Q1 2025 Liquidia Corp Earnings Call
Carter, 2025 Financial Results.
Ari: and Corporate Update Conference call. My name is Ari and I will be your conference operator today.
Ari: Currently, all participants are in a listen-only mode Following the presentation, we will conduct a question-and-answer session And trust 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
Speaker Change: I will now hand the call off to Jason Adair, Chief Business Officer.
[inaudible]
Speaker Change: Thank you operator. It is my pleasure to welcome everyone to the Liquidia Corporation first quarter 2025 financial results and corporate update call. Joining the call today are Chief Executive Officer Dr. Roger Jeff, Chief Medical Officer Dr. Rajeev Saggar, Chief Operating Officer and TFO Michael Kaseta, Chief Commercial Officer Scott Moomaw and General Counsel Rusty Schundler.
Speaker Change: Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited, and forward-looking financial information, as well as the company's future performance and-or achievement.
Speaker Change: These statements are subject to known and unknown risks and uncertainties which may cause our actual results or performance to be materially different for many future results or performance expressed or implied on the call.
Speaker Change: For additional information, including a detailed discussion of our risk factors, please refer to the company's documents file with the Securities and Exchange Commission which can be accessed on our website.
Roger Jeffs: I'd now like to turn the call over to Roger for our prepared remarks after which he will open the call for your questions.
Roger Jeffs: Good morning, everyone, and thank you for joining us today. In a little more than two weeks, May 24th to be precise, we will have reached a do for Goldate for Liquidia's first internally developed commercial product, Etrepia.
Speaker Change: An investigational, inhaled, dry powder formulation of tropostinial for the treatment of pulmonary arterial hypertension, or TAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD.
Speaker Change: With all eyes on the future, we are going to keep our prepared remarks focused on a few key areas.
Speaker Change: First, I'd like to take a moment to highlight last week's news regarding the decision rendered by the District Court, dismissing United Therapeutics cross-claim and sought to challenge our amendment to the New Drug Application for Etrepia, which added the treatment of Ph.I.L.D. to your trepis proposed label.
Speaker Change: While United Therapeutics have the right to appeal the Court's ruling, we are pleased with the Court's decision to dismiss this cross claim.
specifically holding that United Therapeutics failed to establish standing.
Speaker Change: We are proud to say there continued to be no legal barriers following the trepid potential final approval, following the exploration of gating regulatory exclusivity on May 23rd, 2025 .
Speaker Change: With this favorable ruling in hand, we are doubling down our preparations for the potential launch of Qtrapia, with a laser focus on five keys for Qtrapia.
Speaker Change: First, we're developing what we believe is a best-in-class product profile for you, Trepia.
Speaker Change: As we've said before, the Traffy's tolerability, titrateability, ease of use, and future labeling speaks to the fact that it offers a differentiated product profile.
Speaker Change: We continue to further characterize these clear benefits in the company's open level of substance study in Ph.I.L.D. patients.
Speaker Change: As communicated in this morning's press release, cohort A of the Ascension Study is now fully enrolled with more than 50 patients.
Speaker Change: The interim data has shown us that the dosing intolerability profile in the first 20 patients to complete eight weeks of treatment was consistent with observations made in the Inspire study at the AH patient.
Speaker Change: That's far, PHLD patients in the defense study had been able to titrate to doses that are three times higher than the labeled target dose of Nebulae Tadeza.
Speaker Change: These patients have also shown positive trends on exploratory measures of efficacy, including in six-minute walk distance.
Speaker Change: Additional data from the Ascent Study will be presented during two poster sessions at the American The Rats at Society's International Conference in San Francisco on May 20th.
Speaker Change: As part of the Ascent Study, we will begin cohort B, a directed transition study in the coming months where we will take patients unsatisfied with the clinical attributes of anti-versa, anti-versa DPI.
Speaker Change: and transition them to utravia. The goal of this study will be to directly compare the differences and potential benefits that utravia presents both in PAH and PHLD patients.
You will hear more regarding the study in the months ahead.
Speaker Change: Next, we are fully prepared to go to market with a competitive share of voice. We have 50 sales reps in the field who have been on board for about 18 months and a companion medical affair team, all with an impressive level of rare disease experience and most with the
Speaker Change: These groups have been actively surveilling both the major centers of excellence, as well as the community prescriber base in preparation for your trucker's potential launch.
Speaker Change: Our third strategic area focus is our preparation to launch a full suite of patient support services which we have meticulously put into place.
Speaker Change: Physicians and patients should expect no differences in support with Betrepia, where they're starting in hell too possible for the first time, or transitioning from incumbent in hell products.
4th, we've continued to focus on ensuring robust product availability
Speaker Change: Mike and his teammate, Liquidia, have prepared to put product in the channel and only two to three weeks after your trepid's potential approval.
Speaker Change: And finally, the fifth strategic area of focus that will help us ensure success is broad payer access.
Speaker Change: Over the last several years, we have developed strong relationships with players who understand the differentiated product profile that uterpia can offer to patients. We remain confident that patients will have access to uterpia within a short time after launch.
Speaker Change: With all these in play, we feel well prepared to launch your trepia into the marketplace once approved, and we look forward to filling our promise to provide patients with Ph and Ph.I.L.D. a much needed and potentially best in class therapeutic alternative.
Speaker Change: I'll now turn the call over to Mike to provide an overview of our first quarter 2025 financials. Mike?
Thank you, Rob here, and good morning everyone.
Speaker Change: Turning to our first quarter, 2025 financial results, which can be found in the press release. You will see that.
Speaker Change: Revenue was $3.1 million for the three months ended March 31, 2025, compared to $3 million for the three months ended March 31, 2024. Revenue related primarily to the promotion agreement.
Speaker Change: The increase of $0.1 million was primarily due to the impact of unfavorable growth and net returns adjustments recorded in the prior year, offset by lower sales volume in the current year.
Speaker Change: Cost of Revenue was $1.5 million or each of the three months ended March 31st, 2025 and 2024. Cost of Revenue related to the promotion agreement has noted above.
Speaker Change: Research and development expenses were $7 million for the three-month-ended March 31, 2025, compared to $10.1 million for the three-month-ended March 31, 2024.
Speaker Change: The decrease of $3.1 million, or 31%, was primarily due to a $3.6 million decrease in personal expenses, including stock-based compensation, due to a shift from activities related to research and development to preparation for the potential commercialization of e-trepidia. [inaudible]
Speaker Change: These decreases were offset by a $1.7 million increase in clinical expenses related to our L6O6 program, and a $0.4 million decrease in expenses related to our uterpia research and development activities.
Speaker Change: General administrative expenses were $30.1 million for the three months ended March 31st, 2025, compared to $20.2 million for the three months ended March 31st, 2024.
Speaker Change: The increase of $9.9 million or 48 percent was primarily due to an $8.1 million increase in personal expenses, including stock-based compensation, driven by higher-hide count and a shift from activities related to research and development to preparation for the potential commercialization of uterine.
Speaker Change: A 0.6 million dollar increase in legal fees related to our ongoing uterpia related litigation.
Speaker Change: We incurred a net loss for the quarter-ended March 31st, 2025 of $38.4 million, or $0.45 per basic and deluded share, compared to a net loss of $30.1 million, or $0.40 per basic and deluded share for the three-month-ended March 31st, 2024.
Speaker Change: Included in the comparative results we have presented is an immaterial revision of other income as previously reported for fiscal year 2024 This revision is a technical non-cash accounting adjustment
Speaker Change: Related to gain and loss recognized when we made investments to our HCR facility made in 2024 Additional details are included in the form 8K we filed this morning I would now like to turn the call back over to Roger
Roger Jeffs: Thank you, Mike. In summary, we continue to drive forward the right set of strategies to support the successful potential launch of Utrepia in the coming weeks, and we look forward to providing both physicians and patients with what we believe could be soon become the process like on the first choice. I would now like to open the call to questions. Operator, first question please.
Speaker Change: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
Speaker Change: Our first question comes from the line of Julian Harrison of DTIG, so our line is now open.
Julian Harrison: Alright, congrats on all the progress and thank you for taking my questions.
Speaker Change: I'm wondering if you believe United has any injunctive value left on the cross claim that was dismissed last week. Also curious if you had any reaction to the dismissal without prejudice versus with prejudice given the judges express views on standing in the opinion memorandum.
Speaker Change: Good morning, Julian. Good to hear from you. Rest of you with my answering Julian's two questions.
Rusty Schundler: Sure, I'm Julian, thanks for the question. So let me go for a couple things. I mean, one, what's absolutely clear is that there's currently no proceeding.
Speaker Change: actively ongoing in which United Therapeutics are seeking to enjoy either the FDA from giving us approval for your transcript or speaking any sort of...
Speaker Change: Temporary Restraining Order of Preliminary Junction to prevent our launch if you trepia upon approval.
Speaker Change: That's number one. Number two, the dismissal was without prejudice. Again, keep in mind it was a motion to dismiss, so the judge was not addressing the full merits of the case. This was, you know, a question of whether their complaint had even set forth.
Speaker Change: Grounds upon which the court could even entertain their lawsuit.
Um...
Speaker Change: You know, what that does mean is they can try to repurpose or repassion the argument in the future but I think what's clear from the way in which he approached the opinion is
Speaker Change: They can't come back with the exact same argument they did before. I think they still have significant standing issues trying to link the bundling guidance to a 30-months day. And keep in mind, again, this is all just at the motion to dismiss phase. You know, they still have to then show their, you know, correct on the merits as well.
Speaker Change: You know, as far as other things that United Therapeutics might do, which I think is a question alluded to, you know, that's really not true today You know, we don't know what lengths they're going to go to try to deny PH and PHLB patients access to an alternative therapy What I can't say though is
Speaker Change: You know, we'll be ready, you know, whatever form they pursue, something if they pursue anything from here and out, we'll be ready to address it.
Thanks, excellent, very helpful, thank you and congrats again.
Thank you, Julian. Next question, please. Thank you
Speaker Change: Our next question comes from the line of Kambiz Yazdi of Jeffries, your line is now open.
and many more. Thank you. Thank you.
Kambiz, do we have you here?
Speaker Change: All right. Morning, Dean. Thank you so much for the questions and very exciting time for the company. Maybe a little bit on the, you know, before looking in transition studies.
Speaker Change: Any kind of thoughts on what may be interesting patient baseline characteristics that you may be looking to enroll in that study, and then would love to get an update on L6O6 as well.
Speaker Change: Great, so both of those questions fall into Rajeev Saggar's court, so Rajeev, find answer in us.
Rajeev Saggar: Yeah, it can be thanks for the question. So the first question was regarding the upcoming transition study.
This study is specifically-
evaluating the transition from...
Teveso
either debilized and preferably drive powder inhaler
Speaker Change: 2U Trapia, these patients will be specifically in the category of Ph.L.D., and that's very purposeful, as you know, for NDA filing in the Inspire Study, we already showed that we were able to successfully transition.
Patients with Group One PAH.
Speaker Change: from Nebulae's Tyvasso directly to Utropia. And now we're trying to do the same thing in the THLD population. So, first of all, these patients will be on background Tyvasso, with the most majority of them are on dry pattern hailer.
Speaker Change: These patients will have Ph.L.D., and very similar to cohort A.S. in part of the Sun Study that was presented at A.T.S. We're going to be looking for the ability to, we're going to be looking at safety.
Speaker Change: Yeah, just an update there yeah. Thank you so.
Speaker Change: This is a global study with more than 300 patients more than 20 companies and we anticipate that we'll be initiating the study by yours end.
Speaker Change: Thank you. Thank you.
Speaker Change: Our next question comes from the line of Greg Harrison of Scotia Bank. Your line is now open.
Greg Harrison: Hey, good morning, guys. Congrats on the progress and thanks for taking the question. So we've seen the competitor struggle to convert patients to their dry powder formulation and their nebulized formulation has persisted longer than than thought initially could you.
Greg Harrison: The patient perspective on switching to dry powder formulation and and whether you think you Trepia will have a stronger case for keeping patients on a DPI formulation than we've seen with Tybaso and how do you think the ascent data will help with this argument.
Greg Harrison: I'll start with an answer and then receive if you'll give your thoughts as well I think it'll be helpful. So you know again I think I think you're right. It's surprising that there remain residual maybe less type ace of patient base I think it's about 31% of the scripts today.
Greg Harrison: Thoughts, including the competitor's thoughts initially where that all patients would trans transition to the D. P. I for portability alone so that hasn't happened and the question is why.
Greg Harrison: Anything it's formulation driven in their formulation as part of aggregated poly dispersed formulation on a F. T. K P backbone really and a high resistance device and low flow really doesn't deliver the drug to lower airway, which is.
Greg Harrison: That's completely the opposite of what a print enabled you Trep you is going to achieve and which is what we've shown in a sense study that patients can tolerate the drug well they can get two very high doses and then they can get there quickly. So those two points are important in a sense that patients feel better.
Greg Harrison: In portable therapeutic modality, and we think Eutrepia is clearly defined as a differentiated in a better opportunity to do just that so I think what we'll do in the marketplace. First is go after new patient starts to like to let physicians experience.
Greg Harrison: And then once they're comfortable with that then then we'll see if if they will transition, particularly their nebulized patients who are going to be looking for an alternative more portable therapy and then also I think it becomes a question of would you even start Tivaceo D. P I or if your own Tive would you want.
Speaker Change: Just says in the previous question, we're gonna have data directed directing to the specifics of how you transition and the benefits of doing the same. So I. We're really excited about all of the market opportunity, but I I do agree that the Netbuilt tibeso.
Speaker Change: Commercial share is is at risk and Gonna go after time. So regime do you have any thoughts yeah. Thanks, Roger I think again, just highlighting I think we believe in our scientific.
Speaker Change: Formulation and our hypothesis that that the print formulation was a low flow resistance devices actually what these patients need I think from my perspective, I think what's what's really unique is is two things you know in.
Speaker Change: Above the sort of traditional ninth 12, Breadts you know we're dosing. These two at least twofold levels higher than what traditionally is given by by Tivesa, but we can do it in a matter of just you know several weeks not not.
Speaker Change: And I think that's very important because these patients are extremely sick.
Speaker Change: They they all they they they are susceptible to clinical worsening and finally inherently they just have terrible cough and one thing I think to your to your question is that the current incumbents dry pattern formulation I think one of it.
Speaker Change: Patients, it's it's inability to titrate to the appropriate doses to match the clinical severity of the patient in part due to cough and I think one of the things that we are going to continue to highlight especially at.
Speaker Change: Yeah seems to be.
Speaker Change: Well, well well received by the patients and the practitioners that are participating in a study. So I think using that that signal and reshowing that in the transition study I think would be would be would be well received.
Speaker Change: Great. Thank you Regib I think your comments speak to to the snippets of you know why we're so excited about the pending launch operator next question. Please thank you.
Speaker Change: Our next question comes from the line of Corey Jubinville of life likes capital. Your line is now open.
Corey Jubinville: Thanks for taking our questions and congrats on the progress. So you mentioned earlier in the prepared remarks that you're building out this prescriber support team in as we speak to Aol's in in addition to Applicacy Intolerability seems that EF.
Speaker Change: Be a major component to their prescription habits could you just provide a little bit more detail as to what that support team might look like and their activities and specifically what what might you be doing that improves the prescriber experience.
Speaker Change: Presently and how that compares the potential competitors and you know I guess on the patient side in terms of early patient access do you have any details about what a potential bridging program might look like if that's in the plans for patients.
Speaker Change: Benefit by having our chief commercial officer, Scott Mom on the call just got if you wouldn't mind addressing questions. Yeah sure. Good morning. So the specifics I think will we'll sort of share as we get through in past approval around the patient support program, but I would.
Speaker Change: Over a decade, most folks have over a decade of experience with prostenol in the various forms working with a specialty pharmacy working with these this patient population and we have a very good understanding of what the needs of the Hcps and the patients are.
Speaker Change: So we built out a program that we think in all respects will be as good as or better than what's on the market right now in the terms of the way that these patients have been cared for we we completely understand the point that you raised around you know being able to start.
Speaker Change: Very important to early success and we're going to make sure that we have everything in place to make sure that happens and we look forward to sharing that with you hopefully after the end of May great. Thank you Scott. Thank you.
Speaker Change: Our next question comes from the line of Jason Gerberry of B of a your line is now open.
Speaker Change: Hey, guys. This is she on for Jason. Thanks for taking out question. So you have some data presentation at the a T. S meeting in a couple of weeks I'm curious if you can give us an early flavor of these presentations what expectations.
Speaker Change: And when my weekend.
Speaker Change: Since I received you're the leading architect of the cohort a study if you could talk to that question. Yeah. Thanks. Thanks for that question I think at this point you know obviously, we're under embargo to go into the actual details of the study, but essentially we're going to be presenting three posters to.
Speaker Change: To the sense study, which we will showcase the first 20 patients that were treated for eight weeks remember these are patients with newly diagnosed phld that are now taking utrepia. So we'll showcase a few things the.
Speaker Change: We will detail out the tolerability profile of these these patients as well as well as the dosing characteristics that that we're seeing so that's that's the first thing. The second thing is that we'll finally showcase some exp.
Speaker Change: And the first two posters the first one being of course.
Speaker Change: What happens to the exercise Tolerability, which is defined by six and a walk distance compared to baseline through eight weeks and the other thing is we're gonna showcase a novel.
Speaker Change: A novel endpoint, that's known as cardiac effort and that will be presented by Dr. Dan Lashant at University of Rochester, again sort of understanding why potentially these patients are showing.
Speaker Change: Improvements in their exercise capacity and and what what what are the potential reasons for that and how you trip you as modifying the.
Speaker Change: It's performance on the right ventricle, the third poster will be will be presented.
Speaker Change: Looking at transitioning a patient that was participating in the inspire study from.
Speaker Change: Who had acutely worsened and was hospitalized placed on intravenous tree personal and transition to.
Speaker Change: 2861, or U trepia, and just highlighting that safety that ability to transition patients from parental therapy back to back to L. A Q 861 in that in that study. So all in all we're very excited to again showcase some of these.
Speaker Change: Thank you Regib, obviously, the timing of that data quite exciting and the fact that it will be presented literally within a week of a potential approval operator next question.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Serge Bellinger of Needham. Your line is now open.
Speaker Change: N and secondly, do you expect that there could be some warehouse demand for this product or this is a group of physicians that will likely Wanna run their own.
Speaker Change: Internal evaluation before really ramping up usage of Eutria. Thanks, Yeah. Thank you. Thanks for the question services, Scott maybe you could apply on this.
Speaker Change: Sure. So on the awareness question, obviously, you know prior to launch we're very limited in what we can communicate perspective in fact, nothing so but we're looking forward to the launch and I can guarantee you that we will be allowed.
Speaker Change: Will go up extremely quickly there is background awareness you know do the medical information, we've shared et cetera, but once the sales team gets out there we have a full suite of marketing activity electronic activities. Our goal is that every HDP who is involved in P. H.
Speaker Change: P a H or P. H L D will be aware and we'll be able to to try it very soon after launch. The second question was about warehousing I think you know I think there might be some of that due to the tolerability issues in the conversation that came that came up earlier around T.
Roger Jeffs: Certainly as Roger has said I think even earlier in this call we'll be focused on new patients because those are the patients that give the the physician really the best you know option opportunity to try the drug and sort of a clean way, having said that we have heard from.
Roger Jeffs: Patients that have transitioned back to the Nebulized version of Tyveso and I think we all understand that that's not optimal from a convenient standpoint, and the dosing standpoint. So we will get some of those we will work with those physicians to make sure that those are successes, but patience.
Speaker Change: After first and foremost will be those patients that are new to process cycles. Yeah. Thanks, and I think Serge one one way to look at this is there's be almost three phases of how we integrate the trep into the standard of care and I do think we can change the paradigm that currently exist.
Speaker Change: Process like on the first and best choice. So I think we'll do the new patient starts then we'll do the transitions and then you know if you just said what's the the current inhale to process market. That's a 2 billion market opportunity and growing significantly still with the sort of white space. The.
Speaker Change: Within the other 2 billion today market opportunity the oral prostate.
Speaker Change: Some duress that the patients have to undergo to get to therapeutic doses and be maintained on those therapies that we think we can solve for because now with there's for the first time, there's a readily titratable endurable inhaled.
Speaker Change: Process cycle Trepia. So you know those those different promotional cadences will happen at different paces, but I think collectively we're gonna integrate ourselves across all of that so you know so when when you look at what's the current market opportunity.
Speaker Change: John and I think you know there's opportunity for us to be very successful, we don't necessarily need to take income and share, but I think over time that will happen.
Speaker Change: Operator major time, one more question if you have any thank you.
Speaker Change: Our last question comes from the line of Ryan Deshner of Raymond James Your line is now open.
Speaker Change: Good morning curious on what you're anticipating in terms of the split between commercial and public payers N. P. A P. H N P. I L D and I was wondering if you could just quickly walk us through the important points of the 494 patent infringement suite that you recently filed.
Speaker Change: Yeah, So Scott of you'll answer the first part of that and then rest you'll talk about 494 litigation yeah from a pay Rick standpoint, looking at the process cycle market and divestiture about 55%.
Speaker Change: Maybe 10% Medicaid and then 5% other whether that be Tricare, you know D. O D et cetera. So you know, we'll see when we get out there, but that that seems to be what we're expecting.
Speaker Change: And right. Thanks for the question on the 494 lawsuit. So you know we're not really gonna comment much on that I mean, obviously, we filed the lawsuit you know I think the complaint sets forth pretty clearly you know our thoughts as to the grounds on which we're proceeding with lawsuit.
Speaker Change: Very early stages. So you can't really comment on timing and typical with best practice won't comment publicly on on legal theories or legal strategies, we're going to pursue in the case.
Speaker Change: Great. Thank you Scott. Thank you Ryan for the question so with that we'll close and you know as you can see we're very excited and about actually matriculating our mission and vision of delivering a new treatment modality to patients with P. H and P. H L D and hopefully us.
Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
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