Liquidia as the next company presenting this morning. You know, the company's done great, you know, continues to do great as each quarter gets announced, probably because you have a best-in-class asset. It's amazing how that works.
Appreciate that.
You know, it's nice when everything, you know, works the way it kinda should, right? Which isn't always the case, but, you know, sometimes is. Maybe for those a little bit less familiar with things, you can just kinda get people up to speed, and then we can dive into some of the differentiation and what's really driven the strength so far.
Yeah, Andrew, thanks so much for hosting us here today. We couldn't be happier for where we are for as Liquidia and really couldn't be happier for patients who are now have access to our therapy, YUTREPIA. You know, we launched our product in May of 2025. It has been an extremely successful launch. You know, we had prepared to launch this product for several years. We were in the middle of a patent litigation lawsuit. We were finally given clearance to launch in May, and the launch has just been a continued upward trajectory really since last June, and it has stayed on a linear curve, you know, for the entire 10 months that it's been on the market.
We had always hypothesized that our product, which is an inhaled version of treprostinil using a dry powder inhaler, would be a best-in-class product. We believe that product profile is always going to win, and ultimately, we feel we have the best product profile for what's in the market at this point. You know, we market YUTREPIA, and the key tenets to our product profile is what we call the three Ds. We are, you know, our proprietary PRINT technology allows us to manufacture particles of uniform size and shape that are specifically designed to achieve deep lung deposition and really avoid the upper airways and the back of the throat. You know, deep lung deposition is our first D. The second D is our inhaler.
Our DPI, we're able to use a low resistance, which is really the closest thing to inhaler, especially for patients who have lung dysfunction. This is critically important for us. Putting all of that together, our PRINT technology, achieving deep lung deposition, having an easy-to-use, off-the-shelf inhaler allows us to achieve higher doses. The one thing that's non-controversial is more treprostinil is always better for a patient. If you look at, you know, patients who are on parenteral treatment, which continue an infusion, while that is a big problem for patients tolerating and site pain and whatnot, having that continuous infusion is critically important. Our ability to titrate to higher doses, much higher doses than our competitor are able to, is definitely better for patients.
Again, we're very confident coming into the launch and, you know, since launch, our sales force has done an amazing job of being able to, you know, get to large centers, local community physicians and have really enhanced the launch and put us in the position we're in right now.
Yeah, one of the interesting elements of the market has always been when patients come in, so when they need to start a prostacyclin therapy, you know, the high dose is almost maximally important because that's when they're at their sickest. That's when they need to be stabilized. Over time, things can change. As we think about the dynamics of launch, kind of where we are, it seems to me that we're only in the very, you know, first inning really. You know, the ability to deepen penetration of new patients in a broader, you know, group of centers is really just the start.
I mean, having covered United Therapeutics for as anybody, you know, people thought when their market cap was $1 billion, that they were, you know, kind of, you know, fully valued. You know, history has suggested that's not the case, obviously. As you look at things, you know, where do you kind of see things, you know, standing, you know, from a launch perspective?
Yeah, to your point, we really feel we're just scratching the surface. You know, we've had an amazing launch. We recorded $130 million of revenue in our third full quarter of launch. We're profitable as a company. When you look at the overall market opportunity, and if you look distinctly at PAH and PH-ILD, you know, we look at the PAH opportunity as over a $3 billion opportunity. Historically, prior to our launch, inhaled treprostinil was a small piece of the treprostinil overall market in PAH. There's an oral treprostinil market that is over $2 billion and 10,000 patients. There's a parenteral component as well, which is about $500 million, along with the traditional $500 million in inhaled.
Our dosing flexibility, our ability, our overall product profile from a side effect point of view, we believe that we can service all patients that are currently on prostacyclin therapy. Roger, our CEO, has always, you know, yearned to be the prostacyclin of first choice. You know, the oral agents are very difficult on patients, difficult to titrate to a therapeutic dose. The off-target side effects are very hard on patients. To your point, we really are just scratching the surface in PAH.
Even though it's an established market, we think there's a lot of untapped potential that we're just starting to see. We are going to, you know, do some clinical studies, some open label studies to enhance that product profile, both on oral transitions from existing TYVASO patients, and also those patients that are on parenteral treatment that are also on sotatercept of transitioning parenteral patients back to inhaled, given our ability to titrate to those higher doses. That's just PAH. If you look at PH-ILD, you know, we believe, and I think our competitors have also acknowledged that, you know, the first product was approved in PH-ILD just five years ago. That market is still very much under-penetrated. I believe they've said that it's less than 20%.
It's one of the reasons that we're expanding our sales force by 33% here in Q2. The goal really is to expand our reach to get further into the community, local centers where we believe a lot of these patients exist. It's gonna be a longer-term investment to educate doctors how to diagnose patients and ultimately treat these patients. You know, to your point, we believe that this overall market opportunity, if you take the $3 billion in PAH and then $3 billion, $4 billion, $5 billion in PH-ILD, this is a massive opportunity, one that I think we've done a really good job to, you know, in the early stages of our launch. As you said, it's still the early innings.
People appreciate, right? In PH-ILD, patients need higher doses. The attributes of your product play particularly well into the PH-ILD patient population.
Yeah. I think an interesting example of that is we did our ASCENT trial, which was an open -label study in patients with PH-ILD. One of the things we wanted to show in that trial was our ability to titrate to higher doses quickly and what the impact on that is on patients. What we saw was very telling that at eight weeks, our average dose was the equivalent of 132.5 mcg, which is the equivalent of 15 breaths of TYVASO. Most patients that are on TYVASO park at somewhere between nine and 12 breaths. At eight weeks, we were able to get to 132.5 mcg, or the equivalent of 15 breaths, and achieved a walk distance of 21 m.
At 16 weeks, the average dose went up to 159 mcg, which is the equivalent of 18 breaths, and the average walk went up to 31 m. At 24 weeks, we were able to get to 185.5 mcg, which is the equivalent of 21 breaths, and we saw a walk distance improvement of 41 m. Exactly your point is exactly what we wanna show and, you know, these doctors are starving for data. There has not been a tremendous amount of clinical data around inhaled treprostinil. I think we've shown that with ASCENT. The other studies that we're planning, being able to show doctors and patients what YUTREPIA can do and can help their patients, I think is gonna be critically important as we build this opportunity.
I mean, you mentioned, you know, doing some work on the transitioning. You know, history, the market's obviously shifted over time, but, you know, history suggests that transition studies can be very effective even in the context of just being investigator-sponsored, and be very powerful from a physician practice perspective because they lay out an outline, a protocol for other physicians to follow. I mean, going back 10-1 5 years, you know, United Therapeutics very effectively at ATS introduced transition protocols to allow doctors, give doctors a path to move from one form of prostacyclin to another. Maybe you can speak to your efforts there.
Thanks, Andrew. I just came from ATS in Orlando, and to the point that Mike has outlined trials that we're going to do, there's also things that the community is doing. If you just look to what they're doing first, we just saw a poster where physicians at UCLA are looking to transition stable patients who are on sotatercept and parenteral treprostinil or epoprostenol to YUTREPIA because it can be dosed so high. Now, that's not our study. We're going to do a study where we can look in more detail as to what's actually happening hemodynamically, and we look forward to doing that study with sotatercept. To your point, the, a couple studies that we're getting going, that transition of a TYVASO or TYVASO DPI patient to YUTREPIA. That, again, is happening in the real world. Why?
We're interested in understanding, are there suboptimally managed patients? Meaning they stop at a dose due to tolerability or physician, you know, ability to titrate. Can they move them over and move them up? That study doesn't have to be very big to have impact, to your point. It's all through the same real-world transition study. Now, it is interesting, this poster at ATS, they have one patient who was on oral and sotatercept, and they transitioned them to YUTREPIA. We are kind of following in the footsteps of what is already happening in the real world.
You know, once the study gets presented or published at ATS, from a commercial perspective, from a marketing perspective, you then have the ability to take that, the reps have the ability to take that in hand and help disseminate it, help educate physicians with it.
It depends on the study, right? We always wanna do things appropriately, and that means it needs to be presented, you know, by the company at a clinical, or excuse me, at a conference. We wouldn't be looking to only do these small studies so that we could present them, and our medical affairs team would look and compliance would look to say what is appropriate, right? That, that's kind of where we start. Really, it's trying to inform the medical community. That's our goal. And how we do that is through conferences and through the published literature.
Very helpful. Maybe you can speak about, you know, look, there's obviously, it's a noisy space competitively. You know, you have next-generation assets as well. Maybe, you know, you spent a lot of time at the R&D day last year on L606, so maybe you can speak a little bit about that and how that, you know, kind of sets you up going forward.
It's very exciting. I think when you look at Liquidia, we're setting a new bar with YUTREPIA around tolerability, showing that we can effectively deliver doses higher than what historically has been delivered. We wanna keep pushing that bar, and that's where L606 comes in. Yes, tolerability is a key component. This is a liposomal formulation of treprostinil delivered twice daily with a next-generation nebulizer. You have lower Cmax, so you're avoiding some of the acute toxicities in the upper airway. More importantly, you're spreading that exposure more consistently out over 24 hours. That also helps with the tox profile, but more importantly, we have therapeutic levels on board at night while the patient is sleeping. When we look at the history of prostacyclin drugs, it's been the parenteral consistent delivery of pumps that have had the best efficacy.
Our interest isn't just, you know, lowering Cmax or reducing dosing, it's how do you optimize that exposure? We're really excited to take that into the clinic now in a PH-ILD study, that's up and running and I think we have a 2029 endpoint for top-line data.
Maybe, you know, you can just kind of put, you know, L606 in the context of the competitive profile, a competitive environment. You know, obviously, you know, people speak about, you know, United Therapeutics' different assets. People speak about, you know, Insmed's TPIP. You know, at the end of the day, does any of it matter if you're simply able to do what you think you can do?
Yeah, I mean, I think ultimately, like what we've seen with YUTREPIA, product profile is critically important, and we believe that the product profile of L606 is going to be extremely competitive in the market when we complete our phase III. Ultimately, as I said earlier, you know, as Jason said, we're expecting top-line data in 2029. There's a lot of work to be done between now and then on the commercial front with YUTREPIA. If we're successful building that market to $3 billion, $4 billion, $5 billion, we believe that L606 is going to be viewed quite favorably by doctors, by patients. The product profile of being twice a day in the morning, at night, an average patient will be able to do it in one to two minutes.
You're gonna spend more time brushing your teeth twice a day than you will taking your L606. Ultimately, from an efficacy point of view, from a side effect profile, reduced cough, we believe that L606 is gonna compete with whatever agents are in the market come 2030, and we ultimately feel that we will be positioned to be the prostacyclin of choice both now and in the future.
I think it's also important to highlight, you know, the relationship as a company you guys have with centers, and with physicians, and with patients is not, you know, unimportant. You know, we've seen, you know, big companies like Gilead, you know, and Actelion, you know, and then J&J, and, you know, Pfizer at some point. You know, all, you know, and Merck obviously, you know, play within the market, but not have perhaps the depth of relationships either at the centers nor with the patients that some of the smaller companies have, and I think it manifests. It manifests in the comfort of using the product. It manifests in willingness to try and willingness to you know that, you know, research is being sponsored, innovation is being sponsored, and things are done thoughtfully.
It's not just a marketing, you know, battle. I think, you know, the fact that there's familiarity, you know, with the people at Liquidia at the leadership level, you know, among the centers is a big advantage that's not spoken of, you know, often enough in the context of evaluating these different assets and development.
I mean, ultimately, we want to build relationships with these disease spaces, both physicians, patients. We wanna build credibility. We wanna generate data ultimately. These are patients are very sick. You know, we are committed to patients' benefit here. As I said earlier, there has not been a tremendous amount of data generated in the last several years. If you look at how TYVASO DPI was developed, it was developed in a way in a six-week transition study, in less than 50 patients in PAH. Ultimately, our ability through, you know, the registrational study we did in PAH, with YUTREPIA, in the ASCENT data, in all of the transition studies we're gonna look to do now, and then following with L606, that is critically important.
I think the doctors, the physicians, the patients appreciate that, and our ability to contribute to innovation for these patients who desperately need alternate treatments, I think goes a long way and ultimately is why we're doing what we're doing.
Maybe just, you know, spend a moment speaking about, you know, even further expansion opportunities. I mean, Raynaud's is obviously something that's come up. You know, we've seen different companies over the years, you know, dabble in it, but not really speak about it that much. You know, kind of how are you thinking about it, and where does that fit in?
Thanks for bringing that up. You do have a long history, and you know that people have been looking at prostacyclin in lots of indications. We're really excited about the systemic sclerosis with Raynaud's phenomenon because we have seen in the literature that other prostacyclins, when delivered parenterally, are being used outside the United States to treat that disease. Given the profile with YUTREPIA and how high that we can dose in a tolerable way, let's see what we can do to prevent attacks of Raynaud's in this rare disease population where, you know, 90% of systemic sclerosis patients may have this disease. We're cutting new, you know, land here.
We're trying to figure out the market opportunity and how best to treat these patients, and so we're doing studies this year, and we look forward to being able to talk more about that as the data emerges. There's an area where no one is working right now. An area where people have worked in the past is PH-COPD, and we know that that's very large unmet need, no products approved. There was a previous study that was stopped, and it was stopped for reasons that had to do a little bit with trial execution, a little bit with COVID. Not necessarily the underlying science of why treprostinil might be helpful in that group. We have in our plan to move into a pivotal study in 2027. This is a big lift.
We're doing a lot of work right now to make sure that when we start that study, we've learned from the previous trial designs, and we're thinking of how do we optimize exposure in those patients using YUTREPIA. Lastly, I would just mention a lot of interest recently in IPF and PPF with those TETON studies, and those have been great studies, except in one area around dose exposure. If we believe that exposure drives efficacy in this class, when we look at the TETON studies, those patients were dosed up to 12 breaths per session, 4 x a day. We've already established that YUTREPIA can be dosed higher.
The question is, if we run an open-label study in PPF, for example, are we going to be able to see the same tolerability profile first, and second, signals that we might be able to get more clinical efficacy? All of these studies are kicking off. I think we have eight studies that we're either starting, active, or planning currently. It is exciting time for the company as this now new part of clinical is really expanding.
I think one thing to add, Andrew, to that is what's important to understand around the value proposition that Liquidia brings is, you know, we recorded $130 million of sales in Q1. We also generated $30 million of positive cash flow and $70 million of adjusted EBITDA. The trials that Jason just mentioned, the registrational study in L606, all of these open -label studies, moving into 2027 and potentially a registrational study for PH-COPD, we're gonna be able to fund all of that through our current balance sheet.
To be a company that is still inside of the first year of launch, to be a cash-generating engine, and while also being able to develop its entire pipeline, I think is very unique for this space and something that as we've always talked about is we wanna grow profitability quarter-on-quarter. We're gonna reinvest part of that profitability back into our R&D functions and create even more shareholder value that way.
I mean, given all of the success you've described, you know, the litigation still hangs in the.
I thought we'd get through the entire thing without you bringing that up.
in the backdrop. I mean, I don't know what you can say that hasn't been, you know, said, but what changes, you know, post the litigation? What changes?
I mean, obviously it's been a long time. You know, the trial was last June. We're coming up on 11 months since trial. We've talked many times. We expected a ruling sometime between September and the end of October. We are now nine months past when we thought a ruling was coming. All I can say is we will be prepared for any outcome. Like any good management team, we will be prepared. We believe that the facts are on our side. We believe that we should win this case. What I can promise is that we will be prepared in any situation. Again, we feel it's critically important that our drugs are available for all patients in PH and PH-ILD. Like I said, we're confident. We're gonna be prepared either way.
The bottom line right now is there's nothing we can do to impact it, so our focus is on patients, executing a continued successful YUTREPIA launch, and getting L606 and all these other studies into the clinic, and everything else will work itself out.
Great. Well, I think we're all out of time. If anything, any final thoughts you'd like to leave people with?
Again, we really appreciate you having us. We appreciate your support, and ultimately, you know, we want to continue to build shareholder value, continue to serve these patients, as that's so important to our overall goals here, and ultimately very proud to be a part of Liquidia.
Thank you very much.
Thanks, Andrew.
Thanks, Andrew.