Liquidia Corp (LQDA) 2024 Q4 法說會逐字稿

Good morning, and welcome, everyone, to the Liquidia Corporation full year 2024 financial results and corporate update conference call. My name is Shannon, and I will be your conference operator today. (Operator Instructions) I would like to remind everyone that this conference call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer.

早安，歡迎大家參加 Liquidia Corporation 2024 年全年財務表現及公司更新電話會議。我叫香農 (Shannon)，今天我將擔任您的會議接線生。（操作員指示）我想提醒大家，本次電話會議正在錄音。我現在將電話交給首席商務官 Jason Adair。

Thank you, Shannon. It's my pleasure to welcome everyone to the Liquidia Corporation Full Year 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.

謝謝你，香農。我很高興歡迎大家參加 Liquidia Corporation 2024 年全年財務表現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；營運長兼財務長 Michael Kaseta；醫療長 Rajeev Saggar 博士；商務長 Scott Moomaw；以及總法律顧問 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 which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call.

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。這些聲明受已知和未知的風險和不確定性的影響，可能導致我們的實際結果或業績與本次電話會議中表達或暗示的任何未來結果或業績有重大差異。

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.

如需了解更多信息，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 would now like to turn the call over to Roger for our prepared remarks, after which he will open the call for your questions. Roger?

現在我想將電話交給羅傑，讓他發表我們準備好的發言，然後他將開始回答你們的提問。羅傑？

Thank you, Jason. Good morning, everyone, and thank you for joining us today. We believe that 2025 has the potential to be a transformational year for the company as we further build upon the success of 2024, which resulted in the broadening of the tentatively approved label for YUTREPIA to include both the treatment of patients with pulmonary arterial hypertension or PAH, and pulmonary hypertension associated with interstitial lung disease or PH-ILD. There are 4 strategic imperatives that will drive our success and growth, both in the near and long-term. These are seeking to obtain final approval and launching YUTREPIA in both PAH and PH-ILD as soon as possible after expiry of the gating clinical exclusivity on May 23 or just 65 days from now.

謝謝你，傑森。大家早安，感謝大家今天加入我們。我們相信，2025 年有可能成為公司的轉型之年，因為我們將進一步鞏固 2024 年的成功，這導致 YUTREPIA 的臨時批准標籤範圍擴大，既包括治療肺動脈高壓 (PAH) 患者，也包括治療與間質性肺病或 PH-ILD 相關的肺動脈高壓。有四項策略要務將推動我們近期和長期的成功和發展。他們正在尋求最終批准，並在 5 月 23 日或僅 65 天後的門控臨床獨佔期到期後儘快在 PAH 和 PH-ILD 中推出 YUTREPIA。

Secondly, to continue to advance the clinical profile of YUTREPIA to position it as not only the best-in-class inhaled prostacyclin, but also the first in choice prostacyclin for all patients in need of an oral or inhaled prostacyclin who remain underserved by current alternatives. Third, building upon our commercial and medical prowess to compete fiercely for capture of material and enduring market share in this multibillion-dollar and growing market segment.

其次，繼續提升 YUTREPIA 的臨床特性，使其不僅成為同類最佳的吸入性前列環素，而且成為所有需要口服或吸入性前列環素但目前替代方案仍未得到充分治療的患者的首選前列環素。第三，依託我們的商業和醫療實力，在這個價值數十億美元且不斷增長的市場領域中展開激烈競爭，爭奪材料和持久的市場份額。

And finally, to further evolve our mission of being a leader in the PAH space, by continuing to leverage our development expertise to advance treatment options that have the potential to further improve the lives of patients like our Phase III-ready next-gen sustained-release liposomal therapy, L606. I'd like to take a few minutes to expand on each of these strategic goals.

最後，為了進一步實現我們在 PAH 領域處於領先地位的使命，我們將繼續利用我們的開發專業知識來推進治療方案，這些方案有可能進一步改善患者的生活，例如我們已進入 III 期臨床的下一代緩釋脂質體療法 L606。我想花幾分鐘來詳細闡述每一個策略目標。

With regard to the first imperative of seeking to launch YUTREPIA into the marketplace as soon as possible, I'm happy to say that based on the favorable legal decisions over the last few years, there are no legal barriers that currently impact the FDA's ability to issue final approval of YUTREPIA after May 23, when the exclusivity granted to our competitor will expire.

關於盡快將 YUTREPIA 推向市場的首要任務，我很高興地說，基於過去幾年有利的法律​​判決，目前沒有任何法律障礙影響 FDA 在 5 月 23 日（即授予我們競爭對手的獨佔權到期後）對 YUTREPIA 進行最終批准的能力。

It's also important to remember that when the FDA issues a tentative approval of an NDA, it means the NDA has met all requirements for approval, but cannot reapprove due to existing legal or regulatory barriers. In our case, the sole barrier identified by the FDA was the new clinical exclusivity granted to Tyvaso DPI, which expires on May 23, 2025. As directed in the tentative approval label, we plan to submit request for final approval in the coming weeks.

還需要記住的是，當 FDA 發布 NDA 的暫時批准時，這意味著 NDA 已滿足所有批准要求，但由於現有的法律或監管障礙而無法重新批准。在我們的案例中，FDA 發現的唯一障礙是授予 Tyvaso DPI 的新臨床獨佔權，該權將於 2025 年 5 月 23 日到期。按照暫定批准標籤的指示，我們計劃在未來幾週內提交最終批准申請。

With regard to the second imperative of continuing to advance our studies to establish the clinical profile of YUTREPIA, the medical community's interest in YUTREPIA is increasing with particular interest in the data being generated from our ASCENT trial, the open-label safety study of YUTREPIA in PH-ILD patients. I'm happy to report that we are on track to complete enrollment in the coming weeks with 50 or more patients in total to be enrolled.

關於繼續推進我們的研究以確定 YUTREPIA 的臨床特徵的第二個要務，醫學界對 YUTREPIA 的興趣日益增加，尤其是對我們的 ASCENT 試驗生成的數據感興趣，該試驗是針對 PH-ILD 患者進行的 YUTREPIA 開放標籤安全性研究。我很高興地報告，我們將在未來幾週內完成招募，總共招募 50 名或更多患者。

We continue to be encouraged by the positive patient response to escalating doses of YUTREPIA. As a reminder, at the JPMorgan Healthcare Conference in January, we showed the dosing and tolerability profile for the first 20 patients that completed eight weeks of treatment. We noted that the PH-ILD patients on YUTREPIA were able to titrate to doses that are 3 times the comparable therapeutic target of nebulized Tyvaso.

患者對增加 YUTREPIA 劑量的正面反應讓我們繼續受到鼓舞。提醒一下，在一月份的摩根大通醫療保健會議上，我們展示了完成八週治療的前 20 名患者的劑量和耐受性概況。我們注意到，接受 YUTREPIA 治療的 PH-ILD 患者能夠將劑量調整至霧化 Tyvaso 可比治療目標的 3 倍。

And today, we're happy to share some new information from the ASCENT study. We've also been looking at exploratory measures of efficacy. One such measure is the change in six-minute walk test at week eight. We are pleased to report in this same 20-patient cohort, the mean change in baseline improved by 26.4 meters. While it is difficult to draw strong conclusions from cross-study comparisons, it is worth noting that in the Phase III registrational study of nebulized Tyvaso in PH-ILD patients, the INCREASE study, active group patients had an observed mean improvement of the six-minute walk distance of 16 meters at week 8 and 22 meters at week 16.

今天，我們很高興分享來自 ASCENT 研究的一些新資訊。我們也一直在研究功效的探索性測量。其中一個衡量標準是第八週六分鐘步行測試的變化。我們很高興地報告，在同一組 20 名患者中，基線平均變化改善了 26.4 公尺。雖然很難從交叉研究比較中得出有力的結論，但值得注意的是，在 PH-ILD 患者中霧化泰瓦索的 III 期註冊研究（INCREASE 研究）中，活動組患者的六分鐘步行距離在第 8 周平均改善了 16 米，在第 16 周平均改善了 22 米。

We are highly encouraged by this early efficacy data from ASCENT as it demonstrates that YUTREPIA reports the key therapeutic attributes in PH-ILD we aspired for, specifically being well tolerated and amenable to rapid dose escalation to doses well beyond historical standards, leading to an accelerated therapeutic outcome that is in line or better than published results of existing therapies.

ASCENT 的早期療效數據令我們深受鼓舞，因為它表明 YUTREPIA 報告了我們所渴望的 PH-ILD 的關鍵治療屬性，特別是耐受性良好，並且能夠快速增加劑量至遠遠超出歷史標準的劑量，從而導致加速治療結果，與現有療法的已公佈結果一致或更好。

And it should be noted that this data is especially compelling when compared to published data from Tyvaso DPI in the like sample of treatment-naive PH-ILD patients at the National Jewish Health Center that we have discussed previously, where 69% of patients discontinued therapy after a median time of only 40 days with drug-related AEs, especially cough and clinical worsening listed as the primary reasons for discontinuation of Tyvaso DPI.

值得注意的是，與我們之前討論過的國家猶太健康中心未接受過治療的 PH-ILD 患者樣本中 Tyvaso DPI 的已發表數據相比，這些數據尤其引人注目，其中 69% 的患者在平均僅 40 天後就停止了治療，原因是藥物相關不良反應，尤其是停止咳嗽和臨床惡化，這是使用 Tyvaso DPI 的主要原因。

We look forward to highlighting a more robust data set from the ASCENT trial at the ATS International Conference in San Francisco this May. With regard to our third strategic imperative to build upon our commercial and medical prowess, we have built a commercial enterprise that we feel is best-in-class. Our team has been in place for over 1.5 years and continues to support the use of treprostinil injection while also reinforcing relationships with our health care providers and our understanding of the unmet needs of PAH and PH-ILD patients throughout the country.

我們期待在今年 5 月於舊金山舉行的 ATS 國際會議上重點展示 ASCENT 試驗的更強大的數據集。關於我們的第三個策略要務，即鞏固我們的商業和醫療實力，我們已經建立了一個我們認為一流的商業企業。我們的團隊已在位超過 1.5 年，並​​繼續支持使用曲前列尼爾注射劑，同時加強與我們的醫療保健提供者的關係以及我們對全國 PAH 和 PH-ILD 患者未滿足需求的理解。

We are prepared to provide a seamless service to patients and providers upon launch of YUTREPIA and look forward to educating the PAH and PH-ILD communities on the favorable and potentially game-changing product attributes of YUTREPIA.

我們準備在推出 YUTREPIA 後為患者和提供者提供無縫服務，並期待向 PAH 和 PH-ILD 社群介紹 YUTREPIA 有利且可能改變遊戲規則的產品屬性。

Lastly, as we look at our fourth imperative to innovate and develop better therapeutic options, we continue to advance L606, our sustained release liposomal formulation of treprostinil that provides more consistent 24-hour drug exposure in 12-hour dosing segments, including during sleeping hours.

最後，當我們著眼於創新和開發更好的治療方案的第四個要務時，我們將繼續推進 L606，這是我們的曲前列尼爾緩釋脂質體製劑，可在 12 小時的給藥時段（包括睡眠時間）提供更一致的 24 小時藥物暴露。

We know that continuous infusion has shown the best efficacy with prostacyclin analogs, and we believe that the PK profile of L606 may provide the next closest noninvasive approach to maximizing the benefit from the more targeted inhaled route of administration.

我們知道持續輸注已顯示出前列環素類似物的最佳療效，我們相信 L606 的 PK 特性可能提供下一個最接近的非侵入性方法，以最大限度地發揮更有針對性的吸入給藥途徑的益處。

It is for all these reasons and with an eye towards our pending launch of YUTREPIA in the coming months that we decided to further strengthen our balance sheet as announced yesterday, with an extension of our valued partnership with Healthcare Royalty Partners that Mike will speak about now, along with an overview of our 2024 financials. Mike?

正是由於這些原因，並著眼於未來幾個月即將推出的 YUTREPIA，我們決定進一步加強我們的資產負債表（如昨天所宣布的），並延長與 Healthcare Royalty Partners 的寶貴合作夥伴關係（Mike 現在將談到這一點），同時概述我們的 2024 年財務狀況。麥克風？

Thank you, Roger, and good morning, everyone. Before we review our full year 2024 financial results, I'm happy to highlight yesterday's announcement regarding expansion of our financing agreement with Healthcare Royalty Partners, which will provide Liquidia up to an additional $100 million of financing in three tranches, including the $25 million tranche funded at closing.

謝謝你，羅傑，大家早安。在我們回顧 2024 年全年財務業績之前，我很高興強調昨天宣布的有關擴大與 Healthcare Royalty Partners 的融資協議的公告，該協議將分三批向 Liquidia 提供最多 1 億美元的額外融資，其中包括在交易結束時提供的 2500 萬美元融資。

We are grateful for the trust, commitment, and confidence that Healthcare Royalty Partners has demonstrated over the years, and we are optimistic that these proceeds and a successful launch of YUTREPIA following the expiration of exclusivity this May could lead to our reaching profitability without the need for additional capital.

我們感謝 Healthcare Royalty Partners 多年來表現出的信任、承諾和信心，我們樂觀地認為，這些收益以及今年 5 月獨家經營權到期後 YUTREPIA 的成功推出可以讓我們實現盈利，而無需額外資本。

Turning to our full year 2024 financial results, which can be found in the press release, you will see that revenue was $14 million for the year-ended December 31, 2024, compared with $17.5 million for the year-ended December 31, 2023. Revenue related primarily to the promotion agreement.

查看我們的 2024 年全年財務業績（可在新聞稿中找到），您會發現截至 2024 年 12 月 31 日的年度收入為 1400 萬美元，而截至 2023 年 12 月 31 日的年度收入為 1750 萬美元。收入主要與促銷協議有關。

The decrease of $3.5 million was primarily due to lower sales quantities driven by limitations on the availability of pumps used to administer treprostinil injection subcutaneously. Sales quantities will continue to be impacted or at risk until alternative pumps are available.

減少 350 萬美元主要是由於用於皮下注射曲前列尼爾的泵的供應受限導致銷售數量下降。在替代泵可用之前，銷售數量將繼續受到影響或面臨風險。

Cost of revenue was $5.9 million for the year-ended December 31, 2024, compared with $2.9 million for the year-ended December 31, 2023. Cost of revenue related to the promotion agreement as noted above. The increase from the prior year was primarily due to our sales force expansion during the fourth quarter of 2023.

截至 2024 年 12 月 31 日止年度的收入成本為 590 萬美元，而截至 2023 年 12 月 31 日止年度的收入成本為 290 萬美元。與上述促銷協議相關的收入成本。與前一年相比的成長主要歸因於我們 2023 年第四季銷售團隊的擴張。

Research and development expenses were $47.8 million for the year-ended December 31, 2024, compared with $43.2 million for the year-ended December 31, 2023. The increase of $4.6 million or 11% was primarily due to: one, a $6.1 million increase in expenses related to our L606 program. Two, a $5.3 million increase in expenses related to YUTREPIA research and development activities, including the ASCENT trial.

截至 2024 年 12 月 31 日止年度的研發費用為 4,780 萬美元，截至 2023 年 12 月 31 日止年度的研發費用為 4,320 萬美元。增加 460 萬美元或 11% 的主要原因是：一、與我們的 L606 計劃相關的費用增加了 610 萬美元。二、與 YUTREPIA 研究和開發活動（包括 ASCENT 試驗）相關的費用增加了 530 萬美元。

Three, a $5.1 million increase in personnel expenses, including stock-based compensation related to increased head count. And four, a $3.5 million upfront license fee due to Pharmosa for the exclusive license in Europe to develop and commercialize L606 recorded during the year-ended December 31, 2024.

三、人事費用增加510萬美元，包括與員工人數增加相關的股票薪酬。第四，截至 2024 年 12 月 31 日的年度內，我們向 Pharmosa 支付了 350 萬美元的預付許可費，用於獲得在歐洲開發和商業化 L606 的獨家許可。

Offset by: one, $5.1 million in lower commercial manufacturing expenses, reflecting the impact of expensing YUTREPIA inventory costs in the prior year. And two, a $10 million upfront license fee due to Pharmosa for the exclusive license in North America to develop and commercialize L606 during the year-ended December 31, 2023.

抵銷因素：商業製造費用降低 510 萬美元，反映了去年 YUTREPIA 庫存成本費用化的影響。第二，Pharmosa 需支付 1,000 萬美元的預付許可費，以獲得在 2023 年 12 月 31 日止年度內在北美開發和商業化 L606 的獨家許可。

General and administrative expenses were $81.6 million for the year-ended December 31, 2024, compared with $44.7 million for the year-ended December 31, 2023. The increase of $36.9 million or 82% was primarily due to: One, a $19.7 million increase in personnel expenses, including stock-based compensation, driven by higher head count and expansion of our sales force in the fourth quarter of 2023.

截至 2024 年 12 月 31 日止年度的一般及行政開支為 8,160 萬美元，而截至 2023 年 12 月 31 日止年度的一般及行政開支為 4,470 萬美元。增加 3,690 萬美元或 82% 的主要原因是：第一，由於 2023 年第四季員工人數增加和銷售隊伍擴大，人事費用（包括股票薪酬）增加 1,970 萬美元。

Two, a $7.9 million increase in legal fees related to our ongoing YUTREPIA-related litigation. And three, a $6.8 million increase in commercial expenses in preparation for the potential commercialization of YUTREPIA.

第二是與我們正在進行的 YUTREPIA 相關訴訟相關的法律費用增加了 790 萬美元。第三，增加 680 萬美元的商業支出，為 YUTREPIA 的潛在商業化做準備。

In summary, we incurred a net loss for the 12 months ended December 31, 2024, of $130.4 million or $1.66 per basic and diluted share compared to a net loss of $78.5 million or $1.21 per basic and diluted share for the 12 months ended December 31, 2023.

綜上所述，截至 2024 年 12 月 31 日的 12 個月，我們的淨虧損為 1.304 億美元，即每股基本虧損和稀釋虧損均為 1.66 美元，而截至 2023 年 12 月 31 日的 12 個月，我們的淨虧損為 7,850 萬美元，即每股虧損 1,812 淨虧損。

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

說完這些，我現在想把電話轉回給羅傑。

Thank you, Mike. As you can see, we're well positioned clinically, commercially and financially for the potential launch of our first product based on our proprietary print technology, which will serve as the growth engine for our continued evolution and inflection.

謝謝你，麥克。正如您所看到的，我們在臨床、商業和財務方面都處於有利地位，可以推出基於我們專有的列印技術的首款產品，這將成為我們持續發展和轉型的成長引擎。

I now I'd like to open the call for questions. Operator, first question please.

現在我想開始提問。接線員，請問第一個問題。

(Operator Instructions)

（操作員指示）

Julian Harrison, BTIG

朱利安·哈里森（Julian Harrison），BTIG

Hi, good morning. Thank you for taking my questions. Roger, you touched on this a little in your prepared remarks, but just wondering if you could talk more about the administrative sequence and time line to convert YUTREPIA's tentative approvals in PAH and PH-ILD to full approvals?

嗨，早安。感謝您回答我的問題。羅傑，您在準備好的發言中稍微提到了這一點，但我只是想知道您是否可以更多地談談將 YUTREPIA 在 PAH 和 PH-ILD 的臨時批准轉換為完全批准的行政順序和時間表？

Yes. So as we said in the opening -- thank you, Julian, and great to talk to you. So as we said in the opening, we plan to request final approval in the coming weeks. In the tentative approval label that we received in August, it was recommended and suggested that we apply for final approval either two or six months ahead of the action date, which would be May 23, given we view this as a Class I resubmission because no new data will be required for approval.

是的。正如我們在開頭所說的那樣——謝謝你，朱利安，很高興和你交談。正如我們在開頭所說的那樣，我們計劃在未來幾週內請求最終批准。在我們八月份收到的臨時批准標籤中，建議我們在行動日期（即 5 月 23 日）之前兩個月或六個月申請最終批准，因為我們將此視為 I 類重新提交，因為批准不需要任何新資料。

We have been in concert with the agency, working to deliver that letter around the March 24 time frame, so that we can be granted final approval around May 23. I don't know if that specifically addresses what you're seeking.

我們一直與該機構合作，爭取在 3 月 24 日左右遞交該信函，以便我們能夠在 5 月 23 日左右獲得最終批准。我不知道這是否具體解決了您所尋求的問題。

Yes, absolutely. That's very helpful. And then a follow-up, if I may, on L606. I'm curious what the physician feedback has been so far for a lower Cmax, broader AUC, longer half-life alternative to nebulized Tyvaso. And then sorry if I missed it. I'm wondering also when specifically you plan to initiate the Phase III RESPIRE trial?

是的，絕對是。這非常有幫助。如果可以的話，接下來是關於 L606 的後續問題。我很好奇到目前為止醫生對於比霧化 Tyvaso 具有更低 Cmax、更寬 AUC、更長半衰期的替代品的反饋如何。如果我錯過了，我很抱歉。我還想知道您具體計劃何時啟動第三階段 RESPIRE 試驗？

Yeah, great. And we're fortunate to have Dr. Rajeev Saggar on the call today. So Rajeev, if you wouldn't mind?

是的，很棒。我們很榮幸今天能邀請到 Rajeev Saggar 博士來參加我們的電話會議。那麼 Rajeev，你不介意嗎？

Yeah. Thanks, Julian, for the question. So first of all, I think the current open-label study is continues to gate very well. We have long-term safety data that has accrued since the inception of the study. The what -- a clear feedback is twice-a-day dosing is an absolute game changer for these patients when you inhale treprostinil.

是的。謝謝朱利安提出這個問題。首先，我認為目前的開放標籤研究繼續進展良好。我們擁有自研究開始以來累積的長期安全數據。一個明確的回饋是，當你吸入曲前列尼爾時，每天兩次的劑量絕對可以改變這些病人的病情。

I think that's first and foremost. Second of all, I think that the use of the liposome itself has showcased some, what we believe is some -- highlight some impressive safety advantages. And finally, further reducing the Cmax with the twice-a-day dosing profile and the sustained release formulation of the liposome itself. Thus we have noted that systemic side effects continue also to be further abated even beyond what we initially desired. So I think the combination of both of those are going to be highly encouraging for as we advance forward with the RESPIRE study.

我認為這是首要的。其次，我認為脂質體本身的使用已經顯示了一些我們認為令人印象深刻的安全優勢。最後，透過每日兩次的給藥方案和脂質體本身的緩釋配方進一步降低 Cmax。因此，我們注意到系統性副作用也進一步減輕，甚至超出了我們最初的預期。因此，我認為，隨著 RESPIRE 研究的推進，這兩者結合將會非常令人鼓舞。

In regards to initiating the RESPIRE study, we're working full steam ahead to prepare to initiate the study by year's end. We're -- it's around March right now. And so we look forward to providing further information as we get closer to that time frame near the end of the year.

關於啟動 RESPIRE 研究，我們正在全力以赴，準備在年底前啟動這項研究。我們現在大約是三月。因此，我們期待在年底臨近這一時間框架時提供更多資訊。

Okay, great, thank you again, and congrats on all the progress.

好的，太好了，再次感謝您，並祝賀您取得的所有進展。

Thank you, Julian.

謝謝你，朱利安。

Jason Gerberry, Bank of America.

美國銀行的 Jason Gerberry。

Hey, good morning. This is Bhavin Patel on for Jason. Two questions from us. The first is, given the green space in PH-ILD, what's Liquidia's strategy to drive early market penetration for YUTREPIA? Can you share the marketing differentiation that you plan to promote to doctors? And then on, given the 505(b)(2) pathway, should we expect any differences in the label for YUTREPIA versus Tyvaso DPI? I know in the past, you've mentioned demonstrating titration to 3x higher doses compared to Tyvaso DPI.

嘿，早安。我是 Bhavin Patel，取代 Jason。我們有兩個問題。首先，考慮到 PH-ILD 的綠地，Liquidia 推動 YUTREPIA 早期市場滲透的策略是什麼？您能否分享一下您計劃向醫師推廣的行銷差異化？然後，考慮到 505(b)(2) 途徑，我們是否應該預期 YUTREPIA 與 Tyvaso DPI 的標籤會有任何差異？我知道，過去您曾提到過，與 Tyvaso DPI 相比，滴定劑量可高出 3 倍。

Yeah. So I'll answer the second question first, and then I'll ask Scott Moomaw, our Chief Commercial Officer, if he would address the launch dynamics around PH-ILD and differentiation that we intend to emphasize. So you're exactly correct, Bhavin. I think the label, it is a 505(b)(2), so we share, obviously, the indication claims and things like that.

是的。因此，我先回答第二個問題，然後我會詢問我們的首席商務官 Scott Moomaw，他是否會談談我們打算強調的 PH-ILD 的發布動態和差異化。所以你完全正確，Bhavin。我認為該標籤是 505(b)(2)，因此我們顯然共享適應症聲明和諸如此類的東西。

But where we differ from the label is in the dose titration table because in our study that we used to bridge, we showed that we could escalate the doses, as you mentioned, up to 3 times higher than the target therapeutic dose of the brand.

但我們與標籤上的不同之處在於劑量滴定表，因為在我們用來橋接的研究中，我們表明，正如您所提到的，我們可以將劑量提高到品牌目標治療劑量的 3 倍。

So that will be in the label. And I think it's an important point of differentiation because it's what -- it's PRINT-enabled using our proprietary PRINT technology to drive the particles to the lower airway preferentially and avoid the toxicities associated with upper airway deposition.

所以這將在標籤中。我認為這是一個重要的區別點，因為它是使用我們專有的 PRINT 技術實現的，可以優先將顆粒驅至下呼吸道，避免與上呼吸道沉積相關的毒性。

It's going to help us drive a maximal outcome for these patients as they continue to progress, and it's going to -- and therefore, help us keep those patients on therapy longer is our presumption. So we think these are important and critical aspects. If you look across any route of administration of prostacyclin, dose matters, and the ability to drive dose usually predicts the sort of therapeutic utility of that therapy.

隨著這些患者的病情不斷好轉，它將幫助我們達到最佳治療效果，因此，我們推測它將幫助我們讓這些患者接受更長的治療。所以我們認為這些都是重要且關鍵的面向。如果你觀察前列環素的任何給藥途徑，劑量都很重要，而控制劑量的能力通常可以預測該療法的治療效果。

And that's why Tyvaso as labeled has had limitations in dosing, and it's also why other drugs like Uptravi, an oral formulation, which is dose limited and dose ceiling, also has limitations over the long and chronic treatment course of these patients. So lots of opportunity there from us from a labeling and dosing standpoint.

這就是為什麼泰瓦索 (Tyvaso) 的標籤上標註的劑量有限制，也是為什麼其他藥物如 Uptravi（一種口服製劑）的劑量和劑量上限有限制，在這些患者的長期慢性治療過程中也有限制。因此，從標籤和劑量的角度來看，我們有很多機會。

So Scott, if you could talk a little bit about kind of how we want to approach this market without giving away the shop too much?

那麼斯科特，你能不能稍微談談我們如何進入這個市場，但又不至於透露太多商店的資訊？

Sure. Good morning. So if you think about it, we have the usual designation between centers and communities. And we're going -- we are approaching and we will continue to approach both, especially after launch. And the situation in the centers is that the patients are really flowing in. There's an increasing number of patients flowing in as the awareness of PH-ILD increases, and we will obviously only add fuel to that fire.

當然。早安.如果你仔細想想，我們會發現中心和社區之間有通常的稱呼。我們正在努力，並將繼續努力，特別是在產品發布之後。中心的情況是，病人源源不絕地湧入。隨著人們對 PH-ILD 認識的提高，湧入的患者數量不斷增加，我們顯然只會給這種疾病火上加油。

So we're in the centers, and we're going to make sure that we ensure that YUTREPIA is the first choice prostacyclin for those patients that have PH-ILD for a lot of the reasons that Roger just outlined and you've heard us talk about before. So we're going to harvest those patients immediately.

因此，我們處於中心地位，我們將確保 YUTREPIA 是患有 PH-ILD 的患者的首選前列環素，原因有很多，正如 Roger 剛才概述的，您之前也聽我們討論過。所以我們要立即收治這些病人。

The other thing we're doing is in the community, and there's many, many patients out there that doctors don't even know exist. They have ILD. The doctors aren't looking for PAH.

我們所做的另一件事是在社區中，那裡有很多病人，但醫生甚至不知道他們的存在。他們患有間質性肺病 (ILD)。醫生們並沒有尋找肺動脈高壓 (PAH)。

We need to help increase awareness. We need to help increase diagnosis. And then either get that doctor to prescribe or to refer that patient into one of the centers. And we've actually been doing that over the last six months or a year going deeper and deeper into the community, educating on PH-ILD even before we get on the market because we know that that's only going to behoove us once we do get in the market because we do believe we have the superior product.

我們需要幫助提高認識。我們需要幫助增加診斷。然後讓醫生開處方或將患者轉診到其中一個中心。事實上，在過去的六個月或一年裡，我們一直在這樣做，越來越深入地融入社區，甚至在產品進入市場之前就對 PH-ILD 進行教育，因為我們知道，一旦我們進入市場，這才會對我們有利，因為我們確實相信我們擁有優質的產品。

Great, thank you. Thank you so much.

太好了，謝謝。太感謝了。

Serge Belanger, Needham.

塞爾日·貝朗格，尼德漢姆。

Hi, good morning. A couple of commercially related YUTREPIA questions, probably for Scott. Just can you remind us the breakdown between commercial and Medicare coverage for both PAH and PH-ILD? And then assuming we're going to get approval here in a couple of months, can you talk about what you expect in terms of the ramp-up in coverage across both commercial and Medicare, I guess, over the next 12 months or so?

嗨，早安。幾個與商業相關的 YUTREPIA 問題，可能是針對 Scott 的。您能否提醒我們 PAH 和 PH-ILD 的商業和醫療保險覆蓋範圍的細目？然後假設我們將在幾個月內獲得批准，您能否談談您對未來 12 個月左右商業和醫療保險覆蓋範圍的提升的預期？

Yeah, great question, Serge. It's Scott.

是的，很好的問題，Serge。我是史考特。

Yeah, good morning, Serge. So in terms of the breakdown, generally, think of it as Medicare is the biggest. So 50% Medicare, probably 30% to 40% commercial and then the remaining is Medicare, other [DOD] et cetera. In terms of the coverage over the first year, as you probably know, we're not commenting on our strategies. I will say that we have been working with the payers closely for quite some time. And we feel like we have great relationships with us.

是的，早上好，塞爾吉。因此，就細分而言，一般認為醫療保險是最大的。因此，50% 是醫療保險，大概 30% 到 40% 是商業，剩下的是醫療保險、其他 [DOD] 等等。就第一年的覆蓋範圍而言，正如您可能知道的，我們不會對我們的策略發表評論。我想說的是，我們已經與付款人密切合作了很長一段時間。我們感覺我們之間的關係很好。

They have the desire to make sure that we maximize access, so we share that desire. And I think you'll see when we launch that we're very sound on that front.

他們希望確保我們能夠最大限度地獲得訪問權，因此我們也有同樣的願望。而且我認為當我們推出時您就會看到我們在這方面做得非常完善。

Great, thanks Scott. Operator, next question.

太好了，謝謝斯科特。接線員，下一個問題。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Hi, good morning. Remind us what key readouts we should be focusing on for the ASCENT study and what specifically we can expect in the data coming at ATS? And then I have a follow-up.

嗨，早安。提醒我們，在 ASCENT 研究中我們應該關注哪些關鍵讀數，以及我們可以從 ATS 的數據中期待什麼？然後我有一個後續問題。

Yeah, thank you, Ryan. Rajeev, if you wouldn't mind answering that one.

是的，謝謝你，瑞安。Rajeev，如果你不介意回答這個問題的話。

Yeah, thanks, Ryan. So as Roger talked about in the prepared remarks today, one of the highlights that we spoke about was the walk effect that was observed in the first 20 patients treated within 8 weeks, which was -- which showed an observed mean improvement of around 26.4 meters. And I think that, first and foremost, highlights a few key processes.

是的，謝謝，瑞安。正如羅傑在今天的準備好的發言中提到的那樣，我們談到的亮點之一是在 8 週內接受治療的前 20 名患者中觀察到的步行效果，即平均改善幅度約為 26.4 米。我認為，首先要強調的是幾個關鍵流程。

First, that we can get patients to what we believe is a new therapeutic goal that surpasses the traditional 9 to 12 breaths that have typically been the sort of the ceiling effect of Tyvaso since 2009.

首先，我們可以讓患者達到我們認為的新的治療目標，超越傳統的9到12次呼吸，而自2009年以來，這通常是泰瓦索的天花板效應。

We've highlighted that we're able to achieve doses in the overwhelming majority of patients by week 8, that's equivalent to greater than -- greater or equal to 15 breaths by this time. So we can get patients up to what we believe is a very effective dose and even higher at an earlier time point and then allow further titration to further doses to stabilize the patient and plateau them out.

我們已經強調，我們能夠在第 8 週之前為絕大多數患者實現劑量，這相當於此時的呼吸次數大於或等於 15 次。因此，我們可以讓患者達到我們認為非常有效的劑量，甚至在更早的時間點達到更高的劑量，然後進一步滴定到更高的劑量以穩定患者並使其達到穩定狀態。

So I think that's what's going to be quite encouraging. At ATS, we're going to showcase more regarding the data sets, regarding how we dose the patients. We're going to talk a little bit about our effects in terms of some quality of life questionnaires as well.

所以我認為這將會非常令人鼓舞。在 ATS，我們將展示更多有關數據集以及我們如何為患者給藥的資訊。我們還將根據一些生活品質問卷來談談我們的影響。

And in the future, our plan is to -- as we've talked about, the ASCENT study will be fully enrolled within the next few weeks here. So we're really excited about that. And then we do plan to prepare and submit for the final data set later in the year and present that at a major respiratory conference in the future.

而在未來，我們的計劃是——正如我們所討論的，ASCENT 研究將在未來幾週內全面展開。所以我們對此感到非常興奮。然後，我們計劃在今年稍後準備並提交最終數據集，並在未來的主要呼吸會議上展示。

Great, thank you, Rajeev.

太好了，謝謝你，Rajeev。

That's helpful. Thank you very much. And will you be doing additional hiring for the commercial field team after potential approval if both indications is confirmed? And what is the status of the current field team with regards to both hiring and training? Thank you.

這很有幫助。非常感謝。如果兩種適應症都得到確認，在獲得潛在批准後，您是否會為商業領域團隊進行額外招募？目前現場團隊的招募和培訓情況如何？謝謝。

Yeah, so Scott, if you wouldn't mind?

是的，斯科特，你不介意嗎？

Yeah, sure. So the status, I'll start with that one. The status of the current sales team is they're locked and loaded and ready. We've had the team on board for 14 months now, and these were experienced mostly PAH, all rare disease folks to begin with. And so they've been out in the field, strengthening relationships.

是的，當然。那麼關於現狀，我將從那個開始。目前銷售團隊的狀態是他們已經準備就緒。我們團隊已經加入 14 個月了，其中大部分都是有肺動脈高壓 (PAH) 經驗的人，一開始都是罕見疾病患者。因此，他們一直在實地加強關係。

They've been training, training, training. They are absolutely ready to go and very, very excited. On the future front, we actually just went through another exercise over the course of the last few months to take a look at our sales force sizing strategy.

他們一直在訓練、訓練、訓練。他們已經做好了出發的準備，而且非常非常興奮。就未來而言，我們實際上在過去幾個月中進行了另一次演習，以了解我們的銷售團隊規模策略。

We think we're well suited to launch, as I mentioned earlier. We will take another look at that once we get out and start to understand sort of the sensitivity factor for the number of reps, and then we'll look at potentially expanding if that makes sense in the future.

正如我之前提到的，我們認為我們已經非常適合推出該產品。一旦我們開始了解重複次數的敏感度因素，我們就會再次審視這個問題，然後如果將來有意義的話，我們會考慮擴大規模。

Another thing I would add, we are adequately sized for the launch in May in both indications. And then as Scott said, obviously, as we continue to build and present the unique benefits of YUTREPIA, I think we want to articulate that even broader. So we could upsize our sales force probably in the '26 time frame, if necessary.

我想補充的另一件事是，對於這兩種適應症，我們的規模都足夠在五月推出。然後，正如斯科特所說，顯然，隨著我們繼續構建和展示 YUTREPIA 的獨特優勢，我認為我們希望更廣泛地表達這一點。因此，如果有必要，我們可能會在 26 年的時間範圍內擴大銷售團隊的規模。

Greg Harrison, Scotiabank.

加拿大豐業銀行的格雷格·哈里森。

Hey, good morning, guys. Thanks for taking the questions. Wondering if you can comment on your updated cash runway following your recent financing and what assumptions go into that estimate that you could reach profitability with your current balance sheet? And then if you could also comment on which factors play into your decision on pricing given your view of YUTREPIA's profile relative to the competitor? Thanks.

嘿，大家早安。感謝您回答這些問題。想知道您是否可以評論一下您最近融資後更新的現金流情況，以及您根據當前資產負債表可以實現盈利的估計是基於哪些假設？然後，您是否可以根據您對 YUTREPIA 相對於競爭對手的看法，評論一下哪些因素會影響您的定價決策？謝謝。

Great. I think both of those questions are -- would be well answered by Mike.

偉大的。我認為這兩個問題都可以由麥克很好地回答。

Yeah, Greg, great to talk to you again. As it relates to runway, as we said, with this $100 million of additional financing from Healthcare Royalty is $25 million we received at closing. $50 million will be received upon the first commercial sale of YUTREPIA and the final $25 million will be at mutual option once we reach a cumulative $100 million in net sales of YUTREPIA. I think it's pretty simple. We have -- we're very excited about the launch of YUTREPIA.

是的，格雷格，很高興再次與您交談。正如我們所說，就跑道而言，我們在交易結束時從 Healthcare Royalty 獲得了 1 億美元的額外融資，其中 2500 萬美元。 YUTREPIA 首次商業銷售時將獲得 5000 萬美元，一旦 YUTREPIA 的累計淨銷售額達到 1 億美元，最後的 2500 萬美元將由雙方共同選擇。我認為這很簡單。我們對 YUTREPIA 的推出感到非常興奮。

As Roger said and Scott have said, we are fully ready from a commercial readiness point of view, from a supply point of view, we feel very bullish about our ability to launch this successfully. And we feel that if -- assuming, as Roger said, we file for full approval here coming up, we get full approval on or near the expiration of the exclusivity date.

正如羅傑和史考特所說，從商業準備的角度來看，我們已經做好了充分的準備，從供應的角度來看，我們對成功啟動這項計畫的能力非常有信心。我們認為，如果 - 假設，正如羅傑所說，我們在這裡申請全面批准，我們將在獨佔期到期或接近到期時獲得全面批准。

We feel confident if we hit our goals and hit our targets that we could be profitable on this current balance sheet and like I said, fully support the L606 program, all of our Phase IV studies we're doing on YUTREPIA while also the ongoing commercial readiness. So we're very excited. We're very confident.

我們相信，如果我們實現了目標，我們就能在當前的資產負債表上盈利，就像我說過的，全力支持 L606 計劃，我們在 YUTREPIA 上進行的所有 IV 期研究，以及正在進行的商業準備。所以我們非常興奮。我們非常有信心。

We're very happy to have a great partner like Healthcare Royalty on this journey, and we look forward to launch. As to the second question, we're not going to talk about pricing strategy. I think what I would say is as we've demonstrated or continue to demonstrate and what we feel our ASCENT -- early results on ASCENT only reinforce that, that we feel that we have a superior product profile.

我們非常高興在這趟旅程中擁有像 Healthcare Royalty 這樣的優秀合作夥伴，我們期待著它的啟動。至於第二個問題，我們不會談定價策略。我想說的是，正如我們已經展示或繼續展示的那樣，以及我們對 ASCENT 的感受——ASCENT 的早期結果只會強化這一點，即我們認為我們擁有卓越的產品形象。

And based on that, we want to make sure that we are always balancing patient access while also fulfilling the value proposition that YUTREPIA can bring. So we're not going to talk specifically about pricing strategies in totality, but I think we're very confident as we come to market that we will have the right strategy to make sure that patients have choice as we move forward.

基於此，我們希望確保始終平衡患者的就醫機會，同時實現 YUTREPIA 所能帶來的價值主張。因此，我們不會具體討論整體定價策略，但我認為，我們非常有信心，當我們進入市場時，我們將擁有正確的策略，以確保患者在我們前進的過程中擁有選擇權。

Great, that's helpful. Thanks so much.

太好了，很有幫助。非常感謝。

Thanks for the question, Greg. Operator, next question.

謝謝你的提問，格雷格。接線員，下一個問題。

Cory Jubinville, LifeSci Capital

Cory Jubinville，LifeSci Capital

Good morning, and thanks for taking our questions, and congrats on this new efficacy data with ASCENT. It's really exciting. Just kind of following the theme of more drug is better. I recognize that the sample size here might -- is still relatively small. But have you had any type of dose response among patients?

早安，感謝您回答我們的問題，並恭喜 ASCENT 獲得這項新的功效數據。這真是令人興奮。只是遵循了「藥物越多越好」這個主題。我認識到這裡的樣本量可能——仍然相對較小。但是，您是否發現過患者出現任何類型的劑量反應？

Are those who are reaching two to threefold the Tyvaso equivalent dose achieving better outcomes than those in the study who might be kind of in the lower range equivalent to the existing standard of care? And this also might be a naive question, but is it possible to get these efficacy data on label? And how would you go about marketing the six-minute walk to prescribers post approval?

那些達到泰瓦索當量劑量兩到三倍的患者是否比研究中那些可能處於現有護理標準較低範圍內的患者取得更好的結果？這也許也是一個幼稚的問題，但是有可能在標籤上獲得這些功效數據嗎？批准後，您將如何向處方醫生推銷六分鐘步行計劃？

Yeah. I'll take the second question, and then Rajeev can say what he can about the dose versus effect curve. So it's not -- the data is -- would not be available for indication claims per se because it's an open-label safety study. I think it would be part of an annual update to the label once approved, where we could update the clinical pharmacology section to describe the data both in terms of safety and potentially in terms of efficacy. But again, that's a negotiation with the FDA about what we could then include in the clinical pharmacology section of the label.

是的。我來回答第二個問題，然後 Rajeev 可以講說劑量與效應曲線。因此，由於這是一項開放標籤安全性研究，因此資料本身不可用於指示聲明。我認為一旦獲得批准，它將成為標籤年度更新的一部分，我們可以更新臨床藥理學部分以描述安全性和潛在功效方面的數據。但同樣，這是與 FDA 進行的關於我們可以在標籤的臨床藥理學部分中包含哪些內容的談判。

So I'll reserve sort of commitment on that, and we'll do the best we can to get it in there. But I think, certainly, we will abstract and then publish the data. And I think as we're seeing, there's tremendous inbound interest based on what we're describing and there's over 20 doctors doing this current ASCENT study. Many of them are the seminal thought leaders.

因此，我會保留對此的承諾，我們會盡最大努力實現。但我認為，我們肯定會提取並發布數據。我認為，正如我們所看到的，基於我們所描述的內容，人們產生了極大的興趣，目前有超過 20 名醫生參與了這項 ASCENT 研究。他們中的許多人都是開創性的思想領袖。

And I think the fact that they're doing the study, and we're seeing the results that we're seeing is going to help highlight the data when they lead panel sessions, et cetera, because now they're seeing the true value of PRINT as it relates to YUTREPIA.

我認為他們正在進行的研究以及我們所看到的結果將有助於在他們主持小組會議等時突出顯示數據，因為現在他們看到了 PRINT 與 YUTREPIA 相關的真正價值。

So -- and then I will just comment on dose response before I turn it over to Rajeev. It's very hard in a small sample of patients to show dose response, frankly, plus we're allowing patients to individually titrate the dose. So we're not sort of predefining what dose level patients should titrate to and then measuring that versus effect. So it's a continuum. So that's a difficult paradigm to show a dose response in.

所以——在將問題交給 Ljeev 之前，我將對劑量反應進行評論。坦白說，在小樣本患者中很難顯示劑量反應，而且我們允許患者單獨調整劑量。因此，我們不會預先定義患者應滴定到的劑量水平，然後測量其效果。所以它是一個連續體。因此，這是一個很難顯示劑量反應的範例。

But Rajeev, I don't know if you have additional comment there.

但是 Rajeev，我不知道您是否還有其他評論。

Yeah, Cory, I think just -- I think a few things to highlight. First of all, the patients that we're enrolling in ASCENT are quite heterogeneous. We purposely designed the study to showcase safety and tolerability of YUTREPIA. So we not only include patients with mild hemodynamic limitations with their pulmonary hypertension, but also patients with severe hemodynamic impairments with various levels of complexity with the interstitial lung disease and their respiratory physiological impairments.

是的，科里，我認為——我認為有幾件事需要強調。首先，我們在 ASCENT 中招募的患者非常多樣化。我們特意設計了這項研究來展示 YUTREPIA 的安全性和耐受性。因此，我們不僅包括患有輕度血流動力學限制和肺動脈高壓的患者，還包括患有不同複雜程度的間質性肺病和呼吸生理障礙的嚴重血流動力學障礙患者。

But I think despite that heterogeneity, I think what the data is showing despite these small numbers, but even though, as you know, the study continues to enroll and continue to highlight a few things. Number one, clearly, the low resistance inhaler combined with our PRINT formulation is absolutely allowing these patients to titrate YUTREPIA to, again, to what I believe are actually new therapeutic levels.

但我認為，儘管存在這種異質性，但我認為數據顯示，儘管這些數字很小，但正如你所知，這項研究仍在繼續招募，並繼續強調一些事情。首先，顯然，低阻力吸入器與我們的 PRINT 配方相結合絕對可以讓這些患者將 YUTREPIA 滴定到我認為實際上是新的治療水平。

And that's very important because it's well known that prostanoid therapies are titratable. It is dose related. So it tends to -- effects tend to improve as dose is escalated. The problem with current therapies on the market, including oral and systemic parenteral therapies is that they're just significantly limited by terrible systemic side effects, especially in the oral therapies with the GI side effects and of course, the parenterals with indwelling lines or subcutaneous complications.

這非常重要，因為眾所周知前列腺素療法是可滴定的。它與劑量有關。因此，隨著劑量的增加，效果往往會改善。目前市面上的治療方法，包括口服和全身腸外治療，存在的問題在於它們受到可怕的全身性副作用的嚴重限制，尤其是口服療法的胃腸道副作用，當然還有腸外治療的留置管或皮下併發症。

I think with the current inhaled therapies on the market today, we know that at least in the INCREASE study, what was very interesting relative to the ASCENT study is by 8 weeks, only 50% of the patients in the Tyvaso nebulized study for increase with PH-ILD were able to reach the 10 to 12 breath levels versus in the ASCENT study, despite the heterogeneity in the patient population, we're able to get patients -- the overwhelming majority of patients up to more than or equal to 15 breath equivalents.

我認為，就目前市場上的吸入療法而言，我們知道至少在 INCREASE 研究中，相對於 ASCENT 研究非常有趣的是，到 8 週時，在針對 PH-ILD 增加的 Tyvaso 霧化研究中，只有 50% 的患者能夠達到 10 到 12 次呼吸水平，而在 ASCENT 研究中的患者能夠達到 10 到 12 次呼吸水平，而在 ASCENT 研究中達到絕大多數人的呼吸量，儘管當患者達到 15 次呼吸量，而在 ASCENT 研究中達到絕大多數人，儘管當患者達到 15 次呼吸量，而在 ASCENT 研究中達到絕大多數人，儘管當患者達到 15 次呼吸量，而在

So again, I think that what the ASCENT data is going to show at ATS and what KOLs are going to see is that this -- that YUTREPIA is very well tolerated and titratable and that they can customize to whatever needs their patients have with both PAH and PH-ILD in the very near future.

因此，我再次認為 ASCENT 數據將在 ATS 上顯示，並且 KOL 將會看到的是——YUTREPIA 具有很好的耐受性和可滴定性，並且他們可以根據患者對 PAH 和 PH-ILD 的任何需求進行定制，在不久的將來。

And Cory -- that's a great answer, Rajeev. Thank you. I think one way we're going to take on this dose issue directly, we're going to do a directed transition study from patients on Tyvaso and Tyvaso DPI that are underserved by those therapies, probably because of dose limitations, we'll transition them to YUTREPIA, improve their dose.

還有 Cory — — Rajeev，這是一個很好的答案。謝謝。我認為我們直接解決劑量問題的一種方法是，我們將對使用 Tyvaso 和 Tyvaso DPI 的患者進行定向過渡研究，這些患者可能由於劑量限製而無法接受這些療法，我們將把他們過渡到 YUTREPIA，提高他們的劑量。

And then -- and if we show, therefore, an improved outcome, we've shown not only is dose related to outcome, but we've also differentiated the products even in a different way and a helpful way for YUTREPIA. So look for that study to start up in the near future as well.

然後 — — 如果我們顯示出更好的結果，我們不僅表明劑量與結果相關，而且我們還以不同的方式和對 YUTREPIA 有幫助的方式區分了產品。因此，期待該項研究也能在不久的將來啟動。

Thank you. And I'm currently showing no further questions at this time. I'd like to hand the call back over to Roger Jeffs for closing remarks.

謝謝。目前我沒有其他問題。我想將電話轉回給羅傑·傑夫斯，請他做最後發言。

Thank you very much. So we really appreciate everyone joining us today, and we look forward to speaking again soon. Bye-bye.

非常感謝。因此，我們非常感謝今天加入我們的各位，並期待很快再次與您交談。再見。

This concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。