Liquidia Corp - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 total revenue was $8.84M, a significant beat versus Wall Street consensus of $3.89M, driven by initial YUTREPIA channel stocking and early patient starts; however, EPS of -$0.49 missed consensus of -$0.43 as SG&A and interest expense stepped up with commercialization and HCR financing. Revenue Consensus Mean: $3.89M*, EPS Consensus Mean: -$0.431* (Values retrieved from S&P Global).
• Commercial launch momentum: >900 unique prescriptions and >550 patient starts within 11 weeks of approval; ~75% script-to-start conversion in the first six weeks; prescriber breadth >350 physicians; payer access improving with contracts signed with “all major commercial payers” and removal of new-to-market blocks expected to accelerate conversions in 2H25.
• ASCENT interim PH-ILD data reinforced tolerability and efficacy (median 6MWD +31.5m at Week 16), enabling dose escalation with stable cough scores; detailed data slated for September/October conferences, adding potential clinical validation catalysts.
• Operational posture: SG&A (ex non-cash/variable costs tied to sales) expected to remain flat next few quarters; R&D to increase with label studies and L606 pivotal prep; 70k sq ft manufacturing lease signed to triple capacity, targeted 2026 occupancy; $50M HCR tranche received to support launch scale-up.
• Stock-relevant catalysts: accelerating payer coverage, incremental switches from Tyvaso/Tyvaso DPI, upcoming ASCENT readouts, and pending litigation decision timing; near-term narrative likely driven by demonstrated adoption durability beyond initial channel load.

What Went Well and What Went Wrong

What Went Well

• Rapid demand and strong early adoption: “over 900 unique patient prescriptions leading to more than 550 patient starts” in 11 weeks post-approval; CEO emphasized “exceeded my own high expectations” and differentiated tolerability/escation profile versus incumbents.
• PH-ILD clinical momentum: ASCENT interim analyses showed median 6MWD +21.5m (Week 8) and +31.5m (Week 16) with dose titration to median 159 mcg QID and stable mean daytime cough scores, supporting real-world tolerability and efficacy.
• Payer access improving and commercial infrastructure scaling: signed contracts with major commercial payers; market access programs (free voucher 28 days; bridge program) helping rapid start; lease for additional manufacturing capacity to support growth.

What Went Wrong

• EPS miss despite revenue beat: Q2 2025 EPS of -$0.49 missed consensus as SG&A nearly doubled YoY to $38.8M and interest expense rose with HCR borrowings; net loss widened to -$41.6M.
• Heavy initial channel loading: CFO indicated “vast, vast majority” of revenue in the first launch quarter was channel stocking, increasing the need to show sustainable patient demand stacking in Q3+.
• Legal overhang: United Therapeutics ongoing actions and patent litigation continue to pose injunctive risk to commercialization and to label stability; management avoided probablizing outcomes, noting accelerated briefing but uncertain timing.

Transcript

Speaker 8

Morning 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 3

Thank 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 1

Roger 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.

Since 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.

In 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.

YUTREPIA 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.

While 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.

For 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.

However, 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.

The 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 5

Thank you, Roger, and good morning, everyone. In order to save time for more.

Speaker 9

Of 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 5

On the revenue side, we generated $8.8 million.

Speaker 9

Million 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 5

Targeted to further acceleration in YUTREPIA adoption.

Speaker 9

Lastly, 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 1

Thanks. 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.

With that, operator, first question, please.

Speaker 8

Thank 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.

Hi, 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 1

I'm curious if you could talk more.

About 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?

Great, 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.

We 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.

So.

Rajeev, any other comment on that?

Speaker 9

Yeah, 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.

Very helpful all around. Congrats again.

Speaker 1

Thank you, Julian. Always good to hear from you. Operator, next question please.

Speaker 8

Yes, 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 1

Good morning.

Speaker 9

Congratulations on the strong start to your YUTREPIA launch and the ASCENT results.

Speaker 5

What proportion of paid drug is associated?

Speaker 9

With 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 1

Thanks. 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 9

Yeah, thanks.

Speaker 5

Roger 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 9

That provides an additional 28-day supply.

Speaker 5

At any time during a patient's journey.

Speaker 9

What I would say is specifically.

Speaker 5

You 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 1

Great. Scott, if you'll handle the second question. Sure.

Good morning.

Speaker 4

In 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.

That's kind of how it's playing out currently.

Speaker 1

Thanks, 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 8

Yes, 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.

Hey, good morning, guys. Congrats on the launch as well. My question, just thinking about second half in these patients that have started on.

Speaker 1

YUTREPIA, how should we think about sort of the gross to net?

Presumably 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.

A start and that 75% conversion rate.

The other 25% that haven't converted is.

that just a function of time?

Is 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.

Thanks.

Great. Thank you, Jason. Great questions. Mike, if you wouldn't mind answering those questions.

Speaker 3

Mike, you might be on mute.

Speaker 5

Oh, 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 9

Of the major commercial payers.

Speaker 5

We expect those new-to-market blocks.

Speaker 9

To be removed shortly.

Speaker 5

We 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.

As 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 9

Our ability to deliver on that.

Mike, 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 8

Yeah.

Speaker 5

What 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 1

Got it. Thanks.

Speaker 8

Now 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.

Good morning.

Speaker 4

Congrats on all the progress.

It seems like traction has been really great so far as we think about.

Speaker 9

Launch plans throughout the rest of the year.

What 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.

Stay on course versus pull some of these levers.

You also mentioned that you signed contracts with the three major commercial players. When do those contracts, you.

Kick in and you start to.

Speaker 1

Get 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 4

Yeah, 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.

We 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 1

For 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.

I 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 8

Yes, of course. We are going to take our next question. And Colin Sigal from Needham, your line is open. Please ask a question.

Hi, 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 1

All right, thank you, Serge. Mike, can you answer those questions, please?

Speaker 5

Yeah 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.

In 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.

Thanks. 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.

Speaker 0

Yeah, 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.

As 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 8

Thank 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.

Thank 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 1

If that trial reads out positively.

Thanks.

Thanks, 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 8

Thank 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 1

Thank 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 8

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.