United Therapeutics Corporation (UTHR) Earnings Call Transcript & Summary

Okay. Great. Good afternoon, everyone. My name is Jessica Fye. I'm the senior biotech analyst at JPMorgan. And we're continuing the Virtual Napa Valley Biotech Forum with United Therapeutic. I'm joined by the company's Chief Medical Officer, Dr. Gil Golden, and I think this is his first time in front of investors in a venue like this. So I think it's going to be great to get some more insight into the kind of medical point of view on the business. I also want to remind you guys to use the ask a question button on your screen to send me questions, there's a little lag, so just keep them coming, and we'll get to those. Before we get started, I do want to pass it over to Dewey Steadman from IR to cover some of the legal logistics.

Good afternoon, everyone. Today's presentation may include forward-looking statements. And we encourage you to visit our SEC filings for the latest risks and uncertainties related to those disclosures. Thanks.

Awesome. Thanks, Dewey. So Gil, again, thanks for joining us.

I was hoping to start off with some questions on Remodulin. And maybe first with the Remunity pump now that that's kind of starting to launch, can you talk about the key themes as you educate subscribers on that product?

Yes, sure. And first of all, thank you very much for having me here. Happy to talk about Remunity. The microinfusion pumps that are currently on the market were previously available. They're really quite antiquated. They haven't been updated in quite some time. And what the Remunity pump does is it takes advantage of modern technology to provide a state of the art pump, one that's small and elegant. Think more like an Apple device than a typical PC. It has a remote controller. It comes with cassettes that are prefilled. The device is water resistant. It provides a wide array of alerts and alarms, and it's completely abstinent of motor. So it uses acoustic volume sensing technologies and a solid-state actuator to control flow rates. This is much more accurate and precise than those piston-driven devices that are currently on the market. So we really think that this is an exciting new offering.

And guess understanding that it's early on, can you share any insight or feedback that you're hearing from the medical community about Remunity? What are the key questions that doctors tend to ask about transitioning their patients onto this product?

Yes. Sure. So health care providers have appreciated the benefits of Remodulin for nearly 2 decades now. But both health care practitioners and patients recognize that there remains significant challenges in administering Remodulin via chronic indwelling catheter, which is attached to a bulky microinfusion pump. I know that's kind of an interesting juxtaposition, bulky microinfusion pump but that's the reality of it. And for a number of years ago now, Dr. Hap Farber, who at that time was at Boston University, and now he's at Tufts University in Boston. He presented data from the REVEAL Registry that showed that up to 40% of patients with higher risk and later stage pulmonary hypertension who really should be treated with a parenteral prostacyclin are never even given a chance to test out those products and see if they're effective for them. The reasons for this are multifactorial, to be sure. But certainly, the following would play into this. There's a hassle factor associated with preparing medication daily. They're complicated, and these pumps are error prone. And as I mentioned, they're large, they're bulky. They're very noticeable. It affects body image, for example, and you can't get them wet. So there's no swimming. Bathing becomes challenging. Sex becomes challenging, et cetera, et cetera. So UT years ago, addressed the issue of bloodstream infections with the commercialization of subcu Remodulin. And now we're addressing a number of the remaining challenges by bringing forward this Remunity pump. This allows patients to bathe and swim. The pump cassettes are prefilled with Remodulin and the pump itself is small enough that it can be easily hidden under clothing. And I will say, finally, with this state of the art technology, it's less error prone, and it delivers Remodulin more precisely than the pumps that were previously available.

Do you sense any difference in either physicians or patients interest level in Remunity Based on whether a patient is new to Remodulin or already on one of the subcu, CADD, and the free pumps?

Well, it's really too early for me to be able to comment meaningfully with respect to patient interest. But for reasons I just outlined and based on very limited patient discussions, what I can say is that interest in Remunity pump is strong. And Remodulin naive patients and those already receiving Remodulin using the traditional MS3 pump also have commented in their high level of enthusiasm about this pump. So we know from a limited number of sites where we've conducted HCP training on Remunity, there's very strong interest among HCPs at those sites, even from physicians who typically prescribe IV. So that's about all I can say on it at this time.

So I guess kind of related to that, based on the physician feedback you've heard, do you think the availability of Remunity might end up driving a shift towards more subcu use of Remodulin relative to IV?

So there's approximately a 50-50 split between IV and subcu Remodulin use in the U.S. right now with a slight edge going towards subcutaneous use. And the way I would describe this is there are essentially 2 groups of prescribers when it comes to Remodulin. There's those who train using exclusively IV prostanoids like epoprostenol and treprostinil. And some of them still struggle to see how a subcu product can be as effective as an IV product. It's sort of like IV is associated as the big gun, think about how we use anti-infective agents and IV antibiotics versus oral antibiotics and so on. But despite -- this is all despite very clear data that demonstrates similar bioavailability and roughly similar PK among the IV and subcu treprostinil products. And some of these clinicians simply don't have sufficient nursing staff or the desire to manage patients on subcu Remodulin, which admittedly requires more HCP time due to the associated site reactions. So they more or less prescribe IV exclusively. And then there are those who recognize that subcu is a safer option, and generally should be the first choice for Remodulin administration unless, of course, the patient cannot tolerate it because of a site reaction. So at least until ISR is commercially available, the infusion pump used for IV Remodulin, the CADD legacy. It's much larger when compared to the Remunity pump. I do believe there will be pressure on doctors from patients who want the Remunity pump. And this may push some of those IV prescribers towards subcu.

You mentioned the site reactions. Can you help us understand like how heavily does this site pain factor into prescribers choice between subcu and IV?

Well, quite a bit. So most, if not all, patients would prefer to be on sub Remodulin, if not for the site reaction. And so it's safer, subcu is safer. The daily routine is simpler. There's no mixing. So intolerable site pain, can drive, and I want to emphasize this [indiscernible] of patients towards IVs. But I think -- and to your point, and as noted earlier, there are prescribers who simply do not want to deal with subcu patient management and it's really the biggest reason -- the biggest reason for that is because of this subcu site reaction. It occurs in around 90% of patients. But it almost always can be effectively managed. It takes additional HCP time and effort to do that, to be sure. But I would emphasize that this is a small minority of prescribers who will not even give subcu a chance in the newly initiated Remodulin patient.

Okay. So kind of a related question. But longer term, how do you think about the availability of Remunity factoring into prescribers decisions on when to start patients on Remodulin as their prostacyclin or other PAH therapies. I guess for me, is it possible that having a pump like this might kind of lead patients to transition sooner in the course of their disease to Remodulin?

So please understand that any answer to this question will be only speculative on my part at this time. So with that caveat, what I would say is, it should be noted that there are a number of reasons why we might see a shift over time towards earlier use of Remodulin. I mean for one thing, despite 13 approved PAH products in the U.S. market, the parenteral prostacyclins now are used actually later in the course of illness than they were previously because the orals tend to be as first. And yet there's been only a modest and unsatisfactory improvement in survival in recent years. It has been noted in study after study that delaying prostanoid use even by just 12 weeks, so 3 months can cause a situation where the patient status is never able to catch back up to patients who were started earlier on prostanoid therapy. And one other thing I would add is that even though PAH is pulmonary vascular disease, increased pulmonary arterial pressure as the name of the disease suggests is what leads to right heart failure. Ultimately, it's the right heart failure, that is the cause of death in the majority of these patients. So increasingly data are being reported from Asia, Europe and even the U.S., showing that if treatment is targeted at lowering the abnormal pulmonary arterial pressure and it's done early enough in the course of the disease, while some of these processes are still reversible, the RV is there. That's the right ventricle. And the patient will then go on to have a long life, and perhaps die of something else, it becomes more manageable. These reports suggest that the best way to accomplish this is with an early combination therapeutic regimen, including a parenteral prostacyclin. So it's just class specific, not drug specific. UT is actually going to test this, however, directly in an upcoming Phase IV clinical trial. And all this is to say that the rationale for earlier prostanoid therapy is rather compelling. But the challenges in administration have been significant. And UT recognized long ago that the more we can lower those barriers to parenteral prostanoid administration, the more likely HCPs and especially patients will accept this form of therapy. That's why we developed and we are continuing to develop such a wide array of delivery vehicles and formulations for this powerful medicine. Indeed, one size does not fit all in this case.

Okay. There's a portal question here about Remodulin, which is, can you help us understand the process of getting a patient stable on the right dose of Remodulin? How much titration or fine-tuning is required and is this handled differently for subcu versus IV.

Sure. So it's generally -- let me take the second part of that first, which is that it's generally not handled differently for subcu or IV, they're really able to be dosed very similarly. And even we learned a long time ago and it's been published that the issue with subcu with site pain and reaction. It's not related to the dose of Remodulin. So the important thing is to get a patient up to a therapeutic dose of Remodulin really as quickly and according to label, of course, although there are physicians who go faster than what's indicated in the label. This is not something that we actively promote. But -- so you want to push that dose up into a therapeutic level in a reasonable period of time. And again, there are really no differences between IV and subcu. But as we -- as time goes on, remember, this is a progressive disease. And so over time, it's important to continue to monitor that patient symptoms and their overall health status and it may be necessary to increase the dose of Remodulin over time. And this is really key, and it's something that you can do with a true prostanoid product that's fully titratable like Remodulin. Again, these patients progress and the medication whether you add a new therapy or you increase the dose of the current medication is something that's very important to consider. Hopefully, that answers that question for you.

Okay. Got it. And maybe this is related to the fine-tuning required here, but another question we've got in e-mail is what proportion of Remodulin scripts are written as dispense as written?

What proportion of our Remodulin prescriptions are written as dispense as written. Again, on the medical development side of the business, I think I'm probably not the best person to be able to answer that particular question. As we have noted time and time again, there's been essentially no impact of the generic Remodulin on current Remodulin prescriptions. We continue to see robust business. I don't know whether that's because clinicians are writing dispense as written or there are other reasons for it.

Okay. Switching to the ISR. How do you think about those segment of patients who will be candidates for the implantable system for Remodulin once it eventually comes to market?

Yes. So the ISR addresses several of the biggest challenges with respect to parenteral prostanoid administration, the implantable system for Remodulin. Most importantly, it eliminates entirely the risk of bloodstream infections. These can be serious, very rarely, but possibly even leading to sepsis and death. So I already noted that the currently available IV pump in the U.S., the CADD legacy is antiquated and bulky. And further -- and historically, prostanoids for IV administration had to be prepared on a daily basis in an aseptic environment at the patient's home or by the specialty pharmacy and then store them to use. So the ISR completely eliminates all of these challenges. There are no bloodstream infections. There's no mixing of the product and the diluent. And there's no external pump. So the patient is free to shower, swim, exercise, really, to the extent that their health permits and literally to do this untethered. So in short, just about any IV patient is a candidate for ISR. However, there are some candidates who are even more obvious than others. So for example, those who cannot tolerate subcu Remodulin due to infusion site reactions and maybe who have contracted multiple infections with IV Remodulin, so they'd be really good candidates. There are those on IV therapy, who have difficulty managing their drug administration, and or the device itself. So this could be because maybe they have scleroderma, Group 1 pulmonary arterial hypertension. These are patients who maybe have manual dexterity issues or pain in their fingers. And so it prevents them from all the necessary work to prepare the drug and program the device and so on. They might have unsanitary living conditions. There are Remodulin patients who are homeless, for example, and really difficult to manage IV with external pumps in that circumstance. And then there could be other physical and mental health impairments, of course. So to me, these patients represent the really low-hanging fruit.

Okay. Got it. Before we switch gears to Tyvaso, we've got a bunch of questions related to -- from competitor news yesterday. So I'm not sure if you can tackle this through your medical background. But essentially, what's your impression of the Liquidia partner approval for a cartridge for generic Remodulin, is it possible that, that can be automatically substituted at the specialty pharmacy? I guess just how does that work?

Yes. I'm actually glad to take this question. I'll just say a little bit about it. With the established safety profile for Remodulin, it demonstrates supply chain reliability and physicians and payers that haven't historically encouraged substitution of an existing lower cost parenteral alternative. We really don't expect any material impact from this launch. I mean, recall that generic IV Remodulin, it launched in March of 2019, and there has been no material impact on the business, 24 months after launch. So a few other points that I'd like to make specific to the subcutaneous systems that I think should be considered. When Smiths Medical announced way back in 2015 that it would discontinue manufacturing of the CADD-MS 3 pump and the associated cartridges that go along with it, United Therapeutics at that time commissioned additional new pumps and cartridges to ensure a supply for its patients. And as a result of UT's investment and foresight, nearly all CADD-MS 3 pumps manufactured by Smiths Medical since 2016 and nearly all Smiths Medical CADD-MS 3 cartridges that were manufactured since 2017 are owned by UT and available for use only by UT's patients who are on Remodulin. So because of the discontinuation announced in 2015, most of these pumps, most of any pumps that are not owned by UT, they're around 5 or more years old at this point. And pumps sometimes need to be repaired or replaced. And then lastly, what I'll say is, as evidenced by a 20-plus year history and massive investments undertaking treatments and devices for PAH and ultimately towards finding a cure for this disease, UT has made a clear long-term commitment to our patients and really to all patients who suffer from PAH. So again, we're not anticipating material impact.

Okay. Got it. So let's switch gears to Tyvaso. And there's been a lot of focus on the part of investors on the increased data and potential for that to open up the PH-ILD market for Tyvaso. So just to set the stage a little bit, can you describe for us the typical path to diagnosis of pulmonary hypertension in a patient with ILD? Like where are these patients start out? Where are they treated? Why might a physician suspect PH-ILD and kind of how does it go from there?

Sure. So PH has been reported to develop in up to 86% of patients who have severe ILD over the course of their lifetime. And this is important because it's associated with reduced exercise capacity and greater need for supplemental oxygenation. They have decreased quality of life and experience an earlier death. Only a minority of patients with ILD actually present with the symptoms of pulmonary hypertension at their initial diagnosis. So this makes it really challenging to make the diagnosis of PH-ILD patients who develop pulmonary hypertension over the course of their illness because many of these symptoms are actually similar between the 2 diseases. And moreover, and this is really important, with the historical absence of medicines to treat ILD PH, there was very little incentive for pulmonologists to actually look for it. So one of the great opportunities that we have right now in United Therapeutics provided a new indication that is approved for Tyvaso next month is that we now have what is largely a new group of pulmonologists to educate about inhaled treprostinil therapy and the many benefits for this group of patients. So in the INCREASE study, inhaled treprostinil not only improved exercise capacity, but also grouped a host of secondary endpoints, including the cardiac biomarker, NT-proBNP, time to clinical worsening. There were fewer exacerbations on the underlying disease. And there was no change in the safety profile. There was no decrement in lung function. We didn't see VQ mismatching. And so with these data, there has been tremendous excitement among pulmonologists and HCPs with a focus on pulmonary hypertension. And with compelling data, there's now a compelling reason to diagnose and treat it. So to your other part of your question, patients need to be treated by the pulmonologist to diagnose the ILD or in some cases these patients are referred to pulmonary hypertension specialists for their diagnosis of ILD PH and a subsequent PH care. And -- but with this approved new therapy -- well, when it's approved later in April, it seems likely that the prescriber base for Tyvaso will increase. And some of these pulmonologists may actually wish to retain their patients. So we do expect to see that.

Have your MSLs been able to engage with physicians around the increased data? Or has the company kind of more broadly been able to gauge positioning or actions from ad boards? And if so, what's the reception been like to that data set? And is the feedback any different between pulmonologists and cardiologists?

Despite the pandemic, yes, we have been able to engage. The answer really is both. We've had advisory boards, we've had MSL engagement. Our MSLs have been reactively addressing questions from clinicians about increase for quite some time now. The reception has been quite enthusiastic, which only increased, pun intended, once the increased primary manuscript was published in the New England Journal of Medicine. The enthusiasm comes not just from successfully meeting the primary endpoint of improved exercise capacity, but the fact that all of the secondary endpoints were met. And there were no negative effects on gas exchange, as I just mentioned. So remember, I think it's important to remember, it's not like this is an area that hasn't been studied with other vasodilators. I mean not only did others fail, but some actually proved to be dangerous due to adverse impact on the underlying disease. So this is truly a remarkable result. But not surprising since this is an inhaled prostanoid product, and we had the benefit of several small preliminary studies, proof-of-concept studies, where we evaluated the safety and efficacy of Tyvaso in this patient cohort, this very patient cohort. So whereas there's tremendous enthusiasm around the exercise improvement in these patients. It's been noted that this was a relatively short study of just 16 weeks. And the effect on forced vital capacity or FVC was so profound in that short period of time that many would like to see more data on these antifibrotic effects. In other words, impact on the underlying disease. This isn't necessary to convince them to prescribe Tyvaso for ILD PH, but it will be important for a future potential indication in a large subset of ILD patients. And specifically, I mean those with interstitial pulmonary fibrosis and this group of patients that we're studying in the TETON study. And that's in the absence of pulmonary hypertension. So that's why we're conducting the Phase III TETON study, and everyone is really eager to see the results of that study. This is a large new TUT patient cohort of about 100,000 patients. And there was one other aspect of your question is if we're seeing differences between -- among the cardiologists or pulmonologists. And I think it's still a bit early to note that. I would say there's general enthusiasm. I mean, everybody recognizes that this is a disease that we've known about for a long time. It's a very serious disease, and there hasn't been a treatment available. So people are genuinely, whether they're a pulmonologist or a cardiologist or a rheumatologist or some other type of physician, pretty excited about this result. I'm sure with time, we'll begin to learn more, but really outside of pulmonary hypertension, the inhaled pulmonary products tend to be most utilized by pulmonologists and the ILD patients really visit with pulmonology specialists to manage that care. So more attention has been focused on this by pulmonologist thus far.

So you kind of mentioned a number of different endpoints that were evaluated in INCREASE study. I mean just to dig into this a little further, which endpoint or maybe endpoints, in particular, do you think are going to resonate with physicians?

Well, I'm not sure to say that any one endpoint is viewed as more important than others. But rather, what I would say is, in general, they're complementary to or validating of one another. So 6-minute walk distance was chosen in INCREASE study as our primary endpoint. Our objective was to address the pulmonary hypertension component of the disease, not the ILD component at the offset. And we knew from our years and years of experience treating pulmonary hypertension, which approximately 16 weeks is all that we would need to test the ability of Tyvaso to affect exercise capacity using the tried and true endpoint of 6-minute walk distance. This is a traditional endpoint in pulmonary arterial hypertension. It's been studied and validated many times as a good surrogate for exercise capacity. We also knew that this 16 weeks would be long enough to detect any adverse effects on gas exchange as determined by a pulmonary function test, pulse oximetry and changes in potentially supplemental oxygen requirements by these patients because many of them are on supplemental oxygen. So taken together, these data robustly support the positive effect of Tyvaso on symptom management again without adversely impacting on the underlying interstitial lung disease. So what we didn't anticipate finding was a noted improvement in FVC, forced vital capacity. And this suggests the presence of the antifibrotic activity as a result of administration of Tyvaso in these particular patients. And FVC in this study was evaluated as a prespecified but safety endpoint in the study, not an efficacy endpoint. We're looking to avoid doing harm. So that's why we looked at it. And instead, we found benefit. So this is what led to the TETON study in IPF patients, which presently is enrolling, and typically is treated by these very same pulmonologists. So the work that we're doing to educate these patients now, while I'm sorry, these health care practitioners now, but it certainly will help with expanding the prescriber base and utilization of Tyvaso pending FDA approval for the new ILD PH indication. It will pay dividends for if the TETON study is positive.

Can you remind us what in the literature or what the literature suggests about the number of patients in the U.S. with diagnosis of PH ILD that's been confirmed by right heart catheterization? And as you engage with physicians about the increased data, what have they said about how this data might open up and the possibility of an improved treatment might open up the potential for them to kind of pursue confirming a suspected PH ILD diagnosis?

Sure. So there are about 230,000 patients in the U.S. with ILD. And just for a frame of reference, recall, there are about 45,000 or so patients with PAH in the U.S. So several fold more. And about 86% of those with severe disease are, again, our thought that they will at some point during the course of their illness develop pulmonary hypertension component to the disease, but the incidence rate at the time of initial ILD diagnosis is really around 30,000. So as I noted earlier, there is currently no approved medical therapy for ILD pulmonary hypertension. And several therapeutics have been shown to be harmful when used off-label in this group of patients. So it's expected that many patients who have ILD simply haven't been thoroughly worked out to make the diagnosis of ILD PH, and most will have had an echo, but many fewer had an invasive right hard cath. Because once you have the diagnosis, what are you going to do about it, right? So interactions with treating pulmonologists suggests a very high degree of enthusiasm to have an improved medicine to treat this disease. And given this, we would expect to see an increase in the confirmatory right heart cath. And so I would predict an increase again, pun intended in the incidence of ILD pulmonary hypertension diagnosis, a lot of increase.

Switching to some of the questions from the portal, maybe building on one of the comments you made earlier. What's the mechanistic rationale for Tyvaso to work in IPF?

Yes. So yes, I'm glad you brought up this particular question or somebody asked this particular question. So we -- when we look at a true prostanoid product like Remodulin, it hits various receptors and not just the IP receptor. It also works on different cells, whether those are endothelial cells, smooth muscle cells, red blood cells. And so classically, we've said that there are really 3 effects with prostanoid like treprostinil. And those include an anti-fibrotic effect among it more obvious vasodilatory effect that we see in that is still important in part in pulmonary hypertension. And then there's also an anti-platelet effect. So these are all well-known and have been published and demonstrated in animal models. And so because of this anti-fibrotic effect, which has been explored, it perhaps shouldn't be so surprising when we see a result that suggests an antifibrotic effect in a group of patients who have fibrotic lung disease. So I mentioned previously that we measured forced vital capacity, we use spirometry to do that or pulmonary function testing in our INCREASE study and we actually saw that not just at the rate of the deterioration in forced vital capacity over the course of the study was slowed, but that we actually saw improvement, which suggests that there is some antifibrotic effect to using this drug Tyvaso in this particular group of patients. Again, it was just a 16-week study. Typically, studies in this space are 52 weeks or more in duration. And so with other drugs that are approved, the typical antifibrotic agents nintedanib, pirfenidone, they've done longer studies, and they showed that they were able to slow the rate of decrease in FVC. Here, what we want to do is -- and people are questioning this, what happens over a longer period of time. It's truly dramatic that there was such an increase in just a short 16-week study. But it perhaps makes the results even more provocative. And so if this holds up in the TETON study, this -- again, it would be truly remarkable. And perhaps open the field to use of Tyvaso under alone or in combination with the already approved anti-fibrotic agents that are on the market. Now of course that remains to be seen based on the data from the TETON study and ultimately the product labeling at that time.

Thank you all for asking so many questions on the portal really, flying by. I'm going to try and combine a couple of these. One is about the Tyvaso or a couple that I am trying to merge are about the Tyvaso label. So what aspects of the potential ILD label or PH-ILD label are important to keep in mind? And are there any different scenarios to consider for the label? Could it be broader than PH-ILD Group III? Or is there any reason the agency could focus on a narrower subset of patients?

Yes. I can only sort of touch around the margins of this question because we are in label negotiations currently, and I really don't feel comfortable commenting too much on that. What I would say, again, we started out this study to look at the impact on the pulmonary hypertension component of this disease, ILD pulmonary hypertension. The primary endpoint was hit as were a host of secondary endpoints. To me, the fact that the study was so successful and the data are robust should speak to what we anticipate in the labeling. But unfortunately, I can't comment on particulars at this time.

Okay. I'm trying to get through a couple more of these. Is it possible to confirm, I think the company has sort of indicated this in the past, but is it possible to confirm that Medicare is or kind of would be allowing patients to start on Tyvaso based on echo's as opposed to requiring the right heart cath? Will that apply to PH-ILD? And how long could that dynamic last?

Right. So at the moment, and in light of the pandemic that is true, CMS has delayed the requirement or suspended the requirement for right heart cath in pulmonary arterial hypertension at the time of initial diagnosis to start definitive PAH medical therapy. I expect that, that will be reversed once the pandemic dissipates. I can't comment with certainty because it hasn't happened yet, and we don't even have a label yet. But I do expect that CMS and probably other payers will require a right heart cath eventually, once the pandemic passes to confirm the diagnosis of ILD pulmonary hypertension. I also expect that, again, until the pandemic clears, they probably will weigh in this requirement, but there's a little bit of speculation there on my part.

Okay. Makes sense. Another one here. I'm not sure if you've gotten physician feedback on this topic or if you can kind of rely on the feedback for Tyvaso on PAH over the years. But what's -- how receptive are clinicians to having to use the nebulized form of Tyvaso in PH-ILD until we get to Tyvaso DPI?

Well, so I mean, we're going to start with that. This is the first time if FDA-approves Tyvaso for ILD PH, that there will be a medicine specifically for this ILD PH population. This excites health care practitioners and it really excites patients. These patients have symptoms. symptoms in like the ability to exercise and go about the course of their day, that are very important to patients with this disease. They're willing -- more than willing to accept a device like the nebulizer at this point in time in order to have access to a medical therapy that can help them manage their disease. Over time, and hopefully, not much time, hopefully before the end of this year, 2021, all these patients, both in PAH and in ILD PH will have access to a much smaller device, which is the dry powder inhaler, and it's really not that far away. But I don't think the TD-300 nebulizer that's currently available and used is going to be a rate-limiting factor at product launch. And we've certainly seen good uptake amongst PAH patients historically, and we continue to see double-digit increase in sales for Tyvaso in the PAH market.

Great. Maybe on that topic, Tyvaso sales accelerated in the last year, and we've seen a lot of investors wondering if that pickup might be driven by the INCREASE result. Obviously, you're not promoting Tyvaso for PH-ILD yet. But do you think it's possible? Or have you heard any physicians prescribing it for PH-ILD patients because they just couldn't wait until approval?

Yes. So first of all, we are not -- we're obviously not promoting off-label. But there's a lot of excitement about this study as has been mentioned and this potential product and approval, including among PAH patients, or PAH treating clinicians. And so they are aware of the INCREASE study and the INCREASE study results, which were first presented by Dr. Steve Nathan from Inova Fairfax at ATS last summer. They're aware of the New England Journal of Medicine article. So they're hearing about Tyvaso more and more now, and it is likely that there are additional prescriptions being written because of this increased awareness, the increased hype around the product and the study as well as the concomitant publications. There will be additional publications in the future as well that come out of the INCREASE study. So yes, I think we're seeing some increased PAH prescriptions being written. We also perhaps would be naive to think that there might not be clinicians who can't wait and are writing for ILD pulmonary hypertension based on the results of the INCREASE study or possibly their own personal experience in prescribing the product. But I will say that we don't track that. We have no way of tracking the indication for which Tyvaso is being written. And so we don't encourage it, but we'll -- if it is written, and it is currently -- Tyvaso is currently on the market and someone is willing to pay for it then that prescription can be filled.

Okay. Got it. Another question here. With the data set increase, how do you think about the prospects for Tyvaso getting approved in Europe for PH-ILD?

Well, use of the data sets is quite good, but there will have to be additional work for Tyvaso to come to market in Europe. I don't want to get into the particulars on that. But as you know, we have a partner Ferrer S.A. that we work with very closely in Europe, and they would be responsible for pursuing that. So that is something that we will take under consideration.

Great. And maybe the last couple of minutes here, I'll try and combine a number of questions we're getting on Tyvaso DPI, which is what precedent product approval path is a good precedent to think about for the Tyvaso DPI approval, kind of what other drugs have gone from nebulized to DPI? And did you run studies on single actuation content and aerodynamic particle size distribution? And if so, what were the learnings? Are they required for approval?

So there's a lot there to unpack. Again, we haven't yet submitted this and gotten it approved. We're waiting for the agency FDA to weigh in and approve Tyvaso for ILD PH, and then we will shortly thereafter submit the application for DPI so that DPI will capture both PAH and ILD PH, and it's labeling. And again, for that reason, because we haven't gone through that process yet, I'd be hesitant to comment too much. What I will say is that we did have to do these biocompatibility studies, PK studies, human volunteer studies as well as use studies, human factor studies. And our data looked good. We're complete -- we've completed all these studies, and we believe that we have a compatible product and a great device. And so maybe I'll be able to provide a little bit more color to that question in several months.

All right. Got it. We're a little over time here. So I'm going to wrap up with the same last question we've been asking everyone. What's your favorite NAPA Valley wine?

I'm a simple person. I love them all. I love Stag's Leap, is great, if I have to pick one is that hopefully you're not going to tell me that's Sonoma. But yes, I mean -- so I happen to be a big fan of French wines and Italian wines. So I tend to lean a little bit in that direction. Sorry, but I love the background, and I love this thing now.

Okay. We'll leave it there. Gil, thanks so much, and thanks, everyone, for tuning in.

Thank you.