Full Year 2023 Liquidia Corp Earnings Call
Good morning, and welcome everyone to the clicking a corporation full year 2023 financial results and corporate update conference call. My name is Michelle and I will be your conference. Operator today currently all participants are in a listen only mode.
During the presentation, we will conduct a question and answer session and instructions will be provided at that time for you to queue up for a question.
Wed 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.
Thank you Michele 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 can setup.
<unk> commercial officer, Scott Musil, Chief Medical Officer, Dr. Rajiv Saga, and General Counsel Rusty sugar beets.
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. Currently, all participants are in a listen-only mode.
Four 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 our 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.
Operator: Following the presentation, we will conduct a question and answer session. The instructions will be provided at the time for you to queue up for a question. 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. Thank you, Michelle.
Performance expressed or implied on this call for.
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.
Jason Adair: It's my pleasure to welcome everyone to Liquidia's 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 Kaseta, Chief Commercial Officer Scott Moomaw, Chief Medical Officer Dr. Rajeev Saggar, and General Counsel Rusty Schundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results and 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 up the call to your questions. Roger. Thank you, Jason. Good morning, everyone.
Now I'd like to turn the call over to Roger for our prepared remarks, after which we'll open up the call for your questions.
Roger.
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.
That physicians patients and our investors are solely focused on one thing.
Central FDA approval in the coming weeks of <unk>, our novel dry powder formulation for Boston.
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 Ya Chumpier. After March 31, when regulatory exclusivity to treat ph ILD with typefaces expires.
I'll provide a precise final approval date is hard to forecast, but we view the remaining step is 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.
Roger A. Jeffs: 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 Utrepia, our novel dry powder formulation of triposyl. I will ask Rusty to address the legal and regulatory path to approval in more detail shortly. 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 eutrophia after March 31st, when regulatory exclusivity to treat PHLD with type A expires. A precise final approval date is hard to forecast, but we view the remaining steps as largely procedural.
Our expanded field force has been raising the profile of liquidity in there.
Liquidity.
In their territory over the last three months.
Our manufacturing team is preparing inventory in anticipation of a potential launch in both P. H N ph ILD.
Our R&D team continues to build clinical knowledge by studying <unk> in ph ILD patients and 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 enter 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 and our balance sheet grew with keep transactions by marquee investors and insiders and our pipeline grew with the in license about six assets. The most clinically advanced next generation sustained release inhaled <unk> program.
Roger A. Jeffs: 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, and our expanded field force has been raising the profile of Liquidia in their territories over the last three months.
Given the proximity of a potential launch I'd like to spend a little time framing the potential market opportunity for <unk> as we see it both in P. Eight ph ILD and ph.
Roger A. Jeffs: Our manufacturing team is preparing inventory in anticipation of a potential launch in both PAH and PHIs. Our R&D team continues to build clinical knowledge by studying utrepia in PHILD patients in the open-label assent 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 last year.
With regard to ph ILD.
The current <unk> patients.
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 <unk> as the only approved mechanisms to treat ph Audi.
Roger A. Jeffs: Everything grew in the right direction. Our confidence grew with LegalWing. Our balance sheet grew with key transactions by marketing investors and insiders, and our pipeline grew with the in-license of L606, the most clinically advanced, next-generation, sustained-release inhaled-through-processing approach. Given the proximity of a potential launch, I'd like to spend a little time framing the potential market opportunity for you, Trefia, as we see it, both in pH, ILD, and With regard to PHILD, Unknown Speaker. Current. Unknown Speaker. However, these estimates likely undervalue the total adjusted population.
The market penetration is still in its infancy we.
We believe there is significant growth in this market.
Total <unk> revenues currently sit at about a $1 3 billion annual run rate in the U S alone.
With regard to ph. We also believe that <unk> has potential for significant uptake with EU trapping is having the potential to not only be the best in class inhaled <unk>, given its dosing flexibility and ease of use but also the efforts in choice process.
Specifically patients who previously considered the oral prostacyclin that theyre starting choice.
Can now avoid a significant and limiting off target Gi toxicities associated with these drugs, while still achieving therapeutic doses.
Roger A. Jeffs: Since those calculations rely on historical publications before the field had effective tools to treat the disease and, therefore, reasons to diagnose the disease, the market penetration is still in its infancy. We believe there is significant growth in this market. Total in-health professional revenues currently sit at about a 1.3 billion annual run rate in the U.S. alone.
Thus combining current sales of oral prostacyclin of approximately $1 6 billion in ph with a recently reported sales from <unk> of $1 3 billion.
The market opportunity for you drop it could be approaching $3 billion and growing incrementally as the ph ILD patients still remain largely untreated.
With its unique and differentiated.
Okay.
Roger A. Jeffs: With regard to PAH, we also believe that Utrepia has potential for significant uptake. We view Utrepia as having the potential to be not only the best in class inhaled troposomal, given its dosing flexibility and ease of use, but also the first-in-choice prosthesis. Specifically, patients who previously considered the oral process like ones that they're starting towards can now avoid the significant and limiting off-target GI toxicities associated with these drugs while still achieving therapeutic doses. Thus, combining current sales of oral prostacyclines of approximately $1.6 billion in pH with the recently reported sales of inhaler prostatol of $1.3 billion, the market opportunity for utrepia could be approaching $3 billion and growing incremental With its unique and differentiated approach, it is something to think about with great attention for eutrepia and the rapture value in both of these markets. At this time, I would like to ask Rusty to summarize the next steps towards the final appeal. Thank you, Roger.
Bear attention for your trip yet.
After value in both of these markets at this time I would like to ask Rusty to summarize the next steps towards final.
Okay.
Thank you Roger.
I'd like to agree with the recent litigation and regulatory activity into two buckets first ex those items on a critical path to <unk> approval.
Second the recent attempts by United Therapeutics to a certain new legal theories to block approval of each up yet.
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 will be choppy are nearing an end.
And the first bucket I mentioned as we've publicly stated previously there are only two items on the critical path for your trip yet to be launched.
First Andrew Smith's lift the injunction he ordered in August 2022 based on its finding of infringement of 703 patent. The patent that has subsequently been and validated a finding that was affirmed again yesterday when the federal circuit denied United Therapeutics request for rehearing.
And second the regulatory exclusivity granted to Taipei, so for the ph ILD indication must expire which will occur on March 31.
Russell Schundler: I'd like to group the recent litigation and regulatory activity into two buckets. First, those items on the critical path to eutrophia are a, Second, the recent attempts by United Therapeutics to assert new legal theories to block approval of e-trap. 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 the final approval of V-TREPI 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 Utrepia to be launched.
Once both of these have occurred the FDA will have the ability to issue final approval for your trust.
Both the ph and ph ILD indications.
We will not speculate on a specific date when judge Andrews will render its decision, but the matter has been fully briefed and could be decided at any time.
And the second bucket over the last several weeks United Therapeutics has sought to add new impediments FDA approval and our launch of <unk> by seeking preliminary injunctions in multiple proceedings how's.
Russell Schundler: First, Judge Andrews must lift the injunction he ordered in August 2022 based on his finding of infringement of the 793 patent, a patent that has subsequently been invalidated, a finding that was affirmed again yesterday when the Federal Circuit denied United Therapeutics' request for re-hearing. And second, the regulatory exclusivity granted to Taiveso for the PHLD 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 eutrophia for both the PAH and PHLD indications. We will not speculate on the specific date when Judge Andrews will render his decision, but the matter has been fully briefed, and could be decided at any time. In the second bucket, over the last several weeks, United Therapeutics has sought to add new impediments to FDA approval in our launch 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 of those actions. We believe that this burden will be a challenge for United Therapeutics to meet based on the laws and the facts at issue.
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 me based on the laws and the Factset issue.
The first request for preliminary injunction is directed to the second hatch Waxman lawsuit alleging infringement of the <unk> seven patent in the treatment of ph ILD.
Issued after the <unk> NDA was submitted and after your liquidity amended its NDA at THL beats the label for your trip yet.
<unk> seven patent covers the treatment of ph ILD patients with Taipei, So in accordance with the dosing regimen in the <unk> label.
As we've noted previously there is considerable prior art that teaches the treatment of ph ILD patients with zalviso, including the 703 patent and multiple peer reviewed publications in the decade prior to the priority date for the <unk> seven patent described positive results from trading ph ILD patients with type basis.
Of course, a generally refrained from Michigan preliminary injunctions in situations, where there are substantial questions as to the validity of our patents and in light of all the prior art here, we believe substantial questions of Liberty in the 387 patents exist.
Russell Schundler: The first request for preliminary injunction is directed to the second Hatch-Waxman lawsuit alleging infringement of the 327 patent in the treatment of PHLD, issued after the Utrebia NDA was submitted and after Liquidia amended its NDA to add PHLV to the label for Utrebia. The 327 patent covers the treatment of PHLV patients with Tybaso in accordance with the dosing regimen in the Tybaso As we have noted previously, there is considerable prior art that teaches the treatment of PHLV patients with Tybaso, including the 793 patent and multiple peer-reviewed publications in the decade prior to the priority date for the 327 patent that describe positive results from treating PHILV patients with Tybaso. Courts have generally refrained from issuing preliminary injunctions in situations where there are substantial questions as to the validity of a patent.
Second request for preliminary injunction is directed at United Therapeutics recently filed suit against the FDA under the administrative procedures.
Filed in the United States District Court for the district of Columbia to suit alleges that the FDA mistakenly permitted liquidity to amend the NDA for your trip to.
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 et cetera, or 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 and proper is based primarily on our non binding 2004 FDA guidance document ignore.
Russell Schundler: And in light of all the prior art here, we believe substantial questions of validity of the 327 patent exist. The second request for preliminary injunction is directly related to 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. This suit alleges that the FDA mistakenly permitted Liquidia to amend the NDA for eutrophia to add the PHL 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.
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 under 30 months say as they have argued.
For instance, even if the amendment was now rejected by the FDA liquidity. It can simply supplement NDA after approvals and the ph ILD indication.
The exact same process used by United Therapeutics that ph ILD the label for <unk>.
Critically the statute expressly states, but amendments and supplements the exact same way in determining whether a patent can give rise to 30 months day, 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.
Russell Schundler: United Therapeutics argument that an amendment to add a new indication is improper is based primarily on a non-binding 2004 FDA guidance document, while 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 PHL of the indication. The exact same process was used by United Therapeutics to add THLV to the label for Tybaso.
Briefing on the motion for preliminary injunction will be completed on March 18th and the hearing will be held on March 29.
Look forward to this matter being addressed in short order.
In summary liquidity I see as the path to launch New Trophy and two straightforward actions.
The removal of the injunction and approval of the products.
The rest is Alaska to attempt by a competitor to make any and every argument they can to maintain their monopoly and deny patients with access to a meaningful treatment option.
We have long anticipated the possibility that United Therapeutics can engage in such a flurry of activity as we near our clearance of the original hatch Waxman litigation.
Russell Schundler: Critically, the statute expressly states that amendments and supplements should be treated 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 a 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 Eutropean as straightforward, with the removal of the injunction and approval of the product. The rest is 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.
And we are prepared to meet them head on.
With that I will pass to Mike for a review of last year's financials.
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.
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 through 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.
Michael Kaseta: We have long anticipated the possibility that United Therapeutics can engage in such a flurry of activity as we near clearance of the original Hatch-Wesson 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 statements. Thank you, Rusty. And good morning, everyone.
In 2020 to tie to our promotion agreement with Sandoz to commercialize <unk> injection.
The increase of $1 6 million was primarily due to favorable gross to net charge back 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.
Michael Kaseta: The company has never been in a stronger financial position than it is now heading towards its first project and 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 it has demonstrated to 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 optional injections. The increase of $1.6 million was primarily due to favorable growth in that chargeback rebate and managed care adjustments, offset by the impact of lower sales quantities as compared to the prior year. The 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.
Paired 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 <unk> for the exclusive license to develop and commercialize <unk>.
For North America, plus an additional $2 6 million and supportive that program <unk>.
Expenses related to our <unk> program increased to $13 million from $6 $7 million. The prior the year prior primarily due to increased manufacturing of prelaunch commercial supply and the startup of our ascent study.
Personnel and consulting expenses, including stock based compensation expense also increased $5 $1 million, primarily due to increased head count to support the potential commercialization of your trucking yet.
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.
Michael Kaseta: The cost of revenue relates to the promotion. Research and development expenses were $43.2 million in 2023 compared with $19.4 million in 2020. The increase of $23.8 million, or 122%, was primarily due to the $10 million upfront license fee payment to Pharmosa for the exclusive license to develop and commercialize L606 in North America, plus an additional $2.6 million in support of that program. Expenses related to our Utrepia program increased to $13 million from $6.7 million the year prior, primarily due to increased manufacturing of prelaunched 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 Utrecht. General and administrative expenses will be $44.7 million in 2023, compared with $32.4 million in 2020.
In preparation for the commercial potential commercialization of new truck yet.
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 $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.
Thank you Mike 2024 is shaping up to be the translation transformational year end liquidity.
We are poised in the starting blocks and as UN restaurant, both described and fought honestly to get where we are today.
We look forward to proving ourselves in the market, but more importantly, easing the burden of patients suffering from these debilitating diseases.
Rajeev Saggar: 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 $1.4 million increase in commercial expenses in preparation for the potential commercialization of Utrecht. In summary, we incurred a net loss in 2023 of $78.5 million as compared to a net loss of $41 million in. We ended the year with $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 2020. In summary, we are well positioned to achieve our corporate objectives in 2020. I would now like to turn the call back over to Raj. Thank you, Mike. 2024 is shaping up to be a transformational year at Liquidia.
With that I would now like to open our call up for questions. Operator first question. Please.
You can ask a question at this time. Please press star one on your telephone you will hear an automated message advising you. Your hand, just raised to withdraw your question. Please press star one again, one moment, while we compile our Q&A roster.
And our first question is going to come from the line of Greg Harrison with Bank of America. Your line is open. Please go ahead.
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 and launch strategy for PTH can take the ph ILD, maybe why or why not and do you anticipate equal interest in this indication.
Good morning, Thanks for the question.
So we're fortunate to have Scott <unk>, our chief commercial officer on the phone. It's Scott maybe if you would like to opine on that.
Yes.
There is a little bit of difference in strategy. So when PIH as you know there are many medications already available so it's going to be really.
Demonstrating why our process icon as the best alternative relative to the other prostacyclin 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 can trap here because it is so convenient and because of the titration of dose.
Operator: We are poised in the starting blocks, and as you and Rusty have both described, we have fought earnestly to get where we are today. We look forward to proving ourselves in the market, but more importantly, easing the burden of patients suffering from these debilitating diseases. With that, I would now like to open our call to questions. Operator, first question, please.
And so in that space, we will be targeting the big centers.
The physicians that use <unk> already we will get some new physicians probably.
But we will focus on the targets that do use prostacyclin in ph ILD. As you know this is a relatively untapped market and so the strategy there is going to be much more about educating on the.
Operator: Thank you. To ask a question at this time, please press star one one on your telephone, and you will hear an automated message advising you that your hand is raised to withdraw your question. Please press star one one again.
The prevalence of ph ILD.
And then getting physicians to look for it and then getting them.
To treat it and we will be out in the community with community Pulmonologists help any educating them that this condition exists and that its deadly.
Operator: One moment while we compile our Q&A roster, and our first question is going to come from the line of Greg Harrison with Bank of America. Your line is open.
And then we will be educating them on your truck and if they would be willing to use your truck thats, 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.
Unknown Attendee: Please go ahead. Good morning, this is Mary Caton on behalf of Greg. Thanks for taking our questions. So as you guys prepare for your commercial transition, do you see any differences in launch strategy for PAH compared to PHRLD? Maybe why or why not?
Ph center of excellence, where it would be where it would be treated so I think thats a brief summary of how we approach the two markets.
Great. Thank you.
And maybe I'll just add a few comments so I think it is.
Scott Moomaw: And do you anticipate equal interest in both indications? Thanks. Good morning, thanks for the question. So we're fortunate to have Scott Moomaw, our chief commercial officer, on the phone. Scott, maybe you would like to comment on that? Yeah, so there's a little bit of a difference in strategy.
Kind of what I said in my opening statement Mary Kate.
NPA H, we would like to be the first in choice prostacyclin.
And the reason I think we can do that is because really with your trip in its ability to titrate to the doses that are.
Scott Moomaw: So in PAH, as you know, there are many medications already available. So it's going to be really demonstrating why our prostacyclin is the best alternative relative to the other prostacyclins 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 utrepia because it is so convenient and because of the titration dose. And so in that space, we'll be targeting the big centers, the physicians that use prostacyclins already. We'll get some new positions, probably. But we'll focus on the targets that do use prostacyclins. And PHILD, as you know, this is a relatively untapped market. And so the strategy there is going to be much more about educating physicians on The Prevalence of PHIL and then getting physicians to look for it, and then getting them to treat it. And, you know, we'll be out in the community with community pulmonologists, helping educate them that this condition exists and that it's deadly. And then we'll be educating them on Utrepia, and if they are willing to use it, that's great.
On order of three fold more than what was originally possible with <unk> with.
We've changed that therapeutic Pudic 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 ph patients to the side of action through the loan and avoid the significant off target effects.
Which are really hampering for the oral therapies in particular, so I wonder if you look at the op trabi. It start to the 200 microgram dose and it's titratable up to a ceiling at 1600 micrograms, but it has a ceiling.
And that maintenance dose.
As determined by Tolerability, it's indicated to delay disease progression and risk of hospital and decrease the risk of hospitalization.
But its improvement.
Six minute walk distance is modest only 12 meters and I believe that was not significant.
The consequence of that therapy is 42% of those patients have diarrhea at 33% had nausea and 18% at vomiting, so significant.
Off target effects.
In our rent and rent a transit very similar story.
You use tid, it's titrated to a fact, it's indicated to lead delay disease progression and improved six minute walk distance learning.
Roger A. Jeffs: We will aid them in doing that. If they won't, then, of course, we would like them to refer that patient to a PH Center of Excellence, where they would be treated. So I think that's a brief summary of how we will approach the two markets. Great, thank you. And maybe I'll just add a few comments.
But in the largest study of that therapy, and 690 patients 69% of those patients had diarrhea, 40% had nausea and 36 had vomiting.
Which clearly limit dosing.
And in fact user has said lately, but because it's so difficult to titrate they are actually promoting titration.
Roger A. Jeffs: So I think in the, it's kind of what I said in my opening statement, Mary Kate, that in PAH, we would like to be the first in choice process cyclin. And the reason I think we can do that is because, really, with Utrepia and its ability to titrate to doses that are, you know, on the order of threefold more than what was originally 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 that now we can deliver the drug for PAH patients, and that maintenance dose is determined by tolerability. It's indicated to delay disease progression and decrease the risk of hospitalization. But its improvement on the six minute walk distance is modest, only 12 meters, and I believe that was not significant. The consequence of that therapy is 42% of those patients have diarrhea, 33% have nausea, and 18% have vomiting, so there are significant off-target effects. And Oranitram is a very similar story.
The parental route and then transition to oral so you can see this is burdensome and onerous.
What you Trevor will then do is is negate completely these off target effects to the to the Gi tract and allowed those titration so again.
We're going to look at the oral prostacyclin market is significant.
In a market, where we can gain steal share.
And we will do that sort of tactically after we position ourselves as the best in class inhaled Prostacyclin as Scott mentioned for both PIH in ph ILD.
Okay.
Operator next question please.
One moment for our next question.
And our next question is going to come from the line of Julian Harrison with <unk>. Your line is open. Please go ahead.
Hi, Good morning, Thank you for taking my question.
Just to be clear based on some of your prepared remarks. If you are forced to seek approval in ph ILD UBS supplement instead of the current arrangement.
Roger A. Jeffs: It's a used TID, it's titrated to effect, it's indicated to delay disease progression and improve 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, and in fact, Uther has said lately that because it's so difficult to titrate, they are actually promoting titration via the parenteral route and then transitioning to oral. As you can see, this is burdensome and onerous. What Utrepia will then do is completely negate these off-target effects on the GI tract and allow those titrations.
Our view is that filing a supplement with $3 seven patent now in the Orange book should not trigger an automatic stay of am I understanding that correctly.
Yes. Thanks for the question Julian Good morning, ice rested answer directly yes.
Yes.
Let me clarify maybe a couple of things so first.
I think our view is that.
The amendment being rejected and us having to file this by supplement is sort of the worst case scenario.
We think but 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.
And again, it's 21, USD 355 C III UC.
What specifically defines those patents can give rise to a 30 month stay.
Roger A. Jeffs: So, again, we're going to look at the oral prostacyclin market as a significant market where we can gain share, and we'll do that sort of tactically after we position ourselves as the best-in-class in health prostacyclin, as Scott mentioned, for both PAH and PHI. Operator, next question please. One moment for our next question, and our next question is going to come from the line of Julian Harrison with BTIG. Your line is open.
And critically it says only those patents and I'll quote it before the date on which the application.
And then in parentheses, excluding an amendment or supplement the application was submitted so again supplements are treated the exact same way as amendments for purposes of determining what's patents can give rise to a 30 months stay.
And so even if we were required to file a supplement the result would be <unk> 30 months.
Julian Harrison: Please go ahead. Hi, good morning. Thank you for taking my question. Just to be clear, based on some of your prepared remarks, if you are forced to seek approval and PHILD via supplement instead of the current arrangement, your view is that filing a supplement with a 327 patent now in the orange book should not trigger an automatic stay. Am I understanding that correctly? Yes. Thanks for the question, Julian. Good morning. I swear I can answer that.
Very helpful. Thank you.
Thank you Julien operator next question please.
One moment.
And our next question is going to come from the line of Serge Belanger with Needham. Your line is open. Please go ahead.
Hi, good morning, Thanks for taking my questions.
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.
Russell Schundler: Yes, so let me clarify maybe a couple things. So first, I think our view is that, you know, the amendment being rejected and us having to follow this by supplement is sort of the worst-case scenario. You know, we think what the FDA did was absolutely right by accepting our amendment, so we don't think this will even come into play. But if we were required to come up with a supplement, then that's exactly right. So if you look at the statute again, it's 21 U.S.C. 355 C.3.C.
The late January to do for dates for the ph ILD approval.
Have they asked for additional info or giving you.
Any additional.
Information regarding the internal process for that potential approval.
Then secondly, I.
I guess for Rusty.
Maybe just talk about the.
The Prime court decision to deny the liquidity.
Petitions late last month and.
Russell Schundler: You know, what it specifically defines those patents that can give rise to a 30-month stay. And critically, it says, you know, only those patents, and I'll quote it, before the date on which the application and then, in parentheses, excluding an amendment or supplement to the application were submitted. So again, supplements are treated the exact same way as amendments for the purpose 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.
And just what it means to the.
Overall legal proceedings. Thanks.
Thanks, Eric Good morning.
Break this into two parts, so rajeev oversees our regulatory group.
So he can answer the first question regarding interactions with FDA and then Rusty if you'll answer the Supreme Court question.
Rajiv.
Okay. Thanks, Roger good morning.
In regards to our we continue to believe.
I believe very strongly as rescue already alluded to that the amendment, we filed to add on the indication for <unk>.
Russell Schundler: Very helpful. Thank you. Thank you, Julian.
It remains appropriate and in line with our discussions with the FDA.
Serge Belanger: Operator, next question, please, for one moment. And our next question is going to come from the line of Serge Belanger with Needham. Your line is open. Please go ahead. Hi, good morning.
The only really stopping gap was really the clinical exclusivity, which we had received.
Serge Belanger: Thanks for taking my question. I guess the first one, and apologizes if I missed this in the prepared remarks, but have there been any additional interactions with the agency post the late January PDUFA date for the PHILD approval? They asked for additional info or given you any additional 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 deny the Liquidia petition late last month and just what it means to the Overall Legal Proceedings. Thanks. Thanks, Serge. Good morning.
Previous approval that will lead to a tentative approval.
Now we anticipate that data shortly arriving may 31st from the conclude exclusively and therefore.
<unk> package right now.
<unk> will lead to now a full approval for both indications for ph in ph ILD and we remain confident in that manner I'll turn it over to Russ to answer your second question.
Okay.
Sure. Thanks for the question. So the Supreme Court case really has no bearing set so as a reminder, that case was our attempt to overturn the original hatch Waxman decision on the 703 patent.
And raise some arguments that we think.
Roger A. Jeffs: I'll break this into two parts. So Rajeev oversees our regulatory group. So he can answer the first question regarding interactions with FDA, and then Rusty, if you'll answer the Supreme Court question. Rajeev. Yeah, thanks, Roger. Hi, Serge.
Overlooked by the lower courts that there shouldnt identify ending of infringement at all.
Yeah.
Supreme Court didn't pick up that appeal, but again it all relates to 703 patent which separately has been validated at this point and now firms really twice by the federal circuit.
So with that decision from the federal circuit.
The decision of the Supreme Court really doesn't it doesn't there on sort of how this is going to play out.
Rajeev Saggar: Good morning. So, in regards to our, you know, we continue to believe very strongly, as Rusty already alluded to, that the amendment we filed to add the indication for KHLD remains appropriate and in line with our discussions with the FDA. As you know, the only stopping gap was really the clinical exclusivity, which, you know, if we had received previous approval, that would lead to a tentative approval. Now we anticipate that date is shortly arriving, May 31st, when the clinical exclusivity ends, and therefore, the entire package right now will lead to a full approval for both indications for PAH and PHLD, and we remain confident in that matter. I'll turn it over to Rusty to answer your second question. Serge, thanks for the question. So the Supreme Court case really has no bearing.
At all.
Okay. Thank you.
Yes, maybe I'll, just add a little bit to Rajeev I think.
The one communications we've had obviously we missed the January 2000 and for the <unk> action date.
And the reason for that has been communicated is that the FDA is waiting for the injunction to be removed.
So as Russ you said theres, two things that need to happen principally for us to get full approval, which is the injunction removed in and then b.
Potentially the clinical exclusivity to expire at the end of March So as Rajeev said, we're looking now the amendment was filed and asked for full approval, even when we filed it in July.
Ph in ph ILD. So its our expectation now that we will skip definitive approval phase and probably just go to a full approval after the March 31.
Russell Schundler: So, as a reminder, that case was our attempt to overturn the original Hatch-Waxman decision on the 793 patent and, you know, raise some arguments that we think were overlooked by the lower courts that, you know, there shouldn't have been a finding of infringement at all. The Supreme Court didn't take up that appeal. But again, it all relates to the 793 patent, which separately has been invalidated at this point and now has been affirmed, you know, really twice by the federal circuit. So with that decision from the federal circuit, the Supreme Court really doesn't bear on sort of how this is going to play out at all.
Exclusive of the exploration.
Operator next question please.
One moment.
And our next question is going to come from the line of Matt Kaplan with Ladenburg Thalmann. Your line is open. Please go ahead.
Mr. Kaplan your phone could be on mute.
Yeah.
Thank you.
Good morning, and.
Roger just to follow up on that question in terms of end and thank you Rusty for the detail.
Roger A. Jeffs: Yeah, maybe, Serge, I'll just add a little bit to Rajeev, so I think... You know, with the one communication we've had, obviously, we missed the January 24th deadline to take action day, and the reason for that has been communicated is that the FDA is awaiting the injunction to be removed. So, as Rusty said, there are two things that need to happen principally for us to get full approval, which is the injunction removed and then the potential for the clinical exclusivity to expire at the end of March. So, as Rajeev said, you know, we're looking now, the amendment was filed and asked for full approval even when we filed it in July for both PH and PHLD. 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. And our next question is going to come from the line of Matt Kaplan with Lennonburg-Solomon. Your line is open. Please go ahead. Mr. Kaplan, your phone could be on mute.
Play by client in terms of the moving parts here and the litigation, but in terms of the critical path and judge Andrews lifting the.
The injunction can you give us some more detail in terms of the moving parts, there and how that how that.
Portion of it will work, obviously, the regulatory exclusivity exploration.
It is just a date on the calendar so that season.
Yes, Rusty can fill in here, but.
Again, we feel judge Andrews actually has all we need now Matt to remove the injunction.
The December 20th affirmation by the.
The Federal Circuit Court of Appeals should have given them the power to remove it.
I think he was just waiting to see the rehearing request denied and then the mandate issue, which will happen next week I think next Tuesday, when that tradition, so at that point Haley fully empowered.
To do what he needs to do.
Whether or not I think Rusty you can comment on how you see that.
Pending a P I.
How that interplay may impact this.
Yes, so Roger on the existing injunction whats you laid out is exactly correct again thats been fully briefed in front of judge Andrews said that he has what he needs. We also yesterday supplemented.
Matthew Kaplan: Oh, thank you. Good morning. And, Roger, just to follow up on that question, in terms of and, and thank you, Rusty, for the detailed play-by-play in terms of the moving parts and the litigation. But in terms of the critical path and Judge Andrew's lifting of the injunction, can you give us some more detail in terms of the moving parts there and how that portion of it will work? Obviously, the Roga de Tolle exclusivity expiration is just a date on the calendar. Yeah, Rusty can fill in there.
What we had submitted to him to provide M B b.
It also rehearing request that was issued by the Federal Circuit again, he has all the information in front of them.
And obviously they have the new case, the <unk> seven bad case, where they are officers.
Requests are permanent preliminary injunction.
Those cases really don't relate to one another they both in front of the same judge in obviously the patent assume similar but procedurally.
The injunction that currently exists isn't tied to their request for new injunction.
Roger A. Jeffs: But, you know, again, we feel Judge Andrews actually has all he needs now, Matt, to remove the injunction. You know, 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 it should issue. So at that point, he will be fully empowered to do what he needs to do. Whether or not, I think, Rusty, you can comment on how you see this pending PI, how that interplay may impact this. Yes, so Roger, on the existing injunction, 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. We also yesterday supplemented what we had submitted to him to, you know, provide him with the denial of the rehearing request that was issued by the Federal Circuit. So again, he has all the information in front of him.
The new patent.
So.
I don't think Theres any interdependency there between the two actions.
Okay.
That's why that's why we're that's why we're not giving a specific day when we think the approval actually will happen.
Again other than it will be after March 31, when the exclusivity expires.
Right right, Okay, Great and then shifting gears a little bit in terms of our 606 can you give us some more details in terms of the regulatory pathway. There you described meaning one additional study for approval.
And both ph in ph ILD.
What you can't give us a sense in terms of the timeline of that as well.
Yes, I'd love to so Rajiv also overseeing that efforts of Rajeev, if you wouldn't mind answering the question.
Thank you, Matt and good morning to you as well.
So as you as you alluded to.
Russell Schundler: You know, obviously, they have the new case, the 327 patent case where they've also filed a Request for Preliminary Injunction. That's why we're not given a specific day when we think the approval action will happen, but again, other than it'll be after March 31st when the exclusivity expires. Okay, great. And then we shift gears a little bit in terms of L606.
606, as our length of thermal formulation of sustained release for <unk>, that's going to be delivered twice a day.
It really is hard right.
Portable nebulizer. So we're really excited about this program.
Is it sort of the leading the effort to a phase III program. The program is designed using a similar strategy like we have with Ctrip. You answered. This is a 505 <unk> pathway with the label drug being Televisa and.
Matthew Kaplan: Can you give us some more details in terms of the regulatory pathway there? You described needing one additional study for approval in both PH and PHILT. Can you give us a sense in terms of the timeline for that as well? Yeah, I'd love to.
And our type C discussions with FDA that have occurred back in December of 2023. Once again, we have confirmation that a single placebo efficacy study without success.
Would lead to approval for both indications for group, one PIH as well as Q3 ph L D.
Rajeev Saggar: So Rajeev is also overseeing that effort. So Rajeev, if you wouldn't mind answering the question, yes, thank you, Matt. And good morning to you as well.
In that regard.
As you as you stated, we specifically have chosen the indication for <unk> to take.
Rajeev Saggar: So, as you alluded to, L606 is our liposomal formulation of sustained release for 3-prosanol that's going to be delivered twice a day with a really smart portable nebulizer. So we're really excited about this program, as it's sort of the leading effort in a phase three program. The program is designed using a similar strategy as we have with Zikarpia. So this is a 505B2 pathway with the label drug being Tybaso. In our type C discussions with FDA that occurred back in December of 2023, once again, we had confirmation that a single placebo efficacy study with L606 would lead to approval for both indications for group one PIH as well as group three PHLD. In that regard, as you stated, we specifically chose the indication for PHLD to take into a global large phase three study. That study is gated to initiate sometime near Q4 of 2024. Great, thank you, Rajeev.
Take into a global.
Large phase III study.
The study is needed to initiate some time.
Q4 of 2024.
Great. Thank you Rajiv and I think the one thing to add to that is I guess the.
The other part of your question is how long will that take.
Because there is such a.
Scarcity of treatments for ph ILD.
Clinical trial, particularly when we do it in European centers for instance.
Has the potential to enrolled quite rapidly I think.
The normal time course for the sample size were contemplating would be.
Two years or so, but I think maybe we can shorten that a bit and there is time to get through to six months and.
And point and then time to collect the data submit and reviews I think just in broad brush strokes, we're looking at it from the first patient into.
And FDA decision is probably in the three five to four year arrangement.
Okay.
Next question please operator.
And one moment. Our next question. Our next question is going to come from the line of Tim.
Roger A. Jeffs: And I think the one thing to add to that is, you know, I guess the other part of your question is, how long will that take? You know, I think because there's such a scarcity of treatments for PHLD, the clinical trial, particularly when we do it in European centers, for instance, has the potential to involve patients quite rapidly. I think 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.
Yes D with Jefferies. Your line is open. Please go ahead.
Good morning Kim.
With the filed motion for preliminary injunction with regard to pre two seven.
B the timelines associated with that.
And then can you remind us.
Fda's perspective.
And a rehab amendment versus NDA for indication expansion with regards to tentatively approved drugs do we have any precedent there.
Roger A. Jeffs: And there's time to get through the six month end point and then time to collect the data, submit, and review. So I think just in broad brushstrokes, we're looking at it from first patient to an FDA decision probably in the three and a half to four year range. Next question, please. Operator.
Thank you.
Yes, I think both of those questions are in Rusty's court. So if you wouldn't mind Rusty.
Yeah.
Sure. So on the first question for the <unk> seven patents so.
There is a briefing schedule on that.
Therapeutics has filed their brief requesting in support of their request for preliminary injunction or responses do currently due on April 5th.
Operator: And one moment for our next question. Our next question is going to come from the line of Kambiz Yazdi with Jeffries. Your line is open. Please go ahead. McCain.
A replay that will be due April 19th.
The thing I'd add.
And then from there.
Kambiz Yazdi: With the motion for preliminary injunction filed with regard to 327, what would be the timelines associated with that? And then, can you remind us the FDA's perspective of NDA re-amendment versus NDA for indication expansion with regard to tentatively approved drugs? Do we have any precedents for that there? Thank you. Yeah, I think both of those questions are in Rusty's court, so if you wouldn't mind, Rusty. Kambiz Pashneh, Michael Kaseta, Kambiz Yazdi, Roger Jeffs, Russell Schundler, Unknown Attendee, Andreas Argyrides, Scott Moomaw, Liquidia, Sure.
We are discussing with hearing or not and makes a decision. The thing I'd remind you though is that again the default is that if there is no preliminary injunction in place there's nothing to box us from moving forward getting approval or launching.
So the burdens on United Therapeutics to Excel.
The preliminary injunction before that happens.
So.
We'll see if they tried to accelerated proceedings or what they tried to do on that front, but thats. The timeline is currently in place on that.
As far as the FDA position on amendments versus supplements.
Russell Schundler: So on the first question for the 327 patent, there is a briefing schedule for that. United Therapeutics has filed their brief request in support of their request for a preliminary injunction. Our response is due, currently due on April 5th. Their reply then would be due April 19th. You know, the thing I'd and then from there, the court will either schedule the hearing or not and makes a decision.
Again, I think if you look at.
If you look at the FDA.
Existing guidance is so there is a 2000 and for non binding guidance.
That is what United Therapeutics was pointing to.
Which they claim stands for the proposition of that.
You can never add an amendment to our pending NDA I am sorry, I never had an indication to our pending NDA.
However, the 2016 regulations and the site is 21, CFR $3 14, 60 subsection F.
Russell Schundler: 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 and getting approval and launching. So the burden's on United Therapeutics to get a preliminary injunction before that happens. So, you know, we'll see if they try to accelerate the proceedings or what they try to do on that front. But that's the timeline currently in place on that.
Expressly contemplates situations, where new indications could be added to our pending NDA, including <unk> NDA.
Ours, so again I think.
Clearly the FDA is contemplating that there are at least circumstances, where indications can be added to nda's.
As evidenced by the regulations.
Russell Schundler: As far as the FDA position on amendments versus supplements, again, I think if you look at the FDA's existing guidance, so there's a 2004 non-binding guidance. That is what United Therapeutics is pointing to, which they claim stands for the proposition that you can never add an amendment to a pending NDA. I'm sorry, but never add an indication to a pending NDA. However, the 2016 regulations and the cited 21 CFR 314.60 subsection F expressly contemplate situations where new indications could be added to a pending NDA, including a 505 B2 NDA like ours.
And if I may add companies I think.
The guidance that United Therapeutics is pointing towards is the bundling guidance.
It is really more specific if Europe, changing routes dosage form or formulation and providing new data that should be submitted separately and it's a way to make sure that the agency gets there.
<unk>, we've done none of that since the same route same dose same formulation amendment no new data. So we think we're well within that.
The rest of you just described.
Yeah.
Great Operator, and then I guess.
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 A. Jeffs: So again, I think the FDA is contemplating that there are early circumstances where indications can be added to NDAs, you know, as evidenced by the regulations. Income, and if I may add, you know, Kambiz, I think the guidance that they're United Therapeutics is pointing towards is the bundling guidance. But that's really more specific. If you're changing the route, dosage form, or formulation and providing new data, that should be submitted separately. And it's a way to make sure that the agency gets its review fees. We've done none of that.
Yeah, Great question I appreciate that so rajeev, if you wouldn't mind.
Thanks <unk>.
So once again.
The assent study is something that we are extremely excited about more importantly, this is a study that's absolutely needed in the literature.
And has actually been desired by the kols across the entire region of United States requesting that patients that that have been recently diagnosed with <unk> that are naive to any therapy.
Are then placed onto you trip, yet which is.
Roger A. Jeffs: So it's the same route, the same dosage forms, the same formulation, and no new data. So we think we're well within the statutes that Rusty just described. Great. Operator.
Which which really will highlight three pillars that we have continued to suggest that that are very important to patient profiled. The first thing is.
Titrated.
Tolerability and titrate ability. These things are going to be led by our print technology and therefore a formulation.
Kambiz Yazdi: I guess one other follow-up question is on the assent trial; what kind of patient populations are being studied and how is enrollment proceeding? Yeah, great question. Appreciate that. So Rajeev, if you wouldn't mind,
The 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.
Rajeev Saggar: Thanks, Kambiz. So, you know, once again, the SENT study is something that we are extremely excited about. More importantly, this is a study that's absolutely needed in the literature and has actually been desired by KOLs across the entire region of the United States, requesting that patients that have been recently diagnosed with PHLD that are naive to any therapy are then placed onto utrepia, which is..., which really will highlight three pillars that we have continued to suggest that are very important to the patient profile. The first thing is tolerability and titrate ability.
<unk> delivered the dose profiles that we believe are going to be required to not only achieve the minimum therapeutic goals.
Equivalency of 10th Cobra four turns a day of inhaled <unk>, but more importantly lead to actually more improvements in clinical outcomes and efficacy standards that are used such as walk distance.
Actual overall clinical outcomes.
We're very encouraged right now by the current enrollment rates.
That we're seeing as you know we enrolled our first patient.
To the mid to end of December of 2023, and we anticipate that we will complete enrollment of up to 60 patients by the end of this year and we look forward to sharing.
Rajeev Saggar: These things are going to be led by our print technology and, therefore, our formulation. The 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,,,,,,,,,,,,,,,,,,,, As you know, we enrolled our first patient in the mid to end of December of 2023. And we anticipate that we'll complete enrollment of up to 60 patients by the end of this year. So we look forward to sharing some snapshots of that data at future meetings that are coming up shortly. Project Thank you, Rajeev. And I think, Kambiz, it's a great question.
And snapshots that data in a future meeting coming up shortly.
Andrew.
Okay.
Thank you Rajeev I think it's 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 is that makes a DPI, particularly the data out of the.
National Jewish entering Colorado, and you can see that there has been.
In some difficulty with the PPI.
At least there single center patient population.
About 60% of their patients dropped out.
Six months, whether or not they were naive to prostacyclin transition previously for <unk>.
And I think the other thing that's interesting to US is that there is still a retained 40% population of <unk> patients.
I think when you've launched a few years ago. The assumption was that they would convert that entire market quite quickly.
Capex in DPI. So that's not happened with the questions one and we think it may be for the inability to dose those patients to good clinical effect, which we're trying to solve for we can trap yet.
Roger A. Jeffs: I think the other thing, you know, again, why this data is important. And I think when you look at the data, some of the data that's been published on United Therapeutics' Taveza DPI, particularly the data out of the National Jewish Center in Colorado, you can see that there's been some difficulty with the DPI in at least their single center patient population, where about 60% of their patients dropped off between three and six months whether or not they were naive to process icons or transitioned previously from nebul And I think the other thing that's interesting to us is that there's still a 40% population of nebulized patients. I think when MUTHER launched a few years ago, the assumption was that they would convert that entire market quite quickly to type ASO-DPI. So that's not what happened, but the question is why.
If this data bears out the way we think it will then that will certainly auger that this is the best in class therapy, and first and choices.
Next question please.
Yeah.
I'm showing no further questions and I'd like to hand, the conference back over to Roger Jeffs for further remarks.
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 for enhanced your thoughts now and it will come at a critical time as the markets in health care Cross sell rapidly expands thank you and have a good day.
This concludes today's conference call. Thank you for participating you may now disconnect.
Roger A. Jeffs: 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 utrepia. 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 the first-in-choice therapy. Next question, please. I'm showing no further questions, and I'd like to hand the conference back over to Roger Jeffs for further remarks. 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 the earnings call, Liquidia will be providing to patients what we feel is the preferred product for inhaled triposomal, and it will come at a critical time as the market for inhaled triposomal rapidly expands.
[music].
Roger A. Jeffs: Thank you, and have a good day. This concludes today's conference call. Thank you for participating. You may now disconnect.