Liquidia Corporation (LQDA) Earnings Call Transcript & Summary

Good morning. My name is Serge Belanger. I'm one of the health care analysts at Needham. I want to welcome you to Day 3 of our 24th Annual Healthcare Conference. And happy to have for our next fireside chat session here, we have Liquidia Corporation. And from the company, we have the CEO, Roger Jeffs; as well as the CFO and COO, Mike Kaseta, with us this morning. We're going to be talking about, obviously, YUTREPIA and the impending near-term potential approval and launch of the product in PAH and PH-ILD. Before I hand it over to the management team to give us a quick overview of the company, I just want to highlight to those listening in that you do have the option to submit questions via the portal you are watching the presentation on. We'll take those as they come in. So with that said, I'll hand it over to Roger, if you just want to give us a quick overview of the company for those who aren't familiar with Liquidia YUTREPIA.

Yes. Thank you, Serge. It's a delight to be here with you at the Needham Conference virtually. And I'm pleased to have Mike Kaseta, our CFO, with me today. It's a really exciting time for Liquidia. We're only 45 days from our PDUFA date of May 24, that we recently were assigned by the FDA. So excited and poised, we think, to deliver a meaningful improvement in the standard of care for patients with PAH and PH-ILD and with that, a meaningful return to our investors. Kind of want to just -- I'll give you a quick sort of overview of about how we are preparing to vigorously enter the market at full speed with particular focus on the readiness on the following 5 key areas. One, we're develop -- continue to develop a best-in-class product profile. So as we've said before, the tolerability, titratability, the ease of use of the device and the labeling that we will receive that speaks to all of these factors really is a differentiating product profile. We're further characterizing the benefits of YUTREPIA in a study we call the ASCENT trial, which is a prospective study in PH-ILD patients. And we'll talk about that in the Q&A, and then we're going to show some of that data at ATS. But we're also going to begin a directed transition study where we take patients from the incumbent brand TYVASO and TYVASO DPI and begin to transition them to YUTREPIA to show that the differentiated aspects that we speak about are real. The second thing we've been preparing is around competitive share of voice. We have 50 reps in the field. They've been on board for about 18 months, all with deep rare disease experience and most with PAH experience. So we've been surveilling the centers and really preparing for this launch that will occur in the early June time frame. The other thing that we need to be successful is a full suite of patient support services, which we put in place. So there will be a seamless transition when scripting YUTREPIA compared to the incumbent brand. The fourth thing would be product availability. Mike and his team at Liquidia have prepared to put product in the channel in only 2 to 3 short weeks after approval. So that's a speed which not many people can match. And finally, with regard to payer access, we've engaged in forward-looking conversations around positioning and reimbursement with a target audience that is keen to provide value and choice to patients. So with all of those in play, we feel very ready to launch this product into the marketplace and provide the benefits to the patients that we so definitely want to do. And with that, Serge, I'll turn it over to you to begin the Q&A.

Thanks, Roger. Maybe before we jump to questions, one of the topic du jour or topic of the last couple of weeks has been tariffs. And I know so far, pharmaceutical products have been exempted, but it's only going to be temporary and it looks like it's going to be another issue that's going to be the main focus of the markets in the next couple of days. So just curious if you can talk about your potential exposure to tariffs given the manufacturing of YUTREPIA.

Yes. So maybe Mike can speak to how we'll have a minimum -- we feel we'll have a minimum impact from tariffs.

Yes. Thanks, Serge. I guess the way we would portray this is, as you know, we manufacture our product in the United States. We do our bulk powder manufacturing in North Carolina. We do our downstream packaging and kitting elsewhere in the United States. While we do source our API from Korea, and inevitably, that will have an impact through tariffs, we do not believe overall that it will have a direct material impact on YUTREPIA or on Liquidia as a whole.

Okay. Good to know. Think we're getting close to crunch time with the potential approval of YUTREPIA, kind of waiting on the expiration of the exclusivity on TYVASO in late May. So maybe if you can walk us through the last steps to get there and the process with FDA.

Yes. So we've actually already initiated the last step. So the last step for us was to submit the request for the transition from tentative to final approval. The FDA took only 4 days to respond with the May 24 PDUFA date. So it seems that they too are keen to see this drug approved for both PAH and PH-ILD patients. And really, at this point, it's just -- it's waiting on that expiry to actually expire. So there's really nothing else to do. We've talked about all the things with the agency that we needed to do ahead of that submission, and it looks like it's all systems go, and we're clearly on the clock at this point.

Okay. So the recent changes at the FDA over the last few weeks should have minimal impact here given that like what you said, things have been discussed regarding the label and there is no other steps to -- for the review process?

Yes, good question. So we're fortunate that our regulatory liaise, our project manager remains at the FDA. So he has the portfolio history with the YUTREPIA application. There really is in our view, no impact. And we're fortunate in that sort of the adjudication of the application had already been determined. So when you get tentative approval, in essence, they're saying the drug is safe and effective and approvable except for -- and the except for in our instance was the dry powder exclusivity that TYVASO received. So that will expire on May 23. There's really nothing else that needs to happen. There's no other impediment in our way. And come May 24, we should be free and clear to launch the drug in both indications.

Great. And you did go through the 505(b)(2) pathway here to gain approval of YUTREPIA. So what should we expect in terms of the label and how it could be different from TYVASO?

Yes. Good question. So from an indication claim standpoint, the labeling will be very similar. It will be exactly the same as the brand. So that's the consequence of the 505(b)(2) labeling. What will be unique for us is the actual dosing and administration description as well as some of the clinical pharmacology section because we did studies under the 505(b)(2), both to show the PK bioequivalence and to show the safety of the drug in patients with PAH in particular. So what you'll see as a consequence of the studies that we did, the INSPIRE study is that the label will speak to the dosing, which will take it up to a maximum dose that's 2 or more times the label dose for the brand in terms of peak dose. And we certainly evolved that post submission, and we'll update that in time. But again, it speaks to the clear and present advantage of the PRINT-enabled formulation that YUTREPIA has, where we can dose with greater tolerability and to greater levels. So that will be there. And then in the clinical pharmacology section, it will also talk about the fact that we, one, started de novo patients; and two, started -- did transition patients from TYVASO to YUTREPIA. So we've already done that. And while, as I said in the opening, we're going to do a directed transition study in patients on the DPI in particular, to transition to YUTREPIA. We've already shown that patients can transition from TYVASO, prefer unanimously and universally that transition and then can do well and are well managed on YUTREPIA. So for us, it's really now the other -- the newer study will show we can also do that in PH-ILD because we've already shown it in PAH. But it does speak to the fact that there's some low-hanging fruit out there, particularly the nebulized patient population who all prefer a dry powder formulation like YUTREPIA and want to move in a different direction.

Okay. And I believe you look at PAH and PH-ILD as kind of 2 distinct market opportunities. They are 2 different diseases. So that wouldn't make sense. So maybe if we can start with PAH, you can just talk about that specific market opportunity, what it looks like now and maybe how it's changed with the arrival of TYVASO DPI over the last couple of years?

Yes. It's a little bit -- happy to -- let me talk about the PAH marketplace and then the PH-ILD, and it's a little bit hard to talk about specific use of the dry powder formulation in particular, because that's not divulged by the competitor. So -- but just as a topical overview, there's about -- and for PAH only, there's about 100,000 prevalent patients, about 45,000 patients are treated with one form of therapy or another. Within that 45,000, 18,000 of those patients approximately use prostacyclins with orals taking up about 10,000, IV and subcu or parental therapies taking up about 4,000 and the DPI nebulized formulations taking about 4,000. There is a -- so that's 18,000 in total. The inhaled prostacyclins have grown since the launch of DPI. I think previous to that launch, it was more in the 3,000 patient range. So it's grown by 1/3 since the launch of TYVASO DPI in PAH. But of the 18,000 there's about 6,000 annual new starts or what we like to call jump balls, and that's both patients that are new or coming new to a prostacyclin therapy or patients for one reason or another who become intolerant or are failing on existing therapies. Certainly, I think one thing that happens with us when people look at the addressable market, they try to confine us to the -- just to the DPI and nebulized formulation. But really, what we want to do, we do want to go after those new patient starts initially to sort of have physicians see one, do one. We'll teach and preach and then they'll see one, do one, get confidence that YUTREPIA provides all of the flexibility that we suggest that it does, have them do a number of patients so that they get experience and comfort with YUTREPIA. And then we would see if we could displace all new patient starts and start leaning those towards YUTREPIA versus the incumbent brand. Secondarily to that as well, given that we can show titratability and effect without any off-target effects, particularly to the GI tract with orals, we would -- we're then going to approach the oral market and see if we can penetrate and take share from the orals because really, it's a matter of choice. When you need a prostacyclin, the current choices are do you want to take easier choices, earlier choices, do you want to take an oral or do you want to take an inhaled. And as you can see, there's more people typically taking an oral currently. But I think given the product profile that YUTREPIA brings, there's a very good chance that we could infringe on that share significantly. So -- and maybe it's a bit biphasic. I think we'll focus on the new patient -- the typical new patient inhaled's market first, prove ourselves there and then reach out to that same target audience and suggest that maybe this is a better proposition for your patients than an oral therapy start would be. So that's in PAH. So a pretty robust business even in PAH alone. So that's that, if you have any questions there, but I'll talk about PH-ILD now, if you allow me. So in PH-ILD, it's our view, and then we've done this through triangulated data sets that we think there's about 60,000 or more prevalent. There are -- people float ranges anywhere from 30,000 to 100,000, we're somewhere in the medium there. So I think about 60,000 prevalence is a reasonable expectation. If you take the same -- and I think this is conservative, you just haircut that by the same number of treated versus prevalent as in PAH, which is about half, about 45%, you would then come up with about 27,000 patients available for treatment, again, with a significant haircut, which may be conservative. We feel now kind of backtracking on things, it looks like there's probably around 6,000 or more patients treated on either the DPI or nebulized formulation in PH-ILD. So a fairly underpenetrated market with still huge new start opportunity. And we think YUTREPIA as a second brand coming into the market will help drive awareness and there'll be a rising tide phenomenon in terms of treatment. The good news here is we don't -- there's so much opportunity, we don't really need to take the share from the competitive brand to do well. We just need to get our own share. But certainly, as we're seeing with our ASCENT data in PH-ILD, we do seem to offer a different and better value proposition, and we'll continue to progress these types of studies in the future to show that. And as I said, doing directed transitions from patients who may be intolerant to TYVASO DPI because of the way it's formulated and the high-resistance device required to deaggregate that formulation. So lots and lots of opportunity. I think on -- the incumbent has, therefore, about 10,000 patients. They're doing about 10 billion in business. But as I've just described, the opportunity is 2 to 3x that. So lots of room for us to do well here and make significant share gain in the near term as well as the long term.

And you currently have a sales force out in the market, mostly catering to the PAH prescribing physicians with one of the generic for -- forgetting the name, but the injectable treprostinil product. So should we expect that there'll be an initial focus more on the PAH segment? Or there's enough overlap between PAH and PH-ILD that you'll be able to target both at the same time?

Yes. So we're going to focus on both. So obviously, it's -- the only approved therapy in PH-ILD that's competitive would be the TYVASO and TYVASO DPI. So all of the other vasodilator type therapies that work in PAH, don't have been not to work actually or are unsafe in patients with PH-ILD because they cause VQ mismatching because they're systemically delivered. So the PH-ILD opportunity is variable white space. So we have -- what we've been doing there, I can't talk about YUTREPIA in a branded format, but we have surveilled those centers. We've talked about disease awareness. We've talked about prostacyclins in general, potentially helping the competitor in our prelaunch phase, but that's fine. And talked about PRINT. We just can't talk about YUTREPIA. So in PAH, same thing, although we do -- in PAH, we have the, as you pointed out, a generic brand for injection that we promote. So lots of opportunity. There's an overlap -- there's some overlap between PAH and PH-ILD physicians. Some do both. We think that's about -- and again, I'll give you a rough estimate, about 2,000 patients. There's probably, 2,000 prescribers, there's probably 2,000 or more key prescribers that do PAH only and maybe another 2,000 or more prescribers that do PH-ILD alone. So our target sort of calling space in the near term is about 6,000 physicians. mostly pulmonologists, but also with PAH, there's a lot of cardiologists as well that practice. So again, where we're fortunate, those 50 reps that we have, which we feel is adequate and almost at parity in terms of share of voice with our competitor. These are deeply experienced reps who have been in the space and have relationships with these physicians for some 10 to 20 years. So I think, again, we're well positioned to get YUTREPIA into the marketplace in a significant way.

Okay. And for all high-priced product like TYVASO and imagine YUTREPIA, coverage and reimbursement is key here. So maybe you can just break down the components between commercial, Medicare and [ Medicaid ]? And how quickly do you expect to have coverage once you have an approval and you're launching the product?

Yes, great question. Maybe, Mike, you'll take that one.

Yes. So if you look historically at the overall market, what we've seen is Medicare is between -- somewhere between 45% and 50% of the market. We believe the commercial segment is between 35% and 40% of the market. And then we think the mandated markets, like you mentioned, Medicaid, VO/DoD, 340B are probably somewhere in the 10% to 15% range. So as we talk about strategy, as Roger said in the beginning, it's one of our -- one of the key components of our launch strategy is payers. We've been engaging payers for the last couple of years. We've been talking about the value proposition that YUTREPIA will bring. We feel very confident in delivering that message. And one thing that we've -- a [indiscernible] Of ours is we want to make sure that patients have an opportunity to choose. In order for patients to choose -- have an opportunity to choose, we need to have access. And we feel extremely confident based on those conversations across all of those segments that we will be able to achieve access at or near launch. As you know, our competitor has started contracting. That has happened in the last several months. They've talked publicly about not wanting to be disadvantaged. And like I said earlier, we are focused on making sure patients have choice. And as a result, we feel very confident that we'll be able to achieve broad access. Now with that being said, this is a segment, a therapeutic area that has not had historically a tremendous amount of insurance payer coverage. So these doctors, these centers are used to the process of exceptions and prior authorizations. As Roger said, we'll have a full suite of services on the front end to help through that process. But at the end of the day, we do not feel that we will be disadvantaged from a payer point of view, and that will be very important to allow patients to have that choice.

Okay. And how do you -- your competitor, like you said, started contracting. Do you view that as a hurdle for coverage or it's just going to be a regular competition aspect that you have to deal with?

Yes. I mean I don't think we're surprised. Obviously, they know that we're coming. They would not have started contracting if they didn't think we were coming. In addition, they felt that it was important that they contract in order to, as they said, make sure that they are not disadvantaged. So we're not surprised. We are prepared, has not affected any of the conversations that we've been having for payers, and we look forward to, as Roger said, 45 days from today when that exclusivity expires and hopefully, we get approval and we can hit the ground running and make sure we get as much YUTREPIA in patients' hands as possible.

I think one of the questions we often get from investors is how will YUTREPIA compete against TYVASO and United. So I don't think people quite understand yet the differentiation that YUTREPIA offers. So Roger, maybe just highlight -- you talked a little bit about it earlier on the dosing front, but some of the other aspects of differentiation for the product.

Yes. And it's really Serge, driven by the formulation technology, the PRINT formulated technology where we can discretely manufacture particles in the -- with uniform size, shape and form in the lower end of the respirable range. And because they're uniform particles of small size, we can also use a low resistance device, so the patients just have an ease of use in terms of applying the drug through 2 simple breasts. So what that allows is lower lung selective penetration of treprostinil versus upper airway deposition. And what we're seeing, for example, in the ASCENT study with PH-ILD is minimum effects of cough. So what we hear and what we've seen from, for example, the National Jewish Center with TYVASO DPI is that cough is significant. It leads to an inability to dose titrate, which leads to the patient's clinical worsening. So in that National Jewish study, patients -- over 60% of patients who started on TYVASO DPI came off within a median of as early as 40 days. So -- and most of that was due to cough or clinical worsening, which I view those 2 things as interrelated. If you cough, you can't get dose, if you can't get dose, you worsen. So -- and then it's not drug-specific issue. It's actually formulation-specific because those patients were then sandwiched back to nebulized formulation, which is the lowest resistance device because you just do it with regular breathing pattern. So it is an absolute -- the competitor is struggling with an absolute issue of intolerance to the formulation and they're having -- by using that high resistance low flow device, it's, in our view, sticking in the upper airway and causing discomfort. What we've seen in ASCENT is a completely 180 to that. We've seen patients all tolerate the drug. There is mild cough, but it's not dose limiting. We're able to titrate the dose to levels above the therapeutic target that they suggest, and we're able to do that quickly. So I think it's not just the amount of drug that we can give. It's the pace at which we can give the drug. Because if you think about it, the patients are coming to their physician because they are having exacerbating symptoms like shortness of breath and they want to feel better and they want to feel better soon. So the way to do that is to have a therapy like YUTREPIA with the PRINT-enabled technology we just talked about, where they can rapidly get to therapeutic dose. And then really, you can tweak to taste in terms of tuning them up based on their individual response to the drug. So that's the flexibility that YUTREPIA is going to bring to this marketplace, which is a completely new paradigm. And as I said in the opening, we think can change the standard of care for patients, both with PAH and PH-ILD.

Okay. And you are conducting the open-label ASCENT trial currently in PH-ILD patients to kind of highlight these differentiating attributes. So maybe just give us an update on where that study currently is and when we could start seeing data -- more data, I guess?

Yes. So we recently, in our earnings call, we talked about the efficacy correlation with those first -- the first 20 patients at 8 weeks, and we saw a positive 26.4-meter change as a mean change. So what you -- we're going to next present data at ATS. So our Chief Medical Officer, Dr. Rajeev Saggar, has a poster presentation at ATS. And in that study, we will show more mature data, both from that patient subset and from other patients. And we'll talk about some things like we've done longitudinal assessment of cough through a validated cough score. So I'd ask people to tune into the ATS poster that Rajeev is going to present. We announced also that we have completed enrollment in that trial. So we concluded that study with over 50 patients. And then it's a 48-week study. So patients are running through the year, and we'll continue to develop and mature data in that sample. But again, everything that we hope to achieve, at least in the early subset of patients that we've been able to see the data from looks very promising.

And would the ASCENT data ever find itself in the label of YUTREPIA? Is that something you could submit to FDA to augment the label at some point?

Yes, great question. So it's an open-label study. And because there's no control group, it won't be part of an indication claim, but where we will -- we definitely will have to add it to the safety summary. And we could potentially add it to the clinical pharmacology section because it certainly describes experience with YUTREPIA in patients with PH-ILD, which I think the FDA will be keen to add to the label in the clinpharm section, but not in the indication section.

Okay. And how would you describe the level of awareness of YUTREPIA and its differentiation versus TYVASO within -- I imagine patients still aren't aware of it just because it hasn't been approved unless they're part of the ASCENT trial. But from a physician and patient perspective, just the level of awareness of the product at this point?

Yes. Great question. So clearly, we haven't been able to promote. And I think the audience that you mentioned that's done the clinical work with the drug certainly is aware of the attributes and advantages of YUTREPIA. In PAH, that's a very tightnit community that's been using prostacyclin since the early '90s. And they understand that prostacyclins are a hallmark of treatment and a mainstay. And I think there's general awareness in the PAH community about YUTREPIA as an alternative to TYVASO and TYVASO DPI. Certainly, there's more to do there because we have not been able to talk about it in a promotional way. Probably less awareness in the PH-ILD community other than what's in ASCENT. The good news about ASCENT is because we're presenting it at major congresses like ATS, there's massive physician bases there that get the abstract book and can attend the abstract talk that Rajeev will give. So there's growing awareness there, but certainly, we have more work to do, and that's going to be the primary focus of our field sales force and medical affairs teams to help drive that awareness in the near term.

Okay. So like you said, we'll see more data at ATS. I imagine you'll be active with publications. Do you also plan on having a sampling program at launch so that patients and physicians can trial YUTREPIA as they think about transitioning or just get more experience with the product?

Yes. So I won't talk today about our full suite of services. In 45 days, we'll go live with sort of the game plan. And I think you'll find that we've considered every available option and are looking to bring this therapy at full speed and full force to the marketplace.

Got it. Maybe just to wrap up our conversation on YUTREPIA. Can you just get an overview of the IP around the product?

Yes. So the IP extends into the late 2030s. A lot of that's around the PRINT formulation technology. And again, it's a -- there's some trademark, know-how and show-how that we have as well. So we have a very long runway for YUTREPIA to continue to have a protective landscape.

Okay. And we should talk about the L606 program. I know most of the focus is on YUTREPIA, but you do have a pipeline, and I feel this program is pretty exciting for both PAH and PH-ILD. So maybe just give us an overview and how it differs from current inhalables.

Yes, absolutely. So in a way, like the way we look at L606 is moving from strength to strength and that L606 has the potential to deliver on all the advantages that YUTREPIA ports, but it's going to do it in a twice daily format via the sustained release liposomal formulation. So L606 is an in-license with our partner, Pharmosa, and it basically creates liposomal droplets of treprostinil that are -- that depot in the lung and are released over time when they hit the certain salinity and control its rate of release. What happens because of that sustained release is we take the Cmax down and we sustain the duration of therapy, and we can do it in a manner so that we're as best we can trying to mimic parenteral delivery where you get to steady state. So why we're doing twice a day is because we want to provide overnight coverage. So because it's important that the peak and trough performance of the drug be similar. So if you were on a parenteral therapy, a pump therapy where you're getting continuous infusion, obviously, the kinetics don't change. They only change with dose. So once you're at steady state, there is no peak or trough performance difference. So we're trying to get as close to, a, no difference in that kinetic profile so that the peak and trough performance can be the same so that when a patient wakes up in the morning, they don't wake up short of breath because with current therapies, they're basically off drug during the overnight period. And so here's what -- here's the beauty of L606. So YUTREPIA solve for tolerability because of PRINT, titratability because of PRINT, portability with a DPI, but the regimen is the same as TYVASO in the sense that it's still 4 times a day. So there was the one thing we didn't improve. What we're trying to improve on with L606 is also the regimen and move it to a twice a day. It will be tolerable and titratable because it's in a liposome with a sustained release, so we can give you 12 hours of drug in just one session, because we're dropping the Cmax and continuing to cover the AUC over that 12-hour period that you would normally take 2 other sessions to complete. So all of the advantages that YUTREPIA brings in a different way, not with PRINT, but with liposomes, but now in a twice-a-day format. And the reason I want to stress that peak and trough need to be similar is because we could have chosen to do L606 once a day. And you would have seen a very good peak effect, but a lower trough effect because the drug would have -- its exposure would have abated over the 24-hour period. But that's not what you want to do. And so we're trying to get it more smoothed out, closer to a parenteral like steady state. So we're getting a pseudo steady state, if you will with a twice-a-day formulation because, again, therapeutically, the goal is to manage those patients for the 24 hours, not just for their -- for 12 hours, for example. So there's other people in development that are doing a once-a-day formulation -- longer-acting formulation. But what they've recently shown is they don't have a 24-hour effect on 6-minute walk distance. That's not what you want. You definitely want to see a walk effect at trough that is as close to peak as possible. Even with TYVASO in its studies in PAH, there was only about a 35% diminution from peak to trough. So we're trying to like get rid of that diminution in peak to trough effect. And it's important when you think about developing a next-gen therapy that is improving the regimen that you manage the trough effect as best you can.

Okay. And I believe there was an ongoing Phase II trial with L606, and you had plans to initiate a Phase III in relatively near term?

Yes. So L606, there was an open-label study. There's 28 patients in that, that we're not enrolling for other patients, but there's -- all of those patients, I believe, have now gone over a year. And the therapy is performing again exactly as we'd wanted. Those patients are clinically well managed on a twice-a-day treatment regimen. We were -- we've been in negotiations with the FDA and EMA about IND-enabling work and Phase III registration studies. The FDA has agreed that a single study in PH-ILD will serve for approval in both PAH and PH-ILD. And it's our -- we're working hard to get that study started at the end of the year. That's a global Phase III study and over 100 centers, around 350 patients will be studied. And again, it will look very similar to the original TYVASO nebulized PH-ILD study in terms of how it's constructed. So it's just a matter of doing that same study and showing that same result showing it with L606.

Got it. We only have a few minutes left. So maybe I'll ask Mike to give us an overview of financials in terms of free cash balances. I think that's important in the current environment and what you're looking at in terms of operating runway. And I think you even started talking about maybe profitability time lines that are on the horizon.

Yes. So as you know, we ended Q4 with about $176 million in cash. We also, in the last month, entered into an amendment with HealthCare Royalties to add up to $100 million of additional capital. As you know, we've already drawn $100 million on our current facility from HealthCare Royalties. As part of the amendment, we drew an additional $25 million at the time of signing. We will then have access to $50 million after the first commercial sale of YUTREPIA in PAH and PH-ILD. And then a final $25 million will be available at mutual option once YUTREPIA reaches $100 million of net sales no later than June 30, 2026. So, since Roger has been here, we've really focused on fortifying the balance sheet, having strength on our balance sheet while also being disciplined in our investing. What it allows us to do now is -- and what we said is what you're referring to is we feel assuming that we are able to launch in the time period that we talked about here in Q2 and we reach our targets, we actually feel that our current capital along with what we have access to in the future with HealthCare Royalties could bridge us to profitability, and we could be profitable as a company within 3 or 4 quarters after launch. So I think that's very important, especially given the current environment, also allows us to fully invest into the launch, fully fund the L606 pivotal Phase III trial while also putting YUTREPIA on a launch trajectory that would allow us to be profitable with the capital that we have on hand.

Got it. Okay. Maybe just to finish off, is there anything you believe remains underappreciated or misunderstood by investors as we head into the home stretch for the approval and launch of YUTREPIA here?

No. I think you've hit all the seminal points today, Serge. We appreciate your time and attention to Liquidia and our emerging story. We're just -- as you've heard, we're very keen and passionate about the opportunity to launch this drug and provide choice to patients.

Great. Well, Roger and Mike, thanks for joining us today. We appreciate learning more about Liquidia and the YUTREPIA story.

Thanks.