NASDAQ:LQDA Liquidia Q2 2025 Earnings Report $42.40 +0.12 (+0.27%) Closing price 05/8/2026 03:58 PM EasternExtended Trading$42.70 +0.31 (+0.73%) As of 05/8/2026 07:59 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast Liquidia EPS ResultsActual EPS-$0.49Consensus EPS -$0.43Beat/MissMissed by -$0.06One Year Ago EPSN/ALiquidia Revenue ResultsActual Revenue$8.84 millionExpected Revenue$3.90 millionBeat/MissBeat by +$4.94 millionYoY Revenue Growth+141.50%Liquidia Announcement DetailsQuarterQ2 2025Date8/12/2025TimeBefore Market OpensConference Call DateTuesday, August 12, 2025Conference Call Time8:30AM ETUpcoming EarningsLiquidia's Q1 2026 earnings is estimated for Monday, May 11, 2026, based on past reporting schedules, with a conference call scheduled at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2026 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Liquidia Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 12, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Utrepia shipped within a week of FDA approval and achieved over 900 prescriptions and 550 patient starts in just 11 weeks, indicating unprecedented market adoption. Positive Sentiment: The ASCENT study in PH-ILD patients showed only 18.5% discontinuation at week 16 with no serious cough-related events and median 6MWD improvements of 21.5 m at week 8 and 31.5 m at week 16, highlighting a favorable tolerability and efficacy profile. Positive Sentiment: Liquidia ended Q2 with $173 M in cash and equivalents and generated $8.8 M in revenue, including $6.5 M from Utrepia sales, providing a strong financial runway through the commercial ramp-up. Positive Sentiment: The company has signed contracts with major commercial payers, expects to remove new-to-market blocks, and is expanding its North Carolina manufacturing footprint to potentially triple production capacity by 2026. Negative Sentiment: Early gross-to-net details and patient conversion beyond the 75% script-to-start rate remain uncertain, and the timing and outcome of pending patent litigation could impact market exclusivity. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallLiquidia Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 10 speakers on the call. Speaker 800:00:00Morning and welcome everyone to the Liquidia Corporation second quarter 2025 financial results and Corporate Update conference call. My name is Nadia and I will be your conference operator today. Currently, all participants are in listen only mode. Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this conference call is being recorded. I will now hand the conference call over to Jason Nader, Chief Business Officer. Please go ahead, sir. Speaker 300:00:36Thank you, operator, and good morning, everyone. It's my pleasure to welcome you to the Liquidia Corporation second quarter 2025 financial results and Corporate Update call. Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Operating Officer and CFO Michael Kaseta, Chief Medical Officer Dr. Rajeev Saggar, Chief Commercial Officer Scott Moomaw, and General Counsel Rusty Schundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those regarding future results, unaudited and forward-looking financial information, and the company's future performance and/or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause actual results or performance to differ materially. For more information, please refer to the documents filed with the SEC, available on our website. With that, I'd like to turn the call over to Roger for our prepared remarks. Speaker 100:01:31Roger thanks Jason and good morning everyone. We are very pleased and excited to share our first commercial data for YUTREPIA with everyone this morning. It's been a spectacular beginning. Just over 11 weeks ago we were proud to introduce YUTREPIA for the treatment of patients with pulmonary arterial hypertension, PAH, and pulmonary hypertension associated with interstitial lung disease. Within one week of approval we were live and in the market, shipping product, supporting physicians, and most importantly, delivering therapy to patients. This wasn't simply a product introduction, it was a launch executed with purpose and precision and one that has been extremely well received by the physician and patient communities that we now serve. Today we will share data and, as promised, provide additional granularity around key metrics to improve transparency regarding this early launch period. Speaker 100:02:29Since May, specialty pharmacies have reported over 900 unique patient prescriptions leading to more than 550 patient starts on YUTREPIA. That pace of adoption is unprecedented in the treprostinil space and underscores the power of our PRINT-enabled prostacyclin products. We had no doubt about the key attributes of YUTREPIA's profile to enhance deep lung delivery with an easy-to-use, low-effort device enabling a wide range of doses. I can honestly say in all my years of launching drugs in this space, this has truly outpaced all expectations, even mine, which were very, very high. Not only does this signal the value of what we have developed, but also that existing products fall short in addressing the needs of many patients. Speaker 100:03:15In conversations with prescribers and in communications from patients, the ease of use, tolerability, especially with regard to cough, and ability to escalate dose to clinical effect represents a marked and meaningful improvement in the quality of care. YUTREPIA's differentiated product profile, paired with the commercial success in driving brand awareness, has led to an early and enthusiastic uptake, as you have seen in the prescription and start numbers. In fact, it's been an unabated sprint since day one of launch. We've seen broad demand from cardiologists and pulmonologists, with prescriptions occurring at both specialty centers and community practices, and they are treating a broad group of patients across both diseases who are prostacyclin-naive, transitioning from Tyvaso and Tyvaso DPI, and even moving from oral prostacyclins. Speaker 100:04:06YUTREPIA is truly off to a strong start and quickly positioning itself as potentially the best-in-class and first-in-choice option for patients in need of a prostacyclin therapy. Anticipating the strong interest, our market access team prepared premium white glove services and reimbursement support to allow patients to gain early access to YUTREPIA. Healthcare providers have responded positively to the program's copay assistance and 28-day free vouchers, a first for an inhaled prostacyclin therapy. As a way of providing some insight, prescriptions received during the first six weeks of launch had a 75% script-to-start conversion rate. It's especially noteworthy that this early momentum has been achieved in spite of the customary period of new-to-market blocks and non-formulary positioning. We see the potential for accelerating growth and possibly higher conversion rates as we continue to expand market access during the third and fourth quarters. Speaker 100:05:06While the commercial team has been driving YUTREPIA's robust uptake, our clinical team has been analyzing maturing data from the ongoing open-label ASCENT study, which was fully enrolled with 54 PH-ILD patients in March. This analysis includes the safety and observational exploratory efficacy data up to week 16. The ASCENT study was intentionally designed to include a real-world PH-ILD population treated with YUTREPIA. In particular, we treated patients ranging from mild pulmonary hypertension to those with more advanced hemodynamic and forced vital capacity impairments and even patients listed for lung transplantation. The observations at week eight and week 16 are indeed impressive. The tolerability remains very favorable as evidenced by the fact that only 18.5% of patients discontinued the study at week 16 with no discontinuations for serious or drug-related adverse events including cough. Speaker 100:06:04For context, this favorable tolerability is juxtaposed by prospective data of Tyvaso DPI from the National Jewish Health Center, a preeminent pulmonary care center where 69% of treatment-naive patients discontinued Tyvaso DPI in a median time of only 40 days, with the primary reasons for discontinuation being cough and clinical worsening. Taking a slightly deeper look at the favorable tolerability that we are observing in the ASCENT study, of those patients that reported a treatment-related cough, the vast majority or 24 of 26 patients reported mild cough and only two patients reported a moderate cough. Speaker 100:06:43However, it should also be noted that in a longitudinal analysis, the mean data and simplified cough scores remained essentially unchanged from baseline through week 16, suggesting the cough overall tended to be transient in nature and not worsened with the addition of YUTREPIA even with escalating doses, and therefore likely similar to these patients' historical cough that is associated with their underlying interstitial lung disease. This tolerability is helping patients escalate to higher doses. The median dose at week 8 was 132.5 micrograms, or approximately 15 breath equivalents to Tyvaso, and 159 micrograms at week 16, approximately 18 breath equivalents to Tyvaso, with the highest exposure of 318 micrograms, comparable to approximately 36 breaths four times per day of Tyvaso Nebulizer. Speaker 100:07:38The net result of greater tolerability and higher achieved doses also correlates with a robust efficacy result, with the observed median improvements in six-minute walk distance of 21.5 meters at week 8 that increased further to 31.5 meters at week 16. Overall, this data set continues to highlight the robust tolerability, titratability, efficacy, and durability of YUTREPIA in a real-world population of PH-ILD patients. We look forward to sharing the detailed data with the medical community, targeting the PH Professional Network Symposium conference in mid-September and a major respiratory conference in October. Now I will pass the call to Mike, who continues to guide the company with a firm hand on the financials and with an eye towards supporting continued growth. Speaker 500:08:26Thank you, Roger, and good morning, everyone. In order to save time for more. Speaker 900:08:30Of your questions, I'd just like to hit the headlines on the financial statements filed this morning with the SEC and in our press release. We closed the quarter with over $173 million in cash and cash equivalents on the balance sheet, a solid position that will help us bridge to profitability over the coming quarters as we continue the commercial rollout of YUTREPIA, invest in our pipeline, and expand operational capabilities. Speaker 500:08:54On the revenue side, we generated $8.8 million. Speaker 900:08:56Million in the second quarter, of which $6.5 million came from YUTREPIA product sales which began shipping in June. The additional $2.3 million in service revenue related to our ongoing promotion agreement of treprostinil injection with Sandoz. Expenses for the quarter were in line with our expectations as we fully transitioned into commercialization mode. Looking forward to the end of the year, we anticipate increases in quarterly R&D expenses as we continue ongoing label studies and prepare to initiate the pivotal study of L606 SGA expenses. After excluding non-cash and variable costs associated with YUTREPIA, sales should remain flat over the next few quarters. Our planned commercial spending supports the launch, that said, any increase would be. Speaker 500:09:41Targeted to further acceleration in YUTREPIA adoption. Speaker 900:09:45Lastly, with YUTREPIA approved, we are expanding our footprint in North Carolina and have signed a lease for additional manufacturing space to support continuing growth, potentially tripling our production capacity. Targeted for occupancy in 2026, this state-of-the-art facility will include production space to house additional print manufacturing lines and analytical labs to support additional YUTREPIA manufacturing. We are continuing to execute on our plan, and our cash position gives us the flexibility to keep moving forward with confidence. With that, I'll hand it back to Roger. Speaker 100:10:19Thanks. In just over two months, YUTREPIA has delivered on every front, with brand awareness growing, prescriptions rapidly escalating, payer access expanding, and clinical data maturing with a clear and differentiated product profile. We are building a foundation not just for a successful launch but for long-term leadership in the prostacyclin market. I would like to thank our entire team who, like our product, are best in class. One final note before we begin the Q&A session: we plan to host an R&D day in the fall where we will provide an update on our open-label L606 study, which will include data for patients who have been on L606 for up to a year. We are as excited about L606 as we are YUTREPIA, but today is YUTREPIA's day in the spotlight. L606 deserves its own stage to properly highlight its own unique product profile. Speaker 100:11:14With that, operator, first question, please. Speaker 800:11:19Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star 1 1 on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star 1 1 again. Dembau will compile the Q and A queue. This will take a few moments. Now we're going to take our first question and it comes to the line of Julian Harrison from BTIG. Your line is open. Please ask your question. Speaker 800:11:45Hi, good morning. Congrats on the strong launch and thank you for taking my questions. These are very impressive numbers. Three questions from us. First, on a weekly basis, has the YUTREPIA growth generally looked sequential or was there some bolus effect early on? Second, PAH versus PH-ILD mix, along with percentage of patients diagnosed with underlying IPF. Are you able to disclose those numbers now? Finally, on ASCENT, it was great to see the very strong six-minute walk data out to or through 16 weeks. Speaker 100:12:17I'm curious if you could talk more. Speaker 100:12:18About your decision to lead with the median six-minute walk changes instead of the average. Why are median changes maybe more appropriate here, and how does that compare to the competitive landscape? Speaker 100:12:31Great, Julian, thanks for the questions. In terms of uptake, what we said in the script is that we've had accelerating uptake over time. As we've been in the market, you know, again, still just for 11 weeks, each week seems to be a little bit better than the one before. We think that trend hopefully will continue, particularly as we continue to evolve the payer landscape and remove some of the things like new to market blocks that existed when you first launch drugs. Awareness is driving a lot of that. I think that we had a focus on the centers of excellence, the key centers, and certainly the adoption there has been rapid. I think the messages have been resonating very quickly. The result of that is you see that in the referrals and the script. We're not going to give the PAH versus PH-ILD split today. Speaker 100:13:28We want to make sure if we were to do that, that we had absolute clarity on what that is. Just because of the way some of that data has been collected, we can't really confirm exactly and precisely what the therapeutic split would be. For the ASCENT open-label study, maybe I'll hand that over to Rajeev to talk about why we think median data is most appropriate and more reflective. The simple answer is, and I'll give it to Rajeev, is that it minimizes the impact of outliers. Particularly in an open-label study, you really want to look at medians to give a more, I think, accurate and reflective results from a population that we've studied. Speaker 100:14:05So. Speaker 100:14:05Rajeev, any other comment on that? Speaker 900:14:08Yeah, Roger, Julie, nice to hear from you. I completely agree. I think it's less susceptible to being skewed to outliers or extreme values. It's important to provide the central tendency in these situations, especially with small samples. I think it also is more akin to how larger data sets are usually conveyed. I will state that we will be showing more granular detail at the upcoming conference at PHP and in the upcoming conference in October. I think we could say with a high degree of certainty that the mean and median values are fairly near each other. I think that's really important to note as well. Speaker 900:14:54Very helpful all around. Congrats again. Speaker 100:14:56Thank you, Julian. Always good to hear from you. Operator, next question please. Speaker 800:15:00Yes, of course. Now we're going to take our next question. The question comes from the line of Rand Deschner from Raymond James. Your line is open. Please ask a question. Speaker 100:15:12Good morning. Speaker 900:15:13Congratulations on the strong start to your YUTREPIA launch and the ASCENT results. Speaker 500:15:19What proportion of paid drug is associated? Speaker 900:15:21With the reported patient starts, is this in line with your expectations? What proportion of patient starts are switches from Tyvaso DPI or other inhaled or oral treprostinil products? Speaker 100:15:32Thanks. Yeah. Mike, if you wouldn't mind answering the paid drugs question, and Scott, our Chief Commercial Officer, you can talk about proportions as you can. Speaker 900:15:46Yeah, thanks. Speaker 500:15:47Roger and Ryan, great to talk to you. In terms of proportion of paid versus new start, as everyone knows, we have a couple of programs. We have a voucher program that provides the first 28 days free drug for new patients. We also have a bridge program. Speaker 900:16:07That provides an additional 28-day supply. Speaker 500:16:10At any time during a patient's journey. Speaker 900:16:13What I would say is specifically. Speaker 500:16:16You know, the amount of paid versus free drug, especially through the usage of the voucher program, is in line with our expectations of what we've seen in other launches. Less than 50% have been on free voucher drugs. We wanted to make sure we gave patients an opportunity to try our drug immediately to see if it's something that works for them and allows us to start that insurance adjudication process as we go. We're very happy with the services that we provide, the market access services specifically that Scott and his team have provided, and I think have been very helpful for us as we've gotten YUTREPIA off the ground. Speaker 100:16:55Great. Scott, if you'll handle the second question. Sure. Speaker 100:16:58Good morning. Speaker 400:16:59In terms of switches versus new to prostacyclin patients, I think we've said in the past that our primary focus is the new to prostacyclin patients. Commensurate with that, we've certainly seen the preponderance of the patients that are coming in. We have seen switches. I think it's no secret that there are many patients out there who've been on a DPI or nebulized, inhaled and are either on that or are dissatisfied or came off of it. I think, as Roger said in the prepared remarks, we have been surprised, let's say, with the volume of those. We're not going to get into the exact numbers. We are also seeing, as I think Roger mentioned, some oral prostacyclin switches as well. We'll keep an eye on that as time goes along and get a feel for what the run rate is for that. Speaker 400:17:50That's kind of how it's playing out currently. Speaker 100:17:55Thanks, Scott. Thank you. I think the other thing I would add to that is, you know, where we said even I was surprised by the upside here, I think it was because of these switches. What we found is that there is a large number of patients with intolerant cough who remain on Tyvaso DPI but are parked at low dose, so aren't really getting the benefit of the treprostinil that they deserve. Those patients have readily looked forward to receiving YUTREPIA. That's been where the incremental upside has been in this near term. I think that will continue to grow, particularly as the experience in the new patient arena sort of shows prescribers and patients that this drug is very, very effective. It's the therapeutic prodigy that we hoped it would be. Next question, please. Speaker 800:18:40Yes, of course. Just give us a moment. The question comes from the line of Jason Gilberry from Bank of America. Your line is open. Please ask your question. Speaker 800:18:50Hey, good morning, guys. Congrats on the launch as well. My question, just thinking about second half in these patients that have started on. Speaker 100:19:00YUTREPIA, how should we think about sort of the gross to net? Speaker 100:19:03Presumably they've already kind of gone through their 28-day free vouchers, and so I'm just kind of curious if those patients are going to flow through at full whack or if there's a gross-to-net assumption that we should assume for those patients plus those that maybe convert from the prescription referral. Speaker 100:19:22A start and that 75% conversion rate. Speaker 100:19:25The other 25% that haven't converted is. Speaker 100:19:28that just a function of time? Speaker 100:19:30Is there anything structural or gating for those patients? Just trying to get a sense of what that process is like and the typical time from starting the prior authorization process to ensuring coverage. Speaker 100:19:42Thanks. Speaker 100:19:44Great. Thank you, Jason. Great questions. Mike, if you wouldn't mind answering those questions. Speaker 300:19:57Mike, you might be on mute. Speaker 500:19:59Oh, sorry. As it relates to gross to net, it's not something that we've talked about in terms of projecting what our gross nets to be. I mean, I think what we said all along is from a payer point of view, we want to make sure patients have an opportunity to choose YUTREPIA. As Roger said earlier, there have been new to market blocks, especially in areas where our competitor is contracted specifically in the commercial space. We now have signed contracts with all. Speaker 900:20:28Of the major commercial payers. Speaker 500:20:30We expect those new-to-market blocks. Speaker 900:20:32To be removed shortly. Speaker 500:20:34We would expect, like I said, more prescriptions as we move through the year to be subject to rebates. Again, we're very confident in our ability for YUTREPIA to win in this space. I'm very confident for us to be at parity access. Our stated goal from the very beginning was that we would, you know, we want to make sure patients have a choice and I think Scott and his team have done a great job of working towards that. We look forward to, you know, to further development here in the second half of the year. The second question around the convert rate, what I would say is again the patient support services that we put in place, which includes reimbursement specialists to navigate this landscape, we expect, you know, when you look at industry standards, I think that's a very good percentage. Speaker 500:21:26As Roger said, there were some headwinds early on as it relates to these new to market blocks. Those released, we think that could be an accelerant as we get through the back end of the year here and as we move forward to again to make sure patients have the ability to choose and we feel very confident in. Speaker 900:21:42Our ability to deliver on that. Speaker 900:21:45Mike, if I could just squeeze a follow up in, any commentary regarding Symphony data on a go forward basis? Should we look at it? Have you guys interrogated that and how we should interpret that on a go forward basis? Speaker 800:21:57Yeah. Speaker 500:21:57What I would say is, as is pretty standard in the industry, this information is usually not available. We obviously have seen the data like you have. I would not expect to see future data to come out. We look forward to sharing our results as we go through each quarterly earnings call. Speaker 100:22:17Got it. Thanks. Speaker 800:22:20Now we're going to take our next question. The question comes from the line of Corey Jubenwell from Lifeside Capital. Your line is open. Please ask your question. Speaker 800:22:30Good morning. Speaker 400:22:31Congrats on all the progress. Speaker 400:22:32It seems like traction has been really great so far as we think about. Speaker 900:22:35Launch plans throughout the rest of the year. Speaker 900:22:39What kind of near term levers are there to pull to accelerate growth? Given the traction you've seen so far, is the plan to kind of largely. Speaker 900:22:47Stay on course versus pull some of these levers. Speaker 900:22:51You also mentioned that you signed contracts with the three major commercial players. When do those contracts, you. Speaker 900:23:00Kick in and you start to. Speaker 100:23:02Get reimbursement through that? Yeah, thanks for the question, Corey. I'll take the second question first, and then Scott, if you'll comment on the launch plans and levers that we could pull going forward. I guess we're going to stick to the script like in the coming quarters. We think the payer landscape will improve, and that's going to be in place to happen and be an accelerant, as we've said. Scott, maybe you can talk about the levers that could be pulled going forward in terms of launch. Speaker 400:23:35Yeah, sure. The first thing I'd point out is that I think we have immense opportunity both from a breadth and from a depth standpoint to capitalize on. For example, the amount of breadth, I think we said 350 prescribers have prescribed thus far. We've also said in the past that we have 6,500 targets across the country. There's well over 6,000 out there who have not had the opportunity to use YUTREPIA. From a breadth standpoint, we're just getting started. We've been pleased to have physicians with 1, 2, 3, 4, 5 plus patients, but many more of them can have that depth and will have that depth. From an activity sort of leverage standpoint, one is just fuel the fire. We're going to continue to work with the centers to identify on YUTREPIA. We have had community physicians for sure that have prescribed. Speaker 400:24:34We will now start to work our way back out into the community to get PAH patients, but also to start to get PH-ILD patients. Strictly from a tactical perspective, we'll be at all the major conferences, we'll be loud from an electronic standpoint. We still have a full suite of launch marketing that's going on right now and will certainly continue to go on. Speaker 100:24:57For the rest of the year. Scott, maybe I'll add in terms of, I think all of those activities are clearly going to be beneficial to the brand. I think in terms of the levers, I can think of five just off the top of my head. It's like, as Scott said, continue to increase breadth and depth of prescribers, especially as we go out into the community centers more. I think in this initial phase we were somewhat focused on the major centers. As we've said, we'll get acceleration from payer engagement and coverage. The third would be that now that there's traction in switch opportunity, maybe try to leverage that more broadly and talk about that experience more widely with prescribers so that they too can benefit from the transition with their patients. Speaker 100:25:39I think the fourth lever would be to focus on YUTREPIA's dosing flexibility to drive durability. I think it's just as important as starting patients is keeping patients on therapy. That's obviously going to be a key focus for our commercial enterprise going forward. I think we should also now begin to capture this initial data from oral transitions, particularly as they come off Uptravi, is what we've seen early, and begin to focus potentially on an initiative to support that in terms of how to inform doctors how to do that. There are a lot of levers that we can pull, all will drive future business. I think this is a very levered business in terms of what we can accomplish going forward. Operator, next question, please. Speaker 800:26:22Yes, of course. We are going to take our next question. And Colin Sigal from Needham, your line is open. Please ask a question. Speaker 800:26:33Hi, good morning and congrats on a great start. Had some technical difficulties this morning, so apologies if you've covered this already. First of all, on the $6.5 million, can you give us a split between channel inventory and patient demand? Regarding payer coverage, can you tell us where you're currently at and where you expect to be by the next quarter, and is the coverage similar to Tyvaso? I have another follow up, but start there. Speaker 100:27:10All right, thank you, Serge. Mike, can you answer those questions, please? Speaker 500:27:13Yeah Serge, thanks for your question. Specifically on the breakdown on revenue, I'd say especially for first quarter of launch, the vast, vast majority of that revenue was loaded in the channel. As you can imagine, as we previously talked about, we put product into the channel the first week of June. We dosed our first patient shortly thereafter. Just from a pure timing point of view, a lot of that initial revenue would be loading the channel. With that being said, obviously with the accelerating patient numbers that we've seen, we start seeing stacking of patients as we move into second scripts. The vast majority of that has already been absorbed as we move into Q3 as we related to payer coverage. Like we've always said, we want to make sure that patients have choice. Speaker 500:28:11In order for patients to have choice, we need to make sure they have access to YUTREPIA. As I said earlier, we signed contracts with three major commercial payers. As those NDC blocks are removed we feel very confident, as we said, the product profile of YUTREPIA to win and to be the prostacyclin of first choice. As Dr. Roger Jeffs has stated, being in a parity situation with United Therapeutics where we are not disadvantaged. As those kick in we feel very confident that will be the place that we land and feel very confident in our ability to grow. Speaker 500:28:45Thanks. Maybe one for Rusty. Just an update on the 327 patent litigation. There was a hearing a few weeks ago. I guess when you expect potential decision and what the potential outcomes could be. Thanks. Operator00:29:04Yeah, thanks for the question, sir. As you know, trial was held back at the end of June. At this point, all post trial briefing is complete. The judge set a relatively accelerated post trial briefing schedule. Post trial briefing is now complete. As far as when we get a decision, it's always hard to predict how quickly courts are going to rule on things. I think in the first Hatch Waxman trial in front of Judge Andrews, it was about two and a half months between the completion of post trial briefing and his decision. Obviously, here he set an accelerated timeline for the post trial briefing that could indicate that his decision will similarly be a little bit faster than the last time. Again, hard to predict with any degree of precision. Finally, as to the potential outcomes, it's the same outcomes we've been talking about all along. Operator00:29:58As with prior litigations, we won't probabilitize what the outcome is going to be or try to get in front of the judge and guess how he's going to rule. It's sort of the full range of these potential outcomes, consistent with any hedgehogs in litigation. Speaker 800:30:16Thank you, dear participants. As a reminder, if you wish to ask a question, please press star one one on your telephone keypad. We are going to take our next question. The question comes from the line of Thiago Farr from Wells Fargo. Your line is open. Please ask your question. Speaker 800:30:35Thank you. Let me just add my congratulations as well. A quick one for me. Just thinking about United Therapeutics studies. Read through, kind of, what are some of the implications potentially going forward? Some debate on orphan drug exclusivity? Any implications for YUTREPIA or for the development test for L606? Basically how you guys are thinking about. Speaker 100:30:58If that trial reads out positively. Speaker 100:31:00Thanks. Speaker 100:31:02Thanks, Thiago. I'll take that. I think they've said they're expecting that result in September, so there's really no sense in me trying to predict what that trial result will or won't be. I think if they are successful, they will have some orphan protection for that for a period of time. I think for us it would be a matter of developing L606 for that indication so that once that orphan exclusivity expired, we could benefit from that market too, if they are to be successful. We'll soon see where that lands. Speaker 800:31:40Thank you, dear participants, and the last reminder, if you would like to ask a question, please press star 11 on your telephone keypad. Dear speakers, and no further questions for today. I would now like to hand the conference over to Roger Jeffs for any closing remarks. Speaker 100:32:07Thank you everyone for joining today's call. We appreciate your enthusiasm for this initial phase of launch. We remain laser focused on the execution in the back half of the year and look forward to driving continued update, expanding payer access, and laying the groundwork for our broader pipeline. We look forward to speaking with you very, very, very soon, especially in the fall when we have our R&D day for L606. Thank you again. Speaker 800:32:32This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.Read morePowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Liquidia Earnings HeadlinesLiquidia Corporation to Participate in Upcoming Investor ConferencesMay 6 at 8:30 AM | globenewswire.comLiquidia Corporation: I Have Never Been This Bullish On A PositionMay 5, 2026 | seekingalpha.comYou’re Being LIED To About The Iran WarThe mainstream explanation for the Iran airstrikes may not be the full story. Addison Wiggin, Founder of Grey Swan Investment Fraternity, says there's a deeper motive behind the bombing campaign that most coverage is ignoring. If you're making investment decisions based on what you're hearing in the news, Wiggin argues you could be working with an incomplete picture.May 9 at 1:00 AM | Banyan Hill Publishing (Ad)Liquidia Corporation to Report First Quarter 2026 Financial Results on May 11, 2026May 4, 2026 | globenewswire.comDoes Tom Steyer’s YUTREPIA Endorsement Reframe the Bull Case for Liquidia (LQDA)?May 3, 2026 | finance.yahoo.comLiquidia Corporation (LQDA): Billionaire Tom Steyer Admires This Pharma StockMay 2, 2026 | insidermonkey.comSee More Liquidia Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Liquidia? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Liquidia and other key companies, straight to your email. Email Address About LiquidiaLiquidia (NASDAQ:LQDA) Technologies, Inc. is a clinical-stage biopharmaceutical company headquartered in Research Triangle Park, North Carolina. The company leverages its proprietary PRINT® (Particle Replication In Non-wetting Templates) platform to engineer precisely shaped and sized drug particles, with the goal of improving delivery, efficacy and safety profiles. By controlling particle characteristics at the nanoscale, Liquidia seeks to enhance respiratory and other therapies that depend on targeted delivery. The company’s lead product candidate, LIQ861, is a dry powder formulation of treprostinil designed for inhalation in patients with pulmonary arterial hypertension (PAH). LIQ861 aims to offer a more convenient and potentially more consistent dosing approach compared with current liquid-based nebulized therapies. Besides PAH, Liquidia is exploring additional indications and dosage forms to expand the use of its PRINT platform, including collaborations focused on vaccine adjuvants and other respiratory applications. Liquidia Technologies was founded to translate advanced particle-engineering science into therapeutic benefit and has assembled a team with experience in respiratory drug development, regulatory affairs and clinical operations. The company conducts clinical research primarily in the United States, and it plans to pursue regulatory filings in major markets following the completion of pivotal studies. Under the leadership of President and CEO Chris Critelli, Liquidia continues to advance its pipeline toward potential commercialization.View Liquidia ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Rocket Lab Posts Record Q1 Revenue, Raises Q2 GuidanceHims & Hers Earnings Preview: The Novo Nordisk Shift Puts GLP-1 Strategy in FocusAppLovin Pops After Earnings With Growth Catalysts in SightDutch Bros Q1 Earnings: The Newest Starbucks Rival Faces Its First Big Reality CheckThe AI Fear Around Datadog Stock May Have Been Completely WrongAmprius Technologies Ups the Voltage on Forward OutlookWhy Lam Research Still Looks Like a Buy After a 300% Rally Upcoming Earnings Constellation Energy (5/11/2026)Barrick Mining (5/11/2026)Petroleo Brasileiro S.A.- Petrobras (5/11/2026)Simon Property Group (5/11/2026)SEA (5/12/2026)Cisco Systems (5/13/2026)Alibaba Group (5/13/2026)Manulife Financial (5/13/2026)Sumitomo Mitsui Financial Group (5/13/2026)Takeda Pharmaceutical (5/13/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 10 speakers on the call. Speaker 800:00:00Morning and welcome everyone to the Liquidia Corporation second quarter 2025 financial results and Corporate Update conference call. My name is Nadia and I will be your conference operator today. Currently, all participants are in listen only mode. Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this conference call is being recorded. I will now hand the conference call over to Jason Nader, Chief Business Officer. Please go ahead, sir. Speaker 300:00:36Thank you, operator, and good morning, everyone. It's my pleasure to welcome you to the Liquidia Corporation second quarter 2025 financial results and Corporate Update call. Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Operating Officer and CFO Michael Kaseta, Chief Medical Officer Dr. Rajeev Saggar, Chief Commercial Officer Scott Moomaw, and General Counsel Rusty Schundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those regarding future results, unaudited and forward-looking financial information, and the company's future performance and/or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause actual results or performance to differ materially. For more information, please refer to the documents filed with the SEC, available on our website. With that, I'd like to turn the call over to Roger for our prepared remarks. Speaker 100:01:31Roger thanks Jason and good morning everyone. We are very pleased and excited to share our first commercial data for YUTREPIA with everyone this morning. It's been a spectacular beginning. Just over 11 weeks ago we were proud to introduce YUTREPIA for the treatment of patients with pulmonary arterial hypertension, PAH, and pulmonary hypertension associated with interstitial lung disease. Within one week of approval we were live and in the market, shipping product, supporting physicians, and most importantly, delivering therapy to patients. This wasn't simply a product introduction, it was a launch executed with purpose and precision and one that has been extremely well received by the physician and patient communities that we now serve. Today we will share data and, as promised, provide additional granularity around key metrics to improve transparency regarding this early launch period. Speaker 100:02:29Since May, specialty pharmacies have reported over 900 unique patient prescriptions leading to more than 550 patient starts on YUTREPIA. That pace of adoption is unprecedented in the treprostinil space and underscores the power of our PRINT-enabled prostacyclin products. We had no doubt about the key attributes of YUTREPIA's profile to enhance deep lung delivery with an easy-to-use, low-effort device enabling a wide range of doses. I can honestly say in all my years of launching drugs in this space, this has truly outpaced all expectations, even mine, which were very, very high. Not only does this signal the value of what we have developed, but also that existing products fall short in addressing the needs of many patients. Speaker 100:03:15In conversations with prescribers and in communications from patients, the ease of use, tolerability, especially with regard to cough, and ability to escalate dose to clinical effect represents a marked and meaningful improvement in the quality of care. YUTREPIA's differentiated product profile, paired with the commercial success in driving brand awareness, has led to an early and enthusiastic uptake, as you have seen in the prescription and start numbers. In fact, it's been an unabated sprint since day one of launch. We've seen broad demand from cardiologists and pulmonologists, with prescriptions occurring at both specialty centers and community practices, and they are treating a broad group of patients across both diseases who are prostacyclin-naive, transitioning from Tyvaso and Tyvaso DPI, and even moving from oral prostacyclins. Speaker 100:04:06YUTREPIA is truly off to a strong start and quickly positioning itself as potentially the best-in-class and first-in-choice option for patients in need of a prostacyclin therapy. Anticipating the strong interest, our market access team prepared premium white glove services and reimbursement support to allow patients to gain early access to YUTREPIA. Healthcare providers have responded positively to the program's copay assistance and 28-day free vouchers, a first for an inhaled prostacyclin therapy. As a way of providing some insight, prescriptions received during the first six weeks of launch had a 75% script-to-start conversion rate. It's especially noteworthy that this early momentum has been achieved in spite of the customary period of new-to-market blocks and non-formulary positioning. We see the potential for accelerating growth and possibly higher conversion rates as we continue to expand market access during the third and fourth quarters. Speaker 100:05:06While the commercial team has been driving YUTREPIA's robust uptake, our clinical team has been analyzing maturing data from the ongoing open-label ASCENT study, which was fully enrolled with 54 PH-ILD patients in March. This analysis includes the safety and observational exploratory efficacy data up to week 16. The ASCENT study was intentionally designed to include a real-world PH-ILD population treated with YUTREPIA. In particular, we treated patients ranging from mild pulmonary hypertension to those with more advanced hemodynamic and forced vital capacity impairments and even patients listed for lung transplantation. The observations at week eight and week 16 are indeed impressive. The tolerability remains very favorable as evidenced by the fact that only 18.5% of patients discontinued the study at week 16 with no discontinuations for serious or drug-related adverse events including cough. Speaker 100:06:04For context, this favorable tolerability is juxtaposed by prospective data of Tyvaso DPI from the National Jewish Health Center, a preeminent pulmonary care center where 69% of treatment-naive patients discontinued Tyvaso DPI in a median time of only 40 days, with the primary reasons for discontinuation being cough and clinical worsening. Taking a slightly deeper look at the favorable tolerability that we are observing in the ASCENT study, of those patients that reported a treatment-related cough, the vast majority or 24 of 26 patients reported mild cough and only two patients reported a moderate cough. Speaker 100:06:43However, it should also be noted that in a longitudinal analysis, the mean data and simplified cough scores remained essentially unchanged from baseline through week 16, suggesting the cough overall tended to be transient in nature and not worsened with the addition of YUTREPIA even with escalating doses, and therefore likely similar to these patients' historical cough that is associated with their underlying interstitial lung disease. This tolerability is helping patients escalate to higher doses. The median dose at week 8 was 132.5 micrograms, or approximately 15 breath equivalents to Tyvaso, and 159 micrograms at week 16, approximately 18 breath equivalents to Tyvaso, with the highest exposure of 318 micrograms, comparable to approximately 36 breaths four times per day of Tyvaso Nebulizer. Speaker 100:07:38The net result of greater tolerability and higher achieved doses also correlates with a robust efficacy result, with the observed median improvements in six-minute walk distance of 21.5 meters at week 8 that increased further to 31.5 meters at week 16. Overall, this data set continues to highlight the robust tolerability, titratability, efficacy, and durability of YUTREPIA in a real-world population of PH-ILD patients. We look forward to sharing the detailed data with the medical community, targeting the PH Professional Network Symposium conference in mid-September and a major respiratory conference in October. Now I will pass the call to Mike, who continues to guide the company with a firm hand on the financials and with an eye towards supporting continued growth. Speaker 500:08:26Thank you, Roger, and good morning, everyone. In order to save time for more. Speaker 900:08:30Of your questions, I'd just like to hit the headlines on the financial statements filed this morning with the SEC and in our press release. We closed the quarter with over $173 million in cash and cash equivalents on the balance sheet, a solid position that will help us bridge to profitability over the coming quarters as we continue the commercial rollout of YUTREPIA, invest in our pipeline, and expand operational capabilities. Speaker 500:08:54On the revenue side, we generated $8.8 million. Speaker 900:08:56Million in the second quarter, of which $6.5 million came from YUTREPIA product sales which began shipping in June. The additional $2.3 million in service revenue related to our ongoing promotion agreement of treprostinil injection with Sandoz. Expenses for the quarter were in line with our expectations as we fully transitioned into commercialization mode. Looking forward to the end of the year, we anticipate increases in quarterly R&D expenses as we continue ongoing label studies and prepare to initiate the pivotal study of L606 SGA expenses. After excluding non-cash and variable costs associated with YUTREPIA, sales should remain flat over the next few quarters. Our planned commercial spending supports the launch, that said, any increase would be. Speaker 500:09:41Targeted to further acceleration in YUTREPIA adoption. Speaker 900:09:45Lastly, with YUTREPIA approved, we are expanding our footprint in North Carolina and have signed a lease for additional manufacturing space to support continuing growth, potentially tripling our production capacity. Targeted for occupancy in 2026, this state-of-the-art facility will include production space to house additional print manufacturing lines and analytical labs to support additional YUTREPIA manufacturing. We are continuing to execute on our plan, and our cash position gives us the flexibility to keep moving forward with confidence. With that, I'll hand it back to Roger. Speaker 100:10:19Thanks. In just over two months, YUTREPIA has delivered on every front, with brand awareness growing, prescriptions rapidly escalating, payer access expanding, and clinical data maturing with a clear and differentiated product profile. We are building a foundation not just for a successful launch but for long-term leadership in the prostacyclin market. I would like to thank our entire team who, like our product, are best in class. One final note before we begin the Q&A session: we plan to host an R&D day in the fall where we will provide an update on our open-label L606 study, which will include data for patients who have been on L606 for up to a year. We are as excited about L606 as we are YUTREPIA, but today is YUTREPIA's day in the spotlight. L606 deserves its own stage to properly highlight its own unique product profile. Speaker 100:11:14With that, operator, first question, please. Speaker 800:11:19Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star 1 1 on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star 1 1 again. Dembau will compile the Q and A queue. This will take a few moments. Now we're going to take our first question and it comes to the line of Julian Harrison from BTIG. Your line is open. Please ask your question. Speaker 800:11:45Hi, good morning. Congrats on the strong launch and thank you for taking my questions. These are very impressive numbers. Three questions from us. First, on a weekly basis, has the YUTREPIA growth generally looked sequential or was there some bolus effect early on? Second, PAH versus PH-ILD mix, along with percentage of patients diagnosed with underlying IPF. Are you able to disclose those numbers now? Finally, on ASCENT, it was great to see the very strong six-minute walk data out to or through 16 weeks. Speaker 100:12:17I'm curious if you could talk more. Speaker 100:12:18About your decision to lead with the median six-minute walk changes instead of the average. Why are median changes maybe more appropriate here, and how does that compare to the competitive landscape? Speaker 100:12:31Great, Julian, thanks for the questions. In terms of uptake, what we said in the script is that we've had accelerating uptake over time. As we've been in the market, you know, again, still just for 11 weeks, each week seems to be a little bit better than the one before. We think that trend hopefully will continue, particularly as we continue to evolve the payer landscape and remove some of the things like new to market blocks that existed when you first launch drugs. Awareness is driving a lot of that. I think that we had a focus on the centers of excellence, the key centers, and certainly the adoption there has been rapid. I think the messages have been resonating very quickly. The result of that is you see that in the referrals and the script. We're not going to give the PAH versus PH-ILD split today. Speaker 100:13:28We want to make sure if we were to do that, that we had absolute clarity on what that is. Just because of the way some of that data has been collected, we can't really confirm exactly and precisely what the therapeutic split would be. For the ASCENT open-label study, maybe I'll hand that over to Rajeev to talk about why we think median data is most appropriate and more reflective. The simple answer is, and I'll give it to Rajeev, is that it minimizes the impact of outliers. Particularly in an open-label study, you really want to look at medians to give a more, I think, accurate and reflective results from a population that we've studied. Speaker 100:14:05So. Speaker 100:14:05Rajeev, any other comment on that? Speaker 900:14:08Yeah, Roger, Julie, nice to hear from you. I completely agree. I think it's less susceptible to being skewed to outliers or extreme values. It's important to provide the central tendency in these situations, especially with small samples. I think it also is more akin to how larger data sets are usually conveyed. I will state that we will be showing more granular detail at the upcoming conference at PHP and in the upcoming conference in October. I think we could say with a high degree of certainty that the mean and median values are fairly near each other. I think that's really important to note as well. Speaker 900:14:54Very helpful all around. Congrats again. Speaker 100:14:56Thank you, Julian. Always good to hear from you. Operator, next question please. Speaker 800:15:00Yes, of course. Now we're going to take our next question. The question comes from the line of Rand Deschner from Raymond James. Your line is open. Please ask a question. Speaker 100:15:12Good morning. Speaker 900:15:13Congratulations on the strong start to your YUTREPIA launch and the ASCENT results. Speaker 500:15:19What proportion of paid drug is associated? Speaker 900:15:21With the reported patient starts, is this in line with your expectations? What proportion of patient starts are switches from Tyvaso DPI or other inhaled or oral treprostinil products? Speaker 100:15:32Thanks. Yeah. Mike, if you wouldn't mind answering the paid drugs question, and Scott, our Chief Commercial Officer, you can talk about proportions as you can. Speaker 900:15:46Yeah, thanks. Speaker 500:15:47Roger and Ryan, great to talk to you. In terms of proportion of paid versus new start, as everyone knows, we have a couple of programs. We have a voucher program that provides the first 28 days free drug for new patients. We also have a bridge program. Speaker 900:16:07That provides an additional 28-day supply. Speaker 500:16:10At any time during a patient's journey. Speaker 900:16:13What I would say is specifically. Speaker 500:16:16You know, the amount of paid versus free drug, especially through the usage of the voucher program, is in line with our expectations of what we've seen in other launches. Less than 50% have been on free voucher drugs. We wanted to make sure we gave patients an opportunity to try our drug immediately to see if it's something that works for them and allows us to start that insurance adjudication process as we go. We're very happy with the services that we provide, the market access services specifically that Scott and his team have provided, and I think have been very helpful for us as we've gotten YUTREPIA off the ground. Speaker 100:16:55Great. Scott, if you'll handle the second question. Sure. Speaker 100:16:58Good morning. Speaker 400:16:59In terms of switches versus new to prostacyclin patients, I think we've said in the past that our primary focus is the new to prostacyclin patients. Commensurate with that, we've certainly seen the preponderance of the patients that are coming in. We have seen switches. I think it's no secret that there are many patients out there who've been on a DPI or nebulized, inhaled and are either on that or are dissatisfied or came off of it. I think, as Roger said in the prepared remarks, we have been surprised, let's say, with the volume of those. We're not going to get into the exact numbers. We are also seeing, as I think Roger mentioned, some oral prostacyclin switches as well. We'll keep an eye on that as time goes along and get a feel for what the run rate is for that. Speaker 400:17:50That's kind of how it's playing out currently. Speaker 100:17:55Thanks, Scott. Thank you. I think the other thing I would add to that is, you know, where we said even I was surprised by the upside here, I think it was because of these switches. What we found is that there is a large number of patients with intolerant cough who remain on Tyvaso DPI but are parked at low dose, so aren't really getting the benefit of the treprostinil that they deserve. Those patients have readily looked forward to receiving YUTREPIA. That's been where the incremental upside has been in this near term. I think that will continue to grow, particularly as the experience in the new patient arena sort of shows prescribers and patients that this drug is very, very effective. It's the therapeutic prodigy that we hoped it would be. Next question, please. Speaker 800:18:40Yes, of course. Just give us a moment. The question comes from the line of Jason Gilberry from Bank of America. Your line is open. Please ask your question. Speaker 800:18:50Hey, good morning, guys. Congrats on the launch as well. My question, just thinking about second half in these patients that have started on. Speaker 100:19:00YUTREPIA, how should we think about sort of the gross to net? Speaker 100:19:03Presumably they've already kind of gone through their 28-day free vouchers, and so I'm just kind of curious if those patients are going to flow through at full whack or if there's a gross-to-net assumption that we should assume for those patients plus those that maybe convert from the prescription referral. Speaker 100:19:22A start and that 75% conversion rate. Speaker 100:19:25The other 25% that haven't converted is. Speaker 100:19:28that just a function of time? Speaker 100:19:30Is there anything structural or gating for those patients? Just trying to get a sense of what that process is like and the typical time from starting the prior authorization process to ensuring coverage. Speaker 100:19:42Thanks. Speaker 100:19:44Great. Thank you, Jason. Great questions. Mike, if you wouldn't mind answering those questions. Speaker 300:19:57Mike, you might be on mute. Speaker 500:19:59Oh, sorry. As it relates to gross to net, it's not something that we've talked about in terms of projecting what our gross nets to be. I mean, I think what we said all along is from a payer point of view, we want to make sure patients have an opportunity to choose YUTREPIA. As Roger said earlier, there have been new to market blocks, especially in areas where our competitor is contracted specifically in the commercial space. We now have signed contracts with all. Speaker 900:20:28Of the major commercial payers. Speaker 500:20:30We expect those new-to-market blocks. Speaker 900:20:32To be removed shortly. Speaker 500:20:34We would expect, like I said, more prescriptions as we move through the year to be subject to rebates. Again, we're very confident in our ability for YUTREPIA to win in this space. I'm very confident for us to be at parity access. Our stated goal from the very beginning was that we would, you know, we want to make sure patients have a choice and I think Scott and his team have done a great job of working towards that. We look forward to, you know, to further development here in the second half of the year. The second question around the convert rate, what I would say is again the patient support services that we put in place, which includes reimbursement specialists to navigate this landscape, we expect, you know, when you look at industry standards, I think that's a very good percentage. Speaker 500:21:26As Roger said, there were some headwinds early on as it relates to these new to market blocks. Those released, we think that could be an accelerant as we get through the back end of the year here and as we move forward to again to make sure patients have the ability to choose and we feel very confident in. Speaker 900:21:42Our ability to deliver on that. Speaker 900:21:45Mike, if I could just squeeze a follow up in, any commentary regarding Symphony data on a go forward basis? Should we look at it? Have you guys interrogated that and how we should interpret that on a go forward basis? Speaker 800:21:57Yeah. Speaker 500:21:57What I would say is, as is pretty standard in the industry, this information is usually not available. We obviously have seen the data like you have. I would not expect to see future data to come out. We look forward to sharing our results as we go through each quarterly earnings call. Speaker 100:22:17Got it. Thanks. Speaker 800:22:20Now we're going to take our next question. The question comes from the line of Corey Jubenwell from Lifeside Capital. Your line is open. Please ask your question. Speaker 800:22:30Good morning. Speaker 400:22:31Congrats on all the progress. Speaker 400:22:32It seems like traction has been really great so far as we think about. Speaker 900:22:35Launch plans throughout the rest of the year. Speaker 900:22:39What kind of near term levers are there to pull to accelerate growth? Given the traction you've seen so far, is the plan to kind of largely. Speaker 900:22:47Stay on course versus pull some of these levers. Speaker 900:22:51You also mentioned that you signed contracts with the three major commercial players. When do those contracts, you. Speaker 900:23:00Kick in and you start to. Speaker 100:23:02Get reimbursement through that? Yeah, thanks for the question, Corey. I'll take the second question first, and then Scott, if you'll comment on the launch plans and levers that we could pull going forward. I guess we're going to stick to the script like in the coming quarters. We think the payer landscape will improve, and that's going to be in place to happen and be an accelerant, as we've said. Scott, maybe you can talk about the levers that could be pulled going forward in terms of launch. Speaker 400:23:35Yeah, sure. The first thing I'd point out is that I think we have immense opportunity both from a breadth and from a depth standpoint to capitalize on. For example, the amount of breadth, I think we said 350 prescribers have prescribed thus far. We've also said in the past that we have 6,500 targets across the country. There's well over 6,000 out there who have not had the opportunity to use YUTREPIA. From a breadth standpoint, we're just getting started. We've been pleased to have physicians with 1, 2, 3, 4, 5 plus patients, but many more of them can have that depth and will have that depth. From an activity sort of leverage standpoint, one is just fuel the fire. We're going to continue to work with the centers to identify on YUTREPIA. We have had community physicians for sure that have prescribed. Speaker 400:24:34We will now start to work our way back out into the community to get PAH patients, but also to start to get PH-ILD patients. Strictly from a tactical perspective, we'll be at all the major conferences, we'll be loud from an electronic standpoint. We still have a full suite of launch marketing that's going on right now and will certainly continue to go on. Speaker 100:24:57For the rest of the year. Scott, maybe I'll add in terms of, I think all of those activities are clearly going to be beneficial to the brand. I think in terms of the levers, I can think of five just off the top of my head. It's like, as Scott said, continue to increase breadth and depth of prescribers, especially as we go out into the community centers more. I think in this initial phase we were somewhat focused on the major centers. As we've said, we'll get acceleration from payer engagement and coverage. The third would be that now that there's traction in switch opportunity, maybe try to leverage that more broadly and talk about that experience more widely with prescribers so that they too can benefit from the transition with their patients. Speaker 100:25:39I think the fourth lever would be to focus on YUTREPIA's dosing flexibility to drive durability. I think it's just as important as starting patients is keeping patients on therapy. That's obviously going to be a key focus for our commercial enterprise going forward. I think we should also now begin to capture this initial data from oral transitions, particularly as they come off Uptravi, is what we've seen early, and begin to focus potentially on an initiative to support that in terms of how to inform doctors how to do that. There are a lot of levers that we can pull, all will drive future business. I think this is a very levered business in terms of what we can accomplish going forward. Operator, next question, please. Speaker 800:26:22Yes, of course. We are going to take our next question. And Colin Sigal from Needham, your line is open. Please ask a question. Speaker 800:26:33Hi, good morning and congrats on a great start. Had some technical difficulties this morning, so apologies if you've covered this already. First of all, on the $6.5 million, can you give us a split between channel inventory and patient demand? Regarding payer coverage, can you tell us where you're currently at and where you expect to be by the next quarter, and is the coverage similar to Tyvaso? I have another follow up, but start there. Speaker 100:27:10All right, thank you, Serge. Mike, can you answer those questions, please? Speaker 500:27:13Yeah Serge, thanks for your question. Specifically on the breakdown on revenue, I'd say especially for first quarter of launch, the vast, vast majority of that revenue was loaded in the channel. As you can imagine, as we previously talked about, we put product into the channel the first week of June. We dosed our first patient shortly thereafter. Just from a pure timing point of view, a lot of that initial revenue would be loading the channel. With that being said, obviously with the accelerating patient numbers that we've seen, we start seeing stacking of patients as we move into second scripts. The vast majority of that has already been absorbed as we move into Q3 as we related to payer coverage. Like we've always said, we want to make sure that patients have choice. Speaker 500:28:11In order for patients to have choice, we need to make sure they have access to YUTREPIA. As I said earlier, we signed contracts with three major commercial payers. As those NDC blocks are removed we feel very confident, as we said, the product profile of YUTREPIA to win and to be the prostacyclin of first choice. As Dr. Roger Jeffs has stated, being in a parity situation with United Therapeutics where we are not disadvantaged. As those kick in we feel very confident that will be the place that we land and feel very confident in our ability to grow. Speaker 500:28:45Thanks. Maybe one for Rusty. Just an update on the 327 patent litigation. There was a hearing a few weeks ago. I guess when you expect potential decision and what the potential outcomes could be. Thanks. Operator00:29:04Yeah, thanks for the question, sir. As you know, trial was held back at the end of June. At this point, all post trial briefing is complete. The judge set a relatively accelerated post trial briefing schedule. Post trial briefing is now complete. As far as when we get a decision, it's always hard to predict how quickly courts are going to rule on things. I think in the first Hatch Waxman trial in front of Judge Andrews, it was about two and a half months between the completion of post trial briefing and his decision. Obviously, here he set an accelerated timeline for the post trial briefing that could indicate that his decision will similarly be a little bit faster than the last time. Again, hard to predict with any degree of precision. Finally, as to the potential outcomes, it's the same outcomes we've been talking about all along. Operator00:29:58As with prior litigations, we won't probabilitize what the outcome is going to be or try to get in front of the judge and guess how he's going to rule. It's sort of the full range of these potential outcomes, consistent with any hedgehogs in litigation. Speaker 800:30:16Thank you, dear participants. As a reminder, if you wish to ask a question, please press star one one on your telephone keypad. We are going to take our next question. The question comes from the line of Thiago Farr from Wells Fargo. Your line is open. Please ask your question. Speaker 800:30:35Thank you. Let me just add my congratulations as well. A quick one for me. Just thinking about United Therapeutics studies. Read through, kind of, what are some of the implications potentially going forward? Some debate on orphan drug exclusivity? Any implications for YUTREPIA or for the development test for L606? Basically how you guys are thinking about. Speaker 100:30:58If that trial reads out positively. Speaker 100:31:00Thanks. Speaker 100:31:02Thanks, Thiago. I'll take that. I think they've said they're expecting that result in September, so there's really no sense in me trying to predict what that trial result will or won't be. I think if they are successful, they will have some orphan protection for that for a period of time. I think for us it would be a matter of developing L606 for that indication so that once that orphan exclusivity expired, we could benefit from that market too, if they are to be successful. We'll soon see where that lands. Speaker 800:31:40Thank you, dear participants, and the last reminder, if you would like to ask a question, please press star 11 on your telephone keypad. Dear speakers, and no further questions for today. I would now like to hand the conference over to Roger Jeffs for any closing remarks. Speaker 100:32:07Thank you everyone for joining today's call. We appreciate your enthusiasm for this initial phase of launch. We remain laser focused on the execution in the back half of the year and look forward to driving continued update, expanding payer access, and laying the groundwork for our broader pipeline. We look forward to speaking with you very, very, very soon, especially in the fall when we have our R&D day for L606. Thank you again. Speaker 800:32:32This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.Read morePowered by