Q2 2024 Liquidia Corp Earnings Call

August 7, 2024

Thank you, Lisa. It's my pleasure to welcome everyone to Liquidia Corporation's second quarter 2024 financial results and corporate update call.

Jason Adair: Order 2024 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 statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements.

Jason Adair: These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors. Please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I would now like to turn the call over to Roger for our prepared remarks, after which he will open the call to your questions. Roger? Thank you.

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 achievements.

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 from any future results or performance expressed or implied on this call.

Roger Jeffs: Thank you, Jason. Good morning, everyone.

Roger Jeffs: Thank you for joining us today. While we and patients still anxiously await FDA action on the utrepia NDA, seeking approval for both the former... PAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD. We remain hopeful that we are close to achieving this goal. As a reminder, the FDA has had no legal impediments since April 1st to take action on the amendment as submitted, seeking approval for both PH and PHL. What I can say today is that we have been in active and constructive communication with the FDA over these past four months, but I will not comment on the specifics of our conversations with you. To be crystal clear, our medical and commercial teams remain on high alert, ready to launch Utrepia immediately upon approval. Our sales team continues to call on key pH accounts, strengthening relationships and educating them on Liquidia.

Speaker Change: To be crystal clear, our medical and commercial teams remain on high alert and ready to launch utrepia immediately upon approval.

Speaker Change: Our sales team continues to call on key PH accounts, strengthening relationships and educating them on Liquidia. And importantly, we are staging commercial products for rapid distribution to specialty pharmacies upon approval.

Roger Jeffs: And importantly, we are staging commercial product for rapid distribution to specialty pharmacies upon approval. Moving to our clinical programs, the Open Label Assent Study of utrepia in PHIL-B patients continues to ramp up in the number of active clinical sites, with parallel increases in patient screening and patient enrollment. We are pleased with the preliminary feedback from physicians suggesting that patients can readily titrate utrepia to escalating therapeutic levels in these PHLD patients. While the ascent data needs to mature more, our early patient experience today suggests that the benefits of print formulae that you're possible, delivered via a low-effort inhaler. Parallel is a very good experience observed in PAH.

Speaker Change: We are pleased with the preliminary feedback from physicians suggesting that patients can readily titrate utrepia to escalating therapeutic levels in these DHLD patients.

Roger Jeffs: For example, the median dose would be higher for patients currently enrolled beyond eight weeks in the assent trial. 185.5 micrograms per treatment session, or approximately 21 breadth equivalents of Type A supercession, with a top dose of 318 micrograms for approximately 36 breath equivalents. These doses are several orders of magnitude beyond the recommended 9 to 12 breath dose targeted type A and exemplify the paradigm-shifting potential of utrepia for PH and PH IMD patients, especially as it relates to tolerability and potentially durability.

Speaker Change: For example, the median dose of utrepia for patients currently enrolled beyond eight weeks in the assent trial is 185.5 micrograms per treatment session, or approximately 21 breath equivalents of Tybaso per session.

Speaker Change: with a top dose of 318 micrograms, or approximately 36 breath equivalents.

Speaker Change: These doses are several orders of magnitude beyond the recommended 9 to 12 breath dose targeted type ASO, and exemplify the paradigm-shifting potential of utrepia for pH and pH IMD patients, especially as it relates to tolerability and potentially durability.

Roger Jeffs: We plan to submit additional clinical data from the Accenture Hour at future medical conferences, and more to come. With respect to our sustained release glycosamone formulation of inhaled droprocinone, L6 is, The Preliminary Safety Data and Exploratory Efficacy Data from the First 28 Patients, switching from Tyvaso or Tyvaso DPI in our open-label clinical study has been highly encouraged. We continue to observe favorable tolerability and titratability profiles of twice daily dosing of L6O6, likely attributable to the seven-fold lower CMAQ but with a similar systemic exposure over a 24-hour period compared with the four times a day dosing of inhaled troposomal, all while using a rapid, portable, anti-health breath actuated nebulizer.

Speaker Change: With respect to our Sustained Release Glycosomal Formulation of Inhaler Proxenil L606.

Speaker Change: The preliminary safety data and exploratory efficacy data from the first 28 patients switching from Tyvaso or Tyvaso DPI in our open-label clinical study has been highly encouraging.

Speaker Change: We continue to observe favorable tolerability and titratability profile of twice daily dosing of L6O6.

Roger Jeffs: The long-term safety data generated from this study helped solicit favorable scientific advice from the European Medicines Agency, or the EMA, last month on our pivotal trial design, which was very consistent with EFDA's feedback from our Type C meeting in December. While we continue to observe these patients in the Open Labial Study, our focus will now shift to our efforts to initiate the registration on a global trial in patients with PH ILD later this year. At this time, I will turn the call over to Mike to summarize the second quarter financing.

Speaker Change: The long-term safety data generated from this study has helped solicit favorable scientific advice from the European Medicines Agency, or the EMA, last month on our pivotal trial design, which was very consistent with the FDA's feedback from our Type C meeting in December .

Michael Kaseta: Thank you, Roger, and good morning, everyone. I will briefly address our second quarter financial results found in today's press release. As you will see, revenue is $3.7 million for the second quarter of 2024, compared with $4.8 million in the same quarter of 2023. This revenue is tied to our promotion agreement with Sandoz to commercialize troparosinol injections.

Speaker Change: compared with 4.8 million dollars in the same quarter 2023. Revenue is tied to our promotion agreement with Sandoz to commercialize terprosinol injection.

Michael Kaseta: The decrease is primarily due to lower sales quantities in the current year as compared to the same period in the prior year. Cost of revenue increased to $1.5 million for the second quarter 2024 compared to $0.7 million in the same quarter of 2023, with the increase being primarily due to our Salesforce expansion during the fourth quarter of 2023. Research and development expenses were $9.4 million in the second quarter of 2024, compared with $17.7 million in 2Q2023, which included a $10 million upfront license fee to Pharmosa for the exclusive license to L606 in North America.

Michael Kaseta: We saw a $1.4 million decrease in expenses related to our Utrepia program, driven by expensing pre-launch inventory costs in the prior year. These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personnel expenses related to increased headcount. General and administrative expenses were $20 million in the second quarter of 2024, compared to $9.2 million in the same quarter of

Speaker Change: General and administrative expenses were $20 million in the second quarter of 2024 compared to $9.2 million in the same quarter for 2023. The increase of $10.8 million is primarily due to a $6.3 million increase in personnel expenses, which includes stock-based compensation.

Michael Kaseta: The increase of $10.8 million is primarily due to a $6.3 million increase in personnel expenses, which includes stock-based compensation, a $2.2 million increase in commercial and consulting expenses, and a $0.9 million increase in legal fees related to our ongoing utrepia-related litigation. In summary, we incurred a net loss for the three months ended June 30, 2024, of $27.9 million, or $0.37 per basic and diluted chair, compared to a net loss of $23.5 million, or $0.36 per basic and diluted chair, for the three months ended March 31, 2020. We ended the second quarter of 2024 with $133 million cash on hand and remain well positioned financially to achieve our corporate objectives this year. With that, I'd like to now turn the call back over to Roger.

Speaker Change: a $2.2 million increase in commercial and consulting expenses, and a $0.9 million increase in legal fees related to our ongoing utrepia-related litigation.

Roger Jeffs: Thank you, Mike. As you just heard, it's been an active summer on several fronts since our last call.

Roger Jeffs: We were fully prepared for the potential launch of Utrepio with a team of dedicated professionals who are poised to reshape and grow the market for in-outro prosthetics on Utrepio's approval. The market opportunity for inhaler prosthetics is currently at a $1.5 billion run rate, with the potential to grow in excess of $3 billion in the coming years. This market remains keen for a competitive alternative, especially one with the dosing and tolerability advantages that Utrepia can potentially provide once approved. With that said, I would now like to open the call to questions. Operator, first question, please.

Speaker Change: with the potential to grow in excess of $3 billion in the coming years. This market remains keen for a competitive alternative, especially one with the dosing and tolerability advantages that Utrebia can potentially provide once approved. With that, I would now like to open the call to questions.

Operator: Thank you. If you would like to ask a question, please press star 1-1 on your telephone. You'll then hear an automated message to advise that your hand is raised. We also ask that you wait for your name and company to be announced before proceeding with your question. One minute while we prepare for the questions. And our first question today comes from Julian Harrison of BTIG. Your line is open.

Speaker Change: Operator, first question, please. Thank you. If you would like to ask a question, please press star 1 1 on your telephone.

Speaker Change: One minute while we prepare for the questions. And our first question today comes from Julian Harrison of BTIG. Your line is open.

Julian Harrison: Hi, good morning. Thank you for taking my questions and congratulations on the recent progress. I'm wondering if we could briefly review why higher inhaled tryposomal exposure should be beneficial both in PAH and PHILD.

Roger Jeffs: Yeah, Julian, thanks very much for the question. I'll start, and then I'll ask Rajeev to add some additional color.

Speaker Change: Yeah Julian, thanks very much for the question. So I'll start and then I'll ask Rajeev to add some additional color.

Roger Jeffs: So what we know historically from the use of prostacyclines is that one of the beauties of prostacyclines in particular is the ability to continually titrate to effect over time because, unfortunately, these patients have an advancing disease that continues without relent. So the only way, the only therapeutic class that can address this progressive disease and remain a sort of ability to tweak our prostacyclin. So if you look at troprosinol in its various forms, parenteral, oral, and inhaled, you can see that the ability to titrate is a hallmark of the therapy.

Rajeev: So what we know historically from the use of prostacyclines that and one of the beauties of prostacyclines in particular is the ability to continually titrate

Rajeev: to affect over time.

Speaker Change: because unfortunately these patients have an advancing disease that continues without relent. So the only way, the only therapeutic class that can address this progressive disease and remain a

Roger Jeffs: But what had been limiting prior to utrepia, in particular, as you see with tybaso, is the inability to titrate above a fairly low therapeutic ceiling. So what utrepia has done, and this is why I say it's paradigm-shifting, is it gives you all the benefits of parenteral and oral products, but gives it directly to the site of action to limit the systemic side So you now have a highly flexible therapy with high utility that can really be, goes to effect, also while minimizing fat.

Speaker Change: So what Utrepia has done, and this is why I say it's paradigm shifting, is it's giving you all the benefits

Speaker Change: of the parenteral and oral products.

Roger Jeffs: So I think, you know, this is why we're so excited about eutrophia. We think it brings a difference, sort of utility to the marketplace in terms of triprocessional use, and we think this therapeutic profile will lead it to become both best-in-class and first-in-choice when considering starting a process cycle, be it parenteral, oral, or intracranial. Rajeev, I don't know if you have any additional comments.

Speaker Change: goes to effect, also while minimizing the side effects.

Speaker Change: sort of utility to the marketplace in terms of the troposinol use, and we think this therapeutic profile will lead it to become both best-in-class and first-in-choice when considering starting the process cycle, be it parenteral, oral, or inhaled.

Rajeev Saggar: Yeah, Julian, yeah, I think Roger answered most of it correctly. I would just sort of add that, you know, we learned a lot from the increased study in PHLD. I think in that study, the data highlighted that patients that achieved more than at least nine breaths, and especially as you get to higher doses, those patients' clinical observations were that they walked further, and they also had improvements in many of the secondary outcomes.

Julian Harrison: Yeah, Julian, yeah, I think Roger answered most of it correctly. I would just sort of add is that, you know, we learned a lot from the increased study in PHLD. I think in that study, the data highlighted that patients that achieve more than at least nine breaths.

Speaker Change: and especially as you get to higher doses, those patients...

Speaker Change: The clinical observations was that they walked further and they had also improvements in many of the secondary outcomes.

Rajeev Saggar: Also, I think, you know, this is a very heterogeneous group of patients, both in PAH and PHLD, with various degrees of severity. And in many of these patients, the disease, as Roger highlighted, is progressive. The opportunity to continue to titrate and match disease severity and temper that down is, I think, going to be a clear advantage and a great armamentarium for clinicians, as well as for outcomes for patients.

Speaker Change: Also, I think, you know, this is a very heterogeneous group of patients, both in PAH and PHLD.

Speaker Change: with various degrees of severity. And in many of these patients, the disease, as Roger highlighted, it's progressive.

Roger: The opportunity to continue to titrate and match disease severity and temper that down I think is going to be a clear advantage and a great armamentarium for clinicians as well as for the outcomes for patients.

Roger Jeffs: Thank you, Rusty. Thanks for the question.

Julian Harrison: Great, and one more if I may. I was just curious if you have a good sense for when we might expect a comprehensive data disclosure from the ASCENT trial and if we could maybe review, you know, what the key unanswered questions are that you plan to address with that trial?

Speaker Change: Thank you for the question. Okay.

Speaker Change: Great, and one more if I may. I was just curious if you have a good sense for when we might expect a comprehensive data disclosure from the ASCENT trial and can we maybe review, you know, what the key unanswered questions are that you plan to address with that trial?

Roger Jeffs: Yeah, Julian. So, you know, again, just to remind everyone, Ascent is a study studying the safety and tolerability, and the secondary outcomes would be exploratory efficacy of utrepia in patients with PHLD who have not been treated, that patients have to enroll with baseline right heart catheterization. The study is actually for 24 months, and then we follow the patient out to one year. So what is very important here in this study is that what we're looking for is to maintain the patients on the optimal dose of utrepia and also to show durability, because what we do know is that after 16 weeks of increased study, many of these patients start to have a significant amount of instability, so we wanted to show patients definitely have durability.

Speaker Change: is a study studying the safety and tolerability and the secondary outcomes would be.

Speaker Change: Exploratory Efficacy of Utropia in Patients with...

Speaker Change: PHLD who have not been treated, that patients have to enroll with the baseline right heart catheterization. The study is actually for 24 months.

Roger Jeffs: Our focus really coming out, you know, the next set of Congresses that are approaching here is really to highlight some of this exploratory clinical efficacy data. We are following clinical variables, such as, you know, walk distance in terms of a six minute walk. We're also looking at various forms of questionnaires.

Rajeev Saggar: And finally, we're also looking at effects on the lung parenchyma and the lung vasculature by using CT chest imaging really to highlight exactly where the effect is, particularly on the pulmonary vasculature, with the use of utrepia. I just want to highlight, as Roger said, that at least right now, the median dose for those patients now past the eight-week mark is now 185.5 micrograms of This is just to highlight that if you compare this to our Sentinel-INSPIRE study in PAH, by two years, patients were on – about a third of the patients were on 159 micrograms.

Speaker Change: And finally, we're also looking at effects on the lung parenchyma and the lung vasculature by using...

Speaker Change: CT chest imaging, really to highlight really where the effect is, particularly on the pulmonary vasculature with the use of utropia. I just want to highlight, as Roger said.

Rajeev Saggar: So, what we're seeing here is that providers and patients, in particular, are able to tolerate utrepia, and there's also, just to go back to our last question, a very clear understanding by providers that the higher the dose, the potential benefit of the patient. And I think we look forward to highlighting some of these clinical parameters in the very near future.

Speaker Change: So, what we're seeing here is that providers and patients, in particular, are able to tolerate utrepia and there's also, just to go back to our last question, a very clear understanding by providers that dose...

Speaker Change: The higher the dose, the potential, the benefit of the patient, and I think we look forward to highlighting some of these clinical parameters in the very near future.

Roger Jeffs: Thanks, Rajeev. So, Julian, as you can hear, a very robust study. We're trying to complete it by year-end to specifically answer your question. We'll look to publish that in 2025. Operator.

Operator: Welcome. Thank you. Thank you. And our next question will be coming from Serge Belanger of Needham. Your line is open.

Speaker Change: And our next question will be coming from Serge Belanger of Needham. Your line is open.

Serge Belanger: Good morning. Thanks for taking my question. I have a couple legal ones.

Serge Belanger: Good morning. Thanks for taking my question. I have a couple legal ones. First one on the

Speaker Change: I believe in the motion for dismissal, both the agency...

Rick Whittier: and Liquidia.

Serge Belanger: First one on the UT case against FDA. I believe in the motion for dismissal, both the agency and Liquidia completed their briefs. So just curious if you have any visibility on timelines for the next steps here, whether we'll get a hearing or Judge Bates will rule on the brief. And related to this case, how closely is the FDA following this missile motion? How could that be a gating factor for them rendering a decision? on the Utripia NBA. Great search, thanks.

Rusty Schundler: Thanks for the question, Rusty. Yes, sir.

Rick Whittier: Thanks.

Rusty Schundler: Taking your first question first, on the motion to dismiss Next Steps, you know, we don't know yet. The court could hear an oral argument, or it could rule on the briefs.

Speaker Change: I'll take your first question first. On the motion to dismiss Next Steps, we don't know yet. The court could have an oral argument.

Speaker Change: or it could rule on the briefs. You know, we don't have an indication either way yet from the court, so, you know, really can't provide any guidance there just because we're waiting for the court to decide on that. On the second point, you know, obviously it's tough for us to comment on what's in the FDA's head.

Roger: And I think, as Roger said in his opening remarks, I think we want to be careful, you know, not to comment on our communications with the FDA. So, you know, obviously once the FDA has taken definitive action, obviously we will announce that. But in the meantime, you know, we're not going to comment on our communications with the FDA.

Rusty Schundler: You know, we don't have an indication either way yet from the court. So, you know, we really can't provide any guidance there just because we're waiting for the court to decide on that. On the second point, you know, obviously it's tough for us to comment on what's in the FDA's head. And I think, as Roger said in his opening remarks, I think we want to be careful not to comment on our communications with the FDA. So, you know, obviously, once the FDA has taken definitive action, we will obviously announce that. But in the meantime, you know, we're not going to comment on our communications with the FDA.

Roger: Thank you.

Rusty Schundler: Thank you for the question, Serge.

Roger: Thank you for the question, Serge.

Operator: Thank you, and one moment for the next question. Our next question will be coming from... Khabib. Yazda of Jeffrey's, your line is open.

Speaker Change: Our next question will be coming from Kambiz Yazda of Jeffrey's. Your line is open.

Kambiz Yazda: Morning, team. For the registrational study for L606, can you remind us the key features of that study design and when is that slated to start? And then maybe just a few finer points on the stents study. How many more sites have you got on board since the last update? And how many patients so far have you treated in the stents study? Thank you.

Kabiz Yazda: Morning, team. For the registrational study for L606, can you remind us the key features?

Rajeev Saggar: Questions. Rajeev, both of those are in your quarterly.

Rajeev Saggar: Yeah, hi Kambiz. Regarding the global, single placebo-controlled efficacy study with L606, specifically in patients with palmar hypertension associated with interstitial lung disease. We plan to initiate that study by the end of the year. I think we're working feverishly to do all the necessary steps to make sure that our protocols are properly submitted and viewed by agencies, as Roger highlighted. We've had favorable feedback from both the Type C meeting with the FDA and also from scientific advice from the European Medicines Agency. So I think we remain pretty confident in our plans.

Speaker Change: Yeah, hi Kambiz. So, you know, regarding the the global...

Speaker Change: I think we're working feverishly to, you know, do all the necessary steps to make sure that our protocols are properly

Rajeev Saggar: We've already highlighted the primary endpoint in this study is going to be six-minute walk distance, with a whole host of secondary efficacy endpoints that I think would be important to support our target profile. I think we're extremely confident based on the safety data that's emerging from the open-label study in the United States. Again, just highlighting the liposomal.

Speaker Change: in our plans. We've already highlighted the primary endpoint in this study.

Speaker Change: to support our target profile. I think we're extremely confident based on the safety data that's emerging from the Open Label Study in the United States. Again, just highlighting the liposomal...

Rajeev Saggar: Technology on top of the triprocinol has really shown to minimize cough and really support dosing and titratability of this drug, I think, which is going to be a game changer, along with a reduced frequency to twice a day. So we remain very, very excited about the feedback that KOLs throughout the global market have been giving for support of the study. There's an extremely significant amount of unmet need, I think, definitely outside the U.S., in addition to the U.S. in that regard.

Speaker Change: throughout the global market has been showing for for support of the study.

Speaker Change: There's an extremely significant amount of unmet need, I think, definitely outside the U.S., in addition to the U.S. in that regard. In terms of ascent, we're close to about tripling the number of sites by the end of this month, and we remain quite confident on ascent.

Rajeev Saggar: In terms of ascending, we're close to tripling the number of sites by the end of this month, and we remain quite confident of completing the study by the end of the year. We anticipate having close to about 15 patients by the end of this month. Just to highlight that the majority of the sites that have just recently been initiated have come online over the past 45 days, and we anticipate the remainder of sites to come online within the next 30 to 60 days as well. Then by that time, I think we'll have; we'll be on full ramp to support the rest.

Speaker Change: by the end of this month. Just to highlight that the majority of the sites that have been.

Roger Jeffs: Great. Thank you. Thank you, Rajeev. Thanks for your questions, Kambiz.

Roger Jeffs: As you can see, really positive data flowed from both the L6-O6 open-label study and the assent trial. You know, we're obviously very excited to get into the registrational study with L6-O6 and PHIV patients, as Rajeev said, and I think the fact now that we're seeing the ability to titrate as easily as we are and as quickly as we are, as well as to see the durability of the two times a day format, that's an exciting phase three program with a very positive predictive future.

Roger Jeffs: Same for the assent trial, I think, when you see this rapid ability to dose these patients. Quite differentiating, and I think, you know, something that the market will lean on once we get to market. So thanks for the question, Kambiz. Next question, please.

Speaker Change: So thanks for the question, Kambiz. Next question, please. Thank you.

Operator: Our next question will be coming from the line of Matt Kaplan of Leidenberg. Fowlman, your line is open.

Matthew Kaplan: Hi, good morning guys. Thanks for taking the question. I guess, you know, since we're past the kind of legal impediments for FDA approval, I guess with your interaction with the FDA, has the FDA identified any material differences which would prevent approval and would, I guess, necessitate a CRL? Amen.

Speaker Change: Bowman, your line is open.

Bowman: Hi, good morning guys. Thanks for taking the question. Um, I guess, you know, since we're past the

Roger Jeffs: Hey Matt, it's Roger. Thanks for the question. So, you know, as I said in the introduction, we're really not going to comment on specific discussions with the FDA. I think one way to look at this is, yes, we are past the time when there was no legal impediment for approval, that being April 1st, four months past that, and while that's frustrating, I think if you want to put a positive spin on that, it's four months are in the rear view mirror, so there's been four months to work out a solution.

Bowman: I think one way to look at this is, yes, we are past the time when there was no legal impediment for approval, that being April 1st.

Roger Jeffs: So we think we're that much closer to a decision and action, and we won't come in on direct communications with that, but we remain optimistic that we've had constructive discussions with the agency, and we remain highly focused on approval for both indications. So that's as we submitted it; we feel it was appropriate as amended. And we are seeking approval for both PAH and PHILD. We haven't backed away from that position, and that remains our focus. So, apologies that I can't get specifics, but hopefully, we'll have an action soon, and we can talk about that in great detail with you. Operator.

Bowman: And we remain highly focused on approval for both indications. So that's, as we submitted it, we feel it was appropriate as amended. And we are seeking approval for both PAH and PHILD. We haven't backed away from that position and that remains our focus.

Bowman: So apologies that I can't get specifics but hopefully we'll have an action soon and we can talk about that in great detail with you.

Operator: And one moment for the next. Our next question will be coming from the line of Jason Gerberry of Bank of America. Your line is open.

Bowman: Operator, next question.

Speaker Change: Our next question will be coming from the line of Jason Gerberry of Bank of America. Your line is open.

Jason Gerberry: Hey guys, good morning. Thanks for taking my questions. So two for me, just on the cash burn language in the 10-Q, about roughly around a year of cash runway. I assume that that assumes approval and launch costs. Can you talk about, in the alternative scenario, if there are delays, any flexibility to preserve the cash runway, any flexibility or levers that you could pull? And then my second question is just on the United Citizens petition.

Jason Gerberi: Hey guys, good morning. Thanks for taking my questions.

Jason Gerberi: So, two for me, just on the cash burn language in the 10-Q, about roughly around a year of cash runway.

Speaker Change: Can you talk about, you know, in the alternative scenario, if there are delays?

Speaker Change: Any flexibility to preserve the cash runway, any flexibility or levers that you could pull. And then my second question is just...

Jason Gerberry: Is there any plan to submit any correspondence clarifying LGM's role as an importer? Or I assume that most of this is going to be handled behind the scenes, if at all. But just curious if there are any plans to submit any response. Thanks.

Speaker Change: on United Citizens petition. Is there any plans to submit any correspondence clarifying LGM's role as an importer? I assume that most of this is going to handle behind the scenes, if at all, but just curious if there's any plans to submit any response. Thanks.

Roger Jeffs: Yeah, great. Thanks, Jason. So, Michael, if you'll address the cash burn question, and Rusty, if you could talk about the citizens petition, please.

Michael Kaseta: Yeah, so Jason, thanks for the question. I mean, I think where we sit now, we are sitting at $133 million in cash. We're very confident in our cash position. You know, we talked about all of our objectives for the rest of this year and going forward with Ascent, with getting L606 initiated, and also supporting the launch of Utrepia. We've always taken pride in having a strong balance sheet.

Michael Kaseta: We feel that we still have that, and we're very confident in our ability to deliver. Now, with that being said, you know, we'll always focus on what's at hand. And, you know, depending on where things stand, we can make decisions. We will be able to do that. But our focus right now really is to deliver on all three of those objectives of getting Utrepia launched, getting the L606 pivotal trial initiated, and continuing the Ascent trial.

Speaker Change: We've always taken pride of having a strong balance sheet. We feel that we still have that, and we're very confident in our ability to deliver. Now, with that being said...

Michael Kaseta: So, you know, when you look at our cash balance, I think our burn from year end to Q1 to Q2, you know, we've always been disciplined in how we invest. We will continue to do that and look forward to, hopefully, a Utrepia launch here in the not-too-distant future.

Speaker Change: and continuing the Ascent trial. So, you know, when you look at our cash balance, I think our burn from, you know, year end to Q1 to Q2, you know, we've always been disciplined in how we invest. We will continue to do that and look forward to, hopefully, a Utropia launch here in the not-too-distant future.

Rusty Schundler: And Jason, thanks for the question on the citizen petition. You know, we do not currently anticipate filing a public response to the citizen petition. Obviously, you know, any issues that, you know, there would be direct communications between us and the FDA, which, you know, as Roger said before, we won't comment on. The other thing I'd point out is that, I mean, even United Therapeutics had to file an amended citizen petition to cure some of the misstatements on the original citizen petition. That will be public, but again, we won't have a public response, or at least we're not anticipating one at this time.

Speaker Change: And Jason, thanks for the question on the citizen's petition. You know, we do not currently anticipate filing a public response to the citizen's petition. Obviously, you know, any issues that, you know, there would be direct communications between us and the FDA.

Jason Gerberi: which, you know, as Roger said before, we won't comment on. The other thing I'd point out is, I mean, even the United Therapeutics had to file an amended citizen's petition to cure some of the misstatements on the original citizen's petition. That is public, but again, we won't have a public response, or at least we're not anticipating one at this time.

Roger Jeffs: Thank you. And this does conclude today's Q&A session. I would now like to turn the call back over to Roger for his closing remarks. Please go ahead.

Jason Gerberi: Thank you. And this does conclude today's Q&A session. I would now like to turn the call back over to Roger for closing remarks. Please go ahead.

Roger Jeffs: Well, again, I want to thank everybody for joining us today. As you have clearly heard, we remain confident in the approvability of PAH and PHLD, and the competitive profile ones. I look forward to updating you. Thank you for joining today's conference call.

Roger: Great. Well, again, I want to thank everybody for joining us today. As you've clearly heard, we remain confident in the approvability of uTREBI in the near term for both PAH and PHLD and the competitive profile once launched. We look forward to updating you in the near future. Thank you.

Jason Adair: No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Financial Results and Corporate Update Conference. My name is Lisa, and I will be your conference operator. Currently, all participants are on a listen-only mode. Following the presentation, we will conduct a questionnaire. Instructions will be provided at that time for you to queue up. I would now like to remind everyone this conference call is being recorded. I will now hand the call over to Jason Adair. Chief Business Officer.

Speaker Change: Instructions will be provided at that time for you to queue up for questions.

Jason Adair: Thank you, Lisa. It's my pleasure to welcome everyone to Liquidia Corporation's second quarter 2024 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 statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements.

Speaker Change: Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Operating Officer and CFO Michael Kaseta,

Jason Adair: These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I would now like to turn the call over to Roger for our prepared remarks, after which he will open the call to your questions. Thank you.

Roger Jeffs: Thank you, Jason. Good morning, everyone. Thank you for joining us today.

Roger Jeffs: While we and patients still anxiously await FDA action on the Utrepia NDA and seek approval for both formulations, PAH, and Pulmonary Hypertension Associated with Interstitial Lung Disease, or PHILD. We remain hopeful that we are close to achieving. As a reminder, the FDA has had no legal impediments since April 1st to take action on the amendment as submitted, seeking approval for both PH and PHL. What I can say today is that we have been in active and constructive communication with the FDA over these past four months, but I will not comment on the specifics of our conversations with you.

Roger Jeffs: To be crystal clear, our medical and commercial teams remain on high alert and ready to launch Utrepia immediately upon approval. Our sales team continues to call on key pH accounts, strengthening relationships and educating them on Liquidia.

Speaker Change: Our sales team continues to call on key PH accounts, strengthening relationships and educating them on Liquidia. And importantly, we are staging commercial product for rapid distribution to specialty pharmacies upon approval.

Roger Jeffs: And importantly, we are staging commercial product for rapid distribution to specialty pharmacies upon approval. Moving to our clinical programs, the Open Label Assent Study of utrepia in PHIL-B patients continues to ramp up in the number of active clinical sites, with parallel increases in patient screening and patient enrollment. We are pleased with the preliminary feedback from physicians, suggesting that patients can readily titrate utrepia to escalating therapeutic levels in these PHLD patients. While the ascent data needs to mature more, our early patient experience today suggests that the benefits of print formulated triposyls, delivered via a low-effort inhaler. Parallel is a very good experience observed in PAH.

Speaker Change: Moving to our clinical programs, the Open Label Assent Study of utrepia in PHIL-B patients continues to ramp up in the number of active clinical sites, with parallel increases in patient screening and patient enrollment.

Roger Jeffs: For example, the median dose would be higher for patients currently enrolled beyond eight weeks in the assent trial. 185.5 micrograms per treatment session, or approximately 21 breadth equivalents of Type A supercession, with a top dose of 318 micrograms, or approximately 36 breath equivalents. These doses are several orders of magnitude beyond the recommended 9 to 12 breath dose targeted type A and exemplify the paradigm-shifting potential of utrepia for PH and PH-IoD patients, especially as it relates to tolerability and potentially durability.

Roger Jeffs: We plan to submit additional clinical data from the Accenture Hour at future medical conferences, and more to come. With respect to our sustained relief glycosomal formulation of inhaled droproxenil L6, Based on the Preliminary Safety Data and Exploratory Efficacy Data from the First 28 Patients, switching from Tyvaso or Tyvaso DPI in our open-label clinical study has been highly encouraged. We continue to observe favorable tolerability and titratability profiles of twice daily dosing of L6O6, likely attributable to the seven-fold lower CMAQ but with a similar systemic exposure over a 24-hour period compared with the four times a day dosing of enthalo-troposinol, all while using a rapid, portable, anti-health breath-actuated nebulizer.

Speaker Change: especially as it relates to tolerability and potentially durability.

Speaker Change: We plan to submit additional clinical data from the Ascent trial at future medical conferences. There's more to come on that.

Speaker Change: With respect to our Sustained Release Glycosomal Formulation of Inhaler Proxenil, L606.

Speaker Change: We continue to observe favorable tolerability and titratability profile of twice daily dosing of L6O6.

Roger Jeffs: The long-term safety data generated from this study helped solicit favorable scientific advice from the European Medicines Agency, or the EMA, last month on our pivotal trial design, which was very consistent with EFDA's feedback from our Type C meeting in December. While we continue to observe these patients in the open labial study, our focus will now shift to our efforts to initiate the registration or global trial in patients with PHILD later this year. At this time, I will turn the call over to Mike to summarize the second quarter.

Speaker Change: While we continue to observe these patients in the open labial study, our focus will now shift to our efforts to initiate the registration on global trial in patients with PHILD later this year.

Speaker Change: At this time, I'll turn the call over to Mike to summarize the second quarter financial results.

Michael Kaseta: Thank you, Roger, and good morning, everyone. I will briefly address our second quarter financial results, found in today's press release. As you will see, revenue is $3.7 million for the second quarter of 2024, compared with $4.8 million in the same quarter of 2023. This revenue is tied to our promotion agreement with Sandoz to commercialize jopropanol injections.

Mike: As you will see, revenue was $3.7 million for the second quarter of 2024.

Mike: Revenue is tied to our promotion agreement with Sandoz to commercialize terpropanol injections.

Mike: Cost of revenue increased to 1.5 million dollars for the second quarter 2024 compared to 0.7 million dollars in the same quarter for 2023, with the increase being primarily due to our Salesforce expansion during the fourth quarter 2023.

Mike: Research and development expenses were $9.4 million in the second quarter of 2024, compared with $17.7 million in 2Q2023, which included a $10 million upfront license fee to Pharmosa for the exclusive license to L606 in North America.

Mike: We saw a $1.4 million decrease in expenses related to our Utrepia program driven by expensing pre-launch inventory costs in the prior year.

Mike: These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personnel expenses related to increased headcount.

Mike: General and administrative expenses were $20 million in the second quarter of 2024 compared to $9.2 million in the same quarter for 2023. The increase of $10.8 million is primarily due to a $6.3 million increase in personnel expenses, which includes stock-based compensation.

Michael Kaseta: The increase of $10.8 million is primarily due to a $6.3 million increase in personnel expenses, which includes stock-based compensation; a $2.2 million increase in commercial and consulting expenses; and a $0.9 million increase in legal fees related to our ongoing Utrepia-related litigation. In summary, we incurred a net loss for the three months ended June 30, 2024, of $27.9 million, or $0.37 per basic and diluted chair, compared to a net loss of $23.5 million, or $0.36 per basic and diluted chair, for the three months ended March 31, 2020. We ended the second quarter of 2024 with $133 million cash on hand and remain well positioned financially to achieve our corporate objectives this year. With that, I'd now like to turn the call back over to Roger.

Mike: a $2.2 million increase in commercial and consulting expenses, and a $0.9 million increase in legal fees related to our ongoing utrepia-related litigation.

Mike: compared to a net loss of $23.5 million, or $0.36 per basic and diluted share, for the three months ended March 31, 2023.

Mike: We ended the second quarter 2024 with $133 million cash on hand and remain well positioned financially to achieve our corporate objectives this year.

Roger Jeffs: Thank you, Mike. As you've just heard, it's been an active summer on several fronts since our last call. We were fully prepared for the potential launch of Utrepio with a team of dedicated professionals who are poised to reshape and grow the market for in-house repositories on Utrepio's approval. The market opportunity for inhaler procedurals is currently at a $1.5 billion run rate, with the potential to grow in excess of $3 billion in the coming years.

Speaker Change: Thank you, Mike. As you've just heard, it's been an active summer on several fronts since our last call.

Speaker Change: We are fully prepared for the potential launch of Utrepio with a team of dedicated professionals who are poised to reshape and grow the market for in-house repository on Utrepio's approval.

Roger Jeffs: This market remains keen for a competitive alternative, especially one with the dosing and tolerability advantages that Utrepia can potentially provide once approved. With that, I would now like to open the call to questions. Operator, first question, please.

Speaker Change: especially one with the dosing and tolerability advantages.

Speaker Change: You'll then hear an automated message to advise that your hand is raised. We also ask that you wait for your name and company to be announced before proceeding with your question.

Speaker Change: Hi, good morning. Thank you for taking my questions and congrats on the recent progress. I'm wondering if we could briefly review why higher inhaled troposomal exposure should be beneficial both in PAH and PHILD.

Roger Jeffs: Yeah, Julian, thanks very much for the question. I'll start, and then I'll ask Rajeev to add some additional color.

Speaker Change: Yeah Julian, thanks very much for the question. So I'll start and then I'll ask Rajeev to add some additional color.

Roger Jeffs: So what we know historically from the use of prostacyclines is that, and one of the beauties of prostacyclines in particular, is the ability to continually titrate to effect over time because, unfortunately, these patients have an advancing disease that continues without relent. So the only way, the only therapeutic class that can address this progressive disease and remain a sort of ability to tweak our prostacyclin. So if you look at troprosinol in its various forms, parenteral, oral, and inhaled, you can see that the ability to titrate is a hallmark of the therapy.

Rajeev: So what we know historically from the use of prostacyclines, and one of the beauties of prostacyclines in particular, is the ability to continually titrate.

Speaker Change: sort of an ability to tweak our prostacyclin. So if you look at troprosinol in its various forms, parenteral, oral, inhaled, you can see that the ability to titrate is a hallmark of the therapy.

Roger Jeffs: But what had been limiting prior to Utrepia, in particular, as you see with tybaso, is the inability to titrate above a fairly low therapeutic ceiling. So what Utrepia has done, and this is why I say it's paradigm-shifting, is it gives you all the benefits of parenteral and oral products, but gives it directly to the site of action to limit the systemic side effects. So you now have a highly flexible therapy with high utility that can really be, goes to effect, also while minimizing fat.

Speaker Change: fairly low therapeutic ceiling.

Speaker Change: of the parenteral and oral products.

Roger Jeffs: So I think, you know, this is why we're so excited about Utrebia. We think it brings a difference, some utility to the marketplace in terms of Trapasno use, and we think this therapeutic profile will lead it to become both best-in-class and first-in-choice when considering starting the process cycle, be it parenteral, oral, or intracranial. Rajeev, I don't know if you have any additional comments.

Speaker Change: We learned a lot from the increased study in PHLD. I think in that study, the data highlighted that patients that achieve more than at least nine breaths, and especially as you get to higher doses, those patients

Speaker Change: Also, I think, you know, this is a very heterogeneous group of patients, both in PAH and PHLD, with various degrees of severity. And in many of these patients, the disease, as Roger highlighted, is progressive.

Roger Jeffs: Thank you, Rusty. Thank you for the question.

Julian Harrison: Great, and one more if I may. I was just curious if you have a good sense for when we might expect a comprehensive data disclosure from the ASCENT trial and can we maybe get you know what the key unanswered questions are that you plan to address with that trial?

Speaker Change: All right, thank you.

Roger Jeffs: Yeah, maybe Rajeev, if you could comment on that.

Rajeev Saggar: Yeah, Julian. So, you know, again, just to remind everyone, Ascent is a study studying the safety and tolerability, and the secondary outcomes would be exploratory efficacy of utrepia in patients with PHLD who have not been treated, that patients have to enroll with baseline right heart catheterization. The study is actually for 24 months, and then we follow the patient out to one year. So what is very important here in this study is that what we're looking for is to maintain the patients on the optimal dose of utrepia and also to show durability, because what we do know is that after 16 weeks of increased study, many of these patients start to have a significant amount of instability, so we wanted to show patients definitely have durability.

Speaker Change: Yeah, Julian. So, you know, again, just to remind everyone, you know, Ascent is a, is a, uh,

Julian Harrison: is a study studying the safety and tolerability and the secondary outcomes would be.

Speaker Change: Exploratory Efficacy of Utropia in Patients with PHLD who have not been treated, that patients have to enroll with a baseline right heart catheterization. The study is actually for 24 months.

Speaker Change: and then we follow the patient out to one year. So what is very important here in this study is that what we're looking for is to maintain the patients on a...

Rajeev Saggar: Our focus really coming out, you know, the next set of Congresses that are approaching here is really to highlight some of this exploratory clinical efficacy data. We are following clinical variables such as, you know, walk distance in terms of a six minute walk. We're also looking at various forms of questionnaires.

Speaker Change: clinical efficacy data. We are following clinical variables such as, you know, walk distance in terms of six-minute walk. We're also looking at various forms of questionnaires.

Rajeev Saggar: And finally, we're also looking at effects on the lung parenchyma and the lung vasculature by using CT chest imaging, really to highlight exactly where the effect is, particularly on the pulmonary vasculature, with the use of utrepia. I just want to highlight, as Roger said, that at least right now, the median dose for those patients now past the eight-week mark is now 185.5 micrograms of This is just to highlight that if you compare this to our Sentinel-INSPIRE study in PAH, by two years, patients were on, and about a third of the patients were on 159 micrograms.

Speaker Change: And finally, we're also looking at effects on the lung parenchyma and the lung vasculature by using...

Roger Jeffs: CT chest imaging, really to highlight really where the effect is, particularly on the pulmonary vasculature with the use of utrepia. I just want to highlight, as Roger said.

Rajeev Saggar: So, what we're seeing here is that providers and patients, in particular, are able to tolerate utrepia, and there's also, just to go back to our last question, a very clear understanding by providers that the higher the dose, the potential benefit of the patient, and I think we look forward to highlighting some of these clinical parameters in the very near future.

Roger Jeffs: So, what we're seeing here is that providers and patients, in particular, are able to tolerate utrepia and there's also, just to go back to our last question, a very clear understanding by providers that dose...

Speaker Change: The higher the dose, the potential, the benefit of the patient, and I think we look forward to highlighting some of these clinical parameters in the very near future.

Roger Jeffs: Thanks, Rajeev. So, Julian, as you can hear, a very robust study. We're trying to complete it by year end to specifically answer your question. We'll look to publish that in 2025. Operator.

Operator: Welcome. Thank you. Thank you. And our next question will be coming from Serge Belanger of Needham. Your line is open.

Serge Belanger: Good morning. Thanks for taking my question. I have a couple legal ones.

Serge Belanger: First one on the UT case against FDA. I believe in the motion for dismissal, both the agency and Liquidia completed their briefs, so just curious if you have any visibility on timelines for the next steps here, whether we'll get a hearing or Judge Bates will rule on the brief, and related to this case. How closely is the FDA following this missile motion? Could that be a gating factor for them rendering a decision? and the Utopia MBA. Great search. Thanks for the question.

Speaker Change: I believe in the motion for dismissal, both the agency...

Rusty Schundler: Thanks for the question, Rusty. Yes, sir.

Speaker Change: and the Utripia MBA.

Rusty Schundler: Taking your first question first, on the motion to dismiss, the next steps, you know, we don't know yet. The court could hear an oral argument, or it could rule on the briefs.

Speaker Change: Thanks for the question. So on the.

Speaker Change: I'll take your first question first. On the motion to dismiss Next Steps, we don't know yet. The court couldn't have an oral argument.

Roger Jeffs: And I think, as Roger said in his opening remarks, I think we want to be careful, you know, not to comment on our communications with the FDA. So, you know, obviously once the FDA has taken definitive action, obviously we will announce that. But in the meantime, you know, we're not going to comment on our communications with the FDA.

Rusty Schundler: Thank you for the question, Serge.

Operator: Thank you, and one moment for the next question. Our next question will be coming from... Kambiz? Yazda of Jeffrey's, your line is open.

Speaker Change: Thank you for the question, Serge.

Kambiz Yazda: Morning, team. For the registrational study for L606, can you remind us the key features of that study design and when is that slated to start? And then maybe just a few finer points on the stent study. How many more sites have you onboarded since the last update? And how many patients so far have you treated in the stent study? Thank you.

Speaker Change: Morning team. For the registrational study for L606, can you remind us the key features?

Speaker Change: And then maybe just a few finer points on the stent study. How many more sites have you onboarded since the last update? And how many patients so far have you treated in the stent study? Thank you. Questions. Rajeev, both of those are in your court.

Rajeev Saggar: Questions. Rajeev, both of those are in your quarterly.

Rajeev Saggar: Yeah, hi Kambiz. Regarding the global, single placebo-controlled efficacy study with L606 specifically in patients with palmar hypertension associated with interstitial lung disease. We plan to initiate that study by the end of the year. I think we're working feverishly to do all the necessary steps to make sure that our protocols are properly submitted and viewed by agencies, as Roger highlighted. We've had favorable feedback from both the Type C meeting with FDA and also from scientific advice from the European Medicines Agency.

Rajeev: Yeah. Hi, Kambiz. So, you know, regarding the global...

Rajeev Saggar: So I think we remain pretty confident in our plans. We've already highlighted that the primary endpoint in this study is going to be 6-minute walk distance, with a whole host of secondary efficacy endpoints that I think would be important to support our target profile. I think we're extremely confident based on the safety data that's emerging from the open label study in the United States, again, just highlighting the liposomal Technology on top of the triprosanol has really shown to minimize cough and really support dosing and titratability of this drug, I think, which is going to be a game changer, along with a reduced frequency to twice a day.

Speaker Change: is going to be 6-minute walk distance with a whole host of secondary FCM points that I think would be important.

Speaker Change: cough, and really support dosing and titratability of this drug, I think which is going to be a game changer, along with a reduced frequency to twice a day.

Rajeev Saggar: So we remain very, very excited about the feedback that KOLs throughout the global market have been showing for support of the study. There's an extremely significant amount of unmet need, I think, definitely outside the US in addition to the US in that regard. In terms of ascending, we're close to about tripling the number of sites by the end of this month. And we remain quite confident of completing the study by the end of the year. We anticipate having close to about 15 patients by the end of this month.

Speaker Change: So we remain very very excited about about the feedback that KOLs

Speaker Change: throughout the global

Speaker Change: market has been showing for for support of the study.

Speaker Change: completing the study by the end of the year. We anticipate to have close to about 15 patients.

Rajeev Saggar: Just to highlight that the majority of the sites that have just recently been initiated have come on over the past 45 days, and we anticipate the remainder of sites to come on within the next 30 to 60 days as well. By that time, I think we'll have, we'll be on full ramp to support the rest of the sites.

Speaker Change: by the end of this month. Just to highlight that the majority of the sites that have been...

Speaker Change: just recently initiated, have come on over the past 45 days.

Speaker Change: and we anticipate the remainder of sites to come on within the next 30 to 60 days as well. Then, by that time, I think we'll be on full ramp to support the rest of the study.

Roger Jeffs: Thank you, Rajeev. Thanks for your questions, Kambiz.

Speaker Change: Great, thank you Rajeev. Thanks for your questions Kambiz. As you can see...

Operator: As you can see, really positive data flow from both the L606 open-label study and the assent trial. You know, we're obviously very excited to get into the registrational study with L606 and PHIV patients, as Rajeev said. And I think the fact now that we're seeing the ability to titrate as easily as we are and as quickly as we are, as well as to see the durability of a two-time-a-day format, you know, that's an exciting phase three program with a very positive Predictive Future. Same for the offense trial, I think, when you see this rapid ability to dose these patients. So thanks for the question, Kambiz. Next question, please.

Speaker Change: And I think that's a really positive data flow from both the L606 open-label study and the assent trial. We're obviously very excited to get into the registrational study with L606 and PHI-LD patients, as Rajeev said. And I think the fact now that we're seeing the ability to titrate...

Speaker Change: As easily as we are and as quickly as we are, as well as to see the durability of the two-times-a-day format, you know, that's an exciting phase three program with a very...

Speaker Change: Same for the assent trial, I think when you see this rapid ability to dose these patients.

Speaker Change: Quite differentiating, and I think, you know, something that the market will lean on once we get to market.

Speaker Change: Thanks for the question, Kambiz. Next question, please. Thank you.

Speaker Change: And one moment for the next question.

Speaker Change: Our next question will be coming from the line of Matt Kaplan of Leidenberg.

Matthew Kaplan: And one moment for the next question. Our next question will be coming from the line of Matt Kaplan from Leidenberg. Fowlman, your line is open.

Roger Jeffs: Hi, good morning guys. Thanks for taking the question. I guess, you know, since we're past the kind of legal impediments for FDA approval, I guess with your interaction with the FDA, has the FDA identified any material differences which would prevent approval and would, I guess, necessitate a CRL? Amen. Roger.

Matt Kaplan: Hi. Good morning, guys. Thanks for taking the question.

Matt Kaplan: I guess, you know, since we're past the...

Speaker Change: kind of legal impediments for FDA approval.

Matt Kaplan: I guess with your interaction with the FDA, has the FDA identified any material differences which would prevent approval and would I guess necessitate a CRL?

Roger Jeffs: Hey Matt, this is Roger. Thanks for the question. So, you know, as I said in the intro, we're really not going to comment on specific discussions with the FDA.

Speaker Change: I think one way to look at this is, yes, we are past.

Roger Jeffs: The time when there was no legal impediment for approval being April 1st.

Speaker Change: Four months past that, and while that's frustrating, I think if you want to put a positive spin on that, it's four months is in the rear view mirror, so it's been four months to work to a solution. So, we think we're that much closer to a decision and an action, and we won't come in on.

Roger Jeffs: So we think we're that much closer to a decision and action, and we won't come in on direct communications with that, but we remain optimistic that we've had constructive discussions with the agency, and we remain highly focused on approval for both indications. So that's as we submitted it, we feel it was appropriate as amended, and we are seeking approval for both PAH and PHILD. We haven't backed away from that position, and that remains our focus. So apologies that I can't get specifics, but hopefully we'll have an action soon and we can talk about that in great detail with you. Operator.

Speaker Change: to direct communications with that, but we remain optimistic that we've had constructive discussions with the agency.

Speaker Change: And we remain highly focused on approval for both indications. So that's as we submitted it, we feel it was appropriate as amended. And we are seeking approval for both PAH and PHILD. We haven't backed away from that position and that remains our focus.

Speaker Change: So apologies that I can't get specifics but hopefully we'll have an action soon and we can talk about that in great detail with you.

Operator: and one moment for the next. Our next question will be coming from the line of Jason Gerberry of Bank of America. Your line is open.

Speaker Change: Operator, next question.

Speaker Change: Thank you, and one moment for the next question.

Speaker Change: Our next question will be coming from the line of Jason Gerberry of Bank of America, your line is open.

Jason Gerberry: Hey guys, good morning. Thanks for taking my questions.

Jason Gerberi: Hey guys, good morning. Thanks for taking my questions.

Jason Gerberi: So, two for me, just on the cash burn language in the 10-Q, about roughly around a year of cash runway.

Speaker Change: I assume that that assumes an approval and launch cost.

Speaker Change: Can you talk about, you know, in the alternative scenario, if there are delays?

Roger Jeffs: Yeah, great. Thanks, Jason. So, Mike, if you'll address the cash burn question, and Rusty, if you could talk about the citizen's petition.

Speaker Change: Yeah, great. Thanks, Jason. So, Mike, if you'll address the cash burn question, and Rusty, if you could talk to the system.

Michael Kaseta: Yeah, so Jason, thanks for the question. I mean, I think where we sit now, we are sitting at $133 million in cash. We're very confident in our cash position. You know, we talked about all of our objectives for the rest of this year and going forward with Ascent, with getting L6 and 6 initiated, and also supporting the launch of Utrepia. We've always taken pride in having a strong balance sheet.

Speaker Change: Set at this petition, please.

Speaker Change: and also supporting a launch of Utrapia.

Speaker Change: We've always taken pride of having a strong balance sheet. We feel that we still have that, and we're very confident in our ability to deliver. Now with that being said...

Speaker Change: We'll always focus on what's at hand, and depending on where things stand, we can make decisions. We will be able to do that, but our focus right now really is to deliver on all three of those objectives of getting Utrepia launched.

Speaker Change: getting L606 pivotal trial initiated.

Michael Kaseta: So, you know, when you look at our cash balance, I think our burn from, you know, year end to Q1 to Q2, you know, we've always been disciplined in how we invest. We will continue to do that, and look forward to, hopefully, a Utrepia launch here in the not-too-distant future.

Speaker Change: And Jason, thanks for the question on the citizens petition. You know, we do not currently anticipate filing a public response to the citizens petition. Obviously, you know, any issues that, you know, there would be direct communications between us and the FDA.

Roger Jeffs: Thank you. And this does conclude today's Q&A session. I would now like to turn the call back over to Roger for his closing remarks. Please go ahead.

Speaker Change: Thank you. And this does conclude today's Q&A session. I would now like to turn the call back over to Roger for closing remarks. Please go ahead.

Roger Jeffs: Great. Well, again, I want to thank everybody for joining us today. As you've clearly heard, we remain confident in the approvability of uTREBI in the near term for both PAH and PHLD and the competitive profile once launched. We look forward to updating you in the near future. Thank you.

Operator: Thank you for joining today's conference call. You may disconnect.

Roger Jeffs: Thank you for joining today's conference call. You may disconnect.

Q2 2024 Liquidia Corp Earnings Call

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