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spk04: Good morning and welcome to the United Therapeutics Corporation third quarter 2022 earnings webcast. My name is Chantal 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, the number one, again, on your telephone keypad. I will now turn the webcast over to Julie Steadman, Head of Investor Relations at United Therapeutics.
spk10: 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 Edgman, our Chief Financial Officer and Treasurer, and Pat Poisson, our Executive Vice President of Technical Operations, and Dr. Lee 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 send the webcast over to Dr. Rothblatt for an overview of our third quarter 2022 financial results and business activities of United Therapeutics.
spk08: Martin? Thanks, Dewey. Good morning, everyone. Currently, we are helping about 12,000 patients, including over 10,000 troposomal 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 ads per quarter. Over the past year, we have increased our patient ads 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 in 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 ad 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 Renitram. And we have just commenced our WHO Group 3 penetration of ILD with Tyveso. 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 Tyveso DPI. Hence, with three years to go to 2025 and a 30,000 patient group three market waiting to be penetrated with Tyveso, we feel confident that year after year we can increase our quarterly patient ads 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 Relenopeg and continued patient-focused improvements in delivery systems and in protocols for Remunity, Tyveso, and Arenatramp. Now on top of all of that, we expect soon after 2025, a successful outcome of our two ketone phase three trials in pulmonary fibrosis, also known as IPF. That new indication for us, with about 100,000 US 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 lifesaving 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 Nintetamib, or perfenadone 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 Bankowitz, for a whole raft of really great news.
spk02: 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 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 terprozomal therapies, Tyveso, Tyveso DPI, Remodulin, and Arenatrem. Finally, Tyveso 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. So 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 Tyveso. As I said, we reported a really strong quarter for Tyveso, 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 Tyveso prescribers has grown by approximately 50%. And finally, the big driver was the launch of Tyveso DPI. As a result of these things, we added 500 Tyveso patients during the quarter. Regarding the Tyveso 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 Tyveso 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 the patient mix between Tyveso DPI and Tyveso delivered via the TD300 nebulizer to eventually settle out at around 50-50 over time. while our Tyveso new patient referral mix is already at around 50-50. Meanwhile, transitions from the TD300 to DPI are occurring as expected. Also, while still very early, we're really encouraged by the low discontinuation rate of patients using Tyveso DPI as compared to other prostacyclin class therapies. Turning to remodeling, 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 a remunity pump that complements our pre-filled 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 pre-filled cassettes. Offering both pre-filled and patient-filled options is expected to broaden and accelerate uptake for the remunerative pump. Continued adoption of the remunerative pump is becoming increasingly important to ensure that PAH patients do not experience a delay or disruption in their remodulin therapy. One of the prior pumps used for subcutaneous remodulin delivery, the Smith's Medical CAD MS3 pump, was discontinued by the manufacturer in 2015. At that time, United Therapeutics funded the manufacturer 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 CAD MS3 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, their immunity pump is on the market and available as an alternative for subcutaneous remodeling patients. Moving to arenatrem. We released top line data from the recent phase four expedite study investigating the rapid titration and transition of functional class two and three PAH patients from remodulin to arenatram. This study demonstrated that with this treatment approach, a patient can reach a therapeutic dose of arenatram faster and with fewer side effects than starting de novo. Over the long term, we expect arenatram 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 Tyveso, or want to transition from remodulin after their right ventricular function has normalized. The expedite protocol provides physicians with a roadmap to effectively use arenatram in these patients. To wrap up, as many of you know, we established a goal last year to double the number of Tyveso 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 PHILD 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 Tyveso. 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 TD300 to Tyvesa DPI. Our average monthly Tyvesa 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 and December with the 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 PHILD 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, 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 Tyvesa 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 Martin to lead the Q&A section.
spk08: Mike, that was a raft of really great news. So I was totally accurate in that T-U-T up, I'll say. Operator, would you please open up the phone lines for any questions?
spk04: At this time, I would like to remind everyone to ask a question. Please press star 1. To allow time for everyone to ask a question, please limit yourself to one question. Our first question comes from Yun Yang with Jefferies. Your line is open.
spk01: Thank you. Great quarter. So if I heard you correctly, you added additional 500 patients to Tyvesa this quarter. That's the same number as in the second quarter, but sales a lot higher because I guess it's, you know, according to your comment, DPI patients got on pretty early on. But at the same time, given the tremendous sales growth in quarter over quarter, is it fair to assume that patients get on Tyveso, the DPI? Would that be more from the new patients instead of a switcher from nebulizer? Thank you.
spk08: Oh, thank you, Yen. We appreciate your question. And, Mike, I think you've got the most context to answer.
spk02: Sure. I think on the revenue, I think the other thing to keep in mind in terms of comparing the number of patient ads 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 or receiving free drugs. So 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, but that, I think, explains some of the difference in the revenue between Q2 and Q3, even though the patient ads 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's 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 high-vasio patients and to transition them to DPI. They're just waiting for the next regularly scheduled appointment. And so, as I said in my opening remarks, Those transitions are occurring. They're just going to occur over a little bit of time as physicians are waiting for the patients to come in for their next appointment.
spk08: Perfect, Mike. Perfect. Thank you. Operator, we are ready for the next question.
spk04: Your next question comes from Hartaj Singh with Oppenheimer and Company. Your line is open.
spk07: Great. Thank you. 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, and it was interesting to hear some of the excitement around the DPI pump. I mean, you have essentially a third-generation pump there, a second, 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 and why that should be a competitive advantage regardless of competition in the future? Thank you.
spk08: Thank you so much, Hartaj. So great to hear your voice right at the top of the call. And I am not surprised that you would be at the ERF. 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. 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 all along the way.
spk02: 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 one breath four times a day instead of nine 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 that just the United Therapeutic 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, that actually matters to physicians. And then as it relates to the POP, 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. And 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 three seconds. And it allows the device to deliver the drug more efficiently. So, you know, target dose of Tyveso is 9 to 12 breaths. That's equal to about 54 to 72 micrograms via the nebulizer. Tyveso 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 medication is delivered evenly in the airways, as I said, and deep into the lungs. 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.
spk08: Totally. Perfect response. Very insightful question. Operator, next up.
spk04: Our next question comes from Terrence Flynn with Morgan Stanley. Your line is open.
spk06: Hi. Good morning. Thanks for taking the questions. Maybe a two-part for me on Tyveso. 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 you know, 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 Tyveso for PHILD and how that compares or how that you expect that to compare to the PH setting. Thank you so much.
spk02: Yeah, sure. So, the first question on the 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. So as of right now, I think we have around 700 to 800 patients in our PAP program that are PHILD 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'll obviously, I think, help from a revenue standpoint as we head into next year. What was the second part of the question?
spk06: Duration of therapy.
spk02: Oh, duration of therapy. Yeah, sorry. So on duration of therapy, yeah, I think it's still a little early to tell. I would say early on what we were seeing is I think that physicians were taking their, I would say their more advanced stage patients, transitioning over, putting them on Tyvesa. They weren't staying on as long. I think as the physicians are starting to understand the increased data better, understand how to use Tyveso, 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, again, we're still sort of, I think, kind of ramping up these ILD treaters on when's the right time to put these patients on Tyveso. So I think that'll That'll play out over time. We're sort of expecting that once the dust settles, it's going to be roughly the same.
spk08: Great, Mike. Thank you very much. Terrence, great to hear your new platform there at Morgan Stanley. Operator, next call.
spk04: Our next question comes from Joseph Stone with Callen & Company. Your line is open.
spk03: Hi there. Good morning. Congrats on the progress, and thank you for taking my question. In terms of penetration into that PHLD 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 PHLD patients, maybe what are they waiting for before placing their patients on type A zone? Thank you.
spk08: Yeah, very interesting question, Joe. And, you know, Mike will be able to address it. But, you know, just as a, as a tee-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 PH 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 PH, 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 VQ 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 VQ mismatch right away, went to inhaled prostacyclin, and were able to successfully bridge the patient over to transplant. So VQ 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 produced the stellar increase results demonstrating, you know, the strong safety and efficacy of Tyveso for ILD. And then you couple that with the wisdom of the FDA in, you know, enabling whether it's nebulized Teveso 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. And this is why you heard the astounding numbers Mike was giving in terms of, you know, quarterly and monthly ads. 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 will sync 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.
spk02: Yeah, 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 Tyveso. I think the name of the game here is actually screening for pulmonary hypertension. Okay. And, 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 kind of takes time for kind of traction to build, and we haven't seen that with DPI. But I think, you know, PHILD 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. And I think part of that in the case of PHILD is the fact that you've got, 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 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 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. And then the second thing is that, you know, we have, you know, we have an indication to treat the symptoms of pulmonary hypertension. And so we're starting to, we're starting, 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 got to be a tipping point here where I think the floodgates are going to open. And it's as these ILD treaters become more accustomed to screening their patients. And then once the patients are started on Tyveso, 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.
spk08: Perfect, Mike. Thank you so much. I'll take our next question, please.
spk04: Our next question comes from Jessica Fay with J.P. Morgan. Your line is open.
spk05: Hey, guys. Good morning. Great results today. Martine, at the beginning of the call, you were talking about your expectation for quarterly patient ads, 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 ads as largely Tyveso-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 Tyveso number that we should keep in mind when trying to project 4Q revenue? Thank you.
spk08: Yeah. Thanks, Jess. Great to hear your voice this morning. And also, you know, once again, just having the chance to talk with you here on the call, thank you for J.P. Morgan 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 Dimon. 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 PyVeso will be the big driver of this growth that we anticipate in quarterly ads 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. At one time, it might have seemed like hopeful thinking that Tyveso 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 Orinatrem 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 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 millimeters 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 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, you know, three months, six months, you know, maybe up to a year. And then as Expedite showed, we could fast switch the patients to double the dose of arenatram 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 arenatram right up front rather than the previous, you know, couple years since launch, they had kind of the worst effects of arenatran upfront and, you know, maybe gave up before they got to the best effects. So, this is what I mean by the, you know, new prescribing data with regard to arenatran. I think arenatran will be also a major contributor. Not as big as Tyveso and not as big certainly as Tyveso DPI. Tyveso DPI is the star of the show. And that's why I say there was a warm embrace by physicians, patients, payers. It's 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 remodeling. I'll have 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 Justice?
spk02: Sure. So I think, Justice, your second part of your question was just around any anomalies in quarterly ordering patterns in Q3. A short answer is no. That's something that we try to manage pretty tightly because 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 to specialty pharmacy versus the value of what they're dispensing to patients. And so, you know, 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 dispenses, 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 four quarters. So, 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. And like I said, we continue to monitor that pretty closely because we do want to have – we want to minimize that variability.
spk08: Awesome. Awesome. Awesome. Are there a time – Dewey says there is time for one more question, and he's the boss. So next question, operator.
spk04: Our next question comes from Andres Argarides with Wedbush. Your line is open.
spk09: Good morning and congrats on the recording. Thanks, Dewey, for taking my question here. So taking a look at the evolving pH treatment landscape, how are you thinking about the commercial dynamics over the next several years between your prognostical products and therapies with novel mechanisms of action that could be coming onto the market in the near future? Thanks. Yes.
spk08: Thanks for the question. And I refer to this a little bit in the opening remarks in that UT has a 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. 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, 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. So 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 going to say it. So 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, you know, beneficence of that for that patient. It's kind of hard to argue. So we've done, you know, Renitram on top of background therapy and, you know, Other companies, and for example, in our IPF trial, we're on top of Nintetamide and Perfetadone as background therapy. So other companies see the wisdom of this too. And, you know, a lot of the studies of Cetatercept 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 six different pathological pathways that have been identified, prostacycin pathway, nitric oxide pathway, 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.
spk10: Operator, can you go ahead and wrap up the call? Thank you.
spk04: Thank you for participating in today's United Therapeutic Corporation's earning webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the events and presentation section of the United Therapeutics Investor Relations website, at ir.unither.com.
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