Liquidia Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 14, 2024

There are 10 speakers on the call.

Operator

Good morning, and welcome everyone to the Liquidia Corporation First Quarter 2024 Financial Results and Corporate Update Conference Call. My name is Michelle, and I'll be your conference operator today. Currently, all participants are in 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.

Operator

I would like to remind everyone that this call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer.

Speaker 1

Thank you, Michelle. It's my pleasure to welcome everyone to Liquidia Corporation's Q1 2024 financial results and corporate update call. Joining the call today are Chief Executive Officer, Doctor. Roger Jeff Chief Operating Officer and CFO, Michael Cassetta Chief Medical Officer, Doctor. Rajeev Sagar Chief Commercial Officer, Scott Mumma and General Counsel, Rusty Schindler.

Speaker 1

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 would now like to turn the call over to Roger for our prepared remarks, after which he'll open the call for your questions.

Speaker 2

Thank you, Jason. Good morning, everyone, and thank you for joining us today. In the 9 weeks since our last earnings call, we have continued to advance what we believe will be the industry leading portfolio of inhaled treprostinil products. UTREPIA, our dry powder formulation of treprostinil, currently awaits final FDA approval to treat both pulmonary hypertension arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease or PH IOD. We have continued to optimize our commercial preparations in anticipation of potential FDA final action and launch.

Speaker 2

In the clinic, we are seeing encouraging initial data from our central of utrepia in PHIL D. In addition, our sustained release liposomal formulation of treprostinil, L-six zero six also continues to generate encouraging data in our open label safety study in both PAH and PHILD patients. Rajeev and Rusty will provide updates in greater detail on the clinical, regulatory and legal fronts in a moment. But first, I think it is important to reflect on what is happening in the market and why we are so committed to these programs and the patients we seek to treat. We believe the market for inhaled troponin PAH and BH LOD can eclipse $3,000,000,000 at peak sales.

Speaker 2

And this is validated by Tevesa's current total current annual run rate of approximately $1,500,000,000 which continues to grow at an appreciable rate. This growth is driven by the expanded PHLD market, which is only marginally penetrated at this time, along with the availability of the more portable dry powder inhaler option. However, what we also see in our competitor sales data is continued unmet need. In our study of EUTREPRIA, 100 and 3 percent of patients who transition to EUTREPRIA from Tyvaso preferred EUTREPRIA after 4 months of use. Yet approximately 40% of EUTREPR sales continue to come from nebulized Tyvaso with its bulky, challenging and dose limiting nebulizer.

Speaker 2

We do not have any direct knowledge of the totality of issues that may be preventing a more complete conversion of patients from Tyvaso to Tyvaso DPI, but the continued prevalence of Tyvaso seems illogical given the clear portability and use advantages of the DPI. In this regard, data from the National Jewish Pulmonary Hypertension Program may be broadly informative. In September, these experts presented a single center prospective observational study in patients with PHILD who were initiated on terprostin on DPI. Of the 26 patients with PHILD initiated on Tyvaso DPI, 69% of these patients discontinued this treatment after a mean of only 78 days or a median of 40 days. Of importance, 11% or 42.3% of these patients transitioned to the Tyvaso nebulizer upon discontinuation of DPI therapy.

Speaker 2

This is highly consistent with our competitor sales data, highlighting that nearly 40% of its patient base continues to use the more cumbersome nebulizer for Tyvaso administration. From our perspective, clearly, it is not the molecule treprostinil, but rather the limitation of the formulation and the very high resistance DPI utilized with Tyvaso DPI, especially when treating patients with lung impairment in PHILD. That's why we believe that physicians and patients are eager for a new choice, one that delivers a readily titratable and durable inhaled formulation of treprostinil using a portable, patient friendly, low resistance dry powder inhaler with demonstrated high patient preference and satisfaction. UTREPIA is that choice and has the very real potential to become the 1st in choice and best in class prostacyclin in this growing market opportunity. With that, I'd like to ask Rajiv to share more about FDA interactions and our observations in the ongoing clinical studies with Eutrepia and L606.

Speaker 2

Rajiv?

Speaker 3

Thanks, Roger. I'd like to address 3 of the most common questions I have received related to our programs. First, where does the FDA stand in its review of eutropia? 2nd, what observations are emerging from the ASCENT trial, our open label study of utrepia in PHILD patients to better understand dosing and titration in that patient population? And third, when can we expect to see more data on the L-six zero six program?

Speaker 3

I will take each in turn. Regarding the first question, while we cannot speak to a specific action date, the FDA's review division has maintained an active dialogue with Liquidia on the development of Eutrepia since it entered the clinic as the first dry powder formulation of treprostinil. During the course of its review of the NDA for PAH, the FDA has confirmed multiple times over the last 3 years that submitting an amendment to the NDA would be an appropriate way to add PHILD indication. Also, throughout this process, the FDA consistently affirmed that no additional clinical data would be required to add the PHILD indication. We are disappointed that the FDA did not issue an action letter promptly following the expiration of the March 31st clinical investigation exclusivity granted to Tabesa to treat PHLD.

Speaker 3

Nevertheless, we remain hopeful that the FDA will issue final action very soon, given the lack of any legal barriers to approval. Regarding the second question, we initiated the open label Ascent trial in late December to help physicians understand the safety, tolerability and titratability of utrepia in patients with PHLD. We have enrolled 7 patients to date and have several additional sites initiating the study over the next 30 days. Of the 7 patients, the median dose was 106 micrograms during week 4 132.5 micrograms during week 8, which are comparable to nebulized Tyvaso of about 12 to 15 breaths per session respectively. The highest dose of utrepia achieved to date in the study is 3 18 micrograms, which is at least 36 breaths per session of Teveso nebulizer.

Speaker 3

While early in the small sample size, we are encouraged at the tolerability and titratability profile in patients with PHLD and remain confident that we can complete enrollment of the study by the end of the year. We look forward to presenting a more robust clinical data at a future medical conference later this year. Finally, regarding the third question, next week at the American Thoracic Society Conference, we will present an abstract focusing on the clinical data of our liposomal sustained release formulation of treprostinil L606 from the open label safety study in the first 24 patients enrolled with PAH and PHILD. We continue to observe a favorable tolerability and titratability profile of L-six zero six given the 7 fold lower Cmax and twice daily dosing using a rapid breath accentuated nebulizer. To date, patients have titrated to our maximum dose allowed in the study of 3 78 micrograms twice daily, a dosage that would be comparable to 26 to 28 breaths of tabaso nebulized administered 4 times daily.

Speaker 3

We will publish the poster to our website once presented and look forward to discussing the observation in future calls. In addition, we are vigorously engaging in startup activities to enable initiation of our Phase 3 randomized controlled study. This single pivotable study will enable indications to treat both PHLD and PAH. Physician interest globally is robust and we look forward to interacting with regulatory agencies in the next few months as we prepare to initiate the study later this year. At this time, I would like to ask Rusty to summarize the recent legal actions of the last few months.

Speaker 3

Rusty?

Speaker 4

Thank you, Rajeev. The Q1 of 2024 saw significant progress in the legal front. This is the first earnings call in which we can say that there are no legal barriers preventing the FDA from issuing a final action on the amended NDA for eutrepia. The combination of District Court, PTAB and Federal Circuit rulings have led to the removal of the previous injunction issued in 2022. In addition, United Therapeutics regulatory exclusivity tied to PHIL D expired on March 31.

Speaker 4

Thus since April 1, the FDA has had the legal authority to take final action on our NDA for Eutrepia. While we cannot comment on when the FDA will take that final action, we can clarify the status of 2 ongoing lawsuits brought by United Therapeutics against Liquidia and the FDA, each with the same intent to stop the launch of utrepia and PHLD. Neither of these lawsuits currently impact the FDA's ability to approve utrepia for both indications. And even in the worst case, neither lawsuit will ultimately impact our ability to treat PAH patients. In the first of these lawsuits, United Therapeutics has filed a lawsuit alleging infringement of the 327 patent based on our request for approval of the PHILD indication.

Speaker 4

In this lawsuit, United Therapeutics has filed a motion for preliminary injunction. Judge Andrews in the United States District Court for the District of Delaware heard oral arguments from both parties on April 23 regarding the preliminary injunction and may issue a written ruling at any time. We remain confident in our arguments as briefed and argued and continue to believe there are substantial questions regarding the validity of 3/27 patent, which generally covers treatment of PHLB patients with Tyvaso in accordance with the Tyvaso label, something that physicians have been doing for more than a decade as evidenced by multiple publications describing positive results in THLD patients over that period. In the second of these lawsuits, United Therapeutics is seeking to bar the FDA from accepting and approving our amendment to add THLD to the label for eutrepia pursuant to the administrative procedure set. Judge Bates in the United States District Court for the District of Columbia rejected the United Therapeutics motion for a temporary restraining order and preliminary injunction on March 29, indicating that the FDA's acceptance of our amendment for review did not constitute final agency action.

Speaker 4

Judge Bates has retained jurisdiction though and ordered the FDA to provide the court and both United Therapeutics and Liquidia notice 3 days prior to taking any final action on the Utreptia NDA. Additionally, last week, both we and the FDA filed motions to dismiss the entire lawsuit and briefing on the motion to dismiss is in progress. We remain confident that both our amendment was that both that our amendment was properly filed and that United Therapeutics does not have the necessary standing to challenge the FDA's decision. Our priority has been and remains prompt approval of UTREPIA so that we can make it available to patients. We will continue to vigorously defend our ability to do so.

Speaker 4

I will now turn the call over to Mike.

Speaker 5

Thank you, Rusty, and good morning, everyone. We ended the Q1 in the strongest financial position in the company's history. Not only do we have the cash on the balance sheet to achieve our objectives, but we're also poised to launch into one of the fastest growing rare disease markets with what we believe will be a differentiated product for PAH and PAH ILD patients. Our team is fully in place. Our commercial inventories are ready and expanding.

Speaker 5

Our relationships with all key stakeholders are sound and active, and our sales team is fully engaged and ready to launch. We continue to believe that the approval and launch of utrepia this quarter in both indications will enable a rapid transformation in the company's P and L. Turning to our financial results, which can be found in the press release, you will see that revenue was $3,000,000 for the Q1 2024 compared with $4,500,000 in the same quarter for 2023. Revenue is tied to our promotion agreement with Sandoz to commercialize treprostinil injection. The decrease was primarily due to favorable gross to net rebate adjustments recorded in the prior year and the impact of lower sales quantities in the current year as compared to the same period in the prior year.

Speaker 5

Cost of revenue increased to $1,500,000

Speaker 4

for the

Speaker 5

Q1 2024 compared to $700,000 in the same quarter for 20 20 3. Cost of revenue relates to our promotion agreement with the increase being primarily due to our sales force expansion during the Q4 of 2023. Research and development expenses were $10,100,000 in the Q1 2024 compared with $5,300,000 in Q1 of 2023. The increase of $4,800,000 or 91 percent was primarily due to a $2,000,000 increase in personnel expenses, which includes stock based compensation related to higher headcount and a $1,700,000 increase in clinical expenses related to our L-six zero six program. Additionally, there was a $1,300,000 increase in expenses related to our EUTREPIA program driven by higher clinical and supply expenses related to our Ascent study.

Speaker 5

General and administrative expenses were $20,200,000 in the Q1 of 2024 compared to $7,800,000 in the same quarter for 2023. The increase of $12,400,000 was primarily due to increases in legal fees related to our ongoing utrepia related litigation, increase in personnel expenses and increases in commercial and consulting expenses in preparation for the potential commercialization of utrepia. In summary, we incurred a net loss for the 3 months ended March 31, 2024 of $40,900,000 or $0.54 per basic and diluted share compared to a net loss of $11,700,000 or $0.18 per basic and diluted share for the 3 months ended March 31, 2023. We ended the Q1 with $157,900,000 cash on hand, which included $100,000,000 in gross proceeds between a private placement of equity to a single investor and a third advance from healthcare royalty under our agreement. In summary, we are well positioned financially to achieve our corporate objectives in 2024.

Speaker 5

I would now like to turn the call back over to Roger.

Speaker 6

Thank you, Mike.

Speaker 2

Operator, with that, I'd like to now open the call for questions. First question, please.

Operator

Thank Our first question comes from Jason Gerberry with Bank of America. Your line is open.

Speaker 7

Hey guys. Thanks for taking my question. I guess just on last week's filing to dismiss by both Euther and the FDA. How quickly do you think do you have a sense of how quickly Judge Bates may move here? This seems like maybe the one new variable here, if FDA is being asked to give 3 days notice, they don't want to give 3 days notice, they want this dismissed.

Speaker 7

I'm just kind of curious how to put this in proper context. And then ultimately, if you're able to secure a broad approval, both PAH and PHILD, just wondering if there are any specific label variables you might call out that could really impact the commercial opportunity beyond just getting those two indications, how we might think about the label looking different than TAVASO? Thanks. Hey, Jason. Good morning.

Speaker 2

Thanks for the question. Maybe I'll take the second question first, if I can, and then I'll ask Rusty to speak about his perspectives around the timing of the motion to dismiss case. So great question, Jason. Again, what we talk about with Eutropia in terms of being differentiated are around its pillars, which are tolerability, titratability, durability and usability. And all of that is sort of dictated by the PRINT formulation.

Speaker 2

So again, with the ability to make precise and uniform particles in the lower end of the respirable range, it allows for a highly tolerable therapy, which is readily titratable and then will be durable and usable through the low resistance device, so friendly for both PAH and PHIL patients to use. The differentiation that we will see in the label in that regard will be specifically related to the exposures that we've seen in our clinical work versus what's in their label. So we will have up to 212 micrograms 4 times a day described in our label. So again, we're talking about 24, 25 breath equivalents, so much higher than what's in the Tabesa DPI. And as we know from historical standards across all routes of prostacyclin delivery, dose matters.

Speaker 2

So the higher the dose and the more flexibility in driving dose, the more capable that therapy will be. So that's why we think that neutropia has a will have a clear chance to become best in class and 1st in choice prostacyclin, not only to compete with inhaled treprostinone in the Tyvaso formats, but also when physicians are seeking to think about starting therapy, we think they should think about using utrepia as the first choice, not and do that in sort of in place of oral therapies like Orenitram and UPTRAVI. And then also in terms of subcu where those patients are going to have a pretty burdensome time getting to therapeutic dose of drug because of the off target effects for both the oral and the parenteral formulation. So again, tremendous market opportunity, looking forward to launch, but I think we'll have a very clear and distinguishable differentiation at the point of launch. And with that, Rusty, maybe if you could speak about the logistics around the legal case?

Speaker 4

Sure. So Jason, thank you for the question. So the motion to dismiss and briefs that went in last week is the 1st round of briefs on the motion to dismiss. Briefing will continue through June 25. And then from there, we don't have visibility as to what the judge will do and how long it would take him to rule.

Speaker 4

It's possible that at that point he'll schedule a hearing, or it's possible he'll just rule on the briefs. But obviously federal judges, it's hard to predict exactly how long they would take to issue a ruling. Thank you for the question. Yes.

Speaker 2

And just to remind you that decision is not needed for the FDA to take final action, as Rusty said in his comments. Operator, next question please.

Operator

Thank you. Our next question comes from Julian Harrison with BTIG. Your line is open. Our next question comes from Serge Belanger with Needham. Your line is open.

Speaker 8

Hi, good morning. Thanks for taking my questions. I guess the first one, Roger, you mentioned targeting the oral treprostinil market. If you can just maybe elaborate on that in terms of the market opportunity. And I think this would be another differentiated aspect of Eutropia because I don't think your competitor is positioned their DPI product for that segment?

Speaker 8

And then secondly, can you just talk about payer coverage? I think in the past you've highlighted how your launch ready to sales force has been expanded and are in the field. But maybe if you can talk about how quickly you think you can get EUTRIA on formulary post approval? Thanks.

Speaker 2

Yes, thanks. Great question. So I'll take the first one around how we hope to cannibalize the oral market. And then Mike, if you'll talk about the payer landscape, if you will. So in terms of like oral, prostacyclins currently, and again, these are just sort of generalized estimates.

Speaker 2

Orenitram is doing about $400,000,000 per annum and Uptravi is doing about $1,200,000,000 per annum. Both they're different. They're both prostacyclin is different in their sort of mechanistic approach. But Orenitram, it's difficult to titrate. It takes weeks, if not months, to get to a therapeutic dose, causes a lot of off target GI effects.

Speaker 2

And those GI effects are the predominant reason that patients discontinue that therapy and then progress to other therapies, which in the past typically has been parenteral therapy. UPTRAVI has a pretty tight narrowed dose titration curve. It pretty much has a dose ceiling. So patients titrate to their top tolerated dose and then are held on that dose and then removed from therapy once their disease progresses beyond the capabilities of the dose that they're on. So and also comes with the off target effect.

Speaker 2

So we think that we could position Eutrepia, particularly given its titratability. So again, what Eutrepia has done through the PRINT enabled formulation has allowed for a titratable inhaled treprostinil formulation for the first time. So it has a lot more flexibility and can become a much more rigorous and durable choice for physicians and their patients. Now you asked that why has United not pointed this out? Well, again, it might be that they don't quite have the flexibility that we do in terms of dosing, so it has limitations in that regard.

Speaker 2

I think the other aspect here is because they have an oral prostacyclin, they don't want to sort of detail against themselves. And in fact, had they done that, it would have set the table for us quite nicely in terms of what we want to do, as I just described. So you can understand why they're not doing that. But we will not be hindered in any way from that search. So we certainly are going to go after both the totality of the inhaled market and the totality of the prostacyclin market, particularly those patients that are having issues more with off target effects like DI side effects, which are significant and parenteral effects like subcu side pain and erythema.

Speaker 2

So again, attractive markets, dollars 1,600,000,000 dollars with the $1,500,000,000 with PIVASO aggregated opportunity now. So you're already at a $3,000,000,000 opportunity if we aggregate all of those markets together. And that's what the PHYOMT, as I said in my comments, only marginally penetrated at this point. So really, really nice opportunity. I think the other thing I will say, this is not if you talk about inhaled treprostinil, it's not a net zero sum game.

Speaker 2

I think sometimes people try to position us antagonistically against you, there's opportunity. I think in PHILD in particular, again, there's lots of patients there. There's lots of opportunity for both companies to do well and we look forward to launching in the near future and presenting the choice and that's what we're about. So Mike, if you'll talk about payer coverage.

Speaker 5

Yes, Serge, thanks so much for the question. I think what's important to know is the overwhelming feedback we've received from doctors and patients is they're wanting choice and having Utrepti available will provide that choice. But we also understand in order to truly have that choice, access is critically important. So we've been engaging with payers. We received tentative approval in PAH back in November of 2021.

Speaker 5

We've been engaging with payers since that time to discuss the value proposition of utrepia. And I think we are confident that once we are we get full approval from the FDA that we will be able to work through that and make sure patients have that choice and to have that choice and to have access. So we are confident that we will achieve that. But until we get approval, obviously, none of that will be formalized. But we've had really good conversations with payers and feel very confident that patients will be afforded that choice to choose eUTREPRIA through an insurance platform where Eutrepia is on formularysis.

Speaker 8

Yes. Thank you.

Operator

Thank you. Our next question comes from Julian Harris with BTIG. Your line is open.

Speaker 7

Hi, guys. Can you hear me?

Speaker 2

Yes, we can Julian. Good morning.

Speaker 7

All right. Sorry about that before. Thank you for taking my questions. Rusty, you highlighted that there are no lawsuits that directly prevent the FDA from making a potential approval decision at this time. I understand you can't comment on when specifically the FDA is expected to make a decision.

Speaker 7

But are you able to comment on what they could be waiting on at this point? Understand that that might be too speculative of a question and then can you also remind us on where manufacturing stands? Have there been any additional inspections required by the FDA in the current cycle?

Speaker 2

Yes. Julien, thanks for your persistence in getting through the call. Rusty can answer the first question and then Mike if you'll address the supply issue question.

Speaker 4

So Julien, thank you for the question. So first, we don't want to speculate on what the FDA where they are in their process, nor do we want to comment publicly on our interactions with the FDA to date. So again, as I said before, there is no legal impediment to them taking final action on our NDA. We are awaiting that final action. But again, we can't really speak to any specific timing.

Speaker 5

Yes. And Julien, relating to supply, we've been anticipating a launch, obviously, for a long time now. We've been building commercial inventories through that entire time. So once the FDA grants final approval, we will be ready to hit the ground running immediately in all strengths of our product. Related to the inspection, as part of our tentative approval in November of 2021, the FDA did a preapproval inspection in August of 2021, and that was included in our tentative approval.

Speaker 5

So all preapproval inspections have been completed. And as I said, we've been building up commercial inventory since then and look forward to hopefully in a minute launch here.

Speaker 7

Very helpful. Thank you.

Operator

Thank you. Our next question comes from Canvas Yazzie with Jefferies. Your line is open.

Speaker 9

Morning team. Thank you for sharing some of the Ascent data to date. So I guess my question on that open label study is kind of what titration schemes are you looking to assess? And then as a second question, in terms of that overall projected $3,000,000,000 inhaled nebuli, treprostinil market sorry, inhaled treprostinil market. What do you see the split between the different cannibalization of the oral treprostinil market?

Speaker 9

Thank you.

Speaker 2

Hey, Kamil. I'll speak to the market question and then Rajiv, if you could talk about what we're trying to achieve and what we feel is the 1st company sponsored TPI test and PHIL patients. So I think, Combi, when you look at the market opportunity here, again, we're just going to say that Eclipse is $3,000,000,000 and growing. There's I think Euther has said that up there $1,500,000,000 on their last earnings call, they intimated that PHILD represented nearly $1,000,000,000 of that or was approaching $1,000,000,000 in terms of indication opportunity. And that's with marginal penetration.

Speaker 2

So we think that market again, if you believe it's 60,000, some people say it's 100,000. I think you said it's 30,000, but that number I think they're taking north now. But let's just split the difference and call it 60,000. They're probably at high single digits, low double digit penetration, so just marginally penetrated. So lots and lots of room to grow there alone.

Speaker 2

So that's a multibillion dollar opportunity in PHILT for sure with an inhaled prostacyclin moiety. With the orals, again, that's cannibalization and that may take a little bit more time to move along, but eUTREPRIA behaves the way we think it can in the real world, then we think we can really infringe on the oral markets. So we also think that's a for eutrepidus specifically, that's a $1,000,000,000 opportunity as well. So when you aggregate those together, our share of the inhaled, our share of the oral, we think we can have a multi $1,000,000,000 product or more. So I think, again, we need to prove that out.

Speaker 2

We need to generate the launch dynamics that we hope to do to support that to be true. But the first thing is to get the approval and we're working hard to do that. So Rajeev, if you'll talk about some of the things we're trying to achieve in terms of dozing, which will help us achieve this multibillion dollar opportunity.

Speaker 3

Yes. Thank you. And, Kambe, good morning. So first of all, I think one thing we're highlighting here is that this is the first open label prospective study in PHLD using a dry powder inhaler with eutrepia in this regard. Remember, we've already conducted the INSPIRE study in 121 patients.

Speaker 3

So we really understand the tolerability profile and the titratability of Eutrepia. And so we took those learnings and we brought it into patients with PHLD that have no that have never been treated in the past. In this regard, as I highlighted, we have 7 patients that have enrolled to date. And one thing that you had asked is, what is the dosing recommendation for this patient population? Well, clearly, I think the primary objective is that, one, can the tolerability profile that we saw in the INSPIRE study in PH patients be replicated in PHLD?

Speaker 3

And I think the early small sample sizes, the answer is yes, it can. Clearly, what needs to happen is dose matters, right? So the increased study used in Tyvaso suggested that patients who get to at least 9 breadth equivalents of Tyvaso nebulizer portend to have a better clinical effect. But actually patients who can get actually higher to 11 to 12 breaths, looks like the signal actually gets a bit stronger. So the priority of this study is to titrate the patient at least to 9 to 12 breaths, which is the traditional therapeutic goal of inhaled treprostinil.

Speaker 3

But more importantly to exceed that in the right patient profile, right. So some patients may need 9 to 12 breaths, maybe the majority of these actually need somewhere more than that. One thing I think is really intriguing is that I highlighted in the call that the median dose at week 8 is now 132 micrograms of utrepia, which is now equivalent to greater or equal to 15 breaths of Tyvaso. So I think the early findings from the study are quite encouraging and we look forward to completing enrollment in the study by the end of the

Speaker 2

year. So, Kaman, I think when we finish the study, the important data for investors to look at would be what were the what's our ability to titrate, which as Rajeev said, at least in the early data, we're seeing good evidence that we can do that quite aggressively. And then the other question would be how durable is it? And so far, those patients are remaining on studies. Remember, as I stated in the preamble, it was only a meeting of 40 days where people who had started PIVASO DPI within the National Jewish Center data were unable to continue that drug and 50% of those patients dropped off within that 40 day median timeframe.

Speaker 2

So we're trying to make a contradictory statement to that to show that eutropia is much more titratable and much more durable. The reasons that patients predominantly came off in the National Jewish Center experience was for clinical worsening, which I would assume is due to a lack of ability to provide a therapeutic dose, otherwise they wouldn't have worsened. And we're trying to basically show that eutrophic can perform in a very different way. And obviously, that speaks to its differentiated capabilities and market opportunity. So, so far so good, but more to come there.

Speaker 2

Operator?

Operator

Thank you. Our next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is open.

Speaker 6

Hi, good morning guys. Thanks for taking my questions. Just in terms of your commercial prep and readiness, how soon after approval will you launch the drug?

Speaker 2

Thanks. Mike, would you like to answer that question, please?

Speaker 5

Yes. So Matt, thanks for the question. Obviously, once we get full approval, it will take a little bit of time to list our price in compendia. But from a commercial availability, what I can say is our commercial team, our sales force is literally ready to go immediately thereafter. Our commercial inventory will be ready to go within days after of final approval.

Speaker 5

So I know a lot of companies take 30 to 45 days to launch after they get full approval. We will be ready to go literally within days or a week after final approval regardless of when that time comes.

Speaker 2

Okay.

Speaker 3

Okay.

Speaker 6

Thanks. And I know we're all focused and waiting for UTREPA's approval. But thinking out a little bit into the future, can you tell us a little bit more about 606 and L-six zero six and what role and position you think that will play in terms of the inhaled professional market?

Speaker 2

Yes, I'll answer that. Thanks for the question, Matt. So, I think when you look at Eutrepia in terms of what it solves for, it's taken what was a maybe you look at just Tyvaso, nebulized Tyvaso, it was a fixed dose or a not a readily titratable therapy. So we've really transformed the therapeutic index and we've made it much more titratable. So we can get to a higher effective dose while keeping the AE profile the same.

Speaker 2

So you have a better therapeutic index for atrepia than you do with, for instance, nebulized type A as an example. What we didn't do was solve for the 4 times a day curbing regimen and that's the same. That's also true for Tyvasa with DPI. So improved on the therapeutic profile of inhaled treprostinil but still requires 4 times a day administration. So what L-six zero six will do is address that final point and really pull on that lever to make the market instead of just sharing the market with our competitor, we look to then basically dominate the market.

Speaker 2

So if we had a formulation that behaved the same as Eutrevia, but you could do that in a twice a day format and essentially solve for the overnight removal of therapy, which happens because you dose before you go to sleep, the half last 4 hours, you sleep 8 hours, by the time you wake up, the therapy is gone. We will solve for that, provide a more steady state exposure, which we think will also be better for patient outcome. And then as Rajiv said in the open label trial, we're seeing just that. We're seeing that L-six zero six is extremely well tolerated and that's because it has a, as Rajiv said, a 7 times lower Cmax. And that its AUC 0 to 24 hours is the same as over given BID is the same as 4 times a day inhaled treprostinil.

Speaker 2

So its target profile and open label work so far is exactly what we wanted this to be. And now we're just going to try to replicate the Tyvaso INGRED study with L-six zero six. We'll start that at the end of this year, work hard to get that done and improve sometime in the 'twenty eight timeframe. But at that point in time, we think that will become the preferred therapeutic because it's sulfur regimen while still giving all the benefits that your trucking does. Thanks, Roger.

Speaker 2

Thank you, Matt. Operator, next question, if any.

Operator

Thank you. There are no further questions. I'd like to turn the call back over to Roger for closing remarks.

Speaker 2

Great. Thank you, operator. And thank you very much for the questions this morning. My hope is that the next time we address you on our earnings call, we will be providing to patients what we feel is a preferred product for inhaled treprostinil and it will become at a critical time as the market for inhaled treprostinil rapidly expands. Thank you for joining us today, and we look forward to speaking soon.

Speaker 2

Bye bye.

Operator

Thank you for your participation. This does conclude the program. You may now disconnect. Everyone have a great day.

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Earnings Conference Call
Liquidia Q1 2024
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