Hello, everyone, and welcome again to the 43rd Annual J.P. Morgan Healthcare Conference. My name is Ben Davis. I'm an associate with the Healthcare Investment Banking Group out of New York, and I would like to introduce to you the Liquidia team. This morning, Dr. Roger Jeffs, the CEO, is going to be running through his presentation, and then the floor will open up to Q&A with COO and CFO Michael Kaseta and General Counsel Russell Schundler.
Great. Thank you, Ben. Really, really pleased to be here at J.P. Morgan and describe the forthcoming year that's ahead of us, which we're confident will be a transformational year for Liquidia. I also want to introduce Scott Moomaw, our Chief Commercial Officer, Dr. Rajeev Saggar, our Chief Medical Officer, and Jason Adair, our Chief Business Officer, who've had the pleasure of being here at J.P. Morgan with us this week. I'll give you the normal forward-looking statements. We'll make projections today, but we refer you to our filings for a more descriptive characterization of the risks and uncertainties.
So for those of you that are potentially new to the story completely, we are a biopharmaceutical company focused on developing best-in-class therapies for patients with pulmonary hypertension. Our premise is to provide therapeutic options that have improved drug delivery, reduce the burden of administration, and help patients breathe and live longer.
And it's something that I've been trying to achieve in my career for the past 30 years. The foundational elements of Liquidia that are going to launch us into this success now and in the future are really based on three Ps: products, pipeline, and platform. In terms of products, we have a dry powder formulation of Yutrepia that's based on our platform PRINT technology, PRINT. We are regulatory de-risked in the sense that we have tentative approval in hand for PAH and PH-ILD indications, and we have labeling for those drugs as well. And as I'll describe, the only holdback for that now is a dry powder formulation exclusivity that the competitor product has that expires in May of 2025. The pipeline, we have a pipeline product.
We're not satisfied with all the benefits that I'll describe for Yutrepia, and we want to continue to further benefit the ability of these patients to breathe and live longer. We have an L606 inhaled liposomal suspension that we have in partnership with Pharmosa. It's a sustained-release formulation of treprostinil, only two times a day. So it's going to improve the regimen aspect of inhaled delivery of treprostinil. And it's used in a rapid, portable, next-gen breath-actuated nebulizer, which will retain the portability characteristics that Yutrepia provides with a dry powder inhaler. And as I said, the platform technology of PRINT, we've mobilized in the formulation development of Yutrepia, and it has broad capabilities beyond that as well. Maybe I want to spend a little bit of moment setting the stage about what's the market opportunity from just patient numbers and addressable patient populations.
There's two groups that we're going to launch into: WHO Group 1, or pulmonary arterial hypertension, and WHO Group 3, or pulmonary hypertension associated with ILD, which I'll just call PAH and PH-ILD for the rest of the talk. The PAH market is an established, mature market. Since 1995, it became medicalized. There's 13 available treatment options, and the addressable patient base is pretty stable now and in a steady state. 100,000 prevalent, there's 45,000 of those patients that are treated on one form of therapy or another. That's not really changing too much, even with the advent of new therapies. It's a combinatorial approach to addressing these patients with extreme right heart failure and is really not driving increased treatment rates, at least within PAH. Of the 45,000 treated, maybe just drill down on the prostacyclin usage within that.
There's, by our estimates, 18,000 patients that are currently treated with a prostacyclin, but all of those patients that are treated are compromised by the delivery of the current therapies in one way or another, and I'll describe that, so for oral, there's about 10,000 patients, but the issue with the oral therapies, there's quite a tortuous AE profile, particularly to the GI tract. There's a lot of nausea, emesis, and diarrhea associated with those treatments, and it takes weeks to months to get to therapeutic effect, and unfortunately, you have to really drive the dose through the different AEs that I described, and it can become difficult for those patients to maintain that therapy. There's about 4,000 patients on the more severe forms or parenteral forms of prostacyclin.
Very effective drugs can dose to effect, which is important for this class of drugs, but compromised by the delivery side effects for subcutaneous. There's site pain and erythema that's intractable, and there's also the risk of septicemia when you have the indwelling catheter because parenteral therapy takes a pump and a catheter to administer either by the sub-Q or IV route. For inhaled, the two existing branded modalities are Tyvaso DPI and nebulized Tyvaso. The issue there is effective therapy direct to the site of action in the lung, but unfortunately, because of the way those drugs are formulated, there's some deposition in the upper airway, loss of cough, and throat irritation, which limits the ability to titrate those drugs in the manner that has historically been applied with oral and parenteral therapies. And it's viewed as a treprostinil-like formulation, if you will.
It's a good bridge, but a short-term bridge to something else. And so if you take that 18,000 patients and then try to ascertain what's the opportunity value for us, we think, again, with patients newly presenting and patients fatiguing on the other therapies for one reason or another, there's about 6,000 annual new starts per annum. The way to look at that for us, as the way we're looking at it, is those are jump balls, essentially. So as patients are considering a new option, we think Yutrepia, we can tip those patients into the Yutrepia court and really have a more significant share than perhaps most people are thinking. I think the view has been just to look at the DPI nebulized 4,000 patients and sort of squeeze us into that compartment. It's much bigger than that, and I wanted to make sure that was clear today.
For WHO Group 3, it's an emerging and rapidly growing market. treprostinil was first approved for that in, I believe, November or spring of 2021. There's about 60,000 prevalent patients by our estimates, and that's doing a lot through different research techniques that we've tried to triangulate to that number. It's plus or minus on that, for sure. If you just apply the 45% that are treated from the prevalent population in PAH and apply it here, that would predict that there's 27,000 addressable.
Personally, I think the number's higher. I think they're all addressable, but just to be conservative in our estimates here, we'll go ahead and apply the same statistic. There have been about 6,000 patients medicated by our estimates in the first three and a half years, either using a DPI or using the nebulized formulation of treprostinil. So there's still 21,000 of those patients left untreated.
Now, if you look at the revenue opportunity that comes from the prostacyclin class on the left-hand panel, the market for prostacyclins, and this is end-of-year 2023 data because we don't yet have the 2024 data, but it shows that it was at about a $3.3 billion revenue run rate and growing. treprostinil, in its various formulations, accounts for about $2 billion of that $3.3 billion. And then if you look at the right-hand panel, if you look at the revenues in pre-PH-ILD approval in 2021 and the approval of the DPI in 2022, and you can see that the darker blue is the growth in the dry powder formulation in terms of % use versus the nebulized formulation. It was a pretty steady run rate, 2019, like $400-odd million was the historic run rate for Tyvaso as a nebulized formulation.
Since the indication expansion and the dry powder formulation, and this is at the end of the third quarter 2025, about $1.7 billion in annual revenue run rate. I would predict it's soon going to approach $2 billion in annual revenue run rate as we get data from the fourth quarter 2025 and beyond. So very successful. I think one surprise within that, however, is that it's only 65% are on the portable dry powder formulation, whereas 35% remain on the nebulized formulation.
I think that's probably due to some shortcomings of the current dry powder formulation that we hope to address with Yutrepia. So what would be the ideal product profile for this class of patients looking to find the best and most optimized therapy for themselves? So certainly, there's elements that are important. Targeted lung delivery is the first. You want to go right to the site of action.
In this instance, it's the lung vasculature. It reduces the off-target toxicities, particularly of IV and sub-Q, and obviously of the orals, and you really minimize the bad outcomes from very good therapies that are given by the other routes. It should be portable. Certainly, the dry powder inhaler is a portable option for patients. And I think if you look at what we're going to offer patients, this is the actual device. I take my breath, two breaths, put it away, keep it in my pocket, and then take it again four hours later. So highly portable therapy and very attractive in terms of allowing patients to go out their activities of daily living. It must be titratable. So this is a critical aspect that you should leave here today with.
The way prostacyclins are best used is that they're dosed to effect and individualized in some respects for each and every patient. And you have to get beyond a treprostinil-like version for an inhaled therapy because that's a short bridge to something else. And obviously, we want to have a much longer bridge and a much more friendlier and better outcome for these patients. The consequence of having a titratable therapy, which can get to higher and more effective dose, so doses progress as the disease continues to progress, is that you get a durable usage with these patients of your product. So that's critical for them, and it's also good for our business metrics, obviously. And then you want to minimize dosing frequency so it's easy and simple. As you saw, it's very easy to administer with this product device.
So maybe spend a little bit of time specifically on what the value is from an outcome standpoint of dose in patients. So this is in PAH patients. It's about a nine-year survey from 2009 to 2018, retrospective look of 5,000 patients with pulmonary arterial hypertension. So a massive sample of patients for a rare disease. And what you see here is you're looking at the numbers of patients in terms of % that achieved certain levels of dosing in terms of breath equivalents. So inhaled therapies are dosed based on four times daily, based on the number of breaths that you need to administer the therapy versus the nebulized solution. So here you can see about 72%, 73% of patients were only able to achieve seven to nine breaths. 22% could get to 10 to 12 breaths.
The targeted indicated therapeutic dose in the indication label is nine to 12 breaths. And very few patients that any could get beyond the 12-breath equivalents four times a day. Why is that important? And that's if you look at the right-hand side. If you look at the time to transition from inhaled to a parenteral therapy, so an onerous, burdensome route of delivery, nine breaths or fewer, you had a nine-and-a-half-month bridge. If you could get to more than 12 months, 12 breaths, you doubled it. You could get to 18 months being sustained on an inhalation formulation. So that's what you want to achieve. You want to drive dose to drive better outcome. In PH-ILD, the story is very, very similar. So this is from the registrational trial of inhaled nebulized Tyvaso in PH-ILD patients called the INCREASE trial.
Again, you're going to see a picture that's very similar and which has been shown for all routes of treprostinil delivery. More is better. In the left-hand panel, the upper red bars are clinical improvement, and that's % of patients achieving clinical improvement based on the dose achieved. And the lower level, blue bars, is clinical worsening in that same group of patients by dose achieved. Placebo, you can see if you got less than nine breaths, you basically were giving the patients no therapeutic benefit. If you got to greater than nine breaths, you can see now you're starting to see efficacy, 17.3% improved, and only 16.4% of patients declined, which is a very different picture than the placebo measures that you see next to it.
If you also look at six-minute walk distance, so that's the primary outcome measure that's always used for approval of these therapies in this class of disease. If you look at max the studied drug dose, four to six breaths, no effect. Seven to nine breaths, starting to see movement now, 17-meter change in six-minute walk distance, and the patients that got the higher dose, a near doubling of that effect, 33.7 meters improvement in a six-minute walk distance. Dose matters. The more dose you can deliver, the better the outcome for these patients, so having said that, what appears to be a pretty picture for Tyvaso in PH-ILD, here's some real-world data that speaks to specific challenges of their dry powder formulation, which was never studied in PH-ILD patients prior to its launch, so this was the first data set.
This is from the National Jewish Health, one of the most eminent and august pulmonary hypertension centers in the world, and it reviewed the first 48 patients that they treated on Tyvaso DPI, so this is specific data that speaks to the use of Tyvaso DPI, so our most analogous competitor, in patients with PH-ILD, which is the bigger share of the market, as we saw earlier, so two populations here. There were 26 patients that were started naïvely, so new to prostacyclin therapy. Of those 26, 18 discontinued, or 69% of the patients discontinued. In the bottom part of that middle graph, 22 patients were transitioned from nebulized Tyvaso. 11 of those patients discontinued, so 50% discontinuation rates there, a blended discontinuation rate of 60%. The reasons that they discontinued are informing. They discontinued either to AEs or to worsening.
The primary AE that led to discontinuation was cough, which is happening because the drug, as formulated on an FDKP backbone using a high-resistance device, is depositing in the upper airway. So you're getting cough and throat irritation, which is negating the ability to drive dose. And then the primary reason that patients fell out of that study was from clinical worsening. So they weren't able to achieve dose because of AEs, such that the patients worsened and withdrew. And it didn't take long for that to happen. If you look here at the time to discontinuation, the bottom one is for the naive patients, a median discontinuation rate of 40 days. So half of those 18 patients in discontinuation of the 26 that started were off that therapy in 40 days. Very similar picture in the patients transitioned from nebulized.
You can see that the median discontinuation time in terms of days is 223 days, so very short bridge and a very poor outcome, frankly, in terms of what you would really like to see from a data standpoint, so this is why we think we're going to present a product profile that's highly differentiated and has the real potential, very real potential, to become the prostacyclin of first choice, so in terms of targeted lung delivery, we were specifically engineered and designed from day one to enhance lower lung deposition and avoid upper airway deposition.
So we're going to go more directly to the site of action with less off-target activity in the upper airway, which is an off-target effect of this inhaled therapy. We're portable with a proven device that's been used in COPD and asthma. Its unit cost is low. It's available by the tens of thousands.
There's no supply chain issue here. It's a low-resistance device that takes low effort, which is important because the primary symptom for these patients is shortness of breath, and then when you associate that with patients' concomitant interstitial lung disease, in particular, their ability to pull on the device is compromised. You want to use a low-resistance device here. We're going to show you data to convince you that we are titratable both in PAH patients, and now today, we'll show you data that we're titratable in PH-ILD patients to fold changes higher, at least three times higher, so if the target breath indication is nine to 12 breaths, we're already achieving breaths that are 3x that. As I said, dose matters. Dose drives efficacy. You've seen that. It's clear. We're going to present a durable therapy.
We'll show you data on our discontinuation rates in our ASCENT trial, which is our prospective trial in PH-ILD patients. It's given with a dosing frequency, albeit four times a day, very easy to administer with a very patient-friendly device. These are the PRINT particles. Just to remind you of the elegant engineering behind this. The team at Liquidia has been at this a while. I think this is our first go-to-market product that's driven by PRINT formulation technology. There's a lot to applaud here in terms of their efforts scientifically. We can uniformly shape these molecules in the lower end of the respiratory range. This is Yutrepia on the left, 1.3 microns in diameter. You can see the uniformity of those particles.
They're engineered so that their aerodynamic performance will be exquisite, and they'll fly discretely to the lower airway. Here on the right is a preclinical study where you can say, "Let's challenge this hard." We took particles that were 4.6 microns in diameter. And this is not treprostinil data, but nonetheless is representative versus particles that are 1.3 microns in diameter. And you can see on the left, even though you're in the respirable range, if you're polydispersed or have particle sizes in the upper range of the respirable range, you're going to get deposition in the upper airway. And you can see that throat there of that animal has a lot of deposition from a larger particle and less preferential deposition in the lower airway. Now compare that to the right-hand 1.3 micron particle.
You can see what you want to see: exquisite distribution to the lower airway and complete distribution to the site of injury. PRINT enables the use not only of that deposition profile, but of this low-resistance device because the competitive product is on an FDKP backbone. It was principally used first for Afrezza for inhaled insulin delivery, not discretely designed for treprostinil per se. And that comes as an aggregated product. You need the energy of a high-resistance device that's hard to pull on to deagglomerate that product and then to get it into the respirable range so it can have the efficacy that we've seen in terms of being at least a treprostinil-like bridge. Minimal respiratory effort, ideal for patients with PAH, and particularly ideal for patients with PH-ILD. It's robust in the sense that it has fortitude.
If you drop it, mishandle it, or whatever, you're not going to break the thing. And it's pocket-sized. There's minimum opportunity for patient error spillage, like the competitor product that uses cartridges that, if dropped, can spill the drug. Here, it's an encapsulated formulation that we just drop a capsule into the device, pierce it, do your two breaths with it in less than 10 seconds, clean the device, and you're done. And then this is not. I'm not just promoting this naively.
Other companies are using these same devices, devices very similar to ours. If you look at what Gossamer Bio and Insmed are using, they're using these Plastiape devices as well. So this is where the field's going, and the reasons should be somewhat obvious. So maybe here, first, we'll talk about PAH. So I want to talk about each indication in terms of the dosing flexibility separately.
So this is from our own open-label extension study. So the way we got the drug approved is we took patients both naive to prostacyclin with PAH or transitioning from Tyvaso and then measured the kinetics. And then we followed those patients in the long-term open-label study. What we've seen in that long-term open-label study is that we can achieve doses, and this is a 111-patient sample of 33 breaths equivalents as a maximum. And the majority of patients are in the 15 to 18 breath ranges if they are retained on therapy. So we are going to dose levels and breath levels equivalents never seen before. So 3x higher doses. And this is what we're really excited about. And this is the first time we've showed this data to the public.
This is the early look at the first 20 patients who've completed eight weeks of our ASCENT study. We're taking, again, inhaled treprostinil to a whole new dosing level. The patient demographics are in the upper left, very similar to what the Tyvaso nebulized INCREASE study enrolled. Predominantly patients with idiopathic interstitial pulmonary fibrosis, autoimmune ILD, and patients with chronic pulmonary fibrosis and emphysema. You can look at their baseline characteristics in terms of disease severity, very similar again, with a mean pulmonary artery pressure of about 34 millimeters of mercury and a PVR of about 6.2. In these patients who've been on the drug for eight weeks, we have now gotten to upwards of 27 breath equivalents. Again, 3x the nine to 12 breath equivalents that's indicated in their label in which they've struggled to go beyond.
90% of the patients are above 15 breaths or more. We are doing exactly what we want to do to provide a differentiated product with Yutrepia. This is game-changing in my view. We'll provide more of this information at ATS in May, just ahead of our launch. Again, what we'll then tie to this is also safety data. In the lower left-hand corner, here's what's critical. You remember their average discontinuation rate in naive patients was 69%? We've seen no dropouts at week eight, zero. That doesn't mean that there won't be dropouts as we continue to study these patients. They're fragile. Some are on lung transplant lists. They're going to get sent for transplants. They're going to go through seasonal issues with respiratory infections and other things.
But what's critical in the early, what I'll call induction phase of introducing therapy to patients is that they can tolerate it, and you can quickly get to these higher doses to quickly benefit them. The reason they came to the hospital was to feel better. So we're driving dose not only to higher levels, but we're also doing it more rapidly, which is critical. We are having AEs that are typical, like cough, but it's mild. One thing we're going to measure is a cough score. So we'll look at cough as a continuous index. So patients will report on their cough frequency and severity looking back over the previous visit period. So we'll have that data. But what we're seeing so far is really no change. It's a zero to three-point scale. We're seeing no change over this initial eight-week period in cough score.
That's what we want to see. And again, it validates that what we think is true about the PRINT-formulated technology for Yutrepia is true and no drug-related SAEs at this point. So that's the early data. And it's perfect. Today, this is exactly a dream presentation of the data. We will have dropouts as we proceed. But nonetheless, it does show there is a difference in the ability to give inhaled treprostinil via Yutrepia than the other competitive formulations. So that gets in you say, "What is the competitive profile?" Again, we check all the boxes or most of them. So targeted lung delivery, portable, titratable, durable. And the dosing frequency we share is still four times a day. We're not satisfied with that. And that's why we have gone into our next-generation program, sustained drug exposure over a longer interval, which will allow us for twice-daily dosing.
That's the liposomal encapsulated formulation using the next-gen handheld nebulizer that's patient-friendly and portable. You can see the kinetics on the right-hand side. The goal here is to get the same exposure or AUC that you can get with four times a day Tyvaso, but do it in a twice-a-day format. The beauty here is we're lowering the Cmax by 7x. So it actually should produce even less adverse events than what we're seeing with Yutrepia even. So I think very promising therapy. Where we stand in that, we've engaged both the FDA and EMA in conversations now for more than a year. And we have agreement with the FDA that the registration path is quite simple. We have to do a PK comparability study. That's done. That was actually done when we took license.
There's an ongoing open-label safety data that's providing very good outcome data and encouraging data for exactly what we want to see from a twice-daily format, and we're planning to begin our final phase III registration trial, a randomized placebo-controlled study in patients only with PH-ILD across 20 countries globally. The design is, as you would expect, we're just really trying to repeat what was done with inhaled nebulized Tyvaso in ILD, 350 patients, roughly 120 sites, randomized one-to-one for BID versus placebo, and the primary outcome measure will be six-minute walk distance, but we're also powering the study to get time to clinical worsening if it's there. I think we're probably overpowered, frankly, because if we can drive to higher dose, we should drive better outcome. This is just using the Tyvaso as a proxy.
I think, as you've seen, that seems to be more underwhelming than what we're going to produce. The other question is, where do we stand with the regulatory and legal aspects of our product, Yutrepia, in terms of how to get to market? Are there any existing legal barriers or blocking? We'll touch on this, and we can address more of it in more detail with Rusty in the Q&A. The legal decisions that came forward to this point have all been favorable. We've been found not to infringe any of the valid claims of the three patents originally asserted. The beauty now, finally, is that the rulings are final and not subject to any further appeal. Those are done and dusted. The exclusivity is finite. It's expiring in May 23rd of 2025. We've sued the FDA feeling that it was unjust.
So we're going to try to pull that forward if possible, but I think you should all just assert the base case is that we're going to come to market in May 23rd, 2025, and hopefully, we can do better than that, but that's the base case that I would encourage you to follow. There are some ongoing things, so United Therapeutics was denied a preliminary injunction in its original suit versus the FDA, so they sued the FDA saying that our amendment of PH-ILD to the tentatively approved PAH application violated FDA policy. Obviously, the FDA disagreed with that because they gave us a tentative approval for the PH-ILD amendment. United Therapeutics also has what's called the '327 patent that remains. It's specific to PH-ILD also.
They asked for a preliminary injunction on that patent as, again, they thought we were coming to market last year. That was also denied, and Rusty can talk about the specifics of that. There was a trial set in June of 2025 to go through that issue, but both of those are unique to PH-ILD only. None of those would influence in any way PAH. From a financial standard, we're very well capitalized to achieve the objectives that we want to achieve in 2025.
We ended the third quarter of 2024 with $204 million in cash and cash equivalents, and that was bolstered by a $100 million addition to the balance sheet in September of last year, and then upon approval, we're prepared to launch. We're funded through launch and beyond launch. We have our sales force and medical affairs team in place. Our commercial and inventory is on hand.
We have package labeling in a tentative format, but it's not going to change, so we can print that at risk. The distribution channel through the specialties is established. We think we can have from go time, we can have product in the marketplace in two to three weeks, and we're active, active, active in the PH community, not just with our 50 sales member team, but also with our medical affairs team that's also, as you can see, developing data that's highly interesting to the practitioners that will want to use Yutrepia, so with that, I thank you for your time and attention today, and open it up for Q&A. Rusty and Mike and I are pleased to answer any questions you may have.
Perfect. And any questions, raise your hand, and we'll have a microphone coming around.
But to get things started, the observations from the ASCENT trial seem very encouraging. How should investors compare observations from this trial with the real-world data on Tyvaso from the National Jewish Health that you had shared?
Yeah. Again, I think having developed Tyvaso, I think this is presenting a newer modern paradigm for the use of inhaled treprostinil that not only allows us to replace existing forms of inhaled treprostinil, but also to move the use of orals to a second consideration. Because these patients that present and are in need of a prostacyclin, again, we'll describe them. I'm not trying to be a physician here, but we describe them as jump balls. I think it's our belief that Yutrepia will have a very good competitive position against the orals and can begin to displace that market as well.
So the data with DPI, for Tyvaso DPI, is quite limited. The study that I'm showing you was not ours. That was done independently. But I think it speaks to the real and unfortunate issues that Tyvaso DPI have in the PH-ILD population. And we wanted to test, rather than just give you rhetoric, we want to give you empirical data to prove that we are differentiated like the PRINT technology suggests we should be. And so far, highly encouraging data presenting a very different outcome. No dropouts at eight weeks. We're getting to fold orders higher levels of dosing. That's going to drive better benefit for patients. That's known with treprostinil. So I think very encouraged. And we'll just look to execute on that study more and continue to bring value as we head to market.
You had spoken about some of the success that you've had in the courts. I was wondering, what should investors know about the path to final approval and the 327 lawsuit back in June?
Yeah, that's a great question. Rusty, do you mind?
Yes. So thank you for the question. So I think looking forward at the legal and regulatory pathway for us, I think there are really two buckets. There's the FDA side and then the courts. On the FDA side, as Roger mentioned, we got tentative approval for both indications last August. When you get tentative approval from the FDA, that means they've reviewed the application. From their standpoint, it's approvable, subject to whatever the impediment is to getting full approval. In this case, the only impediment they identified is the three-year new clinical investigation exclusivity, which will expire in May.
It's three years from the date of approval of Tyvaso DPI. There's no possibility to extend that exclusivity. And so we have date certainty as to when that exclusivity will expire, and it's May 23rd of this year. Turning over to the courts, as Roger mentioned, there are two ongoing proceedings where United Therapeutics has at various times sought preliminary injunctions. The first is their lawsuit against the FDA claiming that our amendment had PH-ILD to the label was improper. The FDA has come out very clearly saying they think it was absolutely proper, consistent with their regulations, consistent with their past practices. We agree with that. Both we and the FDA have filed motions to seek to dismiss that litigation. And motions to dismiss are usually looking at technical aspects of how they brought the lawsuit. It's not really getting to the merits.
Even if the motion to dismiss is denied, we think the court will set a very quick schedule to produce the administrative record and then tee it up for summary judgment. And again, we think both we and the FDA feel that quite clearly the amendment was permitted. The other thing I note is they had sought a preliminary injunction in the courts previously on this exact issue. It was denied. And so even if they went back into the courts to seek another injunction, we think that question's been asked and answered by the courts.
On the patent side, that's the other proceeding where they've sought an injunction. They have a new patent that covers the treatment of PH-ILD patients with inhaled treprostinil. I'd say a couple of things about that first. As we've said previously publicly, looking at that patent, again, it covers treating PH-ILD patients with Tyvaso.
The filing of that patent was in 2021, I think. Doctors had been treating PH-ILD patients with Tyvaso for over a decade before that patent was ever filed. They were publishing their results. They were publishing that it was effective. United Therapeutics was even announcing to investors that it was effective years before they filed that patent. So from our standpoint, patents have to be novel. They have to cover something new. And that patent, as we've argued in the courts, and we'll have our day in court in June, as Roger mentioned, there's so much prior art out there that we think there are serious problems with that patent. But the other thing I'd say, and maybe more importantly for the launch timeline is, again, they've already sought a preliminary injunction. This exact judge, this exact court already denied that preliminary injunction.
They sought it at a time when I think last year they thought our approval was imminent. Nothing will have changed if they run back into court and seek another preliminary injunction. We think they probably will, but again, nothing's changed, so again, from our standpoint, that question's been asked and answered, so again, we'll go through the process, but looking where we sit today, we don't see that as an impediment to us getting full approval or launching in both indications.
Great. Thank you, Rusty.
You had also pulled up a slide that showed the breakdown of the Tyvaso sales, and I think it showed about 35%-40% nebulized Tyvaso for United Therapeutics. Is that surprising given the choice of a DPI?
Yeah, it's almost nonsensical.
I mean, if you think about you're delivering the same drug as a nebulized formulation with a device that has 13 pieces to it that need to be assembled, disassembled, and cleaned four times a day, that takes upwards of 10 minutes or more each administration session. You're giving the same drug. There's really no reason that that therapy should persist in the marketplace. It should all have ported to dry powder formulation. And I think when they launched, they said it would be maybe a 90-10 split. It's not like it'll completely go away. But the fact that there's a retained nebulized business, I think, is more of a function of the patients aren't tolerating their dry powder formulation, and they're part of that off-rate churn. And the only option in PH-ILD is to go back to the nebulized formulation.
If you look at the National Jewish Health data, that's what patients did. They went back to inhaled treprostinil that's nebulized. So it's not a drug issue. It's a formulation issue. So it's a function of the dry powder not being medical. You just can't medicalize patients on a dry powder at a pretty large percent. So I think that's low-hanging fruit for us. We're going to go after new patients. The way you should look at how we're going to attack the market is biphasic. We're going to go after new patient starts first, convince the doctors of what we say and show are true in their own hands. And then once we've done that, then I think patients will want to transition to Yutrepia preferentially. And then if you have to discern what are you going to start a patient on?
If it's a short bridge, I don't think that's got long legs in the marketplace. You're going to want to go on a therapy that's durable because that's less intensive time for the investigator to have to manage that patient. You put them on something that works, and you can tweak the dose to effect.
Perfect. Well, that's time. Thank you all very much for coming, and thank you very much for the Liquidia team.
Yeah, thank you very much. Pleasure to be here.