Good morning, and welcome to the United Therapeutics Corporation third quarter 2022 earnings webcast. My name is Chantelle, and I will be your conference operator today. All participants on the call portion of the webcast will be in listen-only mode until the question and answer portion of this earnings call. If you would like to ask a question during that time, simply press star, then the number one on your telephone keypad. If you'd like to withdraw your question, simply press star, then the number one again on your telephone keypad. 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 Patrick 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 a 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 send 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. 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 three years seems eminently 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 3 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 three years to go to 2025 and a 30,000 patient Group 3 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 two 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 hearts, 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 evermore unique and important products that produce evermore 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 nintedanib or pirfenidone due to our additive or therapy stacking approach to treatment. We all feel extraordinarily fortunate to work at UT for multi-year 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. I wanna highlight three of these milestones that we're particularly excited about. First, for the last couple of quarters, we've 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 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 quote-unquote, "blockbuster product." 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 two 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 PH is 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%. 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've said in the past that we expect a patient mix between Tyvaso DPI and Tyvaso delivered via the TD-300 nebulizer to eventually settle out at around 50/50 over time. Well, 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 Remunity to grow over the balance of the year and into 2023. In September, we launched a patient-filled version of the 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 PH patients do not experience a delay or disruption in their 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. It is our understanding that the available inventory of CADD-MS 3 pumps at those specialty pharmacy partners and in hospitals for both the pumps that we funded as well as other CADD-MS 3 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 two and three 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 their right ventricular function has normalized. The EXPEDITE protocol provides physicians with a roadmap 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 PAH 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 to Tyvaso DPI. Our average monthly Tyvaso referrals in each of the last three months are around 75% greater than the average monthly referrals pre-DPI launch.
I'm sure that may drop in November, December with the holidays, but they should remain above the pre-DPI average. I think it's fair to say today we're demonstrating that there is a PAH ILD market, and we've tapped into it relatively quickly. Thus, the objectives 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, clinics, 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. 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 tee up, I'll say. Operator, would you please open up the phone lines for any questions?
At this time, I would like to remind everyone, to ask a question, please press star one. To allow time for everyone to ask a question, please limit yourself to one question. Our first question comes from Eun Yang with Jefferies. Your line is open.
Thank you. A great quarter. 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 are a lot higher, because I guess it's according to your comment, DPI patients got on pretty early on. At the same time, given the tremendous sales growth in quarter-over-quarter, is it fair to assume that patients get on Tyvaso, the DPI? Would that be more from the new patients instead of a switcher from nebulizer? Thank you.
Oh, thank you, Eun. We appreciate your question. Mike, I think you've got the most, you know, context to answer.
Sure. Yeah, 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 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. Again, those patients will stay in there through the end of the year and start to transition to commercial drug after the first of the year. 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, you know, the DPI, in terms of the patients coming on, I will say that, the DPI uptake, the uptake's been faster on de novo than transitions. I think that's just a function of, as we're out talking with physicians, they're not proactively calling their existing Tyvaso patients in to transition them to DPI. They're just waiting for the next regularly scheduled appointment. As I said in my opening remarks, those transitions are occurring. They're just gonna occur over a little bit of time as physicians are waiting for the patients to come in for their 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. Your line is open.
Great. Thank you. Really nice update all. Thanks, Martine. Just one question. You know, I was lucky enough to be at European Respiratory Society in Barcelona a few weeks ago, and it was interesting to hear, you know, some of the excitement around the DPI pump. I mean, you know, you have essentially a third-generation pump there, or second, or I guess, versus, you know, potential competitors that could launch on the market whenever, whether it's this year or next year or the year after that. 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.
Thank you so much, Hartaj. Great to hear your voice right at the top of the call. I am not surprised that you would be at the ERS. You are the person in the industry who's got, I think, you know, nobody above them in terms of your going into the deep scientific research at all of the different medical conferences. 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 all along the way.
Sure. Happy to. I think we agree with you, Hartaj. We do think that the DPI does position us well against any current or future competitors. You know, certainly, I think the convenience, the size, the fact that it's one breath four times a day instead of nine to 12 provides a you know, again, a convenience advantage over the nebulizer. That certainly helps in that regard. I think as we get into you know, looking at you know, potentially other competitors for DPI that come on the market, I think there's a couple things that work in our favor. One is...
Just the United Therapeutics Support Services, the fact that we've been in the market for 25 years, physicians know us, they know that we're committed to the patients, I mean, that stuff actually matters to physicians. As it relates to the pump, I mean, one of the things that we, you know, 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. 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.
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 three seconds. It allows the device to deliver the drug more efficiently. You know, target dose of Tyvaso is nine to 12 breaths. That's equal to about 54-72 micrograms via the nebulizer. Tyvaso DPI delivers that same equivalent dose with 48-64 micrograms. It actually takes less drug to deliver the same amount of drug. It also ensures that the delivery, that the medication's delivered evenly in the airways, as I said, and deep into the lungs.
We do think that, you know, that combined with just kind of the easy kind of open-label inhalable administration positions us very well in the marketplace.
Totally. Perfect response. Very insightful question. Operator, next up.
Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.
Hi. Good morning. Thanks for taking the questions. Maybe a two-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. Just wondering if you're seeing something similar there. You know, if that will, as we think about kind of the step-up in coverage in 2023, maybe you could speak through that, Mike. 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 PH setting. Thank you so much.
Yeah, sure. The first question on Medicare, on the mix of Medicare and commercial. Yeah, 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, you know, what to expect next year with respect to the Medicare patients that are in our Patient Assistance Program transitioning to commercial. As of right now, I think we have around 700-800 patients in our Patient Assistance Program that are PH-ILD patients with Medicare insurance. We think a majority, probably not all, but a majority of those will transition over beginning in Q1.
That'll 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.
Duration of therapy. On duration of therapy, it's still a little early to tell. I would say early on, what we were seeing is physicians were taking their more advanced stage patients transitioning over to, you know, 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.
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 still sort of, I think, kind of ramping up these ILD treaters on when's the right time to put these patients on Tyvaso. I think that'll play out over time. We're sort of expecting that once the dust settles, it's gonna 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 TD Cowen. Your line is open.
Hi there. Good morning. Congrats on the progress, and thank you for taking my question. 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, you know, if there are any physicians that do have identified PH-ILD patients, maybe what are they waiting for before placing their patients on Tyvaso? Thank you.
Yeah, very interesting question, Joe. You know, Mike will be able to address it. You know, just as a tee up as you know, 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, you know, as ILD. 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, you know, is a reasonable guess. 14.
You know, 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, you know, directly that one time for a patient who they were trying to transplant and gave them a little bit of Flolan to try to help bring down their pressures before transplant, saw horrible V/Q mismatch right away, went to inhaled prostacyclin and were able to successfully bridge the patient over to transplant. V/Q mismatch is a horrible problem. That basically eliminates all these systemic drugs, be they oral or parenteral from the story of penetrating these 30,000 patients. Due to the amazing work of Dr.
Peterson and her team who are on the call and produced the stellar INCREASE results demonstrating you know the strong safety and efficacy of Tyvaso for ILD. Then you couple that with the wisdom of the FDA in you know enabling whether it's nebulized Tyvaso or DPI to be used in ILD. You have like you know just a very sweet situation from a pharmaceutical company standpoint of being able to rapidly help you know upwards of 30,000 patients who had no previous treatment whatsoever. This is why you heard the astounding numbers Mike was giving in terms of you know quarterly and monthly adds and the big step-up that we've had from 2021 to 2022.
Why very conservatively, we think that that kind of step-up, averaged across 2023 and then averaged across 2024 and averaged across 2025 will sync up with what we need to achieve 25 by 25. Basically, everything is, you know, in the right place, and it's up to us to execute, you know, expertly. Mike, maybe if you can just give a few-
Sure.
insights on our execution there.
Yeah, sure. I don't think it's the case that you've got physicians that have diagnosed 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. You know, in my opening remarks, I made a comment about the fact that, you know, typically, when you have a new product or a new indication, there's a lot of enthusiasm, but then it just kinda takes time for kind of traction to build, and we haven't seen that with DPI.
I think, you know, PH-ILD is probably an example of the norm where there's a lot of enthusiasm, but then the actual call to action and 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. I think part of that in the case of PH-ILD is the fact that you've got, you know, these, particularly with these ILD treaters, there's this term that I continue to hear called like therapeutic nihilism. So these are, like, typically really, really sick patients, and I think the doctors are really just, you know, unless the patients are gonna get a transplant, their long-term outcome is not good.
There's this behavior modification, there's behavior shift that we have to, you know, 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. The second thing is that, you know, we have an indication to treat the symptoms of pulmonary hypertension. We're starting to. You know, we have been making inroads there. I think 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 gotta be a tipping point here where I think the floodgates are gonna open, and it's as these ILD treaters become more accustomed to screening their patients, and then once the patients are started on Tyvaso, they see the benefits. I think once that happens, like I said, I think we're gonna see just, I think a, you know, 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. Your line is open.
Hey, guys. Good morning. 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? Maybe just kind of a housekeeping question, beyond the four key 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 Q4 revenue? Thank you.
Yeah. Thanks, Jess. Great to hear your voice this morning. You know, once again, just wanna have the chance to talk with you here on the call. Thank you for JPMorgan inviting us to speak at the major event that you've 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 Dimon. It was really exciting to be with him there at that conference. 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.
I do believe that Tyvaso will be the big driver of this growth that we anticipate in quarterly adds during 2023, 2024 and 2025. However, as I mentioned in my opening remarks, we do also believe there will be contributions from our other products. At one time it might have seemed, you know, like, you know, 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.
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 no doubt 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 mm of mercury, and then fast switch their patients to a high dose of oral equivalent prostacyclin, that they are reporting, you know, pretty much like Kaplan-Meier survival levels close to 100% at 10 years and even 15 years out.
It's like a way to manage pulmonary hypertension as a lifelong disease that you use Remodulin for a relatively short period of time, you know, three months, six months, you know, maybe up to a year. As EXPEDITE showed, we could fast switch the patients to double the dose of Orenitram that they were out on previously. They are already acclimated to the prostacyclin side effects this way from the parenteral experience. Now you get like the best of Orenitram right up front rather than the previous, you know, couple years since launch. They had kind of the worst effects of Orenitram up front and, you know, maybe gave up before they got to the best effects. This is what I mean by the, you know, 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. That's why I say there was a warm embrace by physicians, patients, payers. It is gonna be the star of the show. Very important are like best supporting actress, best supporting actor. All of these people are very important too. I also mentioned new delivery technologies that we're working on Remodulin. No time to go into all of those. There are a lot of supporting actors and actresses that are gonna get us to this 25 by 25. Mike, do you wanna provide a little bit more granularity to the back end of Jess's question?
Sure. I think, Jess, your second part of your question was just around any anomalies in quarterly ordering patterns in Q3. Short answer is no. That's something that we try to manage pretty tightly because, I mean, yeah, I think we've always talked about the fact that there's variability quarter to quarter, and that's true. To a certain extent, there's not a whole lot we can do about that. We do try and track pretty closely with our specialty pharmacy, what they're dispensing against what they're ordering. One of the metrics that I always kinda look at is what's the value of what we're selling to specialty pharmacy versus the value of what they're dispensing to patients.
You know, generally speaking, there's about a 5%-10% difference, and that can go either way. It could be we're 5% higher on sales versus dispenses, or it could be we're 5% lower. Typically what we see is that smooths out over the course of 12 months or four quarters.
You know, in the third quarter, we were, you know, kind of within that range, so nothing unusual there in terms of, you know, dispenses, and sales. So no anomalies there. Like I said, we continue to monitor that pretty closely because we do wanna minimize that variability.
Awesome. Dewey says there's time for one more question, and he's the boss. Next question, operator.
Our next question comes from Andreas Argyrides with Wedbush. Your line is open.
Good morning and congrats on the quarter, and thanks, Dewey, for taking my question here. Taking a look at the evolving PH treatment landscape, how are you thinking about the commercial dynamics over the next several years between your Treprostinil products and therapies with the novel mechanisms of action that could be coming onto the market in the near future? Thanks.
Yes. Thanks for the question, and I referred to this a little bit in the opening remarks in that, UT has long taken what I would call a therapy stacking approach to our pharmacopedia, if you will. We have a number of drugs, and they help a lot of patients. In most instances, they are stacked on top of other drugs. They are stacked on top of other drugs, first of all, because that's how we did the clinical trial. You know, 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? 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, you know, 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. First of all, you have a little bit of an ethical issue. I'm not saying it's a definite, you know, hard ethical issue, but I don't often get to say that my degree is in medical ethics, so I'm gonna say it.
It is 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 beneficence of that for that patient. It's kind of hard to argue. We've done, you know, Orenitram on top of background therapy and other companies and for example, in our IPF trial, we're on top of nintedanib and pirfenidone as background therapy. Other companies see the wisdom of this too. You know, a lot of the studies of sotatercept are also on top of background therapy.
I think this is the complexion of things in the future. Pulmonary hypertension is a multifactorial disease. There are at least six different pathological pathways that have been identified, prostacyclin pathway, nitric oxide pathway, the endothelin, serotonin pathways and, you know, thromboxane pathways. All these different pathways. 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. With that, Dewey, feel free to wrap up the call.
Operator, can you go ahead and wrap up the call? Thank you.
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