Q3 2025 Liquidia Corp Earnings Call & Business Update
Operator: Good morning, and welcome to the Liquidia Corporation Q3 2025 Financial Results and Corporate Update Conference Call. My name is Carmen, and I will be your operator today. All participants are currently in a 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 now turn the call over to Jason Adair, Chief Business Officer.
Good morning and welcome to the Liquidia Corporation third quarter 2025 financial results and corporate update conference call.
My name is Carmen and I will be your operator today. All participants are currently the song 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.
And I'll turn the call over to Jason Adair, Chief Business Officer.
Jason Adair: Thank you, Carmen, and good morning, everyone. It's my pleasure to welcome you to Liquidia's Q3 2025 Financial Results and Corporate Update Conference Call. Joining me today are Dr. Roger Jeffs, Chief Executive Officer; Michael Kaseta, Chief Operating Officer and Chief Financial Officer; Dr. Rajeev Saggar, Chief Medical Officer; Scott Moomaw, Chief Commercial Officer; and Rusty Schundler, 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 note that our earnings release, our commentary, and our slide deck accompanying this call include non-GAAP financial measures.
Thank you Carmen and good morning, everyone. It's my pleasure, to welcome you to the equity of third quarter 2025 Financial results and corporate update conference call.
Joining me today are Dr. Roger Jeff, chief executive officer. Michael cassetta Chief Operating Officer and Chief Financial Officer. Dr. Rajiv Sagar. Chief medical officer Scott mumo Chief commercial officer and Rusty schundler. 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 web,
Jason Adair: Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures can be found in our earnings release and the slide deck accompanying this call. With that, I'll turn the call over to Roger Jeffs, our Chief Executive Officer. Roger.
Please note that our earnings release and commentary, as well as our slide deck accompanying this call, 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 and the slide deck accompanying this call.
Roger.
Roger Jeffs: Thanks, Jason. Good morning, everyone. This morning, I want to begin by expressing just how proud we are in what Liquidia has accomplished in a remarkably short period of time. Over the last five months, we've not only brought a new and meaningful medicine in YUTREPIA to patients living with PAH and PH-ILD, but we've also begun to influence the way physicians consider how to best introduce epoprostenol into various treatment regimens. Every day, we hear stories from physicians and patients who are thankful to now have an inhaled epoprostenol that fits their lives, one that's simple and well-tolerated. For too long, patients faced limited and difficult choices. YUTREPIA is offering them an attractive alternative. The results speak for themselves. In Q3, YUTREPIA continued to exceed expectations on every front.
Thanks, Jason and good morning everyone.
This morning, I want to begin by expressing just how proud we are of what Liquidia has accomplished in a remarkably short period of time.
Over the last 5 months, we've not only brought a new and meaningful medicine in your tropea to patients, living with ph and pH ald.
But we've also begun to influence the way Physicians, consider how to best introduce a process like into various treatment regimens.
1, that's simple and well tolerated.
For too long, patients have faced limited and difficult choices. Utria is offering them an attractive alternative.
Roger Jeffs: As of October 30, we've received more than 2,000 unique prescriptions, initiated therapy for over 1,500 patients, and have over 600 healthcare practitioners who have prescribed YUTREPIA across the US. In fact, October is our highest month yet for referrals. Through Q3, the vast majority of prescriptions are converting to active patient starts, with the referral-to-start ratio hovering around 85%, an incredible figure for a new-to-market therapy and a true testament to the strength of our commercial and market access infrastructure. We've seen broad application of YUTREPIA and would like to share some details on usage patterns. PAH has accounted for a majority of total prescriptions, with the use in PH-ILD growing steadily. Approximately three out of four patients starting YUTREPIA are new to treprostinil, while about one in four are transitioning from other prostacyclin therapies, typically inhaled.
The results speak for themselves. In the third quarter, Liquidia Corp continued to exceed expectations on every front.
As of October 30th, we've received more than 2,000 unique prescriptions initiated therapy for over 1500 patients and have over 600 Healthcare practitioners. Who have prescribed utra across the US.
In fact, October is our highest month yet for referrals?
Through the third quarter. The vast majority of prescriptions are converting to active. Patient starts with the referral to start ratio, hovering around 85% and incredible figure for a new to Market therapy, and a true Testament to the strength of our commercial and Market access infrastructure.
We've seen broad application of UTIA, and I'd like to share some details on usage patterns.
PH has accounted for a majority of total prescriptions with the use and pH I growing steadily.
Roger Jeffs: Switches from Tyvaso products are similar for both indications at roughly 25% of prescriptions. Notably, around 10% of PAH prescriptions represent switches from oral therapies, a meaningful indicator that physicians may be starting to view YUTREPIA as a viable option to improve exposure and tolerability for patients who are struggling with systemic side effects from their oral prostacyclin therapy. This balance of naive and transition patients demonstrates the flexibility of YUTREPIA across real-world settings in specialized centers and community practices. The feedback we're hearing has been consistent. Many physicians find YUTREPIA easy to initiate, faster to titrate, and better tolerated than other available options, while patients appreciate the convenience and confidence that come with a palm-sized low-effort device. YUTREPIA isn't just gaining traction, it's redefining expectations for inhaled delivery of treprostinil, where exposure drives efficacy, tolerability drives durability, and convenience drives compliance.
Approximately 3 out of 4 patients, starting new tropea are new to your proel. Well about 1 in 4 are transitioning from other prostick therapies typically inhaled,
Switches from taesa products are similar for both indications at roughly 25% of prescriptions.
Notably around 10% of pH, prescriptions, represent switches from oral therapies, a meaningful indicator. That physicians may be starting to view each rep as a viable option to improve exposure and tolerability for patients who are struggling with systemic side effects from their oral process of cyclone therapy.
This balance of naive and transition patients demonstrates the flexibility of Utopia across real-world settings and specialized centers and community practices.
The feedback we're hearing has been consistent.
Many Physicians, find nutropia easy to initiate faceted titrate and better tolerated than other available options while patients. Appreciate the convenience and confidence that come with a palm size, low effort device.
Roger Jeffs: We intend to translate this early commercial success into long-term sustainable growth. As Mike will explain, Liquidia achieved profitability in its first full quarter following launch, and we are well-positioned to reinvest in innovation without compromising our financial discipline. Our clinical strategy in the near term intends to broaden YUTREPIA's clinical utility. We are actively planning niched open label studies to further strengthen the product profile. For example, to help inform what we are already seeing in the field, we will initiate a study in PAH patients transitioning from oral prostacyclins to YUTREPIA. Considering the recent interest in ILD indications, we are evaluating the feasibility of proof-of-concept studies with YUTREPIA in IPF and PPF.
Interpreting it isn't just gaining traction. It's redefining expectations for inhaled delivery of therapy for exposure drives. Efficacy, tolerability drives durability, and convenience drives compliance.
We intend to translate this early Commercial Success into long-term sustainable growth.
As Michael explained liquidity achieved profitability in its first full quarter following launch.
And we are well positioned to reinvest in innovation without compromising our financial discipline.
Our clinical strategy in the near term intends to broaden your truck's clinical utility. We are actively planning niche open-label studies to further strengthen the product profile.
For example to help inform, what we are already seeing in the field. We will initiate a study in PH. Patients, transitioning from oral process. Cyclones to UTP.
Roger Jeffs: We will also explore how YUTREPIA may be used to treat other diseases where patients have unmet needs and smart trial design can expand the value of well-tolerated inhaled treprostinil with opportunities in PAH, COPD, and Raynaud's phenomenon as examples. As you heard during our R&D day, we will further optimize inhaled treprostinil with L606, our sustained release formulation that is rapidly delivered twice daily with a palm-sized nebulizer. We believe that the week 48 data from our US clinical study already demonstrates that L606 may be the most tolerable inhaled treprostinil developed, with clear signals of efficacy in PAH and PH-ILD patients, whether transitioning from Tyvaso or naive to prostacyclin. Our global pivotal study, called RESPIRE, will initiate later this year and planned enrollment to start in H1 2026.
And considering the recent interest in ild indications, we are evaluating the feasibility of proof of concept studies with you trap yet in ipf and ppf.
We will also explore how you tpia may be. Used to treat other diseases for patients have unmet needs and smart. Trial design. Can expand the value of well, tolerated and healthy. Proximal with opportunities, in PH COPD and re notes phenomenon as examples.
And as you heard during our R&D day, we were further optimized and held your proximal with L66, our sustained release formulation that is rapidly delivered twice daily with a palm-sized nebulizer.
We believe that the week 48 data from our us clinical study already demonstrates that El 6066, may be the most tolerable inhaler possible developed with clear signals of efficacy and pH and pH Al patients. Whether transitioning from taesa or naive to process cycling.
Roger Jeffs: Let me hand the call over to Mike to explain how we can maintain our trajectory for increasing the overall value of the company. Mike?
Our global pivotal study called Respire will initiate later this year, with planned enrollment to start in the first half of 2026.
Michael Kaseta: Thank you, Roger, and good morning, everyone. The Q3 2025 was truly a breakthrough quarter for Liquidia, both operationally and financially. During the quarter, our first full quarter of launch, we delivered $51.7 million in net product sales of YUTREPIA. We accomplished this while total R&D and SG&A expenses remained relatively flat compared to Q2 2025. For the quarter, the company recorded a net loss of -$3.6 million. However, when viewed on a non-GAAP basis, we generated positive adjusted EBITDA of +$10.1 million in the first full quarter of YUTREPIA sales, much sooner than our previous guidance of profitability within 3 to 4 quarters post-launch. Cash on hand at the end of the quarter totaled $157.5 million.
Now, let me hand the call over to Mike to explain how we can maintain our trajectory for increasing the overall value of the company. Mike.
Thank you, Roger and good morning everyone. The third quarter of 2025 was truly a breakthrough quarter for liquidia both operationally and financially.
During the quarter, our first full quarter of launch, we delivered 51.7 million in net product sales of UTP.
R&D and SG&A expenses remain relatively flat compared to the second quarter of 2025.
For the quarter, the company recorded a net loss of $3.6 million. However, when viewed on a non-GAAP basis, we generated positive adjusted EBITDA of $10.1 million in the first full quarter of Utre sales, much sooner than our previous guidance of profitability within 3 to 4 quarters post-launch.
Michael Kaseta: Of particular note, I'm especially pleased to say that September marked our first month of positive net cash flow, a major operational milestone that highlights both our rapid success and disciplined approach to cash management. During September, we added $5 million in net cash. We've continued to build on that momentum with additional gains in October. Looking ahead, we expect this positive trend to extend into 2026 as we stay focused on driving profitability while reinvesting in R&D to support sustained long-term growth. Roger, back over to you.
Cash on hand. At the end of the quarter totaled 157.5 million of particular note, an especially, pleased to say that September marked, our first month of positive, net, cash flow, a major operational Milestone that highlights both our rapid success and disciplined approach to cash management.
During September, we added 5 million dollars in net cash and we've continued to build on that momentum with additional gains in October.
Roger Jeffs: Thanks, Mike. As we close out this quarter, I want to emphasize the 3 key foundational elements that are truly defining the success of Liquidia both now and into the future. 1, we have a product in YUTREPIA that is rapidly influencing the standard of care. 2, we have quickly established strong, profitable operating foundation. 3, we have a disciplined growth strategy focused on expanding indications and value for YUTREPIA while also advancing our next-generation product, L606. These pillars, innovation, execution, and reinvestment, are what will guide us as we end this year and enter 2026. Above all, I want to thank our team, our clinical partners, and the patients who trust us. They are the reason we continue to deliver with both passion and precision. With that, operator, please open the line for questions.
Looking ahead. We expect this positive trend to extend into 2026, as we stay focused on driving profitability while reinvesting in R&D to support sustained. Long-term growth, Roger back over to you.
Thanks Mike. And as we close out this quarter, I want to emphasize. The 3 key foundational elements that are truly defining the success of liquidia both now and into the future.
1. We have a product in nutropia that is rapidly inflowing seeing the standard of care.
2. We have quickly established, strong profitable, operating, foundation, and 3. We have a disciplined growth strategy, focused on expanding indications and value for UTPA. While also advancing our next Generation product l66.
These pillars—innovation, execution, and reinvestment—are what will guide us as we end this year and enter 2026.
Above all, I want to thank our team, our clinical partners, and the patients who trust us, they are the reason we continue to deliver with both passion and precision.
Operator: Thank you so much. As a reminder, to ask a question, simply press star one one on your telephone and wait for your name to be announced. To remove yourself, press star one one again. Please stand by for our first question, please. Our first question comes from the line of Amy Lee with Jefferies. Please proceed.
With that operator, please open the line for questions.
Thank you so much. And as I reminder to ask a question, simply press star, 1 1, 1 on your telephone, and wait for your name to be announced to remove yourself press star 11 again.
Please stand by for our first question, please.
Comes from the line of Amy Lee with Jeffreys. Please proceed.
Amy Lee: Hey, thanks so much for taking our question, and congrats on the incredible launch. Based on our back of the envelope math, we're getting to around 1,000 patient adds this quarter, which is doubling what TYVASO DPI reported in their 500, you know, quarter-over-quarter adds earlier in their launch. Can you give us a sense of what's driving this uptake and, in particular, the breakdown between PAH and PH-LD? Finally, how are you thinking about the trajectory of patient adds going forward?
Hey, thanks so much for taking your question and congrats on the incredible launch. Um, based on our back of the envelope math, we're getting to around a thousand patient as this quarter, which is doubling, uh, with hzo, tzo DPI reported, um, in their 500, you know, quarter over quarter ads earlier in their launch. Can you give us a sense of what's driving this uptake and
And uh, in particular, the breakdown between pH and pH. I and then finally how are you thinking about the trajectory of patient ads going forward?
Roger Jeffs: Hi, Amy. Thanks for the question. You know, again, we won't really comment more specifically than what we already have in the earnings release on numbers. I think what you're seeing is very strong demand in the first five months of launch, completely driven by the product profile of YUTREPIA, which is unique and certainly is well on its way to becoming the established prostacyclin of first choice, not only in the inhaled market, but as we alluded to, we're starting to see oral transition, so we can offset some of the GI toxicities with the oral. What we're also seeing somewhat is in the patients that have added sotatercept and may be quote-unquote, normalizing as they deescalate the parenteral therapy.
Hi Annie. Thanks. Thanks for the question. So you know, again we won't really comment more specifically than what we already have in in the earnings release on on numbers. But I think what you're seeing is very strong demand in the first 5 months of of launch completely driven by the product profile of your tia which is unique. And certainly is well on its way to becoming the established processor. First choice
Not only in the inhaled Market, but as we as we alluded to, we're starting to see oral transitions. So we can offset some of the GI toxicities with the oral.
Roger Jeffs: They're replacing that with YUTREPIA so that they can keep the prostacyclin pathway addressed. There's a lot of, I would say, growing opportunity. I think, you know, if you look at the first five months, we've obviously seen very strong demand based on the profile. October, as we said, it has had a slight uptick versus the previous best month, so we're still on an attractive runway. While we can't predict growth in the future, and certainly there will be some seasonality and I think some ordering choppiness as, you know, at the early phase of launch, I think we'll continue to execute well, and we feel very good about our future prospects.
And then what we're also seeing somewhat is in the uh patients that have added satisfaction and maybe uh quote unquote normalizing as they deescalate the uh parental therapy. They're replacing that with your TPA so that they can keep the process of cycling pathway addressed.
So, there's a lot of, I would say, growing opportunity.
um, I think, um, you know, if you look at
the first 5 months, we've obviously seen very strong demand, based on the profile.
Um October as we said, it has had a slight uptick versus the previous best month. So we're still on a on an attractive Runway.
Roger Jeffs: Maybe Scott, if I could ask you to maybe highlight some of the things that you think as Chief Commercial Officer that have highlighted the quarter and address more specifically some of Amy's questions.
Um, and while we can't predict growth in the future and certainly, there will be some seasonality and I think some ordering, uh, choppiness is, you know, at the early phase of launch, I think we'll continue to execute well and we feel very good about our future process prospects.
um,
Scott Moomaw: Yeah, thanks. Good morning. I think that the things that we're focused on right now is one is we're continuing to increase breadth. We're still in launch phase, we're still out there getting awareness and trial. We feel like we have an amazing opportunity still to drive to new prescribers. At the same time, we're still looking at depth from the current prescribers. Each day, we have new prescribers that are over the five prescription mark, which shows, I think, an amazing amount of investment at those centers. We think there's a lot of opportunity left out there. I think, Amy, I think you asked about the PAH, PH-LD split.
maybe Scott if I could ask you to maybe highlight some of the things that you think as Chief commercial officer that the highlight of the quarter and address more specifically, some of the Amy's questions.
Scott Moomaw: One thing we will comment on there is, we have seen that PAH is a majority of the prescriptions. However, PH-LD is definitely growing steadily, which is kind of what you would expect. You know, I think PAH was probably a little bit more the, if you will, the lower hanging fruit, and PH-LD is a growing market, as we all know, and, you know, the sky's the limit, as far as that goes.
Um, at the same time, we're still looking at depth from the current prescribers, we have each day, we have new prescribers that are over the 5 prescriptions Mark, um, which shows, I think an amazing amount of, uh, investment um, at those centers. So, you know, we think there's a lot of opportunity left out there. I think Amy, I think you asked about the PHP hilde split. Um, 1 thing, we will comment on there is um, we have seen that paw is a majority of the prescriptions. However, um, pH ID is definitely growing steadily, which is kind of what you would expect. Um, you know, that I think paw was probably a little bit more the
If you will the lower hanging fruit and pH ID is, uh, is is a growing Market as we all know and, and, you know, the sky's the limit. Uh, as far as that goes,
Amy Lee: Thank you so much.
Thank you so much.
Operator: Thank you. One moment for our next question. That comes from Cory Jubinville with LifeSci Capital. Please proceed.
Thank you, 1 moment for our next question. That comes from Courage of envel with life. Psych Capital, please proceed.
Cory Jubinville: Hey, good morning. Thanks for taking our question and congrats on this really exciting update. I guess, can you just speak to what percentage of revenues might be associated with contracted versus non-contracted reimbursement? I mean, at this point, are you on the formularies for the three major PBMs? I'd say the script volume and the prescriber count is strong, of course, but I think the revenues being recognized to this magnitude this early definitely far exceeds expectations. Just trying to get a sense of what some of those key drivers were in order for you to convert volume to revenues this quickly. Thank you.
Hey, good morning. Thanks for taking our questions and, and congrats on this really exciting update, um,
I guess, can you just speak to what percentage of revenues might be associated with contracted versus non-contracted reimbursement? I mean, at this point are you on the the formulas for the 3 major pbms?
I'd say the script volume and the the prescriber cause is strong, of course. But I think the, the revenues being recognized to this magnitude, this early, definitely far exceeds expectation. So just trying to get a sense of
Roger Jeffs: Yeah. Good morning, Cory. Great question, and we've certainly spent a lot of effort and energy on the market access initiatives. Michael, if I could ask you to comment on that specific question.
Uh what some of those key drivers were in order you for you to convert volume to revenues this quickly. Thank you.
Michael Kaseta: Thanks, Roger, and thanks for your question, Cory. You know, specifically around payers, I think it is also a testament of where we are right now on our pull-through. You know, as we said, we've pulled through approximately 85% of referrals have converted into a script. That's a testament to the, you know, what we had talked about at launch of building these patient support services that will enable that smooth transition and we're very proud of what we've done there. Now, as it relates to payers, as we've previously stated, we've signed contracts with the three major commercial payers. We are the new to market blocks that we referred to previously have or will be removed here in the coming weeks.
Michael Kaseta: As it relates to what is contracted and what is not contracted, you know, to date, as you know, there is no contracting in Medicare Part D, so we are on even footing there. In commercial, have started have contracted and started to receive, you know, start to pay rebates there. You know, as we move forward, as we've always said, we wanted to make sure that patients had an ability to make a choice, and we feel that we have achieved that now and look forward to the future where, you know, if a patient wants to choose YUTREPIA, that they will not be blocked by virtue of a contracting issue.
Yeah, good morning. Corey great. Great question, and we've spent a lot of effort and energy on the market access initiatives. Uh, Mike, if I could ask you to comment on the specific question. Yeah, thanks Roger, and thanks for your question, Corey, you know, specifically around payers, I think it's it. It is also a testament of where we are right now on our poll through. And, you know, as we said, we've pulled through approximately 85% of referrals, have have, uh, uh, converted into a script, um, and that's a testament to the, you know, what we had talked about at the launch of building, these patient Support Services, uh that will enable that smooth transition and and we're very proud of what we've done there. Now, as it relates to payers, as we've previously stated we've, uh, We've signed contracts with the 3. Major commercial payers. Um, we are, um, the, the new to Market blocks that we referred to previously have or will be removed here in the, uh, in the coming weeks. Uh, so as it relates to, what is contracted and what is not contracted, you know, to date. Uh, as you know, we've there is no Contracting in Medicare.
Cory Jubinville: Very helpful. Thanks. Congrats again.
Part D. So we are on even footing there in commercial. We are have started to have contracted and and started to receive uh, you start to pay rebates there. But you know, as we move forward, as we've always said, uh, we wanted to make sure that patients had an ability to to make a choice and we feel that we have achieved that now and and look forward to, to the Future where, you know, if a patient wants to choose uh, UTPA that they will not be uh, blocked by virtue of a uh of a Contracting issue.
Very helpful. Thanks congrats again.
Operator: Thank you. Our next question is from Julian Harrison with BTIG. Please proceed.
Thank you.
Julian Harrison: Hi. Good morning. Congrats on the quarter, and thank you for taking the questions. Of the 1,500 patients on YUTREPIA at end of last week, are you able to say how many are or were in the 28-day voucher period at that time? Also average time from prescription written to YUTREPIA being shipped to a patient, what is that currently looking like?
Our next question is from Julian, Harrison with btig, please proceed.
Roger Jeffs: Yes. Hi, Julian. It was good to see you last week at the R&D day. Mike, if you could answer the question, please.
Hi, good morning. Congrats on the quarter and thank you for taking the questions of the 1500 patients. On your trip. Yeah, end of last week. Are you able to say how many are are, are are in the 28 day voucher period, but but at that time and um, also average time from prescription written to, you try, if you're being shipped to a patient, what is that currently looking like?
Michael Kaseta: Thanks, Julian. In terms of average time from time prescription is written to when it's filled, what we're seeing is it's usually within a few weeks, which was pretty customary for SPs. You know, we have a cross-functional focus on pulling through every prescription, from market access to field reimbursement managers with the SPs, which is in constant coordination with the HCP office. Now, as it relates to our voucher program, again, the voucher program that we offer patients to give them an opportunity to try YUTREPIA with a free 28-day first shipment, that has ticked up a bit.
Yeah, I drew in it was good to see you last week at the R&D day. Um Mike if you could answer the question please,
Michael Kaseta: We are now a bit over 50% of our new patients are using the voucher program, which was, you know, slightly higher from where we were when we had our call in August. We feel it's a great opportunity for patients and doctors to trial YUTREPIA. If it works for them, then they can, you know, continue on their journey. You know, for now, the expectation and where we are is slightly over 50% are using the voucher program.
Yeah, so thanks Julian. Uh, in in terms of average time from, uh, from uh, time prescription is written to, when it's filled. What we're seeing is it's usually within a few, uh, within a few weeks, which is was pretty customary for SPS. Um, you know, we have a cross functional focus on pulling through every prescription, um, from Market access to field, reimbursement, managers with the SPs who which is in constant coordination with the hcp office. Now, as it relates to our Voucher Program, uh, again the voucher program that we offer patients to to give them an opportunity to try utia with a a free 28 day uh for shipment. Uh that has ticked up a bit. We are now uh, a bit over 50% of our new patients are, are using the voucher program, which was, you know, slightly higher from where we were when we, uh, when we had our call in August, but we feel it's a great opportunity for patients and doctors to to trial utia. And if it works for them, uh, then that we, they can, you know, continue on their Journey. But, you know, for now,
Julian Harrison: Excellent. Thank you, Mike. Just to clarify, 50% have utilized the voucher program or were using it as of the end of last week?
Michael Kaseta: from launch to date.
The, uh, the voucher program. Excellent, thank you, Mike. And just to clarify, uh, 50% have utilized the voucher program or were using it as a vendor last week.
Julian Harrison: Got it.
Michael Kaseta: Slightly over 50%. Yes.
Julian Harrison: Thank you.
So from launch to date, we were slightly over 50%. Yes, thank you.
Operator: Thank you. One moment for our next question, please. It's from Ryan Deschner with Raymond James. Please proceed.
Thank you. 1 moment for our next question, please.
Is from Ryan Dashner. With Raymond James, please proceed.
Ryan Deschner: Thanks, congrats on the quarter. In Q2, you reported an elevated level of channel loading, and just wanted to ask how this metric is trending in Q3 and into October. Then, I may have missed it at the beginning, if you could comment again on naive versus treprostinil-experienced patients. Thanks.
Thanks and congrats on the quarter. In the second quarter, you reported an elevated level of channel loading, and I just wanted to ask how this metric is trending in the third quarter and into October. And then, I may have missed it at the beginning, if you could comment again on naïve versus tropos experience patients. Thanks.
Roger Jeffs: Hi, Ryan. Good morning. I'm not sure specifically what you're asking about channel loading because I don't think we commented on that specifically in the prior quarter. In terms of naive versus transition patients, it's been about 75% have been new to prostacyclin therapies and 25% have been transitions, typically from inhaled. Although you can see in PAH where the orals are only approved and not in PH-LHD, we are seeing 10% transitions there. I think one thing that question is related is kind of are we growing the market versus just taking share? I think the correct answer is yes, we are. I think the market's growing now with a second company in there driving awareness.
Yeah. Hi, Ryan. Good morning. Um, so I'm not sure specifically that we're asking about Channel 11 because I don't think we commented on that specifically in the Q3.
Um, in terms of naive versus um transition patients. It's it's been about 75%.
Have been new to process cycling therapies and 25% have been transitions typically from inhaled. Although, you can see in Paw where the orals are only approved and not in PH LD, we are seeing 10% transitions there.
I think 1 thing that
Is it related? Is it kind of? Are we growing the market versus just taking share? And I think the correct answer is yes, we are. I think the market's growing now with...
Roger Jeffs: When you look at things sequentially, I'd say Q2 to Q3, I think we're capturing the lion's share of this new opportunity. For example, I think it was reported last week that Tyvaso increased in aggregate across the nebulized and Tyvaso DPI franchise, $14.8 million, whereas we're now from Q2 to Q3, we've grown by $45.2 million. That represents the revenue growth. Of that revenue growth, we've captured 75% of that, which we're very, very pleased about. You know, a lot of opportunity here to grow the market. I think with the product profile, the commercial acumen and the ability that we've had to drive immediate awareness around the value of YUTREPIA, you're seeing that the uptake is leaning in a one-sided manner towards YUTREPIA.
Us a second company in their driving awareness and I think. But when you look at things sequentially, I'd say quarter second quarter to third quarter.
I think we're capturing the line share of of this new opportunity. For example, I think it was reported last week that Tau increased in aggregate across the, the nebulized, invasive, uh, DPI franchise. 14.8 million.
whereas we're now from Q2 to Q3 we've grown by 45.2 million so that represents the revenue growth and of the that Revenue growth, we've captured 75% of that which were very very pleased about
Roger Jeffs: Again, I don't think we've commented on channel loading, but we can get back to you on that later if that's helpful.
So, you know, a lot of opportunity here to grow the market and I think with the product profile the the commercial Acumen and the ability that we've had to drive immediate awareness around the value of your truck. Yeah. You're seeing that the uptake is is leaning in a 1 side of manner towards you Tia. So um,
Again, I don't think we've commented on channel loading, but we can get back to you on that later.
If that's helpful.
Ryan Deschner: Got it. Thanks, Roger.
Got it. Thanks Roger.
Operator: Thank you. Our next question is from Serge Belanger with Needham. Please proceed.
Thank you. Our next question is from search Bellinger with medium. Please proceed.
Serge Belanger: Hi, good morning and congrats on Q1 of launch. First question regarding payer coverage. Can you kind of give us an update on now on when you expect to be at a steady state of coverage? I believe your competitor had entered some contracts with some commercial plans. Just curious if that has led to some headwinds for coverage of YUTREPIA. Lastly, maybe just expand a little bit on your plans to explore YUTREPIA usage in IPF and PPF. Thanks.
Hi, good morning, and congrats on the first quarter of launch. Um, first question regarding, uh, care coverage? Can you kind of give us an update on now on when you expect to be at a, at a steady state of coverage? And I believe your, your competitor had entered some contracts. Uh, with some commercial plans, just curious if that that has led to some headwinds for for coverage of utria.
And then, lastly maybe just uh, expand a little bit on. Um,
Your plans to explore your triple usage and IPS and PPF. Thanks.
Roger Jeffs: Great. Since Mike handles payer access questions, if you'll handle the first question and then Rajiv, if you wouldn't mind speaking to our explorations in IPF.
Great sentence. Mike handles pair access questions if you'll handle the first question. Then, Rajeev, if you wouldn't mind speaking to our explorations in IBF.
Michael Kaseta: Yes, Serge, great to hear from you. Thanks for the question. As it relates to payers, and you referenced United's comments that they had contracted in the commercial space, which we've spoken previously about, that they contracted at a parity level. As I said earlier, we have signed commercial contracts with the three largest payers. New-to-market blocks have been removed or are in the process of being removed. As a result of that, we feel that we will be on equal footing with United as it relates to that. We feel very confident in our strategy, very confident in where we sit right now that will enable us to have future growth.
Yes, sir. It's great to hear from you. Um, and thanks for the question as it relates to payers. Um, and you, you referenced, uh, United's comments that they had contracted, um, in the commercial space, uh, which we've we've spoken previously about uh, that they contracted uh, at a parody level. Um, as I said earlier, we have signed commercial contracts with the 3, largest payers. Um, new to Market blocks have been removed or in the process of being
Michael Kaseta: One other point I just wanna go back to is around, you know, the channel loading. Obviously, at launch, the channel loading, but, you know, prior to launch, SPs are making an assumption of what's needed. What I would say is we have settled into where I believe is a normal level of inventory. If you wanna say that SPs hold somewhere between 3 and 4 weeks of inventory, you know, we have leveled off there. We have, you know, great relationships with the SPs to understand where ordering patterns are. We're very confident in, you know, as we move forward that we, you know, that can be managed appropriately and feel that we are in line with what our expectations would be.
In line with what our expectations would be.
Roger Jeffs: Great. Rajeev, if you'll speak to the clinical question.
Rajeev Saggar: Thanks, Serge Belanger, for the question. I mean, I think there's a few lessons coming out of TETON-2 that highlight that, you know, inhaled treprostinil appears to, you know, slow the progression of forced vital capacity in patients with, specifically with IPF over a course of 52 weeks. I think the other thing that continues to be something that we as a company and with YUTREPIA are in full agreement is that dose matters. Once again, lo and behold, it strongly suggests in TETON-2 that if you can dose the patient as high as up to 12 breaths, these patients did much better than if you cannot, the patient cannot get to at least a minimum of 9 breaths.
Great Virginia. If you'll speak to the clinical question,
Yeah. Thanks uh, thanks s for the for the question. So I mean I think there's a lot there's a few lessons coming out of uh Teton 2 that highlight that.
you know, inhale tree proximal, um, appears to, you know, slow the progression of Force battle capacity in patients with
Rajeev Saggar: I think obviously our SENSE study strongly suggests that, you know, if we can even dose even higher to that, we actually, and earlier, we potentially can even improve overall patients in regards to exercise capacity, at least in PH-LHD. If you take the entirety of that situation, and of course, the PPF study is not read out yet, but this suggests that I think YUTREPIA has a very strong product profile that may have some significant advantages over nebulized Tyvaso in regards to potentially ease of use, dosing, and titratability, and overall tolerability effect.
Specifically with ipf over a course of uh, 52 weeks. Um, I think the other thing uh that continues to be something that we as a company. And with eutropia um, are in full agreement, is that dose matters and once again, low and behold, um, it it's strongly suggested in Teton 2 that if you can dose the patient. Uh, as high as up to 12 breaths, these patients did much better than, than if you, uh, cannot. Uh, the patient cannot get to, uh, at least a minimum of 9 breaths. I think obviously our sense study strongly suggests that, you know, if we can have a dose of in higher to that, we actually, uh, and earlier, we, we potentially can have an improved, uh, overall patients, uh, in in regards to Exercise capacity at least in PHL. So if you take that, if you take that entirety of that situation, uh, and of course, uh, the, the ppf study has not read out yet, uh, but this this suggests that I think you.
You're trapped. You have a very strong product profile that may have some significant advantages over nebulized teso in regards to...
Uh, potentially ease of use.
Rajeev Saggar: I think, you know, as an organization, we're extremely interested in evaluating and considering this pathway as we move forward.
Dosing and titab uh, and overall tolerability effect. So I think, you know, as a as an organization we're extremely interested in in
Roger Jeffs: Yeah. Thank you, Rajeev. You know, as you stated, you know, this is a real period of renaissance for inhaled treprostinil, and I think the value that YUTREPIA brings, and the market opportunity expansion is immense. That with L606, you know, we have a next-generation opportunity to really complete this paradigm shift over time.
In evaluating and considering this pathway as we move forward.
Yeah, thank you. Reggie, you know, as you stated, you know, this is a, a real period of Renaissance for inhaled your proximal.
And I think the value that you trip your brains, uh,
And the market opportunity expansion is immense.
And that with L6066, you know, we have a next generation opportunity to really complete this paradigm shift over time.
Serge Belanger: Thank you.
Operator: Thank you. Our next question is from Andrew Fein with H.C. Wainwright. Please proceed.
Thank you.
Andrew Fein: Oh, hi. Good morning, everyone, and congratulations. I guess, you know, look, strong sales are always a great thing and patient demand being high is always a great thing. Maybe you can speak to the heightened importance of it in the context of the ongoing litigation with United Therapeutics and the read-through of the strength of sales and strength of patient demand and clear perceived differentiation between the products as we sort of see the litigation come through.
Thank you. Our next question, is from Andrew Fein with HC Wayne Wright, please. Proceed.
Hi, good morning everyone. Congratulations. I got you know look the strong sales are always uh a great thing and additional demands Spring High is always a great thing.
Maybe you can speak to the hyphen importance of it, in the context of the ongoing litigation with United Therapeutics, and the read-through of the strength of sales and strengths of patient demand. And, uh,
Clear perceived differentiation from the way between the product as as you can see in litigation.
Roger Jeffs: Yeah. Andrew, it was a little bit difficult to hear the question specifically. I could hear that you were asking about the litigation and how that's impacting demand.
Yeah, Andrew was a little bit difficult to hear the question specifically.
Andrew Fein: Yeah. The read-through to the robust commercial environment to the litigation.
I could hear that you were asking about the litigation and how that's the reason to the, to the, to the, to the robust.
Commercial environment. See the, uh, the litigation
Roger Jeffs: Yeah. I think, I think the simple answer to that is, you know, physicians and prescribers in general aren't that aware of the litigation and their only concern is patient benefit. I think, you know, when our goal has been to expose the centers to the value of YUTREPIA, get them to try it, particularly within the centers of excellence, and then drive further demand. I think, you know, that's their concern. What happens in a court of law is outside of their jurisdiction, so they don't technically pay any attention to it. So to me, there's not a lot of read-through in terms of how that litigation has impacted the uptake. As you can see, the uptake has been robust. I don't know that.
yeah, I think I think the simple answer to that is, you know,
Don't aren't aren't that aware of the litigation and and they're only concern is patient benefit. So I think you know when
Our goal has been to expose the centers to the value of your trap. You get them to try it, particularly within the Centers of Excellence.
And then drive further demand, I think.
You know that that's their concern. What happens in a court of law is outside of their jurisdiction, so they don't technically pay any attention to it.
Um, that says to me there's not a lot of read-through in terms of how that litigation is impacted the uptake. And as you can see, the been robust, I don't know that phrase.
Andrew Fein: How does it impact the landscape of thought processes Judge Young might go through in deciding his outcome for the litigation? The more the commercial impact that Judge Young might go through.
Roger Jeffs: Yeah. Yeah. Yeah. Understood. Okay. maybe Rusty, if you can count on the, sort of balance of equities and harms.
How does it impact the, the, the, the landscape of of thought, processes judge young might go through and and deciding his outcomes for the litigation, the more, the commercial impact, the judge younger? Yeah.
Rusty Schundler: Yes. We don't, again, it's hard to predict how a judge is gonna consider, or even whether he'd consider commercial results, if that's the question. You know, I think the judge, you know, is gonna be thorough in thinking through the evidence that was presented to him, and evaluate and come up with a decision. Again, I don't think he's gonna be taking into account what's happening in the marketplace sort of post-trial in coming up with his decision. If that was the question.
Yeah, understood. Okay. Um, maybe, Rusty, if you can count on the sort of balance of equities and harm.
The decision is so, so again, I don't think he's going to be taking into account what's happening in the marketplace, sort of post-trial, and coming up with his decision.
If that was the question.
Andrew Fein: That's helpful. Thank you.
That's helpful. Thank you.
Roger Jeffs: Yeah. I would maybe just take this opportunity to, you know, just remind listeners today that the value of the opportunity in PAH alone, I think the oral therapies are doing around $2 billion currently. The inhaled, if you just split the Tyvaso revenue in half, you'd say it's close to $1 billion. Parentals are around $500 million. You can easily get to a $3.5 billion current day revenue opportunity in PAH alone. As you can see, we think the attractiveness that YUTREPIA offers can lead to a leading position across all three of those segments, the oral, inhaled, and the steal of parental share.
Yeah, I would maybe just take this opportunity to, you know, just remind listeners today that the, the value of of the opportunity and and PAW alone.
I think the oral therapies are doing around $2 billion. Currently, the inhaled...
If you if you just split the type A so uh Revenue in half. You'd say it's close to a billion and and then orals are around. I mean, a parental is around 500 million so you can easily get to a 3 and a half billion dollar current day.
Roger Jeffs: You know, again, I know there's some concern around what may or may not happen with 327 patent, but I think, you know, even if you took it in isolation, this is a tremendous opportunity that we have in front of us.
Revenue opportunity with with npah alone. And as you can see, we think the attractiveness that you you trippy offers can lead to a leading position, across all 3 of those segments, the oral inhaled and the steel of Parental share. So,
You know, again, I know there's some concern around what may or may not happen and with 327, but I think, you know, even if you took it in isolation, this is a tremendous opportunity that we have in front of us.
Operator: Our question is from Benjamin Burnett with Wells Fargo. Please proceed.
Benjamin Burnett: Hey, thank you very much and congrats on the quarter. I just wanna follow up on that last question. I guess I think we were maybe anticipating an update from a legal update. Just curious if the timing, from what you're hearing on your end is any changed? I guess maybe could you also just remind us as to what exactly we'll get? Like, should we get an understanding of any sort of ramifications, or is this just purely a decision around this patent that you mentioned? Thank you.
Our question is from Ben Bernett with Wells Fargo. Please proceed.
Hey, thank you very much, and congrats on the quarter. I just want to follow up on that last question. I guess I think we were maybe anticipating an update from a legal standpoint. I'm just curious if the timing...
Roger Jeffs: Yeah. Thanks, Ben. Rusty?
Uh, from what you're hearing on your end, is there any change? And I guess maybe could you also just remind us as to what exactly we'll get? Should we get an understanding of any sort of ramifications, or is this just purely a decision around the patent that you mentioned? Thank you.
Rusty Schundler: Yeah. Thanks, Ben. I mean, as far as timing goes, let me address that first. You know, obviously there's no deadline for judges to rule in cases. You know, I think the judge, you know, the caseload in Delaware is pretty high. You know, I think the judge is going to be thorough in his opinion, but we don't have visibility as to when that decision will come. You know, I think, you know, if you look at the time it took him to render a decision in the first Hatch-Waxman case a few years ago, you know, I'd say we're in the window when we'd expect an opinion. You know, the window is a pretty wide window.
Yeah, thanks Ben Rusty.
Rusty Schundler: You know, I think any time between now and, you know, sometime in Q1 even, wouldn't be unexpected. Then as far as sort of what we would hear from the judge, you know, I think, again, if you look at the last case as a proxy, I think what we expect, you know, to hear first is just a decision essentially as to who won. Then, you know, typically there's then a second step where, you know, the parties then put in front of the judge what they propose the consequence of that decision is one way or the other. Then, you know, if there's a disagreement between the parties, there's potentially additional hearings or whatever the judge wants to do to work through that.
Yeah, thanks man. So I mean as far as timing goes, let me address that first, um, you know, obviously we there's no deadline for judges to rule in cases. Um, you know, I think the judge, you know, the case load in in Delaware is pretty high. Um, you know, I think the judge is going to be thorough in his opinion, um, but we don't have visibility as to when that decision will come. Um, you know, I think, you know, if you look at the time, it took him to render a decision in the first hatchback, in case a few years ago. Um, you know, I would say we're in the window when we'd expect it an opinion. But, you know, the, the window is a pretty Wide Window. Um, you know, I think any time between now and, you know, sometime in the first quarter or even, uh, wouldn't wouldn't be unexpected. Um,
Dennis as far as sort of what we would hear from the judge. You know, I think again if you look at last, the last case is a proxy. I think what we expect, you know, here first is just the decision essentially as to who won and then you know, typically there's then a second step where um, you know the parties then.
Rusty Schundler: You know, at least as far as the initial step is our expectation is just gonna be an opinion as to who won, who lost.
Put in front of the judge what they proposed, the consequence of that decision is 1 way or the other. Um, and then, you know, if there's a disagreement between the parties, there's potentially additional hearings or, or whatever the judge wants to do to, to work through that. So um, you know, at least as, as far as the initial step is, our expectation. Is, is just going to be an opinion as to who 1 who lost
Benjamin Burnett: Okay. Thank you.
Okay, thank you.
Operator: Thank you. Our last question comes from the line of Jason Gerberry with Bank of America. Please proceed.
Jason Gerberry: Hey. Morning, guys. Thanks for taking my question. One litigation follow-up. Do you have a sense whether a royalty is a possible remedy, depending on outcomes of the case as opposed to I think there's a lot of, I guess, thought that perhaps, like, an outcome if there was patent infringement would just be removing ILD from the label. I would love to get your perspective on that. As we look to 2026, why wouldn't it be reasonable to assume there's at least 2,000 patients on paid drug next year, just given the trends and what we're seeing? Just love to get your perspective on that. Thanks.
Thank you. Our last question comes from the line of Jason gbury with a Bank of America, please proceed.
Hey, good morning, guys. Uh, thanks for taking my question. Uh, one lit from follow-up, do you have a sense whether a royalty is a possible remedy, um, depending on the outcomes of the case, as opposed to, I think there's a lot of, uh, uh, I guess thought that perhaps an outcome, if there was patent infringement, would just be removing ID from the label. Um, so I'd just kind of love to get your perspective on that. And then, as we look to 2026, um, why wouldn't it be reasonable to assume that there's at least 2,000 patients on paid drug next year, just given the...
Trends. And what we're seeing just love to get your perspective on that. Thanks.
Roger Jeffs: Yeah. Rusty, if you'll answer the litigation question, please.
Rusty Schundler: Yeah. Jason, thanks for the question. You know, I think there's a wide range of possible remedies here. It just is very dependent on exactly what the judge rules. I think the sides have put in arguments, you know, where the consequence ranges from, you know, YUTREPIA being removed from the market to a royalty. And those are all in sort of the downside scenarios. Again, it's just highly dependent on exactly how the judge rules. You know, I think, you know, depending on which claims he finds are infringed, the basis for the infringement, you know, the consequences could be different. I think it's hard to comment on that now.
Yeah, Rusty. If you left answers to the litigation question, please.
Yes. Jason thanks for the question. You know I I think um there's a wide range of possible remedies here. It just is very dependent on exactly what the judge rules. I think the the sides have put in arguments
Rusty Schundler: I mean, obviously, once we have the opinion, we'll have a more informed take on what we think the likely outcomes are. At this point, you know, I think as we've said consistently in our 10-Qs and other releases, you know, I think we have a wide range of potential outcomes. You know, we're just waiting to see what the judge says.
Point. You know I think as we've said consistently in our, our 10 cues and and other releases you know, I think we have a wide range of potential outcomes um you know we're just waiting to see what the judge says.
Roger Jeffs: Great. On the last question, obviously, we're not gonna forecast patient numbers. I think what we have highlighted is that we've driven brand awareness very quickly. There's been significant uptake of YUTREPIA in this early launch phase, and that our pull-through rate is very, very high at 85%, and we don't see any further impediments to that. We're gonna continue to try to position YUTREPIA as the best in class and first choice for prostacyclin and do what we need to do to benefit every patient that we can possibly benefit. With that, I think we'll end the call. I'd like to thank everyone for joining us today. We're really proud of the progress we've made in just a few short months and even more excited about what lies ahead. I hope everyone has a great day.
Great. And on the last question, obviously, we're not going to forecast patient numbers, I think
What we have highlighted is that we've uh driven brand awareness very quickly. There's been
Significant uptake of of utopian as our early launch phase and that are pulled through. Rate is very very high at 85% and we don't see any further impediments to that. So we're going to continue to try to position UT trophy as the best in class in person and choice process of cycling and do what we need to do to benefit every patient that we can possibly benefit.
Roger Jeffs: Thank you.
So with that, I think we'll end the call. Uh, I'd like to thank everyone for joining us today. We're really proud of the progress we've made in just a few short months and even more excited about what lies ahead and I hope everyone has a great day. Thank you.
Operator: Thank you for participating in today's conference. You may now disconnect.
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