Q3 2024 Liquidia Corp Earnings Call

November 13, 2024

Michelle: Good morning and welcome everyone to Liquidia Corporation's third quarter 2024 financial results on corporate MD conference call. My name is Michelle and I will be your conference operator today.

Michelle: Currently, all participants are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this conference call is being recorded. I would now like to hand the conference over to Jason Adair, Chief Business Officer. Please go ahead.

Thank you.

[inaudible]

Mr. Adair, you can go ahead.

Thank you.

Mr. Adair: Thank you, Michelle. It's my pleasure to welcome everybody today to the Liquidia Corporation Third Quarter 2024 Financial Results and Corporate Update Call.

Mr. Adair: 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 Lumaw, and General Counsel Rusty Schundler.

Mr. Adair: 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.

Mr. 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.

Speaker Change: 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'd now like to turn the call over to Roger for a prepared remark, after which he will open the call for your questions.

Roger Jeffs: Good morning everyone. We're pleased to be speaking with you today.

Roger Jeffs: With the significant progress made over the last few months, we now have a clear line of sight to seeking final approval of utrepia for both PAH and PHILD patients.

Roger Jeffs: Final approval can occur following the expiration of Tyvasive DPI's clinical exclusivity on May 23rd, 2025 or in just six months time.

Roger Jeffs: Critical wins that underpinned this significant milestone included the following. First, the FDA confirmed that the amended NDA to add PHLD to the tentatively approved label for utrepia was proper.

Roger Jeffs: And therefore, I have to determine that we have met the regulatory requirements for approval for PAH and PHIL-D pending the expiration of Tyvaso DPI's clinical exclusivity.

Roger Jeffs: And second, with the Supreme Court's decision in September to deny cert, the legal process with respect to the three patents originally asserted against us has been fully exhausted and these three patents no longer provide any impediment to the commercialization of e-Travis.

Thank you for watching.

Roger Jeffs: As mentioned, the sole item cited by the FDA that is blocking final approval of utrepia is the new clinical investigation exclusivity that was granted to Tyvase and DPI, which will expire in May of 2025, or earlier if we are successful in our lawsuit against the FDA.

Roger Jeffs: Rusty will speak more specifically about this lawsuit in a minute.

Roger Jeffs: On the clinical front, we remain active and productive in advancing our clinical programs that we have developed to prospectively demonstrate the differentiated value of utrebia in THILD patients, as well as advancing our next generation sustained release program, L606.

Roger Jeffs: We feel the combination of utrepia and L606 gives us a compelling portfolio of treatment options for the delivery of inhaled traprosanol to treat PAH and PHILD patients both now and in the future.

Roger Jeffs: On a related business front, in this quarter we have expanded our relationship with PhRMASA with respect to L606.

Roger Jeffs: amending our license agreement to include the EU and other territories outside of North America.

Roger Jeffs: We have also entered into a device license agreement with Pharmos to secure rights to proprietary, next-generation nebulizers for administration of L606 in a small, portable, breath-actuated nebulizer the size of an iPhone.

Speaker Change: Rajeev will speak to the clinical progress of both programs and share excitement that is building within the community based on our prospective studies.

And finally, we have also strengthened our balance sheet.

having closed several simultaneous finances in September.

Speaker Change: Michael will offer more insight on our balance sheet later in the call. But there is no doubt in my mind that we have the team, capital, the products, the vision, and especially the determination to change the treatment landscape for pulmonary hypertension patients in the near and long term. With that, I will ask Rusty to share some more details.

Rusty Schundler: Thank you, Roger. As Roger briefly mentioned, in August we filed a lawsuit challenging the FDA's decision to grant new clinical investigation exclusivity to Tybaso DPI, which has delayed the final approval of utrepia.

Rusty Schundler: This is not a decision we took lightly, and I note that we did not previously challenge the FDA's prior award of new clinical investigation exclusivity to nebulized Tybaso and PHILD that was based on the INCREASE trial, which studied safety and efficacy of nebulized Tybaso in PHILD patients.

Rusty Schundler: Unlike the INCREASE trial, we do not believe the BREEZE study, the clinical trial upon which this new clinical exclusivity was based, is the type of clinical trial

Rusty Schundler: for which exclusivity can be granted. This belief is bolstered by the FDA's own initial decision not to grant any exclusivities to Tybasa BPI when it was first approved in 2022.

Rusty Schundler: For this reason, we continue to believe that the FDA's decision should be vacated and liquidity should be allowed to bring entropy to market for the benefit of patients immediately.

Rusty Schundler: We and the FDA have agreed to an expedited briefing schedule in anticipation of a hearing on our respective motions for summary judgment on December 5th, 2024. And regardless of the outcome of the lawsuit, though, nothing can delay the scheduled expiration of the exclusivity for Tybaso DPI on May 23rd, 2025.

Rusty Schundler: As part of our lawsuit against the FDA, United Therapeutics has filed cross-claims challenging again the appropriateness of the amendment to add PHLV to the utrepia label.

Rusty Schundler: These are essentially the exact same claims that were previously brought and then voluntarily dismissed by United Therapeutics in the lawsuit they initiated against the FDA back in February.

Speaker Change: We continue to believe that these cross-claims have no merit and that Laquitia properly amended the NDA for UTREPIA to add PHLD, a position that the FDA agreed with when they issued tentative approval for UTREPIA in both indications in August.

Speaker Change: Finally, as noted by Roger, we have now successfully concluded the litigation regarding the three patents that were initially asserted against us by United Therapeutics.

Speaker Change: Those decisions, that we do not infringe any valid claims of any of the three patents, are now not subject to any further appeals and are final. This leaves just the 327 patent as the sole patent that United Therapeutics is continuing to assert against Liquidia.

Speaker Change: The 327 patent generally covers the treatment of PHL-B patients with Tyvaso in accordance with the dosing regimen in the Tyvaso label.

Speaker Change: As we have noted previously, there is considerable prior art that teaches the treatment of PHLV patients with Tybaso.

Speaker Change: including the 793 patent and multiple peer-reviewed publications in the decade prior to the priority date for the 327 patent that described positive results from treating PHLD patients with Tyvaso.

Speaker Change: Also, as previously disclosed, United Therapeutics sought a preliminary injunction to block the launch of utrepia for the treatment of PHLD patients based on the 3T7 patent and is denied by the court.

Speaker Change: Trial is now scheduled for June of 2025 and we look forward to resolving the validity of the 327 patent at that time.

Speaker Change: With that, I'd like to turn the call over to Rajeev to summarize the clinical progress to date.

Thanks, Rusty.

Rajeev Saggar: I'm excited to report on the continued positive momentum in Liquidia's clinical programs with utrepia and L606.

Rajeev Saggar: First, let me provide an update on the open-label ASCENT study, which is evaluating the safety, tolerability, and efficacy of utrepia in patients with PHILD.

Rajeev Saggar: We have now doubled the number of clinical sites during the past quarter, with 21 of the 22 planned sites now active.

Rajeev Saggar: To date, we have enrolled over a third of the patients, which keeps us firmly in track to complete enrollment in the first quarter of 2025.

Rajeev Saggar: The preliminary data emerging from the SENS study in PHILD patients

Rajeev Saggar: is highly encouraging in regards to tolerability and titratability. And it is generally consistent with the observations from our pivotable Phase III-inspired study in PAH patients.

Rajeev Saggar: as anticipated with our print formulation coupled with our low-effort dry powder inhaler.

Rajeev Saggar: Patients who have completed eight weeks of treatment have been able to tolerate antitrate utropia to an average dose of 132.5 micrograms with almost one quarter of the patients reaching 159 micrograms four times a day by week eight.

Rajeev Saggar: This dosing observed in the SENT study through week 8 is up to 2 times higher than the comparable doses administered in both the increased study with nebulized Tybaso at 16 weeks and what is typically used in clinical practice.

Rajeev Saggar: While still early, we remain very encouraged by the positive trends noted in the key efficacy endpoints.

including change in six-minute walk distance and patient reported outcomes.

Rajeev Saggar: After week 8, patients have continued to titrate higher and we look forward to reporting the full data set from the study when it completes next year.

Rajeev Saggar: Now, turning our attention to L606, our sustained-release liposomal triprosonal suspension formulation delivered twice daily, we are now solely focused on initiating our placebo-controlled global Phase III study in PHLD called RESPIRE.

Rajeev Saggar: Given the favorable safety and tolerability data observed to date in the open label US trial in PAH and PHLD patients, we have decided to stop enrollment in this very study with a total of 28 patients enrolled.

Rajeev Saggar: L606 continues to be well-tolerated, with some patients reaching our maximum dose of 378 micrograms twice daily, which is approximately three times higher than comparable doses of Tybaso administered in the increased study.

Speaker Change: As Roger mentioned, we have also secured rights to a more streamlined, rechargeable, handheld breath-actuated nebulizer that is capable of delivering doses of L606 in inhalation sessions of less than one to two minutes.

Speaker Change: We've decided to use this new device in our Pivotable Study, which will push initiation into the first half of 2025. More details on the Pivotable Study design and the device will be shared in the near future.

Speaker Change: I would now like to pass the call to Mike Kaseta to review the financial performance from the third quarter. Mike?

I'm

Thank you, Rajeev, and good morning, everyone.

Speaker Change: I'm pleased to say that Liquidia is well prepared to launch its first product, Utrepia, in 2025, as soon as we receive final FDA approval.

Speaker Change: To further support our preparedness, we added even more strength to the balance sheet in the third quarter by executing Simultaneously on three transactions that brought approximately 100 million dollars into the company as announced in September

Speaker Change: We ended the third quarter of 2024 with $204.4 million cash on hand and remain well positioned to achieve our corporate objectives culminating in our potential launch of Utrepia.

Speaker Change: I will now briefly address our third quarter financial results found in today's press release.

First, revenue was $4.4 million for the third quarter 2024.

Speaker Change: compared with 3.7 million dollars in the same quarter 2023. Revenue related primarily to our promotion agreement with Sandos to commercialize traprosanol injection.

Speaker Change: The increase of $0.7 million was primarily due to the impact of higher sales quantities in the current year as compared to the same period in the prior year.

Speaker Change: Cost of revenue remained consistent at 1.7 million dollars for the third quarter 2024 compared to 0.6 million dollars in the same quarter for 2023.

Cost of revenue related to the promotion agreement mentioned earlier.

Speaker Change: The increase from the prior year is primarily due to our Salesforce expansion during the fourth quarter of 2023.

Speaker Change: Research and Development Expenses were $11.9 million in the third quarter of 2024, compared with $7.4 million in the same quarter for 2023.

Speaker Change: The increase of $4.5 million, or 60%, was primarily due to a $2.1 million increase in personnel expenses, including stock-based compensation, related to increased headcount, a $1.3 million increase.

Speaker Change: in clinical expenses related to our L606 program and a $2.5 million increase in expenses related to UTREPIA research and development activities, including the ASCENT trial.

Speaker Change: offset by 1.5 million dollars lower commercial manufacturing expenses reflecting the impact of expensing utopia inventory costs in the prior year

Speaker Change: Moving on to general and administrative expenses, there were 20.2 million dollars in the third quarter 2024 compared to 10.6 million dollars in the same quarter for 2023.

Speaker Change: The increase of $9.6 million, or 91%, was primarily due to a $6.7 million increase in personnel expenses, including stock-based compensation, driven by a higher headcount and expansion of our sales force in the fourth quarter of 2023.

Speaker Change: a $1.5 million increase in legal fees relating to our ongoing utrepia-related litigation and a $0.5 million increase in commercial expenses in preparation for potential commercialization of utrepia.

Speaker Change: In summary, we incurred a net loss for the three months ended September 30, 2024 of $23.2 million, or $0.30 per basic and diluted share, compared to a net loss of $15.8 million, or $0.24 per basic and diluted share, for the three months ended September 30, 2023.

Speaker Change: With that, I'd like to now like to turn the call back over to Roger. Roger?

Roger Jeffs: Thank you, Mike, and thank you, Rusty and Rajeev, for also sharing those insights.

Speaker Change: Operator, I would like to now open the call for questions, please. Thank you. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. We ask that you please limit yourself to one question. One moment while we compile our Q&A roster.

Speaker Change: Our first question is going to come from Julian Harrison with VTIG. Your line is open, please go ahead.

Speaker Change: Hi, good morning and thank you for taking my questions. First, regarding the summary judgment hearing in December, I'm wondering if you have a good sense for how soon a decision could be delivered from there and can you maybe talk about the range of outcomes you're contemplating right now from that hearing?

Speaker Change: Good morning, Julian. Nice to hear from you. Rusty, if you could find on that, please.

Rusty Schundler: Sure, Julian, thanks for the question. So as far as timing for a response,

Rusty Schundler: Typical with any proceedings of the judge, it's hard to predict in advance. There's no set timeline or deadline for judges to rule, and so it's really hard to give any guidance on that point.

Rusty Schundler: As far as the range of outcomes, you know, they're the typical range of outcomes for any Administrative Procedures Act proceeding.

Rusty Schundler: You know, obviously the judge could uphold the decision, the judge could just outright overrule the decision, or the judge could remand back to the FDA for further consideration. You know, there are all sorts of iterations even within those, but those are the main three pathways.

Speaker Change: The next episode of The End of the World War II

Speaker Change: Okay, great. Thank you. That's very helpful. And then quickly on the assent trial, great to hear enrollment completion is expected in first quarter next year. I'm sorry if I missed it, but wondering what your expectation for data disclosure is from there. Do you maybe plan to disclose the data at a conference? Any color on the timing to date, it would be great.

Speaker Change: Thanks again for the question. Rajeev, if you could comment on the timing of the data disclosure.

Rajeev Saggar: Yeah, thanks Julian. Good to hear from you. So, you know, we, we, we, as you know, this is an open label study. We continue to look at the data sets and, and every, with, with certain amount of frequency, we will submit the data to various Congresses coming up. So we have submitted a set of data to a Congress, and it's accepted.

Rajeev Saggar: that we anticipate showcasing that data in the first half of 2025.

Excellent, thank you again.

Speaker Change: Thanks for that, Rajeev. And the thing I would add to that, Julian, is that I think you're going to see some, you know, some critically important information that differentiates the value.

Speaker Change: of Utropia, particularly as it relates to doves, the ability to quickly get to those.

Speaker Change: the impact of driving that dose in terms of clinical outcomes, and then also we'll, you know, we'll disclose data on the persistence and durability of treatment within that patient subset. So I think...

Speaker Change: You know, we can show tolerability, titratability, and durability all through the patient-friendly low-resistance device, which we think will lead to greater persistence.

Speaker Change: then I think that is a differentiated data set, particularly when you look at some of the data sets that have been put out there for the competitive molecule type SDPI to this point.

Thank you. Next question, please. Thank you. One moment.

Speaker Change: Our next question is going to come from the line of Jason Kerberry with V of A. Your line is open. Please go ahead.

Hey, morning guys.

Speaker Change: A couple from me, just as you think about a utrepia launch, just wondering if you

if we should be thinking about any points of friction.

Speaker Change: on the coverage access side as you launch that product or your confidence level that you'll have parity access pretty early in the launch period. Any color you can provide there would be helpful. And then on the L606 update in terms of the plan to go direct to Pivotal and ILD,

Speaker Change: Next year, if I got that right, the design's not formalized, but should we generally think about increases providing a good framework for a type of study that you'd be running? Thanks.

Speaker Change: Great, so I think for the first question, in terms of coverage access, I'll ask Mike to answer that one, and on the second question, Rajeev can speak to the L606 fiscal plan and timing.

Speaker Change: Yeah, Jason, Jason, thanks for the question. You know, relating to access, you know, we've been prepared to launch Utrepia since we received tentative approval in 2021. We've been engaging with payers to talk about the value proposition that Utrepia brings.

Speaker Change: As a result of those conversations, I think we feel confident that access is obviously our goal and something that we're confident that we're going to be able to obtain.

Speaker Change: But as we get closer to our launch, we'll continue to have those conversations, but we are working towards having access as close to launch as possible.

Speaker Change: Great, thanks Mike. So, Rajeev, maybe you can speak to how similar our design is to the INCREASE study.

Rajeev Saggar: and then kind of what we're thinking about in terms of sample size and time.

Rajeev Saggar: Again, as I stated in the prepared remarks, I think the key here is that the open label study for L606 really gave us the confidence about our safety and tolerability in our dosing profile, I think to twice a day.

format for L606 is quite game-changing here.

Rajeev Saggar: in terms of the patients, in terms of compliance and performance. The next step is really to...

Rajeev Saggar: ensure that the nebulizer is the right one for the patient. I think the nebulizer that we have chosen

Rajeev Saggar: absolutely will ensure that the key motif for any nebulizer is drug deposition.

Rajeev Saggar: the replicable study is important to note. I think, you know, understanding that these patients can improve.

Rajeev Saggar: Six-minute walk distance within certain time periods is going to be critical. So I think we use that as a rough estimate

Rajeev Saggar: In terms of the sample size overall, I think we've said, you know, the sample size is going to be somewhere between 300 to 400 patients. Again, this is a global study. This will be enrolled in multiple countries to ensure that we can...

achieve success overall in an appropriate time frame.

Speaker Change: Right and the only thing I'd add to that Jason is that you know with L606 because the Cmax is reduced by 7x or retaining the AUC over 24 hours

Jason: that should further diminish the off-target effects in the upper airway, cough and throat irritation in particular, which then means we should be able to titrate to higher doses, which should lead to higher benefit. So...

Jason: We're going to power around the same assumptions used in Greece, but my expectation is we'll have a better outcome than that study if all of this holds true.

Thank you. Operator, next question, please.

Greg Harrison: Our next question is going to come from the line of Greg Harrison with Scotia Bank. Your line is open, please go ahead.

Greg Harrison: Hey, good morning. Thanks for taking the question. It looks like the Utrecht launch is pretty well set and preparations are ready, so I wanted to ask about L606.

Greg Harrison: Can you help us frame expectations for timelines for development overall, enrollment, just given the global nature and what you can do to expedite this, and then how you view the opportunity for this asset, especially with respect to XUS?

Yes, I'll take that one.

Speaker Change: You know, I think it's always hard to talk about timing when we haven't started, Greg. So I want to be a little bit cautious here and not sort of predict things too early, but as Rajeev said in his opening comments, we plan to start the trial, initiate the trial in the first half of 2025.

Speaker Change: It's our expectation that we can enroll the trial in say 18 to 24 months and then it would take six months to run them through the study, the last patient through.

Speaker Change: three months to assimilate the data, file it, and then you have your typical 10-month review. So if you just put all that together just in sort of

Speaker Change: And in a generalized sense, you're talking from start to finish four years. I think we can beat that. And the reason I say that is we're going to do this. Most of the enrollment will come from ex-U.S. territories where TYVASO and TYVASO-DTI are not available, i.e. in the EU.

China.

Speaker Change: South America, Australia, etc. So it's a massive effort, certainly, and I think our development team's up for the challenge. We're well positioned in terms of logistics to get it done.

Speaker Change: We certainly have a lot of experience, management experience in doing these types of trials, for sure.

Speaker Change: So I'm confident that once we start, we'll get the goal. The reason I think we could potentially beat the timeline is because of the massive unmet need for these patients with PHILD.

Speaker Change: And as we maybe didn't say on this call, but have said before, this study will serve for approval in the U.S. for both PAH and PHILD. That's the agreement we have with the FDA.

Speaker Change: and with the EMA we'll work out if additional studies are required but our goal is to become a global brand provider of L606 to patients and that's why we expanded the license with Pharmoso, you know, very pleased with that partnership.

Speaker Change: What the expansion also came with, as we said, was the acquisition of rights to their next-generation nebulizers. These are very different than the current nebulizer, if you think about it.

The Taivetso Nebulizer was in development 20 years ago.

So it's a dated nebulizer that's bulky and cumbersome.

Speaker Change: This is a nebulizer the size of an iPhone, portable, breath-actuated, and as we, as PhRMOSA has shown in testing, very reliable in terms of its delivery kinetics and ability to deliver the exact and precise amount of drugs that we need to deliver to these.

Speaker Change: these patients, and we can titrate the dose through different times.

Speaker Change: solution strengths quite easily. So everything's setting up well, we just have to get the the final compatibility work done with this this new device. That was some of the delay that we have now. If you would ask why aren't you starting now, we have to just...

Speaker Change: close up shop in terms of doing compatibility work with the new device. That works going spectacularly well, but then we have to put the dossier together and file that to convince the FDA that we have the right device for the drug delivery that we're going to provide to these patients.

Speaker Change: So, again, we'll give you more clarity as we progress with enrollment in terms of timing.

Speaker Change: just sort of pen to paper say three and a half to four years from first patient in to a decision I think that's about right.

Thanks, Frank.

Thank you. One moment for our next question.

Speaker Change: Our next question comes from the line of Cam Bajazdi with Jeffries. Your line is open. Please go ahead.

Good morning, team. For L606,

Speaker Change: For that open-label safety study, how many patients achieved greater than a hundred microgram twice daily dose? Have their AEs been consistent with prior troposinol studies?

Speaker Change: and then maybe a question on launch. Can you remind us on the device side how robust your supply of your DPI inhaler is? Thank you so much.

Speaker Change: Yes, so the first question on, does, Rajeev, if you could describe what we're going to be able to speak to at this time, and then Mike, if you could talk about

Good luck going forward after that.

Rajeev.

Rajeev Saggar: Yeah, sure, Kambis. Thanks for the question. So, in regards to achieving, you know, greater than 100 micrograms twice a day,

know.

Rajeev Saggar: I would say the overwhelming majority of patients, if not, if not

Rajeev Saggar: close to almost all of the patients have achieved that dosing profile. So again, that dosing profile would be early in the titration phase. We have shown at our ATS

Speaker Change: poster in 2024 in May. The overall median dose was exceeded 200 micrograms for the majority of patients. So, you know, I think as Roger pointed out, I think that the key motif here is the liposome itself.

Speaker Change: has lended itself to be quite tolerable for these patients, it's, you know, in both PAH and PHLD patients. And I think that's what's leading to the...

Speaker Change: overall titratability of this of L606 in both populations. So we remain quite confident about the overall safety and tolerability profile of this drug.

Speaker Change: Yeah, and I think just in terms of breath equivalence combis, I think, you know, we're at two to three times the therapeutic target for Tybaso as a nebulize solution.

Speaker Change: So again, a different profile, much like utrepia, where utrepia is formulated as discrete, you know, dry particles in the lower end of the respiratory range.

Speaker Change: that delivers to the lower lung to avoid upper airway deposition and AEs. Here the liposomal formulation

Speaker Change: dimensions with C-Max so that you don't have as many peak AEs at C-Max but then can sustain the benefits. So in a different way it does the same thing and retains the titratability.

Speaker Change: aspect, which is critical, and then allows for higher doses, higher benefit, and we think higher persistence.

Speaker Change: but does it in a twice-a-day format. So it has all of the good of utrepia, but builds on it by taking it from a four times-a-day therapy to a twice-a-day therapy. So that's why we're very, very excited about this program.

Mike, if you could talk about the device plane.

Yeah, absolutely. Great to talk to you, Kambiz.

Speaker Change: since the early part of 22. We are, we will be ultra prepared for a launch here you know upon the expiration of the three-year marking activity that United received. We continue to be

Speaker Change: to manufacturing at full capacity and we'll be ready to launch whenever that time comes.

Speaker Change: you know, in the May-June timeframe, so we have no concern there and feel very confident that we can have a very successful launch with sufficient supply.

Great, thank you Mike. Operator, next question. One moment.

Thank you.

Speaker Change: Our next question comes from the line of Corey Eubenville with Lifesci Capital. Your line is open. Please go ahead.

Speaker Change: Good morning, congrats on the updates and thanks for taking our questions. You know, I guess, can you provide us some more context in regard to the timelines to launch in regard to the two ongoing suits?

Speaker Change: On the FDA hearing in December, assuming the case is ruled in Laquitia's favor and in an optimistic scenario, how quickly would this expedite timelines in relation to the May 23rd tentative approval date?

Speaker Change: And then across the two indications on the 793 patent decision, is it fair to say now that the UTREPIA launch is

Speaker Change: specifically in PAH now totally unencumbered following that May 23rd tentative approval date and

Speaker Change: If so, is the plan to launch in PAH immediately, but in PAH ILD, is there plans to wait on the 327 decision to launch, or do you anticipate launching at risk there, you know, given the recent updates?

Yeah, great question, Rusty, if you wouldn't mind.

Sure, Corey, thanks for the question. So on the

Speaker Change: Just taking the questions in turn, as far as the effect of the FDA lawsuit.

You know it's hard to

Speaker Change: fully answer that question because it's highly dependent on the timing of when we would get a decision and then exactly what the decision is.

Speaker Change: For instance, if the decision was to narrow the exclusivity versus just eliminate the exclusivity, we would have to assess what that means as to the...

Speaker Change: You know the label on our product and and and a number of other things so so again It's hard to hard to know the answer to that question until we see what the decision and when it comes in But you know I think that the main

Speaker Change: take away from our standpoint on the FDA decision is we know the exclusivity ends in May of 2025.

Speaker Change: Obviously, we're pursuing that litigation in the hopes that we can accelerate that approval date. And, you know, if we can, you know, we'll have to assess at the time sort of what that looks like. As to the second question, on the 793 decision, you're correct with that court making its decision to deny Cersei Rory.

Speaker Change: You know, that means that, you know, the first three patents that were asserted against us are no longer, you know, that litigation is now dead.

Speaker Change: There are no claims that United Therapeutics is asserting against us or the FDA related to approval of PAH. So from our perspective...

Speaker Change: You know, there's really nothing at all encumbering PAH at all. You know, as the final question on whether we would launch at risk, as we said consistently, I think over time, you know, that's an assessment we will make.

Speaker Change: You know, when the time comes when we get FDA approval, we'll have to make a decision whether to launch at risk. But the other thing I'd say, and I think we've said consistently, is if we get to that point in time,

Speaker Change: and we look at the patent landscape and don't see any patents that we think are valid and infringed by our products.

Speaker Change: You know, I don't think we're going to hesitate to launch, so, you know, again, that's an assessment we'll make at the time, and obviously, you know, we're going through Discovered in the 327 patent case, but...

Speaker Change: You know, as I said before, you know, our belief is there's substantial prior art out there that predates the 327 patent, and that certainly would weigh heavily in any decision we make at that time.

Thanks. Great.

Speaker Change: Alfred, I think we have time for one more question if there's any. All right, one moment for our next question.

Speaker Change: And it looks like our next question is going to come from the line of Matt Kaplan with Lattenberg Thalman. Your line is open. Please go ahead.

Hey guys, good morning and thanks for taking the question.

My questions have been asked. Just in terms of...

Speaker Change: launch preparation given the near-term opportunity here and at the end of May next year. Can you talk a little bit about how we should think about coming to market size of Salesforce etc in terms of your commercial footprint when you when you're when you're launching?

Speaker Change: Yeah, and we're fortunate to have Scott Moomaw, our chief commercial on the call. So Scott, maybe if you could talk about kind of how we think about

the calling space for both PH and PHILD.

comment.

Speaker Change: Yeah, absolutely. Good morning. So we've actually had the sales team on board for about a year now, actually. Our sales team is extremely experienced in rare disease.

Speaker Change: Most of them are from the pH space and have launched.

Speaker Change: multiple products in pH. So we're very excited about, you know, the depth of experience with them. They're sized, from a general standpoint, they're sized to cover the entire market, and by that I mean both the pH centers, you know, the large academic pH centers.

Speaker Change: as well as the community. And in the community, it would be pH treaters, but also we've included ILD prescribers. So there's pulmonologists out there who don't currently prescribe pH meds.

medications.

Speaker Change: but certainly have PHILD patients in the pool in their offices.

Speaker Change: We've sized our sales force to be able to get into those offices as well.

help them be aware of PHILD.

Speaker Change: diagnosed PHILD and then if the time is right either treat those patients or afford them into a center that'll be willing to treat them. So what you know we think there are probably about six to seven thousand targets in the market were sized to address that entire market. We also have some some other pieces that we have in place such as a team of key account directors.

Speaker Change: who are under the commercial umbrella and they are completely focused on the largest, most key academic medical centers, the PA centers, and so we can go very deep there as well. So we're excited. We just want to get to May and really let these folks loose.

Speaker Change: Great, thanks Scott. As you can hear, we're going to have significant sheer voice from the day of launch. So operator, I believe there's another question that we can take? Just one moment.

Thank you. Thank you.

Speaker Change: Our last question is going to come from the line of Ryan Deschner with Raymond James. Your line is open. Please go ahead.

Speaker Change: Good morning. I was wondering if you could give us a little more detail on the next-generation nebulizer that's party to the latest PharmOS agreement. Where is the nebulizer in terms of, I guess, its own development, and is this nebulizer currently something that's used with commercial products? Thanks.

Thank you.

Speaker Change: Yeah, I'll answer that quickly. So Ryan, I think at this time it's a proprietary nebulizer that we have exclusive rights to. We're looking to...

Speaker Change: secure some of our own IP around that so we're not going to really discuss specifically what the nebulizer is that we're going to use for the trial. Certainly in the coming quarters we'll disclose that to you. But I think Rajeev nicely described that the important aspects of it that it's a you know iPhone size, breath actuated, rechargeable.

Speaker Change: highly portable nebulizer that's very good at the delivery of the drug and precise in the precise dosing aspects that we need. So I'm sorry I can't give you more at this time but we'll provide that information in the coming quarters.

Speaker Change: Thank you, and I would now like to turn the conference back over to Roger Jeffs for any closing remarks. Great. Well, we really appreciate the questions this morning. It's very pleasing to have the analysts that cover us asking so many questions, and we look forward to providing further updates in the coming quarters as we continue to advance our march towards long-term future. Thank you, everyone.

[inaudible]

Music Music Music Music Music Music Music Music Music Music

Whoa, whoa, whoa, whoa,nah, na, nah

[inaudible]

The

[music]

Jason Adair: Thank you, Michelle. It's my pleasure to welcome everybody today to the Liquidia Corporation Third Quarter 2024 Financial Results and Corporate Update Call.

Jason Adair: 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 Mumaw, 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 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.

Speaker Change: 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'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. We're pleased to be speaking with you today.

Roger Jeffs: With the significant progress made over the last few months, we now have a clear line of sight to seeking final approval of utrepia for both PAH and PHILD patients.

Roger Jeffs: Final approval can occur following the expiration of Tyvasive DPI's clinical exclusivity on May 23rd, 2025 or in just six months time.

Critical winds that underpinned this significant milestone included the following.

Roger Jeffs: First, the FDA confirmed that the amended NDA to add PHLD to the tentatively approved label for utrepia was proper, and therefore has determined that we have met the regulatory requirements for approval for PAH and PHLD pending the expiration of Tyvasa DPI's clinical exclusivity.

Roger Jeffs: And second, with the Supreme Court's decision in September to deny CERT, the legal process with respect to the three patents originally asserted against us has been fully exhausted and these three patents no longer provide any impediment to the commercialization of e-Travail.

Thank you.

Roger Jeffs: As mentioned, the sole item cited by the FDA that is blocking final approval of utrepia is the new clinical investigation exclusivity that was granted to Tyvase and DPI.

Roger Jeffs: which will expire in May of 25 or earlier if we are successful in our lawsuit against the FDA. Rusty will speak more specifically about this lawsuit in a minute.

Roger Jeffs: On the clinical front, we remain active and productive in advancing our clinical programs that we have developed to prospectively demonstrate the differentiated value of utrepia in THILD patients, as well as advancing our next generation sustained release program, L606.

Roger Jeffs: We feel the combination of utrepia and L606 gives us a compelling portfolio of treatment options for the delivery of inhaled troposinol to treat PAH and PHILD patients both now and in the future.

Roger Jeffs: On a related business front, in this quarter we have expanded our relationship with PhRMASA with respect to L606.

Roger Jeffs: amending our license agreement to include the EU and other territories outside of North America.

Roger Jeffs: We have also entered into a device license agreement with Formosus to secure rights to proprietary, next-generation nebulizers for administration of L606 in a small, portable, breath-actuated nebulizer the size of an iPhone.

Roger Jeffs: Rajeev will speak to the clinical progress of both programs and share excitement that is building within the community based on our prospective studies.

And finally, we have also strengthened our balance sheet.

having closed several simultaneous finances in September.

Roger Jeffs: Michael will offer more insight on our balance sheet later in the call, but there is no doubt in my mind that we have the team, capital, the products, the vision, and especially the determination to change the treatment landscape for pulmonary hypertension patients in the near and long term. With that, I will ask Rusty to share some more details.

Rusty Schundler: Unlike the INCREASE trial, we do not believe that the BREEZE study, the clinical trial upon which this new clinical exclusivity was based, is the type of clinical trial

Rusty Schundler: for which exclusivity can be granted. This belief is bolstered by the FDA's own initial decision not to grant any exclusivities to Tybasa BPI when it was first approved in 2022.

Rusty Schundler: For this reason, we continue to believe that the FDA's decision should be vacated, and liquidity should be allowed to bring intrepid to market for the benefit of patients immediately.

Speaker Change: We in the FDA have agreed to an expedited briefing schedule in anticipation of a hearing on our respective motions for summary judgment on December 5, 2024.

Speaker Change: And regardless of the outcome of the lawsuit, though, nothing can delay the scheduled expiration of the exclusivity for Tybasa DPI on May 23, 2025.

Speaker Change: As part of our lawsuit against the FDA, United Therapeutics has filed cross-claims challenging again the appropriateness of the amendment to add PHLV to the utrepia label.

Speaker Change: These are essentially the exact same claims that were previously brought and then voluntarily dismissed by United Therapeutics in the lawsuit they initiated against the FDA back in February.

Speaker Change: We continue to believe that these cross-claims have no merit and that Laquitia properly amended the NDA for Utrepia to add PHLD, a position that the FDA agreed with when they issued tentative approval for Utrepia in both indications in August.

Thank you.

Speaker Change: Finally, as noted by Roger, we have now successfully concluded the litigation regarding the three patents that were initially asserted against us by United Therapeutics.

Speaker Change: The 327 patent generally covers the treatment of PHLV patients with Tyvaso in accordance with the dosing regimen in the Tyvaso label.

Speaker Change: As we have noted previously, there is considerable prior art that teaches the treatment of PHLV patients with Tybaso.

Speaker Change: Also, as previously disclosed, United Therapeutics sought a preliminary injunction to block the launch of Utrapia for the treatment of PHLD patients based on the 3T7 patent and is denied by the court.

Speaker Change: Trial is now scheduled for June of 2025 and we look forward to resolving the validity of the 327 patent at that time.

Rajeev Saggar: With that, I'd like to turn the call over to Rajeev to summarize the clinical progress to date.

Thanks, Rusty.

Rajeev Saggar: I'm excited to report on the continued positive momentum in Liquidia's clinical programs with utrepia and L606.

Rajeev Saggar: First, let me provide an update on the open-label ASCENT study, which is evaluating the safety, tolerability, and efficacy of utrepia in patients with PHILD.

Rajeev Saggar: We have now doubled the number of clinical sites during the past quarter, with 21 of the 22 planned sites now active.

Rajeev Saggar: To date, we have enrolled over a third of the patients, which keeps us firmly in track to complete enrollment in the first quarter of 2025.

Rajeev Saggar: The preliminary data emerging from the ASCENT study in PHILD patients

Rajeev Saggar: It's highly encouraging in regards to tolerability and titratability, and it is generally consistent with the observations from our pivotal Phase III-inspired study in PAH patients.

Rajeev Saggar: as anticipated with our print formulation coupled with our low-effort dry powder inhaler.

Rajeev Saggar: While still early, we remain very encouraged by the positive trends noted in the key efficacy endpoints.

including change in six-minute walk distance and patient reported outcomes.

Rajeev Saggar: After week 8, patients have continued to titrate higher and we look forward to reporting the full data set from the study when it completes next year.

Rajeev Saggar: Now, turning our attention to L606, our sustained-release liposomal triprosomal suspension formulation delivered twice daily, we are now solely focused on initiating our placebo-controlled global Phase III study in PHLD called RESPIRE.

Speaker Change: We've decided to use this new device in our Pivotal study, which will push initiation into the first half of 2025.

Speaker Change: More details on the Pivotable Study Design and the device will be shared in the near future.

Speaker Change: I would now like to pass the call to Mike Kaseta to review the financial performance from the third quarter. Mike?

Thank you.

Thank you, Rajeev, and good morning, everyone.

Speaker Change: I'm pleased to say that Liquidia is well prepared to launch its first product, Utrepia, in 2025, as soon as we receive final FDA approval.

Speaker Change: We ended the third quarter of 2024 with $204.4 million cash on hand and remain well positioned to achieve our corporate objectives culminating in our potential launch of Utrepia.

Speaker Change: I will now briefly address our third quarter financial results found in today's press release.

First, revenue was $4.4 million for the third quarter 2024.

Speaker Change: compared with 3.7 million dollars in the same quarter 2023. Revenue related primarily to our promotion agreement with Sandos to commercialize troposinol injection.

Speaker Change: The increase of $0.7 million was primarily due to the impact of higher sales quantities in the current year as compared to the same period in the prior year.

Speaker Change: Cost of revenue remained consistent at 1.7 million dollars for the third quarter 2024 compared to 0.6 million dollars in the same quarter for 2023.

Cost of revenue related to the promotion agreement mentioned earlier.

Speaker Change: The increase from the prior year was primarily due to our Salesforce expansion during the fourth quarter of 2023.

Speaker Change: Research and development expenses were $11.9 million in the third quarter of 2024, compared with $7.4 million in the same quarter for 2023.

Speaker Change: in clinical expenses related to our L606 program and a $2.5 million increase in expenses related to utrepia research and development activities including the ASCENT trial

Speaker Change: offset by 1.5 million dollars lower commercial manufacturing expenses reflecting the impact of expensing Utrepria inventory costs in the prior year.

Speaker Change: Moving on to general and administrative expenses, there were 20.2 million dollars in the third quarter 2024 compared to 10.6 million dollars in the same quarter for 2023.

Speaker Change: In summary, we incurred a net loss for the three months ended September 30th, 2024 of $23.2 million, or $0.30 per basic and diluted share, compared to a net loss of $15.8 million, or $0.24 per basic and diluted share, for the three months ended September 30th, 2023.

Speaker Change: With that, I'd like to now like to turn the call back over to Roger. Roger?

Roger Jeffs: Thank you, Mike, and thank you, Rusty and Rajeev, for also sharing those insights.

Speaker Change: Hi, good morning, and thank you for taking my questions. First, regarding the summary judgment hearing in December, I'm wondering if you have a good sense for how soon a decision could be delivered from there, and can you maybe talk about the range of outcomes you're contemplating right now from that hearing?

Speaker Change: Good morning, Julian. Nice to hear from you. Rusty, if you could find on that please.

Speaker Change: Sure, Julian, thanks for the question. So as far as timing for a response,

Speaker Change: Typical with any proceedings of the judge, it's hard to predict in advance. There's no set timeline or deadline for judges to rule, and so it's really hard to give any guidance on that point.

Speaker Change: As far as the range of outcomes, you know, they're the typical range of outcomes for any Administrative Procedures Act proceeding.

Speaker Change: You know, obviously the judge could uphold the decision, the judge could just outright overrule the decision, or the judge could remand back to the FDA for further consideration. You know, there are all sorts of iterations even within those, but those are the main three pathways.

Bye!

Speaker Change: Okay, great. Thank you. That's very helpful. And then quickly on the assent trial, great to hear enrollment completion is expected in first quarter next year. Sorry if I missed it, but wondering what your expectation for data disclosure is from there. Do you maybe plan to disclose the data at a conference? Any color on the timing to data would be great.

Speaker Change: Yeah, thanks again for the question. Rajeev, if you could comment on the timing of the data disclosure.

Rajeev Saggar: Yeah, thanks Julian. Good to hear from you. So, you know, we, we, we, as you know, this is an open label study. We continue to look at the data sets and, and every, with certain amount of frequency, we will submit the data to various Congresses coming up.

Rajeev Saggar: So we have submitted a set of data to Congress, and if accepted, then we anticipate showcasing that data in the first half of 2025.

Excellent. Thank you again.

Speaker Change: Thanks for that, Rajeev. And I think the thing I would add to that, Julian, is that I think you're going to see some, you know, some critically important information that differentiates the value.

Speaker Change: of Utropia, particularly as it relates to dose, the ability to quickly get to dose.

Speaker Change: The impact of driving that does in terms of clinical outcomes and then also we'll you know We'll disclose data on the persistence and durability of treatment within that patient subset. So I think

Speaker Change: You know, we can show tolerability, titratability, and durability all through the patient-friendly low-resistance device, which we think will lead to greater persistence.

Speaker Change: then I think that is a differentiated data set, particularly when you look at some of the data sets that have been put out there for the Competitive Molecule Types of DPI to this point.

Thank you. Next question, please. Thank you. One moment.

Speaker Change: Our next question is going to come from the line of Jason Gerberi with V of A. Your line is open, please go ahead.

Hey, morning guys.

if we should be thinking about any points of friction.

Speaker Change: on the coverage access side, as you launch that product, or...

Speaker Change: You know, your confidence level that you'll have parity access pretty early in the launch period. Any color you can provide there would be helpful. And then...

Speaker Change: on the L606 update in terms of the plan to go direct to Pivotal and ILD. Next year, if I got that right, I don't know, the design is not formalized, but should we generally think about increases providing a good framework for a type of study that you'd be running? Thanks.

Speaker Change: Great, so I think for the first question, in terms of coverage access, I'll ask Mike to answer that one, and on the second question, Rajeev can speak to the L606 Pivotal Plan and timing.

Speaker Change: Yeah, Jason. Jason, thanks for the question. You know, relating to access, you know, we've been prepared to launch Utrepia since we received tentative approval in 2021. We've been engaging with with payers to talk about the value proposition that that Utrepia brings.

Speaker Change: As a result of those conversations, I think we feel confident that access is obviously our goal and something that we're confident that we're going to be able to obtain.

Speaker Change: But as we get closer to a launch, we'll continue to have those conversations, but we are working towards having access as close to launch as possible.

Speaker Change: Great, thanks Mike. So Rajeev, maybe you can speak to how similar our design is to the increased study.

Speaker Change: and then kind of what we're thinking about in terms of sample size and time.

Rajeev Saggar: Yeah, sure. Thanks, Jason. So, you know, again, as I stated in the prepared remarks,

Rajeev Saggar: I think the key here is that the open label study for L606 really gave us the confidence about our safety and tolerability in our dosing profile, I think to twice a day.

format for L606 is quite game-changing here.

Rajeev Saggar: in terms of the patients, in terms of compliance and performance. The next step is really to...

Rajeev Saggar: ensure that the nebulizer is the right one for the patient. I think the nebulizer that we have chosen

Rajeev Saggar: absolutely will ensure that the key motif for any nebulizer is drug deposition.

Rajeev Saggar: The replicable study is is important to note. I think, you know, understanding that these patients can improve

Rajeev Saggar: Six-minute walk distance within certain time periods is going to be critical. So I think we use that as a rough estimate.

Rajeev Saggar: In terms of the sample size overall, I think we've said the sample size is going to be somewhere between three to four hundred patients. Again, this is a global study. This will be enrolled in multiple countries to ensure that we can...

achieve success overall in an appropriate time frame.

Speaker Change: Right, and the only thing I'd add to that, Jason, is that you know with L606 because the Cmax is reduced by 7x or retaining the AUC over 24 hours

Speaker Change: which then means we should be able to titrate to higher doses, which should lead to higher benefit, so we're going to power around the same assumptions used in increase, but my expectation is we'll have a better outcome than that study if all of this holds true.

Thank you. Operator, next question, please.

Speaker Change: Our next question is going to come from the line of Greg Harrison with Scotiabank. Your line is open. Please go ahead.

Greg Harrison: Hey, good morning. Thanks for taking the question. It looks like the Utrecht launch is pretty well set and preparations are ready, so I wanted to ask about L606.

Can you help us frame expectations for timelines?

Greg Harrison: for development overall, enrollment, just given the global nature and what you can do to expedite this, and then how you view the opportunity for this asset especially with respect to XUS.

Yes, I'll take that one.

You know, I think...

Speaker Change: It's always hard to talk about timing when we haven't started, Greg. So I want to be a little bit cautious here and not sort of predict things too early, but as Rajeev said in his opening comments, we plan to start the trial, initiate the trial in the first half of 25.

Speaker Change: It's our expectation that we can enroll the trial in say 18 to 24 months and then it would take six months to run them through the study, the last patient through.

Speaker Change: three months to assimilate the data, file it, and then you have your typical 10-month review. So if you just put all that together just in sort of

Speaker Change: and a general on sense you're talking from start to finish four years. I think we can beat that and the reason I say that is we're going to do this most of the enrollment will come will come from ex-US territories where type ASO and type ASO DPI are not available, i.e. in the EU.

China

Speaker Change: South America, Australia, etc. So it's a massive effort certainly and I think our development team's up for the challenge. We're well positioned in terms of logistics to get it done.

Speaker Change: We certainly have a lot of experience, management experience, in doing these types of trials, for sure.

Speaker Change: And as we maybe didn't say on this call, but have said before, this study will serve for approval in the U.S. for both PAH and PHILD. That's the agreement we have with the FDA.

Speaker Change: and with the EMA we'll work out if additional studies are required, but our goal is to become a global brand provider of L606 to patients, and that's why we expanded the license with Pharmoso. We're very pleased with that partnership.

The Taivetso Nebulizer was in development 20 years ago.

So it's a dated nebulizer that's bulky and cumbersome.

Speaker Change: This is a nebulizer the size of an iPhone, portable, breath actuated, and as we, as PhRMOSA has shown in testing, very reliable in terms of its delivery kinetics and ability to deliver the exact and precise amount of drugs that we need to deliver to these patients, and we can titrate the dose through different times.

Speaker Change: solution strengths quite easily. So everything's setting up well, we just have to get the final compatibility work done with this new device. That was some of the delay that we have now. The reason people would ask why aren't you starting now is we have to just...

Speaker Change: Close up shop in terms of doing compatibility work with the new device that works going

Speaker Change: spectacularly well, but then we have to put the dossier together and file that to convince the FDA that we have the right device for the drug delivery that we're going to provide to these patients.

Speaker Change: So, again, we'll give you more clarity as we progress with enrollment in terms of timing.

Speaker Change: just sort of pen to paper say three and a half to four years from first patient into a decision I think that's about right.

Thanks, Rick.

Thank you. One moment for our next question.

Speaker Change: Our next question comes from the line of Cam Bejazdi with Jeffries. Your line is open. Please go ahead.

Cam Bejazdi: Morning, team. For L606, for that open-label safety study, how many patients achieved greater than 100 micrograms twice daily dose? Have the AAs been consistent with prior troposinol studies?

Cam Bejazdi: and then maybe a question on launch. Can you remind us on the device side how robust your supply of your DPI inhaler is? Thank you so much.

Speaker Change: Yes, so the first question on what we're going to be able to speak to at this time and then Mike if you could talk about

Good luck going forward after that.

Rajeev?

Rajeev Saggar: Yeah, sure, Kambis. Thanks for the question. So, in regards to achieving, you know, greater than 100 micrograms twice a day,

now.

I would say the overwhelming majority of patients

Rajeev Saggar: to almost all of the patients have achieved that dosing profile. So again, that dosing profile would be.

you know, early in the titration phase.

You know, we have shown at our ATS

Rajeev Saggar: poster in 2024 in May. The overall median dose was exceeded 200 micrograms.

Speaker Change: for the majority of patients. So, I think as Roger pointed out, I think that the key motif here is the liposome itself.

Speaker Change: has lended itself to be quite tolerable for these patients, it's, you know, in both PAH and PHLD patients. And I think that's what's leading to the...

Speaker Change: overall take tradability of this, of this, of L606 in both populations. So we remain quite confident about the overall safety and tolerability profile of this drug.

Speaker Change: Yeah, and I think just in terms of breath equivalence combis, I think, you know, we're at two to three times the therapeutic target for Tybaso as an ambulance solution.

Speaker Change: So, again, a different profile, much like utrepia, where utrepia is formulated as discrete dry particles in the lower end of the respiratory range.

Speaker Change: that delivers to the lower lung to avoid upper airway deposition and AEs. Here, the liposomal formulation.

Speaker Change: dimensions of C-Max so that you don't have as many peak AEs at C-Max but then can sustain the benefits. So in a different way does the same thing and retains the titratability.

Speaker Change: aspect, which is critical, and then allows for higher doses, higher benefit, and we think higher persistence.

Mike if you could talk about the device

Yeah, absolutely. Great to talk to you, Kambiz.

Speaker Change: We've been preparing to launch since we received kind of approval in November of 2021. We've been manufacturing commercial supply

Speaker Change: since the early part of 22. We will be ultra prepared for a launch here upon the expiration of this three-year marketing activity that United received. We continue to be manufacturing at full capacity and we'll be ready to launch whenever that time comes.

Speaker Change: in the May, June timeframe. So we have no concern there and feel very confident that we can have a very successful launch with sufficient supply.

Great, thank you Mike. Operator, next question. One moment.

Thank you.

Speaker Change: Our next question comes from the line of Corey Eubenville with Lifestyle Capital. Your line is open. Please go ahead.

Speaker Change: And then across the two indications on the 793 patent decision, is it fair to say now that the UTREPIA launch is

Speaker Change: specifically in PAH, now totally unencumbered following that May 23rd tentative approval date and

Speaker Change: If so, is the plan to launch in PAH immediately, but in PHILD, is there plans to wait on the 327 decision to launch, or do you anticipate launching at risk there, you know, given the recent updates?

Yeah, great question, Rusty, if you wouldn't mind.

Corey Eubenville: Sure, Corey, thanks for the question. So on the, just taking the questions in turn, as far as the effect of the FDA lawsuit,

You know it's hard to

Corey Eubenville: fully answer that question because it's highly dependent on the timing of when we would get a decision and then exactly what the decision is.

Corey Eubenville: For instance, if the decision was to narrow the exclusivity versus just eliminate the exclusivity, we would have to assess what that means as to the...

Corey Eubenville: you know, the label on our product and a number of other things. So, again, it's hard to know the answer to that question until we see what the decision and when it comes in. But, you know, I think that the main...

Corey Eubenville: Obviously, we're pursuing that litigation in the hopes that we can accelerate that approval date.

Corey Eubenville: And, you know, if we can, you know, we'll have to assess at the time sort of what that looks like. As to the second question on the 793 decision, you're correct with that, making its decision to deny Srishi Rory.

Corey Eubenville: You know, that means that, you know, the first three patents that were asserted against us are no longer, you know, that litigation is now dead.

Corey Eubenville: There are no claims that, you know, therapeutics is asserting against us or the FDA related to approval of PAH. So from our perspective...

Corey Eubenville: You know, there's really nothing at all encumbering PAH at all. You know, as the final question on whether we would launch at risk, as we said consistently, I think over time, you know, that's an assessment we will make.

Corey Eubenville: You know, when the time comes when we get FDA approval, we'll have to make a decision whether to launch at risk. But the other thing I'd say, and I think we've said consistently, is if we get to that point in time,

Corey Eubenville: and we look at the patent landscape and don't see any patents that we think are valid and infringed by our products.

Corey Eubenville: I don't think we're going to hesitate to launch. So again, that's an assessment we'll make at the time, and obviously we're going through Discovered in the 327 patent case, but as I said before, our belief is there's substantial prior art out there that predates the 327 patent, and that certainly would weigh heavily in any decision we make at that time.

Thanks. Great, thank you.

Speaker Change: Alfred, I think we have time for one more question if there's any. All right, one moment for our next question.

Speaker Change: And it looks like our next question is going to come from the line of Matt Kaplan with Lattenberg Thalman. Your line is open. Please go ahead.

Matt Kaplan: Hey guys, good morning and thanks for taking the question. Most of my questions have been asked. Just in terms of

Matt Kaplan: launch preparation given the near-term opportunity here and at the end of May next year. Can you talk a little bit about how we should think about coming to market size of Salesforce etc in terms of your commercial footprint when you when you're when you're launching?

Speaker Change: Yeah, and we're fortunate to have Scott Moomaw, our chief commercial on the call. So Scott, maybe if you could talk about kind of how we think about...

the calling space for both PH and PHILD.

comment.

Speaker Change: Yeah, absolutely. Good morning. So, we've actually had the sales team on board for about a year now, actually. Our sales team is extremely experienced in rare disease.

Speaker Change: Most of them are from the pH space and have launched.

Speaker Change: multiple products in pH. So we're very excited about, you know, the depth of experience with them. Their size, from a general standpoint, their size to cover the entire market, and by that I mean

Speaker Change: both the PH centers, you know, the large academic PH centers.

medications.

Speaker Change: but certainly have PHILD patients in the pool in their offices.

Speaker Change: We've sized our sales force to be able to get into those offices as well, help them be aware of PHILD, diagnose PHILD, and then if the time is right either treat those patients or forward them into a center.

Speaker Change: that'll be willing to treat them. So we think there are probably about six to 7,000 targets in the market, we're sized to address that entire market. We also have some other pieces that we have in place such as a team of key account directors.

Thank you.

Speaker Change: Our last question is going to come from the line of Ryan Deschner with Raymond James. Your line is open. Please go ahead.

Ryan Deschner: Good morning. I was wondering if you could give us a little more detail on the next-generation nebulizer that's party to the latest PharmOS agreement. Where is the nebulizer in terms of, I guess, its own development, and is this nebulizer currently something that's used with commercial products? Thanks.

Speaker Change: Yes, I'll answer that quickly. So Ryan, I think at this time it's a proprietary nebulizer that we have exclusive rights to. We're looking to

Speaker Change: secure some of our own IP around that. So we're not going to really discuss specifically what the nebulizer is that we're going to use for the trial. Certainly in the coming quarters, we'll disclose that to you. But I think Rajeev nicely described the important aspects of it, that it's a, you know, iPhone size, breath actuated, rechargeable.

Thank you.

Q3 2024 Liquidia Corp Earnings Call

Request a DemoDemo

LQDA

Liquidia

Earnings