Q4 2023 Liquidia Corp Earnings Call
Participants
Jason Adair; Chief Business Officer; Liquidia Corporation
Roger Jeffs; CEO & Director; Liquidia Corporation
Russell Schundler; General Counsel, Secretary; Liquidia Corp
Kaseta Kaseta; CFO; Liquidia Corporation
Scott Moomaw; Chief Commercial Officer; Liquidia Corporation
Rajeev Saggar; Chief Medical Officer; Liquidia Corp
Julian Harrison; Analyst; BTIG
Serge Belanger; Senior Analyst; Needham & Company LLC
Matt Kaplan; Analyst; Ladenburg Thalmann
Kambiz Pashneh-Tala Yazdi; Analyst; Jefferies
Presentation
Operator
Good morning, and welcome, everyone, to the Liquidia Corporation full year 2023 financial results and corporate update conference call. My name is Michelle, and I will be your conference operator today. (Operator Instructions) I would like to remind everyone that this conference is being recorded.
I would now like to hand the conference over to Jason Adair, Chief Business Officer.
Jason Adair
Thank you, Michelle, it's my pleasure to welcome everyone to liquidity as full year 2023 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Operating Officer and CFO, Michael Costa, Chief Commercial Officer, Scott Malat, Chief Medical Officer, Dr. Richie Saagar, and General Counsel, Rusty Chandra.
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 we'll open up the call for your questions.
Roger Jeffs
Thank you, Jason. Good morning, everyone, and thank you for joining us today. While today's call is intended to review the Company's accomplishments in the last year, we know that physicians, patients and our investors are solely focused on one thing. The potential FDA approval in the coming weeks of Tremfya, our novel dry powder formulation of treprostinil.
I will ask Randy to address the legal and regulatory path to approval in more detail shortly, but to put it simply with the recent decisions by the Federal Circuit, affirming the invalidity of the sole patent that is blocking our approval. The FDA should be able to grant approval for your Tremfya after March 31, when regulatory exclusivity to treat PH-ILD with Taipei So expires.
I provide a precise final approval date is hard to forecast, but we view the remaining step as largely procedural final FDA approval has always been the goal, and we have never been closer or better prepared than today. Our commercial teams are in place and ready for launch, our expanded field force has been raising the profile of Liquidia in their best of Liquidia in their territories.
Over the last three months, our manufacturing team is preparing inventory in anticipation of eventual launch in both PAH and PH-ILD. Our R & D team continues to build clinical knowledge by studying neutropenia and PH-ILD patients in the open label ASCENT trial and our finance team has positioned the company with the resources and discipline required to execute a successful launch. We entered 2024 at a full sprint due to the resolve and execution of our team in 2023.
Last year, everything grew in the right direction. Our confidence grew with legal wins. Our balance sheet grew with key transactions by marquee investors and insiders and our pipeline grew with the in-license of L. six oh six, the most clinically advanced next generation sustained release inhaled treprostinil program. Given the proximity of a potential launch. I'd like to spend a little time framing the potential market opportunity for you directly as we see it, both in PAPHILD. and PAH. With regard to PH-ILD current festive season pages.
However, these estimates likely undervalue the total addressable population since those calculations rely on historical publications before the field had effective tools to treat the disease and therefore reasons to diagnose the disease with inhaled treprostinil as the only approved mechanism to treat PH-ILD, the market penetration is still in its infancy. We believe there is significant growth in this market. Total inhaled treprostinil revenues currently sit at about a $1.3 billion annual run rate in the US alone.
With regard to PAH, we also believe that Utopia have potential for significant uptake. We view it as having the potential to not only be the best in class inhaled treprostinil, given its dosing flexibility and ease of use but also the First Choice process. Specifically, patients who previously considered to oral prostacyclins at their starting choice, can now avoid the significant and limiting off-target GI toxicities associated with these drugs.
While still achieving therapeutic doses. That's combining current sales of oral prostacyclins of approximately $1.6 billion in PAH, with the recently reported sales from inhaled treprostinil of $1.3 billion. The market opportunity for Intrepid could be approaching $3 billion and growing incrementally as the PH-ILD patients still remain largely untreated with its unique and differentiated differing or approach that I think are very attentive for Utopia for the investor value in both of these markets.
At this time, I would like to ask Rusty to summarize the next steps towards final FDA approval.
Russell Schundler
Yes. Thank you, Roger. I'd like to group the recent litigation and regulatory activity into two buckets. First, this those items on the critical path tiotropium approval. Second, the recent attempts by United Therapeutics to serve new legal theories to block approval, be choppier. All told, we see the increased and frantic litigation activity by United Therapeutics as perhaps a sign that even they believe that the legal impediments to final approval of the drug, we are nearing an end in the first bucket I mentioned as we have publicly stated previously, there are only two items on the critical path for Intrepid to be launched.
First, as Andrew's must lift the injunction who ordered in August 2022, based on this finding of infringement and for seven nine three patent patent. It has subsequently been invalidated a finding that was affirmed again yesterday when the Federal Circuit denied United Therapeutics requests for retail. And second, the regulatory exclusivity granted to TIBCO for the PH-ILD indication must expire, which will occur on March 31st. Once both of these have occurred, the FDA will have the ability to issue final approval for Utopia for both the PAH and PH-ILD indication.
We will not speculate on the specific date when Judge Andrews will render his decision, but the matter has been fully briefed and can be decided at any time in the second bucket. Over the last several weeks, United Therapeutics has sought to add new impediments FDA approval in our launch of Utopia by seeking preliminary injunctions and multiple proceedings. However, as we have stated previously, in order to obtain any preliminary injunctions, the burden will be on United Therapeutics to convince the judge that among other things they are likely to succeed on the merits and those actions. We believe that this burden will be a challenge for them to meet based on the laws and the facts.
That issue first request for preliminary injunction is directed to the second Hatch-Waxman lawsuit alleging infringement of the three to seven patent in the treatment of PH-ILD issued after the Utrecht The NDA was submitted and F3 Liquidia amended its NDA to add THLV.s to label for neutropenia. The three to seven patent covers the treatment of PH-ILD patients with Taipei. So in accordance with the dosing regimen in the database of labels, as we've noted previously, there's considerable prior art teaches the treatment of PH-ILD patients with five Asia, including the 73 patent and multiple peer-reviewed publications in the decade prior to the priority date from three to seven patent that describes positive results from trading PH-ILD patients with diabetes courts have generally refrain from issuing preliminary injunctions and situations where there are substantial questions as to the validity of a patent.
And in light of all the prior art here, we believe substantial questions of validity of the three to seven patent exist. Second Request for preliminary injunction is directly United Therapeutics recently filed suit against the FDA under the Administrative Procedures Act filed in the United States District Court for the District of Columbia to suit alleges that the FDA mistakenly permitted Liquidia to amend the NDA for your you have to add the PH-ILD indication we have intervened in the case and are now a party to the case alongside the FDA. First and foremost, the FDA did, in fact, accept our amendment to the NDA for review, and we believe that the FDA's acceptance of our amendment for review was proper and in full accordance with current FDA regulations, United Therapeutics argument that an amendment to add a new indication is in proper is based primarily on a non-binding 24 FDA guidance documents. Ignoring subsequent FDA regulations adopted in 2016 that expressly contemplate the possibility of adding new indications through an amendment.
Secondly, even if United Therapeutics was correct that the amendment was improper, that would not mean that United Therapeutics would receive a new 30 month stay as they have argued, for instance, even if the amendment was now rejected by the FDA, Liquidia could simply supplement its NDA after approval to add the PH-ILD indication. Exact same process used by United Therapeutics that PH-ILD the label for Tyvaso. Critically, the statute expressly states that amendments and supplements the exact same way in determining whether a patent can give rise to a 30 month stay, meaning that only those patents submitted to the Orange Book prior to the filing date of the original NDA, not the filing date of the amendment or supplement can give rise to a 30 month. Stay briefing on the motion for preliminary injunction will be completed on March 18th and a hearing will be held on March 29th. We look forward to this matter being addressed in short order.
In summary, Liquidia sees the path to launching the trustee and two straightforward actions, removal of the injunction and approval of the products. The rest as a last ditch attempt by a competitor to make any and every argument they can to maintain their monopoly and deny patients access to a meaningful treatment option. We have long anticipated the possibility that United Therapeutics could engage in such a flurry of activity as we need near clearance of the original Hatch-Waxman litigation, and we are prepared to meet them head-on.
With that, I will pass to Mike for a review of last year's financial.
Kaseta Kaseta
Thank you, Rusty, and good morning, everyone. The Company has never been in a stronger financial position than it is now heading towards its first product first major product launch. The financial discipline we've shown to date has not only allowed us to fully engage in defending against the litigation campaign that has been directed against us, but as demonstrated to the savvy investors that we can meet and exceed expectations as we look to build value in the company without overspending or incurring significant dilution.
Turning to our full 2023 financial results, which can be found in the press release, you will see that revenue was $17.5 million for the year in 2023 compared with $15.9 million in 2022 tied to our promotion agreement with Sandoz to commercialize two optional injections. The increase of $1.6 million was primarily due to favorable gross-to-net chargeback rebate and managed care adjustments, offset by the impact of lower sales quantities as compared to the prior year.
Cost of revenue was roughly the same for 2023 and 2022 at $2.9 million. Cost of revenue relates to the promotion agreement. Research and development expenses were $43.2 million in 2023 compared with $19.4 million in 2022. The increase of $23.8 million or 122% was primarily due to the $10 million upfront license fee payment to Formosa for the exclusive license to develop and commercialize L606 from North America, plus an additional $2.6 million in support of that program.
Expenses related to our European program increased to $13 million from $6.7 million the year prior, primarily due to increased manufacturing of prelaunch commercial supply and the start-up of our ASCENT study. Personnel and consulting expenses, including stock-based compensation expense, also increased $5.1 million, primarily due to increased headcount to support the potential commercialization of Utopia.
General and administrative expenses were $44.7 million in 2023 compared with $32.4 million in 2022. The increase of $12.3 million or 38% was primarily due to a $9.8 million increase in personnel and consulting expenses, including stock-based compensation, partially driven by the expansion of our field force and also a $1.4 million increase in commercial expenses in preparation for the commercial potential commercialization of neutropenia.
In summary, we incurred a net loss in 2023 of $78.5 million as compared to a net loss of $41 million in 2022. We ended the year with the $83.7 million cash on hand and then quickly added another $100 million in the first week of January with a private placement of equity to a single investor and a third advance from HealthCare Royalty under our agreement from January 2023.
In summary, we are well positioned to achieve our corporate objectives in 2024 I would now like to turn the call back over to Roger.
Roger Jeffs
Thank you, Mike. 2024 is shaping up to be the translation transformational year as Liquidia. We are fourth in the starting blocks in the EU and rest of both described and saw earnestly to get where we are today. We look forward to proving ourselves in the market with more importantly, easing the burden of patients suffering from these debilitating diseases.
With that, I would now like to open our call up for questions. Operator?
First question, please.
Question and Answer Session
Operator
(Operator Instructions)
Greg Harrison, Bank of America.
Good morning. This is Mary Kate on for Greg. Thanks for taking our question. So as you guys prepare for your commercial transition, do you see any differences in launch strategy for PAH compared to PH-ILD? Maybe why or why not? And do you anticipate equal interest in those indications? Thanks.
Roger Jeffs
Good morning and again, thanks for the question. So we're fortunate to have Scott Moomaw, our Chief Commercial Officer on the phone. And Scott, maybe if he would like to opine on that.
Scott Moomaw
Yes. So the there's a little bit of a difference in strategy. So in PAH, as you know, there are many medications already available. So it's going to be really on demonstrating why our across the cycle is the best alternative relative to the other across the cycles for a lot of reasons that we can obviously get into and we believe that we will be very successful in that space.
Getting earlier use of our inhaled prostacyclin neutropenia because it is so convenient because of the titration of dose. And so in that space, we will be targeting the big centers on the physicians that use prostacyclins are ready. We'll get some new positions probably, but we'll focus on the targets that do use prostacyclins in PHILD., as you know, this is a relatively untapped market.
And so the strategy there is going to be much more about educating on the prevalence of PH-ILD and then getting physicians to look for it. And then getting them up to treat it. And we'll be out in the community with community pulmonologists, help educating them that this condition exists and that it's deadly. And then we'll be educating them on neutropenia. And if they would be willing to use your truck, that's great.
We will aid them in doing that if they won't.
Then, of course, we would like them to refer that patient to a a pH center of excellence on where it would be or would be treated. So I think that's a brief summary of how we'll approach the two markets.
Roger Jeffs
And again, you and maybe I'll just add a few comments. So I think in the kind of what I said in my opening statement indicate that in PAH., we would like to be the first choice prostacyclin. And the reason I think we can do that is because really with neutropenia and its ability to titrate to doses that are on order of threefold more than what was originally. It's possible with Tyvaso. We've changed the therapeutic index of that molecule, and that's all enabled by our print technology.
Why that's important is now we can deliver the drug for PAH patients to the site of action through the loan and avoid the significant off-target effects, which are really hampering for the oral therapies in particular. So when you look that up Uptravi, it starts at the 200 microgram dose and it's titratable up to a ceiling of 600 micrograms, but it has a ceiling and that maintenance dose is determined by tolerability. It's indicated to delay disease progression and at risk of possible and decrease in risk of hospitalization. But it's improvement on 12 on six minute walk distance is modest, only 12 meters, and I believe that was that significant. The consequence of that is net therapies, 42% of those patients have diarrhea 33% have nausea and 18% had vomiting. So significant of off-target effects.
And I ran Orenitram is a very similar story to use t. i. d. It's titrated to effect, its indicated delay, delay disease progression and an improved six minute walk distance. But in the largest study of that therapy in 690 patients, 69% of those patients had diarrhea, 40% had nausea and 36 had vomiting, which clearly limits dosing. So an impact user has said lately that because it's so difficult to titrate, they are actually promoting titration via the parenteral route and then transition to oral. So you can see this is burdensome and onerous. What neutropenia will then do is mitigate completely these off-target effects to the to the GI tract and allow dose titration. So again, we're going to look at the oral prostacyclin market is a significant market where we can gain steal share and we'll do that sort of tactically after we position ourselves as the best-in-class inhaled prostacyclin, as Scott mentioned about PAH and PH-ILD.
Operator, next question, please.
Operator
Julian Harrison, BTIG.
Julian Harrison
Hi, good morning. Thank you for taking my question on just to be clear, based on some of your prepared remarks, if you are forced to seek approval in PH-ILD via supplement instead of the current arrangement and your view, is that filing a supplement with three to seven times now in the orange book should not trigger an automatic stay? And am I understanding that correctly?
Roger Jeffs
Yes, thanks for the question.
Julien, good morning. I let Rusty answer that.
Russell Schundler
Yes. So let me clarify maybe a couple of things. So first, I think our view is that demand being rejected and us having to file this by supplement is sort of the worst case scenario. We think what the FDA did was absolutely right accepting our amendment. So we don't think this will even come into play, but if we were required to come into a supplement, and that's exactly right. So if you look at the statute, again, it's 21 U.S.C. three 55 C. three C., what specifically defines those patents that can give rise to a 30 month stay and critically, it says only those patents and are quoted before the date on which the application. And then in parentheses, excluding and amendments or supplements, the application was submitted. So again, supplements are treated the exact same way as amendments for purposes of determining which patents can give rise to a 30 month stay. And so even if we were required to file a supplement, the result would be no new 30 month stay.
Julian Harrison
Very helpful. Thank you.
Roger Jeffs
Thank you, Julian. Operator, next question.
Operator
Serge Belanger, Needham.
Serge Belanger
Good morning. Thanks for taking my question. I guess the first one, and apologies if I missed this in the prepared remarks, but has there been any additional interactions with the agency post the late January to do for dates for the PHILD.s approval. Have they asked for additional information or giving you any additional and in information regarding their internal process for that potential approval?
And then secondly, I guess for Rusty, maybe just talk about the Supreme Court decision to denied Liquidia it petitioned late last month and just what it means to the overall legal proceedings. Thanks.
Roger Jeffs
Thanks, Serge, and good morning. I'll break this into two parts, so Rajeev oversees our regulatory group. You can answer the first question. We like regarding interactions with FDA and then Rusty, if you'll answer the Supreme Court question, Rajeev?
Rajeev Saggar
Thanks. Good morning. I saw regards to on our We continue to believe very strongly as Rusty and already alluded to that, the amendment we filed to add on the indication for PTLD remains appropriate and in line with our discussions with the FDA, as you know, the only delay stopping gap was really the Concord facility, which if we had received previous approval, that lead to a tentative approval. And now we anticipate that data shortly arriving on May 31st from the CoCos inclusivity. And therefore, the entire package right now is will lead to now a full approval for both indications for PAH and PH-ILD. And we remain confident in that matter. I'll turn it over to Rusty to answer your second question.
Russell Schundler
It serves. Thanks for the question. So the Supreme Court case really has no bearing set So as a reminder, on that case was our attempt to overturn the original Hatch-Waxman decision on the seven and three patent and raise some arguments that we think and you overlooked by the lower court that there shouldn't have been a finding of infringement at all. It's very important take-up that appeal. But again, it all relates to the 7.3 patent which separately has been invalidated at this point and our firms really twice by the Federal Circuit. And so with that decision from the Federal Circuit, the decision of the Supreme Court really doesn't doesn't bear on on sort of how this is going to play out.
Serge Belanger
Thank you.
Roger Jeffs
Serge. I'll just add a little bit to resi. So I think on the one communications we've had had out obviously we missed the January 24th to do the action date. And the reason for that has been communicated is that the FDA is waiting for the injunction to be removed. So as Rusty said, there's two things that need to happen principally for us to get full approval, which is the injunction removed and and then the potential of the clinical exclusivity to expire at the end of March. So as Richie said, we were looking now the amendment was filed and asked for full approval even when we filed it in July for both PAH and PH-ILD. So it's our expectation now that we'll skip the tentative approval phase and probably just go to a full approval after the March 31st clinical exclusivity expiration.
Operator, next question, please for one moment.
Operator
Matt Kaplan, Ladenburg Thalmann.
Matt Kaplan
Thank you. Good morning and Roger, just to follow up on that question in terms of and Thank you roughly for the detail. Play-by-play in terms of the moving parts here in litigation, but in terms of the critical path and Judge Andrews lifting on the injunction, can you give us some more detail in terms of the moving parts there and how that how that that portion of their work. Obviously, their choice exclusive exclusivity expiration is just a date on the calendar.
Roger Jeffs
So that's easy. Yes. And I addressed, it can fill in here. But again, we feel the change is actually has only needs now that to route to remove the injunction and the December 20th affirmation by the Federal Circuit Court of Appeals should have given them the power to remove it. And again, I think he was just waiting to see the rehearing request denied and then the mandate to issue, which will happen next week. I think next Tuesday is when that should issue. So at that point here, really fully empowered to do what he needs to do whether or not, I think rest of you can comment on how you see the pending IPI., how that interplay may impact this.
Russell Schundler
Yes, Roger, on the on the existing injunction of what you laid out is exactly correct. Again, it's been fully briefed in front of Judge Andrews so that he has what he needs. And we also yesterday supplemented from what we had submitted to him to provide them the denial to rehearing request that was issued by the Federal Circuit's again, yes, all the information in front of them. It's in obviously that they have the new case, the three to seven patent case where they've also requested a permanent preliminary injunction. And those cases really don't relate to one another on the books in front of the same judge and obviously the patent system similar. But procedurally, the injunction that currently exists isn't tied to their request for a new injunction on the new patent. And so I don't I don't think there's any interdependency there between the two, and
Roger Jeffs
That's why that's why we're that's why we're not giving a specific date when we think the approval actually will happen. But again, other than it will be after March 31st when the exclusivity expires.
Matt Kaplan
Right, right. Okay, great. And then shift gears a little bit in terms of Altix oh six, can you give us some more details in terms of the regulatory pathway there? You described needing one additional study for approval in both PAH and PH ILT? And what can you give us a sense in terms of the timeline of that as well?
Roger Jeffs
Yes, I'd love to say receives also overseeing that effort to reshape. If you wouldn't mind answering the question.
Rajeev Saggar
Yes. Thank you, Matt, and good morning to you as well. So as you as you alluded to on Altix sixes or liposomal formulation of sustained relief for three partner that's going to be delivered twice a day and with really a smart start them portable nebulizer. So we're really excited about this program as it's sort of leading the effort to a Phase three program that the program is designed using a similar strategy like we have a pickup yet. So this is a filer five b. two pathway with the label drug being TV. So in our Type C discussions with FDA that have occurred back in December of 2023. Once again, we had confirmation that a single placebo efficacy study with Altix oh six, it would lead to approval for both indications for Group one PAH as well as group three PH-ILD in that regard, as you as you stated we specifically have chosen the indication for PH-ILD to take to take into a global large Phase three study, how that study is gated to initiate sometime into your Q4 of 2024.
Roger Jeffs
Great. Thank you, Rajeev. And I think the one thing to add to that is I guess the other part of your question is how long will that take? I think because there's such a scarcity of treatments for PH-ILD, the clinical trial, particularly when we do it in European centers, for instance, it has potential to enroll quite rapidly. I think in the normal time course, for the sample size we're contemplating would be two years or so. But I think maybe we can shorten that a bit and there's time to get through the six month time endpoint and then time to collect the data submit and reviews. I think just in broad brush strokes, we're looking at it from first patient into it and FDA decision is probably in the 3.5 to 4 year arrangement.
Next question, please, operator,
Operator
Kambiz Yazdi, Jefferies.
Kambiz Pashneh-Tala Yazdi
Please go ahead, Argentina with the filed motion for preliminary injunction with regard to three to seven, what would be the timelines associated with that.
And then can you remind us the FDA's perspective of a real amendment versus NDA for indication expansion with regards to tentatively approved drugs? Do we have any precedence there?
Roger Jeffs
I think, yes, I think both of those questions are in Rest these courts. Have you in mind, ST?
Russell Schundler
Sure. So on the first question, for the three to seven patent. So the beyond there is a briefing schedule on that Therapeutics has filed their brief requesting in support of their request for a preliminary injunction. Our responses do currently due on April fifth at their reply them do April ninth 19th.
The thing I'd add, and then from there, the court discussion of the hearing or not and makes a decision. The thing I'd remind you, though, is that again, the default is that if there's no preliminary injunction in place, there's nothing that blocks us from moving forward getting approval and launching. And so the burdens on United Therapeutics to get a temporary injunction before that happens. So we'll see if they're trying to accelerate the proceedings or what they're trying to do on that front, but that's the time line currently in place on that as far as the FDA's position on amendments versus supplements.
And again, I think if you look at if you look at the FDA existing guidances, there's a 24 nonbinding guidance. That is what United Therapeutics is point to which they claim stands for the proposition there. And you can never add an amendment to a pending NDA I'm sorry, never had an indication to a pending NDA. However, the 2016 regulations in the site is 21 CFR three, 14 point 60 subsection expressly contemplates situations where new indications could be added to a pending NDA, including a five or five b. two NDA like ours. So again, I think clearly the FDA is contemplating that there are early circumstances where indications can be added to NDA. And yes, as evidenced by the regulations income.
Roger Jeffs
And if I may add in Acambis, I think the guidance that there that United Therapeutics is pointing towards is the bundling guidance, but that's really more specific in Europe, changing route dosage form or formulation and providing new new data that should be submitted separately. And it's a way to make sure that the agency gets there reduces. We've done none of that same route, same dosage forms that same formulation and no due date, no new data. So we think we're well within that protection. The rest, Rusty just described great operating margin.
Kambiz Pashneh-Tala Yazdi
And I guess one other follow-up is on the ASCEND trial, what kind of patient populations are being studied and how is the enrollment proceeding there?
Roger Jeffs
Yes. Great question. Appreciate that's a rigid. If you wouldn't mind things can be.
Rajeev Saggar
And so once again, the ASCEND study is something that we are extremely excited about. More importantly, this study that's absolutely needed in the literature and and has actually been desired by the KOLs across the entire region of the United States requesting that patients that are that have been recently diagnosed with PHLD. that are naive to any therapy are then placed onto neutropenia, which is which which really will highlight three pillars that we have continued to suggest, though that are very important to have patient profile.
The first thing is titrated type of tolerability and titrate credibility. These things are going to be led by our print technology and therefore, our formulation combination of those two allows us to use a very low resistance off-the-shelf inhaler, which has the simplicity that is needed for patients that have impairments in lung function but can deliver the dose profiles that we believe are going to be required to not only achieve the minimum therapeutic goals of equivalency of 10 to 12 breaths four times a day of inhaled treprostinil, but more importantly, lead to actually more improvements in clinical outcomes and efficacy standards that are used such as walk distance, I mean, actual overall clinical outcomes. We're very encouraged right now by the current enrollment rate that we're seeing as you know, we enrolled our first patient at the mid to end of December of 2023, and we anticipate that we will complete enrollment up to 60 patients by the end of this year. So we look forward to sharing some some snapshots of data in future meetings that are coming up shortly.
Roger Jeffs
Thank you, Rajeev. And I think it's a great question. I think the other thing you know, again, what why this data is important. And I think if when you look at the data, that's some of the data that's been published on United Therapeutics has commenced the DPI., particularly the data at the National Jewish center in Colorado. You can see that there in some difficulty with the KPI. in at least their single-center patient population, about 60% of their patients dropped off between three and six months, whether or not they were naive to and perhaps items that were transitioned previously from nebulized. And I think the other thing that's interesting to us is that there's still a retained 40% population of nebulized patients. I think when you launched a few years ago, the assumption was that they would convert that entire market quite quickly database at DPI. So that's not happened. So the question is why and we think it may be for the inability to dose those patients to good clinical effect, which we're trying to solve for with Interep.
So if this data bears out the way we think it will, then that will certainly augur that this is the best in class therapy and First Choice.
The next question, please.
Operator
I'm showing no further questions and I'd like to hand the conference back over to Roger Jeffs for further remarks.
Roger Jeffs
Great. Thanks, operator. So with no further questions, again, we thank you for joining us today. my sincere hope is that the next time we address you on it on the earnings call, liquidity will be prescribing to patients. What we feel is the preferred product, our in-house resource now and it will come at a critical time as the market for inhale treprostinil rapidly expand. Thank you and have a good day.
Operator
That concludes today's conference call. Thank you for participating.
You may now disconnect.
