Liquidia Corp (LQDA) 2025 Q1 法說會逐字稿

Good morning and welcome everyone to the Liquidia Corporation first quarter 2025 financial results. And corporate update conference call. My name is Ari, and I will be your conference operator today. (Operator Instructions). I will now hand the call off to Jason Adair, Chief Business Officer.

早上好，歡迎大家關注 Liquidia Corporation 2025 年第一季財務表現。以及公司最新動態電話會議。我叫阿里，今天我將擔任您的會議主持人。（操作員指令）。我現在將電話轉給首席商務官 Jason Adair。

Thank you, operator. It is my pleasure to welcome everyone to the Liquidia Corporation first quarter 2025 Financial Results and Corporate Update call. Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Medical Officer Dr. Rajeev Saggar, Chief Operating Officer and CFO Michael Kaseta, Chief Commercial Officer Scott Moomaw, and General Counsel Rusty Schundler.

謝謝您，接線生。我很高興歡迎大家參加 Liquidia Corporation 2025 年第一季財務業績和公司更新電話會議。今天參加電話會議的有執行長 Roger Jeffs 博士、首席醫療官 Rajeev Saggar 博士、首席營運長兼財務長 Michael Kaseta、首席商務官 Scott Moomaw 和總法律顧問 Rusty Schundler。

Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties.

在我們開始之前，請注意，今天的電話會議將包含前瞻性陳述，包括有關未來結果、未經審計和前瞻性財務資訊以及公司未來業績和/或成就的陳述。這些聲明受到已知和未知的風險和不確定性的影響。

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.

這可能會導致我們的實際結果或表現與本次電話會議中表達或暗示的任何未來結果或表現有重大差異。如需更多信息，包括我們的風險因素的詳細討論，請參閱公司向美國證券交易委員會提交的文件，該文件可在我們的網站上查閱。

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

現在我想將電話交給羅傑，讓他發表我們準備好的發言，然後他會開始回答你們的問題。

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

大家早安，感謝大家今天加入我們。再過兩週多一點的時間，確切地說是 5 月 24 日，我們將達到 Liquidia 首個內部開發的商業產品 YUTREPIA 的 PDUFA 目標日期。

An investigational inhaled dry powder formulation of treprostinil for the treatment of Pulmonary Arterial Hypertension, or PAH, and Pulmonary Hypertension Associated with Interstitial Lung Disease or PH-ILD. With all eyes on the future, we are going to keep our prepared remarks focused on a few key areas.

一種用於治療肺動脈高壓（PAH）和與間質性肺病相關的肺動脈高壓（PH-ILD）的試驗性吸入乾粉製劑。著眼於未來，我們準備的發言將重點放在幾個關鍵領域。

First, I'd like to take a moment to highlight last week's news regarding the decision rendered by the district court dismissing United Therapeutics cross claim that sought to challenge our amendment to the new drug application for YUTREPIA, which added the treatment of PH-ILD to YUTREPIA's proposed label.

首先，我想花點時間強調一下上週的新聞，該新聞涉及地方法院作出的裁決，駁回了聯合治療公司的反訴，該反訴旨在挑戰我們對 YUTREPIA 新藥申請的修改，該修改將 PH-ILD 治療添加到 YUTREPIA 的擬議標籤中。

While United Therapeutics has the right to appeal the court's ruling, we are pleased with the court's decision to dismiss this cross claim, specifically holding that United Therapeutics failed to establish standing. We are proud to say there continue to be no legal barriers barring YUTREPIA's potential final approval following the expiration of gating regulatory exclusivity on May 23, 2025.

雖然聯合治療公司有權對法院的裁決提出上訴，但我們對法院駁回這項反訴的決定感到滿意，特別是裁定聯合治療公司未能確立訴訟資格。我們很自豪地說，在 2025 年 5 月 23 日門控監管排他性到期後，YUTREPIA 獲得最終批准不再受到任何法律障礙的阻礙。

With this favorable ruling in hand, we are doubling down on our preparations for the potential launch of YUTREPIA with a laser focused on five key strategic areas. First, we're developing what we believe is the best-in-class product profile for YUTREPIA. As we've said before, YUTREPIA's tolerability, tight tractability, ease of use, and future labeling speaks to the fact that it offers a differentiated product profile.

憑藉這項有利裁決，我們將加倍努力為 YUTREPIA 的啟動做準備，並專注於五個關鍵策略領域。首先，我們正在開發我們認為是 YUTREPIA 一流的產品配置。正如我們之前所說，YUTREPIA 的耐受性、嚴格的可追溯性、易用性和未來的標籤表明它提供了差異化的產品特性。

We continue to further characterize these clear benefits in the company's open label ascent study in PH-ILD patients. As communicated in this morning's press release, Cohort A of the ascent study is now fully enrolled with more than 50 patients. The interim data has shown us that the dosing intolerability profile in the first 20 patients to complete eight weeks of treatment was consistent with observations made in the Inspire study of PAH patients.

我們將繼續在公司針對 PH-ILD 患者的開放標籤上升研究中進一步描述這些明顯的益處。正如今天上午的新聞稿中所述，Ascent 研究的 A 組目前已全部招募患者，共有 50 多名患者。中期數據表明，完成八週治療的前 20 名患者的劑量不耐受情況與 Inspire 對 PAH 患者進行的研究中的觀察結果一致。

Thus far, PH-ILD patients in the study have been able to titrate to doses that are 3 times higher than the label target dose of nebulized Tyvaso. These patients have also shown positive trends on exploratory measures of efficacy, including six-minute walk distance. Additional data from the ascent study will be presented during two poster sessions at the American Thoracic Society's international conference in San Francisco on May 20.

到目前為止，研究中的 PH-ILD 患者已能夠將劑量調整至比霧化泰瓦索標籤目標劑量高 3 倍的劑量。這些患者在療效探索性測量方面也表現出了積極的趨勢，包括六分鐘步行距離。這項上升研究的更多數據將於 5 月 20 日在舊金山舉行的美國胸腔科學會國際會議的兩場海報展示會上展示。

As part of the assent study, we will begin Cohort B, a directed transition study in the coming months where we will take patients unsatisfied with the clinical attributes of Tyvaso and Tyvaso DPI. And transition them to YUTREPIA. The goal of this study will be to directly compare the differences and potential benefits that YUTREPIA presents both in PAH and PH-ILD patients.

作為同意研究的一部分，我們將在未來幾個月內啟動 B 組，這是一項定向過渡研究，我們將接收對 Tyvaso 和 Tyvaso DPI 的臨床屬性不滿意的患者。並將它們轉換為 YUTREPIA。本研究的目標是直接比較 YUTREPIA 在 PAH 和 PH-ILD 患者中表現出的差異和潛在益處。

You'll hear more regarding this study in the months ahead. Next, we are fully prepared to go to market with a competitive share of voices. We have 50 sales reps in the field who have been on board for about 18 months and a companion medical affairs team, all with an impressive level of rare disease experience, and most with PH experience.

您將在接下來的幾個月中聽到更多有關這項研究的消息。接下來，我們已經做好充分準備，以有競爭力的份額走向市場。我們在該領域擁有 50 名銷售代表，他們已加入該領域約 18 個月，並且擁有一支醫療事務團隊，所有成員都擁有令人印象深刻的罕見疾病經驗，並且大多數人擁有 PH 經驗。

These groups have been actively surveilling both the major centers of excellence as well as the community prescriber base in preparation for YUTREPIA 's potential launch. Our third strategic area of focus is our preparation to launch a full suite of patient support services which we have meticulously put into place.

這些團體一直在積極監督主要的卓越中心以及社區處方者基礎，為 YUTREPIA 的潛在推出做準備。我們的第三個策略重點領域是準備推出一整套我們已精心實施的患者支援服務。

Physicians and patients should expect no differences in support with YUTREPIA , whether starting inhale troposo for the first time or transitioning from incumbent inhaled products. Fourth, we've continued to focus on ensuring robust product availability. Mike and his team at Liquidia have prepared to put product in the channel in only 2 weeks to 3 weeks after YUTREPIA's potential approval.

無論是第一次開始吸入 troposo 還是從現有的吸入產品過渡，醫生和患者對 YUTREPIA 的支持應該沒有任何差異。第四，我們持續致力於確保產品的強勁供應。在 YUTREPIA 獲得潛在批准後，Mike 和他的 Liquidia 團隊準備在 2 週到 3 週內將產品投放到通路中。

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

最後，幫助我們確保成功的第五個策略重點領域是廣泛的付款人准入。在過去的幾年裡，我們與付款人建立了牢固的關係，他們了解 YUTREPIA 可以為患者提供的差異化產品。我們堅信，患者在 YUTREPIA 推出後不久就能使用。

With all these in play, we feel well prepared to launch YUTREPIA into the marketplace once approved, and we look forward to fulfilling our promise to provide patients with PAH and PH-ILD a much needed and potentially best in class therapeutic alternative. I'll now turn the call over to Mike to provide an overview of our first quarter, 2025 financials. Mike.

有了這些因素的共同作用，我們感到做好了充分準備，一旦獲得批准，YUTREPIA 就會被推向市場，我們期待履行我們的承諾，為 PAH 和 PH-ILD 患者提供急需的、可能最好的治療替代方案。現在我將把電話轉給麥克，讓他概述一下我們 2025 年第一季的財務狀況。麥克風。

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

謝謝你，羅傑，大家早安。查看我們的 2025 年第一季財務業績（可在新聞稿中找到），您會發現截至 2025 年 3 月 31 日的三個月的收入為 310 萬美元，而截至 2024 年 3 月 31 日的三個月的收入為 300 萬美元。收入主要與促銷協議有關。

The increase of $0.1 million was primarily due to the impact of unfavorable gross to net returns adjustments recorded in the prior year offset by lower sales volumes in the current year. Cost of revenue was $1.5 million for each of the three months ended March 31, 2025 and 2024. Cost of revenue related to the promotion agreement, as noted above.

增加 10 萬美元主要是由於上一年記錄的不利的毛利對淨利調整的影響，但被本年度的銷售量下降所抵消。截至 2025 年 3 月 31 日及 2024 年 3 月 31 日的三個月，每個月的收入成本均為 150 萬美元。如上所述，與促銷協議相關的收入成本。

Research and development expenses were $7 million for the three months ended March 31, 2025 compared to $10.1 million for the three months ended March 31, 2024. The decrease of $3.1 million or 31%, was primarily due to a $3.6 million decrease in personnel expenses, including stock-based compensation, due to a shift from activities related to research and development to preparation for the potential commercialization of YUTREPIA.

截至 2025 年 3 月 31 日的三個月，研發費用為 700 萬美元，截至 2024 年 3 月 31 日的三個月，研發費用為 1,010 萬美元。減少 310 萬美元（31%），主要是由於人員費用（包括股票薪酬）減少 360 萬美元，原因是從與研發相關的活動轉向為 YUTREPIA 的潛在商業化做準備。

These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $0.4 million decrease in expenses related to our YUTREPIA research and development activities. General and administrative expenses were $30.1 million for the three months ended March 31, 2025, compared to $20.2 million for the three months ended March 31, 2024.

這些減少被與我們的 L606 計畫相關的臨床費用增加 170 萬美元和與我們的 YUTREPIA 研究和開發活動相關的費用減少 40 萬美元所抵消。截至 2025 年 3 月 31 日的三個月，一般及行政費用為 3,010 萬美元，而截至 2024 年 3 月 31 日的三個月，一般及行政費用為 2,020 萬美元。

The increase of $9.9 million or 48%, was primarily due to an $8.1 million increase in personnel expenses, including stock-based compensation, driven by higher headcount and a shift from activities related to research and development to preparation for the potential commercialization of YUTREPIA $0.6 million increase in legal fees related to our ongoing YUTREPIA -related litigation.

增加 990 萬美元或 48%，主要是由於人事費用增加 810 萬美元，包括股票薪酬，這是由於員工人數增加以及從與研發相關的活動轉向為 YUTREPIA 的潛在商業化做準備所致；與我們正在進行的 YUTREPIA 相關訴訟相關的法律費用增加 60 萬美元。

And a $0.6 million dollar increase in facilities and infrastructure expenses. We incurred a net loss for the quarter ended March 31, 2025, of $38.4 million or $0.45 per basic and diluted share compared to a net loss of $30.1 million or $0.40 per basic and diluted share for the three months ended March 31, 2024.

設施和基礎設施費用增加了 60 萬美元。截至 2025 年 3 月 31 日的季度，我們的淨虧損為 3,840 萬美元，即每股基本虧損和稀釋虧損均為 0.45 美元，而截至 2024 年 3 月 31 日的三個月的淨虧損為 3,010 萬美元，即每股基本虧損和稀釋虧損均為 40.00.00 美元。

Included in the comparative results we have presented is an immaterial revision of other income as previously reported for fiscal year 2024. This revision is a technical non-cash accounting adjustment related to gain and loss recognized when we made amendments to our HCR facility made in 2024. Additional details are included in the Form 8-K we filed this morning.

我們提供的比較結果包括 2024 財年先前報告的其他收入的非重大修訂。此次修訂是一項技術性非現金會計調整，與我們在 2024 年對 HCR 設施進行修訂時確認的損益有關。我們今天早上提交的 8-K 表格中包含了更多詳細資訊。

I would now like to turn the call back over to Roger.

現在我想把電話轉回給羅傑。

Thank you, Mike. In summary, we continue to drive forward the right set of strategies to support the successful potential launch of YUTREPIA in the coming weeks, and we look forward to providing both physicians and patients with what we believe could soon become the pro cycle of first choice. I would now like to open the call to questions. Operator, first question, please.

謝謝你，麥克。總而言之，我們將繼續推進正確的策略，以支持未來幾週內 YUTREPIA 的成功上市，我們期待為醫生和患者提供我們認為可能很快成為首選的專業週期的產品。現在我想開始提問。接線員，請問第一個問題。

Thank you. At this time, we will conduct the question-and-answer session. (Operator Instructions). Our first question comes from the line of Julian Harrison of BTIG. Your line is now open.

謝謝。此時，我們將進行問答環節。（操作員指令）。我們的第一個問題來自 BTIG 的 Julian Harrison。您的線路現已開通。

I congrats on all the progress and thank you for taking my questions. I'm wondering if you believe United has any injunctive value left on the cross claim that was dismissed last week. I'm also curious if you had any reaction to the dismissal without prejudice versus with prejudice, given the judge's expressed views on standing in the opinion memorandum.

我對所有進展表示祝賀，並感謝您回答我的問題。我想知道您是否認為美聯航對上週被駁回的交叉訴訟仍有任何禁令價值。鑑於法官在意見備忘錄中表達的立場，我也很好奇您對無偏見駁回和有偏見駁回有何反應。

Good morning, Julian. Good to hear from you. Rusty, if you wouldn't mind answering Julian's two questions.

早安，朱利安。很高興收到你的來信。拉斯蒂，如果你不介意的話，請回答朱利安的兩個問題。

Sure, Julian, thanks for the question. So let me, I mean, go over a couple of things. I mean, one, what, what's absolutely clear is that there's currently no proceeding, actively ongoing in which United Therapeutics is seeking to join either the FDA from giving us approval for YUTREPIA or seeking any sort of temporary restraining order preliminary injunction to prevent or launch of YUTREPIA upon approval.

當然，朱利安，謝謝你的提問。所以，我想先討論幾件事。我的意思是，首先，絕對清楚的是，目前沒有正在進行的程序，聯合治療公司正在尋求加入 FDA 以阻止我們批准 YUTREPIA，或尋求任何形式的臨時限制令初步禁令以阻止或在批准後推出 YUTREPIA。

That's number one. Number two, the dismissal was without prejudice. Again, keep in mind there was a motion to dismiss, so the judge was not addressing the full merits of the case. This was, a question of whether their complaint had even set forth grounds upon which the court could even entertain their their their lawsuit.

這是第一點。第二，解僱不具有偏見。再次提醒，請記住，這是一個駁回動議，因此法官並沒有處理案件的全部內容。問題在於，他們的投訴是否提供了法院可以接受其訴訟的理由。

You know what that does mean is they can try to repurpose or refashion the argument in the future, but I think what's clear from the way in which he approached the opinion is they can't come back with the exact same argument they did before.

你知道這意味著他們可以在未來嘗試重新利用或重塑這個論點，但我認為從他處理這個意見的方式可以清楚地看出，他們不能用和以前完全相同的論點來反駁。

I think they still have significant standing issues trying to link the bundling guidance to a 30 month stay and keep in mind again this is all just at the motion to dismiss phase, they still would have to then show that they're, correct on the merits as well. As far as other things that United Therapeutics might do, which I think your question alluded to, that's really not for us today.

我認為他們在試圖將捆綁指導與 30 個月的暫緩期限聯繫起來時仍然存在重大問題，請再次記住，這一切都只是在駁回動議階段，他們仍然必須證明他們在實質上也是正確的。至於聯合治療公司可能做的其他事情，我認為您的問題已經提到了，但這確實不適合我們今天討論。

We don't know what lengths they're going to go to try to deny PAH and PH-ILD patients access to an alternative therapy. What I can say though is, we'll be ready, in whatever form they pursue something if they pursue anything from here on out, we'll be ready to address it.

我們不知道他們會採取何種措施來阻止肺動脈高壓 (PAH) 和肺動脈高壓-間質性肺病 (PH-ILD) 患者獲得替代療法。但我可以說的是，無論他們以何種形式追求什麼，只要他們從現在開始追求任何事情，我們都會做好準備去解決。

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

謝謝，非常好，非常有幫助。再次感謝並恭喜你。

Thank you, Julian. Next question, please.

謝謝你，朱利安。請回答下一個問題。

Thank you. Our next question comes from the line of Kambiz Yazdi of Jefferies. Your line is now open. Kambiz? Do we have you here?

謝謝。我們的下一個問題來自 Jefferies 的 Kambiz Yazdi。您的線路現已開通。坎比茲？我們有你在這裡嗎？

Sorry, morning team. Thank you so much for the questions and very exciting times for the company. Maybe a little bit on the forward-looking transition studies, any kind of thoughts on what may be interesting patient baseline characteristics that you may be looking to enroll in that study and then would love to get an update on L606 as well.

抱歉，早安團隊。非常感謝您的提問，這對公司來說是一個非常令人興奮的時刻。也許是關於前瞻性過渡研究的一些想法，對於您可能希望參與研究的患者基線特徵有什麼有趣的想法，然後也希望獲得有關 L606 的更新。

Great, so both of those questions fall into Rajeev Saggar court. So you mind answering those.

太好了，所以這兩個問題都屬於 Rajeev Saggar 的問題。所以你介意回答這些問題嗎？

Yeah, I can be. Thanks for the question. So the first question was regarding the upcoming transition study. This study is specifically evaluating the transition from Tyvaso, either nebulized and preferably dry powder inhaler to YUTREPIA, these patients will be specifically in the category of PH-ILD, and that's very purposeful.

是的，我可以。謝謝你的提問。第一個問題是關於即將進行的過渡研究。這項研究專門評估了從 Tyvaso（霧化吸入器和最好是乾粉吸入器）到 YUTREPIA 的轉變，這些患者將特別屬於 PH-ILD 類別，這是非常有目的性的。

As in our for NDA filing in the Inspire study, we already showed that we were able to successfully transition patients with Group 1 PAH from nebulized directly YUTREPIA. And now we're trying to do the same thing in the PH-ILD population. So first of all, these patients will be on background Tyvaso, majority of them are on dry powder inhaler.

正如我們在 Inspire 研究中提交的 NDA 申請一樣，我們已經表明我們能夠成功地將 1 組 PAH 患者從直接霧化 YUTREPIA 轉變過來。現在我們正嘗試在 PH-ILD 族群中做同樣的事情。首先，這些患者將使用泰瓦索作為背景治療，其中大多數使用乾粉吸入器。

These patients will have PH-ILD and very similar to Cohort A as in part of the SE study that we're presenting at ATS, we're going to be looking for the ability to, we're going to be looking at safety. So can we safely transition number two? Can we transition them and then continue to showcase our product profile, which we believe is going to be beneficial in terms of our ability to up titrate that patient.

這些患者將患有 PH-ILD，並且與 A 組非常相似，就像我們在 ATS 上展示的 SE 研究的一部分一樣，我們將尋找能力，我們將關注安全性。那麼我們可以安全地進行第二次過渡嗎？我們能否轉變它們，然後繼續展示我們的產品概況，我們相信這對我們提高患者治療效果的能力是有益的。

Maintain their clinical stability or even improve them. So we'll be looking at exploratory efficacy, modalities inclusive of course, six-minute walk, and other, quality of life indicators. So we look forward to showcasing that study and initiating that in the next few months. And your second question is that on L606?

維持其臨床穩定性甚至改善。因此，我們將研究探索性功效、包括六分鐘步行在內的方式以及其他生活品質指標。因此，我們期待展示這項研究並在接下來的幾個月內啟動它。您的第二個問題是關於 L606 的嗎？

Yeah, just an update there.

是的，只是更新一下。

Yeah, thank you. So you know we're working diligently to initiate this global study just to just to recap, this is the liposomal sustained release formulation of treprostinil that we're going to be delivering twice a day. Just to recap, this is a global study with more than 300 patients and more than 20 companies, and we anticipate that we'll be initiating the study by year's end.

是的，謝謝。所以你知道我們正在努力啟動這項全球性研究，只是為了回顧一下，這是我們將每天兩次遞送的曲前列尼爾脂質體緩釋製劑。總結一下，這是一項全球性研究，涉及 300 多名患者和 20 多家公司，我們預計將在今年年底前啟動這項研究。

Thank you.

謝謝。

Thank you. Our next question comes from the line of Greg Harrison of Scotiabank. Your line is now open.

謝謝。我們的下一個問題來自豐業銀行的格雷格·哈里森。您的線路現已開通。

Hey, good morning guys. Congrats on the progress and thanks for taking the question. So we've seen the competitors struggle to convert patients to their dry powder formulation and their nebulized formulation has persisted longer than than thought initially.

嘿，大家早安。恭喜您取得的進展並感謝您提出這個問題。因此，我們看到競爭對手努力讓患者接受他們的乾粉配方，並且他們的霧化配方的持續時間比最初想像的要長。

Could you speak to the patient perspective on switching to dry powder formulation and whether you think YUTREPIA will have a stronger case for keeping patients on a DPI formulation. Than we've seen with Tyvaso and how do you think the assent data will help with this argument?

您能否從患者的角度談談對改用乾粉配方的看法，以及您是否認為 YUTREPIA 更有理由讓患者繼續使用 DPI 配方。比我們在 Tyvaso 身上看到的情況更甚，您認為同意數據將如何幫助支持這一論點？

Yeah, good morning, Greg. Thanks for the question. So I'll start with an answer and then Rajeev will give you thoughts as well. I think that'd be helpful. So, again, I think you are right, it's surprising that there remain residual nebulized type of patient base. I think it's about 31% of the scripts to date.

是的，早上好，格雷格。謝謝你的提問。因此我將首先給出答案，然後 Rajeev 也會給您一些想法。我認為那會有幫助的。所以，我再次認為你是對的，令人驚訝的是仍然存在殘留的霧化類型的患者群體。我認為它佔了迄今為止劇本的 31% 左右。

When all thoughts, including the, competitors thoughts initially were that all patients would trans transition to the DPI for portability reasons alone. So that hasn't happened, and then the question is why. We think it's formulation driven and that their formulation is part of an aggregated poly dispersed formulation on a FTKP backbone really and a high resistance device and low flow really doesn't deliver the drug to the lower airway.

當所有人（包括競爭對手）的想法最初都是認為所有患者都會出於可移植性原因而轉向 DPI 時。所以這並沒有發生，那麼問題是為什麼。我們認為這是由配方驅動的，而且它們的配方實際上是 FTKP 主幹上的聚集多分散配方的一部分，而高阻力裝置和低流量實際上不會將藥物輸送到下呼吸道。

Which is the site of action. So that's completely the opposite of what a print enabled your rep is going to achieve and which is what we've shown in the study. That patients can tolerate the drug well. They can get to very high doses and they can get there quickly. So those two points are important in the sense that patients want to feel better.

哪個是行動地點。所以，這與印刷品使您的代表能夠實現的目標完全相反，這也是我們在研究中所展示的。患者能夠很好地耐受該藥物。他們能夠達到非常高的劑量，而且能夠很快達到目的。因此，從患者希望感覺更好的意義上來說，這兩點很重要。

They want to do it on convenient and portable therapeutic modality, and we think YUTREPIA is clearly defined as a differentiated and a better opportunity to do just that. So I think what we'll do in the marketplace first is go after new patients starts to like to let physicians experience the benefits of utrepia firsthand. And then once they're comfortable with that, then we'll see if they will transition.

他們希望採用方便、便攜的治療方式，我們認為 YUTREPIA 被明確定義為一種差異化且更好的機會來實現這一目標。因此我認為我們在市場上首先要做的就是讓新患者開始喜歡讓醫生親身體驗 utrepia 的好處。一旦他們對此感到滿意，我們就會看看他們是否會轉變。

particularly their nebulized patients who are going to be looking for an alternative, more portable therapy. And then also I think it becomes a question of would you even start Tyvaso DPI or if you're on Tyvaso DPI, would you want to transition and as we just said in the previous question, we're going to have data directed directing to the specifics of how you transition and the benefits of doing the same.

特別是那些接受霧化治療的患者，他們正在尋找一種替代性的、更便攜的治療方法。然後，我認為問題還在於您是否會開始使用 Tyvaso DPI，或者如果您正在使用 Tyvaso DPI，您是否想要轉換，正如我們在上一個問題中所說的那樣，我們將有數據指導您如何轉換的具體細節以及這樣做的好處。

So, we're really excited about. All of the market opportunity, but I do agree that the nebulized Tyvaso, retained, commercial share is at risk and we're they're going to go after. So Rajeev, do you have any thoughts?

所以，我們真的很興奮。所有的市場機會，但我確實同意，霧化 Tyvaso 保留的商業份額存在風險，我們會努力爭取。那麼 Rajeev，您有什麼想法嗎？

Yeah, thanks, Roger. I think again just highlighting, I think we believe in our scientific formulation and our hypothesis that the print formulation with the low flow resistance device is actually what these patients need. I think from my perspective. I think what's what's really unique is two things, in back when we did the Inspire study in Group 1 PAH.

是的，謝謝，羅傑。我想再次強調，我認為我們相信我們的科學配方和我們的假設，即具有低流阻裝置的印刷配方實際上是這些患者所需要的。我從我的角度來思考。我認為真正獨特的是兩件事，當我們在第 1 組 PAH 中進行 Inspire 研究時。

It took a while for patients to titrate up YUTREPIA to get to doses of therapeutic zones. I think what we're seeing now, a few years later, now that we did the first cohort study that we now have fully enrolled, and we're going to showcase the data at ATS is that. Not only can we titrate doses to above the sort of traditional 9 breaths to 12 breaths.

患者需要花一段時間來調整 YUTREPIA 劑量以達到治療區的劑量。我認為我們現在看到的是，幾年後，我們進行了第一項隊列研究，現在已經完全招募了受試者，我們將在 ATS 上展示數據。我們不僅可以將劑量滴定到傳統的 9 次呼吸到 12 次呼吸以上。

We're dosing these to, at least twofold levels higher than what traditionally is given by Tyvaso, but we can do it in a matter of just, several weeks, not, over a course of a year, and I think that's very important because these patients are extremely sick. They are susceptible to clinical worsening and finally inherently they just have terrible coughs.

我們給這些藥物的劑量至少是泰瓦索傳統劑量的兩倍，但我們可以在短短幾週內完成，而不是一年的時間，我認為這非常重要，因為這些病人的病情非常嚴重。他們的臨床症狀很容易惡化，最終導致嚴重的咳嗽。

And one thing I think to your question is that the current incumbents dry powder formulation, I think one of its major limitations is its its inability to titrate to the appropriate doses to match the clinical severity of the patient in part. Due to cost, and I think one of the things that we are going to continue to highlight, especially at ATS is just the tolerability profile of YUTREPIA seems to be.

對於您的問題，我認為目前的乾粉配方，我認為其主要限制之一是無法滴定到適當的劑量以匹配患者的臨床嚴重程度。由於成本原因，我認為我們將繼續強調的事情之一，特別是在 ATS 上，就是 YUTREPIA 的耐受性概況。

Well received by the patients and the practitioners that are participating in the study. So I think using that that signal and reshowing that in the transition study, I think would be would be well received by the scientific community.

受到參與研究的患者和從業者的好評。因此我認為，使用那個訊號並在過渡研究中重新展示它，會受到科學界的歡迎。

Great. Thank you, Rajeev. I think your comments speak to the snippets of, why we're so excited about the pending launch. Operator, next question, please.

偉大的。謝謝你，拉吉夫。我認為您的評論部分說明了我們為何對即將發布的產品如此興奮。接線員，請問下一個問題。

Thank you. Our next question comes from the line of Cory Jubinville of Lifesci Capital. Your line is now open.

謝謝。我們的下一個問題來自 Lifesci Capital 的 Cory Jubinville。您的線路現已開通。

Thanks for taking our questions and congrats on the progress. So you mentioned earlier in the prepared remarks that you're building up this prescriber support team and as we speak to KOLs in addition to efficacy and tolerability, seems that ease of prescribing also appears to be a major component to their prescription habits. Could you just provide a little bit more detail as to what that support team might look like.

感謝您回答我們的問題，並祝賀取得的進展。因此，您在先前準備好的評論中提到，您正在建立這個處方支持團隊，當我們談到 KOL 時，除了功效和耐受性之外，開藥的便利性似乎也是他們開藥習慣的重要組成部分。您能否提供一些有關該支援團隊的詳細資訊？

And their activities and Specifically, what might you be doing that improves the prescriber experience over what's out there presently and how that compares to potential competitors and I guess on the patient side in terms of early patient access, do you have any details about what a potential bridging program might look like if that's in the plans for patients.

以及他們的活動，具體來說，您可能會做些什麼來改善目前的處方體驗，以及與潛在競爭對手相比如何，我想在患者方面，就早期患者訪問而言，您是否可以詳細說明如果在患者的計劃中，潛在的橋接計劃可能是什麼樣的。

Yeah, thanks for the question, Cory. So we're benefited by having our Chief Commercial Officer Scott Moomaw on the call. So Scott, if you wouldn't mind addressing the questions.

是的，謝謝你的提問，科里。因此，我們的商務長 Scott Moomaw 參加電話會議讓我們受益匪淺。那麼史考特，如果你不介意回答這些問題的話。

Yes, sure, good morning. So you know the specifics, I think we'll sort of share as we get through and pass approval around the patient support program, but what I would say is, our team has over a decade, most folks have over a decade of experience with protonol in the various forms.

是的，當然，早安。所以您知道具體細節，我想我們會在患者支持計劃獲得批准後與您分享，但我想說的是，我們的團隊有十多年的經驗，大多數人都有十多年使用各種形式的普羅托諾的經驗。

Working with especially pharmacies, working with these this patient population, and we have a very good understanding of what the needs of the HCPs and the patients are. So we built out a program that we think in all respects will be as good as or better than. What's on the market right now in terms of the way that these patients have been cared for, we completely understand the point that you raised around.

透過與藥局合作、與這些患者群體合作，我們非常了解 HCP 和患者的需求。因此，我們制定了一個我們認為在各方面都一樣好甚至更好的計劃。就目前市場上對這些患者的照護方式而言，我們完全理解您提出的觀點。

Being able to start these patients is what's very important to early success, and we're going to make sure that we have everything in place to make sure that happens, and we look forward to sharing that with you hopefully after the end of May.

能夠開始治療這些患者對於早期成功至關重要，我們將確保一切準備就緒以確保這一點，我們期待在五月底之後與您分享這一消息。

Great, thank you, Scott.

太好了，謝謝你，斯科特。

Thank you. Our next question comes from the line of Jason Gadberry of BFA. Your line is now open.

謝謝。我們的下一個問題來自 BFA 的 Jason Gadberry。您的線路現已開通。

Hey guys, this is [Q on] for Jason. Thanks for taking our question. So you have some data presentation at the, ATS meeting in a couple of weeks. I'm curious if you can give us an early flavor of these presentations, what's your expectations, and, when might we get the full 48 week data from the SN study. Thanks so much.

嘿，大家好，這是 Jason 的 [Q on]。感謝您回答我們的問題。因此，您將在幾週後的 ATS 會議上展示一些數據。我很好奇您是否可以讓我們提前了解這些演示，您的期望是什麼，以及我們什麼時候可以從 SN 研究中獲得完整的 48 週數據。非常感謝。

Great, since Rajeev, you're the leading architect of the cohort I study, you could talk to that question.

太好了，由於 Rajeev，您是我研究的群體中的首席建築師，您可以談談這個問題。

Yeah, thanks for that question. I think at this point, obviously we're under an embargo to go into the actual details of the study, but essentially, we're going to be presenting three posters, two are specifically related to the study which we will showcase the first 20 patients. That were treated for eight weeks. Remember, these are patients with newly diagnosed PH-ILD that are now taking YUTREPIA.

是的，謝謝你的提問。我認為在這一點上，我們顯然無法透露研究的實際細節，但基本上，我們將展示三張海報，其中兩張與研究特別相關，我們將展示前 20 名患者。治療持續了八週。請記住，這些是新診斷的 PH-ILD 患者，目前正在服用 YUTREPIA。

So we'll showcase a few things, the baseline demographics. We will detail out the tolerability profile of these patients as well as well as the dosing characteristics that we're seeing. So that's that's the first thing. The second thing is that we'll finally showcase. Some exploratory endpoints within the first two posters, the first one being, of course, what happens to their exercise tolerability.

因此我們將展示一些基本人口統計。我們將詳細說明這些患者的耐受性概況以及我們所看到的劑量特徵。這就是第一件事。第二件事是我們最終將展示。前兩張海報中的一些探索性終點，當然是他們的運動耐受性會發生什麼變化。

Which is defined by six-minute walk distance compared to baseline through eight weeks. And the other thing is we're going to showcase a novel endpoint that's known as cardiac effort, and that will be presented by Dr. Daniel Leon at the University of Rochester, again, sort of understanding why potentially these patients are showing, improvements in their exercise capacity and what are the potential reasons for that.

其定義為與八週內的基線相比，六分鐘的步行距離。另一件事是，我們將展示一種稱為心臟努力的新型終點，這將由羅徹斯特大學的丹尼爾·萊昂博士介紹，再次了解為什麼這些患者的運動能力可能會有所改善，以及其中的潛在原因是什麼。

And how YUTREPIA is modifying its performance on the right venture pole. The third poster will be presented. Looking at transitioning a patient that was participating in the Inspire study from who had acutely worsened and was hospitalized, placed on Intravenous proton and transition to LIQ861 or YUTREPIA.

以及 YUTREPIA 如何在正確的創投極上改變其表現。第三張海報將會展示。觀察參與 Inspire 研究的患者從病情急劇惡化並住院，接受靜脈質子治療，過渡到接受 LIQ861 或 YUTREPIA 治療。

And just highlighting that safety, that ability to transition patients from parental therapy back to LIQ861 in that in that study. So all in all we're very excited to again showcase some of these our product profiles of ATS.

並且在該研究中強調了安全性，即讓患者從父母治療過渡回 LIQ861 的能力。總而言之，我們非常高興再次展示我們的一些 ATS 產品簡介。

Thank you, Rajeev. Obviously the timing of that data's quite exciting and the fact that it will be presented, literally within a week of potential approval. Operator, next question.

謝謝你，拉吉夫。顯然，這些數據的公佈時機非常令人興奮，而且它將在獲得批准後的一周內公佈。接線員，下一個問題。

Right, thank you.

好的，謝謝。

Thank you. Our next question comes from the line of Serge Belanger of Needham. Your line is now open.

謝謝。我們的下一個問題來自尼德姆的塞爾日貝朗格 (Serge Belanger)。您的線路現已開通。

Hi, good morning. A couple of commercial questions. The first one made for Roger and Scott, can you just describe the level of awareness of YUTREPIA and it's differentiating attributes and the Group of physicians you'll be targeting upon launch.

嗨，早安。幾個商業問題。這是為羅傑和斯科特製作的第一個問題，您能否描述一下人們對 YUTREPIA 的認識程度及其差異化屬性，以及您在推出時所針對的醫生群體。

And secondly, do you expect that there could be some warehouse demand for this product or this is a group of physicians that will likely want to run their own internal evaluation before really ramping up usage of YUTREPIA. Thanks.

其次，您是否預計該產品可能會有一些倉庫需求，或者這是一組醫生可能希望在真正增加 YUTREPIA 的使用之前進行自己的內部評估。謝謝。

Yeah, thank you, thanks for the question. Scott, maybe you could opine on this.

是的，謝謝，感謝您的提問。斯科特，也許你可以對此發表意見。

Sure, so on the awareness question, obviously, prior to launch we're very limited, in, what we can communicate perspective. In fact, nothing. So, but we're looking forward to the launch, and I can guarantee you that we will be loud. The awareness will go up extremely quickly. There is background awareness, to the medical information we've shared, etc.

當然，關於意識問題，顯然，在發布之前，我們能夠傳達的觀點非常有限。事實上，什麼都沒有。所以，但我們期待著發布會的舉行，而且我可以向你保證，我們會非常大聲。意識將會極快地提高。有背景知識、我們分享的醫療資訊等等。

But once the sales team gets out there, we have a full suite of marketing activities, electronic activities. Our goal is that every HCP who is involved in PAH, whether that be PAH, or PH-ILD, will be aware and will be able to try it very soon after launch. The second question was about warehousing. I think there might be some of that due to the tolerability issues in the conversation that came up earlier around the nebulized patients.

但一旦銷售團隊開始行動，我們就會進行全套行銷活動和電子活動。我們的目標是讓每位參與 PAH 的 HCP（無論是 PAH 還是 PH-ILD）都能了解並能夠在推出後很快嘗試它。第二個問題是關於倉儲的。我認為這可能是因為之前討論霧化患者時出現了耐受性問題。

Certainly, as Roger has said, I think even earlier in this call, we'll be focused on new patients because those are the patients that give the physician really the best, op option opportunity to try the drug in sort of a clean way. Having said that, we have heard from a number of physicians that they have patients that have transitioned back to the nebulized.

當然，正如羅傑所說，我認為即使在這次電話會議的早些時候，我們也會把重點放在新患者身上，因為這些患者為醫生提供了真正最好的、手術選擇的機會，讓他們以一種乾淨的方式嘗試這種藥物。話雖如此，我們從許多醫生那裡聽說，他們的患者已經重新開始使用霧化治療。

A version of Tyvaso and I think we all understand that that's not optimal from a convenient standpoint and a dosing standpoint and so we will get some of those. We will work with those physicians to make sure that those are successes, but strategically, the patients that will be going after first and foremost will be those patients that are new to prostacyclin.

泰瓦索 (Tyvaso) 的一個版本，我想我們都明白，從方便的角度和劑量的角度來看，這不是最佳的，所以我們會得到其中的一些。我們將與這些醫生合作，確保治療成功，但從策略上講，我們首先要治療的患者是那些剛開始使用前列環素的患者。

Thanks, and I think Serge, one way to look at this is that there's been almost 3 phases of how we integrate YUTREPIA into the standard of care, and I do think we can change the paradigm that currently exists and become the process like on the first and best choice. So I think we'll do the new patient starts, then we'll do the transitions, and then.

謝謝，我認為 Serge，看待這個問題的一種方式是，我們將 YUTREPIA 融入護理標準的過程幾乎經歷了 3 個階段，我確實認為我們可以改變當前存在的範式，並將其變成像第一個和最佳選擇那樣的過程。所以我認為我們會先接待新病人，然後再進行過渡，然後。

If you just said what's the current inhaled prostate market, that's a 2 billion market opportunity and growing significantly still with the sort of white space that remains in PH-ILD, but then the other 2 billion today market opportunities, the oral prostate cyclones both [Travirannitram] enjoy, and I don't think there's been any counter detailing against those products to date.

如果您剛才說的是當前的吸入式前列腺市場，那就是 20 億美元的市場機會，並且由於 PH-ILD 中仍然存在的空白，該市場仍在顯著增長，但另一方面，今天的另外 20 億美元的市場機會，口服前列腺旋風劑 [Travirannitram] 也享有，我認為到目前為止還沒有任何針對這些產品的反擊。

And we certainly are going to do that because they have significant off-target effects. There's quite a, some duress that the patients have to undergo to get to therapeutic doses and be maintained on those therapies that we think we can solve for because now for the first time. There's a readily titratable and durable inhaled prostacyclin called YUTREPIA.

我們肯定會這樣做，因為它們具有顯著的脫靶效應。患者必須承受相當大的壓力才能達到治療劑量並維持我們認為可以解決的治療，因為這是我們第一次這樣做。有一種易於滴定且持久的吸入性前列環素，稱為 YUTREPIA。

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

因此，不同的促銷節奏將以不同的速度發生，但我認為，我們將共同整合所有這些。因此，當您看看當前的市場機會時，它實際上是 40 億並且還在成長，我想您知道我們有機會獲得巨大成功。我們不一定需要佔據現有份額，但我認為隨著時間的推移，這將會發生。

Operator, make time. One more question, if you have any.

接線員，請抓緊時間。如果您還有問題的話，還有一個問題。

Thank you. Our last question comes from the line of Ryan Deschner of Raymond James. Your line is now open.

謝謝。我們的最後一個問題來自 Raymond James 的 Ryan Deschner。您的線路現已開通。

Good morning. Curious on what you're anticipating in terms of the split between commercial and public payers in PAH and PH-ILD, and I was wondering if you could just quickly walk us through the important points of the 494-patent infringement suit that you recently filed. Thank you.

早安.我很好奇您對 PAH 和 PH-ILD 中商業付款人和公共付款人之間的分歧有何預期，我想知道您是否可以快速向我們介紹一下您最近提起的 494 項專利侵權訴訟的要點。謝謝。

Yeah, so Scott, if you'll answer the first part of that, and then Rusty you'll talk about the 494 litigation.

是的，斯科特，如果你回答第一部分，那麼拉斯蒂你會談論 494 訴訟。

Yeah, from a pay rate standpoint, looking at the process cycling market and specifically, we think we'll probably have about 50% Medicare, about 35%, commercial, maybe 10%, Medicaid, and then 5% other, whether that be Tricare, DOD, etc. So, we'll see when we get out there, but that seems to be what we're expecting.

是的，從支付率的角度來看，具體來說，我們認為我們可能有大約 50% 的醫療保險，大約 35% 的商業保險，也許 10% 的醫療補助，然後 5% 的其他保險，無論是 Tricare、國防部等。所以，當我們到達那裡時，我們會看到，但這似乎是我們所期望的。

And Ryan, thanks for the question on the 494 lawsuit. So we're not really going to comment much on that. I mean, obviously we filed the lawsuit, I think the complaint sets forth pretty clearly, our thoughts as to the grounds on which we're proceeding with an infringement lawsuit, that case is in the very early stages.

Ryan，謝謝你關於 494 訴訟的問題。所以我們實際上不會對此發表太多評論。我的意思是，顯然我們提起了訴訟，我認為投訴非常清楚地表明了我們對提起侵權訴訟的理由的想法，該案件尚處於非常早期的階段。

So again, can't really comment on timing and, typical with best practice won't comment, publicly on legal theories or legal strategies we're going to pursue in the case.

所以，再次強調，我們無法真正評論時機，而且，按照最佳實踐，我們不會公開評論我們將在案件中採取的法律理論或法律策略。

Great, thank you, Scott. Thank you, Rusty. Thank you, Ryan, for the question. So with that, we'll close. And as you can see, we're very excited about actually matriculating our mission and vision of delivering a new treatment modality to patients with PAH and PH-ILD. And hopefully as May 24, approaches, we'll be in touch and speaking with you all very soon. Thank you for your time this morning.

太好了，謝謝你，斯科特。謝謝你，Rusty。感謝 Ryan 提出這個問題。就這樣，我們就結束了。如您所見，我們非常高興能夠真正實現我們的使命和願景，為 PAH 和 PH-ILD 患者提供新的治療方式。希望隨著 5 月 24 日的臨近，我們能很快與大家取得聯繫並進行交談。感謝您今天上午抽出時間。

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

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。