Q4 2025 Liquidia Corp Earnings Call

March 5, 2026

Speaker #1: Good morning and welcome to the Liquidia Corp full year 2025 financial results and corporate update conference call. My name is Josh, and I will be your operator today.

Operator: Good morning, welcome to the Liquidia Corporation Full Year 2025 Financial Results and Corporate Update Conference Call. My name is Josh. 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 #1: 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.

Speaker #1: Please note that today's call is being recorded. I'll now turn the call over to Jason Adair. Chief Business Officer.

Speaker #2: 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 Kaseta, Chief Operating Officer and Chief Financial Officer; Dr. Rajiv Sagar, Chief Medical Officer; Scott Muma, Chief Commercial Officer and Rusty Shundler, our general counsel.

Jason Adair: Thank you. 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, Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Dr. Rajeev Saggar, Chief Medical Officer, Scott Moomaw, 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Please also note that our earnings release and our commentary include non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures can be found in our earnings release.

Jason Adair: With that, I'll turn the call over to Roger. Roger.

Speaker #2: With that, I'll turn the call over to Roger. Roger?

Roger Jeffs: Thanks, Jason. 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 Liquidia 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 YUTREPIA. 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 YUTREPIA as one of the top specialty drug launches over the past 5 years across all therapeutic categories. This did not happen by chance, but with purpose.

Speaker #3: 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.

Speaker #3: Last year demonstrated that Liquidia 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 Eutrepia.

Speaker #3: 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 Eutrepia as one of the top specialty drug launches over the past five years across all therapeutic categories.

Speaker #3: This did not happen by chance, but with purpose as the category defining the SENT study data clearly set a new data-driven standard for therapeutic success.

Roger Jeffs: As the category defining ASCENT study data clearly set a new data-driven standard for therapeutic success. The momentum of 2025 has clearly carried into 2026. As of 28 February, 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 prostacyclins as the best-in-class option. This steady forward momentum is being achieved across PAH and PH-ILD, with new patient prescriptions roughly equal now between the two indications.

Speaker #3: 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.

Speaker #3: 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 upward trajectory without decline.

Speaker #3: 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.

Speaker #3: 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.

Roger Jeffs: Patient starts remain at 75% naive to 25% transitions from other prostacyclins. 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 5 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 YUTREPIA 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: If 2025 was the start of the full commercial phase, 2026 begins the full clinical exploration of what may be possible with Eutrepia and L606.

Speaker #3: Our development strategy is built on principles we have understood for a long time with prostacycline. Exposure drives efficacy, tolerability drives durability, and convenience drives compliance.

Roger Jeffs: Each of these elements is critical to the totality of therapeutic experience and speaks to the high bar that YUTREPIA 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 prostacyclin therapies and a study of new combinations like adjunctive studies with tadalafil that we hope will further advance the changing standard of care. We will work to initiate new studies to support expansion into additional disease areas such as systemic sclerosis-associated Raynaud's phenomenon and PH-COPD, where high unmet but addressable need remains.

Speaker #3: Each of these elements is critical to the totality of therapeutic experience and speaks to the high bar that Eutrepia has quickly established around safety, efficacy, and convenience.

Speaker #3: 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 prostacyclines therapies like adjunctive studies with Tetracept that we hope will further advance the changing standard of care.

Speaker #3: 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 but addressable need remains.

Roger Jeffs: 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 #3: 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.

Speaker #3: Importantly, this discipline expansion of clinical evidence will be funded by cash flow from operations and will help grow the value of the franchise and the company.

Speaker #3: With that, I will turn it over to Mike.

Mike Kaseta: Thank you, Roger. Good morning, everyone. Our financial results are a direct reflection of two things: sustained patient growth, 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, YUTREPIA generated $148.3 million in net product sales, including $90.1 million in Q4, representing 74% growth in net product sales over Q3 2025. The Q4 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.

Michael Kaseta: Thank you, Roger. Good morning, everyone. Our financial results are a direct reflection of two things: sustained patient growth, 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, YUTREPIA generated $148.3 million in net product sales, including $90.1 million in Q4, representing 74% growth in net product sales over Q3 2025. The Q4 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.

Speaker #2: 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.

Speaker #2: 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, Eutrepia 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.

Speaker #2: 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.

Mike Kaseta: We ended the year with approximately $190.7 million in cash and cash equivalents, having generated $33 million of positive cash flow in the Q4 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.

Michael Kaseta: We ended the year with approximately $190.7 million in cash and cash equivalents, having generated $33 million of positive cash flow in the Q4 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 #2: 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.

Speaker #2: 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.

Speaker #2: Roger, back to you.

Roger Jeffs: 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 #3: 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.

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

Speaker #2: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Speaker #2: One moment for questions. Our first question comes from Ryan Deshner with Raymond James. You may proceed.

Ryan Deschner: Thanks for the question and congratulations on the, you know, impressive continued launch so far for YUTREPIA. Curious, you know, given the greater than 2,900 patient starts you're 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? I have a follow-up.

Speaker #4: Thanks for the question and congratulations on the impressive continued launch so far for Eutrepia. I'm curious, given the greater than 2,900 patient starts you're 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?

Speaker #4: And then I have a follow-up.

Roger Jeffs: Yeah. Thanks, Ryan. Appreciate you joining the call this morning. It's hard to give a, you know, an accurate % market share from a patient number standpoint, given the competitor doesn't disclose their numbers. What we have done is talked about we've done an analysis based on revenue, that maybe Mike, if you don't mind going through, that speaks to this question.

Speaker #3: Yeah, thanks, Ryan. Appreciate you joining the call this morning. So it's hard to give a accurate percent market share from a patient number standpoint, given the competitor doesn't disclose their numbers.

Speaker #3: So, what we have done is talked about—we've done an analysis based on revenue. Maybe Mike, if you don't mind going through it, that speaks to this question.

Mike Kaseta: Yeah. Thanks, Roger, thanks, Ryan, for the question. You know, to give everyone an idea, you know, inhaled treprostinil revenue for Q4 was approximately $550 million. 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. Again, as Roger had said, that represents a disproportionate share of new patient starts, along with a fair share of switches from Tyvaso.

Michael Kaseta: Yeah. Thanks, Roger, thanks, Ryan, for the question. You know, to give everyone an idea, you know, inhaled treprostinil revenue for Q4 was approximately $550 million. 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. Again, as Roger had said, that represents a disproportionate share of new patient starts, along with a fair share of switches from Tyvaso.

Speaker #2: Yeah, thanks, Roger. And thanks, Ryan, for the question. So to give everyone an idea, inhaled propostal 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.

Speaker #2: 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 that represents a disproportionate share of new patient starts along with a fair share of switches from Tyveso.

Mike Kaseta: 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. We're seeing a significant increase quarter-over-quarter. As Roger mentioned, the 2,900 patient starts in just 9 months since launch, that is through 28 February. 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.

Michael Kaseta: 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. We're seeing a significant increase quarter-over-quarter. As Roger mentioned, the 2,900 patient starts in just 9 months since launch, that is through 28 February. 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 #2: In terms of what that share is in Q3, we had about, from a revenue point of view, 10% of market revenue. That increased to 17% in Q4.

Speaker #2: So we're seeing a significant increase quarter over quarter. As Roger mentioned, the 2,900 patient starts in just nine months since launch—that is, through February 28.

Speaker #2: 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 bullish on our ability to continue a successful launch.

Roger Jeffs: Thanks, Mike. 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. You know, as we mentioned in the prepared remarks, the depth of prescriptions is increasing. We're working on improving, you know, the duration and durability so that scripts stack upon scripts so that the revenue growth remains. I believe you had another question, Ryan.

Speaker #3: Thanks, Mike. And Ryan, just to add, I don't think it's been very consistent in terms of trajectory. And we don't see any impediment going forward.

Speaker #3: This year, with regard to any change in that trajectory, as we mentioned in the prepared remarks, the depth of prescriptions has increasing. We're working on improving the duration and durability so that scripts stack upon scripts so that the revenue growth remains.

Speaker #3: And I believe you had another question, Ryan.

Ryan Deschner: Yeah. Thanks for that. With the new outcomes 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 YUTREPIA launch?

Speaker #4: Yeah, thanks for that. With the new outcome data from competitor that came out recently, what's your take on the potential impact of a new addition to the oral process cycle and receptor agonist mix on the Eutrepia launch?

Roger Jeffs: Yeah. I mean, it's a good question. You know, first of all, congratulate United Therapeutics on a successful trial with IP one selective agonist. I think for us, it really doesn't have any impact at all. If you look at it's more like Uptravi 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 IP one 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.

Speaker #3: Yeah, I mean, it's a good question. And first, we'll congratulate Therapeutics on a successful trial with a IP1 selective agonist. I think for us, it really doesn't have any impact at all.

Speaker #3: If you look at it, it's more like UpTravi than not. I mean, they're both in the nanomolar range. I think potency-wise, they're generally similar.

Speaker #3: 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.

Speaker #3: But my guess is it's muted. And as you know, with UpTravi, they had no statistical significance or clinical significantly change in six-minute walk distance.

Roger Jeffs: As you know, with Uptravi, they had no statistical significance or clinical significantly change in six-minute walk distance. You know, in these patient-- When you're talking about a first edition of prostacyclin, the patients are symptomatic and looking for improvement. You know, I don't think, like, the oral therapies just aren't gonna give that bang for the buck. What they are gonna bang is the GI. If you look at the AE profile that was shown, you could see, you know, a high degree of GI side effects, diarrhea, emesis, and nausea. You know, I think it's more of the same. All the results that Mike just talked about in terms of our launch trajectory and success are in the presence of Uptravi being in the market. It's really...

Speaker #3: In these patients, when you're talking about a first edition of process cycle, the patients are symptomatic and looking for improvement. So I don't think the oral therapies are going to give that bang for the buck.

Speaker #3: 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.

Speaker #3: 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 UpTravi being in the market.

Roger Jeffs: to me, it's really an interchange between how relinapag will compete with Uptravi in the marketplace once it's launched. 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 dose. It doesn't seem like there's an ability to dose to better outcome there. What you see is what you get based on probably the close to the initial start dose. 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.

Speaker #3: So it's really, to me, it's really an interchange between how that Ralanipeg will compete with UpTravi in the marketplace once it's launched. So not that concerning.

Speaker #3: 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 dose.

Speaker #3: So, it doesn't seem like there's an ability to dose to a better outcome there. So, what you see is what you get, based on probably close to the initial start dose.

Speaker #3: 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.

Ryan Deschner: Got it. Thanks, Roger.

Roger Jeffs: No problem.

Speaker #3: Hopefully, her next question.

Mike Kaseta: Thanks.

Ryan Deschner: Thanks.

Speaker #2: Thanks. Our next question comes from Julian Harrison with BTIG. You may proceed.

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

Julian Harrison: 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 YUTREPIA and maybe L606 as well relative to a soft mist inhaler that was recently announced by another company in the space? Then as a follow-up, regarding the PAH versus PH-ILD split of patients on YUTREPIA, should we still be thinking about that on approximately a 3-to-1 basis? How do you see that maybe evolving over time?

Speaker #5: 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, maybe L606 as well, relative to a soft mist inhaler that was recently announced by another company in the space?

Speaker #5: 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?

Speaker #5: How do you see that maybe evolving over time?

Roger Jeffs: Yes. I'll answer the and maybe ask Scott to help me with the second question first. We've moved to pretty equal split now between PAH and PH-ILD. You know, there's clearly more white space opportunity in PH-ILD, and I think one of the things we're doing is we're gonna grow our sales force significantly, like, by a third. We're gonna have a larger share of voice, and the purpose of that larger share of voice is to get into the community, particularly into the PH-ILD space, to continue to penetrate that market, drive awareness, and either drive starts or drive referrals. You know, I think over time, that should become an increasing value proposition.

Speaker #3: Yes, I'll answer the and maybe ask Scott to help me with a second question first. So we've moved to pretty equal split now between PAH and PHLD.

Speaker #3: There's clearly more white space opportunity in PHLD. And I think as we one of the things we're doing is we're going to grow our sales force significantly by a third.

Speaker #3: So we're going to have a larger share of voice. And the purpose of that larger share of voice is to get into the community particularly into the PHLD space to continue to penetrate that market, drive awareness.

Speaker #3: And either drive starts or drive referrals. So I think over time, that should become an increasing value proposition. But in PAH, don't forget, we have not only the inhaled market opportunity but we're parenteral opportunity.

Roger Jeffs: 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. On aggregate revenue numbers, they may appear similar in terms of the business opportunity, but in pure patient numbers, I think PH-ILD 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 #3: So an 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.

Speaker #3: Scott, do you have any other questions or any other responses that you'd like to add?

Scott Moomaw: I would, excuse me, I would completely just agree with everything Roger said. It's been interesting to see PAH get off to a fast start. As we've mentioned, PH-ILD has come on strong in, you know, about half. Where it's gonna go from here, I, you know, I think PH-ILD. We know PH-ILD is definitely the bigger opportunity long term, as Roger called it, the white space. There's still a load of opportunity in PAH. You know, where it'll settle out, eventually, I think PH-ILD, definitely will be bigger. There's a lot of growth in both buckets, right now to continue in the near term.

Speaker #6: No, 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.

Speaker #6: And about half where it's going to go from here, I think PHLD we know PHLD is definitely the bigger opportunity long-term, as Roger called it, the white space.

Speaker #6: But there's still a load of opportunity in PAH. So where it'll settle out eventually, I think PHLD definitely will be bigger. But there's a lot of growth in both buckets.

Speaker #6: Right now, to continue in the near term.

Roger Jeffs: Yeah. Great. Thanks, Scott. Again, Julian, you know, there's multibillion-dollar opportunities in each indication. We're excited about the opportunity that YUTREPIA and then subsequently L606 will have in these markets. With regard to the SMI, and 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 YUTREPIA because it sounds like they're trying to develop a product that has the product profile of YUTREPIA. And what is that? It's an easy-to-use, low resistance device with high portability.

Speaker #3: Yeah, great. Thanks, Scott. So again, Julian, there's multibillion-dollar opportunities in each indication. So we're excited about the opportunity that Eutrepia and then subsequently markets.

Speaker #3: With regard to the SMI—and 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.

Speaker #3: What I would say is I think there are commentary in general was it sounded very much to me that it was validating of Eutrepia because it sounds like they're trying to develop a product that has the product profile of Eutrepia.

Speaker #3: And what is that? That's an easy-to-use, low-resistance device with high portability. There's mitigation of cough. But for us, it's specifically done view of the print formulation of engineered particles in the lower end of the respiratory range.

Roger Jeffs: There's mitigation of cough. For us, it's specifically done due to the print formulation and of engineered particles in the lower end of the respirable range. Dosing flexibility due to that tolerance and which then correlates, 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 of cough in a population of PH-ILD patients who have a baseline cough and a high predilection for exacerbation of cough when they take inhalation therapy. You know, YUTREPIA is porting an ideal product profile. What Mike described is we're clearly getting a lot of, if not most of the NRx share, and our TRX share is catching up over time. If the SMI to me, it's a repurposed opportunity.

Speaker #3: 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 PHLD patients who have a baseline cough and a high predilection for exacerbation of cough when they take inhalation therapy.

Speaker #3: So Eutrepia is porting an ideal product profile. What Mike described is we're clearly getting a lot of, if not most, of the anorexia and our TRX share is catching up over time.

Speaker #3: And the SMI, to me, is just a it's a repurposed opportunity. So if you go back to the 793 patent that has a priority date of 2006 and look at example one, for in particular, it talks about their single-dose acute administration of traposanol using an SMI.

Roger Jeffs: If you go back to the '793 patent that has a priority date of 2006 and look at example one for in particular. It talks about there a single-dose acute administration of treprostinil using an SMI. In that same patent, there's a single acute dose with the ultrasonic nebulizers, that is Tyvaso nebulized, Tyvaso as we know it today. What that showed is that in PAH 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. Nothing different. You're giving Tyvaso 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.

Speaker #3: And in that same patent, there's a single acute dose with the ultrasonic nebulizers that is titration nebulized as we know it today. And what that showed is that in PAH patients with a single dose, low dose, the cough was prevalent.

Speaker #3: And it described the MMAD, or the median diameter of those particles, to be in the four to five micron range—so nothing different. So you're giving Tyvaso solution.

Speaker #3: 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.

Roger Jeffs: It doesn't really matter if you, 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 Tyvaso nebulized. You know, we don't, 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. 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. The truth to that statement is, remember, when they launched Tyvaso DPI, they had no data in patients. It was done on bioequivalence in PH-ILD.

Speaker #3: 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.

Speaker #3: It will still present itself clinically in terms of how it behaves as Tivaso nebulized. So we don't really view it as competitive. I think you'd have to ask the competitor to explain the comments they made around tolerability.

Speaker #3: They've said they still have to do bioequivalents. 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.

Speaker #3: And the truth to that statement is, remember, when they launched Tivaso DPI, they had no data in patients. It was done on bioequivalents in PHILD.

Roger Jeffs: You've seen the issues they've had through the National Jewish Health, in particular, with the DPI and PH-ILD. 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. 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.

Speaker #3: And you've seen the same the issues they've had through the National Jewish State, 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.

Speaker #3: And they're trying to pivot to another methodology. But I don't see that methodology as providing any forward-looking benefit. So that's kind of my quick view on it.

Speaker #3: I know Rajiv, you have some broader statements around perspective because this has been tried before. In other markets and if I could, I'd ask you to speak to those instances if you will.

Rajeev Saggar: Yeah, sure. Thanks, Roger. I just wanna highlight some key point here. I think the signature of the SMI was primarily derived from the Spiriva Respimat. That was done at a time when the CFC propellants were being removed, and also there was a patent issue from that company. They compared it to Spiriva HandiHaler, which is their dry powder formulation. At that time, the HandiHaler was the highest resistance device ever to be developed in patients with asthma and COPD, which you know tens of millions of patients. The only device that has a higher resistance than the HandiHaler to date is actually the Tyvaso DPI device that's used in PAH and PH-ILD.

Speaker #5: Yeah, sure. Thanks, Roger. So I think just I just want to highlight some key points here. I think the signature of the SMI was primarily derived from the Spiriva Respimat.

Speaker #5: 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 Handhaler, which is their dry powder formulation.

Speaker #5: And at that time, the Handhaler was the highest resistance device ever to be developed in patients with asthma and COPD, which is tens of millions of patients.

Speaker #5: The only device that has a higher resistance than the Handhaler to date is actually the Tivaso DPI device that's used in PAH and PHLD.

Rajeev Saggar: 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 tiotropium, 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.

Speaker #5: 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—and disregard was tiotropium.

Speaker #5: 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 cough.

Serge Belanger: Of the concerns for cough. I just want to highlight as what Roger spoke to, that the SMI does not port any substantial benefit besides the portability itself.

Speaker #5: So I just want to highlight as what Roger spoke to, that the SMI does not port any substantial benefit besides the portability itself.

Roger Jeffs: All right. Thank you, Rajeev. Operator, next question, please.

Speaker #3: All right. Thank you, Rajiv. Operator, next question, please.

Operator: Thank you. Our next question comes from Amy Li with Jefferies. You may proceed.

Speaker #1: Thank you. Our next question comes from Amy Lee with Jeffries. You may proceed.

Amy Li: Hey. Thanks so much for taking our question and congrats on the momentum. When you look at your path to the $1 billion revenue target in 2027 that you laid out, our math suggests that implies sustained patient adds from here. Is that the right way to think about the trajectory? 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? Are you still confident in that number in light of kind of the potential emerging competitive dynamics like SMI?

Speaker #6: 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.

Speaker #6: 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?

Speaker #6: How much visibility do you have into the patient funnel and where are the patients coming from? And then how and are you still confident in that number in light of kind of the potential emerging competitive dynamics like SMI?

Roger Jeffs: I'll ask Mike to speak to some of that, how we get there, at least from a revenue calculation standpoint. As we just said, Amy, like we don't see any influence from the SMI. I think it's, again, it's gonna be Tyvaso and perhaps a more portable format from, you know, using jet nozzles to create aerosolized particles. As I said, they're gonna be polydispersed, they're gonna cause cough, they're gonna have titration issues. I don't really see that impacting us in any other way. As you're noting in the competitors' revenues, that the nebulized business is decreasing, mostly because we're beginning to take that share away. I think more of that will continue to happen.

Speaker #3: 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.

Speaker #3: I think it's, again, it's going to be Tivaso and perhaps a more portable format from using jet nozzles to create an aerosolized particles. But as I said, they're going to be polydispersed.

Speaker #3: 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 competitors' revenue the nebulized business is decreasing, mostly because we're beginning to take that share away.

Roger Jeffs: Mike, you wanna talk about kind of how we see our sales continuing to climb the mountain towards a greater, at least $1 billion in revenue in 2027?

Speaker #3: So I think more of that will continue to happen. Mike, you want to talk about kind of how we see ourselves continuing the climb, the mountain towards greater at least $1 billion in revenue in 2027?

Mike Kaseta: 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 The inhaled treprostinil market's 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. That's another $2 billion opportunity just within PAH that we see. As Scott and Roger had said earlier, we're just scratching the surface in PH-ILD.

Michael Kaseta: 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 The inhaled treprostinil market's 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. That's another $2 billion opportunity just within PAH that we see. As Scott and Roger had said earlier, we're just scratching the surface in PH-ILD.

Speaker #1: Yeah, Amy. Thanks for the question. I mean, if you just look at start with what I talked about earlier, the market for the quarter was over $500 million, which means it's about a two it's already on the inhaled to proximal market's already a $2 billion market.

Speaker #1: You then talk about we are 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.

Speaker #1: 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.

Mike Kaseta: We're enhancing our sales force. We're getting more penetration. We're getting further into the community. When you look at the overall opportunity, a current $2 billion market opportunity in inhaled treprostinil, plus the oral opportunity, plus the enhanced white space in PH-ILD, we feel very bullish in our ability to continue on this trajectory and continue on this path to get us to what, you know, as Roger had said at JPM, a billion-dollar YUTREPIA being a billion-dollar pro-product in 2027.

Michael Kaseta: We're enhancing our sales force. We're getting more penetration. We're getting further into the community. When you look at the overall opportunity, a current $2 billion market opportunity in inhaled treprostinil, plus the oral opportunity, plus the enhanced white space in PH-ILD, we feel very bullish in our ability to continue on this trajectory and continue on this path to get us to what, you know, as Roger had said at JPM, a billion-dollar YUTREPIA being a billion-dollar pro-product in 2027.

Speaker #1: 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 current $2 billion market opportunity in inhaled to proximal 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, $1 billion utopia being $1 billion product in 2027.

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

Speaker #3: Yeah. And 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.

Speaker #3: And show the benefits of moving those patients to direct tolerability. And efficacy. So all of these things just will continue to build a portfolio in a suite of evidence and data-driven proof that utopia is the best-in-class and first-in-choice product.

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

Speaker #3: Operator, next question, please.

Speaker #1: Thank you. Our next question comes from Serge Belanger with Needham. You may proceed.

Serge Belanger: Hi, good morning. First question on the legal front. Any new updates or developments that you can share with us? 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. I guess what additional coverage work is required. I know you had coverage from three major commercial payers, but what additional payers need to come online over the remainder of 2026? Thank you.

Speaker #4: 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.

Speaker #4: Just curious how that number varies across the Medicare and commercial segment. And I guess what additional coverage work is required? I know you had coverage from three major commercial payers, but what additional payers need to come online over the remainder of 2026?

Roger Jeffs: Sure. Hey, good morning, Serge. Thanks for the question. I'll take the legal, and then I'll pass it to Mike for payer. Really nothing new from what we said at JP Morgan, Serge. 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. We're now approaching nine months from trial and seven months from the post-trial briefing. We do think we're in the sweet spot for when an opinion should and could be rendered, but obviously, it's been taking longer than we all expected, so can't really probabilitize on when it actually will come down.

Speaker #4: Thank you.

Speaker #3: 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.

Speaker #3: So, just a reminder for those who may be newer to the story, the oral hearing was in June. Post-trial briefings were completed in August.

Speaker #3: 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.

Speaker #3: But obviously, it's been taking longer than we all expected. So we can't really probabilitize on when it actually will come down. What I would say is we remain very confident in the arguments that we made.

Roger Jeffs: 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 the and the case 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. 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. Mike, if you'll talk to payer access, please.

Speaker #3: And we strongly believe that we should win. And the case should read out favorably to us. We acknowledge there's a lot of potential options here or outcomes.

Speaker #3: 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.

Mike Kaseta: Yeah. Serge, great to hear from you. I think, you know, where we are with payer and pull-through is just another example of how we've executed on this launch. You know, 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. We continue on that pace. We've also said from the beginning of the launch our goal was to make sure that patients have a choice if they want to use YUTREPIA. 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 YUTREPIA, they can get it.

Michael Kaseta: Yeah. Serge, great to hear from you. I think, you know, where we are with payer and pull-through is just another example of how we've executed on this launch. You know, 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. We continue on that pace. We've also said from the beginning of the launch our goal was to make sure that patients have a choice if they want to use YUTREPIA. 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 YUTREPIA, they can get it.

Speaker #3: So Mike, if you'll talk to payer access, please.

Speaker #1: 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.

Speaker #1: Scott and his team have done a masterful job. The fact that we are at we've maintained 85% plus of pull-through from really the very early stages of the launch is just simply staggering.

Speaker #1: And we continue on that pace. We've also said from the beginning of the launch was our goal was to make sure that patients have choice, have a choice if they want to use utopia.

Speaker #1: 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 utopia, they can get it.

Mike Kaseta: I think that's evident in that pull-through percentage, and we don't see any, you know, any change in that coming. Our goal will always be to improve that as we move forward. I really think we're already in a best-in-class state, being at 85 plus %, pull-through percentage.

Michael Kaseta: I think that's evident in that pull-through percentage, and we don't see any, you know, any change in that coming. Our goal will always be to improve that as we move forward. I really think we're already in a best-in-class state, being at 85 plus %, pull-through percentage.

Speaker #1: 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.

Speaker #1: But I really think we're already in a best-in-class state being at 85-plus percent pull-through percentage.

Roger Jeffs: Great. Thanks, Mike. Operator, next question.

Operator: Thank you. Our next question comes from Benjamin Burnett with Wells Fargo. You may proceed.

Speaker #3: Great. Thanks, Mike. Operator, next question.

Speaker #1: Thank you. Our next question comes from Ben Burnett with Wells Fargo. You may proceed.

Benjamin Burnett: Hey, thanks very much. 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 Q1. Anything you can say kind of around inventory, stocking trends or kind of the refill rate that you're seeing?

Speaker #5: 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.

Speaker #5: Anything you can say kind of around inventory, stocking trends, or kind of the refill rate that you're seeing?

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

Mike Kaseta: Yeah, Ben. Thanks for the question. you know, as we said in our press release and Roger reiterated already, we've already had a strong, you know, 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. As we showed today, we continue to see those increases. 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 the of Q1 into Q2 and are on our path to be a billion-dollar product in 2027.

Michael Kaseta: Yeah, Ben. Thanks for the question. you know, as we said in our press release and Roger reiterated already, we've already had a strong, you know, 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. As we showed today, we continue to see those increases. 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 the of Q1 into Q2 and are on our path to be a billion-dollar product in 2027.

Speaker #3: Yeah, Mike, if you wouldn't mind commenting on that.

Speaker #5: 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.

Speaker #5: We're staying on the exact same trajectory we were on in Q4. We've often gotten questions from analysts and from comments from our competitors about seasonality.

Speaker #5: We've seen nothing but increases across the board. And as we showed today, we continue to see those increases. So as we've always said, as Roger had said, we are still very confident as we move through the rest of Q1 into Q2.

Speaker #5: And on our path to be a billion-dollar product in 2027. Now, as it relates to inventory and stocking, I think we're now at the point of the launch, nine months in, where we've really normalized.

Mike Kaseta: 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 end of quarters that we, you know, don't have influence over. 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.

Michael Kaseta: 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 end of quarters that we, you know, don't have influence over. 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 #5: And I don't expect there to be any significant swings now, especially distributors can make decisions that end up quarters that we don't have influence over.

Speaker #5: 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.

Benjamin Burnett: Okay. That's extremely helpful. Thank you. 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 treprostinil and kind of what your path forward is there?

Speaker #5: Okay. That's extremely helpful. Thank you. And I guess just also regarding the systemic sclerosis RP program, I thought that was interesting. Could you maybe walk us through kind of the evidence and support of Tripostanil and kind of what your path forward is there?

Roger Jeffs: Yeah, I'd love to. Rajeev, if you wouldn't mind talking about the Raynaud's program.

Rajeev Saggar: Yeah, sure. Thanks. Thanks for the question. Obviously, you know, systemic sclerosis is a rare condition overall. Obviously, by the nature of their, the actual topic of systemic means they have multiple disorders affecting multiple organ dysfunctions, inclusive of the most deadly, which is PAH and PH-ILD. 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, you know, and it's debatable, but somewhere between 90% to 95% of all patients with systemic sclerosis or scleroderma.

Speaker #3: Yeah, I'd love to. So Rajeev, if you wouldn't mind talking about the Raynaud's program?

Speaker #4: Yeah, sure. Thanks. Thanks for the question. So obviously, systemic sclerosis is a rare condition overall. And obviously, by the nature of their actual topic of systemic means they have multiple disorders affecting multiple organ dysfunctions, inclusive of the most deadly, which is PAH and PHLD.

Speaker #4: 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 percent of all patients with systemic sclerosis or scleroderma.

Rajeev Saggar: 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 end complication of Raynaud's phenomenon, which is known as digital ulcers, inclusive of prostacyclins. In fact, in the European and the US guidelines for the management of Raynaud's phenomenon, iloprost and/or Flolan is used as salvage therapy in the event that patients are recalcitrant to treatments such as calcium channel blockers and/or even PDE5 inhibitors which is used off-label. 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.

Speaker #4: 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.

Speaker #4: Specifically, on the end complication of Raynaud's phenomenon, which is known as digital ulcers, inclusive of prostacyclines, in fact, in the European and the US guidelines, for the management of Raynaud's phenomenon, alloprost and/or Flowlan is used as salvage therapy in the event that patients are recalcitrant to treatments such as calcium channel blockers.

Speaker #4: 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.

Rajeev Saggar: One of the challenges, oral treprostinil was studied in this 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 treprostinil. Again, highlighting that if we can provide YUTREPIA for these patients, we know that the tolerability profile of inhaled treprostinil 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. You know, we look forward to initiating, you know, our Phase 2a program in systemic sclerosis RP here in near the end of the year.

Speaker #4: One of the challenges oral tripostanil 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 tripostanil.

Speaker #4: Again, highlighting that if we can provide utopia for these patients, we know that the tolerability profile of inhaled tripostanil is significantly improved; we can 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.

Speaker #4: And so we look forward to initiating our phase two aid program in systemic sclerosis RP here in the near the end of the year.

Roger Jeffs: Great. Thank you, Rajeev. Next question, operator.

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

Speaker #3: Great. Thank you, Rajeev. Next question, operator.

Speaker #1: Thank you. Our next question comes from Jason Gerber with Bank of America; you may proceed.

Mike Kaseta: Hey, guys. thanks for taking my question. Two for me. Just, first on PAH. wanted to just get your view on sort of the role for an inhaled treprostinil in the PAH setting. It's a bit confusing. You know, on the one hand, you know, your competitor flagged that maybe inhalation approaches are gonna see a diminished role in PAH. When we talk to KOLs, what they're saying is they're not putting new starts-

Jason Gerberry: Hey, guys. thanks for taking my question. Two for me. Just, first on PAH. wanted to just get your view on sort of the role for an inhaled treprostinil in the PAH setting. It's a bit confusing. You know, on the one hand, you know, your competitor flagged that maybe inhalation approaches are gonna see a diminished role in PAH. When we talk to KOLs, what they're saying is they're not putting new starts-

Speaker #5: Hey, guys. Thanks for taking my question. Two for me. First, on PAH, I wanted to get your view on the role for an inhaled treprostinil in the PAH setting.

Speaker #5: It's a bit confusing. And so on the one hand, 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 Opdravi.

Jason Gerberry: On Uptravi. Yet when we look at IQVIA data, the Uptravi NRx look pretty stable. There's a lot of conflicting data points in this, and it's a dynamic space. You know, Winrevair is now getting used more in newly diagnosed PAH. How do you see this dynamic, where the role of, say, oral versus an inhaled prostacyclins in PAH? Then my second question for Mike, just when I look at Q4 numbers, it looks like really good revenue recognition per patient when taking the average, the Q3 number versus the Q4 number, over sales or under sales, I should say.

Speaker #5: But yet, when we look at IQVIA data, the Opdravi NRX look pretty stable. So there's a lot of conflicting data points in this. And it's a dynamic space.

Speaker #5: When Reverr 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?

Speaker #5: And then my second question for Mike—just when I look at fourth quarter numbers, it looks like really good revenue recognition per patient. Just taking the average of the Q3 number versus the Q4 number, over sales, or under sales, I should say.

Jason Gerberry: When we look ahead to 2026, it doesn't seem like that there's gonna 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 #5: 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 in the revenue capture, but wanted to get your perspective there.

Roger Jeffs: Yeah. Thanks for the question, Jason. I'll speak to the PAH issue in terms of oral versus inhaled. I think the field is moving, the paradigm shifting to where patients aren't gonna be willing to accept off-target effects any longer. 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. 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. 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.

Speaker #5: Thanks.

Speaker #3: Yeah. Thanks for the question, Jason. So I'll speak to the PAH issue, in terms of oral versus inhaled. And 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.

Speaker #3: 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.

Speaker #3: So the oral is 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.

Speaker #3: In the day, and then if you don't, 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.

Roger Jeffs: I think going forward, particularly as we continue to evolve data around the ability of YUTREPIA to dose nitrate, drive effect, and really eradicate off-target effects to the GI or from parental issues related to septicemia and subcutaneous site pain and irritation. There really there's 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. You know, I do think, and our competitors said it when they spoke about their SMIs, you know, like they're, you know, people are tired now of off-target effects and they're, you know. What you wanna see is a better benefit to risk profile, which YUTREPIA provides.

Speaker #3: So, I think going forward, particularly as we continue to evolve data around the ability of YUTREPIA 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, really there's nobody who 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.

Speaker #3: So I do think, and our competitors said it when they spoke about their SMIs, people are tired now of off-target effects, and people what you want to see is a better benefit to risk profile, which utopia provides.

Roger Jeffs: It is a 4 times a day therapy, that would be the only sort of negative there. We're gonna negate that negative with L606. The importance of that study is it will achieve in a different way through liposomal encapsulation all the benefits of YUTREPIA. 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. You know, what we're trying to do is, 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, you know, they can take an easy portable therapy without risk. I think we're well on our way to doing that.

Speaker #3: 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.

Speaker #3: So the importance of that study is it will achieve in a different way through liposomal encapsulation. All the benefits of utopia but now it will do it in a twice-a-day format.

Speaker #3: 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.

Roger Jeffs: I think clearly YUTREPIA has become the preferred inhaled, and as we continue to sort of cannibalize share from orals, you'll see more and more of that. Again, very excited across the board and I think that's it for the PH to oral. Maybe Mike, if you'll talk about the Q4 dynamics.

Speaker #3: So I think we're well on our way to doing that. I think clearly utopia has become the preferred inhaled and as we continue to sort of cannibalize share from orals, you'll see more and more of that.

Speaker #3: So again, very excited about what we've got 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.

Mike Kaseta: Yeah. Jason, thanks for the questions. You know, as we look at our gross to net from 2025 to 2026, you know, as we had said in previous quarters, you know, working on access in the back half of the year, we had some new-to-market blocks that had existed on the commercial front. These were slowly removed. The result of that is gonna 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. You know, what I would say is, you know, as we have kept saying, we are extremely confident in our trajectory as we move into 2026 and into 2027.

Michael Kaseta: Yeah. Jason, thanks for the questions. You know, as we look at our gross to net from 2025 to 2026, you know, as we had said in previous quarters, you know, working on access in the back half of the year, we had some new-to-market blocks that had existed on the commercial front. These were slowly removed. The result of that is gonna 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. You know, what I would say is, you know, as we have kept saying, we are extremely confident in our trajectory as we move into 2026 and into 2027.

Speaker #5: Yeah, Jason, thanks for the question. So, as we look at our gross-to-net 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.

Speaker #5: These 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.

Speaker #5: 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.

Mike Kaseta: What I would say is maybe there'll be a very small incremental increase in our gross to net, but that is, you know, it goes to our goal of making sure patients have choice and patients have access. We will have achieved that goal. I think we'll sit at a place where we're very comfortable and can still achieve our goals in 2026, as we've said, this being a billion-dollar product in 2027.

Michael Kaseta: What I would say is maybe there'll be a very small incremental increase in our gross to net, but that is, you know, it goes to our goal of making sure patients have choice and patients have access. We will have achieved that goal. I think we'll sit at a place where we're very comfortable and can still achieve our goals in 2026, as we've said, this being a billion-dollar product in 2027.

Speaker #5: But what I would say is maybe there'll be a very small incremental increase in our gross-to-net, but that is it goes to our goal of making sure patients have choice and patients have access.

Speaker #5: So, we will have achieved that goal. And I think we'll 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.

Roger Jeffs: Thanks, Mike.

Mike Kaseta: Great.

Michael Kaseta: Great.

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

Operator: Thank you. Our next question comes from Gaurav Mani with LifeSci Capital. You may proceed.

Speaker #3: Thanks, Mike. Operator, I think you have time for one more question.

Speaker #4: Thank you. Our next question comes from Grove Maney with LifeSite Capital. You may proceed.

Gaurav Mani: Hey, good morning, everyone. Congrats on the great print and continued strong launch of YUTREPIA. Just two for me, if that's okay. Can the team give some color on that, you know, 1 in 4 prostacyclin transition patients and kind of what bucket of prostacyclin therapy, i.e., oral versus inhaled, these patients are coming from? Secondly, on the new exploratory YUTREPIA trials, can you just describe how these are expected, or if they are, I guess, to be, label-enhancing?

Speaker #3: Hey, good morning, everyone. Congrats on the great print and continued strong launch of utopia. Just two for me, if that's okay. Could the team give some color on that one-in-four prostacyclin transition patients and kind of what bucket of prostacyclin therapy, i.e., oral versus inhaled, these patients are coming from?

Speaker #3: And then secondly, on the new exploratory utopia trials, can you just describe how these are expected or if they are, I guess, to be label-enhancing?

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

Speaker #1: Yeah. So maybe I'll ask Scott to talk about sort of how the transition market kind of the demographics of that, and then Rajeev, you'll speak to the benefits of the trials that we're doing.

Scott Moomaw: Sure. As we've said, you alluded to, we've said that 75% of the patients are new to prostacyclin, and then 25% are switch. Obviously in PH-ILD, that's, you know, there aren't other options, so those are 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 bulk of those are coming, the rest of those are coming from inhaled. Now, we are starting to see more patients transition off of parenterals onto YUTREPIA. 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.

Speaker #1: So, Scott?

Speaker #5: Sure. So, as we've said—and you alluded to it—we've said that 75% of the patients are new to prostacyclin, and then 25% are switch.

Speaker #5: Obviously, in PHID, that's 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.

Speaker #5: And then the bulk of those are coming the rest of those are coming from inhaled. Now, we are starting to see more patients transition off of parenterals onto utopia 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.

Scott Moomaw: You know, when I'm out there in the market, I can tell you that the enthusiasm around using YUTREPIA instead of the oral prostacyclins, for all the reasons Roger elucidated earlier, is only growing. We think that, you know, whether they're switching the patient off of an oral prostacyclin or they're using it instead, using YUTREPIA instead of an oral prostacyclin, I think, you know, again, I think there's a big opportunity there for us.

Speaker #5: But when I'm out there in the market, I can tell you that the enthusiasm around using utopia instead of the oral prostacyclines for all the reasons Roger elucidated earlier, is only growing and so we think that whether they're switching the patient off of an oral prostacyclin or they're using it instead, using utopia instead of an oral prostacyclin, I think, again, I think there's a big opportunity there for us.

Roger Jeffs: Great. Thank you, Scott. Rajiv, if you'll speak to the trials, please.

Rajeev Saggar: Yeah. Thanks for the question. You know, listen, I, I firmly believe we're entering into a decade and beyond of an inhaled renaissance here in PAH and in PH-ILD. I think YUTREPIA is leading the charge today, and L606 is gonna definitely lead it tomorrow. In that regard, the trials that we are purposely conducting is defining how to switch from the oral prostanoid to YUTREPIA. 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 sotatercept to the armamentarium, which has, I think, completely negated and limited the utility of parenteral therapies at this time.

Speaker #1: All right. Thank you, Scott. So, Rajeev, you'll speak to the trials, please.

Speaker #2: Yeah, thanks for the question. So, listen, I firmly believe we're entering into a decade and beyond of an inhaled renaissance here in PAH and in PHLD.

Speaker #2: And I think utopia is leading the charge today and L606 is going to definitely lead it the trials that we are purposely conducting is defining how to switch from the oral prosenoid to utopia.

Speaker #2: 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.

Speaker #2: I think this has been highlighted by the addition of citalopramide to the armamentarium, which has, I think, completely negated and limited the utility of parenteral therapies at this time.

Rajeev Saggar: We have several large anecdotal cases of YUTREPIA being used acutely in the hospital, and to combine that also with sotatercept to maximize the benefit of that combination. In regards to oral prostanoids, we plan to switch studies from selexipag to YUTREPIA. It would detail to the practitioners how to do that effectively and safely. Also, again, the advantage of YUTREPIA is that we can dose 2 to 4 times that typically what is used traditionally by Tyvaso. In those studies, we'll also highlight some of the hemodynamic capacity of YUTREPIA, 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.

Speaker #2: We have several large anecdotal cases of utopia being used acutely in the hospital. And to combine that also with citalopramide to maximize the benefit of that combination.

Speaker #2: In regards to oral prosenoids, we plan to switch studies from celecepig to utopia. It would detail to the practitioners how to do that, effectively and safely.

Speaker #2: And also, again, the advantage of utopia is that we can dose two to four times that typically what is used traditionally by Tivaso. In those studies, we'll also highlight some of the hemodynamic capacity of utopia, which I think would be very exciting.

Speaker #2: 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.

Rajeev Saggar: Finally, I think we've highlighted just to highlight again the sotatercept study. The purpose of this study is to transition patients that are on sotatercept in combination with either forms of prostanoid, inclusive of parenteral and/or oral, and transition those off those therapies safely and effectively to YUTREPIA. Those are the studies that we are keenly and working across to initiate this year.

Speaker #2: And then finally, I think we've highlighted just to highlight, again, that citalopramide study the purpose of the study is to transition patients that are on citalopramide in combination with either forms of prosenoid inclusive of parenteral and/or oral and transition those off those therapies safely and effectively to utopia.

Speaker #2: So those are the studies that we are keenly and working across to initiate this year.

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

Speaker #1: 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.

Speaker #1: And we look forward to speaking with everyone again in May when we update you on our Q1 outcome. Thank you, everyone.

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

Q4 2025 Liquidia Corp Earnings Call

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