Liquidia Corporation (LQDA) Earnings Call Transcript & Summary

Good morning, and welcome, everyone, to the Liquidia Corporation conference call. My name is Michelle, and I will be the conference operator today. [Operator Instructions]. I'd like to remind everyone that this conference call is being recorded. I'll now hand the call over to Jason Adair, Chief Business Officer. Please go ahead.

Good morning, everyone. Thanks for joining us today. Whether you're a patient, a physician, a partner, an investor, a member of the media or one of our own Liquidia teammates, welcome. We're so glad you're here with us for what is truly a milestone moment. I'm joined today by a group of colleagues who've been instrumental in getting us to this point. On the line are CEO, Dr. Roger Jeffs; COO and CFO, Michael Kaseta; Chief Medical Officer, Dr. Rajeev Saggar; Chief Commercial Officer, Scott Moomaw; and General Counsel, Rusty Schundler. Before we get to the exciting news, we're here to share, I do need to remind everyone that today's presentation and our responses to questions may include forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause our actual results to differ materially. For more information, please refer to our filings with the SEC, which are available on our website. With that, I'll hand it over to Roger, who will refer to the accompanying slides during his prepared remarks. Roger?

Thank you, Jason. It's truly an honor to be speaking with everyone today. As someone who spent the majority of my career working on prostacyclin therapies, I can say without hesitation that this moment is incredibly meaningful. I've seen firsthand the impact prostacyclin therapies can have. And I've also seen the limitations that patients and providers have had to work around. So today, I'm both proud and humbled to introduce the most recently approved treprostinil-based product, YUTREPIA. On Friday, the FDA granted final approval for YUTREPIA for the treatment of pulmonary arterial hypertension, PAH, and pulmonary hypertension associated with interstitial lung disease, PH-ILD. This approval is more than just a regulatory milestone. It's a breakthrough for patients in the defining moment for Liquidia, representing the culmination of years of persistence, beliefs and innovation and it opens the door to a new era of treatment, one where patients and physicians finally have a choice in how inhaled treprostinil is delivered. Let's take a closer look at what we call the power of prostacyclin and what makes YUTREPIA unique. On Slide 4, you'll see a graphic that brings this to life. What we've achieved here is more than just a new formulation. YUTREPIA offers the potential to rapidly escalate doses of prostacyclin with ease. This is the first product ever approved using our proprietary PRINT technology. That's a big deal. PRINT allows us to engineer drug particles with uniform size and shape in the low end of the respirable range to preferentially target deep delivery into the distal airway, where it matters most for patients with pulmonary hypertension as this is the site of injury. PRINT also enables the use of a device that's familiar to pulmonologists and widely used by patients across other respiratory conditions. It's a low-resistance dry powder inhaler, which requires minimal patient effort, is readily available and easily portable. The blister pack capsules allow a full day's dosing to easily slip into a purse or a pocket. And then there's the dose range, thanks to the large study we conducted in PAH patients. We've shown that YUTREPIA can be safely titrated, to significantly higher levels than the target maintenance dose for existing inhaled therapies. That flexibility gives physicians more control and gives patients a broader opportunity to respond to and maintain therapy. So when we talk about the power of prostacyclin, we're not just talking about the molecule. We're talking about how we've reimagined its delivery, its usability and its potential to impact patients needing inhaled treprostinil as described in Slide 5. In PAH, we're entering a well-established market, but one that's far from satisfied. Thousands of patients are still looking for a better, more tolerable way to add prostacyclin to their treatment plan or to elevate their dosing to better manage their disease, including those who have off-target side effects typical of oral and parenteral prostacyclin therapies as well as those managed at suboptimal doses of inhaled treatments. And in PH-ILD, the need is even more urgent. Inhaled treprostinil is the only approved treatment and for many patients, it's a lifeline. But this is still a relatively new space. it will take time for the clinical community to fully understand how and when to use it. That's why we're committed not just to launching a product, but to drive an awareness, education and diagnosis of a disease where only approximately 35% of patients survived 3 years after diagnosis. That's a staggering statistic and a call to action. We believe YUTREPIA can change that story, and we're ready to lead the way. So let's look at some of the components of the approved labeling that our team will be using to educate the medical community. Slide 6 shows a snapshot from YUTREPIA package insert and a few key points I want to highlight. First, we have a full label. YUTREPIA is approved to treat both PAH and PH-ILD, which gives physicians the confidence to describe it across both indications. Second, the dosing and administration are straightforward. And finally, the most common side effects are consistent with what physicians already know about inhaled treprostinil. However, looking further into the package insert, you will see other areas where our INSPIRE study helped create differentiation. Slide 7 describes one of the most important distinctions with YUTREPIA, the breadth and depth of our dosing data, which translates into real clinical flexibility. We've generated robust evidence supporting initiation at the lowest dose for prostacyclin-naive patients with the ability to titrate upward across a wide therapeutic range. That same flexibility applies to patients transitioning from nebulized treprostinil. In fact, the dosing range we've studied in INSPIRE extends to doses that would be comparable to 24 breaths of nebulized TYVASO 4 times daily. In the open-label extension study, we continue to titrate and treat PAH patients for the last 6 years with some patients administering doses comparable to 36 breaths per session of TYVASO. Additionally, we can clearly discuss with physicians for safety and tolerability findings, regardless of prior prostacyclin exposure. That gives physicians the confidence that they can personalize treatment without compromising safety and feel confident that they can initiate a dry powder inhaler without needing to start on a nebulizer. This is the kind of data-driven flexibility that physicians want and patients deserve. We're also becoming equally confident in YUTREPIA's tolerability in PH-ILD patients from our ongoing ASCENT trial, shown on Slide 8. In the ASCENT study, we're seeing that patients are not only able to initiate therapy, they are titrating at 2 doses at or above what was previously considered the therapeutic maintenance dose. At the ATS conference last week in San Francisco, we presented data showing that PH-ILD patients achieved a median dose 132.5 micrograms at 8 weeks, with some reaching as high as 238.5 micrograms. Importantly, the simplified cough score showed no meaningful increase in cough comparable to baseline. This is a clear example of how PRINT technology and low effort dry powder inhaler may offer a better experience for patients with PH-ILD patients who are already prone to cough and often struggle with existing inhaled therapies. We believe this combination, PRINT formulation, low-effort device and demonstrated tolerability has the very real potential to position YUTREPIA as a preferred option in PAH and PH-ILD patients, and we are ready to meet the demand. Slide 9 shows that we've built a comprehensive suite of patient access programs to ensure that affordability is never a barrier to treatment. These include co-pay assistance, free vouchers for eligible patients and bridge programs designed to support patients through coverage transitions. Our commitment is simple, access to innovation should be based on clinical need, not financial means. In addition to financial support, we're offering a full suite of patient services to help ensure a smooth and confident start on therapy from in-home or virtual training to adherent support, to ongoing education for both patients and care teams, our goal is to make the experience of starting and staying on YUTREPIA as seamless and supported as possible, which brings me to the commercial team who has been anxiously awaiting this opportunity to bring their plan to life. Our commercial team described on Slide 10, is ready to reshape a market that has lacked meaningful choice and a new voice. We're bringing competition, clarity and most importantly, hope. Our commercial team is fully mobilized. Detailing begins today, and we expect YUTREPIA to be in the channel within the next 14 days or so. Our field team of experienced professionals with deep expertise in rare disease and pulmonary hypertension will be engaging physicians across specialty centers and community practices who treat PAH or PH-ILD or both. Our initial focus is clear, to reach newly diagnosed patients and existing patients with unmet need. We will expand options, elevate care and along the way, switch some unsatisfied TYVASO patients. The infrastructure is ready. The supply chain is in place, payer engagement is well underway, and our patient support programs are live. We're not easing into this. We're moving with purpose, precision and urgency. This is a moment we've worked towards for years, and we're ready. For the first time, physicians and patients have access to a dry powder of prostacyclin that combines precision, ease of use and flexibility in one product. YUTREPIA has now approved, we are fully prepared, and we are committed to broad patient access. We believe YUTREPIA has the potential to become the prostacyclin of first choice for any patient who may benefit from the power of prostacyclin therapy. And we're confident that every stakeholder, patients, providers, payers and partners will see the value in what we've built. With nearly $170 million in cash on hand at the end of March. We are well capitalized to support a successful launch. We have confidence in our go-to-market strategy and operational readiness. Based on our projections, we believe that we could achieve profitability within 3 to 4 quarters after launch. Lastly and importantly, we would like to extend our sincere gratitude to the patients, caregivers, investigators, partner and Liquidia employees, who participated in the clinical development of YUTREPIA, both firsthand and behind scenes. Your dedication and perseverance has paid off and the impact will be great. And with that, we're excited to open it up for questions. We know there's a lot of interest today and likely a lot of questions, so we'll aim to take 1 or 2 per analyst to keep things moving. But this is just the start of the conversation. We look forward to connecting with many of you in the days and weeks ahead. Operator, let's take the first question, please.

[Operator Instructions] The first question comes from Julian Harrison with BTIG.

Congratulations on this much awaited milestone. First, I'm wondering to what extent you expect the study sites from INSPIRE and ASCENT to convert to early commercial adopters of YUTREPIA? And then payer coverage, can you talk more about what that looks like now and how you expect that to trend through the remainder of 2025?

Julian, thank you for the congratulations. Certainly, a wonderful day here for all of us at Liquidia. In terms of study sites that may convert to rapid adoption, I think their experience to date has been favorable. Obviously, the data, it's very data-driven. I think they are engaged in the innovation and scientific support that we're trying to provide for the product. So we're not speaking about what it may do. We're actually showing what it can do. So I think those sites, many of whom are major thought leaders in this space, both in PAH and PH-ILD, will lead the charge, so to speak, as we look to launch this product and engage centers both in the centers of excellence and in the community. With regard to payer coverage, maybe I'll ask Mike Kaseta, if he could provide a few comments on that.

Yes. Thanks, Julian. As it relates to payers, as we've said from the very beginning, we want to make sure patients have an opportunity to choose. In order to provide that choice, we need to make sure there are no barriers relating to access. So we've been working hard over the last several years talking about the value proposition YUTREPIA can bring. We feel confident in our ability to deliver on that. And we're working hard to make sure that we are able to achieve that broad access that we feel that we can achieve during this launch period in the coming months, both in Part D and in commercial.

And our next question will come from Serge Belanger with Needham.

And also I would like to offer my congratulations. It's been a long, hard path to get here. So congrats. First question on the legal front. Just any other color regarding the pending TRO decision and whether you expect the next step to be a motion for preliminary injunction? And then secondly, on the commercial launch, are you ready to talk about pricing for the product today?

So I'll ask Rusty to answer the legal question and then Mike, will speak to it.

Serge, thanks for the question. So in the 782 patent case, which I think is the case you're referring to, at this point, we're just waiting to hear from the judge. I think we would expect a decision on the motion for at least temporary restraining order soon. He could also roll on the preliminary injunction in the same time frame or he could wait for additional briefing on that. So at this point, again, we're just waiting on the court. And could hear at any time really at this point.

And Serge, as it relates to pricing, so we will be pricing on a 28-day WAC supply at $24,000, $24,362. That equates to about $317,000, annually. And is at parity to TYVASO DPI.

And the next question will come from Kambiz Yazdi from Jefferies.

Congratulations on the approval. Long time coming. A couple of questions. Just a quick clarification on the WAC price. Is that going to be flat across the different dose pods? And then in terms of -- or sorry, the capsules. And then in terms of how will your commercial team approach kind of the value proposition for treprostinil naive or inhaled treprostinil naive patients compared to which patients? And yes, I guess those are my questions.

Great. Thanks for the questions, Kambiz. Mike, if you'll comment on the WAC flat pricing? And then Scott, if you'll address the commercial question.

Yes. So Kambiz, we currently have 4 NDCs at each of our capital strengths of 26.5, 53, 79.5 and 106 micrograms. So they will be, to your point, priced at flat pricing at the WAC prices that we talked about. And as we've talked about, one of the things that we are -- that Roger talked about in his prepared remarks were around being able to escalate dose. And one thing that we are working on is a co-pack program where we'll be able to combine NDCs. As we move forward, we needed to wait until after we got full approval to approach the FDA and our hope is here in the coming months that we can introduce that for SKUs up to 212 micrograms.

Great. Thank you, Mike. Scott, if you can comment on the commercial question.

Sure. So I think in Roger's second and third slide in, it was a good summary of how we're going to approach differentiation. Really, the message is about deep lung delivery. It's about a low-effort device, and it's about achieving doses that haven't traditionally been reached by inhaled prostacyclins. So that's sort of the message that the team is going to be going into the field with maybe a bit more color on the strategy. So the goal here really is, one, to drive awareness, and we have a -- we have a very large program both through the sales representatives plus digitally, PRINT everywhere we can be where these physicians are, and we're going to drive awareness of YUTREPIA. And then behind that, we're going to drive trial. And we're going to get as many doctors to try this as can because we believe that they're going to have a great experience when they do that. And we're going to do that both in the big centers. And we're going to do that in the community as well, where our representatives have been creating relationships over the last 18 months.

And the next question comes from Cory Jubinville with LifeSci.

Congrats. Can you just walk us through some of the more nuanced points of depreciation on YUTREPIA's label. I noticed there's a potential for greater dosing flexibility with YUTREPIA 3 to 5x a day versus 4 times a day with TYVASO, where does that flexibility stem from? And are there any others to highlight throughout the label? And then I guess one on your commercial strategy. Can you walk us through the initial launch strategy as it relates to which prescribers you'll be targeting in the field first, thinking about how much bang you get for your buck in patient concentration? What percentage of PAH and PH-ILD patients are treated at these 140 specialty centers versus the 650 community practices? And does that differ between PH and PH-ILD?

Yes. Great question, Cory. So I'll ask Rajeev Saggar, our Chief Medical Officer. He'll talk about the nuances of the package insert and particularly the 3 to 5x dosing flexibility and what that imparts. And then Scott, again, he'll talk about commercial strategy and focus.

Yes. Cory, thanks for the question. So -- as you know, our NDA was used study -- the INSPIRE study for its approval. In that study, patients were given YUTREPIA 4 times a day. The goal of the therapy, as you see in the label, is to achieve a maintenance dose, a targeted maintenance dose of 79.5 to 106, 4x daily. However, as Roger also alluded to, obviously, one of our product profiles is that we can dose higher, but you will also see that we are allowed in the label itself -- that treatment timing can also be adjusted for planned activities that the patient needs. In other words, that customization can be allowed both in the timing of the treatment as well as the dosing frequency. So that's how the label sort of was created. But again, highlighting the goal is 4 times a day with the target maintenance of 79.5 to 106.

Great. And maybe, Scott, on the commercial strategy.

Yes, Cory. So I think to the first question about where we'll go first. So of course, the centers have many of these patients already, the centers of excellence. And -- so it will be our strategy and it would sort of be in the sales representatives best interest to go there, the old adage, fish where there's fish. So certainly, they will be visiting those centers starting today. Having said that, every launch I've experienced, there are some community physicians who get interested and anxious and are willing to try it, maybe early adopters. And you'll get some surprises out of them, too. So there'll be quickly moving to the community as well to make sure we're getting the awareness and trial that I referred to earlier from them. I think one of the reasons we put the numbers in the slide about 140 center accounts and 650 community accounts is to get a little bit to your question about kind of what's the distribution of volume. That one is a little bit hard for us to wrap our heads around until we get out there. But certainly, maybe 50% of the patients are in the centers, maybe 50% of the patients are in the community, and then longer term, as we know, that 50% is going to grow quite a bit in the community as we're able to get the education, diagnosis and treatment there as well.

Thanks, Scott. And I think what it points out also is that it's a very concentrated prescriber base, where we have very good share of voice with the commercial field sales team and the medical affairs teams that we put in place, and I think we'll drive awareness very, very quickly in these centers.

And the next question will come from Jason Gerberry with Bank of America.

And I'll extend my congrats as well on the approval. So for me, just a question, how do you envision SG&A evolving here post approval? I imagine there are additional selling and marketing costs beyond just the field force reps, which are already sort of factored into your trailing SG&A numbers. But when we look forward, and you made the comment, I think, about 3, 4 quarters in getting to a breakeven point. So I think it will be helpful for us to just understand the evolution of the OpEx here in the coming quarters? And then, on the pricing that was discussed, I think, annualized around $317 or something like that, what would you think might be a reasonable steady-state gross to net and average month for patient treatment based on legacy treprostinil DPI utilization?

Jason, that's -- both of those questions in Mike's court.

Yes, Jason, thanks for the question. As it relates to SG&A, I mean I think what we said previously and our SG&A is already fully loaded from a sales force point of view, so that's already included. And what I would say is that, that is the vast majority of our sales and marketing costs are our sales force. We will have some incremental marketing spend that we think will be -- will increase our SG&A negligibly. The only other part that will increase SG&A will be our selling costs relating to distribution. So they will be variable costs related to sales. As sales increase, there will be a pro rata increase, again, not overly significant. But the vast majority of our commercial costs are already included in our P&L. As Scott had said, there will be some incremental marketing costs digital, print, things like that. But when you look at in the big picture, it is those costs will be negligible. As it relates to pricing, we have not talked about where our -- where we feel our gross to net will sit. We feel that 50% of those -- approximately 50% of the business will sit in Part D. About 35% will sit in commercial -- in commercial insurers and then in government-mandated channels. So we're working with payers as we speak, like I said, our goal is to achieve broad access. And we feel confident that we can get there. And as we progress, as we move through, we will potentially provide more updates there.

The next question will come from Ryan Deschner with Raymond James.

Congratulations on the approval. Are you expecting any kind of a bolus in patients in the second quarter and/or the third quarter? And are you expecting any meaningful revenues in 2Q? And then I have a follow-up.

Yes. So Again, we're going to be in the market for a very short period of 2Q. So the initial orders will be to the specialty channels, and they'll be in line, I think, with early estimates of what the specialties think we need to have in stock to start patients reliably. So I wouldn't look for that the second quarter to be a big bolus, so to speak, of revenue or patients just because the time is constrained. I think then as we get into the third and fourth quarters of the year, obviously, we'll look for acceleration and growth as we begin to drive awareness at each of the centers that Scott talked about earlier. So I would look at it that way, sort of an initial entry point, getting familiar with the systems, getting -- price companion done and all of that, those sorts of things and then moving quickly into a growth phase.

Got it. And then on L606, has your strategy for this program or time line changed at all, now that YUTREPIA is approved?

Yes. No, not at all. In fact, I think, again, what we've tried to demonstrate over the past few years is that we're a company of innovation. So we've invested in studies in basically post tentative approval stage to continue to define the product profile so we can differentiate. The other aspect of that is we wanted to have a next-generation program that was -- has the potential to be incrementally better than even YUTREPIA, which we think is incrementally better than what's currently available. So -- this just gives us a bigger and broader opportunity to fund those types of studies like L606, which is a -- will be a Phase III registrational study that will start later this year. It gives us the confidence that we can leverage the infrastructure that we're building with the next-generation program. So it has tremendous synergy. We have expertise in the development of treprostinil programs in PAH and PH-ILD. And we'll have sort of commonality and collegiality with the centers around the world where we're going to do the study and impacted ATS we met with the steering committee members, while there, and there's tremendous excitement about L606 and what the twice a day dosing paradigm can provide, particularly in terms of overnight coverage and maintenance of effect for the 24-hour interval, which is the critical aspect of a next-generation sustained release program. So I think this just amplifies everything that we can do. As a company, it really sets the stage for us to be the company with the best portfolio of programs in pulmonary hypertension.

[Operator Instructions] The next question comes from Greg Harrison with Scotiabank.

Congratulations on the approval. First, how do you think that the inclusion of the dosing comparison on your label between TYVASO and YUTREPIA could help drive switching maybe among patients who aren't tolerating TYVASO DPI well? And do you see these patients as maybe low-hanging fruit for early switches? And then also wanted to ask, if you have a sense, yet of what metrics that you would be able to provide throughout the launch?

Yes, so maybe I'll have some leading comments and then ask Rajeev to comment on the dosing. I think to remind everybody on the call, we've already done switches from TYVASO nebulized. So part of the INSPIRE study, nearly half the population was patients who switched from nebulized TYVASO to YUTREPIA and did that flawlessly and with preference. So if you looked at -- what patients preferred after the switch, it was universal that 100% of patients preferred switching to YUTREPIA from TYVASO nebulized. So in PAH, that experience is there. What we said we're going to do and which we're working very hard to start soon, is a study in PH-ILD patients that are on either nebulized TYVASO or TYVASO DPI and begin directed transitions of those patients to YUTREPIA to see if we port the same benefits, which we clearly feel we will. And I think what it points out is, look, we're trying to do this in a very scientific and data-generated way. And we're unafraid to do it because we believe that the product profile of YUTREPIA is superior to TYVASO and TYVASO DPI, particularly, as it relates to dose flexibility. So I don't know, Rajeev, if you want to add to some of that. But I think one of the things we could do is, hopefully switch those patients who are unsatisfied on that ground TYVASO, TYVASO DPI and then satisfy their clinical outcome measures, i.e., make them feel better. And then also tune them up because we can accelerate the dose to a different and better place. So again, we think that has great promise, and we'll be quick to get that study done. There's -- again, we were at ATS last week and there's a lot of enthusiasm from centers who have expressed concern about their ability to use TYVASO, TYVASO DPI particularly in the [IOD] subset because of intolerant cough. And they're excited about trying to switch patients over and want to understand how to do that, and that's the point of this study as it would inform them. And then in terms of metrics, maybe, I'll give a few comments, and then maybe Mike, if you want to also add to that. I think what we'll do, Greg, in the early phase of our launch is try to give you some granularity because it's going to go through the [FPS] channels, and you won't have transparency to kind of how the demand curve is looking. So we can try to -- I think in the early phase give you some data, potential patient starts, for example early. And then over time, as revenues become the major driver, we'll blend to less granularity and more just topical types of description, similar to what other people in the space give. I don't know Mike, any other comments on that?

As Roger said, building on that, we'll look at new patient starts, potentially look at prescribers, unique prescribers and things like that. But I agree with Roger, that early on to give an indication of the success of the launch we'll taper off as we move through the early phase of the launch.

But we're -- I think it's a good question, Greg, and we're sensitive to the issue, and we'll try to be as transparent as we can be.

And the next question comes from Tiago Fauth with Wells Fargo.

And let me add my congrats on the approval as well. You guys have made a pretty compelling case on where it could differentiate versus TYVASO, fundamentally. But I'm curious, looking at the actual base of new patient adds. What is reasonable here given patient churn, new starts, PH-ILD expansion? I'm curious what is a successful launch in terms of patients on therapy by the end of the year? Or however you want to frame that. And the related question is related to near-term consensus numbers, if you have any comments on how comfortable you are around those -- how achievable they are in terms of how the curve may actually play out in commercial practice?

Yes. So again, we won't provide a forecast, I think we're just going to be in full operational mode, and we'll let the results speak for themselves. What I will say is the opportunity that Scott spoke about is new patient starts will be our first effort. And then once we get the depth and breadth of prescriptions around new patient starts, then I think there'll be a lot of inertia around switching those unsatisfied patients on either an inhaled treprostinil or on an oral therapy who are having a lot of off-target GI side effects, for example. So kind of looking at doing our approach to patients and growth in phases, if you will. And obviously, that will -- there'll be a different blend rate across different centers and kind of their own experience and rate of prescription of YUTREPIA. So -- having said that, I think the key metric that we've tried to express and how we'll look at this is that within 3 to 4 quarters, we believe we can drive to profitability. So I think that should give you a signal that we do feel this will be a fairly robust uptake and generate significant revenue, so that we don't have to access the capital markets repeatedly. So I think we're very confident in the product profile and in the opportunity. And I think we need to remind ourselves in PH-ILD for example, there's really only low double-digit penetration of that market and it's a market where there's extreme and dire need because patients are dying at a rapid clip. So we think, again, just driving awareness and educating both the centers and the community docs around the need to treat PH when it's associated with concomitant interstitial lung disease. And the gravity of that entails will be a pretty quick and easy story to tell. And then we'll have a drug paradigm that's very flexible and usable, as we say, because we've got an easy-to-use device with an well tolerated drug because as we've said in the prepared remarks, that we're not seeing in spite of pushing the dose, we're not seeing an exacerbation of cough. So that's a very different situation than what we hear anecdotally from physicians about the competitor molecule. So we think that alone will give us tremendous competitive advantage, and hopefully, we can quickly become the prostacyclin of first choice. And the second question, I'm not sure I picked that up. Mike, did you get that?

Yes. So as it relates to consensus, as Roger said, we're not going to speak to revenue targets. I mean what I would say is, we ended Q1 with $170 million of cash. We'll have access to another $50 million through our amendment with health care royalties, when our first commercial sale in both PH and PH-ILD goes out. We're very confident in our ability, as Roger said, to achieve that profitability. We feel we can reach profitability on the capital that we on hand plus what we have access to through that facility. And we're just focused on the launch. We're focused on bending the launch curve and focusing on bringing tremendous value to patients and shareholders alike.

I show no further questions. At this time, I would like to turn the call back to Roger for closing remarks.

Thank you very much. And it's been a thrill to be able to have this call this morning with everybody today. We're excited about the potential of YUTREPIA to really change the standard of care. We spent the time where we've been unfortunately fighting litigation by trying to trump that through innovation. And doing studies to basically improve our product profile and support it in a very scientific way. As we also described today, we're coming at this full steam with premiums, not only parity support services, but we what feel our premium patient support services, where we can have -- make YUTREPIA have access to patients in spite of financial consequences they may have. So really exciting time for the company. Mike, Jason and I will be at the Jefferies Conference next week. So we look forward to speaking again then soon. Thanks, everyone.

This concludes today's conference call. Thank you for participating. You may now disconnect.