Q1 2024 Liquidia Corp Earnings Call

May 14, 2024

Operator: Good morning and welcome everyone to the Liquidia Corporation First Quarter 2024 Financial Results and Corporate Update Conference Call. My name is Michelle, and I'll be your conference operator today. Currently, all participants are in listen-only mode.

Good morning, and welcome everyone to the liquidity of Corporation first quarter 2024 financial results and corporate update conference call. My name is Michelle and I'll be your conference operator today.

Speaker Change: Currently all participants are in listen only mode.

Operator: Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer. Thank you, Michelle.

Speaker Change: Following the presentation, we will conduct a question and answer session and instructions will be provided at that time for you to queue up for questions.

Speaker Change: Like to remind everyone that this call.

Michelle: Is being recorded I.

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

Jason Adair: It's my pleasure to welcome everyone to Liquidia Corporation's first quarter 2024 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Operating Officer, and CFO, Michael Kaseta, Chief Medical Officer, Dr. Rajeev Saggar, Chief Commercial Officer, Scott Moomaw, and General Counsel, Rusty Schundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements.

Jason Adair: Thank you Michele it's my pleasure to welcome everyone to the liquidity of corporations first quarter 2024 financial results and corporate update call.

Jason Adair: Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief operating officer, and CFO, Michael <unk>, Chief Medical Officer, Dr. Rajiv <unk>, our Chief Commercial Officer, Scott <unk> and General counsel roughly similar.

unknown: 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.

unknown: 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.

Company Representative: For additional information, including a detailed discussion of our risk factors. Please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website.

Jason Adair: These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I would now like to turn the call over to Roger for our prepared remarks, after which he'll open the call to your questions. Thank you, Jason. Good morning, everyone, and thank you for joining us today.

Roger A. Jeffs: I would now like to turn the call over to Roger for our prepared remarks, after which we'll open the call for your questions.

Roger: Thank you Jason.

Roger: Good morning, everyone and thank you for joining us today and the nine weeks since our last earnings call. We have continued to advance what we believe will be the industry, leading portfolio of <unk> products neutropenia.

Roger A. Jeffs: In the nine weeks since our last earnings call, we have continued to advance what we believe will be the industry-leading portfolio of inhaled drug processing oil products. Utrepia, our dry powder formulation of Trapasinil, currently awaits final FDA approval to treat both pulmonary hypertension, arterial hypertension, or PAH, and Pulmonary Hypertension Associated with Interstitial Lung Disease, or PHILD. We have continued to optimize our commercial preparations in anticipation of potential FDA final action and launch. In the clinic, we are seeing encouraging initial data from our central nervous system utrepia and PHILD. In addition, our sustained release liposomal formulation of troposinil, L606, also continues to generate encouraging data in our open-label safety study in both PH and PHILD patients.

Roger: <unk>, our dry powder formulation of <unk> personnel currently await final FDA approval to treat the pulmonary hypertension arterial hypertension or ph.

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

Roger: We have continued to optimize our commercial preparations in anticipation of potential FDA final action and launch in.

Speaker Change: In the clinic, we are seeing encouraging initial data from our <unk> trial would be trivia in ph ILD. In addition, our <unk>.

unknown: <unk> released liposome formulation of <unk>.

Speaker Change: <unk> hundred six also continues to generate encouraging data in our open label safety study in the ph in ph ILD patients.

Roger A. Jeffs: Rajeev and Rusty will provide updates in greater detail on the clinical, regulatory, and legal fronts in a moment. But first, I think it is important to reflect on what is happening in the market and why we are so committed to these programs and the patients we seek to treat. We believe the market for inhaled triprosanone, PAH, and PHLE can eclipse $3 billion at peak sales. And this is validated by Tevesa's total current annual run rate of approximately $1.5 billion, which continues to grow at an appreciable rate.

Rajeev: Rajeev and rescue will provide updates in greater detail on the clinical regulatory and legal front in a moment, but first I think it is important to reflect on what is happening in the market and why are we still committed to these programs patients we seek to treat.

Roger A. Jeffs: His growth is driven by the expanded PHLD market, which is only marginally penetrated at this time, along with the availability of the more portable dry powder inhaler option. However, what we also see in our competitive sales data is continued unmet need. In our study of utrepia, 100% of patients who transitioned to utrepia from divasive preferred utrepia after four months of use. Yet, approximately 40% of uterus sales continue to come from nebulized tybaso with its bulky, challenging, and dose-limiting nebuli.

Speaker Change: We believe the market for <unk> ph in ph ILD can eclipse $3 billion at peak sales.

Rajeev: And this is validated by 10 basis current total current annual run rate of approximately $1 5 billion.

Rajeev: Which continues to grow at an appreciable rate.

Rajeev: This growth is driven by the expanded <unk> market.

Speaker Change: Which is only marginally penetrated at this time.

Speaker Change: Along with the availability of the more affordable dry powder inhaler option.

Speaker Change: However, what we also see in our competitive sales data is continued unmet need.

Rajeev: Our steady future.

Speaker Change: Percent of patients who transition to your Trump yet from today is that preferred would be truck after four months of use.

Speaker Change: Yes, approximately 40% of user sales continued to come from <unk> <unk> with its bulky challenging and dose limiting nebulizer.

Roger A. Jeffs: We do not have any direct knowledge of the totality of issues that may be preventing a more complete conversion of patients from Tyvaso to Tyvaso DPI, but the continued prevalence of Tyvasive seems illogical, given the clear portability and use advantages of the DPI.

Speaker Change: We do not have any direct knowledge of the totality of the issues that may be preventing a more complete conversion of patients from today, So database of DPI.

Speaker Change: But the continued prevalence of tight today, so it seems illogical given the clear portability and use advantages of the DPI.

Speaker Change: In this regard data from the National Jewish pulmonary hypertension program, maybe broadly and informative in September. These experts presented a single center prospective observational study in patients with ph ILD, who initiated untrusted Charterhouse genome DPI.

Roger A. Jeffs: 69% of these patients discontinued this treatment after a mean of only 78 days or a median of 40 days. Of importance, 11 or 42.3% of these patients transitioned to the Tyveza nebulizer upon discontinuation of DPI therapy. This is highly consistent with our competitor sales data, highlighting that nearly 40% of its patient base continues to use the more cumbersome nebulizer for type A cell administration. From our perspective, clearly it is not the molecule troposinol, but rather the limitation of the formulation and the very high resistance DPI utilized with divasive DPI, especially when treating patients with lung impairment in PHILD.

Speaker Change: Of the 26 patients with ph ILD initiated arent tied they said epi.

Speaker Change: 69% of these patients tend to discontinue this treatment after a main at only 78 days, our median of 40 days.

Experts: The importance 11, or 42, 3% of these patients transitioned to the <unk> nebulizer upon discontinuation of DPI therapy.

Speaker Change: This is highly consistent with our competitors' sales data.

Speaker Change: Highlighting that nearly 40% of its patient base continues to use the more cumbersome nebulizer for 10 days of administration.

competitors: From our perspective, clearly it is not the molecule <unk>, but rather the limitation of the formulation and the very high resistance DPI utilized with ebay seller DPI, especially when treating patients with lung impairment in ph ILD.

Roger A. Jeffs: That's why we believe that physicians and patients are eager for a new choice, one that delivers a readily titratable and durable inhaled formulation of traprosanol using a portable, patient-friendly, low-resistance dry bowel inhaler with demonstrated high patient preference and satisfaction.

Company Representative: That's why we believe that physicians and patients are eager for a new choice one that delivers a readily titratable and durable inhaled formulation of <unk> using a portable patient friendly growth.

Speaker Change: Low resistance dry powder inhaler with demonstrated high patient preference and satisfaction.

Roger A. Jeffs: Utrepia is that choice and has the very real potential to become the first in choice in best-in-class process cycling in this growing market opportunity. With that, I'd like to ask Rajeev to share more about FDA interactions and our observations in the ongoing clinical studies with utrepia and L6S6.

Speaker Change: Is that choice and has the very real potential to become the first in choice and best in class Prostacyclin in this growing market opportunity.

Rajiv: With that I'd like to ask Rajiv to share more about FDA interactions and our observations in the ongoing clinical studies with you trap yet announced success.

Rajeev Saggar: Six Essex Rajiv.

Rajeev Saggar: Thanks, Roger. I'd like to address three of the most common questions I have received related to our program. First, where does the FDA stand in its review of Utrecht? Second, what observations are emerging from the ASCENT trial, our open-label study of utrepia in PHILD patients? to better understand dosing and antitration in that patient population. And third, when can we expect to see more data on the L606 program? I will take each one in turn.

Rajeev Saggar: Thanks, Roger I'd like to address three of the most common questions I've received related to our programs.

Rajeev Saggar: First where does the FDA stand in its review of your trip here.

Rajeev Saggar: What observations are emerging from the ascent trial. Our open label study of your trip yet in ph ILD patients to better understand dosing and titration in that patient population and third when can we expect to see more data on the <unk> six.

Speaker Change: <unk> hundred six program I will take each in turn.

Rajeev Saggar: Regarding the first question, while we cannot speak to a specific action date, the FDA's Review Division has maintained an active dialogue with Liquidia on the development of Utrecht since it entered the clinic as a first-drive powder formulation or tree process. During the course of its review of the NDA for PAH, the FDA has confirmed multiple times over the last three years that submitting an amendment to the NDA would be an appropriate way to add PAH.

Speaker Change: Regarding the first question, while we cannot speak to a specific action date Fda's Review Division has maintained an active dialogue with the <unk>.

Speaker Change: The development of neutropenia since it entered the clinic as the first dry powder formulation of <unk>.

Speaker Change: During the course of its review of the NDA for <unk>. The FDA has confirmed multiple times over the last three years Thats submitting an amendment to the NDA would be inappropriate way to add ph.

Rajeev Saggar: PHILD Indication. Also, throughout this process, the FDA consistently affirmed that no additional clinical data would be required to add the PHILD indication. We are disappointed that the FDA did not issue an action letter promptly following the expiration of the March 31st Clinical Investigation Exclusivity Granted to TAVESA to Treat PHLD.

FDA: Ph ILD indication.

FDA: Throughout this process the FDA consistently affirmed at no additional clinical data would be required to add the ph ILD indication.

Speaker Change: We are disappointed that the FDA did not issue an action letter promptly following the exploration of the March 31.

<unk>: Clinical investigation exclusivity granted to <unk> to treat ph L D.

Rajeev Saggar: Nevertheless, we remain hopeful that the FDA will issue final action very soon, given the lack of any legal barriers to our approval. Regarding the second question, we initiated the Open Label Assent Trial in late December to help physicians understand the safety, tolerability, and titratability of utropia in patients with PHLD. We have enrolled seven patients to date and have several additional sites initiating the study over the next 30 days. Of the seven patients, the median dose was 106 micrograms during week 4 and 132.5 micrograms during week 8, which is comparable to nebulized tybaso of about 12 to 15 breaths per session, respectively. The highest dose of utrepia achieved to date in the study is 318 micrograms, which is at least 36 breaths per session of tibetanibiline.

Speaker Change: Nevertheless, we remain hopeful that the FDA will issue final action very soon given the lack of any legal barriers to approval.

We: Regarding the second question, we initiated the open label are set trial in late December to help physicians understand the safety Tolerability and titrated ability of your trip young patients with ph ILD.

Speaker Change: We have enrolled seven patients to date and have several additions additional sites initiating that study over the next 30 days.

Speaker Change: Of the seven patients. The median dose was 106 micrograms during week, four and $132 five micrograms during week, eight which are comparable to nebulize Tobey so of about 12 to 15 breath precession respectively.

Joseph: Highest Joseph <unk> achieved to date in this study is 318 micrograms, which is at least 36 breaths per session of today's the nebulizer.

Rajeev Saggar: While early and a small sample size, we are encouraged by the tolerability and titratability profile in patients with PHLD and remain confident that we can complete enrollment of the study by the end of the year. We look forward to presenting more robust clinical data at a future medical conference later this year. Finally, regarding the third question, next week at the American Threat Society conference, we will present an abstract focusing on the clinical data of our liposomal sustained release formulation of triprocinol L6-O6 from the open-label safety study in the first 24 patients enrolled with PAH and PHILD.

Joseph: While early in the small sample size, we are encouraged at the Tolerability anti trade ability profile in patients with ph ILD and remain confident that we can complete enrollment of the study by the end of the year.

Speaker Change: We look forward to presenting a more robust clinical data at a future Medical conference later this year.

Speaker Change: Finally regarding the third question next week at the American Thoracic Society Conference we.

He: He will presented an abstract focusing on the clinical data of our life of Somal sustained release formulation of <unk> <unk> from the open label safety study in the first 24 patients enrolled with PIH in ph ILD.

Rajeev Saggar: We continue to observe a favorable tolerability and titratability profile of L606 given the 7-fold lower Cmax and twice daily dosing using a rapid breath-accentuated nebulizer. To date, patients have titrated to our maximum dose allowed in the study of 378 micrograms twice daily, a dosage that would be comparable to 26 to 28 breaths of Tebaso nebulized administered four times

He: Continue to observe a favorable tolerability and titrate ability profile with all 606, given the seven fold lower C. Max and twice daily dosing using a rapid breath accentuated nebulizer.

Speaker Change: To date patients have titrated to a maximum dose allowed in the study of 378 micrograms twice daily.

Speaker Change: Dosage that would be comparable to 2006 to 28 breath of TB. So nebulizer administrated administered four times daily.

Rajeev Saggar: We will publish the poster on our website once presented and look forward to discussing the observation in future calls. In addition, we are vigorously engaging in startup activities to enable initiation of our Phase 3 Randomized Controlled Study. The single, pivotable study will enable indications to treat both PHLD and PAH.

Speaker Change: We will publish the posted to our website once presented and look forward to discussing the observation in future calls. In addition, we are vigorously engaging and startup activities to enable initiation of our phase III randomized controlled study.

Speaker Change: A single pivotal study will enable indications to treat both.

Speaker Change: Aldi and PIH.

Rusty Schundler: Physician interest globally is robust, and we look forward to interacting with regulatory agencies in the next few months as we prepare to initiate the study later this year. At this time, I would like to ask Rusty to summarize the recent legal actions of the last few months. Rusty?

Speaker Change: Physician interest globally is robust and we look forward to interacting with regulatory agencies in the next few months as we prepare to initiate the study later this year.

Speaker Change: At this time I would like to ask Rusty to summarize the recent legal actions over the last few months.

Speaker Change: <unk>.

Rusty Schundler: Thank you, Rajeev. The first quarter of 2024 saw significant progress on the legal front. This is the first earnings call in which we can say that there are no legal barriers preventing the FDA from issuing a final action on the amended NDA for Utrecht. The combination of district court, PTAB, and federal circuit rulings led to the removal of the previous injunction issued in 2022.

Rusty: Thank you Rajeev.

Rajeev Saggar: The first quarter of 2024 saw significant progress on the legal front. This.

Rajeev Saggar: This is the first earnings call in which we can say that there are no legal barriers preventing the FDA permission. The final action on the amended NDA for you Chuck.

Chuck: The combination of district Court P tab and federal circuit ruling have led to the removal of the previous injunction issued in 2022.

Rusty Schundler: In addition, United Therapeutics' regulatory exclusivity tied to PHLD expired on March 31st. Thus, since April 1st, the FDA has had the legal authority to take final action on our NDA for each. While we cannot comment on whether the FDA will take that final action, we can clarify the status of two ongoing lawsuits brought by United Therapeutics against Liquidia and the FDA, each with the same intent to stop the launch of utrepia and PHLD. Neither of these lawsuits currently impact the FDA's ability to approve utrepia for both indications. And even in the worst case, neither lawsuit will ultimately impact our ability to treat PAH.

Chuck: In addition, United Therapeutics regulatory exclusivity tied to ph ILD expired on March 31.

Roger A. Jeffs: Thus since April one the FDA has had the legal authority to take final action on our NDA for your trip yet.

Roger A. Jeffs: While we cannot comment on when the FDA will take that final action. We can clarify the status of two ongoing lawsuits brought by United Therapeutics against liquidity and the FDA each with the same intent just lap the launch of <unk> in ph ILD.

Roger A. Jeffs: Neither of these lawsuits currently impact the fda's ability to approve your trip via for both indications and even in the worst case, neither lawsuit will ultimately impact our ability to treat <unk> patients.

Rusty Schundler: In the first of these lawsuits, United Therapeutics filed a lawsuit alleging infringement of the 327 patent based on our requests for approval of the PHLD indication. In this lawsuit, United Therapeutics filed a motion for preliminary injunction. Judge Andrews in the United States District Court for the District of Delaware heard oral arguments from both parties on April 23rd regarding the motion for preliminary injunction, and may issue a written ruling at any time.

Roger A. Jeffs: And our first of these lawsuits United Therapeutics has filed a lawsuit.

Roger A. Jeffs: Alleging infringement of the 387 patent based on a request for approval of the ph ILD indication.

Roger A. Jeffs: And this lawsuit.

Roger A. Jeffs: <unk> filed a motion for preliminary injunction.

Roger A. Jeffs: Judge Andrews in the United States District Court for the district of Delaware heard oral arguments from both parties on April 23rd regarding the preliminary injunction and May issue, a written ruling at anytime.

Rusty Schundler: We remain confident in our arguments as briefed and argued, and continue to believe there are substantial questions regarding the validity of the 327 patent, which generally covers treatment of THLV patients with Tyvaso in accordance with the Tyvaso label, something that physicians have been doing for more than a decade, as evidenced by multiple publications describing positive results in THLV patients over that period. In the second of these lawsuits, United Therapeutics was seeking to bar the FDA from accepting and approving our amendment to add PHLD to the label for utrepia, pursuant to the Administrative Procedures, Judge Bates in the United States District Court for the District of Columbia rejected United Therapeutics' motion for a temporary restraining order, and Preliminary Injunction on March 29, indicating that the FDA's acceptance of our amendment for review did not constitute final agency action.

Judge Andrews: We remain confident in our arguments has briefed and argued and continue to believe there are substantial questions regarding the validity of $32 seven patents, which generally covers treatment of ph ILD patients with Taipei. So in accordance with the <unk> label something that physicians have been doing for more than a decade as evidenced by multiple publications describing positive results.

Speaker Change: In ph ILD patients over that period.

Speaker Change: And the second of these lawsuits United Therapeutics is seeking to bar the FDA from accepting and approving our amendment ph ILD to the label for your trip yet pursuant to the administrative procedure set.

Speaker Change: <unk> space in the United States District Court for the district of Columbia, rejecting the United Therapeutics motion for a temporary restraining order.

Roger A. Jeffs: And preliminary injunction on March 29th.

Roger A. Jeffs: Indicating that the Fda's acceptance of our amendment for a review did not constitute final agency action.

Rusty Schundler: Judge Bates has retained jurisdiction, though, and ordered the FDA to provide the court and both United Therapeutics and Liquidia notice three days prior to taking any final action on the utrepia NDA. Additionally, last week, both we and the FDA filed motions to dismiss the entire lawsuit in briefing on the motion of dismissal in progress. We remain confident that both that our amendment was properly filed and that United Therapeutics does not have the necessary standing to challenge the FDA's decision.

Speaker Change: <unk> has retained jurisdiction, though and ordered the FDA to provide the court in both United Therapeutics and liquidity I noticed three days prior to taking any final action on the <unk> NDA.

Roger A. Jeffs: Additionally, last week, both we and the FDA filed motions to dismiss the entire lawsuit and briefing on the motion to dismiss is in progress we remain confident that both on the amendment was that both at our amendment was properly filed and United Therapeutics does not have the necessary standing to challenge the Fda's decision.

Rusty Schundler: Our priority has been, and remains, prompt approval of utrepia so that we can make it available to patients. We will continue to vigorously defend our ability to do so. I will now turn the call over to Mike. Thank you, Rusty. And good morning, everyone.

Roger A. Jeffs: Our priority has been and remains prompt approval of your trip yet so that we can make it available to patients. We will continue to vigorously defend our ability to do so.

Speaker Change: I'll now turn the call over to Mike.

Speaker Change: Yes.

Mike: Thank you Rusty and good morning, everyone. We ended the first quarter in the strongest financial position in our company's history not only do we have the cash on the balance sheet to achieve our objectives, but we're also poised to launch into one of the fastest growing rare disease market with what we believe will be a differentiated product for PVH in ph ILD patients.

Michael Kaseta: Not only do we have to cash in on the balance sheet to achieve our objectives, but we're also poised to launch into one of the fastest growing rare disease markets with what we believe will be a differentiated product for PAH and PHILD patients. Our team is fully in place, our commercial inventories are ready and expanding, our relationships with all key stakeholders are sound and active, and our sales team is fully engaged and ready to launch.

Speaker Change: Our team is fully in place our commercial inventories are ready and expanding our relationships with all key stakeholders stakeholders are sound and active and.

Speaker Change: And our sales team is fully engaged and ready to launch we.

Michael Kaseta: We continue to believe that the approval and launch of Utrepia this quarter in both indications will enable a rapid transformation in the company's P&L. Turning to our financial results, which can be found in the press release, you will see that revenue was $3 million for the first quarter of 2024, compared with $4.5 million in the same quarter of 2023. Revenue is tied to our promotion agreement with Sandos to commercialize troprostenol injection. The decrease was primarily due to favorable growth in net rebate adjustments recorded in the prior year and the impact of lower sales quantities in the current year as compared to the same period in the prior year.

Speaker Change: We continue to believe that the approval and launch of your trip here this quarter in both indications will enable a rapid transformation in the company's P&L.

Michael Kaseta: Cost of revenue increased to $1.5 million for the first quarter 2024 compared to $0.7 million in the same quarter for 2020. Cost of revenue relates to our promotion agreement, with the increase being primarily due to our Salesforce expansion during the fourth quarter of 2020, research and development expenses were $10.1 million in the first quarter 2024 compared with $5.3 million in first quarter 23, The increase of $4.8 million, or 91%, was primarily due to a $2 million increase in personnel expenses, which includes stock-based compensation related to higher headcount, and a $1.7 million increase in clinical expenses related to our L606 program.

Speaker Change: Turning to our financial results, which can be found in the press release, you will see that.

Michael Kaseta: Additionally, there was a $1.3 million increase in expenses related to our utrepia program driven by higher clinical and supply expenses related to our assent study. General and administrative expenses were $20.2 million in the first quarter of 2024, compared to $7.8 million in the same quarter of 2020.

Sandoz: Revenue was $3 million for the first quarter 2024, compared with $4 5 million in the same quarter for 2023 revenue was tied to our promotion agreement with Sandoz to commercial to commercialize <unk> injection.

Sandoz: The decrease was primarily due to favorable gross to net rebate adjustments recorded in the prior year and the impact of lower sales quantities in the current year as compared to the same period in the prior year.

Sandoz: Cost of revenue increased to $1 5 million for the first quarter 2024, compared to <unk> 7 million in the same quarter for 2023.

Speaker Change: Cost of revenue relates to our promotion agreement with the increase being primarily due to our sales force expansion during the fourth quarter of 2023.

Speaker Change: Research and development expenses were $10 1 million in the first quarter 2024, compared with $5 3 million in first quarter 'twenty three.

Speaker Change: The increase of $4 8 million or <unk>, 91% was primarily due to a $2 million increase in personnel expenses, which include stock based compensation related to higher head count and a $1 7 million increase in clinical expenses related to our <unk> hundred six program.

Speaker Change: Additionally, there was a $1 $3 million increase in expenses related to our <unk> program, driven by higher clinical and supply expenses related to our offense study.

Speaker Change: General and administrative expenses were $22 million in the first quarter of 2024 compared to $7 8 million in the same quarter for 2023 the.

Michael Kaseta: The increase of $12.4 million was primarily due to increases in legal fees related to our ongoing utrepia-related litigation, increases in personnel expenses, and increases in commercial and consulting expenses in preparation for the potential commercialization of utrepia. In summary, we incurred a net loss for the three months ended March 31, 2024 of $40.9 million, or $0.54 per basic and diluted share, compared to a net loss of $11.7 million, or $0.18 per basic and diluted share for the three months ended March 31, 2020.

Speaker Change: The increase of $12 4 million was primarily due to increases in legal fees related to our ongoing <unk> related litigation increase in personnel expenses and increases in commercial and consulting expenses in preparation for the potential commercialization of <unk>.

Speaker Change: In summary, we incurred a net loss for the three months ended March 31, 2024 up $49 million.

Speaker Change: <unk> <unk> 54 per basic and diluted share compared to a net loss of $11 $7 million or <unk> 18 per.

Speaker Change: Basic and diluted share for the three months ended March 31 2023.

Michael Kaseta: We ended the first quarter with $157.9 million cash on hand, which included $100 million in gross proceeds between a private placement of equity to a single investor and a third advance from healthcare royalty under our. In summary, we are well positioned financially to achieve our corporate objectives in 2020. I would now like to turn the call back over to Mike. Thank you, Mike. Operator, with that, I'd like to now open the call for questions. First question. Thank you. If you'd like to ask a question, please press star 11. If your question hasn't been answered and you'd like to remove yourself from the queue, please press star 11 again.

Speaker Change: We ended the first quarter with $157 $9 million cash on hand, which included $100 million in gross in gross proceeds between a private placement of equity to a single investor and a third advance from healthcare royalty under our agreement.

Roger: In summary, we are well positioned financially to achieve our corporate objectives in 2024, I would now like to turn the call back over to Roger.

Roger: Thank you Mike.

Roger: Operator with that I'd like to now open the call for questions first question. Please.

Operator: Thank you if you'd like to ask a question. Please press star one one if your question has been answered and you'd like to remove yourself from the queue. Please press star one again.

Operator: Our first question comes from Jason Gerberry with Bank of America. Your line is open. It's open.

Jason Adair: Our first question comes from Jason <unk> with Bank of America. Your line is open.

Jason Adair: Hey guys, thanks for taking my questions. I guess just on last week's filing to dismiss by both Uther and the FDA, how quickly do you think? Do you have a sense of how quickly Judge Bates may move here? This seems like maybe the one new variable here. If FDA is being asked to give three days' notice, they don't want to give three days' notice; they want this dismissed. I'm just kind of curious how to put this in the proper context.

Jason Adair: Hey, guys. Thanks for taking my question.

Jason Adair: I guess just on.

Jason Adair: On last weeks.

Jason Adair: Filing to dismiss.

Speaker Change: Both user and.

FDA Representative: The FDA how quickly do you think you have a sense of how quickly judge Bates may move here. It seems like maybe the one new variable here.

FDA Representative: FDA is being asked to give 30 days notice they don't want to get rid of it noticed they want this dismissal I'm just kind of curious how to put this in proper context and then.

Roger A. Jeffs: And then, ultimately, if you're able to secure a broad approval, both PH and PHILD, just wondering if there are any specific label variables you might call out that could really impact the commercial opportunity beyond just getting those two indications, how we might think about the label looking different than Teveso. Thanks. Hey Jason, good morning.

FDA Representative: Ultimately if you are able to secure approval of broad approval, both ph in ph ILD.

Speaker Change: If there are any specific label variables you might call out that could really impact the commercial opportunity beyond just getting those two indications how we might think about the labor looking different.

Speaker Change: Then seveso thanks.

Roger A. Jeffs: Thanks for the question. Maybe I'll take the second question first, if I can, and then I'll ask Rusty to speak about his perspectives around the timing of the Motion to Dismiss case. So, great question, Jason. You know, again, what we talk about with utrepia in terms of being differentiated is around its pillars, which are tolerability, titratability, durability, and usability.

Jason Adair: Hey, Jason Good morning. Thanks. Thanks for the question maybe I'll take the second question first if I can and then I'll ask <unk> to speak about.

Jason Adair: Perspectives around the timing of the.

Jason: Motion to dismiss case.

Jason Adair: So great question, Jason again, what we talked about with each rep in terms of being differentiated are around its pillars, which are tolerability titrated ability durability and usability.

Jason: And all of that is sort of dictated by the print formulation. So again with the ability to make precise and uniform particles in the lower end of the rest of the range allows for highly tolerable tolerable therapy, which is readily titratable.

Roger A. Jeffs: So again, with the ability to make precise and uniform particles in the lower end of the respirable range, it allows for a highly tolerable therapy, which is readily titratable, and then will be durable and usable through the low resistance device, so it is so easy for both PH and PHLD patients to use. The differentiation that we will see in the label in that regard will be specifically related to the exposures that we've seen in our clinical work versus what's in their label. So we will have up to 212 micrograms four times a day as described in our label. So again, we're talking about 24, 25 breath equivalents, so much higher than what's in the Tyvezin DPI.

Jason: And then will be durable and usable through the low resistance device a friendly for both ph ph ILD patients to use.

Speaker Change: The differentiation that we that we will see in the label in that regard will be specifically related to the exposures that we've seen in our clinical work versus what's in their labels that we will have up to 212 micrograms four times a day described in our label.

Speaker Change: Again, we're talking about 2425 breath equivalents, so much higher than what's in the DPI.

Roger A. Jeffs: And as we know from historical standards, across all routes, across the cycle of delivery, dose matters. So the higher the dose and the more flexibility in driving those, the more.., capable that therapy will be. So that's why we think that utrepia has a, will have a clear chance to become best in class and first in choice prostacyclin, not only to compete with inhaled triprosanone in the Tyvaso formats, but also when physicians are seeking to think about starting therapy, we think they should think about using utrepia as the first choice, not, and do that in sort of in place of oral therapies like orenatrium and uptropi.

Speaker Change: And as we know from historical standards across all proud to prostacyclin delivery dose matters. So the higher the dose and then more flexibility and driving because the more.

unknown: Capable that therapy will be so that's why we think that <unk> has a will have a clear chance to become best in class and first in choice prostacyclin.

Speaker Change: Not only to compete with inhaled <unk> personnel and the time, they said formats that also.

Speaker Change: Physicians are seeking to think about starting therapy.

physicians: Think they should think of that using <unk> as the first choice not and do that in sort of in place of oral therapies like <unk>.

Roger A. Jeffs: And then also, in terms of sub-Q, where those patients, you know, are going to have a pretty burdensome time getting to a therapeutic dose of the drug because of the off-target effects of both the oral and the parenteral formulation.

physicians: And then also in terms of sub Q, where those patients are going to have a pretty burdensome time getting two therapeutic doses of drug.

Speaker Change: Because of the off target effects for both the oral and the parental formulations. So.

Rusty Schundler: So, again, tremendous market opportunity. Looking forward to launch, but I think we'll have very clear and distinguishable differentiation at the point of launch. And with that, Rusty, maybe you could speak about the logistics around the legal case. Sure. So, Jason, thank you for the question. The motion to dismiss and briefs that went in last week are the first round of briefs on the motion to dismiss. The briefing will continue through June 25th.

Speaker Change: Tremendous market opportunity.

Speaker Change: Looking forward to launch, but I think what we will have.

Speaker Change: Very clear indistinguishable differentiation pointed launch.

Rusty Schundler: And then from there, you know, we don't have visibility as to what the judge will do and how long it will take him to rule. It's possible that at that point, he'll schedule a hearing, or it's possible he'll just rule on the briefs. But, you know, obviously, federal judges; it's hard to predict exactly how long they will take to issue a ruling.

Speaker Change: And with that rest and maybe if you could speak about the logistics around the legal case sure. So Jason's question. So.

Speaker Change: The motion to dismiss and briefs that went in last week is the first round of briefs on the motion to dismiss.

Speaker Change: Briefing will continue through June 25.

physicians: And then from there we do.

physicians: Not have visibility as to.

physicians: What the judge will do and how long it would take them to rule, it's possible that at that point I will schedule, a hearing or it's possible I will just roll on the briefs, but obviously federal judges its hard to predict exactly how long they would they would take to issue a ruling thank.

physicians: Thank you for the question.

Rusty Schundler: Thank you for the question. And just a reminder, that decision is not needed for the FDA to take final action. I've heard your name, understood.

physicians: And just a reminder.

Rusty: That decision is not needed for the FDA to take final action as Rusty said in his comments.

Rusty: And then kind of a sudden please.

Operator: Thank you. Our next question comes from Julian Harrison with BTIG. Your line is open. Julian Harrison, your line is open.

physicians: Thank you. Our next question comes from Julian Harrison with BTG. Your line is open.

physicians: Okay.

physicians: Julian Harrison your line is open.

Operator: Our next question comes from Serge Belanger with Needham. Your line is open. Hi, good morning.

physicians: Our next question comes from Serge Belanger with Needham Your line is open.

Serge D. Belanger: Thanks for taking my question. I guess the first one, Roger, you mentioned targeting the oral troposomal market. Could you maybe elaborate on that in terms of the market opportunity, and I think this would be another differentiated aspect of Utropia, because I don't think your competitor has positioned their DPI product for that segment. And then, secondly, can you just talk about payer coverage?

Serge D. Belanger: Hi, good morning, Thanks for taking my questions.

Roger: The first one Roger you mentioned.

Serge D. Belanger: Targeting the oral <unk> market if you can.

Serge D. Belanger: Just maybe elaborate on that.

Roger: Terms of the market opportunity and I think this would be another differentiated aspect of neutropenia, because I don't think your competitor is positioned there.

Roger: DPI product for that segment and then secondly can you just talk about payer coverage.

Roger A. Jeffs: In the past, you've highlighted how you're launch-ready, the sales force has been expanded and is in the field, but maybe if you could talk about how quickly you think you can get to that. Utripia on formulary post-approval. Thanks. Yeah, thanks. Great question. So I'll take the first one on how we hope to cannibalize the oral market. And Mike, if you'd talk about the

Roger: I think in the past you've highlighted how you're you are launch ready to Salesforce has been expanded in Europe and are in the fields.

Roger: But maybe if you can talk about.

Roger: How quickly you think you can get.

Roger: [noise] neutropenia on formulary post approval.

Mike: Yes. Thanks, Great question, So I'll take the first one around how we hope to cannibalize the oral market and Mike if you'll talk about the payor.

Roger A. Jeffs: Transcribed by https://otter.ai Both, they're different, they're both process cyclones, different in their sort of mechanistic approach, but Orenotram is difficult to titrate, it takes weeks, if not months, to get to a therapeutic dose, and it causes a lot of off-target GI effects. And those GI effects are the predominant reason that patients discontinue that therapy and then progress UPTRAVI has a pretty tight and narrow dosed titration per, pretty much has a dose ceiling, so patients titrate to their top tolerated dose, and they're held on that dose and then removed from therapy once their disease progresses beyond the capabilities of the dose that they're on, and also comes with off-target effects.

Michael Kaseta: The payer landscape if you will.

Mike: In terms of like oral prostacyclin currently and again these are just sort of generalized estimates.

Michael Kaseta: When the trans doing about 400 million per annum, and <unk> doing about $1 2 billion per annum.

Michael Kaseta: Both they are different they are both prostacyclin is different and they're sort of missing a mechanistic approach, but a rent a trend.

Speaker Change: It's difficult to titrate. It takes weeks, if not months to get to a therapeutic dose causes a lot of off target Gi effects and those Gi effects are are the predominant reason that patients discontinue that therapy, and then progress to other therapies, which in the past typically has been a perennial therapy.

Speaker Change: <unk> has a pretty tightened narrowed does titration curve.

Speaker Change: Pretty much has a dose ceiling so patients titrate to there.

Speaker Change: Top tolerate it does and then are held on that dose and then removed from therapy once they their disease progresses beyond the capabilities of the depths that they're on so.

unknown: And also comes with the off target effects. So we think that we could position you trap, yeah, particularly given its titrate ability. So again, what <unk> has done to the print enabled formulation.

Roger A. Jeffs: So we think that we could position Utrepia, particularly given its titratability, so again, what Utrepi has done through the print-enabled formulation has allowed for a titratable inhaled triprostenone formulation for the first time. So it has a lot more flexibility and can become a much more rigorous and durable choice for physicians and their patients. You asked that, you know, why has United not pointed this out?

Speaker Change: Allowed for.

unknown: Titratable inhaled <unk> formulation for the first time.

unknown: So it has a lot more flexibility and can become.

Speaker Change: A much more rigorous and durable choice for physicians and their patients.

Speaker Change: No.

Speaker Change: Yes.

Speaker Change: <unk> has United not pointed this out well again it might be that they don't quite have the flexibility that we do in terms of dosing. So it has limitations in that regard I think the other aspect here is because they have an oral prostacyclin.

Roger A. Jeffs: Well, again, it might be that they don't quite have the flexibility that we do in terms of dosing. So it has limitations in that regard. I think the other aspect here is that they have oral prostacyclin. They don't want to sort of detail against themselves, and in fact, had they done that, it would have set the table for us quite nicely in terms of what we want to do, as I just described.

Roger A. Jeffs: They don't want to sort of detail against themselves and in fact had they done that it would have set the table for us quite nicely in terms of what we want to do as I just described.

Roger A. Jeffs: So, you can understand why they're not doing that, but we will not be hindered in any way from that search. So, you know, we certainly are going to go after both the totality of the inhaled market and the totality of the process cycling market, particularly those patients that are having issues more with off-target effects like GI side effects, which are significant, and parenteral effects like sub-Q site pain and erythema So, again, attractive markets, $1.6 billion, with the $1.5 billion with Paveso aggregated opportunity now.

Speaker Change: You can understand why they're not doing that but we will not be hindered in any way from that search. So we certainly are going to go after both the totality of the inhaled market and the totality of the prostacyclin market, particularly those patients that are <unk>.

Speaker Change: Having issues more and more with off target effects like Gi side effects, which are significant and.

Speaker Change: Parental effects like <unk> pain and everything so.

Speaker Change: Again attractive markets $1 6 billion with $1 5 billion.

Speaker Change #101: They aggregated opportunity now so you are already at $3 billion.

Roger A. Jeffs: So, you're already at a $3 billion opportunity if we aggregate all of those markets together, and that's with PHARMV, as I said in my comments, only marginally penetrated at this point. So, you know, really, really nice opportunity.

Speaker Change: Opportunity, if we aggregate all of those markets together and Thats, absolutely <unk> as I said in my comments only marginally penetrated at this point so.

Speaker Change: Really very nice opportunity I think the other thing I'll say and this is not if you can talk about inhaled crossed another it's not a net zero sum game I think sometimes people are trying to position us.

Roger A. Jeffs: I think the other thing I will say, and this is not, if you talk about inhaled, it's not a net zero-sum game. I think sometimes people try to position us antagonistically against users' opportunities, you know, I think in PHARMV in particular. Again, there's a lot of patience there.

Speaker Change: Thank goodness, particularly against you there.

Speaker Change #103: Opportunity I think in ph ILD in particular.

Speaker Change: Again, there's lots of patients there theres lots of opportunity for both companies to do well and we look forward to launching in the near future and presenting the choice and that's what we're about so Mike if you could talk about payer coverage.

Michael Kaseta: There's lots of opportunity for both companies to do well. And, you know, we look forward to launching in the near future and presenting the choice. And that's what we're about. So, Mike, if you'd talk about pair coverage,

Michael Kaseta: Yeah, Serge, thanks so much for the question. I think what's important to know is the overwhelming feedback we've received from doctors and patients is that they want choice, and having utrepia available will provide that choice. But we also understand that in order to truly have that choice, access is critically important.

Michael Kaseta: Yes, Serge thanks, so much for the question.

Michael Kaseta: I think what's important to know is the overwhelming feedback we've received from from doctors and patients as they're wanting choice.

Michael Kaseta: And having your choppy available, we'll provide that choice, but we also understand in order to truly have that choice access is critically important so we've been engaging with payers.

PAA: We received tentative approval in PAA is back in November of 2021, we've been engaging with payers since that time to discuss the value proposition of neutropenia and I think we are confident that once we are we get full approval from the FDA.

Michael Kaseta: So we've been engaging with payers, you know; we received tentative approval in PAH back in November of 2021. We've been engaging with payers since that time to discuss the value proposition of utrepia. And I think we are confident that once we get full approval for it from the FDA, we will be able to work through that and make sure patients have that choice and have that choice and have access.

PAA: We will be able to work through that.

Speaker Change #105: And make sure patients how about choice and to have that choice and to have access. So we are confident that we will achieve that but until we get approval. Obviously, none of that will be formalized, but we've had really good conversations with payers and feel very confident that patients will be afforded that choice to choose your trip.

Michael Kaseta: So we are confident that we will achieve that. But until we get approval, obviously, none of that will be formalized, but we've had really good conversations with payers and feel very confident that patients will be afforded that choice to choose utrepia through an insurance platform where utrepia is on formulary. Yeah, thank you.

Speaker Change: Through an insurance platform.

Speaker Change: The neutropenia is on formulary.

Speaker Change: Okay. Thank you.

Operator: Thank you. Our next question comes from Julian Harris with BTIG. Your line is open. Hi guys, can you hear me?

Speaker Change: Thank you. Our next question comes from Julian Harris with BTG. Your line is open.

Julian Reed Harrison: Hi, guys can you hear me.

Julian Reed Harrison: Yes, we can, Julian. Good morning. All right. Sorry about that before.

Julian Reed Harrison: Yes, we cant Julien good morning, Alright, sorry about that before and thank you for taking my questions. Rusty you highlighted that there are no lawsuits that directly prevent the FDA for making a potential approval decision at this time I understand you can't comment on when specifically the FDA is expected to make a decision.

Operator: Thank you for taking my questions. Rusty, you highlighted that there are no lawsuits that directly prevent the FDA from making a potential approval decision at this time. I understand you can't comment on when specifically the FDA is expected to make a decision, but are you able to comment on what they could be waiting on at this point? I understand that that might be too speculative of a question and completely understand if you can't comment on that. And then can you also remind us where manufacturing stands?

Julian Reed Harrison: But are you able to comment on what they could be waiting on at this point understand it that might be too speculative question.

Julian Reed Harrison: And completely understand if you can't comment on that and then can you also remind us on where manufacturing stance have there been any additional inspections required by the FDA in the current cycle.

Rusty Schundler: Have there been any additional inspections required by the FDA in the current cycle? Yes, Julian, thanks for your perseverance in getting through the call. Rusty can answer the first question on the mic if you'll address the supply.

Julian Reed Harrison: Yes, Julian Thanks for your persistence and getting through the call.

Julian Reed Harrison: Rusty can answer the first question and then Mike If you will address the supply chain question.

Rusty Schundler: So Julian, thank you for the question. So, you know, first, we don't want to speculate on what the FDA is doing, where they are in their process, nor do we want to comment publicly on our interactions with the FDA to date. So, you know, again, as I said before, there is no legal impediment to them taking final action on our NDA. You know, we are awaiting that final action, but again, we can't really speak to any specifics. Yes, and Julian, relating to supply, you know, we've been anticipating a launch for a long time now, and we've been building commercial inventories throughout that entire time.

Julien: So Julien thank you for the question so.

Michael Kaseta: First we don't want to speculate.

Michael Kaseta: On what the FDA.

Michael Kaseta: Where they are in their process.

Michael Kaseta: Nor do we want to comment publicly on our interactions with the FDA to date so.

Julien: Again as I said before there is no legal impediment to them taking final action on our NDA.

Julien: We are awaiting that final action.

Julien: But again, we can't really speak to any specific timing.

Julien: Yes.

Julien: Yes, Julian relating to supply.

Julien: We've been we've been anticipating a launch obviously for a long time now we've been building commercial inventories through that entire time, so once the FDA.

Michael Kaseta: So once the FDA grants final approval, we will be ready to hit the ground running immediately in all strengths of our product. Related to the inspection, as part of our tentative approval in November of 2021, the FDA did a pre-approval inspection in August of 2021, and that was included in our tentative approval. So all the pre-approval inspections have been completed, and, you know, as I said, we've been building up commercial inventory since then and look forward to, you know, hopefully an imminent launch. Very helpful, thank you.

Julien: Final approval, we will be ready to hit the ground running immediately and all strengths.

Julien: Of our product.

Julien: Related to the inspection as part of our tentative approval in November of 2021, the FDA did a pre approval inspection in August of 2021 and that was included in our full our tentative approval. So.

Speaker Change #108: All of them pre approval inspections have been completed.

Julien: And.

Speaker Change #161: As I said, we've been building up commercial inventories since then and look forward to.

Speaker Change #161: Hopefully in a minute launch here.

Julien: Very helpful. Thank you.

Operator: Thank you. Our next question comes from Kambiz Yazi, with Jeffreys. Your line is open.

canvas Yahtzee: Thank you. Our next question comes from canvas Yahtzee with Jefferies. Your line is open.

Kambiz Pashneh: Good morning, team. Thank you for sharing some of the ascent data to date. So I guess my question on that open-label study is kind of what titration schemes are you looking to assess? And then as a second question, in terms of that overall projected $3 billion inhaled nebuli-troposinol market, or sorry, inhaled troposinol market, what is the split between the different indications in that market, and is that also kind of including some cannibalization of the oral troposinol market?

canvas Yahtzee: Good morning team.

Speaker Change #104: Thank you for sharing some of the U S.

Speaker Change #114: Data to date.

Speaker Change #102: So I guess my question on that open label study is kind of what titration schemes are you.

Speaker Change #107: Looking to SaaS.

Speaker Change #107: And then as a second question.

Speaker Change #102: In terms of that.

Speaker Change #102: Overall projected $3 billion.

Speaker Change #176: Inhaled <unk>.

Speaker Change #102: <unk>.

Speaker Change #110: Cross sell market.

Speaker Change #116: To cross sell in market.

Speaker Change #111: What do you see the split.

Speaker Change #111: Between the different indications in that market and is that also kind of including some cannibalization of the <unk>.

Speaker Change #109: Oral <unk> market. Thank you.

Kambiz Pashneh: Hey, Kambiz, I'll speak to the market question. And then Rajeev, you're going to talk about what we're trying to achieve and what we feel is the first company-sponsored DPI test in PHRD patients. So, I think, Kambiz, when you look at the market opportunity here, we're just going to say that Eclipse is 3 billion and growing. You know, there is.

Tom: Hey, Tom.

Tom: Ill stick to the market question and then Rajiv if you talk about what we're trying to achieve and what we feel is the first company sponsored.

Rajeev Saggar: TPI test in ph ILD patients.

Rajeev Saggar: So I think companies when you look at the market opportunity here.

Rajeev Saggar: Again, we're just going to say it eclipses $3 billion and growing.

Roger A. Jeffs: I think Uther has said that up to $1.5 billion on their last earnings call, they intimated that PHILD represented nearly $1 billion of that, approaching the billion in terms of indication opportunity, and that's with marginal penetration. So we think that market, again, if you believe it's $60,000, some people say $100,000. I think you said $30,000, but that number, I think they're taking north now, split the difference and call it $60,000. They're probably at high single digits, low double digit penetration, so just marginally penetrated, so lots and lots of room to grow there alone.

Speaker Change #166: And I think user has said that up there $1 5 billion on their last earnings call. They intimated that ph ILD represented nearly $1 billion of that are approaching $1 billion.

Rajeev Saggar: In terms of indication opportunity and thats with marginal penetration, so we think that market.

Rajeev Saggar: Again, if you believe that 60000 and some people say 100000.

Speaker Change #160: <unk> said 30000 that number I think theyre, taking north now, but let's just.

Speaker Change #117: Split the difference and call it 60000.

Speaker Change #113: Theyre, probably it at high single digits low double digit penetration. So just marginally penetrated so lots and lots of room to grow there alone.

Roger A. Jeffs: So that's a multi-billion dollar opportunity, and PHILD is for sure with an inhaled prostacyclin moiety. With the orals, again, that's cannibalization, and that may take a little bit more time to move along. But if utropia behaves the way we think it does in the real world, then we think we can really infringe on the oral market. So we also think that's, for Utreptia specifically, that's a billion-dollar opportunity as well.

unknown: Multibillion dollar opportunity in ph ILD for sure with an inhaled prostacyclin moiety.

unknown: With the oral is again, that's cannibalization and that May take a little bit more time to move along but if you trip.

Speaker Change #115: Behaves the way we think it can in the in the real World and we think we can really infringe on the oral market.

unknown: So we also think that's a very good track, specifically, that's $8 billion opportunity as well so when you aggregate those together.

Roger A. Jeffs: So when you aggregate those together, our share of the inhaled and our share of the oral, we think we can have a multi-billion dollar product, or more. So I think, you know, again... We need to prove that out. We need to generate the launch dynamics that we hope to do to support that.

unknown: Our share of the inhaled our share of the oral we think we can we can have a multibillion dollar product.

unknown: Or more so I think you know again we.

unknown: We need to prove that out we need to generate the launch.

unknown: The dynamics that we hope to do to support that to be true but.

Roger A. Jeffs: But the first thing is to get the approval, and we're working hard. So Rajeev, if you could talk about some of the things we're trying to achieve in terms of dosing, which will help us achieve this multi-billion dollar opportunity? Thank you, and Kambiz, good morning. So first of all, I think, you know, one thing we're highlighting here is that this is the first, open-label prospective study in PHLD using a dry powder inhaler. Trepia in this regard.

unknown: The first thing is to get the approval and we're working hard to do that.

Rajeev Saggar: So rajeev, if you'll talk about some of the things we're trying to achieve.

Speaker Change #194: In terms of dosing, which will help us achieve this multibillion dollar opportunity.

Speaker Change #162: Yeah, Thank you and can be <unk> and good morning.

Rajeev: So first of all I think one thing we're highlighting here is that this is the first.

Speaker Change #197: Open label in a prospective study in ph ILD using a dry powder inhaler with your trip here in this regard remember we've already conducted the inspire study in 121 patients. So we really understand the tolerability profile and the titrated ability of your trip yet.

Rajeev Saggar: Remember, we've already conducted the INSPIRE study in 121 patients, so we really understand the tolerability profile and the titratability of utrepia. And so we took those learnings and we brought them to patients with PHLD who have never been treated in the past. In this regard, as I highlighted, we have we have seven patients that have enrolled to date. And one thing that you had asked is, you know, what is the dosing recommendation for this patient population?

Rajeev: And so we took those learnings and we brought it into patients with ph ILD.

Rajeev: That debt has no debt have never been treated in the past and disregard as I highlighted we have we have seven patients that have enrolled to date.

Speaker Change #121: And one thing that.

Speaker Change #121: You had asked is what is what is the dosing recommendation for this patient population well clearly I think the primary objective is that one.

Rajeev Saggar: Well, clearly, I think the primary objective is one, you know, can the tolerability profile that we saw in the INSPIRE study in pH patients be replicated in PHLD? And I think the early small sample sizes suggest the answer is yes, it can.

Speaker Change #121: Can the Tolerability profile that we saw in the inspire study in ph patients be replicated in ph ILD and I think the early small sample sizes. The answer is yes. It can.

Rajeev Saggar: Clearly, what needs to happen is dose matters, right? So the increased study used in Tybaso suggested that patients who get to at least nine breath equivalents of Tybaso nebulizer portend to have a better clinical effect, but actually patients who can get actually higher to 11 to 12 breaths, looks like the signal actually gets a bit stronger. So the priority of this study is to titrate the patient at least to nine to 12 breaths, which is the traditional therapeutic goal of inhalatory prostanol, but more importantly, to exceed that in the right patient profile, right?

Speaker Change #121: Clearly what needs to happen is dose matters right. So the increased study used in Tobey. So suggested that patients who get to at least nine breaths equivalents of <unk> <unk>.

Speaker Change #121: Tend to have a.

Speaker Change #121: Better clinical effect, but actually patients who can get actually hire 211% to 12 breaths.

Speaker Change #121: It looks like the signal actually gets a bit stronger. So the priority of this study is to titrate the patient at least to nine to 12 breads, which is the traditional therapeutic goal of inhibitory <unk>, but more importantly to exceed that.

Speaker Change #118: In the right patient profile right. So some patients.

Rajeev Saggar: So some patients may need nine to 12 breaths; maybe the majority of these actually need somewhere more than that. One thing I think is really intriguing is that I highlighted in the call that the median dose at week eight is now 132 micrograms of utrepia, which is now equivalent to greater or equal to 15 breaths of Tybaso. So I think the early findings from the study are quite encouraging, and we look forward to completing enrollment in the study by the end of the year.

Speaker Change #119: May need <unk>.

Speaker Change #119: Nine to 12 breaths.

Speaker Change #119: Maybe the majority of these actually need somewhere more than that.

Speaker Change #120: One thing I think is really intriguing is that I highlighted in the call that the median dose at week eight is now a 132.

Speaker Change #120: <unk> of you trip, yet, which is now equivalent to greater equal to 15 breadth of <unk>. So so I think the early the early findings from this study are quite encouraging and we look forward to completing enrollment in this study by the end of the year.

Rajeev Saggar: So, Kambiz, I think when we finish the study, the important data for investors to look at would be our ability to titrate, which, as Rajeev said, at least in the early data, we're seeing good evidence that we can do that quite aggressively. And then the other question would be, how durable is it?

Speaker Change #120: So comment is I think when we when we finish this day the important data for investors to look at would be.

Rajeev: What were the what's our ability to titrate, which which as Rajeev said at least in the early data. We're seeing good evidence that we can do that quite aggressively.

Speaker Change #120: And then the other question would be how durable is it and so far those patients are remaining on study remember as I stated in the preamble.

Roger A. Jeffs: And so far, those patients are remaining on study. So, as I stated in the preamble, It was only a median of 40 days where people who had started PIVASA-DPI in the National Jewish Center data were unable to continue that drug, and 50% of those patients dropped off within that 40-day median time frame. We're trying to make a contradictory statement to that, to show that Utrepia is much more titratable and much more durable.

Speaker Change #120: It was only a median of 40 days, where people people, who had started as I said DPI within International Jewish Center data.

Speaker Change #120: Unable to continue that driving 50% of those patients dropped off within that 40 day median timeframe. So.

Speaker Change #120: We're trying to make a contradictory statement to that to show that <unk> is much more titratable and much more durable the reasons that patients predominantly came off.

Roger A. Jeffs: The reasons that patients predominantly came off in the National Jewish Center experience were clinical worsening, which I would assume is due to a lack of ability to provide a therapeutic dose; otherwise, they wouldn't have worsened. And, you know, we're trying to basically show that Utrecht can perform in a very different way.

Speaker Change #120: National Jewish Center experience was for clinical worsening, which I would assume is due to a lack of ability to provide a therapeutic dose otherwise they wouldn't have worsened.

Speaker Change #120: And we're trying to basic.

Speaker Change #210: Basically show that you trip it can can perform in a very different way and obviously that speaks to its differentiated capabilities and market opportunity. So so far so good but more to come there.

Operator: And obviously, that speaks to its differentiated capabilities in the market. So, so far, so good, but more to come there. Thank you. Our next question comes from Matt Kaplan with Ladenburg Tallman. Your line is open.

Speaker Change #119: Operator.

Speaker Change #193: Thank you. Our next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is open hi.

Matthew Lee Kaplan: Hi, good morning guys. Thanks for taking the questions. Just in terms of your commercial preparation and readiness, how soon after approval will you launch the drug? Thanks. Mike, would you like to answer that question, please? Yeah, so Matt, thanks for the question.

Matthew Lee Kaplan: Good morning, guys. Thanks for taking my questions.

Matthew Lee Kaplan: Just in terms of your commercial prep and readiness.

Matthew Lee Kaplan: How soon after approval.

Speaker Change #119: You.

Speaker Change #119: When you launch the drug.

Speaker Change #183: Thanks, Mike would you like to answer that question. Please yes.

Michael Kaseta: You know, obviously, once we get full approval, it'll take a little bit of time to, you know, list our price in compendia. But from a commercial availability standpoint, what I can say is our commercial team, our sales force, is literally ready to go immediately thereafter. Our commercial inventory will be ready to go within days after final approval. So, you know, I know a lot of companies take 30 to 45 days to launch after they get full approval.

Speaker Change #119: Yes, so Matt thanks for the question.

Michael Kaseta: Obviously once we get full approval it will take a little bit of time too.

Speaker Change #119: List price and the <unk>.

Speaker Change #179: But from a from a commercial availability or what I can say is our commercial team our sales forces literally ready to go immediately thereafter, our commercial inventory will be ready to go within days after.

Michael Kaseta: We will be ready to go literally within days or a week after final approval, you know, regardless of when that time comes. Thanks. And I know we're all focused and waiting for Utrecht's approval, but thinking out a little bit into the future, can you tell us a little bit more about 6.06 and L6.06 and what role and position you think that will play in terms of inhaled propulsion? Yeah, I'll answer that.

Speaker Change #225: Final approval so.

Speaker Change #179: I know a lot of companies take 30% to 45 days to launch after they get full approval, we will be ready to go.

Speaker Change #179: Literally within days or a week after final approval.

Speaker Change #119: Regardless of when that time comes.

Speaker Change #119: Okay. Okay. Thanks, and I know, we're all focused on waiting for <unk> approval, but.

Speaker Change #119: Thinking out a little bit into the future can you tell us a little bit more about <unk> and <unk>.

Speaker Change #123: What role and position you think that will client in terms of the handheld the plasma market.

Michael Kaseta: Thanks for the question, Matt. So, you know, I think when you look at utrepia in terms, What it solves for, it's taken what was a, you know, if you look at just Tyvasa, nebulized Tyvasa, it was a fixed dose, or not a readily titratable therapy, so we really transformed therapeutic index, so we've made it much more titratable, so we can get to a higher effective dose, while keeping the AE profile the same.

Matthew Lee Kaplan: Yes, I'll answer that thanks for the question Matt.

Speaker Change #126: I think when you look at <unk> in terms of what it solves for its taken what was a maybe you look at that just highlights the Netherlands today. So it was a fixed dose not readily titratable therapy. So we've really transformed therapeutic index and we've made it much more titratable. So we can get to a higher effective dose.

Speaker Change #126: While keeping the AE profile. The same so you have a better therapeutic index 40 choppy than you do with for instance, <unk> as an example.

Michael Kaseta: So you have a better therapeutic index for utrepia than you do with, for instance, nebulized type A, so as an example. But what we didn't do was solve for the four times a day treatment regimen, and that's the same, that's also true for type A with EPI. So it improves on the therapeutic profile of inhaled troposinol but still requires four times a day administration. So what L606 will do is address that final point and really pull on that lever to make the market, instead of just sharing the market with our competitor, we look to then basically dominate the market.

Speaker Change #126: What we didn't do we solve for the four times, a day and treatment regimen and that's the same that's also true for 10 days of the DPI so improve.

Speaker Change #122: Improved on the therapeutic profile of <unk>, but still requires four times a day administration. So what <unk> will do is address that final point and really pull on that lever to make the market incentives just sharing the market with our competitor. We would look to then basically dominate the market. So.

Michael Kaseta: So if we had a formulation that behaved the same as utrepia, but you could do that twice a day format and essentially solve for the overnight removal of therapy, which happens because you dose before you go to sleep, the half lasts four hours, and if you sleep eight hours, by the time you wake up, the therapy's gone.

Speaker Change #128: If we had a a formulation that behave the same as your trip yet, but you could do that in a twice a day format and essentially solves for the <unk>.

Speaker Change #128: Overnight removal of therapy, which happens because E dose before you go to sleep. They have plans for hours eight hours that time, you wake up the therapy is gone.

Roger A. Jeffs: We will solve for that, provide a more steady-state exposure, which we think will also be better for patient outcomes. And then, as Rajeev said, in the open-label trial, we're seeing just that. We're seeing that L606 is extremely well-tolerated.

Speaker Change #124: We will solve for that provide a more steady state exposure.

Rajeev: Exposure exposure, which we think will also be better patient outcome and then as Rajeev said in the open label trial, we're seeing just that we're seeing that <unk> is extremely well tolerated.

Speaker Change #191: And that's because it has a university each had a seven times lower C. Max.

Speaker Change #211: And then it's AUC zero to 24 hours this assignment.

Speaker Change #127: <unk> is the same as four times a day in <unk>.

Rajeev: Its target profile in open label work, so far is exactly what we would want it.

Speaker Change #127: It can be and now we're just going to try to replicate the time based on increased study with Asics will start that at the end of this year work hard to get that kind of an improved sometime in the 2008 timeframe, but at that point in time, we think that will become the preferred therapeutic because itself for regimen, while still giving all the benefits that you're tracking to that.

Speaker Change #124: Okay.

Speaker Change #124: Thank you Matt Operator next question if any thank you there are no further questions I'd like to turn the call back over to Roger for closing remarks.

Roger: Great. Thank you operator, and thank you very much for the questions. This morning.

Roger: I hope is that the next time, we addressed on our earnings call, we will be providing to patients. What we feel is a preferred product for inhaled <unk> and it will be kind of a critical critical time as the market for inhaled <unk> rapidly expands.

Speaker Change #212: Thank you for joining us today, and we look forward to speaking soon bye bye.

Speaker Change #125: Thank you for your participation. This does conclude the program you may now disconnect everyone have a great day.

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Roger A. Jeffs: And that's because it has, as we already said, a seven times lower CMAG, and that its AUC, 0 to 24 hours, is the same as, given BID, is the same as four times a day inhaled troposinil. So, its target profile in open label work so far is exactly what we wanted this to be, and now we're just going to try to replicate the type A some increased study with L6 We'll start that at the end of this year, work hard to get that done and improved sometime in the 28 time frame, but at that point in time, we think that will become the preferred treatment because it's a solved for regimen while still giving all the benefits that you trusted. Thanks, Roger. Thank you, Matt. Operator, next question, if any?

Michelle: Good morning, and welcome everyone to the liquidity of Corporation first quarter 2024 financial results and corporate update conference call. My name is Michelle and I'll be your conference operator today.

Operator: Thank you. There are no further questions. I'd like to turn the call back over to Roger for his closing remarks. All right. Thank you, operator. And thank you very much for the questions this morning. My hope is that the next time we address you on our earnings call, we will be providing to patients what we feel is a preferred product for inhaled troposinil, and it will come at a critical time as the market for inhaled troposinil rapidly expands. Thank you for joining us today, and we look forward to speaking soon. Bye-bye.

Michelle: Currently all participants are in listen only mode.

Michelle: Following the presentation, we will conduct a question and answer session.

Michelle: Jackson's will be provided at that time for you to queue up for questions.

Speaker Change #129: I would like to remind everyone that this call is being recorded.

Operator: Thank you for your participation. This does conclude the program. You may now disconnect.

Speaker Change #129: Now hand, the call over to Jason Adair Chief business Officer.

Jason Adair: Thank you Michele it's my pleasure to welcome everyone to the liquidity of corporations first quarter 2024 financial results and corporate update call joining.

Speaker Change #130: Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief operating officer, and CFO, Michael Chris.

Speaker Change #133: Chief Medical Officer, Dr. Rajiv <unk>, our Chief commercial Officer, Scott <unk> and General counsel roughly similar.

Speaker Change #132: 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.

Speaker Change #130: 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 #130: 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 web site.

Speaker Change #143: I would now like to turn the call over to Roger for our prepared remarks, after which we'll open the call for your questions.

Roger: Thank you Jason.

Operator: Everyone, have a great day. Copyright © 2020, New Thinking Allowed Foundation, ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? [inaudible] Good morning and welcome everyone to the Liquidia Corporation First Quarter 2024 Financial Results and Corporate Update Conference Call. My name is Michelle and I'll be your conference operator today. Apparently all participants are in listen-only mode.

Jason Adair: Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer. Thank you, Michelle.

Roger A. Jeffs: It's my pleasure to welcome everyone to Liquidia Corporation's first quarter 2024 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Operating Officer, and CFO, Michael Kaseta, Chief Medical Officer, Dr. Rajeev Saggar, Chief Commercial Officer, Scott Moomaw, and General Counsel, Rusty Schundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements.

Roger: Currently awaits final FDA approval to treat both pulmonary hypertension arterial hypertension or ph and pulmonary hypertension associated with interstitial lung disease or ph ILD.

Speaker Change #144: We have continued to optimize our commercial preparations in anticipation of potential FDA final action and launch in the clinic. We are seeing encouraging initial data from our centrality trivia in ph ILD. In addition.

Roger A. Jeffs: These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I would now like to turn the call over to Roger for our prepared remarks, after which he'll open the call to your questions. Thank you, Jason. Good morning, everyone, and thank you for joining us today.

Roger A. Jeffs: In the nine weeks since our last earnings call, we have continued to advance what we believe will be the industry-leading portfolio of inhaled drug processing oil products. Utrepia, our dry powder formulation of Trapasinil, currently awaits final FDA approval to treat both pulmonary hypertension, arterial hypertension, or PAA, and Pulmonary Hypertension Associated with Interstitial Lung Disease, or PHILD. We have continued to optimize our commercial preparations in anticipation of potential FDA final action and launch. In the clinic, we are seeing encouraging initial data from our central nervous system utrepia and PHILD. In addition, our sustained-release liposomal formulation of troposinil, L606, also continues to generate encouraging data in our open-label safety study in both PH and PHILD patients.

Roger: Sustained release Microsomal formulation <unk> <unk> six also continues to generate encouraging data in our open label safety study in the ph in ph ILD patients.

Roger A. Jeffs: Rajeev and Rusty will provide updates in greater detail on the clinical, regulatory, and legal fronts in a moment. But first, I think it is important to reflect on what is happening in the market and why we are so committed to these programs and the patients we seek to treat. We believe the market for inhaled triprosanone, PAH, and PAHality can eclipse $3 billion at peak sales. And this is validated by Tevesa's total current annual run rate of approximately $1.5 billion, which continues to grow at an appreciable rate.

Speaker Change #136: Rajeev and rescue we will provide updates in greater detail on the clinical regulatory and legal front in a moment.

Speaker Change #146: At first I think it is important to reflect on what is happening in the market and why are we still committed to these programs and the patients we seek to treat.

Speaker Change #136: We believe the market for <unk> and ph and BHI can eclipse $3 billion at peak sales.

Speaker Change #134: And this is validated by 10 basis current total current annual run rate of approximately $1 5 billion.

Speaker Change #138: Which continues to grow at any appreciable rate.

Roger A. Jeffs: This growth is driven by the expanded PHLD market, which is only marginally penetrated at this time, along with the availability of the more portable dry powder inhaler options. However, what we also see in our competitive sales data is continued unmet need. In our study of utrepia, 100% of patients who transitioned to utrepia from Pivesa preferred utrepia after four months of use. Yet, approximately 40% of uterus sales continue to come from nebulized Tyvezo with its bulky, challenging, and dose-limiting nebulizer.

Roger: This growth is driven by the expanded ph ILD market, which is which is only marginally penetrated at this time.

Roger: Along with the availability of the more portable dry powder inhaler option.

Roger: However, what we also see in our competitive sales data is continued unmet need.

Speaker Change #131: <unk> hundred three.

Speaker Change #131: A set of patients who transition to your Trump yet from today is that preferred return after four months of use.

Speaker Change #151: Yes, approximately 40% of users sales continued to come from <unk> <unk> with its bulky challenging and dose limiting nebulizer.

Speaker Change #151: We do not have any direct knowledge of the totality of the issues that may be preventing a more complete conversion of patients from <unk> DPI.

Speaker Change #151: But the continued prevalence of tight it seems illogical, given the clear portability and use advantages of the DPI.

Roger A. Jeffs: In this regard, data from the National Jewish Pulmonary Hypertension Program may be broadly informative. In September, these experts presented a single-center perspective observational study in patients with PHILD who were initiated on Trarocinome DPI, of the 26 patients with PHILD initiated on Trivaso DTI. 69% of these patients discontinued this treatment after a mean of only 78 days or a median of 40 days. Of importance, 11 or 42.3% of these patients transitioned to the divasive nebulizer upon discontinuation of DPI therapy.

Speaker Change #137: In this regard data from the National Jewish pulmonary hypertension program may be broadly and informative.

Speaker Change #154: In September these experts presented a single center prospective observational study in patients with ph ILD, who initiated untrusted characterized genome DPI.

Speaker Change #131: Roughly 26 patients with ph ILD initiated on time, they said epi.

Speaker Change #153: 69% of these patients discontinue this treatment after a median of only 78 days or a median of 40 days.

Speaker Change #131: Of importance 11, or 42, 3% of these patients transitioned to the <unk> nebulizer upon discontinuation of DPI therapy.

Roger A. Jeffs: This is highly consistent with our competitor sales data, highlighting that nearly 40% of its patient base continues to use the more cumbersome nebulizer for type A cell administration. From our perspective, clearly it is not the molecule troposinol, but rather the limitation of the formulation and the very high resistance DPI utilized with divaso DPI, especially when treating patients with lung impairment in PHILD. That's why we believe that physicians and patients are eager for a new choice, one that delivers a readily titratable and durable inhaled formulation of traprosanol using a portable, patient-friendly, low-resistance dry bowel inhaler with demonstrated high patient preference and satisfaction.

Speaker Change #131: This is highly consistent with our competitors' sales data.

Speaker Change #131: Highlighting that nearly 40% of its patient base continues to use the more cumbersome nebulizer for 10 days of administration.

Speaker Change #131: From our perspective, clearly it is not the molecule <unk>, but rather the limitation of the formulation and the very high resistance DPI utilized with diverse set of DPI, especially when treating patients with lung impairment in ph ILD.

Speaker Change #131: That's why we believe that physicians and patients are eager for a new choice one that delivers a readily titratable and durable inhaled formulation of <unk> using a portable patient friendly.

Speaker Change #145: Low resistance dry powder inhaler.

Speaker Change #131: With demonstrated high patient preference and satisfaction.

Roger A. Jeffs: Utrepia is that choice and has the very real potential to become the first in choice investing class process cycling in this growing market opportunity. With that, I'd like to ask Rajeev to share more about FDA interactions and our observations in the ongoing clinical studies with utrepia and L6S6.

Speaker Change #135: Is that choice and has a very real potential to become the first in choice and best in class Prostacyclin in this growing market opportunity.

Speaker Change #158: With that I'd like to ask Rajiv to share more about FDA interactions and our observations in the ongoing clinical studies with <unk> and <unk>.

Speaker Change #139: 606 Rajiv.

Rajeev Saggar: Thanks, Roger I'd like to address three of the most common questions I've received related to our programs.

Rajeev Saggar: First where does the FDA stand in its review of your trip here.

Rajeev Saggar: What observations are emerging from the ascent trial, our open label study of <unk> in ph ILD patients to better understand dosing and titration in that patient population and third when can we expect to see more data on the <unk>. So 606 program I will take each in turn.

Rajeev Saggar: to better understand dosing and antitration in that patient population. And third, when can we expect to see more data on the L606 program? I will take each in turn.

Rajeev Saggar: Regarding the first question, while we cannot speak to a specific action date, the FDA's Review Division has maintained an active dialogue with Liquidia on the development of Utrecht since it entered the clinic as a first-drive powder formulation for tree processing. During the course of its review of the NDA for PAH, the FDA has confirmed multiple times over the last three years that submitting an amendment to the NDA would be an appropriate way to add PAH.

Speaker Change #150: Regarding the first question, while we cannot speak to a specific action date Fda's Review Division has maintained an active dialogue with the <unk>.

Rajeev Saggar: The amount of neutropenia since it entered the clinic as the first dry powder formulation of <unk> <unk>.

Rajeev Saggar: During the course of its review of the NDA for PIH. The FDA has confirmed multiple times over the last three years that submitting an amendment to the NDA would be inappropriate way to add ph.

Rajeev Saggar: PHILD Indication. Also, throughout this process, the FDA consistently affirmed that no additional clinical data would be required to add the PHLD indication. We are disappointed that the FDA did not issue an action letter promptly following the expiration of the March 31st Clinical Investigation Exclusivity Granted to TAVESA to Treat PHLD.

Rajeev Saggar: ILD indication.

Rajeev Saggar: Also throughout this process the FDA consistently affirmed at no additional clinical data would be required to add the ph ILD indication.

Rajeev Saggar: We are disappointed that the FDA did not issue an action letter promptly following the exploration of the March 31.

Speaker Change #141: Clinical investigation of exclusivity granted to <unk> to treat ph L. D. Nevertheless, we remain hopeful that the FDA will issue final action very soon given the lack of any legal barriers to approval.

Rajeev Saggar: Nevertheless, we remain hopeful that the FDA will issue final action very soon, given the lack of any legal barriers to our approval. Regarding the second question, we initiated the Open Label Assent Trial in late December to help physicians understand the safety, tolerability, and titratability of utropion patients with PHLD. We have enrolled seven patients to date and have several additional sites initiating the study over the next 30 days. Of the seven patients, the median dose was 106 micrograms during week 4 and 132.5 micrograms during week 8, which is comparable to nebulized tybaso of about 12 to 15 breaths per session, respectively. The highest dose of utrepia achieved to date in the study is 318 micrograms, which is at least 36 breaths per session of tereza nebulae.

Speaker Change #140: Regarding the second question, we initiated the open label are set trial in late December to help physicians understand the safety Tolerability and titrated ability of your trip young patients with ph L D.

Speaker Change #140: We have enrolled seven patients to date and have several addition, additional sites initiating that study over the next 30 days.

Speaker Change #140: Of the seven patients the median dose was 106 micrograms during week four.

Speaker Change #140: $132 five micrograms during week, eight which are comparable to nebulize Tobey so of about 12% to 15 breath precession, respectively.

Joseph <unk>: Joseph <unk> achieved to date in the study is 318 micrograms, which is at least 36 breaths per session of today's the nebulizer.

Rajeev Saggar: While early and a small sample size, we are encouraged by the tolerability and titratability profile in patients with PHLD and remain confident that we can complete enrollment of the study by the end of the year. We look forward to presenting more robust clinical data at a future medical conference later this year. Finally, regarding the third question, next week at the American Threats Society conference... We will present an abstract focusing on the clinical data of our liposomal sustained release formulation of triprosanil L6O6 from the open-label safety study in the first 24 patients enrolled with PAH and PHILD.

Speaker Change #142: While early in the small sample size, we are encouraged at the Tolerability and titrated ability profile in patients with ph ILD and remain confident that we can complete enrollment of the study by the end of the year.

Speaker Change #142: We look forward to presenting a more robust clinical data at a future Medical conference later this year.

Speaker Change #142: Finally regarding the third question next week at the American Thoracic Society Conference, we will presented an abstract focusing on the clinical data of our life of Somal sustained release formulation of <unk> <unk> from the open label safety study in the first 24 patients enrolled with PIH in ph ILD.

Speaker Change #142: We continue to observe a favorable tolerability and titrate ability profile with all 606, given the seven fold lower C. Max and twice daily dosing using a rapid breath accentuated nebulizer.

Speaker Change #142: To date patients have titrated to our maximum dose allowed in the study of 378 micrograms twice daily.

Speaker Change #142: Dosage that would be comparable to <unk> 26 to 28 breath of TB. So nebulizer administrated administered four times daily.

Rajeev Saggar: We will publish the poster on our website once presented and look forward to discussing the observation in future calls. In addition, we are vigorously engaging in startup activities to enable initiation of our Phase 3 Randomized Controlled Study. The single pivotable study will enable indications to treat both PHLD and PAH.

Speaker Change #142: We will publish the posted to our website once presented and look forward to discussing the observation in future calls. In addition, we are vigorously engaging and startup activities to enable initiation of our phase III randomized controlled study.

Speaker Change #142: A single pivotal study will enable indications to treat both.

Speaker Change #142: Audi and ph.

Rajeev Saggar: Physician interest globally is robust, and we look forward to interacting with regulatory agencies in the next few months as we prepare to initiate the study later this year. At this time, I would like to ask Rusty to summarize the recent legal actions of the last few months. Rusty?

Speaker Change #142: <unk> interest globally is robust and we look forward to interacting with regulatory agencies in the next few months as we as we prepare to initiate the study later this year.

Speaker Change #156: At this time I would like to ask Rusty to summarize the recent legal actions over the last few months Rusty.

Rusty Schundler: Thank you, Rajeev. The first quarter of 2024 saw significant progress on the legal front. This is the first earnings call in which we can say that there are no legal barriers preventing the FDA from issuing a final action on the amended NDA for Utrecht. The combination of District Court PTAB and Federal Circuit rulings led to the removal of the previous injunction issued in 2022.

Speaker Change #142: Rusty.

Rajeev: Thank you Rajeev.

Rusty Schundler: The first quarter of 2024 saw significant progress on the legal front.

Speaker Change #149: This is the first earnings call in which we can say that there are no legal barriers preventing the FDA from issuing a final action on the amended NDA for <unk> yet.

Speaker Change #149: The combination of district Court P tab and federal circuit ruling have led to the removal of the previous injunction issued in 2022.

Rusty Schundler: In addition, United Therapeutics' regulatory exclusivity tied to PHLD expired on March 31st. Thus, since April 1st, the FDA has had the legal authority to take final action on our NDA for each. While we cannot comment on whether the FDA will take that final action, we can clarify the status of two ongoing lawsuits brought by United Therapeutics against Liquidia and the FDA, each with the same intent to stop the launch of Utrecht BNPHL. Neither of these lawsuits currently impact the FDA's ability to approve utrepia for both indications.

Speaker Change #149: In addition, United Therapeutics regulatory exclusivity tied to ph ILD expired on March 31.

Speaker Change #149: Since April one the FDA has had the legal authority to take final action on our NDA for your trip yet.

Rusty Schundler: And even in the worst case, neither lawsuit will ultimately impact our ability to treat PA. In the first of these lawsuits, United Therapeutics filed a lawsuit alleging infringement of the 327 patent based on our requests for approval of the PHLD indication. In this lawsuit, United Therapeutics has filed a motion for preliminary injunction. Judge Andrews in the United States District Court for the District of Delaware heard oral arguments from both parties on April 23rd regarding the preliminary injunction, and may issue a written ruling at any time.

Rusty Jones: While we cannot comment on when the FDA will take that final action. We can clarify the status of two ongoing lawsuits brought by United Therapeutics against liquidity and the FDA each with the same intent just lap the launch of <unk> in ph ILD.

Rusty Jones: Neither of these lawsuits currently impact the fda's ability to approve your trip via for both indications and even in the worst case, neither lawsuit will ultimately impact our ability to treat <unk> patients.

Rusty Jones: And the first of these lawsuits United Therapeutics has filed a lawsuit.

Rusty Jones: Alleging infringement of the $3 seven patent based on a request for approval of the ph ILD indication.

Rusty Jones: And this lawsuit.

Rajeev: <unk> filed a motion for preliminary injunction.

Rajeev: Judge Andrews in the United States District Court for the district of Delaware heard oral arguments from both parties on April 23rd regarding the preliminary injunction and May issue, a written ruling at anytime.

Rusty Schundler: We remain confident in our arguments as briefed and argued and continue to believe there are substantial questions regarding the validity of the 327 patent, which generally covers treatment of PHLD patients with Tyvaso in accordance with the Tyvaso label, something that physicians have been doing for more than a decade, as evidenced by multiple publications describing positive results in PHLD patients over that period. In the second of these lawsuits, United Therapeutics is seeking to bar the FDA from accepting and approving our amendment to add PHLD to the label for utrepia, pursuant to the Administrative Procedures, Judge Bates in the United States District Court for the District of Columbia rejected United Therapeutics' motion for a temporary restraining order, and Preliminary Injunction on March 29, indicating that the FDA's acceptance of our amendment for review did not constitute final agency action.

Speaker Change #157: We remain confident in our arguments has briefed and argued and continue to believe there are substantial questions regarding the validity of $3 seven patents, which generally covers treatment of ph ILD patients with Taipei. So in accordance with <unk> with the <unk> label something that physicians have been doing for more than a decade as evidenced by multiple publications describing positive results.

Speaker Change #157: In ph ILD patients over that period.

Rajeev: And the second of these lawsuits United Therapeutics is seeking to bar the FDA from accepting and approving our amendment ph ILD to the label for your trip yet pursuant to the administrative procedure set.

Rajeev: <unk> space in the United States District Court for the district of Columbia, rejecting United Therapeutics motion for a temporary restraining order.

Rajeev: And preliminary injunction on March 29th.

Rajeev: Indicating that the Fda's acceptance of our amendment for a review did not constitute final agency action.

Rusty Schundler: Judge Bates has retained jurisdiction, though, and ordered the FDA to provide the court and both United Therapeutics and Liquidia notice three days prior to taking any final action on the Utrepia NDA. Additionally, last week, both we and the FDA filed motions to dismiss the entire lawsuit in briefing on the motion of dismissal in progress. We remain confident that both that our amendment was properly filed and that United Therapeutics does not have the necessary standing to challenge the FDA's decision.

Rajeev: <unk> has retained jurisdiction, though and ordered the FDA to provide the court in both United Therapeutics and liquidity I noticed three days prior to taking any final action on the <unk> NDA.

Rajeev: Additionally, last week, both we and the FDA filed motions to dismiss the entire lawsuit and briefing on the motion to dismiss is in progress we remain confident.

Rajeev: Both that our amendment was properly filed and that United Therapeutics does not have the necessary standing to challenge the Fda's decision.

Rusty Schundler: Our priority has been, and remains, prompt approval of Utrepia so that we can make it available to patients. We will continue to vigorously defend our ability to do so. I will now turn the call over to Mike. Thank you, Rusty. And good morning, everyone. We ended the first quarter in the strongest financial position in the company's history. Not only do we have to cash in on the balance sheet to achieve our objectives, but we're also poised to launch into one of the fastest growing rare disease markets with what we believe will be a differentiated product for PAH and PAH ILD patients. And our team is fully in place.

Rajeev: Our priority has been and remains prompt approval of your trip here. So that we can make it available to patients. We will continue to vigorously defend our ability to do so.

Michael Kaseta: I'll now turn the call over to Mike.

Rajeev: Yes.

Michael Kaseta: Thank you Rusty and good morning, everyone. We ended the first quarter in the strongest financial position in our company's history not only do we have the cash on the balance sheet to achieve our objectives, but we're also poised to launch into one of the fastest growing rare disease market with what we believe will be a differentiated product for ph in ph ILD patients.

Rajeev: Our team is fully in place our commercial inventories already in expanding our relationships with all key stakeholders are sound enacted.

Michael Kaseta: Our commercial inventories are ready and expanding, and our relationships with all key stakeholders are sound and active. And our sales team is fully engaged and ready to launch. We continue to believe that the approval and launch of Utrepia this quarter in both indications will enable a rapid transformation in the company's P&L. Turning to our financial results, which can be found in the press release, you will see that revenue was $3 million for the first quarter of 2024, compared with $4.5 million in the same quarter of 2023.

Rajeev: And our sales team is fully engaged and ready to launch.

Rajeev: We continue to believe that the approval and launch of your trip here this quarter in both indications will enable a rapid transformation in the company's P&L.

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

Rajeev: Revenue was $3 million for the first quarter 2024, compared with $4 5 million in the same quarter for 2023 revenue was tied to our promotion agreement with Sandoz to commercial to commercialize <unk> injection.

Michael Kaseta: The revenue is tied to our promotion agreement with Sandos to commercialize troposinol injections. The decrease was primarily due to favorable growth-to-net rebate adjustments recorded in the prior year and the impact of lower sales quantities in the current year as compared to the same period in the prior year.

Rajeev: The decrease was primarily due to favorable gross to net rebate adjustments recorded in the prior year and the impact of lower sales quantities in the current year as compared to the same period in the prior year.

Rajeev: Cost of revenue increased to $1 5 million for the first quarter 2024, compared to <unk> 7 million in the same quarter for 2023.

Rajeev: Cost of revenue relates to our promotion agreement with the increase being primarily due to our sales force expansion during the fourth quarter of 2023.

Rajeev: Research and development expenses were $10 1 million in the first quarter 2024, compared with $5 $3 million in first quarter 'twenty three.

Rajeev: The increase of $4 8 million or 91% was primarily due to a $2 million increase in personnel expenses, which include stock based compensation related to higher head count.

Rajeev: At $1 $7 million increase in clinical expenses related to our <unk> hundred six program.

Rajeev: Additionally, there was a $1 $3 million increase in expenses related to our <unk> program, driven by higher clinical and supply expenses related to our offense study.

Rajeev: General and administrative expenses were $22 million in the first quarter of 2024 compared to $7 $8 million in the same quarter for 2023.

Michael Kaseta: The increase of $12.4 million was primarily due to increases in legal fees related to our ongoing Utrepia-related litigation, increases in personnel expenses, and increases in commercial and consulting expenses in preparation for the potential commercialization of Utrepia. In summary, we incurred a net loss for the three-month-ended March 31, 2024 of $40.9 million, or $0.54 per basic and diluted share, compared to a net loss of $11.7 million, or $0.18 per basic and diluted share, for the three-month-ended March 31, 2020.

Rajeev: The increase of $12 4 million was primarily due to increases in legal fees related to our ongoing <unk> related litigation increase in personnel expenses and increases in commercial and consulting expenses in preparation for the potential commercialization of <unk>.

Rajeev: In summary, we incurred a net loss for the three months ended March 31, 2024 of $40 9 million.

Rajeev: Or <unk> 54 per basic and diluted share compared to a net loss of $11 7 million or 18.

Rajeev: Per basic and diluted share for the three months ended March 31 2023.

Michael Kaseta: We ended the first quarter with $157.9 million cash on hand, which included $100 million in gross gross proceeds between a private placement of equity to a single investor and a third advance from healthcare royalty under our. In summary, we are well positioned financially to achieve our corporate objectives in 2020. I would now like to turn the call back over to Rob. Thank you, Mike. Operator, with that, I'd like to now open the call for questions. Thank you. If you'd like to ask a question, please press star 11. If your question hasn't been answered and you'd like to remove yourself from the queue, please press star 11 again.

Rajeev: We ended the first quarter with $157 $9 million cash on hand, which included $100 million in gross in gross proceeds between a private placement of equity to a single investor and a third advance from healthcare royalty under our agreement in.

Speaker Change #169: In summary, we are well positioned financially to achieve our corporate objectives in 2024, I would now like to turn the call back over to Roger.

Roger: Thank you Mike.

Speaker Change #159: Operator with that I'd like to now open the call for questions first question. Please.

Speaker Change #163: Thank you if you'd like to ask a question. Please press star one one if your question has been answered and you'd like to remove yourself from the queue. Please press star one again.

Operator: Our first question comes from Jason Gerberry with Bank of America. Your line is open.

Speaker Change #164: Our first question comes from Jason <unk> with Bank of America. Your line is open.

Jason Adair: Hey guys, thanks for taking my question. I guess just on last week's filing to dismiss by both Uther and the FDA, how quickly do you think? Do you have a sense of how quickly Judge Bates may move here? This seems like maybe the one new variable here. If FDA is being asked to give three days' notice, they don't want to give three days' notice; they want this dismissed. I'm just kind of curious how to put this in the proper context.

Speaker Change #168: Hey, guys. Thanks for taking my question.

Jason Adair: I guess just on.

Speaker Change #165: On last weeks.

Speaker Change #178: Filing to dismiss.

Speaker Change #170: Both user and.

Jason Adair: The FDA how quickly do you think you have a sense of how quickly judge Bates may move here. It seems like maybe the one new variable here.

Speaker Change #171: FDA is being asked to give 30 days notice they don't want to get rid of it noticed they want this dismissal I'm just kind of curious how to put this in proper context and then.

Roger A. Jeffs: And then, you know, ultimately, if you're able to secure approval, a broad approval, both PAH and PHILD, just wondering if there are any specific label variables you might call out that could really impact the commercial opportunity beyond just getting those two indications, how we might think about the label looking different than Teveso. Thanks. Hey Jason, good morning.

Speaker Change #180: Ultimately if you are able to secure approval of broad approval, both ph in ph ILD.

Jason Adair: If there are any specific label variables you might call out that could really impact the commercial opportunity beyond just getting those two indications how we might think about the labor looking different.

Speaker Change #172: Then today so thanks.

Roger A. Jeffs: Thanks for the question. I'll take the second question first, if I can, and then I'll ask Rusty to speak about his perspectives on the timing of the Motion to Dismiss case. So, great question, Jason. You know, again, what we talk about with utropia in terms of being differentiated is around its pillars, which are tolerability, titratability, durability, and usability. And all of that is sort of dictated by the print formulation.

Speaker Change #177: Hey, Jason Good morning. Thanks. Thanks for the question maybe I'll take the second question first if I can and then I'll ask <unk> to speak about.

Speaker Change #167: Prospectus around the timing of the.

Speaker Change #175: Motion to dismiss case.

Speaker Change #173: So great question, Jason you know again, what we talked about with each rep in terms of being differentiated are around its pillars, which are tolerability titrated ability durability and usability.

Speaker Change #173: And all of that is sort of dictated by the print formulation. So again with the ability to make precise and uniform particles in the lower end that the rest of the range. It allows for highly tolerable tolerable therapy, which is readily titratable.

Speaker Change #173: And then will be durable and usable through the the low resistance device that friendly for both <unk> ph ILD patients to use.

Speaker Change #173: The differentiation that we that we will see in the label in that regard will be specifically related to the exposures that we've seen in our clinical work versus what's in their labels that we will have up to 212 micrograms four times a day described in our label.

Speaker Change #173: Again, we're talking about 2425 breath equivalents, so much higher than what's in there today is a DPI.

Roger A. Jeffs: And as we know from historical standards, across all routes, across the cycle of delivery, dose matters. So the higher the dose and the more flexibility in driving those, the more.., capable that therapy will be. So that's why we think that utrepia will have a clear chance to become best in class and first in choice prostacyclin, not only to compete with inhaled triprosanone in the Tyvaso formats, but also when physicians are seeking to think about starting therapy, we think they should think about using utrepia as the first choice, and do that in sort of in place of oral therapies, And then also, in terms of sub-Q, where those patients, you know, are going to have a pretty burdensome time getting to a therapeutic dose of drug because of the off-target effects for both the oral and the parenteral formulation.

Speaker Change #173: And as we know from historical standards across all right proud to prostacyclin delivery dose matters. So the higher the dose in the north.

Speaker Change #173: Disability and driving because the more.

Speaker Change #173: Capable that therapy will be so that's why we think that neutropenia has a will have a clear chance to become best in class and first in choice prostacyclin.

Speaker Change #173: They compete with inhaled <unk> in the time, they said formats, but also when physicians are seeking to think about starting therapy.

Speaker Change #173: We think they should think of that using <unk> as the first choice not and do that in sort of in place of oral therapies like <unk>.

Speaker Change #173: And then also in terms of sub key where those patients are going to have a pretty burdensome time getting two therapeutic doses of drug because of the off target effects for both the oral and the parental formulations, so again tremendous market opportunity.

Roger A. Jeffs: So, again, tremendous market opportunity. Looking forward to launch, but I think we'll have very clear and distinguishable differentiation at the point of launch. And with that, Rusty, maybe you could speak about the logistics around the legal case. Sure. So, Jason, thank you for the question. The motion to dismiss and briefs that went in last week are the first round of briefs on the motion to dismiss. The briefing will continue through June 25th.

Speaker Change #173: Looking forward to launch, but I think what we will have a very clear indistinguishable differentiation.

Speaker Change #173: Pointed launch.

Speaker Change #184: And with that rest and maybe if you could speak about the logistics around the legal case sure. So Jason good question.

Speaker Change #187: The motion to dismiss and briefs that went in last week is the first round of briefs on the motion to dismiss.

Roger A. Jeffs: And then from there, you know, we don't have visibility as to what the judge will do and how long it will take him to rule. It's possible that at that point, he'll schedule a hearing, or it's possible he'll just rule on the briefs. But, you know, obviously, federal judges; it's hard to predict exactly how long they will take to issue a ruling.

Speaker Change #187: Briefing will continue through June 25th.

Speaker Change #187: And then from there we don't have visibility to.

Speaker Change #187: What the judge will do and how long it would take them to rule its possible.

Speaker Change #187: At that point his schedule, a hearing or it's possible they'll just roll on the briefs, but obviously federal judges its hard to predict exactly how long they would they would take to issue a ruling.

Rusty Schundler: Thank you for the questions. And just a reminder, that decision is not needed for the FDA to take final action. I've heard your name, understood.

Speaker Change #181: For the question.

Speaker Change #200: And just a reminder.

Speaker Change #184: That decision is not needed for the FDA to take final action as Rusty said in his comments.

Speaker Change #182: Operator next question please.

Operator: Thank you. Our next question comes from Julian Harrison with BTIG. Your line is open. Julian Harrison, your line is open.

Speaker Change #201: Thank you. Our next question comes from Julian Harrison with BTG. Your line is open Julien.

Speaker Change #188: Julian Harrison your line is open.

Operator: Our next question comes from Serge Belanger with Needham. Your line is open. Hi, good morning.

Speaker Change #188: Our next question comes from Serge Belanger with Needham Your line is open.

Serge D. Belanger: Thanks for taking my question. I guess the first one, Roger, you mentioned targeting the oral triplosomal market. Could you maybe elaborate on that in terms of the market opportunity, and I think this would be another differentiated aspect of Utropia, because I don't think your competitor has positioned their DPI product for that segment? And then secondly, can you just talk about payer coverage?

Speaker Change #186: Hi, good morning, Thanks for taking my questions.

Speaker Change #189: I guess the first one Roger you mentioned.

Speaker Change #192: Targeting the oral to possible market.

Speaker Change #194: If you can just maybe elaborate on that in terms of the market opportunity and I think this would be another differentiated aspect of your trip here because I don't think your competitors.

Speaker Change #194: <unk>.

Speaker Change #194: DPI product for that segment and then secondly can you just talk about payer coverage.

Speaker Change #202: I think in the past you've highlighted how you're you are launch ready to Salesforce has been expanded in Europe and are in the field.

Speaker Change #194: But maybe if you can talk about.

Speaker Change #186: How quickly you think you can get.

Speaker Change #190: Neutropenia on formulary post approval. Thanks.

Speaker Change #198: Yes. Thanks, Great question, So I'll take the first one around how we hope to cannibalize the oral market and then Mike if you'll talk about the payer to.

Roger A. Jeffs: So in terms of oral prostacyclines currently, and again these are just sort of generalized estimates, Oranitram is doing about 400 million per annum, and Uptravi's doing about 1.2 billion per annum. Both of them are different, they're both process cyclones, different in their sort of mechanistic approach, but Orenatram is difficult to titrate, it takes weeks, if not months to get to And those GI effects are the predominant reason that patients discontinue that therapy and then progress to other therapies, which in the past typically have been parenteral therapy.

Michael Kaseta: The payer landscape if you will.

Speaker Change #199: In terms of like oral prostacyclin currently and again these are just sort of generalized estimates.

Speaker Change #194: When the trans doing about 400 million per annum, and <unk> doing about $1 2 billion per annum.

Michael Kaseta: Both that they are different they are both process cycle is different and they're sort of missing a mechanistic approach, but a rent a trend.

Michael Kaseta: It's difficult to titrate. It takes weeks, if not months to get to a therapeutic dose causes a lot of off target Gi effects and those Gi effects are are the predominant reason that patients discontinue that therapy, and then progress to other therapies, which in the past typically has been a perennial therapy.

Roger A. Jeffs: UPTRAVI has a pretty tight and narrow dosed titration per, pretty much has a dose ceiling, so patients titrate to their top tolerated dose, and they're held on that dose and then removed from therapy once their disease progresses beyond the capabilities of the dose that they're on, and also comes with off-target effects. So we think that we could position utrepia. Particularly given its titratability, so again, what Utrepi has done through the print-enabled formulation is allowed for a titratable inhaled triprostenone formulation for the first time. It has a lot more flexibility and can become a much more rigorous and durable choice for physicians and their patients. You asked, you know, why United has not pointed this out.

Michael Kaseta: <unk> has a pretty tightened narrowed does titration curve.

Michael Kaseta: Pretty much has a dose ceiling so patients titrate to there.

Michael Kaseta: Top tolerate it does and then are held on that does and then removed from therapy once they their disease progresses beyond the capabilities of the depths that they're on so.

Michael Kaseta: And also comes with the off target effects. So we think that we could position you trap, yeah, particularly given its titrate ability. So again, what <unk> has done to the print enabled formulation.

Michael Kaseta: Allowed for.

Michael Kaseta: Titratable in inhaled <unk> formulation for the first time.

Michael Kaseta: So it has a lot more flexibility and can become.

Michael Kaseta: A much more rigorous and durable choice for physicians and their patients.

Michael Kaseta: No.

Michael Kaseta: Yes.

Speaker Change #203: <unk> has United not pointed this out well again it might be that they don't quite have the flexibility that we do in terms of dosing. So it has limitations in that regard I think the other aspect here is because they have an oral prostacyclin.

Speaker Change #203: They don't want it sort of detail against themselves and in fact had they done that it would have set the table for us quite nicely in terms of what we want to do as I just described.

Speaker Change #222: You can understand why they're not doing that but we will not be hindered in any way from that search. So we certainly are going to go after both the totality of the inhaled market and the totality of the prostacyclin market, particularly those patients that are <unk>.

Speaker Change #203: Having issues more with off target effects like Gi side effects, which are significant and.

Speaker Change #206: Parental effects like <unk> pain, and everything so again attractive markets $1 6 billion with $1 5 billion.

Speaker Change #204: They said aggregated opportunity now so you are already at a $3 billion.

Roger A. Jeffs: So, you're already at a $3 billion opportunity if we aggregate all of those markets together, and that's what the PHI will be, as I said in my comments, only marginally penetrated at this point. You know, really, really nice opportunity. I think the other thing I will say, and this is not, if you talk about inhalations, it's not a net zero-sum game. I think sometimes people try to position us antagonistically against users' opportunities, you know; I think in PHILD in particular.

Speaker Change #205: Opportunity, if we aggregate all of those markets together and that's absolutely a timing as I said in my comments only marginally penetrated at this point.

Speaker Change #207: Really very nice opportunity I think the other thing I'll say and this is not if you can talk about inhaled crossed another it's not a net zero sum game I think sometimes people are trying to position us.

Speaker Change #207: Thanks, Agonistic Lee against you that there is opportunity I think in ph ILD in particular.

Roger A. Jeffs: Again, there are lots of patients there. There's lots of opportunity for both companies to do well. And, you know, we look forward to launching in the near future and presenting the choice. And that's what we're about. So, Mike, if you'd talk about payer coverage,

Speaker Change #207: Again, there's lots of patients there does lots of opportunity for both companies to do well and we look forward to launching in the near future and presenting the choice and that's what we're about so Mike if you could talk about payer coverage.

Michael Kaseta: Yes, Serge thanks, so much for the question.

Serge: I think what's important to know is the overwhelming feedback we've received from from doctors and patients as they're wanting choice.

Michael Kaseta: Having you choppy available, we'll provide that choice, but we also understand in order to truly have that choice access thats critically important so we've been engaging with payers.

PAA: Received tentative approval in PAA is back in November of 2021, we've been engaging with payers since that time to discuss the value proposition of <unk> and I think we are confident that once we are we get full approval from the FDA.

Michael Kaseta: So we've been engaging with payers, you know; we received tentative approval in PAH back in November of 2021. And we've been engaging with payers since that time to discuss the value proposition of utrepia. And I think we are confident that once we get full approval for it from the FDA, we will be able to work through that and make sure patients have that choice and have that choice and have access.

Payer Representative: We will be able to work through that and make sure patients have that choice and to have that choice and to have access. So we are confident that we will achieve that but until we get approval. Obviously, none of that will be formalized, but we've had really good conversations with payers and feel very confident that patients will be afforded that choice to choose your trip.

Michael Kaseta: So, we are confident that we will achieve that, but until we get approval, obviously, none of that will be formalized, but we've had really good conversations with payers and feel very confident that patients will be afforded that choice to choose utrepia through an insurance platform where utrepia is on formula. Yeah, thank you.

PAA: Through an insurance platform.

PAA: Neutropenia is on formulary.

PAA: Okay. Thank you.

Operator: Thank you. Our next question comes from Julian Harris with BTIG. Your line is open. Hi guys, can you hear me?

PAA: Sure.

PAA: Thank you. Our next question comes from Julian Harris with BTG. Your line is open.

Julian Reed Harrison: Hi, guys can you hear me.

Julian Reed Harrison: Yes, we can, Julian. Good morning. All right. Sorry about that before.

Julian Reed Harrison: Yes, we can Julien good morning, Alright, sorry about that before and thank you for taking my questions. Rusty you highlighted that there are no lawsuits that directly prevent the FDA for making a potential approval decision at this time I understand you can't comment on when specifically the FDA is expected to make a decision.

Rusty: But are you able to comment on what they could be waiting on at this point understand it that might be too speculative question.

Rusty: And completely understand if you can't comment on that and then can you also remind us on where manufacturing stance have there been any additional inspections required by the FDA in the current cycle.

Julian: Yes, Julian Thanks for your persistence and getting through the call.

Julian: Rusty can answer the first question and then Mike If you will address the supply chain question.

Rusty: So Julien thank you for the question so.

Michael Kaseta: First we don't want to speculate.

Michael Kaseta: On what the FDA.

Michael Kaseta: Where they are in their process.

Michael Kaseta: Nor do we want to comment publicly on our interactions with the FDA to date so.

Julian Reed Harrison: Again as I said before there is no legal impediment to them taking final action on our NDA.

Julian Reed Harrison: We are awaiting that final action.

Michael Kaseta: But again, we can't really speak to any specific timing.

Michael Kaseta: Yes.

Michael Kaseta: Yes, Julian relating to supply.

Michael Kaseta: We've been we've been anticipating a launch obviously for a long time now we've been building commercial inventories through that entire time, so once the FDA.

Michael Kaseta: So, once the FDA grants final approval, we will be ready to hit the ground running immediately in all strengths of our product. Related to the inspection, as part of our tentative approval in November of 2021, the FDA did a pre-approval inspection in August of 2021, and that was included in our tentative approval. So, all the pre-approval inspections have been completed, and, you know, as I said, we've been building up commercial inventories since then and look forward to, you know, hopefully, an imminent launch. Very helpful, thank you.

Michael Kaseta: Final approval, we will be ready to hit the ground running immediately and all strengths.

Michael Kaseta: Of our product.

Michael Kaseta: Related to the inspection as part of our tentative approval in November of 2021, the FDA did a pre approval inspection in August of 2021 and that was included in our full our tentative approval. So.

Speaker Change #213: All of them pre approval inspections have been completed.

Michael Kaseta: And.

Speaker Change #217: As I said, we've been building up commercial inventories since then and look forward to.

Speaker Change #214: Hopefully in a minute launch here.

Speaker Change #214: Very helpful. Thank you.

Operator: Thank you. Our next question comes from Kambiz Yazi, with Jeffries. Your line is open.

canvas Yahtzee: Thank you. Our next question comes from canvas Yahtzee with Jefferies. Your line is open.

Kambiz Pashneh: Good morning team. Thank you for sharing some of the ascent data to date. So, I guess my question on that open-label study is kind of what titration schemes are you looking to assess?

canvas Yahtzee: Good morning team.

Speaker Change #214: Thank you for sharing some of the U S.

Speaker Change #218: Data to date.

Speaker Change #219: So I guess my question on that open label study is kind of what titration schemes are you.

Speaker Change #216: Looking to SaaS.

Rajeev Saggar: And then as a second question, in terms of that overall projected $3 billion inhaled nebuli-troposinol market, or sorry, inhaled troposinol market, what is the split between the different indications in that market, and is that also kind of including some cannibalization of the oral troposinol market? Hey, Kambiz. I'll speak to the market question. And then Rajeev, you're going to talk about what we're trying to achieve and what we feel is the first company-sponsored DPI test in PHLD patients. So, I think, Kambiz, when you look at the market opportunity here. Again, we're just going to say that Eclipse is 3 billion and growing. You know, there are.

Speaker Change #214: And then as a second question.

Speaker Change #214: In terms of that.

Speaker Change #214: Overall projected $3 billion.

Speaker Change #214: Inhaled <unk>.

Speaker Change #214: <unk>.

Speaker Change #223: Cross sell market.

Speaker Change #224: To cross sell in market.

Speaker Change #220: What do you see the split.

Speaker Change #221: Between the different indications in that market and is that also kind of including some cannibalization of the <unk>.

unknown: Overall <unk> market. Thank you.

Tom: Hey, Tom.

Tom: Ill stick to the market question and then Rajiv if you talk about what we're trying to achieve and what we feel is the first company sponsored.

Rajeev Saggar: TPI test in ph ILD patients.

Rajeev Saggar: So I think companies when you look at the market opportunity here.

Rajeev Saggar: Again, we're just going to say it eclipses $3 billion and growing.

Speaker Change #221:

Roger A. Jeffs: I think Uther has said that of their $1.5 billion on their last earnings call, they intimated that PHILD represented nearly $1 billion of that, approaching the billion in terms of indication opportunity, and that's with marginal penetration. So we think that market, again, if you believe it's $60,000, some people say it's $100,000. I think you said $30,000, but that number, I think they're taking north now, split the difference and call it $60,000. They're probably at high single digits, low double digit penetration, so just marginally penetrated, so lots and lots of room to grow there alone.

User: And I think user has said that up there $1 5 billion on their last earnings call. They intimated that ph ILD represented nearly $1 billion of that.

Speaker Change #225: Approaching a $1 billion.

User: In terms of indication opportunity and thats with marginal penetration. So we think that market again, if you believe at 60000 and some people say that the 100000 I think you said 30000, but that number I think theyre, taking north now, but let's just.

User: Split the difference and call it 60000.

Speaker Change #236: Theyre, probably it at high single digits low double digit penetration. So just marginally penetrated so lots and lots of room to grow there alone. So that's a multibillion dollar opportunity in ph ILD for sure with an inhaled prostacyclin moiety.

Roger A. Jeffs: So that's a multi-billion dollar opportunity, and P-H-I-L-D for sure with an inhaled prostacyclin moiety. With the orals, again, that's cannibalization, and that may take a little bit more time to move along, but if Utropia behaves the way we think it does, it can in the real world, then we think we can really infringe So we also think that's, for eutrophia specifically, that's a billion dollar opportunity as well.

User: With the oral is again, that's cannibalization and that May take a little bit more time to move along but he trivia.

User: Behaves the way we think it can.

Speaker Change #230: The real World and we think we can really infringe on the oral market.

Speaker Change #232: So we also think that's a very good track specifically, that's a billion dollar opportunity as well so when you aggregate those together.

Rajeev Saggar: So when you aggregate those together... Our share of the inhaled, our share of the oral, we think we can have a multi-billion dollar product, or more. So, I think, you know, again... We need to prove that out. We need to generate the law, uh... dynamics that we hope to do to support that, but the first thing is to get the approval, and we're working on it. So Rajeev, if you could talk about some of the things we're trying to achieve in terms of dosing, which will help us achieve this multi-billion dollar opportunity.

Speaker Change #229: Our share of the inhaled our share of the oral we think we can that we can have a multibillion dollar product.

Speaker Change #233: Or more so I think you know again.

Speaker Change #231: We need to prove that out we need to generate the launch.

Speaker Change #235: The dynamics that we hope to do to support that to be true but.

Speaker Change #237: The first thing is to get the approval and we're working hard to do that.

Speaker Change #235: So rajeev, if you'll talk about some of the things we're trying to achieve.

Rajeev: In terms of dosing, which will help us achieve this multibillion dollar opportunity.

Rajeev Saggar: Thank you, and Kambiz, good morning. So first of all, I think, you know, one thing we're highlighting here is that this is the first, open-label prospective study in PHLD using a dry powder inhaler. Utrepia in this regard.

Rajeev: Yeah, Thank you and can be <unk> and good morning.

Speaker Change #238: So first of all I think one thing we're highlighting here is that this is the first.

Speaker Change #234: And in the open label in a prospective study in ph ILD using a dry powder inhaler with your trip here in this regard remember we've already conducted the inspire study in 121 patients. So we really understand the tolerability profile and the titrated ability of your trip yet.

Speaker Change #239: And so we took those learnings and we brought it into patients with ph ILD.

Speaker Change #239: That debt has no debt have never been treated in the past and disregard as I highlighted we have we have seven patients that have enrolled to date.

Speaker Change #239: And one thing that.

Speaker Change #239: You had asked is what is what is the dosing recommendation for this patient population well clearly I think the primary objective is that one.

Rajeev Saggar: Well, clearly, I think the primary objective is one, you know, can the tolerability profile that we saw in the INSPIRE study in pH patients be replicated in pHLD? And I think the early small sample sizes, the answer is yes, it can.

Speaker Change #239: Can the Tolerability profile that we saw in the inspire study in ph patients be replicated in ph ILD and I think the early small sample sizes. The answer is yes. It can.

Taipei So: Clearly what needs to happen is dose matters right. So the increased study used in Taipei, So suggested that patients who get to at least nine breaths equivalents of <unk>.

Taipei So: <unk> tend to have a.

Taipei So: Better clinical effect, but actually patients who can get actually hire 211% to 12 breaths looks.

Speaker Change #242: It looks like the signal actually gets a bit stronger. So the priority of this study is to titrate the patient at least to nine to 12 breads, which is the traditional therapeutic goal of inhibitory <unk>, but more importantly to exceed that.

Taipei So: In the right patient profile right. So some patients.

Taipei So: May need now.

Taipei So: Nine to 12 breaths, maybe the majority of these actually need somewhere more than that.

Rajeev Saggar: One thing I think is really intriguing is that I highlighted in the call that the median dose at week eight is now 132 micrograms of utrepia, which is now equivalent to greater or equal to 15 breaths of Tybaso. So I think the early findings from the study are quite encouraging, and we look forward to completing enrollment in the study by the end of the year. So, Kambiz, I think when we finish the study, the important data for investors to look at would be our ability to titrate, which, as Rajeev said, at least in the early data, we're seeing good evidence that we can do that quite aggressively. And then the other question would be, how durable is it?

Speaker Change #243: One thing I think is really intriguing is that I highlighted in the call that the median dose at week eight is now a 132.

Speaker Change #244: Micrograms of your trip, yet, which is now equivalent to.

Taipei So: Greater equal to 15 breadth of <unk>. So so I think the early the early findings from this study are quite encouraging and we look forward to completing enrollment in this study by the end of the year.

Speaker Change #248: So comments I think when we when we finish this day the important data for investors to look at would be.

Speaker Change #241: What were the what's our ability to titrate, which which as Rajeev said at least in the early data. We're seeing good evidence that we can do that quite aggressively.

Speaker Change #241: And then the other question would be how durable is it and so far those patients are remaining on study remember as I stated in the preamble.

Roger A. Jeffs: And so far, those patients are remaining on study. So, as I stated in the preamble, It was only a median of 40 days where people who had started Pegasodpi in the National Jewish Center data were unable to continue that drug, and 50% of those patients dropped off within that 40-day median time frame. We're trying to make a contradictory statement to that to show that Utrepia is much more titratable and much more durable.

Speaker Change #248: It was only a median of 40 days, where people people, who had started as I said DPI within International Jewish Center data.

Taipei So: Unable to continue that drug and 50% of those patients dropped off within that 40 day median time frames.

Taipei So: We're trying to make a contradictory statement to that to show that <unk> is much more titratable and much more durable the reasons that patients predominantly came off.

Roger A. Jeffs: The reasons that patients predominantly came off in the National Jewish Center experience were clinical worsening, which I would assume is due to a lack of ability to provide a therapeutic dose; otherwise, they wouldn't worsen. And, you know, we're trying to basically show that Utrecht can perform in a very different way.

Speaker Change #246: National Jewish Center experience was for clinical worsening, which I would assume is due to a lack of ability to provide a therapeutic dose otherwise they wouldn't have worsened.

Taipei So: We're trying to.

Speaker Change #246: Basically show that you trip it can can perform in a very different way and obviously that speaks to its differentiated capabilities and market opportunity.

Roger A. Jeffs: And obviously, that speaks to its differentiated capabilities in the market. So, so far, so good, but more to come there. Thank you. Our next question comes from Matt Kaplan with Ladenburg Tallman. Your line is open.

Taipei So: So good that more and more to come there.

Taipei So: Operator.

Taipei So: Thank you. Our next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is open.

Matthew Lee Kaplan: Hi, good morning, guys. Thanks for taking the questions. Just in terms of your commercial preparation and readiness, how soon after approval will you launch the drug? Thanks. Mike, would you like to answer that question, please?

Matthew Lee Kaplan: Hi, Good morning, guys. Thanks for taking my questions.

Matthew Lee Kaplan: Just in terms of your commercial crop and readiness.

Speaker Change #251: How soon after approval.

Speaker Change #251: You are.

Speaker Change #247: When you launch the drug.

Speaker Change #247: Thanks, Mike would you like to answer that question. Please yes.

Michael Kaseta: Yeah, so Matt, thanks for the question. You know, obviously, once we get full approval, it'll take a little bit of time to, you know, list our price in compendia. But from a commercial availability standpoint, what I can say is our commercial team, our sales force, is literally ready to go immediately thereafter. Our commercial inventory will be ready to go within days after final approval. So, you know, I know a lot of companies take 30 to 45 days to launch after they get full approval.

Speaker Change #247: Yes, so Matt thanks for the question.

Michael Kaseta: Obviously once we get full approval it will take a little bit of time too.

Speaker Change #248: List price and the <unk>.

Michael Kaseta: But from a from a commercial availability or what I can say is our commercial team our sales forces literally ready to go immediately thereafter, our commercial inventory will be ready to go within days after.

Speaker Change #248: Final approval so.

Speaker Change #248: I know a lot of companies take 30% to 45 days to launch after they get full approval, we will be ready to go.

Speaker Change #248: Literally within days or a week after final approval.

Speaker Change #248: Regardless of when that time comes.

Speaker Change #248: Okay. Okay.

Speaker Change #256: And I know, we're all focused on waiting for <unk> approval, but <unk>.

Speaker Change #255: Thinking out a little bit into the future can you tell us a little bit more about <unk> and <unk>.

Speaker Change #255: And especially when you think that will play out in terms of the handheld the plasma market.

Michael Kaseta: Thanks for the question, Matt. So, you know, I think when you look at utrepia in terms, What it solves for, it's taken what was a, you know, if you look at just Tyvaso, nebulized Tyvaso, it was a fixed dose, or a non-readily titratable therapy, so we really transformed the therapeutic index, so we've made it much more titratable, so we can get to a higher effective dose, while keeping the AE profile the same, so you have a better therapeutic index for utrepia than you do with, for instance, nebulized tybasa, as an example.

Speaker Change #255: Yeah, I'll answer that thanks for the question Matt.

Speaker Change #253: I think when you look at your trip you in terms of what it solves for its taken what was a maybe you look at the <unk> in the Netherlands today.

Speaker Change #252: As a fixed dose.

Speaker Change #252: Not readily titratable therapy, so we've really transformed therapeutic index and we've made it much more titratable. So we can get to a higher effective dose.

Speaker Change #262: Keeping the AE profile. The same so you have a better therapeutic index 40 chirpy than you do with for instance, <unk> as an example.

Roger A. Jeffs: What we didn't solve for the four times a day treatment regimen, and that's the same, that's also true for tybasa with EPI. So, it improved the therapeutic profile of inhaled troposinol, but it still requires four times a day administration. So, what L606 will do is address that final point and really pull on that lever to make the market. Instead of just sharing the market with our competitor, we look to then basically dominate the market.

Speaker Change #252: What we didn't do was sell for the four times a day treatment regimen and that's the same that's also true for 10 days of the DPI.

Speaker Change #252: Improved on the therapeutic profile of inhibitor personnel, but still requires four times a day administration. So what <unk> will do is address that final point and really pull on that lever to make the market instead of just sharing the market with our competitor. We would look to then basically dominate the market.

Roger A. Jeffs: So, if we had a formulation that behaved the same as utrepia, but you could do that twice a day format and essentially solve for the overnight removal of therapy, which happens because you dose before you go to sleep, the half lasts four hours, and if you sleep eight hours, by the time you wake up, the therapy's gone.

Speaker Change #254: If we had a a formulation that behaved the same as your trip yet, but you could do that in a twice a day format and essentially solve for.

Speaker Change #259: Overnight removal of therapy, which happens because he does before you go to sleep. They have plans for hours, obviously paid out at that time, you wake up the therapy is gone we will solve that provide a more steady state.

Roger A. Jeffs: We will solve for that, provide a more steady state exposure, which we think will also be better for patient outcomes. And then, as Rajeev said, in the open-label trial, we're seeing just that. We're seeing that L606 is extremely well-tolerated, and that's because it has a, as we originally said, a seven times lower CMAG, and that it's UC zero to 24 hours is the same as given BID is the same as four times a day inhaled troposomal.

Speaker Change #261: Exposure, which we think will also be better patient outcome and then as Rajeev said in the open label trial, we're seeing just that we're seeing at El <unk> is extremely well tolerated and.

Speaker Change #263: And thats because it has a S.

Speaker Change #257: <unk> had a seven times lower <unk>.

Speaker Change #257: And then it's AUC zero to 24 hours this assignment.

Speaker Change #257: <unk> is the same as four times a day in Hampshire personnel. So.

Roger A. Jeffs: So, its target profile in open-label work so far is exactly what we'd want it to be, and now we're just going to try to replicate the type-A sub-increase study with L606. We'll start that at the end of this year and work hard to get that done and improve it sometime in the 28-time frame.

Speaker Change #257: Its target profile in open label works, if ours is exactly what we would want it to.

Speaker Change #257: Can be and now we're just going to try to replicate the time based on increased study with <unk> Asics will start that at the end of this year worked hard to get that done and improve sometime in the 2008 timeframe, but at that point in time.

Roger A. Jeffs: But at that point in time, we think that will be comfortable for QB because it's all for Regiment, while still giving all the benefits that Utrecht is. Thanks, Roger. Thank you, Matt. Operator, next question, if any.

Speaker Change #254: Okay.

Speaker Change #254: Right.

Operator: Thank you. There are no further questions. I'd like to turn the call back over to Roger for closing remarks. Okay.

Speaker Change #254: So getting all the benefits that you're tracking to that.

Speaker Change #254: Yes.

Speaker Change #266: Thank you Matt Operator next question if any.

Roger A. Jeffs: Thank you, operator. And thank you very much for the questions this morning. My hope is that the next time we address you on our earnings call, we will be providing to patients what we feel is a preferred product for inhaled troposinil, and it will come at a critical time as the market for inhaled troposinil rapidly expands.

Speaker Change #254: There are no further questions I would like to turn the call back over to Roger for closing remarks.

Operator: Great. Thank you operator.

Roger: Thank you very much for the questions. This morning.

Speaker Change #264: My hope is that the next time, we addressed on our earnings call, we will be providing to patients what we feel.

Speaker Change #260: Preferred product for inhibitor process now and it will be kind of a critical critical time as the market for inhaled <unk> rapidly expands.

Operator: Thank you for joining us today, and we look forward to speaking with you soon. Bye-bye. Thank you for your participation. This does conclude the program. You may now disconnect. Everyone, have a great day.

Speaker Change #260: Thank you for joining us today, and we look forward to speaking soon bye bye.

Speaker Change #265: Thank you for your participation. This does conclude the program you may now disconnect everyone have a great day.

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