Liquidia Corporation

Good morning and welcome everyone to Liquidia Corporation third quarter 2024 financial results on corporate update conference call. My name is Michelle and I will be your conference operator today. 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, Michelle. It's my pleasure to welcome everybody today to the Liquida Corporation Third Quarter 2024 Financial Results and Corporate Update Call. Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Operating Officer and CFO Michael Cassetta, Chief Medical Officer Dr. Rajiv Sagar, Chief Commercial Officer Scott Lumaw, and General Counsel Rusty Schundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I'd now like to turn the call over to Roger for our prepared remarks, after which you will open the call for your questions.

Good morning, everyone. We're pleased to be speaking with you today. With the significant progress made over the last few months, we now have a clear line of sight to seeking final approval of eutrapia for both PAH and PHILD patients. Final approval could occur following the expiration of Tyvaso DPI's clinical exclusivity on May 23, 2025, or in just a six-month time. 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 eutrepia was proper, and therefore has determined that we have met the regulatory requirements for approval for PAH and PHLD pending the expiration of Tyvesa DPI's clinical exclusivity. And second, with the Supreme Court's decision in September to deny SIRT, 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 eutrapia. As mentioned, the sole item cited by the FDA that is blocking final approval of eutrapia is the new clinical investigation exclusivity that was granted to Tyves and DPI, 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. 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 eutropia in PHILD patients, as well as advancing our next generation sustained release program, L606. We feel the combination of eutropia and L606 gives us a compelling portfolio of treatment options for the delivery of inhaled tryprosinol to treat PAH and PHILD patients both now and in the future. On a related business front, in this quarter we have expanded our relationship with Pharmosa with respect to L606, amending our license agreement to include the EU and other territories outside of North America. We have also entered into a device license agreement with Pharmosa to secure rights to proprietary next generation nebulizers for administration of L606 in a small portable breath actuated nebulizer the size of an iPhone. Rajiv 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 financings in September. Mike 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.

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 Tyvesia DPI, which has delayed the final approval of Eutrepia. 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 nebulize Tyvesia in PHILD that was based on the increased trial, which studied safety and efficacy of nebulized Tyveso in PHLD patients. Unlike the increased 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 for which exclusivity can be granted. This belief is bolstered by the FDA's own initial decision not to grant any exclusivities to Tyveso BPI when it was first approved in 2022. For this reason, we continue to believe that the FDA's decision should be vacated, and liquidity should be allowed to bring a trepidator market for the benefit of patients immediately. 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 5th, 2024. And regardless of the outcome of the lawsuit, though, nothing can delay the scheduled expiration of the exclusivity for Tyvesa BPI on May 23rd, 2025. As part of our lawsuit against the FDA, United Therapeutics has filed cross-claims challenging again the appropriateness of the amendment to add PHLD to the eutrepia label. 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. We continue to believe that these cross-claims have no merit and that Liquidia properly amended the NDA for eutrepia to add PHLD, a position that the FDA agreed with when they issued tentative approval for eutrepia in both indications in August. 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. 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. The 327 patent generally covers the treatment of PHLD patients with Tyveso in accordance with the dosing regimen in the Tyveso label. As we have noted previously, there is considerable prior art that teaches the treatment of PHLD patients with Tyveso, 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 Tyveso. Also, as previously disclosed, United Therapeutics sought a preliminary injunction to block the launch of eutrapia for the treatment of PHLD patients based on the 3T7 patent and is denied by the court. The trial is now scheduled for June of 2025, and we look forward to resolving the validity of the 3T7 patent at that time. With that, I'd like to turn the call over to Rajiv to summarize the clinical progress to date.

Thanks, Rusty. I'm excited to report on the continued positive momentum in Liquidia's clinical programs with Eutrepia and L606. First, let me provide an update on the open-label ASCENT study, which is evaluating the safety, tolerability, and efficacy of Eutrepia in patients with PH ILD. We have now doubled the number of clinical sites during the past quarter, with 21 of the 22 planned sites now active. 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. The preliminary data emerging from the ASCEND study in PAH ILD patients is highly encouraging in regards to tolerability and titratability, and it is generally consistent with the observations from our Pivotal Phase III INSPIRE study in PAH patients. As anticipated, with our print formulation coupled with our low effort dry powder inhaler, patients who have completed eight weeks of treatment have been able to tolerate antitrate eutropia 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. This dosing observed in the SENS study through week eight is up to two times higher than the comparable doses administered in both the increased study with nebulized tibeso at 16 weeks and what is typically used in clinical practice. 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. After week eight, patients have continued to titrate higher, and we look forward to reporting the full data set from the study when it completes next year. Now, turning our attention to L606, our sustained-release liposomal treprostenol suspension formulation delivered twice daily, we are now solely focused on initiating our placebo-controlled global phase 3 study in PHLD called RESPIRE. Given the favorable safety and tolerability data observed to date in the open-label U.S. trial in PAH and PHLD patients, we have decided to stop enrollment in this very study with a total of 28 patients enrolled. 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. 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. We've decided to use this new device in our pivotal study, which will push initiation into the first half of 2025. More details on the pivotal study design and the device will be shared in the near future. I would now like to pass the call to Mike Cassetta to review the financial performance from the third quarter. Mike?

Thank you, Rajiv, and good morning, everyone. 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. 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 into the company as announced in September. 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. 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 of 2024 compared with $3.7 million in the same quarter of 2023. Revenue related primarily to our promotion agreement with Sandoz to commercialize tryprosinol injection. 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. Cost of revenue remained consistent at $1.7 million for the third quarter of 2024 compared to $0.6 million in the same quarter for 2023. Cost of revenue related to the promotion agreement mentioned earlier. The increase from the prior year was primarily due to our Salesforce expansion during the fourth quarter of 2023. 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. 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 in clinical expenses related to our L606 program, and a $2.5 million increase in expenses related to EUTREPIA research and development activities, including the ASCENT trial, offset by $1.5 million lower commercial manufacturing expenses, reflecting the impact of expensing EUTREPIA inventory costs in the prior year. Moving on to general and administrative expenses, there were $20.2 million in the third quarter of 2024 compared to $10.6 million in the same quarter for 2023. 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 higher headcount and expansion of our sales force in the fourth quarter of 23, a $1.5 million increase in legal fees relating to our ongoing EUTREPIA related litigation and a $0.5 million increase in commercial expenses in preparation for potential commercialization of EUTREPIA. In summary, we incurred a net loss for the three months ended September 30th, 2024 of $23.2 million or 30 cents per basic and diluted share compared to a net loss of $15.8 million or 24 cents per basic and diluted share for the three months ended September 30th, 2023. With that, I'd like to now like to turn the call back over to Roger. Roger?

Thank you, Mike, and thank you, Rusty and Rajiv, for also sharing those insights. Operator, I would like to now open the call for questions, please.

Thank you. To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask that you please limit yourself to one question. One moment while we compile our Q&A roster. Our first question is going to come from Julian Harrison with BTIG. Your line is open. Please go ahead.

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?

Good morning, Julian. Nice to hear from you. Rusty, if you could respond on that, please.

Sure. Julian, thanks for the question. So as far as timing for a response, typical with any proceedings with a judge, it's hard to predict in advance. You know, there's no set timeline or deadline for judges to rule, and so it's really hard to give any guidance on that point. As far as the range of outcomes, you know, they're the typical range of outcomes for any Administrative Procedures Act proceeding. 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.

Okay, great. Thank you. That's very helpful. And then quickly on the Ascent 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 data would be great.

Yeah, thanks again for the question. Rajiv, if you could comment on the timing of the data disclosure.

Yeah, thanks, Julian. Good to hear from you. You know, as you know, this is an open-label study. We continue to look at the data sets, and with a 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 if accepted, then we anticipate showcasing that data in the first half of 2025.

Excellent. Thank you again.

Great. Thanks for that, Rajiv. And I think the thing I would add to that, Julian, is I think you're going to see some, you know, some critically important information that differentiates the value of eutrophia, particularly as it relates to dose, the ability to quickly get to dose, the impact of driving that dose in terms of clinical outcomes. And then also, you know, we'll disclose data on the persistence and durability of treatment within that patient subset. So I think, you know, if we can show tolerability, titratability, and durability all through the patient-friendly low-resistance device, which we think will lead to greater persistence, 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 tubase or DPI to this point. Thank you. Next question, please.

Thank you. One moment. 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. A couple from me. Just as you think about a Utrepia launch, just wondering if we should be thinking about any points of friction 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, next year, if I got that right, the design's not formalized, but should we generally think about increase as providing a good framework for a type of study that you'd be running? Thanks.

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, Rajiv can speak to the L606 Pivotal plan in timing.

Jason, thanks for the question. Relating to access, we've been prepared to launch Utrepia since we received kind of approval in 2021. We've been engaging with payers to talk about the value proposition that Utrepia brings. You know, as a result of those conversations, I think we feel confident that, you know, access is obviously our goal and something that we're confident that we're going to be able to obtain. 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.

Great. Thanks, Mike. So, Rasheed, maybe you can speak to how similar our design is to the increased study. and then kind of what we're thinking about in terms of sample size and time.

Yeah, sure. Thanks, Jason. So, you know, 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 the twice-a-day format for L606 is quite game-changing here in terms of the patients, in terms of compliance and performance. The next step is really to you know, ensure that the nebulizer is the right one for the patient. I think the nebulizer that we have chosen absolutely will ensure that the key motif for any nebulizer is drug deposition. So we believe we've hit that target. We think that's going to maximize our performance for L606 in patients with PHLD. In regards to the overall patient, sorry, the trial format, I think using increase as a replicable study is important to note. I think, you know, understanding that these patients can improve six-minute walk distance within certain time periods is going to be critical. So I think we use that as a rough estimate. 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 timeframe.

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, 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 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.

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

Hey, good morning, and thanks for taking the question. It looks like the eTrepi launch is pretty well set and preparations are ready. So I wanted to ask about L606. 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.

So, 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 Rajiv said in his opening comments, we plan to start the trial, initiate the trial in the first half of 25. 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, 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 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-US territories where Tyveso and Tyveso DPI are not available, i.e. in the EU, China. South America, Australia, et cetera. 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. We certainly have a lot of management experience in doing these types of trials, for sure. So I'm confident that once we start, we'll get the goal. The reason I think we could potentially be The timeline is because of the massive unmet need for these patients with PHI-LD. And as we maybe didn't say on this call, but have said before, this study will serve for approval in the US for both PH and PHI-LD. That's the agreement we have with the FDA. 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. I'm also very pleased with that partnership. What the expansion also came with, as we said, was the acquisition of rights to their next generation nebulizers. And these are very different than the current nebulizer. If you think about it, the Tyvesio nebulizer was in development 20 years ago. So it's a dated nebulizer that's bulky and cumbersome. This is a nebulizer the size of an iPhone, portable, breath-actuated, and 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 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, if you would ask, why aren't you starting now? We have to just close up shop in terms of doing compatibility work with the new device. That work's 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. So, you know, again, we'll give you more clarity as we progress with enrollment in terms of timing, but if you 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, Frank.

Thank you. One moment for our next question. Our next question comes from the line of Kambiz Yazdi with Jefferies. Your line is open. Please go ahead.

Good morning, Kane. For that open-label safety study, how many patients achieved greater than 100 micrograms twice daily dose? Have they been consistent with prior propranol studies? 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.

Yeah, so the first question on dosing Rajeev, if you can provide what we're going to be able to speak to at this time. And then, Mike, if you could talk about going forward after that. Rajeev?

Yeah, sure, Kambiz. Thanks for the question. So, in regards to achieving, you know, greater than 100 micrograms twice a day, you know, I would say the overwhelming majority of patients, if not, you know, close 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 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 and the sustained release process has lent 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 overall titratability of this, of L606 in both populations. So we remain quite confident about the overall safety and tolerability profile of this drug.

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 Tyveso as a nebulized solution. So, again, a different profile, much like Eutrepia, where Eutrepia is formulated as discrete, you know, dry particles in the lower end of the respiratory range. That delivers to the lower lung to avoid upper airway deposition and AEs. Here, the liposomal formulation diminishes the 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. It retains the titratability aspect, which is critical, and then allows for higher doses, higher opiates. higher benefit and we think higher persistence, but does it in a twice a day format. So it has all of the good of Utopia, 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 supply.

Yeah, absolutely. Great to talk to you, Kambiz. So we've been preparing to launch since we received kind of approval in November of 2021. We've been manufacturing commercial supply Since the early part of 22, we will be ultra prepared for a launch here upon the expiration of the 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 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. Our next question comes from the line of Corey Ubenville with LifeSide Capital. Your line is open. Please go ahead.

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? I guess On the FDA hearing in December, assuming the case is ruled in Liquidea's favor and in an optimistic scenario, how quickly would this expedite timelines in relation to the May 23rd tentative approval date? And then across the two indications on the 793 patent decision, is it fair to say now that the EUTREPIA launches, specifically in PAH, now totally unencumbered following that May 23rd tentative approval date, and 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. taking the questions in turn as far as the effect of the fda lawsuit um you know it's hard to to 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 um uh you know for instance if the decision was to narrow the exclusivity versus just eliminate the exclusivity we would have to assess you know what that means as to the um 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 takeaway from our standpoint on the FDA decision is we know the exclusivity ends in May of 2025. 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 On the 793 decision, you're correct with that making its decision to deny certiorari. That means that the first three patents that were asserted against us are no longer, that litigation is now dead. There are no claims that therapeutics is asserting against us or the FDA related to approval of PAH. So from our perspective, 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, 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 and we look at the patent landscape and don't see any patents that we think are valid and infringed by our products, 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 discovery in the 327 patent case. But, 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. Thank you, Rusty. Operator, I think we have time for one more question, if there's any.

All right. One moment for our next question. And it looks like our next question is going to come from the line of Matt Kaplan with Lattenberg Thalmann. Your line is open. Please go ahead.

Hey, guys. Good morning, and thanks for taking the question. Most of my questions have been asked. Just in terms of launch preparation, given the near-term opportunity here 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, et cetera, in terms of your commercial footprint when you're launching.

Yeah, and we're fortunate to have Scott Muma, 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 and Salesforce sizing around that.

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. Most of them are from the pH space and have launched multiple products in pH. So we're very excited about 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, 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 medications, but certainly have pH ILD patients in the pool in their offices. And so 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 that'll be willing to treat them. So we think there are probably about 6,000 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 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.

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

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 PharmOSA 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.

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 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 Rajiv nicely described the important aspects of it, that it's an iPhone-sized, breath-actuated, rechargeable, highly portable nebulizer that's very good at the delivery of the drug 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.

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 covered asking so many questions, and we look forward to providing further updates in the coming quarters as we continue to advance our march towards launch of Utopia. Thank you, everyone.

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