Q1 and Q2, we did not have the CMS coverage, so you still had a number of patients that were going through our patient assistance program are receiving free drugs.

So again, those patients will stay in there through the end of the year, start to transition to commercial drug after the first of the year. But that, I think, explains some of the difference in the revenue between Q2 and Q3, even though the patient adds were about the same.

In terms of the DPI, in terms of the patients coming on, I will say that the DPI uptake -- the uptake has been faster on de novo than transitions. And I think that's just a function of, as we're out talking with physicians, they're not proactively calling their existing Tyvaso patients and to transition them to DPI. They're just waiting for the next regularly scheduled to payment. And so as I said in my opening remarks, those transitions are occurring, they're just going to -- they're going to occur over a little bit of time as physicians are waiting for the patients to come in for the next appointment.

Perfect, Mike. Perfect. Thank you. Operator, we are ready for the next question.

Your next question comes from Hartaj Singh with Oppenheimer & Co.

Great. Really nice update all. Thanks, Martine. Just one question. I was lucky enough to be at European Respiratory Society in Barcelona a few weeks ago. It was interesting to hear some of the excitement around the DPI pump, you have essentially a third-generation pump there second or, I guess, versus potential competitors that could launch on the market whenever, whether it's this year or next year or the year after that. But can you just speak to that a little bit about how advanced the DPI pump is and why that should be a competitive advantage regardless of competition in the future?

Thank you so much, Hartaj. So great to hear your voice right at the top of the call. And I'm not surprised that you would be at the ERS. You are the person in the industry who's got I think nobody above them in terms of your going into the deep scientific research at all of the different medical conferences. But in terms of the details of answering your question, I think maybe, again, Mike, I might ask you to hit on that since you've really shepherded that DPI along the way.

Sure, happy to. So I think we agree with you, Hartaj, we do think that the DPI does position us well against any current or future competitors. Certainly, I think the convenience, the size, the fact that it's 1 breath 4 times a day instead of 9 to 12 provides, again, a convenience advantage over the nebulizer. So that certainly helps in that regard.

And then I think as we get into looking at potentially other competitors for DPI that come on the market, I think there's a couple of things that work in our favor. One is -- one, just I think just the United Therapeutics support services, the fact that we've been in the market for 25 years, physicians know us that we're committed to the patients. I mean that stuff, that actually matters to physicians.

And then as it relates to the pump, I mean, one of the things that we're particularly proud of and think is really a good thing for patients is that the DPI is what we call a low-flow, high-resistance device. And so that may sound a little counterintuitive, but that's actually an advantage because with a low flow, high-resistance device, you're relying more on the pump to do the work and less on the patient. So what that does, it means that a strong breath is not required to deliver a consistent dose to the distal airways. It's only one breath per cartridge in under 3 seconds. And it allows the device to deliver the drug more efficiently.

So a target dose of Tyvaso is 9 to 12 breaths. That's equal to about 54 to 72 micrograms via the nebulizer. Tyvaso DPI delivers that same equivalent dose with 48 to 64 micrograms. So it actually takes less drug to deliver the same amount of drug. And it also ensures that the delivery -- that the medications delivered evenly in the airways, as I said, and deep into the lung. So we do think that, that combined with just kind of the easy kind of open load inhaled administration positions us very well in the marketplace.

Totally. Perfect response, a very insightful question. Operator, next up.

Our next question comes from Terry Flynn with Morgan Stanley.

Maybe a 2-part for me on Tyvaso. I was wondering if you can tell us anything about the current Medicare mix. I think in some real-world studies in ILD, it's about 50% of patients overall would be eligible. So just wondering if you're seeing something similar there. And then if that will -- as we think about kind of the step-up in coverage in '23, maybe you could speak through that, Mike.

And then just wondering, any early read on the duration of therapy with Tyvaso for PH-ILD and how that compares or how you expect that to compare to the PAH setting?

Yes, sure. So the first question on the Medicare -- on the mix of Medicare and commercial, yes, that's essentially what we see is it's roughly a 50-50 mix. And it varies month-to-month, but I think 50-50 is a good number to kind of model off of.

In terms of what to expect next year with respect to the Medicare patients that are in our patient assistance program transitioning to commercial, so as of right now, I think we have around 700 to 800 patients in our PAP program that are PH-ILD patients with Medicare insurance. So we think a majority, probably not all, but a majority of those will transition over beginning in Q1. So that will obviously, I think, help from a revenue standpoint as we head into next year.

What was the second part of the question?

Duration of therapy for ILD?

Yes. I think -- sorry. So on duration of therapy, yes, it's -- I think it's still a little early to tell. It's -- as I would say early on, what we were seeing is, I think, that physicians were taking their -- I would say, they're more advanced-stage patients transitioning over -- putting them on Tyvaso. They weren't staying on as long. I think as the physicians are starting to understand the increased data better, understand how to use Tyvaso, understand how to dose, particularly in the newer treaters, that's starting to improve.

So it's still really, I think, too early to tell whether there's a distinct difference between PAH patients and ILD patients because I think we're -- again, we're still sort of, I think, kind of ramping up these ILD treaters on when is the right time to put these patients on Tyvaso. So I think that will play out over time. We would sort of expecting it once the dust settles, it's going to be roughly the same.

Great, Mike. Thank you very much. Terence, great to hear your new platform there at Morgan Stanley. Operator, next call.

Our next question comes from Joseph Thome with Cowen and Company.

Congrats on the progress. In terms of penetration into that PH-ILD market, now that Medicare is behind us, is it really just patient identification that is key here? Or if there are any physicians that do have identified PH-ILD patients, maybe what are they waiting for before placing their patients on Tyvaso?

Yes, very interesting question. Joe and Mike will be able to address it. But just as a key up as Mike's gathering his thoughts here, just to mention that we are talking about 30,000 patients in this ILD market. It is almost like PAH was reborn as ILD.

But from the standpoint of United Therapeutics, it's actually a lot better because while there are -- I've actually lost track of how many drugs are approved for PAH, 12 is a reasonable I guess or 14. Almost none of them can be used in ILD because of the very real problem of V/Q mismatch, which I was talking with a physician the other day, and they were telling me directly that one time for a patient who they are trying to transplant and gave them a little bit of flow to try to help bring down their pressures before transplant saw horrible V/Q mismatch right away, went to inhaled prostacyclin and we're able to successfully bridge the patient over to transplant.

So V/Q mismatch is a horrible problem. So that basically eliminates all these systemic drugs, be they oral or parenteral from the story of penetrating these 30,000 patients. Now due to the amazing work of Dr. Peterson and her team who are on the call and produce the stellar INCREASE results, demonstrating the strong safety and efficacy of Tyvaso for ILD, and then you couple that with the wisdom of the FDA in enabling whether it's nebulized Tyvaso or DPI to be used in ILD, you have like just a very sweet situation from a pharmaceutical company standpoint of being able to rapidly help upwards of 30,000 patients who were -- had no previous treatment whatsoever.

And this is why you heard the astounding numbers Mike was giving in terms of quarterly and monthly adds and the big step-up that we've had from '21 to '22, why very conservatively we think that, that kind of step up averaged across '23 and then averaged across '24 and averaged across '25. We will synced up with what we need to achieve 25 by '25. So basically, everything is in the right place, and it's up to us to execute expertly.

And Mike, maybe if you can just give a few insights on our execution there.

Yes, sure. So I don't think it's the case that you've got physicians that have diagnosed their patients with their ILD patients with pulmonary hypertension and are just sitting back and not prescribing Tyvaso. I think the name of the game here is actually screening for pulmonary hypertension.

And in my opening remarks, I made a comment about the fact that typically when you have a new product or a new indication, there's a lot of enthusiasm, but then it just kind of takes time for kind of traction to build. And we haven't seen that with DPI. But I think PH-ILD is probably an example of the norm where there's a lot of enthusiasm, but then the actual call to action of getting people to move and change behaviors has been, I mean, it's been good. It's probably been a little bit slower than what we would have expected, but it's starting to happen.

And I think part of that in the case of PH-ILD is the fact that you've got -- particularly with these ILD treaters, there's this term that I continue to hear call it like therapeutic nihilism. So these are like typically really, really sick patients. And I think the doctors are really just -- unless the patients are going to get a transplant, their long-term outcome is not good. So there's this behavior modification, there's behavior shift that we have to undertake and execute with these doctors to educate them on the fact that the prognosis for these patients if they have pulmonary hypertension is like twice as worse than if they just have ILD. That's sort of the first thing.

And then the second thing is that we have an indication to treat the symptoms of pulmonary hypertension. And so we're starting to -- we have been making inroads there. I think we're -- there's still a lot of opportunity ahead of us. I do think at some point, and I'm not sure what the quarterly patient number is, but there's going to be a tipping point here where I think the floodgates are going to open. And as these ILD treaters become more accustomed to screening their patients and then once the patients are started on Tyvaso, they see the benefits. And I think once that happens, like I said, I think we're going to see just, I think, another kind of step function in our growth.

Perfect, Mike. Thank you so much. Operator, next question, please.

Our next question comes from Jessica Fye with JPMorgan.

Great results today. Martine, at the beginning of the call, you were talking about your expectations for quarterly patient adds, even if they were sort of half of what they've been in 2022 to put you on track for your long-term targets. I guess in the near to medium term, do you see those adds as largely Tyvaso-driven?

And maybe just kind of a housekeeping question. Beyond the 4Q factors, you mentioned like the holidays, were there any favorable ordering patterns in the third quarter that helped the Tyvaso number that we should keep in mind when trying to project 4Q revenue?

Yes. Thanks, Jess. Great to hear your voice this morning. And also, once again, just want to having the chance to talk with you here on the call. Thank you for JPMorgan inviting us to speak at the major event that you had in New York honoring women entrepreneurs and women in business and focusing on the importance of that. And pass on our thanks to Jamie Diamond. It was really exciting to be with him there at that conference.

So going on to the particulars of your question, I do believe that -- I'll answer like the first part, and Mike, if you can answer the second part. So I do believe that Tyvaso will be the big driver of this growth that we anticipate in quarterly adds; during '23, '24 and '25. However, as I mentioned in my opening remarks, we do also believe there will be contributions from our other products. And at one time, it might have seemed like hopeful thinking that Tyvaso could become a blockbuster. I think we're there, and we'll continue to grow on that.

Right now, it might seem a little bit hopeful to think that Orenitram could become a blockbuster. But with the type of results that you're seeing in EXPEDITE and we have another even stronger study going on called ARTISAN, which will show the same sort of thing that physicians throughout the world, and you've seen these posters rolled out at ERS and other conferences, that physicians have shown that if they aggressively dose Remodulin over a short period of time, bring pulmonary artery pressures down below 35 millimeters of mercury and then fast switch their patients to a high dose of oral equivalent prostacyclin, that they are reporting pretty much like Capital Myer survival level close to 100% at 10 years and even 15 years out.

So it's like a way to manage pulmonary hypertension as a lifelong disease that you use Remodulin for a relatively short period of time, 3 months, 6 months, maybe up to a year. And then as expedite showed, we could fast switch the patients to double the dose of Orenitram that they were out on previously. And also, they are already acclimated to the prostacyclin side effects this way from the parenteral experience.

So now you get like the best of Orenitram right upfront rather than the previous couple of years since launch, they had kind of the worst effects of Orenitram upfront and maybe gave up before they got to the best effects. So this is what I mean by the new prescribing data with regard to Orenitram. I think Orenitram will be also a major contributor, not as big as Tyvaso and not as big certainly as Tyvaso DPI.

Tyvaso DPI is the star of the show. And that's why I say there was a warm embrace by physicians, patients, payers. It is going to be the star of the show. But very important are like best supporting actress, best supporting actor, all of these people are very important too. And I also mentioned new delivery technologies that we're working on, on Remodulin, of time to go into all of those, but there are a lot of supporting actors and actresses that are going to get us to this 25 by '25.

Mike, do you want to provide a little bit more granularity to the back end of Tyvaso?

Sure. So I think just, your second part of your question was just around any anomalies quarterly ordering patterns in Q3. The short answer is no. That's something that we try to manage pretty tightly because yes, I think we've always talked about the fact that there's variability quarter-to-quarter. And that's true. And to a certain extent, there's not a whole lot we can do about that. But we do try and track pretty closely with our specialty pharmacy what they're dispensing against what they're ordering.

And so one of the metrics that I always kind of look at is what's the value of what we're selling especially versus the value of what they're dispensing to patients. And so generally speaking, there's about a 5% to 10% difference, and that can go either way. So it could be we're 5% higher on sales versus dispensers or it could be we're 5% lower. And then typically, what we see is that smooths out over the course of 12 months or 4 quarters.

So in the third quarter, we were kind of within that range. So nothing unusual there in terms of expenses and sales. So no anomalies there. And like I said, we continue to monitor that pretty closely because we do want to have -- we want to minimize that variability.

Awesome, awesome, awesome. Are there time -- Dewey says there is time for one more question, and he's the boss. So next question, operator.

Our next question comes from Andreas Argyrides with Wedbush.

Congrats on the quarter. Taking a look at the evolving PAH treatment landscape, how are you thinking about the commercial dynamics over the next several years between your treprostinil products and therapies with novel mechanism of action that could be coming on to the market in the near future?

Yes. So thanks for the question. And I refer to this a little bit in the opening remarks in that UT has long taken what I would call a therapy approach to our pharmacopedia, if you will. We have a number of drugs and to help a lot of patients. But in most instances, they are stacked on top of other drugs. And they are stacked on top of other drugs, first of all, because that's how we did the clinical trial. And what we did is we showed our drugs had such and such an effect on top of background therapy.

Why did we do it that way? Well, there -- first of all, it's a lot easier to enroll a clinical trial on top of a background therapy, which is generally used. If you go in there and you say, there's a background therapy that's already approved and already generally used, and you say you've got a clinical trial that the patients have to be naive to all therapy, so first of all, you have a little bit of an ethical issue. I'm not saying it's a definite hard ethical issue. But I don't often get to say that my degree is in medical ethics. So I'm going to say it, so there's a little bit of a medical ethics issue that it's better to be able to show your treatment works on top of background therapy than to take a patient who has a bad disease, there are approved therapies and you kind of condemn them to placebo only and what is really the beneficial of that for that patient, if it's kind of kind of hard to argue.

So we've done Orenitram on top of background therapy. And other companies and, for example, in our IPF trial, we're on top of nicotinamide and pirfenidone as background therapy. So other companies see the wisdom of this too. And a lot of the studies of sotatercept are also on top of background therapy. So I think this is the complexion of things in the future. Pulmonary hypertension is a multifactorial disease. There are at least 6 different pathological pathways that have been identified, prostacyclin path, nitric oxide pathway, the even serotonin pathways and thromboxine pathways, so all these different pathways. So when you have a multifactorial disease like this, it calls for a therapy stacking approach because different drugs can help address different pathways. I hope that's responsive to your question.

And with that, Dewey, feel free to wrap up the call.

Operator, can you go ahead and wrap up the call? Thank you.

Thank you for participating in today's United Therapeutics Corporation's earnings webcast. A rebroadcast of this webcast will be available for replay for 1 week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir.unither.com.