Full Year 2024 Liquidia Corp Earnings Call & Business Update
[music].
Yeah.
Good morning, and welcome everyone to the liquidity our corporation for full year 2024 financial results and corporate update conference call My.
Shannon: My name is Shannon and I'll be your conference operator today.
Currently all participants are in a listen only mode.
Speaker Change: Following the presentation, we will conduct a question and answer session and instructions will be provided at that time for you to queue up for your questions I would like to remind everyone that this conference call is being recorded I will now hand, the call over to Jason Adair Chief business Officer.
Jason Adair: Thank you Shannon, it's my pleasure to welcome everyone to the liquidity of Corporation full year 2024 financial results and corporate update call.
Speaker Change: Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief operating Officer, and CFO, Michael <unk>, Chief Medical Officer, Dr. Rajiv Saga, Chief Commercial Officer, Scott <unk> and <unk>.
Jason Adair: General Counsel Rusty sugar.
Jason Adair: Before we begin please note that today's conference call will contain forward looking statements, including those statements regarding future results.
Jason Adair: And forward looking financial information as well as the Companys future performance <unk> achievements.
Jason Adair: Agents are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call.
Jason Adair: For additional information, including a detailed discussion of our risk factors.
Jason Adair: Please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website.
Jason Adair: I would now like to turn the call over to Roger for our prepared remarks, after which he will open the call for your questions Roger.
Roger: Thank you Jason.
Roger: Morning, everyone and thank you for joining us today.
Roger: We believe that 2025 has the potential to be a transformational year for the company.
Roger: Are there build upon the successes of 2024, which.
Roger: Which resulted in the broadening of the tentatively approved label for <unk>.
Roger: Both the treatment of patients with pulmonary arterial hypertension or ph.
Roger: Pulmonary hypertension associated with interstitial lung disease or ph ILD.
Roger: There are four strategic imperatives that will drive our success and growth both in the near and long term.
Roger: These are seeking to obtain final approval and launching new traffic and both ph in ph ILD as soon as possible after X free up the gating clinical exclusivity on may 23rd or just 65 days from now.
Roger: Secondly, we continue to advance the clinical profile of your trip yet to position. It is not only the best in class inhaled prostacyclin.
Roger: But also the first in choice prostacyclin, where all patients in need and world or inhaled prostacyclin.
Roger: Underserved by current alternatives.
Roger: Third.
Roger: Building upon our commercial and medical prowess to compete fiercely for capture material and enduring market share in this multibillion dollar and growing market segment.
Roger: Finally to further our vault evolve our mission of being a leader in the ph space I.
Roger: By continuing to leverage our development expertise to advance treatment options that have the potential to further improve the lives of patients.
Roger: Phase III ready nextgen sustained release likely several therapy.
Roger: Six.
Speaker Change: I'd like to take a few minutes to expand on each of these strategic goals with.
Speaker Change: With regard to the first imperative is seeking to launch into the marketplace as soon as soon as possible.
Speaker Change: Happy to say that based on the favorable legal decisions over the last few years.
Speaker Change: There are no legal barriers that currently impacts the FDA issued final approval of the trip here after may 23rd.
Speaker Change: When the exclusive exclusivity granted to our competitor will expire.
Speaker Change: It's also important to remember that when the FDA issued a tentative approval of an NDA.
Speaker Change: India has met all requirements for approval.
Speaker Change: Cannot reapproved existing legal or regulatory barriers.
Speaker Change: In our case, so Barry are identified by the FDA whats new clinical exclusivity granted database of BPI, which expires on May 23 2025.
Speaker Change: As directed in the tentative approval label, we plan to submit the request for final approval in the coming weeks.
Speaker Change: Okay.
Speaker Change: With regards to the second imperative content.
Speaker Change: To advance our studies to establish the clinical profile of your trip yet.
Speaker Change: Medical community's interest in your traffic is increasing with particular interest in the data being generated from our central openly.
Speaker Change: The open label safety study of contribute in ph ILD patients.
Speaker Change: I'm happy to report.
Speaker Change: Yeah.
Speaker Change: Sorry, I haven't asked this morning.
Speaker Change: I'm happy to report that we are on track to complete enrollment in the coming weeks.
Speaker Change: With 50 or more patients in total to be enrolled.
Speaker Change: We continue to be encouraged by the positive patient response.
Speaker Change: The escalating doses. If you trip you as a reminder, at the J P. Morgan JP Morgan Health Care Conference in January we shared that dosing and Tolerability profile.
Speaker Change: The first 20 patients that completed eight weeks of treatment.
Speaker Change: We noted that the ph ILD patients on your traffic and were able to titrate. The doses that are three times, the comparable therapeutic target of nebulizer today Sir.
Speaker Change: And today, we're happy to share some new information from the ascent study.
Speaker Change: We've also been looking at exploratory efficacy measures of efficacy.
Speaker Change: One such measure is the change in six minute walk test at week eight.
Speaker Change: We are pleased to report in this.
Speaker Change: Same 20 patient cohort the main change in baseline improved by $26 four meters.
Speaker Change: While it is difficult to draw.
Speaker Change: Strong conclusions from some cross study comparisons it is worth noting in the phase III Registrational study of nebulous today, certainly in ph ILD patients the increase study.
Speaker Change: Group patients had an observed mean improvements six minute walk distance at 16 meters at week, eight and 22 meters at week 16.
Speaker Change: We are highly encouraged by this early efficacy data from ascent as it demonstrates that you trap airports the key therapeutic attributes in ph ILD, we aspired for it specifically being well tolerated.
Speaker Change: And Amanda amenable to rapid dose escalation to dose as well beyond historical standards, leading to an accelerated therapeutic outcome that is in line or better than published results of existing therapies.
Speaker Change: And it should be noted that this data is especially compelling when compared to published data from 10 days with TPI and a light like sample of treatment naive ph ILD patients at the National Jewish Health Center that we have discussed previously were 69% of patients discontinued therapy. After a median time of only 40 days.
Speaker Change: With drug related Aes, especially cough and clinical worsening listed as the primary reasons for discontinuation of <unk> DPI.
Speaker Change: We look forward to highlighting more robust data set from the ascent trial at the Ats International Conference in San Francisco This may.
Speaker Change: With regard to our third share of its imperative to build upon our commercial and medical prowess. We have built the commercial enterprise. We feel is best in class. Our team has been in place for every year and a half and continues to support the use of rescue injection, while also reinforcing relationships with our health care providers in our understanding of the unmet needs of ph in ph ILD patients.
Speaker Change: Throughout the country.
Speaker Change: We are prepared to provide a seamless service to patients and providers. Upon launch if you strip out and look forward to educating the ph pitch in ph ILD gets deep communities on the favorable potentially game changing product atrophy, which attributes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Lastly, as we look at our fourth imperative to innovate and develop better therapeutic options. We continue to advance <unk> 606, our sustained release formulation of personnel that provides for consistent 24 hour drug exposure and 212 hour dosing segments, including during sleeping hours.
Speaker Change: We know that continuous infusion has shown the best efficacy with prostacyclin analogues and well and we believe that the PK profile of their success.
Speaker Change: The next closest noninvasive approach to maximizing the benefits from the more targeted inhaled route of administration.
Speaker Change: It is for all those reasons and with an eye towards our pending launch would be trapped in the coming months that we decided to further strengthen our balance sheet as announced yesterday with an extension of our valued partnership with healthcare royalty partners that Mike will speak about now along with an overview of our 2020 for financials Mike.
Mike: Thank you Roger and good morning, everyone before I review, our full year 2024 financial results I'm happy to highlight yesterday's announcement regarding expansion of our financing agreement with healthcare royalty partners.
Mike: Which will provide liquidity up to an additional $100 million of financing in three tranches, including the $25 million tranche funded at closing we.
Mike: We are grateful for the trust commitment and confidence that healthcare royalty partners has demonstrated over the years and we are optimistic that these proceeds in a successful launch of <unk>. Following the exploration of exclusivity. This may could lead to our reaching profitability without the need for additional capital.
Mike: Turning to our full year 2024 financial results, which can be found in the press release, you will see that red.
Mike: Our revenue was $14 million for the year ended December 31 2024.
Mike: Paired with $17 $5 million for the year ended December 31 2023.
Mike: Revenue related primarily to the promotion agreement with.
Mike: The decrease of $3 $5 million was primarily due to lower sales quantities driven by limitations on the availability of pumps used to administer postal injection subcutaneously sales.
Mike: Sales quantities will continued to be impacted or at risk until alternative pumps are available.
Mike: Cost of revenue was $5 9 million for the year ended December 31, 2024, compared with $2 9 million for the year ended December 31 2023.
Mike: Cost of cost of revenue related to the promotion agreement as noted above the increase from the prior year was primarily due to our sales force expansion during the fourth quarter of 2023.
Mike: Research and development expenses were $47 8 million for the year ended December 31, 2024, compared with $43 $2 million for the year ended December 31, 2023, the increase of $4 6 million or 11% was primarily due to.
Mike: One a $6 $1 million increase in expenses related to our <unk> hundred six program to a $5 $3 million increase in expenses related to <unk> research and development activities, including the ascend trial.
Mike: Three of $5 $1 million increase in personnel expenses, including stock based compensation related to increased head count.
Mike: For a $3 5 million upfront license fee due to formula for the exclusive license in Europe to develop and commercialize <unk> recorded during the year ended December 31 2024.
Mike: Offset by one $5 1 million and lower commercial manufacturing expenses, reflecting the impact of expensing you true up your inventory cost in the prior year and two a $10 million upfront license fee due to <unk> for the exclusive license in North America to develop and commercialize <unk>. During the year ended December 31 2023.
Mike: General and administrative expenses were $81 6 million for the year ended December 31, 2024, compared with $44 7 million for.
Mike: For the year ended December 31, 2023, the increase of $36 9 million or <unk>, 82% was primarily due to one.
Mike: $19 $7 million increase in personnel expenses, including stock based compensation driven by higher head count and expansion of our sales force in the fourth quarter of 2023.
Mike: Two a $7 $9 million increase in legal fees related to our ongoing <unk> related litigation and three a $6 $8 million increase in commercial expenses in preparation for the potential commercialization of <unk>.
Mike: In summary, we incurred a net loss for the 12 months ended December 31, 2024 of $134 million or $1.66 per basic and diluted share compared to a net loss of $78 5 million or $1 21 per basic and diluted share for the 12 months ended December 31.
Roger: 2023 with that I would now like to turn the call back over to Roger.
Roger: Thank you Mike as you can see we are well positioned clinically commercially and financially for them.
Roger: <unk> launch of our first product based on our proprietary print technology, which will serve as the growth engine for our continued evolution in inflection.
Roger: Now I'd like to open the call for questions. Operator first question. Please.
Speaker Change: Thank you as a reminder to ask a question. Please press star one one of your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Speaker Change: Our first question comes from the line of Julian Harrison with <unk>. Your line is now open.
Speaker Change: Hi, Good morning. Thank you for taking my questions. Roger you touched on this a little in your prepared remarks, but just wondering if you could talk more about the administrative sequence and timeline to convert new trackless tentative approvals and ph in ph ILD the full approvals.
Speaker Change: Yes, so as we sit in.
Speaker Change: Thank you Julian and great to talk to you as we've said in the opening.
Speaker Change: We plan to request final approval in the coming weeks.
Speaker Change: The tentative approval label that we received in August It was recommended and suggested that we apply for timing of approval either two or six months ahead of the.
Speaker Change: The action date, which would be May 23.
Speaker Change: We view this as a class one resubmission because no new data will be required for approval.
Speaker Change: Approval.
Speaker Change: We have been in concert with agency working to deliver that letter.
Speaker Change: Around the March 'twenty timeframe, so that we can be granted final approval around like 20 <unk>.
Speaker Change: I don't know that specifically addresses what you're seeking yes, absolutely. That's very helpful. Thank you and then a follow up if I may on <unk> 606, I am curious what the physician feedback has been so far for our lower <unk> broader AUC longer half life alternative to Nebulize titles, So and then sorry, if I missed it.
Speaker Change: I'm wondering also when specific when specifically you plan to initiate the phase three respire trial.
Jason Adair: Yes, great and we were fortunate to have Dr. Rajiv soccer on the call today, So rajeev if you wouldn't mind.
Rajiv: Yes, Thanks, Julian for the question.
Rajiv: So first of all I think the current open label studies.
Rajiv: Continues to gate very well, we had we have long term safety data that is accrued since the inception of the study.
Rajiv: What we're clear feedback is as twice a day dosing is an absolute game changer for.
Rajiv: For these patients when you inhale entry approximately I think thats first and foremost.
Rajiv: Second of all I think that.
Rajiv: The use of the life of some itself has showcased some what we believe is some highlight some impressive safety advantages.
Rajiv: And finally further reducing the C Max with Detroit today dosing profile and the sustained release formulation of the ribosome itself does we have noted that systemic side effects continue also to be further abated.
Even beyond what we initially.
Rajiv: So I think the combination of both of those are going to be highly encouraging.
Rajiv: Four four as we advance towards with the inspire study.
Speaker Change: Lars to initiating the <unk> study, we're working full steam ahead to to prepare to initiate the study by by year's end.
Speaker Change: We're it's around March right now and so we look forward to providing further information as we get closer to that timeframe at the end of the year.
Speaker Change: Okay, great. Thank you again and congrats on all the progress.
Speaker Change: Thank you Julien.
Speaker Change: Our next question comes from the line of Jason <unk> with Bank of America. Your line is now open.
Bob Patel: Hey, Good morning, This is Bob Patel on for Jason.
Speaker Change: Two questions from us the first is given a green space in ph ILD, what's liquidity a strategy to drive early market penetration for Ya <unk>.
Speaker Change: Can you share the market marketing differentiation that you plan to promote to doctors and then given the 500 <unk> pathway should we expect any differences in the label for <unk> versus <unk>, So DPI I know.
Speaker Change: In the past you've mentioned.
Speaker Change: Demonstrating penetration to three times higher doses compared to previous a DPI.
Speaker Change: Yes, So I'll answer the second question first and then I'll add.
Scott: As Scott <unk>, our Chief commercial officer, if he would address.
Scott: The launch dynamics around ph, ILD and differentiation that we intend to emphasize.
Speaker Change: So youre exactly correct path and I think the label it as a 500 <unk> said, we share obviously, the indication claims and things like that but where we differ from the label is in the.
Scott: Dose titration table.
Scott: Because in our.
Scott: Study that we use to bridge.
Scott: So that we could escalate the doses as you mentioned that the three times higher than the target therapeutic dose of the brand.
Scott: That will be in the label and I think it's an important point of differentiation because it is what it is.
Scott: Enabled using our proprietary print technology to drive the particles to lower airway preferentially and avoid the toxicities associated with that upper airway deposition.
Scott: It's going to help us drive the maximal outcome for these patients as they continue to progress and it's and therefore help us keep those patients on therapy longer as our presumption. So.
Scott: We think these are important and critical aspects. If you look across any route of administration of prostacyclin dose matters.
Scott: And the ability to drive does usually predict the sort of therapeutic utility of that therapy and that's why.
Scott: So as labeled has had limitations in dosing and it sounds like my other drugs like <unk>, an oral formulation.
Scott: Which is does limited and does ceiling also has limitations over the long and chronic treatment course of these patients so lots of.
Scott: <unk> there from us from a labeling and dosing standpoint.
Scott: Scott if you could talk a little bit about kind of how we are going to approach this market without giving away the shop too much.
Scott: Sure.
Speaker Change: Good morning, so so.
Speaker Change: If you think about it we have the usual designation between centers and communities.
Speaker Change: We are going we are approaching and we will continue to approach both especially after launch.
Speaker Change: The situation in the centers is that the patients are really flowing in.
Speaker Change: Increasing number of patients flowing in as the awareness of ph ILD.
Speaker Change: Increases in we will obviously only add fuel to that fire. So we're in the centers and we're going to make sure that we.
Speaker Change: Ensure that <unk> is the first choice.
Speaker Change: Prostacyclin for those patients that have ph ILD for a lot of the reasons that Roger just outlined and you've heard us talk about before so we're going to harvest those patients immediately.
Speaker Change: Doing as in the community and Theres. Many many patients out there that doctors don't even know exist they have ILD.
Speaker Change: Doctors aren't looking for ph.
Speaker Change: Help increase awareness, we need to help increase diagnosis, and then either get that doctor to prescribe or to refer that patient into one of the centers and we've actually been doing that over the last six months or a year going deeper and deeper into the community educating on ph ILD, even before we get on the market because we know that.
Speaker Change: That's only going to behoove us once we do get out in the market because we do believe we have the.
Speaker Change: The superior product.
Great. Thank you Scott so much.
Operator: Our next question comes from the line of Serge Belanger with Needham. Your line is now open.
Serge Belanger: Hi, good morning.
Serge Belanger: A couple of commercially related you terrific questions probably for Scott.
Speaker Change: Can you remind us the breakdown between commercial and Medicare coverage for both ph.
ILD.
Speaker Change: And then assuming we're going to get approval here in a couple of months.
Speaker Change: Can you talk about what you expect in terms of the ramp up in coverage across boats.
Commercial and Medicare.
Speaker Change: I guess over the next 12 months or so.
Scott: Yes, Great question, Great question search it's Scott.
Speaker Change: Yes, good morning Serge.
Speaker Change: So in terms of the breakdown generally think of it as Medicare is the biggest so 50% Medicare probably 30% to 40% commercial and then the remaining is Medicare other Dod et cetera.
Speaker Change: In terms of the coverage over the first year.
Speaker Change: As you probably know we're not commenting on our strategies I will say that we have been working with the payers closely for quite some time.
Speaker Change: And we feel like we have great relationships with us they have the desire to make sure that we maximize access so we share that desire and I think youll see when we launch that.
Speaker Change: Were very sound on that front.
Speaker Change: Great. Thanks, Scott Operator next question.
Speaker Change: Next question comes from the line of Brian <unk> with Raymond James Your line is now open.
Brian: Hi, good morning.
Speaker Change: Remind us what key Readouts, we should be focusing on for Ya study.
Brian: Pacifically, we can expect.
Speaker Change: The data coming at ETF, when I have a follow up.
Speaker Change: Sure.
Rajeev: Yes. Thank you Ron Rajeev, if you wouldn't mind internally.
Rajeev: Yeah, Thanks, Ryan so.
Speaker Change: Roger talked about in the prepared remarks today one of the highlights.
Rajeev: That we spoke about was the.
Rajeev: The walk effect that was observed in the first 20 patients treated within eight weeks, which was which showed an observed mean improvement of around 26 four meters.
Rajeev: That first and foremost to highlights a few key key processes first.
Rajeev: We can get patients to what we believe is if in a new therapeutic goal that surpasses the traditional nine to 12 breadth that has typically been.
Rajeev: Sort of a ceiling effect of tavy. So since 2009, we've highlighted that we're able to achieve doses and the overwhelming majority of patients by week eight that's equivalent to greater than greater than 50, greater or equal to 15 breath by this time. So so we can get patients up to what we believe is a very effective.
Rajeev: And even higher at an earlier time point and then allow further titration to further doses to stabilize the patient impact the amount. So I think that's what's going to be quite encouraging.
Rajeev: Met Etfs were going to showcase more regarding the datasets regarding how we how we dose the patients we're going to talk a little bit about.
Rajeev: Our effects in terms of.
Rajeev: Some quality of life questionnaires as well.
Rajeev: And in the future our plan is to as we've talked about the assent study will be fully enrolled within the next few weeks here. So we're really excited about that and then we do plan to prepare and submit for the final data set later in the year and present that at a major and respiratory conference in the future.
Speaker Change: Great. Thank you Rajeev.
Rajeev: That's helpful. Thank you very much.
Speaker Change: We're doing additional hiring for the commercial field team after potential approval in both indications is confirmed.
Speaker Change: What is the status of the current field team with regards to both hiring and training. Thank you.
Speaker Change: Yes, so Scott if you wouldn't mind.
Speaker Change: Yes, sure. So the status I'll start with that one the status of the current sales team is there.
Speaker Change: They are locked and loaded and ready.
Speaker Change: Had the team onboard for 14 months now and these were experienced.
Speaker Change: Mostly ph all rare disease folks to begin with and so they've been out in the field strengthening relationships they've been training training training they are absolutely ready.
Speaker Change: Ready to go and very very excited.
Speaker Change: On the future front, we actually just went through another exercise over the course of the last few months to take a look at our our Salesforce sizing strategy.
Speaker Change: We think we're well suited to launch as I mentioned earlier, we will take another look at that once we get out and start to understand sort of the.
Speaker Change: Sensitivity.
Speaker Change: After for the number of reps and then we'll look at potentially.
Spanning if that makes sense.
Speaker Change: In the future.
Speaker Change: Another thing.
Speaker Change: I would add we are.
Speaker Change: Are adequately sized sport launching in may in both indications and then as Scott said, obviously as we continued to build in.
Speaker Change: The unique benefits of each ramp yet.
Speaker Change: I think I want to articulate that even broader so.
Speaker Change: We could upsize, our salesforce, probably in the 2006 timeframe if necessary.
Speaker Change: Operator.
Speaker Change: <unk>.
Speaker Change: Our next question comes from the line of Greg Harrison with Scotiabank. Your line is now open.
Greg Harrison: Hey, good morning, guys. Thanks for taking the questions.
Speaker Change: I'm wondering if you can comment.
Speaker Change: On on your updated cash runway. Following your recent financing then and what assumptions go into that estimate that you could reach profitability with your.
Speaker Change: Current balance sheet and then if you could also comment on which factors play into your decision on pricing given your view on future Ipos profile relative to the competitor. Thanks.
Speaker Change: Great I think both of those questions would be what language about Mike.
Mike: Yes, Greg Great to talk to you again.
Speaker Change: As it relates to runway as we said.
Speaker Change: With this $100 million of additional financing from Heska royalties $25 million.
Speaker Change: Received we received at closing.
Speaker Change: $50 million will be received upon first commercial sale of <unk>.
Speaker Change: And the final $25 million will be at mutual option. Once we reach a cumulative $100 million in net sales of <unk>.
Speaker Change: I think it's pretty simple we have we're very excited about the launch of <unk>.
Speaker Change: As Roger said and Scott have said, we are fully ready from a commercial readiness point of view.
Speaker Change: From a supply point of view, we feel very bullish about our ability to launch this successfully and we feel that are.
Speaker Change: Assuming as Roger said, we filed for full approval here coming up we get full approval on or near the expiration of the exclusivity date.
Speaker Change: We feel confident if we hit our goals and hit our targets that we can be profitable on this current balance sheet and.
Speaker Change: No.
Speaker Change: Like I said fully support <unk> hundred six program all of our <unk>.
Speaker Change: These four studies, we are doing on your truck.
Speaker Change: While also the.
Speaker Change: Ongoing commercial readiness. So we're very excited we're very confident.
Speaker Change: Very happy to have a great partner like healthcare royalties.
Speaker Change: On this journey and we look forward to launch.
Speaker Change: The second question.
Speaker Change: We're not going to talk about pricing strategy.
Speaker Change: I think what I would say is as we've demonstrated or continue to demonstrate and what we feel.
Speaker Change: Our early results understand only reinforced that.
Speaker Change: But we feel that we have a superior product profile.
Speaker Change: And based on that.
Speaker Change: We want to make sure that we are always balancing patient access.
Speaker Change: While also fulfilling the value proposition that you're trucking it can bring so we're not going to talk specifically about.
Speaker Change: Pricing strategies in totality, but I think we're very confident as we come to market that we will have the right strategy to make sure that patients have choice as we as we move forward.
Speaker Change: Great. That's helpful. Thanks, so much thanks.
Speaker Change: Thanks for the question, Greg Operator next question.
Speaker Change: Our next question comes from the line of Corey Jumonville with lifestyle capital. Your line is now open.
Corey Jumonville: Good morning, and thanks for taking our questions and congrats on this new efficacy data with the science, it's really exciting.
Speaker Change: Just kind of following the theme of more drug is better I recognize that the sample size here.
Speaker Change: Still relatively small but have you had any type of dose response among patients are those who are reaching two to three fold the <unk> equivalent dose achieving better outcomes than those in the study might be.
Speaker Change: In the lower range equivalent to the existing standard of care.
Speaker Change: And this also might be a naive question, but is it possible to get these efficacy data on label and how would you go about marketing.
Speaker Change: Marketing the six minute walk to prescribers post approval.
Speaker Change: Yes, I'll take the second question and then Rajiv can say what he can about that it does.
Speaker Change: That's versus effect curve.
Speaker Change: So it's not the data is would not be available for <unk>.
Speaker Change: Indication claims per se because it's an open label safety study I think it would be part of our annual update to the label once approved where we could update the clinical pharmacology section.
Speaker Change: To describe the data both in terms of safety and potentially in terms of efficacy, but again thats a negotiation with the FDA about what we could and could that include in the clinical pharmacology section of the label.
Speaker Change: I'll reserve.
Speaker Change: Commitment on that.
Speaker Change: We can indicate it in there, but I think certainly we will abstract and then publish the data and I think as we're seeing this tremendous inbound interest based on LIBOR.
Speaker Change: Describing.
Speaker Change: Curious over 20 doctors doing this current assent study many of them I think are the seminal thought leaders and I think the fact that they are doing the study and we're seeing the results that we're seeing.
Speaker Change: He is going to help highlight the data when they lead panel sessions et cetera, because now they are seeing the true value of print as it relates to.
Speaker Change: The trip yet.
Speaker Change: And then I will just comment on dose response before I turn it over to Rajeev, it's very hard in a small sample of patients to show a dose response, frankly, plus we're allowing patients to individually titrate the dose that we're not sort of pre defining what dose level.
Speaker Change: Patients should titrate to and then measuring that versus effect.
Speaker Change: So that's a different difficult paradigm to show the dose response in that Rajiv I don't know if you have additional comment there.
Rajiv Soccer: Yes, Corey I think I think just I think a few things to highlight first of all the patients that were rolling in a center are quite heterogeneous.
Speaker Change: We purposely designed the study to showcase safety and Tolerability of your trip here. So we not only include patients with mild <unk>.
Rajiv Soccer: Hemodynamic limitations with their pulmonary retention.
Rajiv Soccer: But also patients with severe hemodynamic impairments with various levels of complexity with the interstitial lung disease and the respiratory.
Rajiv Soccer: CVR physiological impairments, but but I think despite that heterogeneity I think what the data is showing despite the.
Rajiv Soccer: Small numbers, but even though.
Rajiv Soccer: <unk> continues to enroll and continue to highlight a few things number one.
Rajiv Soccer: Clearly the low resistance inhaler combined with our print formulation is absolutely, allowing these patients to titrate.
Rajiv Soccer: Trump year to again to what I believe are actually new therapeutic levels.
Speaker Change: And that's very important because it's well known that Prost genomic therapies are titratable. It is dose related so it tends to affect tend to improve as dose is escalated the problem with current therapies on the market, including oral and systemic parental therapies is that they are just signet.
Speaker Change: <unk> limited by terrible systemic side effects, especially in the oral therapies with the Gi side effects and of course, the potentials within dwelling lines or subcutaneous.
Speaker Change: Complications I think with the current inhaled therapies on the market today, we know that.
Speaker Change: Leased and the increased study what was very interesting relative to the ascent study is by eight weeks only 50% of the patients in the <unk> basin Nebulize steady increase with <unk>, we're able to reach the 10 to 12 breath levels.
Speaker Change: Versus in the sense steady despite the.
Speaker Change: Heterogeneity.
Speaker Change: The patient population, we're able to get patients.
Speaker Change: The overwhelming majority of patients up to more than or equal to 15, Brent equivalents. So again I think that what <unk>.
Speaker Change: That data is going to show in Etfs, and what Kols that are going to see that.
Speaker Change: <unk> is very well tolerated and titratable and that they can customize to whatever needs of their patients.
Speaker Change: <unk> with both ph in ph ILD in the very near future.
Corey Jumonville: And Corey that's great answer as you think you I think one way we're going to take on this does issue directly.
Speaker Change: They're going to do a directed transition study from patients on time based on how they sell DPI that are underserved by those therapies.
Speaker Change: And probably because it does limitations, we will transition the MTA trivia improve their does and then and if we should therefore, an improved outcome. We've shown not only it does related to outcome.
Speaker Change: All such differentiated products.
Speaker Change: And in a different way in a helpful way for you to ramp yes. So look for that study to start up in the near future as well.
Speaker Change: So operator next question please.
Speaker Change: Thank you and I'm currently showing no further questions at this time I would like to hand, the call back over to Roger Jeffs for closing remarks.
Speaker Change: Thank you very much. So we really appreciate everyone joining us joining us today and we look forward to speaking again soon bye bye.
Speaker Change: This concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Uh huh.
Speaker Change: Okay.
Speaker Change: Hi.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: So.
Speaker Change: Hum.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: So.
Speaker Change: Hum.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: Yes.
Yeah.
Speaker Change: Yes.
Speaker Change: Thanks.
Speaker Change: Thanks.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Hum.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Thanks.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Thanks.
Speaker Change: Okay.
Okay.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Earnings.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Alright.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: <unk>.
Speaker Change: Yes.