Full Year 2023 Liquidia Corp Earnings Call
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.
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 Michele it's my pleasure to welcome everyone to liquidity of 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 Casella, Chief Commercial Officer, Scott Musil, Chief Medical Officer, Dr. Rajiv Saga in general.
Counsel Rusty sugar.
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 Companys future performance <unk> 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.
Performance expressed or implied on this call.
For additional information, including a detailed discussion of our risk factors. Please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website.
I'd now like to turn the call over to Roger for our prepared remarks, after which 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, we know 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 to Boston.
I will ask Rusty 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 pervasive expires.
I'll provide a precise final approval dated 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.
Our expanded field force has been raising the profile of liquidity in their bet.
Liquidity.
In their territory over the last three months or.
Our manufacturing team is preparing inventory in anticipation of a potential launch in both P. H N P. H I L D.
Our R&D team continues to build clinical knowledge by studying <unk> in ph ILD patients and the open label 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 and our balance sheet grew with keep transactions by marquee investors and insiders and our pipeline grew with the in license of El <unk>. The most clinically advanced next generation sustained release inhaled <unk> program.
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.
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 ILD.
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 you are dropping as having the potential to not only be the best in class inhaled. Your pass now given its dosing flexibility and ease of use but also the first in choice prostacyclin.
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.
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.
Got it.
Bear attention for your trip yet.
After value in both of these markets at this time I would like to as rescue to summarize the next steps towards final SEC pricing.
Yes.
Thank you Roger.
I'd like to agree with the recent litigation and regulatory activity into two buckets first us those items on the critical path to your truck is 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 or 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 judge Andrews must lift the injunction he ordered in August 2022 based on its finding of infringement of 703 patent. The patent that has subsequently been invalidated a finding that was affirmed again yesterday when the federal circuit denied United Therapeutics request for rehearing.
And second the regulatory exclusivity granted to <unk> for the ph ILD indication must expire which will occur on March 31.
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.
In 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.
However, as we have stated previously in order to obtain any preliminary injunctions the burden will be on United Therapeutics convinced the Jones 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 $32 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 teachers, the treatment of ph ILD patients with <unk>, 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 <unk>.
Of course, a generally refrain from issuing 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 ability of the <unk> seven patent exists.
A second request for preliminary injunction is directed in 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 liquidator to amend the NDA for your trip yet to add the ph ILD indication.
We are intervening in the case and are now a party to the case alongside the FDA.
First and foremost the FDA did in fact, except 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.
<unk> therapeutics argument that an amendment to add a new indications and proper is based primarily on our non binding 2004 FDA guidance document.
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, but 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 could simply supplement its NDA after approval to add the ph ILD indication.
The exact same processes by United Therapeutics at Th elevates the label for <unk>.
Critically the statute expressly states that amendments and supplements the exact same way in determining whether a patent can give rise to a 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.
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 as soon as the path to launch New Trophy and two straightforward actions.
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 could engage in such a flurry of activity as we near our 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 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.
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 had 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.
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 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.
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 into.
Part of that program.
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 2020 to the.
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 $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're poised in the starting blocks and as you and restaurant, both described and fault earnestly to get where we are today.
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 up for questions. Operator first question. Please.
Thank you John asked 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 <unk>. 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 ph compared to ph ILD, maybe why or why not and do you anticipate equal interest in this indication.
Good morning.
For the question.
So we're fortunate to have Scott <unk>, our chief commercial officer on the phone Scott, maybe if you would like to opine on that.
Yes.
There's a little bit of difference in strategy. So and PIH is you know there are many medications already available so it's going to be.
Demonstrating why our process like when is 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 tropea, because it is so convenient and because of the titration of dose.
And so in that space, we will be targeting the big centers.
The physicians that use process <unk> already we'll get some new physicians probably.
But we will focus on the targets that you 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.
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 Eddie educating them that this condition exists and that its deadly.
And then will be educating them on your truck and if they would be willing to use your trip you. 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.
<unk> Center of excellence, where it would be where it would be treated so I think thats a brief summary of how we will approach the two markets.
Great. Thank you.
Maybe I'll just add a few comments so I think in the.
It's kind of what I said in my opening statement Mary Kay.
N P. A H, we would like to be the first in choice prostacyclin.
And the reason I think we can do that is because.
Really with the Trump in its ability to titrate to the doses that are.
On order of three fold more than what was originally possible with Televisa.
We've changed the therapeutic Pudic index event 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.
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 hasnt ceiling.
And that maintenance does is.
As determined by Tolerability, it's indicated to delay disease progression.
<unk> risk of hospital and decrease the risk of hospitalization.
But it is improvement.
Six minute walk distance is modest only 12 meters and I believe that was not significant.
The consequence of that net therapies, 42% of those patients have diarrhea, 33% had nausea, and 18% had 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.
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.
Because it's so difficult to titrate their actually promoting titration.
Via the parental route and then transition to oral so you can see this is burdensome and onerous.
What you trumpet 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.
Our 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 P. H 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 were forced to seek approval in ph ILD UBS supplement instead of the current arrangement.
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 resting incidentally, 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 'twenty, one USD 355 C C.
What specifically defines those patents that can give rise to a 30 months stay.
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.
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 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 could do for dates for the ph ILD approval.
Have they asked for additional info or giving you.
Any additional.
Information regarding their internal process for that potential approval and then secondly I.
I guess for Rusty maybe.
Maybe just talk about the.
Supreme Court decision to deny the liquidity.
Petitions late last month and.
And just what it means to the.
Overall legal proceedings. Thanks.
Thanks, Sara 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 unless you go into the Supreme Court question.
Rajiv.
Okay. Thanks, Roger good morning.
In regards to our we continue to believe.
I believe very strongly as Ruskin already alluded to that the amendment, we filed to add on the <unk>.
The case for <unk>.
It remains appropriate and in line with our discussions with the FDA as you know the only the only stopping gap was really the clinical exclusivity, which if we had received.
Previous approval that will lead to a tentative approval.
Now we anticipate that data shortly arriving on may 31st from the conclude inclusivity and and therefore the.
Package right now.
It will lead to an hour full approval for both indications for <unk> and we remain confident in that manner I'll turn it over to Ross 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.
Overlooked by the lower courts that there shouldn't have been a finding of infringement at all.
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 are firms really twice by the federal circuit.
So with that decision from the federal circuit.
The Supreme Court really doesn't it doesn't thereon.
How this is going to play out.
Al.
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 2014 due to 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 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'll skip definitive approval phase and probably just go to a full approval after the March 31.
Exclusive of the exploration.
Operator next question please.
Oh, 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.
Sure.
Thank you.
Good morning.
Roger just a follow up on that question in terms of end and thank you Rusty for the detail.
Play by client in terms of the moving parts here and the litigation, but in terms of the critical path and judge Andrews lifting of the <unk>.
Injunction can you give us some more detail in terms of the moving parts, there and how that how that.
A portion of that work, obviously, the regulatory exclusivity exclusivity exploration.
Is just a date on the calendar so that season.
Yes, Rusty can fill in here, but.
Again, we feel Hey, George Andrew is actually has all I 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 that.
The rehearing request denied and then the mandate to issue, which will happen next week I think the next tuesday's limit should issue 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 are pending.
Pending pi, how that interplay may impact us.
Yes, so Roger.
Existing injunction whats you laid out is exactly correct again, it's been fully briefed in front of judge Andrews said that he has what he needs.
Also yesterday supplemented.
We had submitted to Ams.
And the denial of a rehearing request that was issued by the federal circuits. So again he has all the information in front of them.
And obviously they have the new case.
<unk> hundred 87, bad case, where they've also.
Requests are permanent preliminary injunction.
Cases, really don't relate to one another they both in front of the same judge in obviously the patents assume similar but procedurally.
The injunction that currently exists isn't tied to their request for new injunction.
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 I'll shift gears, a little bit in terms of all 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 Rajeev is also overseeing that effort. So 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.
606, as our length of thermal formulation.
Pain relief for treat products and all of that's going to be delivered twice a day.
It really is hard.
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 <unk>. So this is a five or five <unk> pathway with the label drug being <unk>. So in 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 <unk> six.
Would lead to APA.
Approval for both indications for group, one PIH as well as Q3 ph ILD.
In that regard.
As you as you stated, we specifically have chosen the indication for ph L D to take to take into a global.
Large phase III study that 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.
I think 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 than the normal time course for the sample size were contemplating would be.
Two two years or so, but I think maybe we can shorten that a bit.
There is time to get through the 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 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 is yes.
<unk> with Jefferies. Your line is open. Please go ahead.
Good morning Kim.
With the filed a motion for preliminary injunction with regard to pre two seven what would be the timeline associated with that.
And then can you remind us the <unk>.
<unk> perspective and.
<unk> Rehab Amendment Christmas MBA for indication expansion with regards to tentatively approved drugs do we have any precedent there.
Thank you.
Yes, I think both of those questions are in Rusty's court. So if you wouldn't mind Rusty.
Sure. So on the first question for the <unk> seven patents so.
There is a briefing schedule on that.
Therapeutics has filed a brief requesting in support of their request for preliminary injunction or responses do currently due on April 5th.
<unk> that would be due April 19th.
The thing I might add.
And then from there.
The court, you're discussing the hearing or not and makes a decision. The thing I would remind you though is that again the default is that theres 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 pillar.
Preliminary injunction before that happens.
So.
We'll see if they tried 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.
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 that.
You can never add an amendment to our pending NDA I'm, sorry never had an indication to our pending NDA.
However, the 2016 regulations and the site is 21, CFR $3 14, 60 subsection F.
Expressly contemplates situations, where new indications could be added to our pending NDA, including the <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.
And if I may add.
And I think.
The guidance that United Therapeutics is pointing towards is the bundling guidance.
But that's really more specific in 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.
Review fees, we've done none of that since the same route same dose same formulation and no. There's no new data. So we think we're well within the statute that Rajiv just described.
Great Operator, and then I guess.
I guess one other follow up is on on the ascend trial, what kind of patient populations are being studied and how is the enrollment proceeding there.
Yeah, Great question I appreciate that so rajeev, if you wouldn't mind.
Okay. Thanks can be.
So once again the assent study is something that we are extremely excited about more importantly, this is a study that is absolutely needed in the literature.
And has actually been desired by the kols across the entire region of the United States requesting that patients that that have been recently diagnosed with ph D that are naive to any therapy.
Are then placed onto your Trump yet which is.
Which which really will highlight three pillars that we have continued to suggest that that are very important to the patient profile. The first thing is.
Titrated.
Tolerability and titrate ability. These things are going to be led by our print technology in their firm formulation the.
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 can deliver 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 inhibitory <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 rate.
We're seeing as you know we enrolled our first patient.
To the mid to end of December 2023, and we anticipate that we will complete enrollment of up to 60 patients by the end of this year and so we look forward to sharing.
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 when you look at the data. That's some of the data that's been published on United Therapeutics is that makes a DPI.
The data out of the.
National Jewish entering Colorado, and you can see that there has.
In some difficulty with the PPI at least their single center patient population.
<unk>.
About 60% of their patients dropped off between three and six months, whether or not they were naive to <unk>.
<unk> transitioned previously for <unk>.
And I think the other thing that's interesting to US is that there is still a retained 40% population of nebulizer nation.
When a user launched a few years ago. The assumption was that they would convert that entire market quite quickly to <unk>. So that has not happened with the questions as well and we think it may be for the inability to dose those patients to good clinical effect, which we're trying to solve for within trap yet.
So 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 in choice.
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.
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 liquor.
Liquidity will be comprising two patients what we feel is the preferred product for enhanced with hospital and it will come at a critical time as the markets and hedge trapasso rapidly expands thank you and have a good day.
This concludes today's conference call. Thank you for participating you may now disconnect.
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