Liquidia Corp (LQDA) 2024 Q3 法說會逐字稿

Good morning and welcome everyone to Liquidia Corporation third quarter, 2024 financial results and corporate update conference call. My name is Michelle, and I will be your conference operator today.

早安，歡迎大家參加 Liquidia Corporation 2024 年第三季財務表現及公司更新電話會議。我叫米歇爾，今天我將擔任您的會議主持人。

(Operator Instructions) I would like to remind everyone that this conference call is being recorded. I would now like to hand the conference over to Jason Adair, Chief Business Officer. Please go ahead.

（操作員指示）我想提醒大家，本次電話會議正在錄音。現在，我想將會議移交給首席商務官傑森·阿代爾 (Jason Adair)。請繼續。

Thank you, Michelle. It's my pleasure to welcome everybody today to the Liquidia Corporation third 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.

謝謝你，米歇爾。我很高興今天歡迎大家參加 Liquidia Corporation 2024 年第三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、營運長兼財務長 Michael Kaseta、首席醫療官 Rajeev Saggar 博士、商務長 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 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'd now like to turn the call over to Roger for our prepared remarks after which he will open the call for your questions.

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。請參閱該公司向美國證券交易委員會提交的文件，可在我們的網站上查閱。現在，我想將電話轉給羅傑，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。

Good morning, everyone. We're pleased to be speaking with you today. With the significant progress made over the last few months. We now have a clear line of sight to seeking final approval of [Reia for both Pah and Phild] patients. Final approval could occur following the expiration of TYVASO DPI is clinical exclusivity on 2025 May 23 or in just six months’ time.

大家早安。我們很高興今天能與您交談。過去幾個月取得了重大進展。現在，我們已經明確了尋求 [Reia 對 Pah 和 Phild 患者的] 最終批准的路線圖。TYVASO DPI 臨床獨佔期將於 2025 年 5 月 23 日到期，即僅僅六個月後，可能會獲得最終批准。

Critical wins that underpinned the significant milestone included the following. First, the FDA confirmed that the amended NDA to add PH-ILD to tentatively approved label for YUTREPIA was proper and therefore had to determine that we have met the regulatory requirements for approval for PAH and PH-ILD pending the expiration of TYVASO DPIs clinical exclusivity.

支撐這一重要里程碑的關鍵勝利包括以下內容。首先，FDA 確認，修訂後的 NDA 將 PH-ILD 添加到 YUTREPIA 的臨時批准標籤中是恰當的，因此必須確定我們在 TYVASO DPIs 臨床獨佔期到期之前已滿足 PAH 和 PH-ILD 批准的監管要求。

And second, with the Supreme Court's decision in September to deny cert the legal process with respect to the three patents originally asserted against us has been fully exhausted and these three patents no longer provide any impediment to the commercialization of YUTREPIA . As mentioned the sole item cited by the FDA that is blocking final approval of YUTREPIA is the new clinical investigation exclusivity that was granted to TYVASO DPI which will expire in May of 25' or earlier if we are successful in our lawsuit against the FDA, Rusty will speak more specifically about this lawsuit in a minute.

其次，隨著最高法院 9 月決定拒絕頒發證書，針對我們最初主張的三項專利的法律程序已完全用盡，這三項專利不再對 YUTREPIA 的商業化構成任何障礙。如上所述，FDA 指出阻礙YUTREPIA 最終批准的唯一原因是授予TYVASO DPI 的新臨床研究獨佔權，該獨佔權將於25 年5 月到期，如果我們在針對FDA 的訴訟中勝訴，則該獨佔權將提前到期，Rusty稍後我將更具體地談論這起訴訟。

The clinical front, we remain active and productive in advancing our clinical programs that we have developed to prospectively demonstrate the differentiated value of YUTREPIA in PH-ILD patients as well as advancing our next generation sustained release program L606. We feel the combination of YUTREPIA and L606 gives us a compelling portfolio of treatment options for the delivery of [inhaled] personnel to treat PAH and PH-ILD patients both now and in the future.

在臨床方面，我們繼續積極有效地推進我們開發的臨床項目，以前瞻性地展示 YUTREPIA 對 PH-ILD 患者的差異化價值，並推進我們的下一代緩釋項目 L606。我們認為 YUTREPIA 和 L606 的結合為我們提供了一系列引人注目的治療選擇，可供現在和將來運送 [吸入] 人員治療 PAH 和 PH-ILD 患者。

On a related business front, in this quarter, we have expanded our relationship with [hermosa] with respect to L606 amending our license agreement to include the EU and other territories outside of North America.

在相關業務方面，本季度，我們擴大了與 [hermosa] 的關係，就 L606 修改了我們的許可協議，將歐盟和北美以外的其他地區納入其中。

We have also entered into a device license agreement with Pharma’s to secure rights to proprietary next generation nebulizers for administration of L606 in a small portable breath actuated nebulizer the size of an iPhone. Rajeev will speak to the clinical progress of both programs and share excitement that is building within the community based on our prospective studies.

我們還與製藥公司達成了設備許可協議，以確保對下一代霧化器的專有權利，該霧化器用於在 iPhone 大小的便攜式呼吸驅動霧化器中管理 L606。Rajeev 將介紹這兩個計畫的臨床進展，並分享基於我們的前瞻性研究而產生的社區內興奮之情。

And finally, we have also strengthened our balance sheet. Having closed several simultaneous financing in September, Michael will offer more insight on our balance sheet later in the call. But there is no doubt in my mind that we have the team, capital, the products, the vision and especially determination to change the treatment landscape for from your hypertension patients in the near and long term. With that, I will ask Rusty to share some more details.

最後，我們也加強了我們的資產負債表。Michael 已於 9 月完成了幾筆同時進行的融資，他將在稍後的電話會議中提供有關我們資產負債表的更多見解。但我堅信我們擁有團隊、資本、產品、願景，尤其是決心，能夠在近期和長期內改變高血壓患者的治療格局。因此，我會請 Rusty 分享更多細節。

Thank you, Roger. As Roger briefly mentioned in August, we filed a lawsuit challenging the FDA's decision to grant new clinical investigation exclusivity to TYVASO DPI which has delayed the final approval of YUTREPIA.

謝謝你，羅傑。正如羅傑在八月份簡要提到的那樣，我們提起了訴訟，質疑 FDA 授予 TYVASO DPI 新的臨床研究獨佔權的決定，這推遲了 YUTREPIA 的最終批准。

This is not a decision we took lightly and I note that we did not previously challenge the FDA's prior award of new clinical investigation exclusivity to nebulized TYVASO and PH-ILD that was based on the increased trial which studied safety and efficacy of nebulized TYVASO in PH-ILD patients.

這不是我們輕率做出的決定，我注意到我們之前並沒有質疑FDA 先前授予霧化TYVASO 和PH-ILD 的新臨床研究獨佔權，該獨佔權是基於一項研究霧化TYVASO 在PH 中的安全性和有效性的增加試驗。

Unlike the increased trial, we do not believe the breeze study the clinical trial upon which this new clinical exclusivity was based is the type of clinical trial for which exclusivity can be granted. This belief is bolstered by the FDA's own initial decision not to grant any exclusivities to TYVASO DPI I when it was first approved in 2022.

與增加的試驗不同，我們不認為這項新的臨床獨佔權所依據的微風研究臨床試驗是可以授予獨佔權的臨床試驗類型。這種信念得到了 FDA 最初的決定的支持，當時 TYVASO DPI I 於 2022 年首次獲得批准，不授予其任何獨佔權。

For this reason, we continue to believe that the FDA decision should be vacated and Liquidia should be allowed to bring your (technical difficulty) to market for the benefit of patients immediately.

出於這個原因，我們仍然認為 FDA 的決定應該被撤銷，並且應該允許 Liquidia 立即將您的（技術難題）推向市場，以造福患者。

We and the FDA have agreed to an expedited briefing schedule in anticipation of a hearing on our respective motions for summary judgment on 2024 December 5, and regardless of the outcome of the lawsuit, though, nothing can delay the scheduled expiration of the exclusivity for TYVASO DPI on 2025 May 23.

我們和 FDA 已同意加快簡報時間表，以期在 2024 年 12 月 5 日就我們各自的簡易判決動議舉行聽證會，但無論訴訟結果如何，都無法推遲 TYVASO 獨佔權的預定到期日DPI 於2025 年5 月23 日。

As part of our lawsuit against the FDI, United Therapeutics has filed cross claims challenging again the appropriateness of the amendment to add PH-ILD to the YUTREPIA label. These are essentially the exact same claims that were previously brought and then voluntarily dismissed by United Therapeutics in the lawsuit they initiated against the FDA back in February. We continue to believe that these cross claims have no merit and that Liquidia properly amended the NDA for YUTREPIA to add PH-ILD position that the FDA agreed with when they issued tentative approval for YUTREPIA in both indications in August.

作為我們對 FDI 訴訟的一部分，United Therapeutics 已提起交叉訴訟，再次質疑在 YUTREPIA 標籤中添加 PH-ILD 的修正案的適當性。這些指控基本上與 United Therapeutics 公司在今年 2 月對 FDA 提起的訴訟中提出但後來自願駁回的指控完全相同。我們仍然認為這些交叉指控毫無根據，並且 Liquidia 正確修改了 YUTREPIA 的 NDA，並添加了 PH-ILD 立場，FDA 在 8 月為 YUTREPIA 的兩種適應症發布臨時批准時同意了這一立場。

Finally, as noted by Roger, we have now successfully concluded the litigation regarding the three patents that were initially asserted against us by United Therapeutics. Those decisions that we do not infringe any valid claims of any of the three patents are now not subject to any further appeals and are final. This leaves just the 327 patent as the sole patent that United Therapeutics is continuing to assert against Liquidia.

最後，正如羅傑所說，我們現在已經成功結束了聯合治療公司最初對我們提出的三項專利的訴訟。我們沒有侵犯三項專利中任何一項的有效權利要求的裁決現在不受任何進一步上訴，並且是最終裁決。這使得 327 專利成為 United Therapeutics 繼續向 Liquidia 主張的唯一專利。

The 327 patent generally covers the treatment of PH-ILD patients with TYVASO in accordance with the dosing regimen in the TYVASO label, as we have noted previously, there is considerable prior art that teaches the treatment of PH-ILD patients with Tyvaso including the 793 patent and multiple peer review publications in the decade priority date for the 327 patent that described positive results from treating PH-ILD patients with TYVASO.

327 專利通常涵蓋根據 TYVASO 標籤中的給藥方案使用 TYVASO 治療 PH-ILD 患者，正如我們之前所指出的，有大量現有技術教導使用 Tyvaso 治療 PH-ILD 患者，包括 793 327 專利的十年優先權日內的專利和多個同行評審出版物描述了使用TYVASO 治療PH-ILD 患者的積極結果。

Also as previously disclosed, United Therapeutics sought a preliminary injunction to block the launch of YUTREPIA for the treatment of PH-ILD patients based on the 327 patent and is denied by the court. Trial is now scheduled for June of 2025, and we look forward to resolving the validity of the 327 patents at that time.

另外如先前披露的那樣，United Therapeutics依據327專利尋求初步禁令，以阻止YUTREPIA上市用於治療PH-ILD患者，但遭到法院駁回。目前審判定於 2025 年 6 月進行，我們期待屆時能解決這 327 項專利的有效性問題。

With that, I'd like to turn the call over to Rajeev to summarize the clinical progress to date.

說到這裡，我想把電話轉給 Rajeev，讓他總結迄今為止的臨床進展。

Thanks Rusty. I'm excited to report on the continued positive momentum in Liquidia's clinical programs with YUTREPIA and L606. First, let me provide an update on the open label ascent study which is evaluating the safety tolerability and efficacy of YUTREPIA in patients with PH-ILD.

謝謝 Rusty。我很高興地報告 Liquidia 與 YUTREPIA 和 L606 的臨床計畫繼續保持積極勢頭。首先，讓我提供有關開放標籤上升研究的最新進展，該研究正在評估 YUTREPIA 對 PH-ILD 患者的安全性、耐受性和有效性。

We have now doubled the number of clinical sites during the past quarter with 21 of the 22 planned sites now active. Today we have enrolled over a third of the patients which keeps us firmly in track to complete enrolment in the first quarter of 2025.

我們在過去的一個季度中將臨床站點的數量增加了一倍，原計劃的 22 個臨床站點中已有 21 個投入運作。今天我們已經招募了超過三分之一的患者，這使我們能夠穩固地在 2025 年第一季完成招募。

The preliminary data emerging from the ascent study in PH-ILD patients is highly encouraging in regards to tolerability and titratability and it is generally consistent with the observations from our pivotal phase three inspire study in PAH patients. As anticipated with our print formulation coupled with our low effort dry powder inhaler patients who have completed eight weeks of treatment have been able to tolerate anti trait YUTREPIA to an average dose of 132.5mg with almost one quarter of the patients reaching 159mg four times a day by week eight. This dosing observed in the study through week eight is up to two times higher than the comparable doses administered in both the increased study would nebulize [Tiso] at 16 weeks and what is typically used in clinical practice, while still early we remain very encouraged by the positive trends noted in the key efficacy endpoints including change in six minute walk distance and patient reported outcomes.

在 PH-ILD 患者中上升研究中出現的初步數據在耐受性和可滴定性方面非常令人鼓舞，並且與我們在 PAH 患者中關鍵的第三階段啟發研究中的觀察結果基本一致。正如預期的那樣，使用我們的印刷配方加上我們的低努力乾粉吸入器，完成八週治療的患者能夠耐受抗性YUTREPIA，平均劑量為132.5毫克，近四分之一的患者每天四次達到159毫克到第八週。在研究中觀察到的第八週劑量比增加的研究中施用的可比劑量高出兩倍，該研究將在16 週時霧化[Tiso]，並且通常用於臨床實踐，儘管仍處於早期階段，但我們仍然非常鼓舞主要療效終點顯示的正面趨勢，包括六分鐘步行距離的變化和患者報告的結果。

After week eight, patients have continued to titrate higher and we look forward to reporting the full data set from the study when it completes next year.

第八週後，患者的劑量繼續增加，我們期待明年研究完成後報告完整的數據集。

Now turning our attention to L606 our sustained release [liposomal tree prosal] suspension formulation delivered twice daily. We are now solely focused on initiating our placebo controlled global phase three study in PH-ILD called respire, given the favorable safety and tolerability data observed to date in the open label US trial in PAH and PH-ILD patients, we have decided to stop enrolment in this very study with a total of 28 patients enrolled. L606 continues to be well tolerated with some patients reaching our maximum dose of 378mg twice daily, which is approximately three times higher than comparable doses of [Tiso] administered in the increased study.

現在我們將注意力轉向 L606，這是我們的緩釋 [脂質體樹 prosal] 懸浮液配方，每天給藥兩次。我們現在只專注於啟動一項安慰劑對照的全球PH-ILD 第三階段臨床試驗，稱為respire，鑑於迄今為止在美國對PAH 和PH-ILD 患者的開放標籤試驗中觀察到的良好安全性和耐受性數據，我們決定停止本研究共有 28 名患者入組。L606 的耐受性仍然很好，有些患者達到了我們的最大劑量，即每天兩次 378 毫克，這大約是增加研究中施用的同類 [Tiso] 劑量的三倍。

As Roger mentioned, we have also secured rights to a more streamlined rechargeable handheld breath actuated nebulizer that is capable of delivering doses of L606 in inhalation sessions of less than 1 to 2 minutes.

正如羅傑所提到的，我們也獲得了更精簡的可充電手持式呼吸驅動霧化器的權利，該霧化器能夠在不到 1 到 2 分鐘的吸入時間內輸送 L606 劑量。

We've decided to use this new device in our pivotal study which will push initiation into the first half of 2025. More details on the pivotal study design and the device will be shared in the near future.

我們決定在我們的關鍵研究中使用這種新設備，該研究將啟動時間推遲到 2025 年上半年。有關關鍵研究設計和設備的更多細節將在不久的將來分享。

I would now like to pass the call to Mike Kaseta to review the financial performance from the third quarter, Mike.

現在我想將電話轉給 Mike Kaseta，讓他回顧一下第三季的財務業績，Mike。

Thank you Rajeev and good morning everyone.

謝謝 Rajeev，大家早安。

I'm pleased to say that Liquidia is well prepared to launch its first product YUTREPIA in 2025 as soon as we receive final FDA approval. To further support our preparedness, we added even more strength to the balance sheet in the third quarter by executing simultaneously on three transactions that brought approximately $100 million into the company as announced in September.

我很高興地說，Liquidia 已做好充分準備，一旦我們獲得 FDA 的最終批准，我們將在 2025 年推出第一款產品 YUTREPIA。為了進一步增強我們的準備，我們在第三季同時執行了三筆交易，為公司帶來了約 1 億美元的收入，正如 9 月宣布的那樣，從而進一步增強了資產負債表的實力。

We ended the third quarter, 2024 with $204.4 million cash on hand and remain well positioned to achieve our corporate objectives culminating in our potential launch of YUTREPIA.

截至 2024 年第三季度，我們手頭上有 2.044 億美元現金，並且仍處於有利地位，可以實現我們的企業目標，最終推出 YUTREPIA。

I will now briefly address our third quarter financial results found in today's press release. First revenue was $4.4 million for the third quarter, 2024 compared with $3.7 million in the same quarter 2023. Revenue related primarily to our promotion agreement with Sandoz to commercialize Treprostinil injection. The increase of $0.7 million was primarily due to the impact of higher sales quantities in the current year as compared to the same period in the prior year, cost of revenue remained consistent at $1.7 million for the third quarter 2024 compared to $0.6 million in the same quarter for 2023.

我現在將簡要介紹一下今天新聞稿中發布的第三季財務結果。2024 年第三季的第一筆營收為 440 萬美元，而 2023 年同期為 370 萬美元。收入主要與我們與 Sandoz 簽署的推廣曲前列尼爾注射劑商業化的協議有關。70 萬美元的增幅主要由於本年度銷售量較上年同期增加的影響，2024 年第三季的收入成本保持不變，為 170 萬美元，而上年同期為 60 萬美元。

Cost of revenue related to the promotion agreement mentioned earlier. The increase from the prior year is primarily due to our sales force expansion during the fourth quarter of 2023, research and development expenses were $11.9 million in the third quarter 24' compared with 7.4 million in the same quarter for 2023.

與前面提到的促銷協議相關的收入成本。較上年同期的成長主要歸因於我們在 2023 年第四季的銷售隊伍擴張，24 年第三季的研發費用為 1,190 萬美元，而 2023 年同期為 740 萬美元。

The increase of $4.5 million or 60% was primarily due to a $2.1 million increase in personnel expenses including stock-based compensation related to increased head count. A 1.3 million increase in clinical expenses related to our L606 program and a $2.5 million increase in expenses related to YUTREPIA research and development activities including the ascent trial. Offset by $1.5 million lower commercial manufacturing expenses reflecting the impact of expensing YUTREPIA inventory costs in the prior year.

增加 450 萬美元或 60% 主要是因為人事費用增加 210 萬美元，包括與員工人數增加相關的股票薪酬。與我們的 L606 計畫相關的臨床費用增加了 130 萬美元，與 YUTREPIA 研究和開發活動（包括上升試驗）相關的費用增加了 250 萬美元。抵銷了 150 萬美元的商業製造費用降低，反映了去年 YUTREPIA 庫存成本費用化的影響。

Moving on to general and administrative expenses there were $20.2 million in the third quarter 2024 compared to $10.6 million in the same quarter for 2023 the increase of $9.6 million or 91% was primarily due to a $6.7 million increase in personnel expenses including stock based compensation driven by higher headcount and expansion of our sales force in the fourth quarter of 23' a $1.5 million increase in legal fees relating to our ongoing YUTREPIA related litigation and a $0.5 million increase in commercial expenses in preparation for potential commercialization of YUTREPIA.

至於一般及行政開支，2024 年第三季為 2,020 萬美元，而 2023 年同期為 1,060 萬美元，增加 960 萬美元或 91%，主要是由於人員開支增加 670 萬美元，包括股票薪酬推動增加員工人數和擴大我們的銷售隊伍，23 年第四季度與我們正在進行的YUTREPIA 相關訴訟相關的法律費用增加了150 萬美元，並且為YUTREPIA 的潛在商業化做準備的商業費用增加了50 萬美元。

In summary, we incurred a net loss for the three months ended, 2024 September 30, of $23.2 million or $0.30 per basic and diluted share compared to a net loss of $15.8 million or $0.24 per basic and diluted share for the three months ended 2023 September 30.

綜上所述，截至2024 年9 月30 日的三個月，我們的淨虧損為2,320 萬美元，即每股基本虧損和稀釋虧損均為0.30 美元，而截至2023 年9 月30 日的三個月，我們的淨虧損為1580 萬美元，即每股基本虧損和稀釋虧損均為0.24 美元。

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

說完這些，我現在想把電話轉回給羅傑。收到。

Thank you, Mike and thank you Rusty, Rajeev for also sharing those insights.

謝謝你，Mike，也謝謝你，Rusty，Rajeev 分享這些見解。

Operator I would like to now open the call for questions, please.

接線生：我現在想開始提問。

(Operator Instructions) Julian Harrison, BTIG.

(操作員指示) Julian Harrison, BTIG。

Hi, good morning and thank you for taking my questions. First, regarding the summary judgment hearing in December, I'm wondering if you have a good sense for how soon a decision could be delivered from there and can you maybe talk about the range of outcomes you're contemplating right now? From that hearing?

大家好，早安，感謝您回答我的問題。首先，關於 12 月的簡易判決聽證會，我想知道您是否清楚聽證會多久會做出判決，能否談談您目前正在考慮的一系列結果？從那次聽證會上？

Good morning, Julian. Like to hear from you Rusty, if you could find on that, please.

早安，朱利安。很高興收到你的來信，Rusty，如果你能找到的話，請告訴我。

Sure, Julian, thanks for the question. So as far as timing for response, typical with any proceedings with the judge, it's hard to predict in advance. You know that there's no set timeline or deadline for judges to rule. And so, it's really hard to give any guidance on that point. As far as the range of outcomes, you know, that they're the typical range of outcomes for any Administrative Procedures Act proceeding. You know, obviously the judge could uphold the decision, the judge could just outright overrule the decision, or the judge could remand back to the FDA for further consideration. You know there are all sorts of durations even within those. But but those are the main three pathways.

當然，朱利安，謝謝你的提問。因此就回應時間而言，與法官進行的任何訴訟程序一樣，很難提前預測。您知道法官沒有設定裁決的時間表或最後期限。因此，就這一點而言，很難給出任何指導。就結果範圍而言，您知道，它們是任何《行政程序法》程序的典型結果範圍。你知道，法官顯然可以維持該決定，法官可以直接推翻該決定，或者法官可以將案件發回 FDA 進行進一步審議。您知道，即使在其中，也存在各種各樣的持續時間。但這些是三條主要途徑。

Okay, great. Thank you. That's very helpful and then quickly on the ascent trial great to hear enrolment completion is expected in first quarter next year. Sorry if I missed it, but wondering what your expectation for data disclosure is from there. Do you maybe plan to disclose the data at a conference? Any colour on the timing to data would be great.

好的，太好了。謝謝。這非常有幫助，然後很快在上升試驗中很高興聽到預計明年第一季完成招生。抱歉，如果我沒注意到，但我想知道您對那裡的數據披露有什麼期望。您是否計劃在會議上揭露這些數據？任何與數據時間相關的顏色都很好。

Yeah, thanks again for the question. Rajeev, if you could come in on the timing of the data disclosure.

是的，再次感謝您的提問。Rajeev，您能否介紹一下資料揭露的時間？

Yeah, thanks Julian. Good to hear from you. So, as you know this is an open label study, we continue to look at the data sets and with certain amount of frequency, we will submit the data to various Congresses coming up. So, we have submitted a set of data to a congress and if it's accepted then we anticipate showcasing that data in the first half of 2025.

是的，謝謝朱利安。很高興收到你的來信。因此，如您所知，這是一項開放標籤研究，我們會繼續查看資料集，並以一定的頻率將資料提交給即將召開的各種大會。因此，我們已經向大會提交了一組數據，如果被接受，我們預計將在 2025 年上半年展示這些數據。

Excellent. Thank you again.

出色的。再次感謝您。

Great. Thanks for that. And the thing, the thing I would add to that Julian is that I think you're going to see some, you know, some critically important information that differentiates the value of YUTREPIA, particularly as it relates to dose, that the ability to quickly get to dose, the impact of driving that dose in terms of clinical outcomes and then also we'll, you know, we'll disclose data on the persistence and durability of treatment within that patient subset. So, I think, you know, if we can show tolerability, titrate ability and durability all through the, you know, patient friendly low resistance device, which we think will lead to greater persistence. Then I think that is a differentiated data set, particularly when you look at some of the data sets that have been put out there for the competitive molecule TYVASO DPI to this point. Thank you. Next question.

偉大的。謝謝。我想補充的是，朱利安，我認為你會看到一些至關重要的信息，這些信息區分了 YUTREPIA 的價值，特別是與劑量有關，能夠快速達到劑量，即從臨床結果的角度考慮劑量的影響，然後我們也會揭露該患者子集內治療的持久性和耐久性的數據。因此，我認為，如果我們能夠透過患者友善的低阻力設備來展示耐受性、滴定能力和耐用性，我們認為這將帶來更大的持久性。那麼我認為這是一個差異化的資料集，特別是當你查看迄今為止針對競爭分子 TYVASO DPI 發布的某些資料集時。謝謝。下一個問題。

Jason Gerberry, Bank of America Securities.

美國銀行證券公司的 Jason Gerberry。

Hey, good morning, guys. Couple from me just as you think about a YUTREPIA launch, just wondering if we should be thinking about any points of friction on the coverage access side as you launch that product or you know, your confidence level that you'll have parity access pretty early in the launch period, any colour you can provide, there would be helpful. And then on the L606 update, in terms of the plan to go direct to pivotal at I'll d next year if I got that right. I don't know, the design is not formalized but should we generally think about increases providing a good framework for, for a type of study that you'd be running?

嘿，大家早安。當您考慮推出 YUTREPIA 時，我只是想知道我們是否應該考慮在推出該產品時覆蓋接入方面的任何摩擦點，或者您知道，您對很早就能獲得同等接入的信心水平在發布期間，您提供的任何顏色都會有所幫助。然後關於 L606 的更新，就直接進入關鍵階段的計劃而言，如果我沒有記錯的話，我明年就會完成。我不知道，設計尚未正式化，但我們是否應該普遍考慮為您正在進行的研究類型提供一個良好的框架？

Thanks.

謝謝。

Great. So, I think for the first question in terms of coverage access, I'll ask Mike to answer that one and on the second question Rajeev can speak to the L606 pivotal plan and timing.

偉大的。因此，我認為對於覆蓋範圍方面的第一個問題，我會請 Mike 來回答，對於第二個問題，Rajeev 可以談談 L606 的關鍵計劃和時間安排。

Yeah, Jason, thanks for the question. You know, relating to access, you know, we've been prepared to launch YUTREPIA since we received tentative approval in 2021. We've been engaging with payers to talk about the value proposition that YUTREPIA brings. You know, as a result of those conversations, I think we feel confident that, you know, access is obviously our goal and something that we're confident that we're going to be able to obtain. But as we get closer to our launch, we'll continue to have those conversations. But we are working towards having access as close to launch as possible.

是的，傑森，謝謝你的提問。您知道，關於訪問，您知道，自 2021 年獲得初步批准以來，我們就一直準備推出 YUTREPIA。我們一直在與付款人討論 YUTREPIA 帶來的價值主張。你知道，透過這些對話，我認為我們有信心，你知道，訪問權顯然是我們的目標，我們有信心能夠獲得它。但隨著發布日期的臨近，我們會繼續進行這些討論。但我們正在努力使其盡可能接近發布日期。

Great, thanks Mike. So, Rajeev maybe you can speak to how similar our design is to the increase study and then kind of what we're thinking about in terms of sample size and time.

太好了，謝謝邁克。因此，Rajeev，也許您可以談談我們的設計與增加研究有多相似，然後談談我們在樣本量和時間方面的考慮。

Yeah, sure. Thanks Jason. So, so, you know, again, as I, as I stated in the prepared remarks, I think the key here is that the open label study for L606 really gave us the confidence about our safety and tolerability and our dosing profile. I think the twice a day format for L606 is quite game changing here. In terms of the patients, in terms of compliance and performance, the next step is really to you know, ensure that the nebulizer is the right one for the patient. I think the nebulizer that we have chosen absolutely will ensure that the key [motif] for any nebulizer is drug deposition.

是的，當然。謝謝傑森。所以，正如我在準備好的評論中所說的那樣，我認為這裡的關鍵是 L606 的開放標籤研究確實讓我們對我們的安全性、耐受性以及我們的劑量特性充滿信心。我認為 L606 每天兩次的格式在這裡具有很大的變化。就患者、依從性和性能而言，下一步實際上是確保霧化器適合患者。我認為我們選擇的霧化器絕對會確保任何霧化器的關鍵[主題]是藥物沉積。

So we believe we've hit that that target. We think that's going to maximize our performance for L606 in patients with PH-ILD in regards to the overall patient I'm sorry, the trial format, I think using increase as a replicable study is important to note, I think, you know, understanding that these patients can improve six-minute walk distance within certain time periods is going to be critical. So, I think we use that as a rough estimate. In terms of the sample size overall I think we've, we've said, you know, the sample size will be somewhere between 300 to 400 patients again, this is a global study this will be enrolled in multiple countries to ensure that we can achieve success overall in an appropriate time frame.

因此我們相信我們已經達到了這個目標。我們認為這將最大限度地提高 L606 在 PH-ILD 患者中的表現，就整體患者而言，對不起，試驗格式，我認為使用增加作為可複製的研究是值得注意的，我認為，你知道，了解這些患者能否在一定時間內改善六分鐘步行距離至關重要。因此，我認為我們將其用作粗略估計。就總體樣本量而言，我認為我們已經說過，樣本量將在 300 到 400 名患者之間，這是一項全球性研究，將在多個國家進行招募，以確保我們能在適當的時間內取得整體成功。

Right? And the only thing I'd add to that Jason is that you know, with L606, because the [C max] is reduced by [seven X] or retaining the [AUC] over 24 hours that should further diminish the off target effects in the upper airway, cough and throat irritation in particular, which then means we should be able to titrate to higher doses which should lead to higher benefit. So, we're going to power around the same assumptions used to increase but my expectation is we'll have a better outcome than, than that study of all of this holds true.

正確的？我唯一想補充的是 Jason，你知道，使用 L606，因為 [C max] 降低了 [7 倍] 或保留了 24 小時內的 [AUC]，這應該會進一步減少脫靶效應尤其是上呼吸道、咳嗽和喉嚨刺激，這意味著我們應該能夠滴定到更高的劑量，從而帶來更大的益處。所以，我們將圍繞相同的假設來增加權力，但我的期望是，我們將得到比所有這些研究成立更好的結果。

Thank you. Operator, next question, please.

謝謝。接線員，請問下一個問題。

Greg Harrison, Scotiabank.

加拿大豐業銀行的格雷格·哈里森。

Hey, good morning. Thanks for taking the question. It looks like YUTREPIA launch is pretty well set and preparations are already. So, I wanted to ask about L606. Can you help us frame expectations for timelines for development overall? Enrolment just given the global nature and what you can do to expedite this and then how you view the opportunity for this asset, especially with respect to [X US]?

嘿，早安。感謝您回答這個問題。看起來 YUTREPIA 的發布已經準備就緒，並且已經開始籌備。所以，我想問一下有關 L606 的問題。您能幫助我們制定整體開發時間表的預期嗎？考慮到全球性的招生，以及你能做些什麼來加快這一進程，以及你如何看待這項資產的機會，特別是在[X 美國]？

Yes, I'll take that one so, you know, I think it's always hard to talk about timing when we haven't started Greg. So, I want to be a little bit cautious here and not, sort of predict things too early. But as Rajeev said in his opening comments, we plan to start the trial, initiate the trial in the first half of 25'.

是的，我會接受這一點，你知道，我認為當我們還沒有讓格雷格首發時，談論時機總是很困難。因此，我要在這裡保持謹慎，不要過早預測事情。但正如 Rajeev 在開場白中所說，我們計劃在 25 年上半年開始試驗。

It's our expectation that we can enrol the trial in say 18 to 24 months and then it would take six months to run them through the study, the last patient through three months to assimilate the data file it and then you have your typical 10 month review. So if you, if you just put all that together, just in sort of in a generalized sense, you're talking from start to finish four years, I think we can beat that.

我們預計，我們可以在 18 到 24 個月內招募試驗，然後需要六個月的時間來完成研究，最後一名患者需要三個月的時間才能吸收數據文件，然後進行典型的 10 個月審查。所以，如果你把所有這些放在一起，只是以一種廣義的角度，從頭到尾說的是四年，我認為我們可以打破這個記錄。

And the reason I say that is we're going to do this, most of the enrolment will come, will come from Ex US territories where TYVASO and TYVASO DPI are not available IE and the EU, China, South America, Australia, et cetera. So, it's a massive effort, certainly. And I think our development teams up for the challenge we're very well positioned in terms of logistics to get it done.

我之所以這麼說，是因為我們打算這樣做，大部分的註冊學生將來自美國以外的地區，這些地區沒有 TYVASO 和 TYVASO DPI，例如歐盟、中國、南美、澳洲等。所以，這無疑需要付出巨大的努力。我認為我們的開發團隊已經做好了迎接挑戰的準備，在後勤方面我們已經做好了充分的準備來完成任務。

We certainly have a lot of experience management experience in doing these types of trials for sure. So, I'm not, I'm confident that once we start, we'll get to go. The reason I think we could potentially be the timeline is because of the massive unmet need for these patients with PH-ILD and that we maybe didn't say on this call but have said before this, this study will serve for approval in the US for both PAH and PH-ILD that's the agreement we have with the FDA and with the EMA, we work out of additional studies are required. But our goal is to become a global brand provider of L606 to patients and that's why we expanded the license with Formosa, you know, very pleased with that partnership.

我們在進行此類試驗方面確實擁有豐富的管理經驗。所以，我相信，一旦我們開始，我們就會成功。我認為我們可能成為時間表的原因是因為這些 PH-ILD 患者有大量未滿足的需求，我們可能沒有在這次電話會議上提到，但之前已經說過，這項研究將在美國獲得批准對於PAH 和PH-ILD，這是我們與FDA 和EMA 達成的協議，我們需要進行額外的研究。但我們的目標是成為為患者提供 L606 的全球品牌供應商，這就是我們與 Formosa 擴大許可的原因，我們對這種合作關係感到非常高興。

What the expansion also came with, as we said was this was the acquisition of rights to their next generation nebulizers. And you know, these are very different than the current nebulizer. If you think about it, the Tyvaso nebulizer was in development 20 years ago. So, it's a, it's a dated nebulizer that's bulky and cumbersome. This is a nebulizer, that's the size of the iPhone portable breath actuated. And as we [Barosa] has shown in testing, very reliable in terms of its delivery kinetics and ability to deliver the exact and precise amount of drugs that we need to deliver to these, these patients and we can titrate, titrate the dose through different times solution strength quite easily.

正如我們所說，此次擴張也帶來了對下一代霧化器權利的收購。你知道，這些與目前的霧化器非常不同。如果你仔細想想，Tyvaso 霧化器是 20 年前開發的。所以，它是一種過時的霧化器，體積龐大且笨重。這是一款霧化器，大小與 iPhone 便攜式呼吸驅動設備相當。正如我們 [Barosa] 在測試中所展示的，其傳輸動力學非常可靠，能夠為這些患者提供我們所需的精確劑量的藥物，我們可以透過不同的方法滴定劑量。

So everything setting up well, oh, we just have to get the final compatibility work done with this, this new device. That was some of the delay that we have. Now, the reason if you would ask, why aren't you starting now we have to just close up shop in terms of doing the compatibility work with the new device that works going spectacularly well. But then we have to put the dossier together and file that to convince the FDA that we have the right device for the drug delivery that we're going to provide to these patients. So, you know, again, we'll give you more clarity as we progress with enrolment in terms of timing. But I just, if you just sort of pen to paper, say 3.5 to 4 years from first patient into a decision, I think that's about right.

一切設定好後，哦，我們只需要完成這個新設備的最終相容性工作。這是我們遇到的一些延遲。現在，如果您要問，為什麼你們不現在就開始，我們必須關閉商店，以便與運行良好的新設備進行相容性工作。但隨後，我們必須整理檔案並提交文件，以說服 FDA，我們擁有可以為這些患者提供的合適的藥物輸送設備。所以，您知道，隨著招生時間的推進，我們會再次為您提供更清晰的資訊。但是，如果您只是用筆寫下來，那麼從第一個患者到做出決定需要 3.5 到 4 年的時間，我認為這差不多是正確的。

Thanks, Greg.

謝謝，格雷格。

Kambiz Yazdi, Jefferies.

坎比茲·亞茲迪（Kambiz Yazdi），傑富瑞（Jefferies）。

Morning team for L606 for that open label safety study. How many patients achieved greater than 100 mcg twice daily dose? Are there, have they been consistent with the prior pro studies?

上午為 L606 團隊進行開放標籤安全研究。有多少患者每日服用兩次超過 100 微克的劑量？它們與先前的專業研究一致嗎？

And then maybe a question on launch. Can you remind us on the device side how robust your supply of your DPI inhaler is? Thank you so much.

然後也許是關於發布的一個問題。您能否在設備方面提醒我們，你們的 DPI 吸入器的供應有多充足？太感謝了。

Yes. So, the first question on dosing. Rajeev if you going to be able to speak to at this time and then Mike, if you could talk about [wise] going forward after that?

是的。因此，第一個問題是關於劑量的。Rajeev，您現在可以和他談談嗎？

Yeah, sure. It can be Thanks for the question. So in regards to achieving you know, greater than 100mg twice a day, you know, I would say the overwhelming majority of patients, if not close to almost all of the patients have had achieved that dosing profile. So again, that dosing profile would be you know, early in the titration phase. You know, we, we have shown at, at our ATS poster in 2024 in May, the overall median dose was, was exceeded 200mg for the majority of patients. So, you know, I think as Roger pointed out, I think that the key motive here is the liposome itself and the sustained release process has lend itself to be quite tolerable for these patients. It's, you know, in both PAH and PH-ILD patients and I think that's what's leading to the overall take credibility of this L606 in both populations. So, we remain quite confident about the overall safety and tolerability profile of this drug.

是的，當然。可以，感謝您的提問。因此，關於每天兩次服用超過 100 毫克的劑量，我想說絕大多數患者（如果不是接近所有患者的話）都已經達到了該劑量標準。所以，您再說一遍，劑量方案應處於滴定階段的早期。您知道，我們在 2024 年 5 月的 ATS 海報上已經展示過，大多數患者的整體中位劑量超過了 200 毫克。所以，你知道，我認為正如羅傑所指出的那樣，我認為這裡的關鍵動機是脂質體本身，而緩釋過程對於這些患者來說相當耐受。您知道，它同時適用於 PAH 和 PH-ILD 患者，我認為這就是導致 L606 在這兩個人群中都具有整體可信度的原因。因此，我們對該藥物的整體安全性和耐受性仍然非常有信心。

Yeah. And I think just in terms of breadth equivalent [cies] I think, you know, we're at 2 to 3 times that the therapeutic target for [Tadeso] is a nebula solution.

是的。而且我認為，僅從廣度等效 [cies] 的角度來看，您知道，我們的 [Tadeso] 治療目標是星雲解決方案，是其 2 到 3 倍。

So, again, a different profile, much like YUTREPIA where YUTREPIA is formulated is discrete dry, you know, dry particles in the lower end of the respiratory range that delivers to the lower lung to avoid upper airway deposition and here, the liposomal formulation dimensions, the C max so that you don't have as many peak [AEs at C max], but then can sustain the benefits. So, in a different way, does the same thing, it retains the titrate ability aspect which is critical and then allows for higher doses, higher benefit and we think higher persistence but does it in a twice a day format. So, it has all of the good of YUTREPIA but builds on it by taking it from a four times a day therapy to a twice a day therapy. So that's why we're very excited about this program, Mike, if you could talk about the device supply.

因此，再次重申一下，YUTREPIA 的不同之處，與YUTREPIA 非常相似，YUTREPIA 的配方是離散乾燥的，你知道，乾燥的顆粒在呼吸範圍的下端，輸送到下肺，以避免上呼吸道沉積，這裡是脂質體配方尺寸，C max ，這樣您就不會有那麼多的峰值 [C max 時的 AE]，但又能維持益處。因此，以不同的方式做同樣的事情，它保留了至關重要的滴定能力方面，然後允許更高的劑量、更高的效益，我們認為更高的持久性，但以每天兩次的形式進行。因此，它具有 YUTREPIA 的所有優點，但在此基礎上將每天四次的治療變為每天兩次的治療。所以這就是為什麼我們對這個項目感到非常興奮，麥克，如果你可以談論設備供應的話。

Absolutely. Great to talk to you Kambiz. So, we've been preparing to launch since we received prior approval in November of 2021. We've been manufacturing commercial supply. Since the early part of 22' we are, we will be ultra prepared for a launch. Here, you know, upon the expiration of the three-year marketing exclusivity that that United received, we continue to be to manufacturing at full capacity and we'll be ready to launch whenever that time comes. You know, in, in the May-June time frame. So, we have no concern there and feel very confident that we can have a very successful launch with, with sufficient supply.

絕對地。很高興與您交談，Kambiz。因此，自 2021 年 11 月獲得事先批准以來，我們一直在準備推出。我們一直在生產商業供應。從 22 年初開始，我們將為發射做好充分的準備。您知道，在美聯航獲得的三年行銷獨佔權到期後，我們將繼續全力生產，並隨時準備推出產品。您知道，在五月至六月的時間範圍內。因此，我們對此沒有任何擔心，並且非常有信心，只要供應充足，我們就能夠成功推出產品。

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

偉大的。謝謝你，麥克。接線員，下一個問題。

Cory Jubinville, LifeSci Capital.

Cory Jubinville，LifeSci Capital。

Good morning and congrats on the updates and thanks for taking our questions. You know, I guess can you provide us some more context in regard to the timelines to launch, in regard to the two ongoing suits? I guess on the FDA hearing in December assuming that the case is ruled in Liquidia's favour and in an optimistic scenario, how quickly would this expedite timelines in relation to the May 23rd tentative approval date and then across the two indications on the 793 patent decision, is it fair to say now that the YUTREPIA launches specifically in PAH now totally unencumbered following that May 23rd tentative approval date. And if so, is the plan to launch in PAH immediately? But, in PH-ILD, is there plans to wait on the, the 327 decisions to launch or do you anticipate launching at risk there you know, given the recent updates.

早安，恭喜您的更新，感謝您回答我們的問題。您能否為我們提供一些關於這兩起正在進行的訴訟的啟動時間表的更多背景資訊？我猜想，假設12 月的FDA 聽證會上該案的裁決對Liquidia 有利，並且在樂觀的情況下，這將多快加快與5 月23 日的暫定批准日期相關的時間表，然後加快793 專利決定的兩項適應症，現在是否可以說，YUTREPIA 在 PAH 的專門啟動在 5 月 23 日的暫定批准日期之後完全不受阻礙。如果是的話，是否計劃立即在 PAH 啟動？但是，在 PH-ILD，是否有計劃等待 327 號決定再啟動，或者根據最近的更新，您是否預計在那裡啟動會面臨風險。

Yeah. Great question, Rusty if you wouldn't mind.

是的。很好的問題，Rusty，如果你不介意的話。

Sure. Corey, thanks for the question. So, on the, just taking the questions in turn as far as the effect of the FDA lawsuit, you know, it's hard to fully answer that question because it's highly dependent on the timing of when we would get a decision and then exactly what the decision is. You know, for instance, if the decision was to narrow the exclusivity versus just eliminate the exclusivity, we would have to assess, you know, what that means as to the, you know, the label on our product and a number of other things. So, so again, it, it's hard to hard to know the answer to that question until we see what decision and when it comes in. But, you know, I think that the main takeaway from our standpoint on the FDA decision is we know the exclusivity ends in May of 2025. Obviously, we're pursuing that litigation in the hopes that we can accelerate that, that approval date. And, you know, if we can, you know, what we'll have to assess at the time, sort of what, what that looks like.

當然。科里，謝謝你的提問。因此，關於 FDA 訴訟的影響，這個問題很難完全回答，因為它高度依賴我們何時做出決定，以及最終結果如何。例如，如果決定是縮小獨家經營權而不是直接取消獨家經營權，我們就必須評估這對我們產品標籤和其他一些事情意味著什麼。所以，再說一遍，在我們看到做出何種決定以及何時做出決定之前，很難知道這個問題的答案。但是，你知道，我認為從我們對 FDA 決定的立場來看，主要結論是我們知道獨佔期將於 2025 年 5 月結束。顯然，我們正在進行訴訟，希望能夠加快批准日期。而且，您知道，如果我們可以的話，您知道，我們當時必須評估的是，它是什麼樣子的。

As to the second question on the 793 decision, you're correct with that, making its decision to [deny certiorari]. You know, that means that the first three patents that were asserted against us are no longer, you know, that, that litigation is now dead. There are no claims that, you know, therapeutics is asserting against us, or the FDA related to approval of PAH. So, from our perspective you know, there's really nothing at all in cumbering PAH at all. You know, as, as the final question on, on whether we would launch at risk. As we said consistently, I think over time, you know, that's an assessment we will make, you know, when the time comes, when we get FDA approval. We'll, we'll have to make a decision whether to launch at risk.

至於關於 793 決定的第二個問題，你說得對，它所做的決定[拒絕提審]。你知道，這意味著針對我們主張的前三項專利不再存在，你知道，那場訴訟現在已經結束了。您知道，沒有任何證據表明治療學對我們或 FDA 在批准 PAH 方面存在問題。因此，從我們的角度來看，阻礙 PAH 實際上根本沒有意義。你知道，最後一個問題是，我們是否願意冒險發射。正如我們一直所說的那樣，我認為隨著時間的推移，當我們獲得 FDA 批准時，我們會做出評估。我們必須決定是否要冒險發射。

But the other thing I'd say, and I, and I think we've said consistently is if we get to that point in time and we look at the patent landscape and don't see any patents that we think are valid and infringed by our product. You know, I don't think we're going to hesitate to launch. So, you know, again, that's an assessment we'll make at the time and obviously, you know, we're going through discovered in the 3 to 7 patent case. But, you know, as I said before, you know, our belief is there's substantial prior art out there that predates the 3-7 patent and that certainly would weigh heavily in any decision we make at that time.

但我想說的另一件事，也是我們一直強調的，如果我們到了那個時候，我們審視專利狀況，沒有發現任何我們認為有效且被侵權的專利通過我們的產品。你知道，我認為我們不會猶豫推出。所以，您知道，這是我們當時會做出的評估，顯然，我們正在研究 3 到 7 項專利案件。但是，正如我之前所說，我們相信在 3-7 專利之前存在大量現有技術，而且這肯定會對我們當時做出的任何決定產生重大影響。

Thanks. Great. Thank you, Rusty.

謝謝。偉大的。謝謝你，拉斯蒂。

Operator, I think we have time for one more question if there's any.

接線員，我想我們還有時間再回答一個問題（如果有的話）。

Matthew Kaplan, Ladenburg Thalmann & Co. Inc.

卡普蘭（Matthew Kaplan），Ladenburg Thalmann & Co. Inc.

Hey guys, good morning. And thanks for taking the question. Most of my questions have been asked, just in terms of launch preparation, given the near-term opportunity here and at the end of May next year, can you talk a little bit about how we should think about, coming to market, size of sales force, etcetera in terms of your commercial footprint when you're launching.

嘿，大家早安。感謝您回答這個問題。我的大部分問題都是關於發布準備的，考慮到目前的短期機會以及明年 5 月底，您能否談談我們應該如何考慮上市，規模銷售人員等等，這些都是您在推出產品時的商業足跡。

Yeah. And we're, we're fortunate to have Scott Moomaw our Chief Commercial Officer on the call. So, Scott, maybe if you could talk about kind of how we think about the calling space for both PAH and PH-ILD and size sales force sizing around that. Yeah.

是的。我們很榮幸能請到我們的首席商務官 Scott Moomaw 參加此次電話會議。所以，史考特，也許你可以談談我們如何看待 PAH 和 PH-ILD 的呼叫空間，以及圍繞該空間的銷售隊伍規模。是的。

Absolutely. Good morning. So, we've actually had the sales team on board for about a year now actually, our sales team is extremely experienced in rare disease. Most of them are from the PAH space and have launched multiple products in PAH. So, we're very excited about, you know, the, the depth of experience with them, their size from a general standpoint, they're sized to cover the entire market. And by that, I mean, both the PAH centers, you know, the large academic PAH centers as well as the community and in the community, it would be PAH treaters, but also, we've included ILD prescribers. So, there's pulmonologists out there who don't currently prescribe PAH medications.

絕對地。早安.因此，我們的銷售團隊實際上已經加入大約一年了，我們的銷售團隊在罕見疾病方面經驗豐富。他們中的大多數來自 PAH 領域，並已在 PAH 領域推出了多種產品。所以，我們對他們豐富的經驗感到非常興奮，從整體角度來看，他們的規模可以涵蓋整個市場。我的意思是，無論是 PAH 中心，還是大型學術 PAH 中心，以及社區，在社區中，都有 PAH 治療者，而且，我們還包括 ILD 處方者。所以，目前有些肺病專家不會開 PAH 藥物。

But certainly have PH-ILD patients in the pool in their offices and so, we've sized the, our sales force to be able to get into those offices as well. Help them be aware of PH-ILD, diagnose PH-ILD and then if the time is right, either treat those patients or for them into a center, that'll be willing to treat them so well, you know, we think there are probably about 6000-7000 targets in the market. We sized to, to address that entire market. We also have some, some other pieces that we have in place such as a team of key account directors who are under the commercial umbrella and they are completely focused on the largest most key academic medical centers, the PAH centers and so we can go very deep there as well. So, we're excited, we just want to get to May and then really let these folks loose.

但是他們的辦公室裡肯定有 PH-ILD 患者，因此，我們調整了銷售隊伍的規模，以便能夠進入這些辦公室。幫助他們了解 PH-ILD，診斷 PH-ILD，然後如果時間合適，要么治療這些患者，要么把他們送到願意為他們提供良好治療的中心，你知道，我們認為市場上大概有6000-7000個目標。我們調整規模以滿足整個市場的需求。我們還有一些其他的部分，例如由商業部門領導的大客戶總監團隊，他們完全專注於最大的、最重要的學術醫療中心，即肺動脈高壓中心，所以我們可以在那裡也很深。所以，我們很興奮，我們只想等到五月，然後真正讓這些人放鬆一下。

Great thanks Scott. So, as you can hear, we, we're going to have significant share of voice from the day of launch.

非常感謝斯科特。所以，正如您所聽到的，從發布之日起，我們將擁有相當大的話語權。

So operator, I believe there's, there's another question that we can take.

因此，接線員，我相信還有另一個問題我們可以回答。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Good morning. I was wondering if you could give us a little more detail on the next generation nebulizer that's party to the latest Foremost Agreement. You know, where is the nebulizer in terms of, I guess its own development? And is this nebulizer currently something that's used with commercial products? Thanks.

早安.我想知道您是否可以向我們詳細介紹最新的 Foremost 協議中涉及的下一代霧化器。您知道，就霧化器本身的發展而言，它處於什麼位置？這款霧化器目前是用於商業產品嗎？謝謝。

Yeah, I'll answer that quickly. So, Ryan, I think at this time it's a proprietary nebulizer that we have exclusive rights to we're looking to secure some of our own IP around that. So, we're not going to really discuss specifically what the nebulizer is that we're going to use for the trial. Certainly, in the coming quarters, we'll disclose that to you. But I think our regime nicely described that the important aspect of it, that it's a, you know, iPhone size breadth actuated, rechargeable, highly portable nebulizer. That's very good at the delivery of the drug and precise in the precise dosing aspects that we need. So, I'm sorry, I can't give you more at this time, but we'll, we'll provide that information in the coming quarters.

是的，我會很快回答這個問題。所以，Ryan，我認為現在這是我們擁有專有權利的專有霧化器，我們正在尋求保護我們的一些智慧財產權。因此，我們不會真正討論我們將在試驗中使用的霧化器具體是什麼。當然，在接下來的幾個季度裡，我們會向您透露這項消息。但我認為我們的方案很好地描述了它的重要方面，即它是一種像 iPhone 大小一樣的寬度驅動、可充電、高度便攜的霧化器。這對於藥物的傳遞非常有效，並且在我們所需的精確劑量方面也非常準確。所以，很抱歉，我目前無法給您更多信息，但我們會在接下來的幾個季度提供這些信息。

Thank you. And I would now like to turn the conference back over to Roger Jeffs for any closing remarks.

謝謝。現在我想將會議交還給羅傑·傑夫斯並請他作最後發言。

Great. Well, we really appreciate the questions this morning. It's very pleasing to have the analyst of the coverage asking so many questions and we look forward to providing further updates in the coming quarters as we continue to advance our march towards launch of YUTREPIA.

偉大的。嗯，我們非常感謝今天早上提出的這些問題。很高興報告的分析師提出了這麼多問題，我們期待在接下來的幾季提供進一步的更新，因為我們將繼續推動 YUTREPIA 的推出。

Thank you, everyone.

謝謝大家。

This concludes today's conference call. Thank you for participating. 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。