3/5/2026

speaker
Josh
Operator

Good morning and welcome to the Liquidia Corporation full year 2025 financial results and corporate update conference call. My name is Josh and I will be your operator today. All participants are currently in listen-only mode. Following the presentation, we will conduct a question and answer session. Instructions for joining the queue will be provided at that time. Please note that today's call is being recorded. I'll now turn the call over to Jason Adair, Chief Business Officer.

speaker
Jason Adair
Chief Business Officer

Thank you and good morning, everyone. It's my pleasure to welcome you to our full year 2025 financial results and corporate update call. Joining me today are Dr. Roger Jeffs, Chief Executive Officer, Michael Cassetta, Chief Operating Officer and Chief Financial Officer, Dr. Rajiv Sagar, Chief Medical Officer, Scott Mumaw, Chief Commercial Officer, and Rusty Schundler, our General Counsel. Before we begin, please note that today's discussion will include forward-looking statements, including statements regarding future results product performance, and ongoing clinical or commercial activities. These statements are subject to risks and uncertainties that may cause actual results to differ materially. For further information, please refer to our filings with the SEC available on our website. Please also note that our earnings release and our commentary includes non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures can be found in our earnings release. With that, I'll turn the call over to Roger. Roger?

speaker
Dr. Roger Jeffs
Chief Executive Officer

Thanks, Jason, and good morning, everyone. As we look back on 2025 and forward into 2026, what stands out is the rapid establishment of our preferred product profile paired with precise execution. Last year demonstrated that liquidity could launch, scale, and reach profitability quickly within only 120 days of launch, in fact. Most importantly, we demonstrated that physicians were willing to rapidly change prescribing behavior when presented with a new differentiated option in eutropia. The benefits of its product profile, deep lung delivery, low effort device, and wide dose range are taking hold in clinical practice and help place eutropia as one of the top specialty drug launches over the past five years across all therapeutic categories. This did not happen by chance, but with purpose, as the category-defining assent study data clearly set a new data-driven standard for therapeutic success. The momentum of 2025 has clearly carried into 2026. As of February 28th, we have received more than 3,600 unique patient referrals and shipped therapy for more than 2,900 patients since launch, maintaining our robust trajectory. While others have observed stagnation from supposed seasonality, that has not been our initial experience as we continue on the same trajectory without decline. which would suggest that our percent market share is rising and that we are capturing a disproportionate number of new patient starts for inhaled prostacyclines as the best-in-class option. This steady forward momentum is being achieved across PAH and PHILD, with new patient prescriptions roughly equal now between the two indications. Patient starts remain at 75% naive to 25% transitions from other prostacyclines. Importantly, breadth and depth are also improving in a measurable way, We have increased total prescribers to around 860 as centers gain confidence and usage expands in the community. A key indicator of that depth is that roughly 25% of physicians have already referred five or more patients, which is exactly the pattern you want to see when a therapy evolves into becoming the standard of choice rather than an initial trial. If 2025 was the start of the full commercial phase, 2026 begins the full clinical exploration of what may be possible with eutropia and L606. Our development strategy is built on principles we have understood for a long time with prostacyclin. Exposure drives efficacy, tolerability drives durability, and convenience drives compliance. Each of these elements is critical to the totality of therapeutic experience and speaks to the high bar that eutropia has quickly established around safety, efficacy, and convenience. This year, we will look to further cement this best-in-class product profile via the initiation of multiple new studies, including studies that will transition patients from oral and inhaled-process psychotherapies, and a study of new combinations, like adjunctive studies with cetacet, that we hope will further advance the changing standard of care. Further, we will work to initiate new studies to support expansion into additional disease areas, such as systemic sclerosis-associated Raynaud's phenomenon and PHCOPD, where high unmet addressable need remains. And of course, we will look to move the therapeutic needle even further via the advancement of our next generation L606 pivotal study with a study initiated in multiple territories and enrollment expected to begin in the following quarters. Importantly, this disciplined expansion of clinical evidence will be funded by cash flow from operations and will help grow the value of the franchise and the company. With that, I will turn it over to Mike.

speaker
Michael Cassetta
Chief Operating Officer and Chief Financial Officer

Thank you, Roger, and good morning, everyone. Our financial results are a direct reflection of two things, sustained patient growth and retention and disciplined execution. Over the last nine months, as the referral and start curves have moved higher, so have revenue, margin contribution, and cash generation. For the full year 2025, Eutrekia generated $148.3 million in net product sales, including $90.1 million in the fourth quarter, representing 74% growth in net product sales over the third quarter 2025. The fourth quarter also marked our second consecutive quarter of increasing profitability. with not only non-GAAP adjusted EBITDA of $27.3 million, but also $14.6 million of net income. We ended the year with approximately $190.7 million in cash and cash equivalents, having generated $33 million of positive cash flow in the fourth quarter alone. Liquidia is now operating as a cash generating growth engine. That is not aspirational. It is visible in the quarterly numbers and on the balance sheet. Roger, back to you.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Thanks, Mike. We're confident in 2026 and the years ahead as we focus on building a durable franchise with increasing patient preference and a clear path towards at least a billion-dollar franchise in 2027 with increasing growth in the years beyond. With that, operator, please open the line for questions.

speaker
Josh
Operator

Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment for questions. Our first question comes from Ryan Deschner with Raymond James. You may proceed.

speaker
Ryan Deschner
Analyst, Raymond James

Thanks for the question, and congratulations on the, you know, impressive continued launch so far for Utrepia. I'm curious, you know, given the greater than 2,900 patients starts your reporting today, where do you think this puts you in terms of current market share And how are you thinking about continued growth in the first half of 2026? And then I have a follow-up.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah, thanks, Ryan. I appreciate you joining the call this morning. So it's hard to give an accurate percent market share from a patient number standpoint, given the competitor doesn't disclose their numbers. So what we have done is we've done an analysis based on revenue that maybe, Mike, if you don't mind going through it, that speaks to this question.

speaker
Michael Cassetta
Chief Operating Officer and Chief Financial Officer

Yeah, thanks, Roger, and thanks, Ryan, for the question. You know, to give everyone an idea, you know, inhaled tripostal revenue for Q4 was approximately $550 million. And as Roger said, despite what our competitors have talked about with seasonality in Q4 in their business and their corresponding decrease in revenue from Q3, that's still an increase of 5% revenue from Q3 of 2025. You know, the fact that we had an 80% increase in revenue quarter over quarter means that we're accounting for more than 100% of market growth in Q4. And again, as Roger said, that represents the disproportionate share of new patient starts, along with a fair share of switches from Tyveso. You know, in terms of what that share is, you know, in Q3, we had about from a revenue point of view, 10% of market revenue that increased to 17% in Q4. So we're seeing a significant increase quarter of a quarter. As Roger mentioned, the 2,900 patient starts in just nine months since launch. That is through February 28th. So we're seeing that continued momentum that we've seen in Q4 in the first two-thirds of Q1 of 2026 and feel very excited and, you know, bullish on our ability to continue a successful launch.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Thanks, Mike. And Ryan, just to add, you know, it's been very consistent in terms of trajectory, and we don't see any impediment going forward. this year with regard to any change in that trajectory. As we mentioned in the prepared remarks, the depth of prescriptions is increasing. We're working on improving the duration and durability so that scripts stack upon scripts so that the revenue growth remains. And I believe you had another question, Ryan?

speaker
Ryan Deschner
Analyst, Raymond James

Yeah, thanks for that. With the new outcome data from a competitor that came out recently, what's your take on the potential impact of a new addition to the oral prostacyclin receptor agonist mix on the utrepia launch?

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah, I mean, it's a good question. And, you know, first of all, congratulate, you know, therapeutics on a successful trial with a, IP1 selective agonist. I think for us, it really doesn't have any impact at all. If you look at it, it's more like Updravi than not. I mean, they're both in the nanomolar range. I think potency-wise, they're generally similar. Their target binding profile is highly selective just to the IP1 agonist, and I think the results are similar. You're seeing an effect long-term over years in clinical worsening with a very muted effect on symptomatology, which primarily, if you look at the six-minute walk distance, which they didn't disclose, they said it was significant, but my guess is it's muted. And as you know, with Upravi, they had no statistical significance or clinical significance change in six-minute walk distance. When you're talking about a first edition of prostacyclin, the patients are symptomatic and looking for improvement. I don't think the oral therapies just aren't going to give that bang for the buck. What they are going to bang is the GI. And if you look at the AE profile that was shown, you could see a high degree of GI side effects, diarrhea, emesis, and nausea. So I think it's more of the same. And all the results that Mike just talked about in terms of our launch trajectory and success are in the presence of UpTravie being in the market. So it's really, to me, it's really an interchange between how that, how Rolanda PEG will compete with UpTravie in the marketplace once it's launched. So, you know, not that concerning. I think also if you look at their box and whisker plot, while they did have success across a lot of different subgroups, one thing that was not differentiated was does. So it doesn't seem like there's an ability to does to better outcome there. So what you see is what you get based on probably close to the initial start dose. So again, more of the same, and I don't think it'll be impactful in any way in terms of how we view our business. Thanks for the question. Thanks.

speaker
Josh
Operator

Our next question comes from Julian Harrison with BTIG. You may proceed.

speaker
Julian Harrison
Analyst, BTIG

Hi, congrats on the progress, and thank you for taking the questions. Roger, I'm sure you're very familiar with soft mist inhalers. Can you help us better understand the differentiation potentially of eutrepia and maybe L606 as well relative to a soft mist inhaler that was recently announced by another company in the space? And then as a follow-up, regarding the PAH versus PHLD split of patients on eutrepia, should we still be thinking about that on approximately a three-to-one basis? How do you see that maybe evolving over time?

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yes, I'll answer and maybe ask Scott to help me with a second question first. So we've moved to pretty equal split now between PAH and PHILD. You know, there's clearly more white space opportunity in PHILD. And I think one of the things we're doing is we're going to grow our sales force significantly by a third. So we're going to have a larger share of voice. And at purpose of that larger share of voice is to get into the community, particularly into the PHILD space, to continue to penetrate that market, drive awareness, and either drive starts or drive referrals. So, you know, I think over time that should become an increasing value proposition. But in PAH, don't forget, you know, we have not only the inhaled market opportunity, but we're also going after the oral and parenteral opportunity. So on aggregate revenue numbers, They may appear similar in terms of the business opportunity, but in pure patient numbers, I think PHLD has the opportunity to be more successful. Scott, do you have any other questions or any other responses that you'd like to add?

speaker
Scott Mumaw
Chief Commercial Officer

Excuse me. I would completely just agree with everything Roger said. It's been interesting to see PAH get off to a fast start. But as we've mentioned, PHLD has come on strong in about half. where it's going to go from here. You know, I think PHILD, we know PHILD is definitely the bigger opportunity long term, as Roger called it, the white space. But there's still a load of opportunity in PAH. So, you know, where it'll settle out eventually, I think PHILD definitely will be bigger. But there's a lot of growth in both buckets right now to continue in the near term.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah, great. Thanks, Scott. So, again, Julian, you know, there's multi-billion dollar opportunities in each indication. So we're excited about the opportunity that Eutropia and then subsequently L606 will have in these markets. With regard to the SMI, I know it's a seminal question for everybody and sort of front of mind because there were some pretty hyperbolic comments made about it. What I would say is I think their commentary in general was it sounded very much to me that it was validating of eutrefia because it sounds like they're trying to develop a product that has the product profile of eutrefia. And what is that? It's an easy-to-use, low-resistance device with high portability. There's mitigation of cough, but for us, it's specifically done due to the print formulation of engineered particles in the lower end of the respirable range. And then dosing flexibility due to that tolerance, which then parlays, as we've clearly shown in the ASCENT study, that we can rapidly and aggressively dose patients to two or four times the past standard with absolutely no exacerbation in cough in a population of PHLT patients who have a baseline cough and a high predilection for exacerbation of cough when they take inhalation therapy. So, you know, eutrophia is porting an ideal product profile. What Mike described is we're clearly getting a lot, if not most, of the NREX share. And our TRX share is catching up over time. And the SMI, to me, is just a repurposed opportunity. So if you go back to the 793 patent that has a priority date of 2006 and look at example one in particular, it talks about there a single dose acute administration of tryprosinol using an SMI And in that same pattern, there's a single acute dose with the ultrasonic nebulizers that is Tyveso as we know it today. And what that showed is that in pH patients with a single dose, low dose, that cough was prevalent. And it described the MMAD or the median diameter of those particles to be in the 4 to 5 micron range. So nothing different. So you're giving... Tyvesa solution. You're not doing anything to improve its tolerability or penetration to the lower airway. You're just using a different way to present an aerosolized mist. So it doesn't really matter if you use a soft mist inhaler. Yes, that's probably better from a portability standpoint, but that will be it. It will still present itself clinically in terms of how it behaves as Tyveso nebulized. So, you know, we don't really view it as competitive. I think, you know, you'd have to ask the competitor to explain the comments they made around tolerability. They've said they still have to do bioequivalence. So whatever data they have, my guess is it's just single-dose acute studies in normal volunteers, which is a very bad proxy for what may happen in patients with a high predilection of cough. And the The truth to that statement is, remember, when they launched Tyveso DPI, they had no data in patients. It was done on bioequivalence in PHILD. And you've seen the issues they've had through the National Jewish Data in particular with the DPI and PHILD. And now it seems like they've capitulated and feel that DPIs are now not useful, at least their DPI, and they're trying to pivot to another methodology, but I don't see that methodology as providing any forward-looking benefit. That's kind of my quick view on it. I know, Rajiv, you have some broader statements around perspective because this has been tried before in other markets. If I could, I'd ask you to speak to those instances, if you will. Yes, sure. Thanks, Roger.

speaker
Dr. Rajiv Sagar
Chief Medical Officer

I just want to highlight a key point here. I think the signature of of the SMI was primarily derived from the Spiriva Respirant and that was done at a time when the CFC propellants were being removed and also there was a patent issue from that company and they compared it to Spiriva Handehaler which is their dry powder formulation and at that time the Handehaler was the highest resistance device ever to be developed in patients with asthma and COPD, which is tens of millions of patients. The only device that has a higher resistance than the hand inhaler to date is actually the Tevisa DPI device that's used in PH and PHLD. But what's really interesting is with all the studies done comparing the soft mist inhaler to a dry powder inhaler using the same formulation in disregard was teatropium. The SMI has never been shown to change the clinical efficacy, the pharmacokinetics, and most importantly, has never been shown to improve or modify safety and or tolerability inclusive of the concerns for cost. So I just want to highlight, as what Roger spoke to, that the SMI does not port any substantial benefit besides the portability itself.

speaker
Dr. Roger Jeffs
Chief Executive Officer

All right, thank you, Rajiv. Operator, next question, please.

speaker
Josh
Operator

Thank you. Our next question comes from Amy Lee with Jefferies. You may proceed.

speaker
Amy Lee
Analyst, Jefferies

Hey, thanks so much for taking your question, and congrats on the momentum. So when we look at your path to the $1 billion revenue target in 2027 that you laid out, Our math suggests that implies sustained patient ads from here. So is that the right way to think about the trajectory? And more importantly, what gives you confidence in maintaining your current pace in the next couple of years? How much visibility do you have into the patient funnel and where are the patients coming from? And are you still confident in that number in light of kind of the potential emerging competitive dynamics like SMI?

speaker
Dr. Roger Jeffs
Chief Executive Officer

So I'll ask Mike to speak to some of how we get there, at least from a revenue calculation standpoint. But as we just said, Amy, we don't see any influence from the SMI. I think it's, again, it's going to be Tyveso and perhaps a more portable format from using jet nozzles to create aerosolized particles. But as I said, they're going to be poly dispersed. They're going to cause cough. They're going to have titration issues. So I don't really see that impacting us in any other way. And as you're noting in the competitor's revenue, the nebulized business is decreasing, mostly because we're beginning to take that share away. So I think more of that will continue to happen. Mike, you want to talk about kind of how we see ourselves continuing to climb the mountain towards at least a billion dollars in revenue in 2027?

speaker
Michael Cassetta
Chief Operating Officer and Chief Financial Officer

Yeah, Amy, thanks for the question. I mean, if you just look at, you know, start with what I talked about earlier, you know, the market for the quarter was over $500 billion, which means it's about a two, it's already on it. The inhale to profit market is already a $2 billion market. You then talk about, you know, our share of that revenue has increased considerably quarter over quarter. We believe that will continue as well. Then you look at the opportunity that we talked about in PAH with the $2 billion oral opportunity, where we believe that there will be significant opportunity for us to gain significant share from that. So that's another $2 billion opportunity just within PAH that we see. And then as Scott and Roger had said earlier, we're just scratching the surface in PHILD. We're enhancing our sales force. We're getting more penetration. We're getting further into the community. So when you look at the overall opportunity, a current $2 billion market opportunity in Hale-Troposynol, plus the oral opportunity, plus the enhanced white space in PHILD, we feel very bullish in our ability to continue on this trajectory and continue on this path to get us to what, as Roger had said at JPM, a billion dollar, eutropia being a billion dollar product in 2027.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah, I think the other thing, Amy, too, great response, Mike, is look, we're doing directed studies that we're going to transition patients from the competitive agents, either oral or inhaled, and show the benefits of moving those patients to to direct tolerability and efficacy. So, you know, all of these things just will continue to build a portfolio and a suite of evidence and data-driven proof that EUTREP is the best in class and first in choice product. Operator, next question, please.

speaker
Josh
Operator

Thank you. Our next question comes from Serge Belanger with Needham. You may proceed.

speaker
Serge Belanger
Analyst, Needham & Company

Hi, good morning. First question on the legal front, any new updates or developments that you can share with us? And then secondly, regarding payer access, I think you reported another 85% prescription to patient start conversion. Just curious how that number varies across the Medicare and commercial segment, and I guess what additional coverage I know you had coverage from three major commercial payers, but would additional payers need to come online over the remainder of 2026? Thank you.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Sure. Hey, good morning, Serge. Thanks for the question. So I'll take the legal and then I'll pass it to Mike for payer. So really nothing new from what we said at JPMorgan, Serge. So, you know, just a reminder for those who may be newer to the story that the oral hearing was in June. Post-trial briefings were completed in August, so we're now approaching nine months from trial and seven months from the post-trial briefing. So we do think we're in the sweet spot for when an opinion should and could be rendered, but obviously it's been taken longer than we all expected, so we can't really probabilitize on when it actually will come down. What I would say is, you know, we remain very confident in the arguments that we made, and we strongly believe that we should win and the case should should read out favorably to us. We acknowledge there's a lot of potential options here or outcomes, but regardless of what happens, we're prepared for any and all outcomes. So really nothing new to state today other than we remain confident in our position and look forward to hearing from the judge in due time. So Mike, if you'll talk to payer access, please.

speaker
Michael Cassetta
Chief Operating Officer and Chief Financial Officer

Yeah, Serge, great to hear from you. I think where we are with payer and pull-through is just another example of how we've executed on this launch. Scott and his team have done a masterful job. The fact that we've maintained 85% plus of pull-through from really the very early stages of the launch is simply staggering. And we continue on that pace. We've also said from the beginning of launch, our goal was to make sure that patients have a choice if they want to use eutrapia. And what we can say is we've achieved that. And we continue to work through our pull-through, making sure that we provide a suite of services to patients to make sure that if they want eutropia, they can get it. And I think that's evident in that pull-through percentage. And we don't see any change in that coming. And our goal will always be to improve that as we move forward. But I really think we're already in a best-in-class state, being at 85-plus percent pull-through percentage.

speaker
Dr. Roger Jeffs
Chief Executive Officer

All right, thanks, Mike. Operator, next question.

speaker
Josh
Operator

Thank you. Our next question comes from Ben Burnett with Wells Fargo. You may proceed.

speaker
Ben Burnett
Analyst, Wells Fargo

Hey, thanks very much, and congrats on all the progress. I just wanted to see if I could get a little bit of color on some of the launch dynamics into the first quarter. Anything you can say kind of around inventory, stocking trends, or kind of the refill rate that you're seeing?

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah, Mike, if you wouldn't mind commenting on that.

speaker
Michael Cassetta
Chief Operating Officer and Chief Financial Officer

Yeah, Ben, thanks for the question. As we said in our press release and Roger reiterated already, we've already had a strong January and February when it comes to both new patient starts and referrals. We're staying on the exact same trajectory we were on In Q4, you know, we've often gotten questions from analysts and from comments from our competitors about seasonality. We've seen nothing but increases across the board. And as we showed today, we continue to see those increases. So, you know, as we've always said, you know, As Roger had said, we are still very confident as we move through the rest of Q1 into Q2 and are on our path to be a billion-dollar product in 2027. Now, as it relates to inventory and stocking, You know, I think we're now at the point of the launch nine months in where we've really normalized, and I don't expect there to be any significant swings now. You know, especially distributors can make decisions at ends of quarters that we, you know, don't have influence over. But at the end of the day, we are tracking well. Our demand is extremely strong, and as a result, we feel very confident in the revenue as we move forward.

speaker
Ben Burnett
Analyst, Wells Fargo

Okay. That's extremely helpful. Thank you. And I guess just also regarding the systemic sclerosis RP program, I thought that was interesting. Can you maybe walk us through kind of the evidence in support of trypostenil and kind of what your path forward is there?

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah, I'd love to. So, Rajiv, if you wouldn't mind talking about the Raynaud's program.

speaker
Dr. Rajiv Sagar
Chief Medical Officer

Yeah, sure. Thanks. Thanks for the question. So, obviously, you know, systemic sclerosis is a rare condition overall. And obviously, by the nature of their actual condition, Topic of systemic means they have multiple disorders affecting multiple organ dysfunctions, inclusive of the most deadly, which is PAH and PHLD. And despite that, their single most complaints of what drives their quality of life is the problem that occurs with Raynaud's phenomenon, which occurs in at least, and it's debatable, but somewhere between 90% to 95% of all patients with systemic sclerosis or scleroderma. The reason why we think we have good rationale is that actually many of the drugs that have been approved for pulmonary hypertension have been studied, specifically on the endocomplication of Raynaud's phenomenon, which is known as digital ulcers, inclusive of prostacyclines. In fact, in the European and the U.S. guidelines for the management of Raynaud's phenomenon, alloprost and or Flolan is used as salvage therapies in the event that patients are recalcitrant to treatments such as calcium channel blockers and or even PD-5 inhibitors, which is used off-label. So that just shows that the prostacyclin class in and of itself is able to prevent worsening ischemic episodes, therefore potentially leading to avoiding issues of gangrene and or amputation of these digits that's affecting these patients. One of the challenges, oral truprocinol was studied in condition, again, to try to modify the digital ulcers. The problem with that was the trial was fraught with tolerability issues and patients coming off because of the intolerability of oral truprocinol, again, highlighting that If we can provide eutrepia for these patients, we know that the tolerability profile of the inhaled tryprosinol is significantly improved. We also know from our data that we can dose to a significantly high level, ensuring that we obtain appropriate pharmacokinetic profile to modify the disease. And so, you know, we look forward to initiating, you know, our Phase IIa program. in systemic sclerosis RP here near the end of the year.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Great. Thank you, Rajesh. Next question, Operator.

speaker
Josh
Operator

Thank you. Our next question goes from Jason Gerberry with Bank of America. You may proceed.

speaker
Jason Gerberry
Analyst, Bank of America

Hey, guys. Thanks for taking my question. Two for me. Just first on PAH. I wanted to just get your view on sort of the role for an inhaled trypospinol in the PAH setting. It's a bit confusing. And so, on the one hand, you know, your competitor flag that maybe inhalation approaches are going to see a diminished role in PAH. And then when we talk to KOLs, what they're saying is they're not putting new starts on Updravi. But yet, when we look at IQVIA data, the Updravi NRX look pretty stable. There's a lot of conflicting data points in this, and it's a dynamic space. You know, Wind River is now getting used more in newly diagnosed PAH. So how do you see this dynamic where the role of, say, oral versus inhaled prostacyclines in PAH? And then my second question for Mike, just when I look at fourth quarter numbers, it looks like really good revenue recognition per patient. You're taking the average, the 3Q number versus the 4Q number. over sales or under sales, I should say. So when we look ahead to 2026, it doesn't seem like that there's going to be a huge gross to net adjustment in the numbers relative to the patients and the revenue capture, but wanted to get your perspective there. Thanks.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah, thanks for the question, Jason. So I'll speak to the PAH issue in terms of oral versus inhaled. And I think I think the field is moving, the paradigm is shifting to where patients aren't going to be willing to accept off-target effects any longer. And because the burden of those off-target effects can be as bad as the burden of the disease in terms of impact on daily living. So the orals, clearly, if you look at the frequency of AEs related to the GI toxicities, they're significant. And they occur daily. They occur over hours in the day. And if you then pair that with minimal symptomatic benefit to the disease, that benefit to risk exchange is not a good negotiation for the patient. So I think going forward, particularly as we continue to evolve data around the ability of eutropia to dose titrate, drive effect, and really eradicate off-target effects to the GI or from parenteral issues related to septicemia and subcutaneous site pain and irritation, nobody would be willing to make a trade-off because now you can get the symptomatic benefit without sacrificing your daily living through these off-target effects. So I do think, and our competitors said it when they spoke about their SMIs, like they're, you know, people are tired now of off-target effects, and they're, you know, people, what you want to see is a better benefit-to-risk profile, which eutropia provides, and then it is a four-times-a-day therapy, so that would be the only sort of negative there. We're going to negate that negative with L606, so the importance of that study will achieve in a different way through liposomal encapsulation all the benefits of eutropia, But now we'll do it in a twice-a-day format, and it will also minimize peak-to-trough excursions so that trough benefit is steady to the peak benefit. So what we're trying to do at this company is really improve patient outcome, have patients feel better, remove these off-target effects, and then get them to a point in time where they can take an easy portable therapy without risk. I think we're well on our way to doing that. I think clearly eutrapia has become the preferred inhaled. And as we continue to sort of cannibalize share from orals, you'll see more and more of that. So again, very excited across the board. And I think that's it for the pH to oral. So maybe, Mike, if you'll talk about the fourth quarter dynamics.

speaker
Michael Cassetta
Chief Operating Officer and Chief Financial Officer

Yeah, Jason, thanks for the questions. So as we look at our growth from 2025 to 2026, as we had said in previous quarters, working on access in the back half of the year, we had some new-to-market blocks that had existed on the commercial front. Those were slowly removed. The result of that is going to be twofold. One, we will pay more rebates on more of our business as we move forward in 2026. But that will be offset by having more patients having access. So what I would say is, as we have kept saying, we are extremely confident in our trajectory as we move into 26 and into 27. But what I would say is maybe there'll be a very small incremental increase in our growth to net, but that is... you know, it goes to our goal of making sure patients have choice and patients have access. So, we will have achieved that goal, and I think we will sit at a place where we're very comfortable and can still achieve our goals in 2026 and, as we've said, being a billion-dollar product in 2027. Thanks, Mike.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Operator, I think we have time for one more question.

speaker
Josh
Operator

Thank you. Our next question comes from Gaurav Mani with LifeSite Capital. You may proceed.

speaker
Gaurav Mani
Analyst, LifeSite Capital

Hey, good morning, everyone. Congrats on the great print and continued strong launch of eutropia. Just two for me, if that's okay. Could the team give some color on that, you know, one in four prostacyclin transition patients and kind of what bucket of prostacyclin therapy, i.e. oral versus inhaled, these patients are coming from? And then secondly, on the new exploratory eutropia trials, can you just describe how these are expected or if they are, I guess, to be label enhancing.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Yeah. So maybe I'll ask Scott to talk about sort of how the transition market, kind of the demographics of that, and then Rajiv, you'll speak to the benefits of the trials that we're doing. So Scott?

speaker
Scott Mumaw
Chief Commercial Officer

Sure. So as we've said, you alluded to, we've said that 75% of the patients are new to prostacyclin and then 25% are switched. Obviously, in PHID, there aren't other options, so those switches are coming from inhaled. In PAH, what we've said is that about 30% of the 25% in PAH are coming from the orals, and then the rest of those are coming from inhaled. Now, we are starting to see more patients transition off of perineurals onto eutropia I don't think that's going to necessarily become material in terms of the switches, but it is interesting and shows that in the future we'll probably kind of encroach on the parenteral space. But, you know, when I'm out there in the market, I can tell you that the enthusiasm around using eutrepia instead of the oral prostacyclines, for all the reasons Roger elucidated earlier, is only growing. And so, we think that, you know, whether they're switching the patient off of an oral prostacyclin or they're using it instead, using eutropia instead of an oral prostacyclin, I think, you know, again, I think there's a big opportunity to that force.

speaker
Dr. Roger Jeffs
Chief Executive Officer

All right. Thank you, Scott. So, Rajiv, you'll speak to the trials, please. Yeah, thanks for the question.

speaker
Dr. Rajiv Sagar
Chief Medical Officer

So, you know, listen, I firmly believe we're entering into a decade and beyond of an inhaled renaissance here in PAH and in PHLD. I think eutropia is leading the charge today, and L606 is going to definitely lead it tomorrow. In that regard, the trials that we are purposely conducting is defining how to switch from the oral prosonoid to eutropia. I think we highlighted a few things on this call. Number one, It is very clear that practitioners across the board are very interested in delivering the most tolerable drug. I think this has been highlighted by the addition of cetatocept to the armamentarium, which has, I think, completely negated and limited the utility of parenteral therapies at this time. We have several large anecdotal cases of eutrapia being used acutely in the hospital. and to combine that also with Cetatercept to maximize the benefit of that combination. In regards to oral prosanoids, we plan to switch studies from Celexapeg to Eutropia. It would detail to the practitioners how to do that effectively and safely. And also, again, the advantage of Eutropia is that we can dose two to four times that typically what is used traditionally by Tyveso. In those studies, We'll also highlight some of the hemodynamic capacity of eutropia, which I think would be very exciting. In regards to label enhancing, I think we reserve the right to always present our data to the agency for consideration for label discussions in that regard. And then finally, I think we've highlighted, just to highlight again, the Cetatocep study. The purpose of this study is to transition patients that are on cetatocept in combination with either forms of prostanoid inclusive of parenteral and or oral and transition off those therapies safely and effectively to eutropia. So those are the studies that we are keenly working across to initiate this year.

speaker
Dr. Roger Jeffs
Chief Executive Officer

Thank you, Rajeev. Very well said, both from you and Scott. So I'll close by just saying, as you can hear, Liquidity is all in for our patients and trying to provide better and better opportunities, both now and in the future. And we look forward to speaking with everyone again in May when we update you on our Q1 outcome. Thank you, everyone.

speaker
Josh
Operator

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-