NASDAQ:LQDA Liquidia Q4 2024 Earnings Report $13.68 +0.08 (+0.59%) As of 04:00 PM Eastern Earnings HistoryForecast Liquidia EPS ResultsActual EPS-$0.46Consensus EPS -$0.38Beat/MissMissed by -$0.08One Year Ago EPSN/ALiquidia Revenue ResultsActual Revenue$2.92 millionExpected Revenue$4.60 millionBeat/MissMissed by -$1.68 millionYoY Revenue GrowthN/ALiquidia Announcement DetailsQuarterQ4 2024Date3/19/2025TimeBefore Market OpensConference Call DateWednesday, March 19, 2025Conference Call Time8:30AM ETUpcoming EarningsLiquidia's Q1 2025 earnings is scheduled for Monday, May 12, 2025, with a conference call scheduled on Tuesday, May 13, 2025 at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by Liquidia Q4 2024 Earnings Call TranscriptProvided by QuartrMarch 19, 2025 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Good morning, and welcome everyone to the Liquidia Corporation Full Year twenty twenty four Financial Results and Corporate Update Conference Call. My name is Shannon, 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 the time for you to queue up for your questions. Operator00:00:20I would like to remind everyone that this conference call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer. Speaker 100:00:29Thank you, Shannon. It's my pleasure to welcome everyone to the Liquidia Corporation full year twenty twenty four financial results and corporate update call. Joining the call today are Chief Executive Officer, Doctor. Roger Jeffs Chief Operating Officer and CFO, Michael Caseta Chief Medical Officer, Doctor. Rajeev Sagar Chief Commercial Officer, Scott Mumma and General Counsel, Rusty Schumler. Speaker 100:00:52Before 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 would now like to turn the call over to Roger for our prepared remarks, after which he will open the call for your questions. Roger? Speaker 200:01:34Thank you, Jason. Good morning, everyone, and thank you for joining us today. We believe that 2025 has the potential to be a transformational year for the company as we further build upon the success of 2024, which resulted in the broadening of the tentatively approved label for Eutravia to include both the treatment of patients with pulmonary arterial hypertension or PAH and pulmonary hypertension associated with interstitial lung disease or PH ILD. There are four strategic imperatives that will drive our success and growth both in the near and long term. These are seeking to obtain final approval and launching new treatment in both PH and PHIL D as soon as possible after expiry of the gating clinical exclusivity on May 23 or just sixty five days from now. Speaker 200:02:21Secondly, we continue to advance the clinical profile of EUTREPEA to position that it's not only the best in class inhaled prostacyclin, but also the first in choice prostacyclin for all patients in need of an oral or inhaled prostacyclin who remain underserved by current alternatives third, building upon our commercial and medical prowess to compete fiercely for capture of material and enduring market share in this multibillion dollar and growing market segment And finally, to further evolve our mission of being a leader in the PH phase by continuing to leverage our development expertise to advance treatment options that have the potential to further improve the lives of patients like our Phase III ready next gen sustained release liposomal therapy L-six zero six. I'd like to take a few minutes to expand on each of these strategic goals. With regard to the first imperative of seeking to launch ETRKIA into the marketplace as soon as possible, I'm happy to say that based on the favorable legal decisions over the last few years, there are no legal barriers that currently impact the FDA's ability to issue final approval of ETRFIA after May 23, when the exclusivity exclusivity granted to our competitor will expire. Speaker 200:03:35It's also important to remember that when the FDA issues a tentative approval of an NDA, it means the NDA has met all requirements for approval but cannot be approved due to existing legal or regulatory barriers. In our case, the sole barrier identified by the FDA was the new clinical exclusivity granted to Tyvasa DPI, which expires on 05/23/2025. As directed in the tentative approval label, we plan to submit the request for final approval in the coming weeks. With regard to the second imperative of continuing to advance our studies to establish the clinical profile of Eutrepia, the medical community's interest in Eutrepia is increasing with particular interest in the data being generated from our ASCENT trial, the open label safety study of TRTREPREA NPHI patients. I'm happy to report Sorry, I have half a call this morning. Speaker 200:04:37I'm happy to report that we are on track to complete enrollment in the coming weeks with 50 or more patients in total to be enrolled. We continue to be encouraged by the positive patient response to escalating doses of EUTREPEA. As a reminder, at the J. P. Morgan Healthcare Conference in January, we showed the dosing and tolerability profile for the first twenty patients that completed eight weeks of treatment. Speaker 200:05:01We noted that the PHLD patients on Eutrepia were able to titrate to dose better three times the comparable therapeutic target of nebulized TAVAZA. And today, we're happy to share some new information from the ASCEND study. We've also been looking at exploratory measures of efficacy. One such measure is the change in six minute walk test at week eight. We are pleased to report in this same 20 patient cohort, the main change in baseline improved by 26.4 meters. Speaker 200:05:31While it is difficult to draw strong conclusions from cross study comparisons, it is worth noting that in the Phase III registrational study of nebulized TAVASO and PHIV patients, the INCRE study, active group patients had an observed mean improvement of six minute walk distance of 16 meters at week eight and twenty two meters at week 16. We are highly encouraged by this early efficacy data from Ascent as it demonstrates that atrial fibrils the key therapeutic attributes in PHIL D we aspire for it, specifically being well tolerated and amenable to rapid dose escalation to doses well beyond historical standards, leading to an accelerated therapeutic outcome that is in line or better than published results of existing therapies. And it should be noted that this data is especially compelling when compared to published data from Tyvaso tPI and a light sample of treatment naive BHILD patients at the National Jewish Health Center that we have discussed previously, where sixty nine percent of patients discontinued therapy after a median time of only forty days with drug related AEs, especially cough and clinical worsening listed as the primary reasons for discontinuation of Tyvaso dpi. We look forward to highlighting a more robust dataset from the ASCENT trial at the ATS International Conference in San Francisco this May. Speaker 200:06:50With regard to our third initiative imperative to build upon our commercial and medical prowess, we have built a commercial enterprise that we feel is best in class. Our team has been in place for over a year and a half and continues to support the use of treprostinil injection, while also reinforcing relationships with our healthcare providers and our understanding of the unmet needs of PAH and PHILD patients throughout the country. We are prepared to provide a seamless service to patients and providers upon launch of Eutrepia and look forward to educating the PAH and PHILDB communities on the favorable and potentially game changing product attributes of Eutrovia. And lastly, as we look at our fourth imperative to innovate and develop better therapeutic options, we continue to advance L-six zero six, our sustained release liposomal formulation of treprostinol that provides more consistent twenty four hour drug exposure in two twelve hour dosing segments, including during sleeping hours. We know that continuous infusion has shown the best efficacy with prostacyclin analogs and we believe that the PK profile of L6O6 may provide the next closest non invasive approach to maximizing the benefit from the more targeted inhaled route of administration. Speaker 200:08:03It is for all these reasons and with an eye towards our pending launch of Eutrepia in the coming months that we decided to further strengthen our balance sheet as announced yesterday with an extension of our valued partnership with Healthcare Royalty Partners that Mike will speak about now along with an overview of our 2024 financials. Mike? Speaker 300:08:26Thank you, Roger, and good morning, everyone. Before we review our full year 2024 financial results, I'm happy to highlight yesterday's announcement regarding expansion of our financing agreement with Healthcare Royalty Partners, which will provide Liquidia up to an additional $100,000,000 of financing in three tranches, including the $25,000,000 tranche funded at closing. We are grateful for the trust, commitment and confidence that Healthcare Royalty Partners has demonstrated over the years and we are optimistic that these proceeds and a successful launch of Utrevia following the expiration of exclusivity this May could lead to our reaching profitability without the need for additional capital. Turning to our full year 2024 financial results, which can be found in the press release, you will see that revenue was $14,000,000 for the year ended 12/31/2024, compared with $17,500,000 for the year ended 12/31/2023. Revenue related primarily to the promotion agreement. Speaker 300:09:26The decrease of $3,500,000 was primarily due to lower sales quantities driven by limitations on the availability of pumps used to administer treprostinil injections subcutaneously. Sales quantities will continue to be impacted or at risk until alternative pumps are available. Cost of revenue was $5,900,000 for the year ended 12/31/2024 compared with $2,900,000 for the year ended 12/31/2023. Cost of revenue related to the promotion agreement as noted above. The increase from the prior year was primarily due to our sales force expansion during the fourth quarter of twenty twenty three. Speaker 300:10:05Research and development expenses were $47,800,000 for the year ended 12/31/2024, compared with $43,200,000 for the year ended 12/31/2023. The increase of $4,600,000 or 11% was primarily due to one, a $6,100,000 increase in expenses related to our L six zero six program. Two, a 5,300,000 increase in expenses related to Eutrepia research and development activities, including the Ascent trial. Three, a $5,100,000 increase in personnel expenses including stock based compensation related to increased headcount. And four, a $3,500,000 upfront license fee due to Formosa for the exclusive license in Europe to develop and commercialize L-six zero six recorded during the year ended 12/31/2024, offset by one, dollars five point one million in lower commercial manufacturing expenses reflecting the impact of expensing EUTREPRIA inventory costs in the prior year and two, a $10,000,000 upfront licensee due to Formosa for the exclusive license in North America to develop and commercialize L-six zero six during the year ended 12/31/2023. Speaker 300:11:13General and administrative expenses were $81,600,000 for the year ended 12/31/2024, compared with $44,700,000 for the year ended 12/31/2023. The increase of $36,900,000 or 82% was primarily due to one, a $19,700,000 increase in personnel expenses, including stock based compensation, driven by higher headcount and expansion of our sales force in the fourth quarter of twenty twenty three two, a $7,900,000 increase in legal fees related to our ongoing Eutrepia related litigation. And three, a $6,800,000 increase in commercial expenses in preparation for the potential commercialization of Eutrepia. In summary, we incurred a net loss for the twelve months ended 12/31/2024 of $130,400,000 or $1.66 per basic and diluted share compared to a net loss of $78,500,000 or $1.21 per basic and diluted share for the twelve months ended 12/31/2023. With that, I would now like to turn the call back over to Roger. Speaker 200:12:20Thank you, Mike. As you can see, we're well positioned clinically, commercially and financially for the potential launch of our first product based on our proprietary print technology, which will serve as the growth engine for our continued evolution and inflection. I would now like to open the call for questions. Operator, first question please. Operator00:12:39Thank you. Our first question comes from the line of Julian Harrison with BTIG. Your line is now open. Speaker 400:12:55Hi, good morning. Thank you for taking my questions. Roger, you touched on this a little in your prepared remarks, but just wondering if you could talk more about the administrative sequence and timeline to convert ETRAPIIS tentative approvals in PAH and PHIL D to full approvals? Speaker 200:13:13Yes. So as we said in the opening thank you, Julian, and great to talk to you. So as we said in the opening, we plan to request final approval in the coming weeks In the tentative approval label that we received in August, it was recommended and suggested that we apply for final approval either two or six months ahead of the action date, which would be May 23, Given we view this as a Class one resubmission because no new data will be required for approval, we have been in concert with the agency working to deliver that letter around the March 24 timeframe so that we can be granted final approval around May 23. I don't know if that specifically addresses what you're seeking. Speaker 400:14:01Yes, absolutely. That's very helpful. Thank you. And then a follow-up, if I may, on 06. I'm curious what the physician feedback has been so far for a lower Cmax, broader AUC, longer half life alternative to nebulized TIVASO? Speaker 400:14:15And then sorry if I missed it. I'm wondering also when specifically you plan to initiate the Phase three of ASPIRE trial? Speaker 200:14:23Yes, great. And we're fortunate to have Doctor. Rajeev Sagar on the call today. So Rajeev, if you wouldn't mind? Speaker 500:14:29Yes. Thanks, Julian, for the question. So first of all, I think the current open label study continues to gate very well. We have long term safety data that is accrued since the inception of the study. What clear feedback is twice a day dosing is an absolute game changer for these patients when you inhale treprostinil. Speaker 500:14:55I think that's first and foremost. Second of all, I think that the use of the liposome itself has showcased some what we believe is some highlights some impressive safety advantages. And finally, further reducing the Cmax with the twice a day dosing profile and the sustained release formulation of the liposome itself does we have noted that systemic side effects continue also to be further abated even beyond what we initially desired. So I think the combination of both of those are going to be highly encouraging for as we advance forward with the RASPIRE study. In regards to initiating the RASPIRE study, we're working full steam ahead to prepare to initiate the study by year's end. Speaker 500:15:48We're it's around March right now. And so we look forward to providing further information as we get closer to that timeframe near the end of the year. Speaker 400:15:58Okay, great. Thank you again and congrats on all the progress. Thank you, Julie. Operator00:16:05Our next question comes from the line of Jason Gerberry with Bank of America. Your line is now open. Speaker 600:16:12Hey, good morning. This is Bhavan Patel on for Jason. Two questions from us. The first is given the green space in PHILD, what's Liquidia's strategy to drive early market penetration for Eutrepia? Can you share the marketing differentiation that you plan to promote to doctors? Speaker 600:16:31And then given the five zero five(two) pathway, should we expect any differences in the label for Eutrepia versus Teveso DPI? I know in the past you've mentioned demonstrating titration to three times higher doses compared to Teveso DPI. Speaker 200:16:50Yes. So I'll answer the second question first and then I'll ask Scott Munnar, our Chief Commercial Officer, if he would address the launch dynamics around PHIL, ILD and differentiation that we intend to emphasize. So you're exactly correct, Pavan. I think the label, it is a five zero five(two) so we share obviously the indication claims and things like that. But where we differ from the label is in the dose titration table, because in our study that we used to bridge, we showed that we could escalate the doses as you mentioned up to three times higher than the target therapeutic dose of the brand. Speaker 200:17:30So that will be in the label and I think it's an important point of differentiation because it's what it's print enabled using our proprietary print technology to drive the particles to the lower airway preferentially and avoid the toxicities associated with upper airway deposition. It's going to help us drive a maximal outcome for these patients as they continue to progress and it's going to and therefore help us keep those patients on therapy longer is our presumption. So, we think these are important and critical aspects. If you look across any route of administration across the cycling dose matters and the ability to drive dose usually predicts the sort of therapeutic utility of that therapy and that's why Tyvaso as labeled has had limitations in dosing and it's also why other drugs like Uptravi, an oral formulation, which is dose limited and dose ceiling also has limitations over the long and chronic treatment course of these patients. So lots of opportunity there from us from a labeling and dosing standpoint. Speaker 200:18:34So Scott, if you could talk a little bit about kind of how we want to approach this market without giving away the shop too much? Speaker 700:18:41Sure. Good morning. So if you think about it, we have the usual designation between centers and communities and we're going we are approaching and we will continue to approach both, especially after launch. And the situation in the centers is that the patients are really flowing in. There's an increasing number of patients flowing in as the awareness of PHILD increases and we will obviously only add fuel to that fire. Speaker 700:19:10So we're in the centers and we're going to make sure that we ensure that Eutrepia is the first choice prostacyclin for those patients that have PHIL D for a lot of the reasons that Roger just outlined and you've heard us talk about before. So we're going to harvest those patients immediately. The thing we're doing is in the community and there's many, many patients out there that doctors don't even know exist. They have ILD, the doctors aren't looking for pH. We need to help increase awareness. Speaker 700:19:40We need to help increase diagnosis and then either get that doctor to prescribe or to refer that patient into one of the centers. And we've actually been doing that over the last six months or a year, going deeper and deeper into the community, educating on PHILD even before we get on the market because we know that that's only going to behoove us once we do get on the market because we do believe we have the superior product. Speaker 200:20:07Great. Thank you, Scott, so much. Operator00:20:10Our next question comes from the line of Serge Belanger with Needham. Your line is now open. Speaker 800:20:17Hi, good morning. A couple of commercially related, terrific questions probably for Scott. Just can you remind us the breakdown between commercial and Medicare coverage for both PH and PHILD? And then assuming we're going to get approval here in a couple of months, can you talk about what you expect in terms of the ramp up in coverage across both commercial and Medicare, I guess over Speaker 200:20:46the next twelve months or so? Yes, great question Serge. It's Scott. Yes, Speaker 700:20:51good morning Serge. So in terms of the breakdown, generally think of it as Medicare is the biggest, so 50% Medicare, probably 30% to 40% commercial and then the rate the remaining is Medicare, other DOD, etcetera. In terms of the coverage over the first year, as you probably know, we're not commenting on our strategies. I will say that we have been working with the payers closely for quite some time, and we feel like we have great relationships with us. They have the desire to make sure that we maximize access, so we share that desire. Speaker 700:21:28And I think you'll see when we launch that we're very sound on that front. Speaker 200:21:37Great. Thanks, Scott. Operator, next question. Operator00:21:39Our next question comes from the line of Ryan Deschner with Raymond James. Your line is now open. Speaker 900:21:47Hi, good morning. Remind us what key readouts we should be focusing on for the ASCEND study and what specifically we can expect in the data coming at ATF? And then Speaker 400:21:57I have a follow-up. Speaker 200:21:59Yes. Thank you, Ryan. Rajeev, if you wouldn't mind answering that one. Speaker 500:22:03Yes. Thanks, Ryan. So as Roger talked about in the prepared remarks today, one of the highlights that we spoke about was the walk effect that was observed in the first twenty patients treated within eight weeks, which was which showed an observed mean improvement of around 26.4 meters. And I think that first and foremost highlights a few key processes. First, that we can get patients to what we believe is even a new therapeutic goal that surpasses the traditional nine to 12 breaths that have typically been sort of the ceiling effect of Tyvaso since 02/2009. Speaker 500:22:48We've highlighted that we're able to achieve doses in the overall majority of patients by week eight that's equivalent to greater than 50 greater or equal to 15 breaths by this time. So we can get patients up to what we believe is a very effective dose and even higher at an earlier time point and then allow further titration to further doses to stabilize the patient and plateau them out. So I think that's what's going to be quite encouraging. At ATS, we're going to showcase more regarding the datasets, regarding how we dose the patients. We're going to talk a little bit about our effects in terms of some quality of life questionnaires as well. Speaker 500:23:31And in the future, our plan is to, as we've talked about, the SENSE study will be fully enrolled within the next few weeks here. So we're really excited about that. And then we do plan to prepare and submit for the final dataset later in the year and present that at a major respiratory conference in the future. Speaker 200:23:54Great. Thank you, Rajeev. Speaker 900:23:56That's helpful. Thank you very much. And will you be doing additional hiring for the commercial field team after potential approval in both indications is confirmed? And what is the status of the current field team with regards to both hiring and training? Thank you. Speaker 200:24:11Yes. So Scott, if you wouldn't mind? Speaker 700:24:14Yes, sure. So the status I'll start with that one. The status of the current sales team is they're locked and loaded and ready. We've had the team on board for fourteen months now and these were experienced mostly PH, all rare disease folks to begin with. And so they've been out in the field strengthening relationships. Speaker 700:24:35They've been training, training, training. They are absolutely ready to go and very, very excited. On the future front, we actually just went through another exercise over the course of the last few months to take a look at our sales force sizing strategy. We think we're well suited to launch, as I mentioned earlier. We will take another look at that once we get out and start to understand sort of the sensitivity factor for the number of reps and then we'll look at potentially expanding if that makes sense in the future. Speaker 200:25:13Another thing I would add, we are adequately sized for launch in May in both indications. And then as Scott said, obviously, as we continue to build and present the unique benefits of EUTREVIA, I think we want to articulate that even broader. So we could upsize our sales force probably in the '26 timeframe if necessary. Operator, is there another question? Operator00:25:42Our next question comes from the line of Greg Harrison with Scotiabank. Your line is now open. Speaker 1000:25:49Hey, good morning guys. Thanks for taking the questions. Wondering if you can comment on your updated cash runway following your recent financing And what assumptions go into that estimate that you could reach profitability with your current balance sheet? And then if you could also comment on which factors play into your decision on pricing given your view of Eutrepia's profile relative to the competitor? Thanks. Speaker 200:26:19Great. I think both of those questions are would be well answered by Mike. Speaker 400:26:24Yes, Greg, great to talk Speaker 300:26:25to you again. As it relates to Runway, as we said, with this $100,000,000 of additional financing from healthcare royalties, $25,000,000 we received at closing, $50,000,000 will be received upon the first commercial sale of atrepia and the final $25,000,000 will be at mutual option once we reach a cumulative $100,000,000 in net sales of Eutrepia. I think it's pretty simple. We have we're very excited about the launch of Eutrepia. As Roger said and Scott have said, we are fully ready from a commercial readiness point of view. Speaker 300:27:06From a supply point of view, we feel very bullish about our ability to launch this successfully and we feel that if assuming as Roger said, we filed for full approval here coming up, we get full approval on or near the expiration of the exclusivity date. We feel confident if we hit our goals and hit our targets that we can be profitable on this current balance sheet and like I said fully support the L-six zero six program, all of our Phase four studies we're doing on neutropia, while also the ongoing commercial readiness. So we're very excited. We're very confident. We're very happy to have a great partner like Healthcare Royalty on this journey and we look forward to launch. Speaker 300:27:50As to the second question, we're not going to talk about pricing strategy. I think what I would say is, as we've demonstrated or continue to demonstrate and what we feel our Ascent early results on Ascent only reinforce that, that we feel that we have a superior product profile. And based on that, we want to make sure that we are always balancing patient access, while also fulfilling the value proposition that Eutrepia can bring. So we're not going to talk specifically about pricing strategies in totality, but I think we're very confident as we come to market that we will have the right strategy to make sure that patients have choice as we move forward. Speaker 1000:28:36Great. That's helpful. Thanks so much. Speaker 200:28:38Thanks for the question, Greg. Operator, next question. Operator00:28:42Our next question comes from the line of Corey Juventil with LifeSci Capital. Your line is now open. Speaker 1000:28:48Good morning and thanks for taking our questions and congrats on this new efficacy data with the science, it's really exciting. Just kind of following the theme of more drug is better, I recognize that the sample size here might be still relatively small, but have you had any type of dose response among patients? Are those who are reaching two to three fold the Tyvaso equivalent dose achieving better outcomes than those in the study who might be kind of in the lower range equivalent to the existing standard of care. And this also might be a naive question, but is it possible to get these efficacy data on label and how would you go about marketing the six minute walk to prescribers post approval? Speaker 200:29:34Yes, I'll take the second question and then Rajeev can say what he can about the dose versus effect curve. So that's not the data is would not be available for indication claims per se because it's an open label safety study. I think it would be part of a annual update to the label once approved where we could update the clinical pharmacology section to describe the data both in terms of safety and potentially in terms of efficacy. But again, that's a negotiation with the FDA about what we could then include in the clinical pharmacology section of the label. So I'll reserve sort of commitment on that and we'll do the best we can to get it in there. Speaker 200:30:18But I think certainly we will abstract and then publish the data. And I think as we're seeing there's tremendous inbound interest based on what we're describing. And there's over 20 doctors doing this current Ascent study, many of them are the seminal thought leaders. And I think the fact that they're doing the study and we're seeing the results that we're seeing is going to help highlight the data when they lead panel sessions etcetera because now they're seeing the true value of PRINT as it relates to the new TRIPIA. So and then I will just comment on dose response before I turn it over to Rajeev. Speaker 200:30:56It's very hard in a small sample of patients to show those response frankly, plus we're allowing patients to individually titrate to dose. So we're not sort of predefining what those level patients should titrate to and then measuring that versus effect. So it's a continuum. So that's a difficult paradigm to show dose response in. But Rajeev, I don't know if you have additional comment there. Speaker 500:31:17Yes, Corey, I think just I think a few things to highlight. First of all, the patients that we're rolling in Ascent are quite heterogeneous. We purposely designed the study to showcase safety and tolerability of atropia. So we not only include patients with mild hemodynamic limitations with their palmar hypertension, but also patients with severe hemodynamic impairments with various levels of complexity with the interstitial lung disease and their respiratory physiological impairments. But I think despite that heterogeneity, I think what the data is showing, despite these small numbers, but even though the study continues to enroll and continue to highlight a few things. Speaker 500:32:06Number one, clearly the low resistance inhaler combined with our print formulation is absolutely allowing these patients to titrate, Eutrepia to again to what I believe are actually new therapeutic levels. And that's very important because it's well known that prostenoid therapies are titratable, it is dose related. So it tends to effects tend to improve as doses escalated. The problem with current therapies on the market, including oral and systemic parenteral therapies is that they're just significantly limited by terrible systemic side effects, especially in the oral therapies with the GI side effects and of course the parenterals with indwelling lines or subcutaneous complications. I think with the current inhaled therapies on the market today, we know that at least in the INCREASE study, what was very interesting relative to the SENSE study is by eight weeks, only fifty percent of the patients in the Tyvaso nebulized study for increase of PHLD were able to reach the 10 to 12 breath levels versus in the SENSE study despite the heterogeneity in the patient population, we're able to get patients, the overwhelming majority of patients up to more than or equal to 15 breath equivalents. Speaker 500:33:32So again, I think that what the Ascent data is going to show at ATS and what KOLs are going to see is that this that Eutropia is very well tolerated anti treatable and that they can customize to whatever needs their patients have with both PAH and PHLD in the very near future. Speaker 200:33:51And Corey, that's great answer, Rajiv. Thank you. I think one way we're going to take on this dose issue directly, we're going to do a direct to transition study from patients on Tyvaso and Tyvaso DPI that are underserved by those therapies. And probably because of those limitations, we'll transition them to Eutrepia, improve their dose. And then and if we show therefore an improved outcome, we've shown not only is dose related to outcome, but we've also differentiated the products even in a different way and a helpful way for atripea. Speaker 200:34:24So look for that starting to start up in the near future as well. So operator, next question please. Operator00:34:30Thank you. And I'm currently showing no further questions at this time. I'd like to hand the call back over to Roger Jeffs for closing remarks. Speaker 200:34:37Thank you very much. So we really appreciate everyone joining us today and we look forward to speaking again soon. Bye bye. Operator00:34:45This concludes today's conference call. Thank you for your participation. You may now disconnect.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallLiquidia Q4 202400:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Annual report(10-K) Liquidia Earnings HeadlinesGreat week for Liquidia Corporation (NASDAQ:LQDA) institutional investors after losing 1.5% over the previous yearApril 14 at 4:00 PM | finance.yahoo.comLiquidia's (LQDA) "Buy" Rating Reiterated at Needham & Company LLCApril 13 at 4:03 AM | americanbankingnews.comTrump’s treachery Trump’s Final Reset Inside the shocking plot to re-engineer America’s financial system…and why you need to move your money now.April 16, 2025 | Porter & Company (Ad)Liquidia Technologies (LQDA) Receives a Buy from Bank of America SecuritiesApril 8, 2025 | markets.businessinsider.comUPDATE – Liquidia Corporation to Present at the 24th Annual Needham Virtual Healthcare ConferenceApril 1, 2025 | globenewswire.comLiquidia Corporation to Present at the 24th Annual Needham Virtual Healthcare ConferenceApril 1, 2025 | globenewswire.comSee More Liquidia Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Liquidia? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Liquidia and other key companies, straight to your email. Email Address About LiquidiaLiquidia (NASDAQ:LQDA), a biopharmaceutical company, develops, manufactures, and commercializes various products for unmet patient needs in the United States. Its lead product candidates include YUTREPIA, an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company also offers Remodulin, a treprostinil administered through continuous intravenous and subcutaneous infusion. The company also a license agreement with Pharmosa Biopharm Inc to develop and commercialize L606, an inhaled sustained-release formulation of Treprostinil for the treatment of PAH and PH-ILD. Liquidia Corporation was founded in 2004 and is headquartered in Morrisville, North Carolina.View Liquidia ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Tesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 11 speakers on the call. Operator00:00:00Good morning, and welcome everyone to the Liquidia Corporation Full Year twenty twenty four Financial Results and Corporate Update Conference Call. My name is Shannon, 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 the time for you to queue up for your questions. Operator00:00:20I would like to remind everyone that this conference call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer. Speaker 100:00:29Thank you, Shannon. It's my pleasure to welcome everyone to the Liquidia Corporation full year twenty twenty four financial results and corporate update call. Joining the call today are Chief Executive Officer, Doctor. Roger Jeffs Chief Operating Officer and CFO, Michael Caseta Chief Medical Officer, Doctor. Rajeev Sagar Chief Commercial Officer, Scott Mumma and General Counsel, Rusty Schumler. Speaker 100:00:52Before 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 would now like to turn the call over to Roger for our prepared remarks, after which he will open the call for your questions. Roger? Speaker 200:01:34Thank you, Jason. Good morning, everyone, and thank you for joining us today. We believe that 2025 has the potential to be a transformational year for the company as we further build upon the success of 2024, which resulted in the broadening of the tentatively approved label for Eutravia to include both the treatment of patients with pulmonary arterial hypertension or PAH and pulmonary hypertension associated with interstitial lung disease or PH ILD. There are four strategic imperatives that will drive our success and growth both in the near and long term. These are seeking to obtain final approval and launching new treatment in both PH and PHIL D as soon as possible after expiry of the gating clinical exclusivity on May 23 or just sixty five days from now. Speaker 200:02:21Secondly, we continue to advance the clinical profile of EUTREPEA to position that it's not only the best in class inhaled prostacyclin, but also the first in choice prostacyclin for all patients in need of an oral or inhaled prostacyclin who remain underserved by current alternatives third, building upon our commercial and medical prowess to compete fiercely for capture of material and enduring market share in this multibillion dollar and growing market segment And finally, to further evolve our mission of being a leader in the PH phase by continuing to leverage our development expertise to advance treatment options that have the potential to further improve the lives of patients like our Phase III ready next gen sustained release liposomal therapy L-six zero six. I'd like to take a few minutes to expand on each of these strategic goals. With regard to the first imperative of seeking to launch ETRKIA into the marketplace as soon as possible, I'm happy to say that based on the favorable legal decisions over the last few years, there are no legal barriers that currently impact the FDA's ability to issue final approval of ETRFIA after May 23, when the exclusivity exclusivity granted to our competitor will expire. Speaker 200:03:35It's also important to remember that when the FDA issues a tentative approval of an NDA, it means the NDA has met all requirements for approval but cannot be approved due to existing legal or regulatory barriers. In our case, the sole barrier identified by the FDA was the new clinical exclusivity granted to Tyvasa DPI, which expires on 05/23/2025. As directed in the tentative approval label, we plan to submit the request for final approval in the coming weeks. With regard to the second imperative of continuing to advance our studies to establish the clinical profile of Eutrepia, the medical community's interest in Eutrepia is increasing with particular interest in the data being generated from our ASCENT trial, the open label safety study of TRTREPREA NPHI patients. I'm happy to report Sorry, I have half a call this morning. Speaker 200:04:37I'm happy to report that we are on track to complete enrollment in the coming weeks with 50 or more patients in total to be enrolled. We continue to be encouraged by the positive patient response to escalating doses of EUTREPEA. As a reminder, at the J. P. Morgan Healthcare Conference in January, we showed the dosing and tolerability profile for the first twenty patients that completed eight weeks of treatment. Speaker 200:05:01We noted that the PHLD patients on Eutrepia were able to titrate to dose better three times the comparable therapeutic target of nebulized TAVAZA. And today, we're happy to share some new information from the ASCEND study. We've also been looking at exploratory measures of efficacy. One such measure is the change in six minute walk test at week eight. We are pleased to report in this same 20 patient cohort, the main change in baseline improved by 26.4 meters. Speaker 200:05:31While it is difficult to draw strong conclusions from cross study comparisons, it is worth noting that in the Phase III registrational study of nebulized TAVASO and PHIV patients, the INCRE study, active group patients had an observed mean improvement of six minute walk distance of 16 meters at week eight and twenty two meters at week 16. We are highly encouraged by this early efficacy data from Ascent as it demonstrates that atrial fibrils the key therapeutic attributes in PHIL D we aspire for it, specifically being well tolerated and amenable to rapid dose escalation to doses well beyond historical standards, leading to an accelerated therapeutic outcome that is in line or better than published results of existing therapies. And it should be noted that this data is especially compelling when compared to published data from Tyvaso tPI and a light sample of treatment naive BHILD patients at the National Jewish Health Center that we have discussed previously, where sixty nine percent of patients discontinued therapy after a median time of only forty days with drug related AEs, especially cough and clinical worsening listed as the primary reasons for discontinuation of Tyvaso dpi. We look forward to highlighting a more robust dataset from the ASCENT trial at the ATS International Conference in San Francisco this May. Speaker 200:06:50With regard to our third initiative imperative to build upon our commercial and medical prowess, we have built a commercial enterprise that we feel is best in class. Our team has been in place for over a year and a half and continues to support the use of treprostinil injection, while also reinforcing relationships with our healthcare providers and our understanding of the unmet needs of PAH and PHILD patients throughout the country. We are prepared to provide a seamless service to patients and providers upon launch of Eutrepia and look forward to educating the PAH and PHILDB communities on the favorable and potentially game changing product attributes of Eutrovia. And lastly, as we look at our fourth imperative to innovate and develop better therapeutic options, we continue to advance L-six zero six, our sustained release liposomal formulation of treprostinol that provides more consistent twenty four hour drug exposure in two twelve hour dosing segments, including during sleeping hours. We know that continuous infusion has shown the best efficacy with prostacyclin analogs and we believe that the PK profile of L6O6 may provide the next closest non invasive approach to maximizing the benefit from the more targeted inhaled route of administration. Speaker 200:08:03It is for all these reasons and with an eye towards our pending launch of Eutrepia in the coming months that we decided to further strengthen our balance sheet as announced yesterday with an extension of our valued partnership with Healthcare Royalty Partners that Mike will speak about now along with an overview of our 2024 financials. Mike? Speaker 300:08:26Thank you, Roger, and good morning, everyone. Before we review our full year 2024 financial results, I'm happy to highlight yesterday's announcement regarding expansion of our financing agreement with Healthcare Royalty Partners, which will provide Liquidia up to an additional $100,000,000 of financing in three tranches, including the $25,000,000 tranche funded at closing. We are grateful for the trust, commitment and confidence that Healthcare Royalty Partners has demonstrated over the years and we are optimistic that these proceeds and a successful launch of Utrevia following the expiration of exclusivity this May could lead to our reaching profitability without the need for additional capital. Turning to our full year 2024 financial results, which can be found in the press release, you will see that revenue was $14,000,000 for the year ended 12/31/2024, compared with $17,500,000 for the year ended 12/31/2023. Revenue related primarily to the promotion agreement. Speaker 300:09:26The decrease of $3,500,000 was primarily due to lower sales quantities driven by limitations on the availability of pumps used to administer treprostinil injections subcutaneously. Sales quantities will continue to be impacted or at risk until alternative pumps are available. Cost of revenue was $5,900,000 for the year ended 12/31/2024 compared with $2,900,000 for the year ended 12/31/2023. Cost of revenue related to the promotion agreement as noted above. The increase from the prior year was primarily due to our sales force expansion during the fourth quarter of twenty twenty three. Speaker 300:10:05Research and development expenses were $47,800,000 for the year ended 12/31/2024, compared with $43,200,000 for the year ended 12/31/2023. The increase of $4,600,000 or 11% was primarily due to one, a $6,100,000 increase in expenses related to our L six zero six program. Two, a 5,300,000 increase in expenses related to Eutrepia research and development activities, including the Ascent trial. Three, a $5,100,000 increase in personnel expenses including stock based compensation related to increased headcount. And four, a $3,500,000 upfront license fee due to Formosa for the exclusive license in Europe to develop and commercialize L-six zero six recorded during the year ended 12/31/2024, offset by one, dollars five point one million in lower commercial manufacturing expenses reflecting the impact of expensing EUTREPRIA inventory costs in the prior year and two, a $10,000,000 upfront licensee due to Formosa for the exclusive license in North America to develop and commercialize L-six zero six during the year ended 12/31/2023. Speaker 300:11:13General and administrative expenses were $81,600,000 for the year ended 12/31/2024, compared with $44,700,000 for the year ended 12/31/2023. The increase of $36,900,000 or 82% was primarily due to one, a $19,700,000 increase in personnel expenses, including stock based compensation, driven by higher headcount and expansion of our sales force in the fourth quarter of twenty twenty three two, a $7,900,000 increase in legal fees related to our ongoing Eutrepia related litigation. And three, a $6,800,000 increase in commercial expenses in preparation for the potential commercialization of Eutrepia. In summary, we incurred a net loss for the twelve months ended 12/31/2024 of $130,400,000 or $1.66 per basic and diluted share compared to a net loss of $78,500,000 or $1.21 per basic and diluted share for the twelve months ended 12/31/2023. With that, I would now like to turn the call back over to Roger. Speaker 200:12:20Thank you, Mike. As you can see, we're well positioned clinically, commercially and financially for the potential launch of our first product based on our proprietary print technology, which will serve as the growth engine for our continued evolution and inflection. I would now like to open the call for questions. Operator, first question please. Operator00:12:39Thank you. Our first question comes from the line of Julian Harrison with BTIG. Your line is now open. Speaker 400:12:55Hi, good morning. Thank you for taking my questions. Roger, you touched on this a little in your prepared remarks, but just wondering if you could talk more about the administrative sequence and timeline to convert ETRAPIIS tentative approvals in PAH and PHIL D to full approvals? Speaker 200:13:13Yes. So as we said in the opening thank you, Julian, and great to talk to you. So as we said in the opening, we plan to request final approval in the coming weeks In the tentative approval label that we received in August, it was recommended and suggested that we apply for final approval either two or six months ahead of the action date, which would be May 23, Given we view this as a Class one resubmission because no new data will be required for approval, we have been in concert with the agency working to deliver that letter around the March 24 timeframe so that we can be granted final approval around May 23. I don't know if that specifically addresses what you're seeking. Speaker 400:14:01Yes, absolutely. That's very helpful. Thank you. And then a follow-up, if I may, on 06. I'm curious what the physician feedback has been so far for a lower Cmax, broader AUC, longer half life alternative to nebulized TIVASO? Speaker 400:14:15And then sorry if I missed it. I'm wondering also when specifically you plan to initiate the Phase three of ASPIRE trial? Speaker 200:14:23Yes, great. And we're fortunate to have Doctor. Rajeev Sagar on the call today. So Rajeev, if you wouldn't mind? Speaker 500:14:29Yes. Thanks, Julian, for the question. So first of all, I think the current open label study continues to gate very well. We have long term safety data that is accrued since the inception of the study. What clear feedback is twice a day dosing is an absolute game changer for these patients when you inhale treprostinil. Speaker 500:14:55I think that's first and foremost. Second of all, I think that the use of the liposome itself has showcased some what we believe is some highlights some impressive safety advantages. And finally, further reducing the Cmax with the twice a day dosing profile and the sustained release formulation of the liposome itself does we have noted that systemic side effects continue also to be further abated even beyond what we initially desired. So I think the combination of both of those are going to be highly encouraging for as we advance forward with the RASPIRE study. In regards to initiating the RASPIRE study, we're working full steam ahead to prepare to initiate the study by year's end. Speaker 500:15:48We're it's around March right now. And so we look forward to providing further information as we get closer to that timeframe near the end of the year. Speaker 400:15:58Okay, great. Thank you again and congrats on all the progress. Thank you, Julie. Operator00:16:05Our next question comes from the line of Jason Gerberry with Bank of America. Your line is now open. Speaker 600:16:12Hey, good morning. This is Bhavan Patel on for Jason. Two questions from us. The first is given the green space in PHILD, what's Liquidia's strategy to drive early market penetration for Eutrepia? Can you share the marketing differentiation that you plan to promote to doctors? Speaker 600:16:31And then given the five zero five(two) pathway, should we expect any differences in the label for Eutrepia versus Teveso DPI? I know in the past you've mentioned demonstrating titration to three times higher doses compared to Teveso DPI. Speaker 200:16:50Yes. So I'll answer the second question first and then I'll ask Scott Munnar, our Chief Commercial Officer, if he would address the launch dynamics around PHIL, ILD and differentiation that we intend to emphasize. So you're exactly correct, Pavan. I think the label, it is a five zero five(two) so we share obviously the indication claims and things like that. But where we differ from the label is in the dose titration table, because in our study that we used to bridge, we showed that we could escalate the doses as you mentioned up to three times higher than the target therapeutic dose of the brand. Speaker 200:17:30So that will be in the label and I think it's an important point of differentiation because it's what it's print enabled using our proprietary print technology to drive the particles to the lower airway preferentially and avoid the toxicities associated with upper airway deposition. It's going to help us drive a maximal outcome for these patients as they continue to progress and it's going to and therefore help us keep those patients on therapy longer is our presumption. So, we think these are important and critical aspects. If you look across any route of administration across the cycling dose matters and the ability to drive dose usually predicts the sort of therapeutic utility of that therapy and that's why Tyvaso as labeled has had limitations in dosing and it's also why other drugs like Uptravi, an oral formulation, which is dose limited and dose ceiling also has limitations over the long and chronic treatment course of these patients. So lots of opportunity there from us from a labeling and dosing standpoint. Speaker 200:18:34So Scott, if you could talk a little bit about kind of how we want to approach this market without giving away the shop too much? Speaker 700:18:41Sure. Good morning. So if you think about it, we have the usual designation between centers and communities and we're going we are approaching and we will continue to approach both, especially after launch. And the situation in the centers is that the patients are really flowing in. There's an increasing number of patients flowing in as the awareness of PHILD increases and we will obviously only add fuel to that fire. Speaker 700:19:10So we're in the centers and we're going to make sure that we ensure that Eutrepia is the first choice prostacyclin for those patients that have PHIL D for a lot of the reasons that Roger just outlined and you've heard us talk about before. So we're going to harvest those patients immediately. The thing we're doing is in the community and there's many, many patients out there that doctors don't even know exist. They have ILD, the doctors aren't looking for pH. We need to help increase awareness. Speaker 700:19:40We need to help increase diagnosis and then either get that doctor to prescribe or to refer that patient into one of the centers. And we've actually been doing that over the last six months or a year, going deeper and deeper into the community, educating on PHILD even before we get on the market because we know that that's only going to behoove us once we do get on the market because we do believe we have the superior product. Speaker 200:20:07Great. Thank you, Scott, so much. Operator00:20:10Our next question comes from the line of Serge Belanger with Needham. Your line is now open. Speaker 800:20:17Hi, good morning. A couple of commercially related, terrific questions probably for Scott. Just can you remind us the breakdown between commercial and Medicare coverage for both PH and PHILD? And then assuming we're going to get approval here in a couple of months, can you talk about what you expect in terms of the ramp up in coverage across both commercial and Medicare, I guess over Speaker 200:20:46the next twelve months or so? Yes, great question Serge. It's Scott. Yes, Speaker 700:20:51good morning Serge. So in terms of the breakdown, generally think of it as Medicare is the biggest, so 50% Medicare, probably 30% to 40% commercial and then the rate the remaining is Medicare, other DOD, etcetera. In terms of the coverage over the first year, as you probably know, we're not commenting on our strategies. I will say that we have been working with the payers closely for quite some time, and we feel like we have great relationships with us. They have the desire to make sure that we maximize access, so we share that desire. Speaker 700:21:28And I think you'll see when we launch that we're very sound on that front. Speaker 200:21:37Great. Thanks, Scott. Operator, next question. Operator00:21:39Our next question comes from the line of Ryan Deschner with Raymond James. Your line is now open. Speaker 900:21:47Hi, good morning. Remind us what key readouts we should be focusing on for the ASCEND study and what specifically we can expect in the data coming at ATF? And then Speaker 400:21:57I have a follow-up. Speaker 200:21:59Yes. Thank you, Ryan. Rajeev, if you wouldn't mind answering that one. Speaker 500:22:03Yes. Thanks, Ryan. So as Roger talked about in the prepared remarks today, one of the highlights that we spoke about was the walk effect that was observed in the first twenty patients treated within eight weeks, which was which showed an observed mean improvement of around 26.4 meters. And I think that first and foremost highlights a few key processes. First, that we can get patients to what we believe is even a new therapeutic goal that surpasses the traditional nine to 12 breaths that have typically been sort of the ceiling effect of Tyvaso since 02/2009. Speaker 500:22:48We've highlighted that we're able to achieve doses in the overall majority of patients by week eight that's equivalent to greater than 50 greater or equal to 15 breaths by this time. So we can get patients up to what we believe is a very effective dose and even higher at an earlier time point and then allow further titration to further doses to stabilize the patient and plateau them out. So I think that's what's going to be quite encouraging. At ATS, we're going to showcase more regarding the datasets, regarding how we dose the patients. We're going to talk a little bit about our effects in terms of some quality of life questionnaires as well. Speaker 500:23:31And in the future, our plan is to, as we've talked about, the SENSE study will be fully enrolled within the next few weeks here. So we're really excited about that. And then we do plan to prepare and submit for the final dataset later in the year and present that at a major respiratory conference in the future. Speaker 200:23:54Great. Thank you, Rajeev. Speaker 900:23:56That's helpful. Thank you very much. And will you be doing additional hiring for the commercial field team after potential approval in both indications is confirmed? And what is the status of the current field team with regards to both hiring and training? Thank you. Speaker 200:24:11Yes. So Scott, if you wouldn't mind? Speaker 700:24:14Yes, sure. So the status I'll start with that one. The status of the current sales team is they're locked and loaded and ready. We've had the team on board for fourteen months now and these were experienced mostly PH, all rare disease folks to begin with. And so they've been out in the field strengthening relationships. Speaker 700:24:35They've been training, training, training. They are absolutely ready to go and very, very excited. On the future front, we actually just went through another exercise over the course of the last few months to take a look at our sales force sizing strategy. We think we're well suited to launch, as I mentioned earlier. We will take another look at that once we get out and start to understand sort of the sensitivity factor for the number of reps and then we'll look at potentially expanding if that makes sense in the future. Speaker 200:25:13Another thing I would add, we are adequately sized for launch in May in both indications. And then as Scott said, obviously, as we continue to build and present the unique benefits of EUTREVIA, I think we want to articulate that even broader. So we could upsize our sales force probably in the '26 timeframe if necessary. Operator, is there another question? Operator00:25:42Our next question comes from the line of Greg Harrison with Scotiabank. Your line is now open. Speaker 1000:25:49Hey, good morning guys. Thanks for taking the questions. Wondering if you can comment on your updated cash runway following your recent financing And what assumptions go into that estimate that you could reach profitability with your current balance sheet? And then if you could also comment on which factors play into your decision on pricing given your view of Eutrepia's profile relative to the competitor? Thanks. Speaker 200:26:19Great. I think both of those questions are would be well answered by Mike. Speaker 400:26:24Yes, Greg, great to talk Speaker 300:26:25to you again. As it relates to Runway, as we said, with this $100,000,000 of additional financing from healthcare royalties, $25,000,000 we received at closing, $50,000,000 will be received upon the first commercial sale of atrepia and the final $25,000,000 will be at mutual option once we reach a cumulative $100,000,000 in net sales of Eutrepia. I think it's pretty simple. We have we're very excited about the launch of Eutrepia. As Roger said and Scott have said, we are fully ready from a commercial readiness point of view. Speaker 300:27:06From a supply point of view, we feel very bullish about our ability to launch this successfully and we feel that if assuming as Roger said, we filed for full approval here coming up, we get full approval on or near the expiration of the exclusivity date. We feel confident if we hit our goals and hit our targets that we can be profitable on this current balance sheet and like I said fully support the L-six zero six program, all of our Phase four studies we're doing on neutropia, while also the ongoing commercial readiness. So we're very excited. We're very confident. We're very happy to have a great partner like Healthcare Royalty on this journey and we look forward to launch. Speaker 300:27:50As to the second question, we're not going to talk about pricing strategy. I think what I would say is, as we've demonstrated or continue to demonstrate and what we feel our Ascent early results on Ascent only reinforce that, that we feel that we have a superior product profile. And based on that, we want to make sure that we are always balancing patient access, while also fulfilling the value proposition that Eutrepia can bring. So we're not going to talk specifically about pricing strategies in totality, but I think we're very confident as we come to market that we will have the right strategy to make sure that patients have choice as we move forward. Speaker 1000:28:36Great. That's helpful. Thanks so much. Speaker 200:28:38Thanks for the question, Greg. Operator, next question. Operator00:28:42Our next question comes from the line of Corey Juventil with LifeSci Capital. Your line is now open. Speaker 1000:28:48Good morning and thanks for taking our questions and congrats on this new efficacy data with the science, it's really exciting. Just kind of following the theme of more drug is better, I recognize that the sample size here might be still relatively small, but have you had any type of dose response among patients? Are those who are reaching two to three fold the Tyvaso equivalent dose achieving better outcomes than those in the study who might be kind of in the lower range equivalent to the existing standard of care. And this also might be a naive question, but is it possible to get these efficacy data on label and how would you go about marketing the six minute walk to prescribers post approval? Speaker 200:29:34Yes, I'll take the second question and then Rajeev can say what he can about the dose versus effect curve. So that's not the data is would not be available for indication claims per se because it's an open label safety study. I think it would be part of a annual update to the label once approved where we could update the clinical pharmacology section to describe the data both in terms of safety and potentially in terms of efficacy. But again, that's a negotiation with the FDA about what we could then include in the clinical pharmacology section of the label. So I'll reserve sort of commitment on that and we'll do the best we can to get it in there. Speaker 200:30:18But I think certainly we will abstract and then publish the data. And I think as we're seeing there's tremendous inbound interest based on what we're describing. And there's over 20 doctors doing this current Ascent study, many of them are the seminal thought leaders. And I think the fact that they're doing the study and we're seeing the results that we're seeing is going to help highlight the data when they lead panel sessions etcetera because now they're seeing the true value of PRINT as it relates to the new TRIPIA. So and then I will just comment on dose response before I turn it over to Rajeev. Speaker 200:30:56It's very hard in a small sample of patients to show those response frankly, plus we're allowing patients to individually titrate to dose. So we're not sort of predefining what those level patients should titrate to and then measuring that versus effect. So it's a continuum. So that's a difficult paradigm to show dose response in. But Rajeev, I don't know if you have additional comment there. Speaker 500:31:17Yes, Corey, I think just I think a few things to highlight. First of all, the patients that we're rolling in Ascent are quite heterogeneous. We purposely designed the study to showcase safety and tolerability of atropia. So we not only include patients with mild hemodynamic limitations with their palmar hypertension, but also patients with severe hemodynamic impairments with various levels of complexity with the interstitial lung disease and their respiratory physiological impairments. But I think despite that heterogeneity, I think what the data is showing, despite these small numbers, but even though the study continues to enroll and continue to highlight a few things. Speaker 500:32:06Number one, clearly the low resistance inhaler combined with our print formulation is absolutely allowing these patients to titrate, Eutrepia to again to what I believe are actually new therapeutic levels. And that's very important because it's well known that prostenoid therapies are titratable, it is dose related. So it tends to effects tend to improve as doses escalated. The problem with current therapies on the market, including oral and systemic parenteral therapies is that they're just significantly limited by terrible systemic side effects, especially in the oral therapies with the GI side effects and of course the parenterals with indwelling lines or subcutaneous complications. I think with the current inhaled therapies on the market today, we know that at least in the INCREASE study, what was very interesting relative to the SENSE study is by eight weeks, only fifty percent of the patients in the Tyvaso nebulized study for increase of PHLD were able to reach the 10 to 12 breath levels versus in the SENSE study despite the heterogeneity in the patient population, we're able to get patients, the overwhelming majority of patients up to more than or equal to 15 breath equivalents. Speaker 500:33:32So again, I think that what the Ascent data is going to show at ATS and what KOLs are going to see is that this that Eutropia is very well tolerated anti treatable and that they can customize to whatever needs their patients have with both PAH and PHLD in the very near future. Speaker 200:33:51And Corey, that's great answer, Rajiv. Thank you. I think one way we're going to take on this dose issue directly, we're going to do a direct to transition study from patients on Tyvaso and Tyvaso DPI that are underserved by those therapies. And probably because of those limitations, we'll transition them to Eutrepia, improve their dose. And then and if we show therefore an improved outcome, we've shown not only is dose related to outcome, but we've also differentiated the products even in a different way and a helpful way for atripea. Speaker 200:34:24So look for that starting to start up in the near future as well. So operator, next question please. Operator00:34:30Thank you. And I'm currently showing no further questions at this time. I'd like to hand the call back over to Roger Jeffs for closing remarks. Speaker 200:34:37Thank you very much. So we really appreciate everyone joining us today and we look forward to speaking again soon. Bye bye. Operator00:34:45This concludes today's conference call. 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