Q1 2025 Liquidia Corp Earnings Call

Only mode. 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 questions I would like to remind everyone that this conference call is being recorded.

Speaker Change: I'll now hand, the call off to Jason Adair Chief business Officer.

Speaker Change: Thank you operator, it is my pleasure to welcome everyone to the liquidity Corporation first quarter 2025 financial results and corporate update call joining.

Speaker Change: Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Medical Officer, Dr. Rajiv <unk>, Chief operating officer, and CFO, Michael Cassata, Chief Commercial Officer, Scott <unk> and General Counsel Rusty Schuttler.

Jason Adair: 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.

Good morning and welcome everyone to the Liquidia Corporation, 1st quarter 2025 financial results.

and Corporate Update Conference call. My name is Ari and I will be your conference operator today.

Roger Jeffs: 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. Good morning, everyone. And thank you for joining us today.

Speaker Change: 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.

Currently, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session. Interest instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this conference call is being recorded.

Roger Jeffs: In a little more than two weeks, May 24, to be precise, we will have reached the PDUFA goal date for Liquidia's first internally developed commercial product, Utrepia. an investigational inhaled dry powder formulation of troposinil for the treatment of pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD.

Speaker Change: These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call.

Speaker Change: I will now hand the call off to Jason Adair, Chief Business Officer.

[inaudible]

Speaker Change: Thank you, operator. It is my pleasure to welcome everyone to the Liquidia Corporation first quarter 2025 financial results and corporate update call.

Speaker Change: 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.

Roger Jeffs: With all eyes on the future, we are going to keep our prepared remarks focused on a few key areas. First, I'd like to take a moment to highlight last week's news regarding the decision rendered by the District Court dismissing United Therapeutics' cross-claim that sought to challenge our amendment to the new drug application for utrepia, which added the treatment of PHILD to utrepia's proposed label. While United Therapeutics has the right to appeal the court's ruling, we are pleased with the court's decision to dismiss this cross-court hearing. specifically holding that United Therapeutics failed to establish standing. We are proud to say there continue to be no legal barriers barring Utrecht as potential final approval following the expiration of gating regulatory exclusivity on May 23rd, 2025.

Speaker Change: Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Medical Officer, Dr. Rajeev Saggar, Chief Operating Officer, and TFO, Michael Kaseta, Chief Commercial Officer Scott Moomaw, and General Counsel, Rusty Schundler.

Roger: 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: Good morning, everyone and thank you for joining us today and a little more than two weeks may 24th to be precise we will have reached at the <unk> date for liquidity as first internally developed commercial product <unk>.

Speaker Change: 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 achievement.

Roger: An investigational inhaled dry powder formulation of <unk> for the treatment of pulmonary arterial hypertension.

Roger: Th in pulmonary hypertension associated with interstitial lung disease or ph ILD.

Speaker Change: These statements are subject to known and unknown risks and uncertainties which may cause our actual results or performance to be materially different from many future results or performance expressed or implied on the call.

Roger: With all eyes on the future, we're going to keep our prepared remarks focused on a few key areas.

Roger: First I'd like to take a moment to highlight last week's news regarding the decision rendered by the district Court dismissing United Therapeutics Cross clean and sought to challenge our amendment to the new drug application for <unk>.

Roger Jeffs: With this favorable ruling in hand, we are doubling down on our preparations for the potential launch of Utrebia with a laser focus on five key strategic areas. First, we're developing what we believe is a best-in-class product profile for utrepia. As we've said before, Utropia's tolerability, titratability, ease of use, and future labeling speaks to the fact that it offers a differentiated product profile. We continue to further characterize these clear benefits in the company's Open Label Assent Study in PHILD patients. As communicated in this morning's press release, cohort A of the ASCENT study is now fully enrolled with more than 50 patients.

Speaker Change: For additional information, including a detailed discussion of our risk factors, please refer to the company's documents, file out with the Securities and Exchange Commission, which can be accessed on our website.

Roger: Which added the treatment of ph ILD G. Trump has proposed label.

Roger: I'd now like to turn the call over to Roger for our prepared remarks after which he will open the call for your questions.

Roger: While United Therapeutics has the right to appeal. The court's ruling we are pleased with the court's decision to dismiss this cross claim spin.

Roger: Good morning everyone and thank you for joining us today. In a little more than two weeks, May 24th to be precise, we will have reached a BDUFA goal date for Liquidia's first internally developed commercial product, Utrepia.

Roger: Specifically holding that United Therapeutics failed to establish standing.

Roger: We are proud to say that continued to be no legal barriers barring truck as potential final approval. Following the exploration of gating regulatory exclusivity on may 23rd 2025.

Roger: An investigational, inhaled, dry powder formulation for the treatment of pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD.

Roger: With this favorable ruling in hand, we are doubling down on our preparations for the potential launch of future IPO with a laser focus on five key strategic areas.

Roger Jeffs: The interim data has shown us that the dosing and tolerability profile in the first 20 patients to complete eight weeks of treatment was consistent with observations made in the INSPIRE study of PAH patients. Thus far, PHILG patients in the ASCENT study have been able to titrate to doses that are three times higher than the labeled target dose of nebulized titasos. These patients have also shown positive trends on exploratory measures of epicanthoplasm. including six-minute walk test.

Roger: With all eyes on the future, we are going to keep our prepared remarks focused on a few key areas.

Roger: First we are developing what we believe is a best in class product profile for <unk>.

Roger: First, I'd like to take a moment to highlight last week's news regarding the decision rendered by the District Court dismissing United Therapeutics' cross-claim that sought to challenge our amendment to the new drug application for Utrepia, which added the treatment of PHILD to Utrepia's proposed label.

Roger: As we've said before each herpes tolerability titrate ability.

Roger: He's abuse and future labeling speaks to the fact that it offers a differentiated product profile.

Roger: While United Therapeutics have the right to appeal the court's ruling, we are pleased with the court's decision to dismiss this cross claim.

Roger: We continued to further characterize these clear benefits in the company's open label ascent study in ph ILD patients.

Roger Jeffs: Additional data from the ASCENT study will be presented during two poster sessions at the American Thoracic Society's International Conference in San Francisco on May 20. As part of the ASCENT study, we will begin Cohort B, a directed transition study in the coming months, where we will take patients unsatisfied with the clinical attributes of Tyvaso and Tyvaso DPI and transition them to utrebia. The goal of this study will be to directly compare the different. potential benefits that utrepia presents both in PAH and PHILD patients.

specifically holding the United Dharaputics Felt to establish standing.

Roger: As communicated in this morning's press release cohort of the ascent study is now fully enrolled with more than 50 patients.

Roger: We are proud to say there continued to be no legal barriers for any trepid potential final approval following the exploration of gating regulatory exclusivity on May 23rd, 2025.

Roger: The interim data has shown us that the dosing and Tolerability profile in the first 20 patients to complete eight weeks of treatment was consistent with observations made in the inspire study ph patients.

Roger: With his favorable rolling in hand, we are doubling down our preparations for the potential launch of Qtrapia, with a laser focus on five keys for Qtrapia.

Roger: Thus far ph ILD patients in the study had been able to titrate. The doses that are three times higher than the label target dose of nebulizer today Sir.

Roger: First, we're developing what we believe is the best-in-class product profile for you, Trepia.

Roger: These patients have also shown positive trends on exploratory measures of efficacy.

Roger: As we've said before, Returfie's tolerability, titrateability, ease of use, and future labeling speaks to the fact that it offers a differentiated product profile.

Roger Jeffs: You'll hear more regarding this study in the months ahead.

Roger: Including six minute walk distance.

Roger: Additional data from the ascend study will be presented during two poster session at the American Thoracic Society International Conference in San Francisco on May 20th.

Roger Jeffs: Next, we are fully prepared to go to market with a competitive share of voice. We have 50 sales reps in the field who have been on board for about 18 months and a companion medical affair team, all with an impressive level of rare disease experience and most with PH experience. These groups have been actively surveilling both the major centers of excellence as well as the community prescriber base in preparation for Utrecht's potential launch.

Roger: We continue to further characterize these clear benefits in the company's open label of substance study in Ph.I.L.D. patients.

Roger: As part of the <unk> study, we will begin cohort b a directed transition study in the coming months, where we will take patients unsatisfied with the clinical attributes of pervasive and divest of DPI.

Roger: As communicated in this morning's press release, cohort A of the Ascensities is now fully enrolled with more than 50 patients.

Roger: The interim data has shown us that the dosing intolerability profile in the first 20 patients to complete 8 weeks of treatment was consistent with observations made in the Inspire Study of the HIV patient.

Roger: And transitioning them to your trivia. The goal of this study will be to directly compare the differences.

Roger Jeffs: Our third strategic area of focus is our preparation to launch a full suite of patient support services, which we have meticulously put into place. Physicians and patients should expect no differences in support with utrepia, whether starting inhaled trapezoid for the first time or transitioning from incumbent inhaled products.

Roger: Potential benefits that <unk> presents both in ph and ph ILD patients.

Roger: Thus far, PHLD patients in the defense study had been able to titrate the doses that are three times higher than the labelled target dose of Nebulae Tadeza.

Roger: You'll hear more regarding this study in the months ahead.

Roger: Next we are fully prepared to go to market with a competitive share of voice. We have 50 sales reps in the field, who have been on board for about 18 months and a companion medical affairs team all with an impressive level of rare disease experience and most with ph experience.

Roger: These patients have also shown positive trends on exploratory measures of efficacy.

Roger Jeffs: Fourth, we've continued to focus on ensuring robust product availability. Mike and his team at Liquidia have prepared to put product in the channel in only two to three weeks after Utrepit's potential approval.

including six-minute walk distance.

Roger: Additional data from the Ascent Study will be presented during two poster sessions at the American The Rats of Society's International Conference in San Francisco on May 20th.

Roger: These groups have been actively surveilling, both the major centers of excellence as well as the community prescriber base and preparation for <unk> potential launch.

Roger Jeffs: And finally, the fifth strategic area of focus that will help us ensure success is broad payer access. Over the last several years, we have developed strong relationships with payers who understand the differentiated product profile that Utrepia can offer to patients. We remain confident that patients will have access to Utrepia within a short time after launch.

Roger: As part of the Ascent study, we will begin cohort B, a directed transition study in the coming months, where we will take patients unsatisfied with the clinical attributes of Taipeiza and Taipeiza DPI and transition them to utrebia. The goal of this study will be to directly compare the differences.

Roger: Our third strategic area of focus is our preparation to launch a full suite of patient support services, which we have meticulously put into place.

Roger: Physicians and patients should expect no differences in support with neutropenia with Theyre starting in <unk> for the first time, we're transitioning from incumbent inhaled products.

Roger: A potential benefit that utopia presents both in PH and PHLD patients.

Roger Jeffs: With all these in play, we feel well-prepared to launch Utrecha into the marketplace once approved, and we look forward to fulfilling our promise to provide patients with PAH and PHLD, a much-needed and potentially best-in-class therapeutic alternative.

Roger: Fourth we've continued to focus on ensuring robust product availability.

You'll hear more regarding this study in the months ahead.

Speaker Change: Mike and his team that liquidity and prepared to put product in the channel and on a two to three weeks after your trip its potential approval and.

Roger: Next, we are fully prepared to go to market with a competitive share of voice. We have 50 sales reps in the field who have been on board for about 18 months and a companion medical affair team, all with an impressive level of rare disease experience and most with pH experience.

Michael Kaseta: I'll now turn the call over to Mike to provide an overview of our first quarter 2025 financials, Mike. Thank you, Roger, and good morning, everyone. Turning to our first quarter 2025 financial results, which can be found in the press release, you will see that revenue was $3.1 million for the three months ended March 31st, 2025, compared to $3 million for the three months ended March 31st, 2024. Revenue related primarily to the promotion. The increase of $0.1 million was primarily due to the impact of unfavorable growth-to-net returns adjustments recorded in the prior year, offset by lower sales volumes in the current year.

Roger: And finally, the fifth strategic area of focus that will help us ensure success is broad payer access.

Roger: Over the last several years, we have developed strong relationships with payers, who understand the differentiated product profile that you trip you can offer to patients. We remain confident that patients will have access to the trap yet within a short time after launch.

Roger: These groups have been actively surveilling both the major centers of excellence, as well as the community prescriber base in preparation for your trepid potential launch.

Roger: Our third strategic area of focus is our preparation to launch a full suite of patient support services which we have meticulously put into place.

Roger: With all of these in play we feel well prepared to launch <unk> into the marketplace. Once approved and we look forward to filling our promise to provide patients with ph and ph ILD, a much needed and potentially best in class therapeutic alternative.

Roger: Physicians and patients should expect no differences in support with Etrepia, with their starting inhale triposil for the first time, or transitioning from incumbent inhale projects.

Roger: I'll now turn the call over to Mike to provide an overview of our first quarter 2025 financials Mike.

Michael Kaseta: Cost of revenue was $1.5 million for each of the three months ended March 31st, 2025 and 2024. Cost of revenue related to the promotion agreement as noted above. Research and development expenses were $7 million for the three months ended March 31st, 2025, compared to $10.1 million for the three months ended March 31st, 2024. The decrease of $3.1 million, or 31%, was primarily due to a $3.6 million decrease in personnel expenses, including stock-based compensation, due to a shift from activities related to research and development to preparation for the potential commercialization of Utrecht.

Fourth, we've continued to focus on ensuring robust product availability.

Mike: Thank you Roger and good morning, everyone.

Roger: Mike and his teammate, Liquidia, have prepared to put product in the channel and only two to three weeks after you trepid potential approval.

Mike: Turning to our first quarter 2025 financial results, which can be found in the press release, you will see that.

Roger: and finally, the fifth strategic area of focus that will help us ensure success is broad payer access.

Mike: Revenue was $3 1 million for the three months ended March 31, 2025 compared to $3 million for the three months ended March 31, 2024 revenue related primarily to the promotion agreement the increase of <unk> 1 million.

Roger: Over the last several years, we have developed strong relationships with players who understand the differentiated product profile that uterpia can offer to patients. We remain confident that patients will have access to uterpia within a short time after launch.

Mike: It was primarily due to the impact of unfavorable gross to net returns adjustments recorded in the prior year offset by lower sales volumes in the current year.

Roger: With all these in play, we feel well prepared to mount your trepid into the marketplace once approved and we look forward to filling our promise to provide patients with Ph and Ph.I.L.D., a much needed and potentially best in class therapeutic alternative.

Mike: Cost of revenue was $1 $5 million for each of the three months ended March 31, 2025, and 2020 for cost of revenue related to the promotion agreement as noted above.

Michael Kaseta: These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $0.4 million decrease in expenses related to our Utrebia Research and Development General and administrative expenses were $30.1 million for the three months ended March 31st, 2025, compared to $20.2 million for the three months ended March 31st, 2025. The increase of $9.9 million, or 48%, was primarily due to an $8.1 million increase in personnel expenses, including stock-based compensation, driven by higher headcount and a shift from activities related to research and development to preparation for the potential commercialization of UTREPIA, a $0.6 million increase in legal fees related to our ongoing UTREPIA-related litigation.

Roger: I'll now turn the call over to Mike to provide an overview of our first quarter 2025 financials. Mike?

Mike: Research and development expenses were $7 million for the three months ended March 31, 2025, compared to $10 1 million for the three months ended March 31 2024.

Thank you.

Thank you, Rob here, and good morning, everyone.

Roger: Turning to our first quarter, 2025 financial results which can be found in the press release, you will see that Revenue was $3.1 million for the three months ended March 31st, 2025 compared to $3 million for the three months ended March 31st, 2024. Revenue related primarily to the promotion agreement.

Mike: The decrease of $3 1 million or 31% was primarily due to a $3 $6 million decrease in personnel expenses, including stock based compensation due to a shift from activities related to research and development to preparation for the potential commercialization of neutropenia.

Roger: The increase of $0.1 million was primarily due to the impact of unfavorable growth to net return of adjustments recorded in the prior year, offset by lower sales volume in the current year.

Mike: These decreases were offset by a $1 $7 million increase in clinical expenses related to our <unk> hundred six program and a zero point $4 million decrease in expenses related to our <unk> research and development activities.

Roger: Foster Revenue was $1.5 million for each of the three months ended March 31st, 2025 and 2024. Kaplan Revenue related to the promotion agreement has noted above.

Michael Kaseta: and the $0.6 million increase in facilities and infrastructure.

Mike: General and administrative expenses were $30 1 million for the three months ended March 31, 2025, compared to $20 2 million for the three months ended March 31 2024.

Michael Kaseta: We incurred a net loss for the quarter-ended March 31, 2025, of $38.4 million, or $0.45 per basic and diluted share, compared to a net loss of $30.1 million, or $0.40 per basic and diluted share, for the three-month-ended March 31, 2021. Included in the comparative results we have presented is an immaterial revision of other income as previously reported for fiscal year 2024. This revision is a technical, non-cash accounting adjustment related to gain and loss recognized when we made amendments to our HCR facility made in 2024.

Roger: Research and development expenses were $7 million for the three-month-ended March 31st, 2025, compared to $10.1 million for the three-month-ended March 31st, 2024.

Mike: The increase of $9 9 million or 48% was primarily due to an $8 $1 million increase in personnel expenses, including stock based compensation driven by higher head count and a shift from activities related to research and development to preparation for the potential commercialization of <unk> <unk>.

Roger: The decrease of $3.1 million, or 31%, was primarily due to a $3.6 million decrease in personal expenses, including stock-based compensation, due to a shift from activities related to research and development to preparation for the potential commercialization of utrepia.

Mike: Zero point $6 million increase in legal fees related to our ongoing <unk> related litigation.

Mike: And the zero point $6 million increase in facilities and infrastructure expenses.

Roger: These decreases were offset by a $1.7 million increase in clinical expenses related to our L6O6 program, and a $0.4 million decrease in expenses related to our uterpia research and development activities.

Michael Kaseta: Additional details are included in the Form 8K we filed this morning.

Mike: We incurred a net loss for the quarter ended March 31, 2025 of $38 4 million.

Roger Jeffs: I would now like to turn the call back over to Roger. Thank you, Mike. In summary, we continue to drive forward the right set of strategies to support the successful potential launch of utrepia in the coming weeks, and we look forward to providing both physicians and patients with what we believe could be soon become the prostacyclin of first choice.

Mike: Or <unk> 45 per basic and diluted share compared to a net loss of $30 1 million or <unk> 40 per.

Roger: General Administrative Expenses were $30.1 million for the three-month-cended March 31st, 2025, compared to $20.2 million for the three-month-cended March 31st, 2024.

Mike: Per basic and diluted share for the three months ended March 31 2024.

Mike: Included in the comparative results, we have presented at an immaterial revision of other income as previously reported for fiscal year 2020 for this revision is a technical noncash accounting adjustment related to a gain and loss recognized when we made amendments to our HCR facility made in 2024 additional details are included in the form.

Roger Jeffs: I would now like to open the call to questions. Operator, first question. Thank you.

Roger: The increase of $9.9 million or 48%, was primarily due to...

Operator: At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Mike: 8-K, we filed this morning, I would now like to turn the call back over to Roger.

Julian Harrison: Our first question comes from the line of Julian Harrison of VTIG. Your line is now open. Hi, congrats on all the progress and thank you for taking my questions.

Speaker Change: Thank you Mike in summary, we continue to drive forward the right set of strategies to support the successful potential launch of <unk> in the coming weeks and we look forward to providing both physicians and patients with what we believe could be soon become the prostacyclin a first choice I would now like to open the call to questions. Operator first question. Please.

and a $0.6 million increase in facilities and infrastructure expenses.

Roger: We incurred a net loss for the quarter-ended March 31, 2025 of $38.4 million or $45 per basic and deluded share compared to a net loss of $30.1 million or $40 per basic and deluded share for the three-month-ended March 31, 2024.

Julian Harrison: I'm wondering if you believe United has any injunctive value left on the cross claim that was dismissed last week. I'm also curious if you had any reaction to the dismissal without prejudice versus with prejudice, given the judges expressed views on standing in the opinion memorandum.

Speaker Change: Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Roger: Included in the comparative results we have presented is an immaterial revision of other income as previously reported for fiscal year 2024. This revision is a technical non-cash accounting adjustment.

Rusty Schundler: Good morning, Julian. Good to hear from you.

Rusty Schundler: Rusty, if you wouldn't mind answering Julian's two questions. Sure. Julian, thanks for the question. So let me, I mean, go over a couple of things.

Operator: Our first question comes from the line of Julian Harrison of <unk>. Your line is now open.

Roger: Related to gain and loss recognized when we made a Bedminster HCR facility made in 2024 Additional details are included in the Form 8K we filed this morning. I would now like to turn the call back over to Roger

Rusty Schundler: I mean, one, what's absolutely clear is that there's currently no proceeding actively ongoing in which United Therapeutics is seeking to adjoin either the FDA from giving us approval for utrepia or seeking any sort of temporary restraining order or preliminary injunction to prevent our launch of utrepia upon approval. So that's number one. Number two, the dismissal was without prejudice. Again, keep in mind it was a motion to dismiss, so the judge was not addressing the full merits of the case. This was, you know, a question of whether their complaint had even set forth grounds upon which the court could even entertain their lawsuit.

Julian Harrison: Hi, Congrats on all the progress and thank you for taking my questions.

Julian Harrison: I'm wondering if you believe United has any injunctive value left on the cross claim that was dismissed last week.

Roger: Thank you, Mike. In summary, we continue to drive forward the right set of strategies to support the successful potential launch of Utrepia in the coming weeks, and we look forward to providing both physicians and patients with what we believe could be soon become the proffedocycle in the first choice. We'd now like to open the call to questions. Operator, first question please.

Julian Harrison: Also curious if you had any reaction to the dismissal without prejudice versus with prejudice given the judge's expressed views on standing in the opinion memorandum.

Julian Harrison: Good morning, Julien good to hear from you rest of you wouldn't mind answering julians two questions.

Roger: Thank you. At this time we will conduct the question and answer session. As a reminder to ask a question you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Julian Harrison: Sure Julian Thanks for the question.

Julian Harrison: So let me cover a couple of things I mean, one.

Rusty Schundler: You know, what that does mean is they can try to repurpose or refashion the argument in the future, but I think what's clear from the way in which he approached the opinion is they can't come back with the exact same argument they did before. I think they still have significant standing issues trying to link the bundling guidance to a 30-month stay. And keep in mind, again, this is all just at the motion to dismiss phase. You know, they still would have to then show that they're, you know, correct on the merits as well.

Julian Harrison: What is absolutely clear is that Theres currently no proceeding.

Julian Harrison: Actively ongoing and which United Therapeutics is seeking to enjoin, either the FDA from giving us approval for your trip or seeking any sort of.

Yeah.

Speaker Change: Our first question comes from the line of Julian Harrison of DTIG to our line is now open.

Julian Harrison: Temporary restraining order a preliminary injunction to prevent our launch if you try to upon approval.

Julian Harrison: Hi, congrats on all the progress, and thank you for taking my questions.

Julian Harrison: <unk> number two.

Julian Harrison: I'm wondering if you believe United has any injunctive value left on the cross claim that was dismissed last week. Also curious if you had any reaction to the dismissal without prejudice versus with prejudice given the judges express views on standing in the opinion memorandum.

Julian Harrison: The dismissal was without prejudice again keep in mind as motion to dismiss so the judge was not addressing the full merits of the case.

Julian Harrison: You know, as far as other things that United Therapeutics might do, which I think your question alluded to, you know, that's really not for us to say. You know, we don't know what lengths they're going to go to try to deny PAH and PHLV patients access to an alternative therapy. What I can say, though, is, you know, we'll be ready, you know, whatever form they pursue something, if they pursue anything from here on out, we'll be ready to address it. Thanks. Very helpful. Thank you and congrats again. Thank you, Julian.

Julian Harrison: <unk> was a question of whether their complaint had even set forth ground's upon which the court could even entertain their lawsuit.

Julian Harrison: What that does mean is they can try to re purpose recession the argument.

Rusty: Good morning, Julian. Good to hear from you. Rest of you in my answering Julian's two questions.

Julian Harrison: The future, but I think what's clear.

Rusty: Sure, I'm Julian, thanks for the question. So let me go over a couple things. I mean, what's absolutely clear is that there's currently no proceeding.

Julian Harrison: And which he approached the opinion is.

Julian Harrison: They can't come back with the exact same argument than it did before I think they still have significant standing issues trying to link the bundling guidance to 30 months day and keep in mind again. This is all just at the motion to dismiss phase.

Rusty: actively ongoing in which United Therapeutics are seeking to join either the FDA from giving us approval for your Ethiopia or seeking any sort of...

Operator: Next question, please. Thank you.

Julian Harrison: They still would have to then show that there.

Kambiz Yazdi: Our next question comes from the line of Kambiz Yazdi of Jeffries. Your line is now open. Kambiz?

Rusty: Temporary Restraining Order, preliminary junction to prevent our launch if you trepid upon approval.

Speaker Change: Correct on the merits as well.

Julian Harrison: As far as other things that United Therapeutics might do which I think to your question related to that.

Rusty: Number one, number two, the dismissal was without prejudice. Again, keep in mind there's some motion to dismiss, so the judge was not addressing the full merits of the case. This was, you know, question of whether they're complaint had even set forth.

Julian Harrison: That's really not trust.

Julian Harrison: We don't know what lengths, they're going to go try to deny ph in ph ILD patients access to an alternative therapy, what I can say, though is.

Kambiz Yazdi: to be happy here. All right. Morning, team. Thank you so much for the questions and very exciting times for the company. Maybe a little bit on the, you know, the forward-looking transition studies. Any kind of thoughts on what may be interesting patient baseline characteristics that you may be looking to enroll in that study? And then would love to get an update on L607.

Julian Harrison: We will be ready whatever.

Grounds upon which the court could even entertain their lawsuit.

Julian Harrison: A.

Julian Harrison: Pursue something if they pursue anything from here on out will be it will be ready to address.

Um, um,

Rusty: You know, what that does mean is they can try to repurpose or repassion the argument in the future, but I think what's clear from the way in which he approached the opinion is.

Speaker Change: Excellent very helpful. Thank you and congrats again.

Julien Harrison: Thank you Julien next question please.

Rusty: They can't come back with the exact same argument they did before. I think they still have significant standing issues trying to link the bundling guidance to a 30-month day. And keep in mind, again, this is all just at the motion to Smith's phase. You know, they still would have to then show that they're correct on the merits as well.

Speaker Change: Thank you.

Speaker Change: Our next question comes from the line of Ken <unk> of Jefferies. Your line is now open.

Rajeev Saggar: Great, so both of those questions fall into Rajeev Saggar's court. So, Rajeev, do you mind answering those? Yeah, hi, Kambiz. Thanks for the question. So, the first question was regarding the upcoming transition study. This study is specifically evaluating the transition from Tyvezo, either nebulized and preferably dry powder inhaler, to utropia. These patients will be specifically in the category of PHLD, and that's very purposeful. As you know, for our NDA filing in the INSPIRE study, we already showed that we were able to successfully transition patients with group 1 PAH from nebulized Tyvezo directly to utropia, and now we're trying to do the same thing in the PHLD population.

Speaker Change: Campus to.

Speaker Change: To be happy here.

Rusty: You know, as far as other things that United States therapeutics might do, which I think your question will lead it to you.

Speaker Change: Alright, good morning team. Thank you so much for the questions and very exciting times for the company.

Rusty: You know, that's really not true today, you know, we don't know what lengths they're going to go to try to deny pH and pH-LV patients' access to an alternative therapy. What I can't say though is, you know, we'll be ready, you know, whatever form they pursue something, if they pursue anything from here and out, we'll be ready to do it. Okay.

Speaker Change: Maybe a little bit on the.

Speaker Change: Before looking transitioned studies.

Speaker Change: Any kind of thoughts on what maybe interesting patient baseline characteristics that.

Speaker Change: You may be looking to enroll in that study and then what.

Speaker Change: I would love to get an update on <unk>.

Thanks, excellent, very helpful, thank you and congrats again.

Speaker Change: Great. So both of those questions volunteer Rajeev, cyber score and Rajiv and answering that.

Thank you, Julian. Next question please.

Thank you.

Speaker Change: It can be thanks for the question. So the first question is regarding the upcoming transition study.

Speaker Change: Our next question comes from the line of Kambiz Yazdi of Jeffries. Your line is now open.

Speaker Change: This study is specifically.

Rajeev Saggar: So, first of all, these patients will be on background Tyvezo. The vast majority of them are on dry powder inhaler. These patients will have PHLD, and very similar to cohort A in part of the SENT study that we're presenting at ATS, we're going to be looking at safety. So, can we safely transition number two? Can we transition them and then continue to showcase our product profile, which we believe is going to be beneficial in terms of our ability to up titrate that patient, maintain their clinical stability, or even improve them? So, we'll be looking at exploratory efficacy modalities, inclusive of, of course, six-minute walk and other quality-of-life indicators.

Speaker Change: Evaluating the transition from tavy so.

Campus.

Speaker Change: Either nebulizer and preferably a dry powder inhaler to your trip, yes. These patients will be specifically in the category of ph D and that's very purposeful as you know.

To be happy here

Speaker Change: Sorry. Morning, team. Thank you so much for the questions and very exciting times for the company. Maybe a little bit on the, you know, before looking in transition studies.

Speaker Change: In our.

Speaker Change: Any kind of thoughts on what maybe interesting patient baseline characteristics that you may be looking to enroll in that study, and then would love to get an update on L6 or L6 as well.

Speaker Change: For our NDA filing in the inspire study we already shows that we were able to successfully transition.

Speaker Change: Patients with group one ph from Nebulize Tobey so directly to your trip here and now we're trying to do the same thing in the ph ILD population. So first of all these patients will be.

Speaker Change: Great, so both of those questions fall into Rajeev Saggar's court, so Rajeev, find answer enough.

Speaker Change: You know how it can be thanks for the question. So the first question was regarding the upcoming transition study.

Speaker Change: On background <unk>.

Speaker Change: So let's assume majority of them are on dry powder inhaler.

This study is specifically-

Speaker Change: Patients will have ph ILD and very similar to cohort a is in part of the ascent study that were presenting at Ats.

evaluating the transition from...

Rajeev Saggar: So, we look forward to showcasing that study and initiating that in the next few months.

and Tea Vaso.

either debilized and preferably dry powder inhaler.

Speaker Change: We're going to be looking for the ability to to we're going to be looking at safety.

Rajeev Saggar: And your second question, Kambiz, is that on L606? Yeah, just an update there. Yeah, thank you. So, you know, we're working diligently to initiate this global study.

Speaker Change: 2U Trapia, these patients will be specifically in the category of Ph.L.D., and that's very purposeful, as you know, for NDA filing in the inspire study, we already showed that we were able to successfully transition.

Speaker Change: So can we safely transition over to to make transition them and then continue to showcase our product profile, which we believe is going to be beneficial in terms of our ability to up titrate that patients maintain their clinical stability at or even improve them. So we'll be looking at.

Rajeev Saggar: Just to just to recap, this is the liposomal sustained release formulation of triprostyl that we're going to be delivering twice a day. Just to recap, this is a global study with more than 300 patients and more than 20 companies. And we anticipate that we'll be initiating the study by year's end. Thank you.

patients with group 1 PAH.

Speaker Change: Exploratory efficacy modalities inclusive of course six minute walk.

Speaker Change: from Nebalyze, Taipei, so directly to Utropia. And now we're trying to do the same thing in the Ph.L.D. population. So, first of all, these patients will be on background Taipei, so let's look, majority of them are on dry powder inhaler.

Speaker Change: Other another.

Speaker Change: Quality of life indicators, so we look forward to showcasing that steady.

Speaker Change: And initiating that in the next in next few months.

Speaker Change: And your second question companies is that on <unk> 606.

Gregory Harrison: Our next question comes from the line of Greg Harrison of Scotiabank. Your line is now open. Hey, good morning, guys. Congrats on the progress, and thanks for taking the question. So, we've seen the competitors struggle to convert patients to their dry powder formulation, and their nebulized formulations persisted longer than thought initially.

Speaker Change: these patients will have Ph.L.D., and very similar to cohort A as in part of the Sanstery that was presented at H.S.

Speaker Change: Yes, just an update there.

Speaker Change: Yes. Thank you so we're working diligently to initiate.

Speaker Change: We're going to be looking for the ability to we're going to be looking at safety.

Speaker Change: This global study.

Speaker Change: Just to recap this is the LIFO soma sustained release formulation of <unk> that we're going to be delivering twice a day.

Speaker Change: So can we safely transition number two? Can we transition them and then continue to showcase our product profile?

Speaker Change: Just to recap this is a global study with more than 300 patients to more than 20.

Speaker Change: which we believe is going to be beneficial in terms of ability to uptightrate that patient, maintain their clinical stability or even improve them. So we'll be looking at...

Roger Jeffs: Could you speak to the patient perspective on switching to dry powder formulation, and whether you think utrepia will have a stronger case for keeping patients on a DPI formulation than we've seen with Tybaso, and how do you think the assent data will help with this argument? Yeah, good morning, Greg. Thanks for the question. So I'll start with an answer and then Rajeev, if you'll give your thoughts as well, it could be helpful. So, you know, again, I think I think you are right. It's surprising that there remain residual nebulized typhus in the patient base. I think it's about 31 percent of the scripts today, when all thoughts, including the competitors, thoughts initially were that all patients would transition to the DPI for portability reasons alone.

Speaker Change: <unk> companies and we anticipate that we'll be initiating the study by year's end.

Exploratory Advocacy, Modalities Inclusive, of course.

Speaker Change: Thank you.

Thank you.

Speaker Change: Six Minute Walk and another Claudia of Life Indicator. So, we look forward to showcasing that study and initiating that in the next few months.

Speaker Change: Our next question comes from the line of Greg Harrison of Scotiabank. Your line is now open.

Greg Harrison: Hey, good morning, guys. Congrats on the progress and thanks for taking the question.

In your second question, Kambiz, Zadar, L606.

Speaker Change: So we've seen the competitors struggle to convert patients to their dry powder formulation.

Yeah, just an update there.

Speaker Change: Yeah, thank you. So, you know, we're working diligently to initiate this global study.

Greg Harrison: And then <unk> formulation has persisted longer than then Todd initially.

just to recap, this is the light of summer.

Speaker Change: Could you speak to the patient perspective.

Speaker Change: Sustained Release Formulation of Tree Prostal that we're going to be delivering twice a day. Just to recap, this is a global study with more than 300 patients and more than 20 companies, and we anticipate that we'll be initiating this study by year's end.

Speaker Change: Which into a dry powder formulation and whether you think <unk> will have a stronger case for keeping patients on the DPI formulation than we've seen with Thai base. So how do you think DSS data will help with those arguments.

Roger Jeffs: So that hasn't happened. And the question is why? We think it's formulation driven in that their formulation is part of an aggregated polydisperse formulation on an FTKP backbone, really, and a high resistance device and low flow really doesn't deliver the drug to the lower airway, which is the site of action. So that's completely the opposite of what a print-enabled utrepia is going to achieve, and which is what we've shown in the Ascent study, that patients can tolerate the drug well, they can get to very high doses, and they can get there quickly. So those two points are important in the sense that patients want to feel better, they want to do it on convenient and portable therapeutic modality, and we think utrepia is clearly defined as a differentiated and a better opportunity to do just that.

Speaker Change: Yeah. Good morning. Thanks for the question. So I'll start with an answer and then Rajiv if you give your thoughts as well I think it would be helpful.

Thank you.

Thank you.

Speaker Change: Our next question comes from the line of Greg Harrison of Scotiabank. Your line is now open.

Speaker Change: So.

Rajiv: Again, I think I think you are right its surprising that there remain residual nebulizer.

Speaker Change: I think it's about 31% of the script today.

Greg Harrison: Hey, good morning, guys. Congrats on the progress and thanks for taking the question.

Speaker Change: When all costs, including the competitors thoughts initially where that all patients with transit transition to the DPI for portability.

Thank you. Thank you.

Greg Harrison: So we've seen the competitor struggle to convert patients to their drive powder formulation and their nebulized formulation is persisted longer than Thab initially.

Speaker Change: So that hasn't happened and then the question is why.

Speaker Change: We think its formulation driven and that their formulation as part of the aggregated palliative.

Greg Harrison: Could you speak to the patient perspective on switching to dry powder formulation and...

Roger Jeffs: So I think what we'll do in the marketplace first is go after new patient starts to let physicians experience the benefits of utrepia firsthand, and then once they're comfortable with that, then we'll see if they will transition, particularly their nebulized patients who are going to be looking for an alternative, more portable therapy. And then also I think it becomes a question of would you even start Tyveso DPI, or if you're on Tyveso DPI, would you want to transition? And as Rajeev just said in the previous question, we're going to have data directing to the specifics of how you transition and the benefits of doing the same.

Speaker Change: Holly disbursed formulation on the F T K P backbone really and a high resistance device and loan flow really doesn't deliver the drug to lower airway, which is the site of action. So.

Greg Harrison: and whether you think he trepia will have a stronger case for keeping patients on a DPI formulation than we've seen with Taipei so, and how do you think the assent data will help with this argument?

Speaker Change: And that is completely the opposite of what a print enabled to Trump is going to achieve and which is what we've shown in the essence study.

Speaker Change: Okay, good morning, great. Thanks for the question. So I'll start with an answer and then with you all, give your thoughts as well. I think I'll be helpful.

Speaker Change: So that patients can tolerate the drug well they can get to very high doses and then they can get there quickly. So those two points are important in the sense. It may just want to feel better they want to do it on convenient portable their therapeutic modality and we think each rep is clearly defined as a differentiator and a better opportunity to do just that so I think.

Speaker Change: So, you know, again, I think you are right. It's surprising that there are remain residual nebulous type ace of patient base. I think it's about 31% of the scripts today.

Speaker Change: when all thoughts, including the competitors thoughts initially, were that all patients would transition to the DPI for portability results alone. So that hasn't happened, and the question is why?

Rajeev Saggar: So we're really excited about all of the market opportunity, but I do agree that the nebulized Tyveso retained commercial share is at risk, and we're going to go after that in time.

Speaker Change: What we'll do in the marketplace versus go after a new patient starts to like to let physicians experienced the benefits to be choppy. It firsthand and then once they are comfortable with that and then we'll see if they will transition, particularly their nebulize patients who are going to be looking for an alternative more portable therapy and then also I think it becomes a question.

Speaker Change: We think it's a formulation driven in their formulation, it's part of an aggregated polydisperse formulation on an FDKP backbone.

Rajeev Saggar: So Rajeev, do you have any thoughts? Yeah, thanks, Roger. I think, again, just highlighting, I think we believe in our scientific formulation and our hypothesis that the print formulation with the low-flow resistance device is actually what these patients need. I think from my perspective, I think what's really unique is two things. You know, back when we did the Inspire study in Group 1 PAH, you know, it took a while for patients to titrate up utrepia to get to doses of therapeutic zones. I think what we're seeing now, you know, a few years later, now that we did the first cohort study that we now have fully enrolled, and we're going to showcase that data at ATS, is that not only can we titrate doses to above the sort of traditional 9 to 12 breaths, you know, we're dosing these to, you know, at least two-fold levels higher than what traditionally is given by Tyrevesa, but we can do it in a matter of just, you know, several weeks, not, you know, over a course of a year.

Speaker Change: Really and a high resistance device in low flow really doesn't deliver the drug to lower airway which is the site of action so.

Speaker Change: You may even start to have a say a DPI or have your own <unk> DPI would you want to transition and as Rajiv just said in the previous question, we're going to have data directed directing to the specifics of how you transition and the benefits of doing so.

Speaker Change: That's completely the opposite of what a print and nail with your trapeze is going to achieve and which is what we've shown in a sense study

Speaker Change: that patients can tolerate the drug well. They can get to very high doses and they can get there quickly. So those two points are important in the sense that

Speaker Change: We're really excited about.

Speaker Change: Patients want to feel better, they want to do it on convenient and portable therapeutic modality, and we think Utrepia is clearly defined as a differentiated and a better opportunity to do just that. So I think what we'll do in the marketplace first is go out to a new page, starts to

Speaker Change: All of the market opportunity, but I do agree that the net device that they said.

Speaker Change: Retained.

Speaker Change: Commercial share is at risk and we're not going to go after it in time to Rajiv do you have any thoughts.

Rajiv: Yes, Thanks, Roger I think again, just highlighting I think we believe in our scientific.

Like, to let physicians experience the benefits to be trepid your first hand.

Speaker Change: and then once they're comfortable with that, then we'll see if they will transition particularly their nebulized patients who are going to be looking for an alternative more portable therapy.

Speaker Change:

Speaker Change: Formulation and our hypothesis that the print formulation with the low flow.

Speaker Change: Resistance devices actually what these patients need I think from my perspective, I think what's really unique is is two things.

Speaker Change: and then also I think it becomes a question of would you even start TAVSA DPI?

Speaker Change: or if you're on type A to DPI, would you want to transition? And as Rajeev just said in the previous question, we're going to have data directing to the specifics of how you transition and the benefits of doing the same. And so...

Speaker Change: Back when we did the inspire study in group one PIH.

Speaker Change: It took a while for patients to titrate up your trip yet to get to doses.

Rajeev Saggar: And I think that's very important because these patients are extremely sick. They are susceptible to clinical worsening. And finally, inherently, they just have terrible coughs. And one thing, I think, to your question is that the current incumbent's dry powder formulation, I think one of its major limitations is its inability to titrate to the appropriate doses to match the clinical severity of the patient, in part due to cough. And I think one of the things that we are going to continue to highlight, especially at ATS, is just the tolerability profile of utropia seems to be. well well well received by the patients and the practitioners that are participating in the study.

Speaker Change: We're really excited about all of the market opportunity, but I do agree that the Netview by Taipei so retained commercial share is at risk and we're just going to go after some time. So, Rajeev, the Japanese, the thoughts.

Speaker Change: Of therapy.

Speaker Change: <unk> therapeutics zones, I think what we're seeing now few later few years later and now that we did the first cohort study that we know it's fully enrolled and we're going to showcase that data at Ats as that.

Speaker Change: Not only can we titrated doses to above the sort of traditional nine to 12 breads.

Rajeev Saggar: Yeah, thanks, Roger. I think, again, just highlighting, I think we believe in our scientific...

Speaker Change: We're dosing in these two at least twofold levels higher than what traditionally is given by <unk>.

Speaker Change: <unk>, but we can do it in a matter of just several weeks not not over a course of a year and I think that's very important because these patients are extremely sick.

Rajeev Saggar: Resistance, Devices, actually what these patients need. I think from my perspective, I think what's really unique is two things, you know, in back when we did the Inspire Study in Group 1 PAH.

Speaker Change: They they are they.

Rajeev Saggar: You know, it took a while for patients to titrate oputropia to get to doses.

Speaker Change: They are susceptible to clinical worsening and finally inherently they just have terrible costs and one thing I think to your to your question is that the current incumbents dry powder formulation I think one of its major limitations. It is it's it's inability.

Rajeev Saggar: So I think using that that signal and re-showing that in the transition study I think would be would be would be well received by the scientists. Great. Thank you, Rajeev. I think your comments speak to the snippets of, you know, why we're so excited about the pending.

Titrate to the appropriate doses can match the clinical severity of the patient in part due to cost and I think one of the things that we are going to continue to highlight especially etfs as it is just the tolerability profile if you trip here.

to above the sort of traditional 9-12 breaths.

Operator: Operator, next question. Thank you.

Rajeev Saggar: We're dosing these to at least two full levels higher than what traditionally is given by today, but we can do it in a matter of just several weeks.

Cory Jubinville: Our next question comes from the line of Cory Jubinville of Lakeside Capital. Your line is now open. Thanks for taking our questions and congrats on the progress. So you mentioned earlier in the prepared remarks that you're building out this prescriber support team.

Speaker Change: It seems to be.

Speaker Change: Well, well well received by the patients and practitioners that are participating in the study so I think using that.

Rajeev Saggar: Not, not, you know, over a course of a year and I think that's very important because these patients are extremely sick.

Rajeev Saggar: They are susceptible to clinical worsening and finally inherently they just have terrible cause.

Speaker Change: That signal.

Cory Jubinville: And as we speak to KOLs, in addition to efficacy and tolerability, seems that ease of prescribing also appears to be a major component to their prescription habits. Could you just provide a little bit more detail as to what that support team might look like in their activities and specifically what might you be doing that improves the prescriber experience over what's out there presently and how that compares to potential competitors?

Speaker Change: And re showing that in the transition study I think would be would be would be well received by the scientific community.

Rajeev Saggar: and one thing I think to your question is that the current incumbent's dry powder formulation

Speaker Change: Great. Thank you Rajeev I think you comment speak to the snippets of why we're so excited about the pending launch.

Rajeev Saggar: I think one of its major limitations is its inability to titrate to the appropriate doses to match the clinical severity of the patient.

Speaker Change: Operator next question please.

Speaker Change: Thank you.

Speaker Change: Our next question comes from the line of Corey and Bill of life like site capital. Your line is now open.

Rajeev Saggar: In part, due to cost. And I think one of the things that we are going to continue to highlight, especially at ATSS, is just the tolerability profile if you trepia, seems to be...

Speaker Change: Thanks for taking our questions and congrats on the progress.

Scott Moomaw: And I guess on the patient side, in terms of early patient access, do you have any details about what a potential bridging program might look like if that's in the plans for patients? Yeah, thanks for the question, Cory.

Speaker Change: So you mentioned earlier in the prepared remarks that you are building out this prescriber support team as we speak to in addition to efficacy and Tolerability.

Rajeev Saggar: Well received by the patients and the practitioners that are participating in the study. So I think using that signal and re-showing that in the transition study, I think will be well received by the scientific community.

Scott Moomaw: So we're benefited by having our Chief Commercial Officer, Scott Moomaw on the call. So Scott, if you wouldn't mind addressing the question. Yeah, sure. Good morning. So, you know, the specifics, I think we'll sort of share as we get through and pass approval around the patient support program. But what I would say is, you know, our team has Yeah, over a decade. Most folks have over a decade of experience with troposinol in the various forms, working with especially pharmacies, working with this patient population. And we have a very good understanding of what the needs of the HCPs and the patients are.

Speaker Change: Seems like ease of prescribing also appears to be a major component to their prescription habits could you just provide a little bit more detail as to what that support team might look like in their activities and specifically what what might you be doing that improves the prescriber experience over.

Thank you for your time. Thank you.

Speaker Change: Great, thank you, Rajeev. I think your comments speak to the snippets of why we're so excited about the pending mark.

Speaker Change: Or what's out there presently and how that compares to potential competitors.

Operator, next question please.

Thank you.

Speaker Change: I guess on the patient side in terms of early patient access do you have any details about what a potential bridging program might look like.

Speaker Change: Our next question becomes from the line of Cory Jubinville of Life, Bikeside Capital. Your line is now open.

Speaker Change: If that's in the plans applications.

Speaker Change: Thanks for taking our questions and congrats on the progress. So you mentioned earlier in the prepared remarks that you're building out this prescriber support team. And as we speak to KOL in addition to advocacy and tolerability. Thank you.

Speaker Change: Yes, thanks for the question of course.

Scott Moomaw: So we've built out a program that we think in all respects will be as good as or better than what's on the market right now in terms of the way that these patients have been cared for. Completely understand the point that you raised around, you know, being able to start these patients is what's very important to early success. And we're going to make sure that we have everything in place to make sure that happens. And we look forward to sharing that with you, hopefully after the end of May. Great. Thank you, Scott. Thank you.

Speaker Change: Benefit by having our chief commercial officer, Scott Lamar on the call Scott of human monetizing the questions.

Scott Lamar: Sure good morning.

Scott Lamar: So the specifics I think we'll sort of share as we get through and past approval around the patient support program, but what I would say is our team has.

Speaker Change: Seems that ease of prescribing also appears to be a major component to their prescription habits.

Speaker Change: Could you just provide a little bit more detail as to what that support team might look like in their activities?

Scott Lamar: Yes over a decade, most folks have over a decade of experience with.

Scott Lamar: Coprostanol in the various forms working with specialty pharmacies working with this patient population and we have a very good understanding of what the needs of the Hep's and the patients are so we've built out a program that we think in all respects will be as good as or better than.

Speaker Change: Specifically, what might you be doing that improves the prescriber experience over what's out there presently and how that compares the potential competitors in...

Jason Gerberry: Our next question comes from the line of Jason Gerberry of BofA. Your line is now open. Hey, guys, this is Chi for Jason. Thanks for taking our question. So you have some data presentation at the ATS meeting in a couple of weeks. I'm curious if you can give us an early flavor of these presentations. What's your expectations? And when might we get the full 48-week data from the ASCENT study? Thanks so much. Great.

Speaker Change: You know, I guess on the patient side, in terms of early patient access, do you have any details about what a potential bridging program might look like if that's in the plans for patients?

Scott Lamar: What's on the market right now in terms of the way that these patients have been cared for.

Speaker Change: Yeah, thanks for the question, of course. We're benefited by having our chief commercial officer, Scott Moomaw, on the call. So, Scott, if you would mind addressing the question.

Scott Lamar: Clearly I understand the point that you raised around.

Scott Lamar: Being able to start these patients is whats very important.

Scott Muma: Yes, sure. Good morning. So, you know, specifics, I think we'll sort of share as we get through and pass approval around the patient support program, but what I would say is, you know, our team has...

Scott Lamar: The early success and we're going to make sure that we have everything in place.

Scott Lamar: To make sure that happens and we look forward to sharing that with you hopefully after after the end of May.

Speaker Change: Alright, Thank you Scott.

Scott Muma: Over a decade, most folks have over a decade of experience with Trostano in the various forms.

Rajeev Saggar: Since Rajeev, you're the leading architect of the cohort I study, if you could talk to that. Yeah, thanks. Thanks for that question. I think at this point, you know, obviously we're under embargo to go into the actual details of the study, but essentially we're going to be presenting three posters. Two are specifically related to the SENS study, which we will showcase the first 20 patients that were treated for eight weeks. Remember, these are patients with newly diagnosed PHLD that are now taking utrepia. So we'll showcase a few things, the baseline demographics. We will detail out the tolerability profile of these patients, as well as the dosing characteristics that we're seeing.

Scott Lamar: Thank you.

Speaker Change: Our next question comes from the line of Jason <unk> of Bofa. Your line is now open.

Working with especially pharmacies, working with this patient population.

Scott Muma: and we have a very good understanding of what the needs of the HCPs and the patients are. So we built out a program that we think in all respects will be as good as or better than.

Chi: Hey, guys. This is chi on for Jason Thanks for taking our question.

Speaker Change: So you have some data presentation at Ada.

Speaker Change: <unk> Ats meeting in a couple of weeks.

Scott Muma: What's on the market right now in the terms of the way that these patients have been cared for? We completely understand the point that you raised around being able to start these patients is what's very important to early success and we're going to make sure that we have everything in place.

Speaker Change: Im curious if you can give us an early flavor of these presentations, what's your expectations and when might we get the full 48 week data from the ascend study. Thanks, so much.

Rajeev: Great sense Rajeev, you're the leading architect of the cohort I studied if you could talk to that question yes.

Scott Muma: to make sure that happens, and we look forward to sharing that with you hopefully after the end of May.

Speaker Change: Yes. Thanks. Thanks for that question I think at this point you know obviously were under embargo to.

Great. Thank you, Scott.

Rajeev Saggar: So that's the first thing. The second thing is that we'll finally showcase some exploratory endpoints within the first two posters. The first one being, of course, what happens to their exercise tolerability, which is defined by a six minute walk distance compared to baseline through eight weeks. And the other thing is we're gonna showcase a novel endpoint that's known as cardiac effort. And that will be presented by Dr. Dan LeChant at the University of Rochester. Again, sort of understanding why potentially these patients are showing improvements in their exercise capacity and what are the potential reasons for that and how utrepia is modifying the...

Speaker Change: Go into the actual details of the study, but essentially we're going to be presenting three posters tumors, specifically related to the ascent study, which we will showcase.

Thank you.

Speaker Change: Our next question comes from the line of Jason Gerberry of BIAV. Your line is open.

Speaker Change: The first 20 patients.

Chi: Hey guys, this is Chi on for Jason. Thanks for taking out questions. So you have some data of presentation at the ATS Eating in a couple of weeks.

Speaker Change: That were treated for eight weeks remember these are patients with newly diagnosed ph ILD that are now taking your trip here.

Speaker Change: We will showcase a few things the baseline demographics.

Chi: I'm curious if you can give us an early flavor of these presentations, what's your expectations and when might we get the full 48-week data from the SN study? Thanks so much.

Speaker Change: We will detail out the tolerability profile.

Speaker Change: These these patients as well as well as the dosing characteristics.

Speaker Change: That we're seeing.

Speaker Change: So that's.

Speaker Change: Great, since Rajeev, you're the leading architect of the cohort A study, if you could talk to that question.

Speaker Change: That's the first thing the second thing is that we'll finally showcase.

Speaker Change: Some exploratory endpoints within the first two posters the first one being of course.

Speaker Change: Yeah, thanks. Thanks for that question. I think at this point, you know, obviously we're under embargo to go into the actual details of the study, but essentially we're going to be presenting three posters.

Speaker Change: What happens to their exercise Tolerability, which is defined by six minute walk distance compared to baseline through.

Rajeev Saggar: its performance on the right ventricle.

Speaker Change: Two were specifically related to the Sun Study, which we will showcase.

Rajeev Saggar: The third poster will be presented. Looking at transitioning a patient that was participating in the INSPIRE study who had acutely worsened and was hospitalized, placed on intravenous treprosyl and transitioned to LIQ861 or utrepia, and just highlighting that ability to transition patients from parental therapy back to LIQ861 in that study. So, all in all, we're very excited to again showcase some of these, our product profiles.

Speaker Change: Through eight weeks and the other thing is we're going to showcase our novel.

The First 20 Patients,

Speaker Change: <unk>.

Speaker Change: that were treated for eight weeks. Remember, these are patients with newly diagnosed Ph.L.D. that are now taking utrepia, so we'll showcase a few things, the baseline demographics.

Speaker Change: <unk> endpoint, that's known as <unk>.

Speaker Change: Cardiac effort.

Speaker Change: And that will be presented by Dr. Dan the shine to it.

Speaker Change: University of Rochester.

Speaker Change: Again sort of understanding why potentially these patients are showing.

Speaker Change: We will detail out the tolerability profile of these patients as well as the dosing characteristics that we're seeing.

Speaker Change: Sure.

Speaker Change: Improvements in their exercise capacity in what.

Speaker Change: The potential reasons for that and how you trip years modifying.

Speaker Change: So, that's the first thing. The second thing is that we'll finally showcase...

Speaker Change: The.

Speaker Change: Performance on the right ventricle.

Speaker Change: some exploratory endpoints within the first two posters. The first one being, of course,

Speaker Change: Third poster will be will be presented.

Rajeev Saggar: Thank you, Rajeev. Obviously, the timing of that data... Quite exciting in the fact that it will be presented. literally within a week of a potential approval.

Speaker Change: Okay.

Speaker Change: Looking at transitioning a patient that was participating in the inspire study.

Speaker Change: Who had acutely worsened I was hospitalized placed on intravenous <unk> transitioned to.

Operator: Operator, next question. Great. Thank you.

Speaker Change: and the other thing is we're going to showcase a novel.

Serge Belanger: Our next question comes from the line of Serge Belanger of Needham. Your line is now open. Hi, good morning. A couple of commercial questions.

Speaker Change: <unk> six one of your trip, yes, and just highlighting that safety that ability to transition patients from parental therapy back to back to <unk> six one in that in that study so.

Speaker Change: and that will be presented by Dr. Dan LaShant at the University of Rochester.

Scott Moomaw: The first one, maybe for Roger and Scott, can you just describe the level of awareness of utropia and its differentiating attributes in the group of physicians you'll be targeting upon launch? And secondly, do you expect that there could be some warehouse demand for this product or this is a group of physicians that will likely want to run their own? Internal evaluation before really ramping up usage of uterpia. Yeah, thank you. Thanks for the question, Serge. Scott, maybe you could opine on this. Sure. So on the awareness question, obviously, you know, prior to launch, we're very limited in, you know, what we can communicate from a personal perspective.

Speaker Change: Again, sort of understanding why potentially these patients are showing, you know, improvements in their exercise capacity and what are the potential reasons for that.

Speaker Change: All in all we're very excited to again showcase some of these.

Speaker Change: Our product profiles of Etfs.

Speaker Change: Thank you Rajeev, obviously, the timing of that data.

Speaker Change: and how you trip as modifying its performance on the right ventricle. The third poster will be presented.

Speaker Change: Exciting.

Speaker Change: It will be presented.

Speaker Change: Literally within a week of potential approval.

Speaker Change: Operator next question. Thank you.

Um...

Speaker Change: Thank you.

Speaker Change: looking at transitioning a patient that was participating in the Inspire Study.

Speaker Change: Our next question comes from the line of search a belanger of need him. Your line is now open.

Speaker Change: from who had acutely worsened, and was hospitalized, placed on intravenous, three-prosonal in

Speaker Change: Hi, good morning.

Speaker Change: A couple of commercial questions. The first one maybe for Roger and Scott can you just describe to the level of awareness of <unk> and its differentiating attributes in the.

LIQ861 or UTREPIA.

Speaker Change: and just highlighting that safety, that ability to transition patients from parental therapy.

Scott Moomaw: In fact, nothing. So, but we're looking forward to the launch, and I can guarantee you that we will be loud. The awareness will go up extremely quickly. There is background awareness, you know, due to the medical information we've shared, etc. But once the sales team gets out there, we have a full suite of marketing activities, electronic activities. Our goal is that every HCP who is involved in PH, whether that be PH or PHLD, will be aware and will be able to try it very soon after launch. The second question was about warehousing. I think, you know, I think there might be some of that due to the tolerability issues in the conversation that came up earlier around the nebulized patients.

Speaker Change: back to Elecureate 61 in that study. So all in all, we're very excited to, again, showcase some of these, our product profiles at ATF.

Speaker Change: Group of physicians, you'll be targeting upon launch and secondly, do you expect there could be.

Speaker Change: Some warehouse demand for this product or.

Speaker Change: This is a group of physicians that will likely want to run their own.

Speaker Change: Thank you, Rajeev. Obviously, the timing of that data is quite exciting and the fact that it will be presented literally within a week of potential approval.

Speaker Change: Internal evaluation before really ramping up usage of neutropenia.

Speaker Change: Yes. Thank you. Thanks for the question Scott, maybe if you can opine on that.

Operator, next question, right. Thank you.

Thank you.

Scott Lamar: Sure. So on the awareness question, obviously prior to launch we are very limited.

Speaker Change: Our next question comes from the line of Serge Belanger of Needham. Your line is now open.

Speaker Change: What we can communicate.

Speaker Change: Hi, good morning. A couple of commercial questions. The first one made for Roger and Scott, can you just describe the level of awareness of utropia and its differentiating attributes in the...

Speaker Change: Perspective in fact nothing.

But we're looking forward to the launch and I can guarantee you that we will be loud.

Scott Moomaw: Certainly, as Roger has said, I think even earlier in this call, we'll be focused on new patients, because those are the patients that give the physician really the best, you know, opportunity to try the drug in sort of a clean way. Having said that, we have heard from a number of physicians that they have patients that have transitioned back to the nebulized version of Tyvaso, and I think we all understand that that's not optimal from a convenience standpoint and a dosing standpoint. And so we will get some of those. We will work with those positions to make sure that those are successes.

Speaker Change: The awareness will go up extremely quickly.

Speaker Change: His background awareness due to the medical information, we've shared et cetera, but once the sales team gets out there we have a full suite of marketing activities electronic activities. Our goal is that.

Speaker Change: Group of Physicians, you'll be targeting upon launch, and secondly, do you expect there could be some warehouse demand for this product, or this is a group of physicians that will likely want to run their own?

Speaker Change: Every <unk>.

Speaker Change: HCP, who is involved in th whether that be PHP <unk> ph ILD.

Internal Evaluation before really ramping up usage of Utopia. Thanks.

Speaker Change: We'll be aware and we'll be able to try it very soon after launch.

Speaker Change: The second question was about warehousing I think I think there might be some of that due to the tolerability issues and the conversation that can't that came up earlier around the nebulizer patients.

Scott Muma: Yeah, thank you. Thanks for the question, Serge. Scott, maybe you could apply it on this.

Roger Jeffs: But strategically, you know, the patients that we'll be going after, first and foremost, will be those patients that are new to processing. Yeah, thanks.

Scott Muma: Sure. So on the awareness question, obviously, prior to launch, we're very limited in

Speaker Change: Certainly as Roger has said I think even earlier in this call will be focused on new patients because those are the patients that gives us a position really the best.

Scott Muma: You know, what we can't communicate with the perspective, in fact nothing.

Roger Jeffs: And I think, Serge, one way to look at this is that there's been almost three phases of how we integrate Utrecht into the standard of care. And I do think we can change the paradigm that currently exists and become the process like on the first and best choice. So I think we'll do the new patient starts, then we'll do the transitions. And then, you know, if you just said, what's the current inhaled triprostano market, that's a $2 billion market opportunity and growing significantly still. With the sort of white space that remains in PHILD. But then the other $2 billion today market opportunities, the oral prostacyclines, both of Travian and Renatran enjoy.

Scott Muma: So, but we're looking forward to the launch and I can guarantee you that we will be loud.

Speaker Change: <unk>.

Speaker Change: <unk> to try the drug and sort of a clean way, having said that we have heard from a number of physicians that they have patients that have transitioned back to the nebulizer.

Speaker Change: Version of <unk>. So I think we all understand that that's not optimal from a convenience standpoint, and the dosing standpoint. So we will get some of those we will work with those physicians to make sure that those are successes.

Scott Muma: HDP, who is involved in PH, whether that be PH or PHLD, we'll be aware and we'll be able to try it very soon after launch.

Speaker Change: But strategically the patients that will be going after first and foremost will be those patients that are new to prostacyclin.

Scott Muma: The second question was about warehousing. I think, you know, I think there might be some of that due to the tolerability issues in the conversation that came up earlier around the nebulized patients.

Roger Jeffs: And, you know, I don't think there's been any counter detailing against those products to date. And we certainly are going to do that because they have significant off target effects. There's quite a some duress that the patients have to undergo to get to therapeutic doses and be maintained on those therapies that we think we can solve for. Because now for the first time, there's a readily titratable and durable inhaled prostacycline called Utrechia. So, you know, those those different promotional cadences will happen at different paces. But I think collectively we're going to integrate ourselves across all of that.

Speaker Change: Yes, Thanks, and I think one way to look at this as the B.

Speaker Change: Almost three phases of how we.

Greg Harrison: Greg <unk> dropping into the standard of care and I do think we can change the paradigm that currently exist and become the prostacyclin are first and best choice. So I think we'll do the new patient starts then we'll do the transitions and then if you just said what's the.

Scott Muma: Certainly, as Roger has said, I think even earlier in this call, we'll be focused on new patients because those are the patients that give the physician really the best opportunity to try the drug and sort of a...

Speaker Change: Current inhaled coprostanol market, Thats, a $2 billion market opportunity and growing significantly still in with the sort of white space that remains in ph ILD.

Scott Muma: a clean way. I haven't said that. We have heard from a number of physicians that they have patients that have transitioned back to the nebulized.

Scott Muma: version of Taipei so, and I think we all understand that that's not optimal from a convenience standpoint and a dosing standpoint. So we will get some of those, we will work with those positions to make sure that those are successes, but strategically, you know, the patients that will be going after, first and foremost, will be those patients that are new to process cyclones.

Speaker Change: And then the other 2 billion today market opportunities the oral prostacyclin <unk> enjoy.

Roger Jeffs: So, you know, so when you look at what's the current market opportunity, it's really $4 billion and growing. And I think, you know, there's opportunity for us to be very successful. We don't necessarily need to take incumbent share, but I think over time that will happen.

Speaker Change: I don't think theres been any counter detailing against those products to date and we certainly are going to do that because they have significant off target effects.

Speaker Change: There is quite some.

Speaker Change: Some duress that the patients have to undergo to get two therapeutic doses be maintained on those therapies that we think we can solve for because now with us for the first time, there is a readily titratable and durable inhaled.

Speaker Change: This is a production of WXXI. Thank you for watching. This is a production of WXXI.

Operator: Operator, may I have your time please? One more question if you have any.

Ryan Deschner: Thank you. Our last question comes from the line of Ryan Deschner of Raymond James.

Ryan Deschner: Your line is now open. Good morning. I'm curious on what you're anticipating in terms of the split between commercial and public payers in PAH and PILD, and was wondering if you could just quickly walk us through the important points of the 494 patent infringement suit that you recently filed. Thank you.

Speaker Change: Prostacyclin Kottke trucking so.

Prostus Lycona, first and best choice.

Speaker Change: It does.

Speaker Change: So I think we'll do the new patient starts, then we'll do the transitions, and then, you know, if you just said, what's the current and hailtroprocental market, that's a two-billion market opportunity and growing significantly still with the sort of white space that remains in Ph.I.L.D.

Speaker Change: <unk>.

Speaker Change: Promotional cadences will happen at different paces, but I think.

Speaker Change: Collectively we're going to integrate ourselves across all of that so.

Speaker Change: So when you look at what's the current market opportunities really for $1 billion and growing and I think there's an opportunity for us to be very successful, we don't necessarily need to take incumbent share, but I think over time that will happen.

Speaker Change: But then the other two billion today, market opportunities, the oral cross-discipline, both of Trabi and the Renatron enjoy. And, you know, I don't think there's been any counter detail in against those products today, and we certainly are going to do that because they have significant off-target effects.

Scott Moomaw: Yeah, so Scott, if you'll answer the first part of that, and then Rusty, you'll talk about 494 litigation. Yeah, from a pay rate standpoint, looking at the process cycling market and Tyvasia specifically, we think we'll probably have about 50% Medicare, about 35% commercial, maybe 10% Medicaid, and then 5% other whether that be TRICARE, you know, DOD, etc. So, you know, we'll see when we get out there, but that that seems to be what we're expecting.

Speaker Change: Operator, Thank you Tom for one more question if you have any.

Speaker Change: Thank you.

Speaker Change: Sure.

Speaker Change: Our last question comes from the line of Ryan Deschner of Raymond James Your line is now open.

Speaker Change: There's quite some duress that the patients have to undergo to get to therapeutic doses and be maintained on those therapies that we think we can solve for, because now, for the first time, there's a readily titratable, endureable, inhaled...

Speaker Change: Good morning.

Speaker Change: Curious on what you are anticipating in terms of the split between commercial and public payers NBA <unk> and I was wondering if you could just quickly walk us through the important points of the 49 four patent infringement suit that you recently filed thank you.

process cyclin called utrepia. So, you know, those, those

Rusty Schundler: And Ryan, thanks for the question on the 494 lawsuit. So, you know, we're not really going to comment much on that. I mean, obviously, we filed the lawsuit. You know, I think the complaint sets forth pretty clearly, you know, our thoughts as to the grounds on which we're proceeding with an infringement lawsuit. You know, that case is in the very early stages. So, again, can't really comment on timing and, you know, typical with past practice won't comment, you know, publicly on legal theories or legal strategies we're going to pursue in the case. Great.

Speaker Change: and different promotional cadences will happen at different paces, but I think collectively we're going to integrate ourselves across all of that. So when you look at what's the current market opportunity, it's really 4 billion in growing. And I think there's opportunity for us to be very successful. We don't necessarily need to take income and share, but I think over time that will happen.

Speaker Change: Yes, so Scott if youll answer the first part of that and then you can talk about four nine for litigation.

Speaker Change: Yes from a payback standpoint, looking at the prostacyclin market and.

Speaker Change: Specifically, we think we'll probably have about 50% Medicare about 35%.

Speaker Change: Commercial.

Speaker Change: 10%.

Speaker Change: operator, major time, one more question, if you have any. Thank you.

Speaker Change: Medicaid and then 5% other whether that'd be tri care Vod et cetera. So.

Scott Moomaw: Thank you, Scott. Thank you, Ryan, for the question.

Speaker Change: We will see when we get out there, but that seems to be what we're expecting.

Speaker Change: Our last question comes from the line of Ryan Deschner of Raymond James, your line is now open.

Roger Jeffs: So with that, we'll close. And, you know, as you can see, we're very excited about actually matriculating our mission and vision of delivering a new treatment modality to patients with PH and PHLD. And hopefully, as May 24th approaches, we'll be in touch and speaking with you all very soon.

Speaker Change: And.

Thank you. Thank you. Thank you.

Ryan Deschner: Good morning. I'm curious on what you're anticipating in terms of the split between commercial and public payers, NPA, H-P-A-H, N-P-I-L-D, and I was wondering if you could just quickly walk us through the important points of the 4-9-4 patent infringement suit that you reasonably file. Thank you.

Brian: Brian Thanks for the question on the final report of lawsuits.

Brian: We're not really going to comment much on that I mean, obviously, we filed the lawsuit I think the complaint sets forth pretty clearly.

Operator: Thank you for your time this morning. Thank you for your participation in today's conference.

Brian: Our thoughts as to the grounds on which we're proceeding with an infringement lawsuit that.

Brian: That cases in the very early stages. So again I can't really comment on timing and then typical with best practice won't comments.

Operator: This does conclude the program.

Speaker Change: Yeah, so Scott of you'll answer the first part of that and then rest you go talk about the 494 litigation.

Operator: You may now disconnect.

Brian: Beyond on legal theories your legal strategy is we're going to pursue in the case.

Speaker Change: Great. Thank you Scott.

Speaker Change: Thank you Brian for the question so with that we'll close.

Speaker Change: Commercial, maybe 10% Medicaid, and then 5% other whether that be tri-care, you know, DOD, etc. So, you know, we'll see when we get out there, but that seems to be what we're expecting.

Speaker Change: As you can see we're very excited.

Speaker Change: About actually matriculate in our mission and vision of delivering a new treatment modality to patients with ph in ph ILD.

Speaker Change: And hopefully the SMA twenty-fourth approaches will be in touch and speaking with you all very soon thank you for your time this morning.

Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Speaker Change: You know, we're not really going to comment much on that. I mean, obviously, we filed the lawsuit. You know, I think the complaint sets forth pretty clearly. You know, our thoughts is to the grounds on which we're proceeding with an infringement lawsuit.

Michael Kaseta, Jason Adair, Russell Schundler, Roger Jeffs

Speaker Change: Great. Thank you, Scott. Thank you, Ryan, for the question. So with that, we'll close. And you know, as you can see, we're very excited about actually matriculating our mission and vision of delivering a new treatment modality to patients with pH and Ph.L.D. and hopefully, S.M.A. 24th approaches will be in touch in speaking with you all very soon. Thank you for your time this morning.

Speaker Change: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Speaker Change: Matthew Kaplan, Serge Belanger

What's it Like to Be

and Richard Pillard as collaborators and coaches.

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Speaker Change: [music].

Speaker Change: [music].