Liquidia Corp (LQDA) 2024 Q1 法說會逐字稿

Good morning. And welcome everyone to the Liquidia Corporation first-quarter 2024 financial results and corporate update conference call. My name is Michelle, and I'll be your conference operator today. Currently all participants are in listen-only mode.

早安.歡迎大家參加 Liquidia Corporation 2024 年第一季財務表現及公司更新電話會議。我叫米歇爾，今天我將擔任你們的會議操作員。目前所有參與者都處於僅監聽模式。

Following the presentation, we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this call is being recorded.

演講結束後，我們將進行問答環節。屆時將提供指導，讓您排隊提問。我想提醒大家，這次通話正在錄音。

I'll now hand the call over to Jason Adair, Chief Business Officer.

現在我將電話轉給首席商務官 Jason Adair。

Thank you, Michelle. It's my pleasure to welcome everyone to the Liquidia Corporation's first quarter 2024 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs; Chief Operating Officer and CFO, Michael Kaseta; Chief Medical Officer, Dr. Rajeev Saggar; Chief Commercial Officer, Scott Moomaw; and General Counsel, Rusty Schundler.

謝謝你，米歇爾。我很高興歡迎大家參加 Liquidia Corporation 2024 年第一季財務業績和公司最新情況電話會議。今天加入電話會議的還有執行長 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.

在開始之前，請注意，今天的電話會議將包含前瞻性聲明，包括有關未來業績、未經審計和前瞻性財務資訊以及公司未來業績和/或成就的聲明。

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.

這些陳述受到已知和未知的風險和不確定性的影響，這可能導致我們的實際結果或業績與本次電話會議中明示或暗示的任何未來結果或業績存在重大差異。

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.

有關更多信息，包括對我們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，這些文件可以在我們的網站上訪問。

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

我現在想將電話轉給羅傑，讓他聽我們準備好的發言，然後他將開始電話會議，回答你們的問題。

Thank you, Jason. Good morning, everyone, and thank you for joining us today. In the nine weeks since our last earnings call, we have continued to advance what we believe will be the industry-leading portfolio of inhaled treprostinil products.

謝謝你，傑森。大家早安，感謝您今天加入我們。自上次財報電話會議以來的九週內，我們繼續推進我們認為將成為業界領先的吸入曲前列環素產品組合。

YUTREPIA, our dry powder formulation of treprostinil, currently awaits final FDA approval to treat both pulmonary hypertension -- arterial hypertension or PAH and pulmonary hypertension associated with interstitial lung disease or PH-ILD.

YUTREPIA 是我們的曲前列環素乾粉製劑，目前正在等待 FDA 最終批准，用於治療肺動脈高壓（動脈高壓或 PAH）以及與間質性肺病或 PH-ILD 相關的肺動脈高壓。

We have continued to optimize our commercial preparations in anticipation of potential FDA final action and launch. In the clinic, we are seeing encouraging initial data from our ASCENT trial of YUTREPIA and PH-ILD. In addition, our sustained release liposomal formulation of treprostinil, L606, also continues to generate encouraging data in our open-label safety study in both PAH and PH-ILD patients.

我們繼續優化我們的商業準備工作，以應對 FDA 潛在的最終行動和上市。在臨床上，我們從 YUTREPIA 和 PH-ILD 的 ASCENT 試驗中看到了令人鼓舞的初步數據。此外，我們的曲前列環素緩釋脂質體製劑 L606 在針對 PAH 和 PH-ILD 患者的開放標籤安全性研究中也持續產生令人鼓舞的數據。

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

Rajeev 和 Rusty 稍後將提供有關臨床、監管和法律方面的更詳細的最新資訊。但首先，我認為重要的是要反思市場上正在發生的事情，以及為什麼我們如此致力於這些項目和我們尋求治療的患者。

We believe the market for inhaled treprostinil in PAH and PH-ILD can eclipse $3 billion at peak sales. And this is validated by Tyvaso's total current annual run rate of approximately $1.5 billion, which continues to grow at an appreciable rate. This growth is driven by the expanded PH-ILD market, which is only marginally penetrated at this time, along with the availability of the more portable dry powder inhaler option.

我們相信，用於治療 PAH 和 PH-ILD 的吸入曲前列環素市場在高峰期銷售額可能會超過 30 億美元。Tyvaso 目前約 15 億美元的總年營業額證實了這一點，並且該數字仍在以可觀的速度繼續增長。這一增長是由擴大的 PH-ILD 市場（目前該市場僅略有滲透）以及更便攜式乾粉吸入器選項的可用性所推動的。

However, what we also see in our competitive sales data is continued unmet need. In our study of YUTREPIA, 100% of patients who transitioned to YUTREPIA from Tyvaso preferred YUTREPIA after four months of use. Yet, approximately 40% of [UTHR] sales continue to come from nebulized Tyvaso with its bulky, challenging and dose-limiting nebulizer.

然而，我們在競爭性銷售數據中也看到，需求仍然未被滿足。在我們的 YUTREPIA 研究中，從 Tyvaso 過渡到 YUTREPIA 的患者在使用四個月後，100% 首選 YUTREPIA。然而，約 40% 的 [UTHR] 銷售額仍來自霧化 Tyvaso，其體積龐大、具有挑戰性且劑量限制的霧化器。

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

我們對可能阻礙患者從 Tyvaso 更徹底地轉換為 Tyvaso DPI 的全部問題沒有任何直接了解。但考慮到 DPI 明顯的便攜性和使用優勢，Tyvaso 的持續流行似乎不合邏輯。

In this regard, data from the National Jewish Health Pulmonary Hypertension Program may be broadly informative. In September, these experts presented a single-center perspective observational study in patients with PH-ILD who were initiated on treprostinil DPI.

在這方面，國家猶太健康肺動脈高壓計畫的數據可能提供廣泛的資訊。9 月份，這些專家對開始接受曲前列環素 DPI 治療的 PH-ILD 患者進行了一項單中心透視觀察研究。

Of the 26 patients with PH-ILD initiated on Tyvaso DPI, 69% of these patients discontinued this treatment after a mean of only 78 days or a median of 40 days. Of importance, 11 or 42.3% of these patients, transitioned to the Tyvaso nebulizer upon discontinuation of DPI therapy. This is highly consistent with our competitor sales data, highlighting that nearly 40% of its patient base continues to use the more cumbersome nebulizer for Tyvaso administration.

在開始接受 Tyvaso DPI 治療的 26 名 PH-ILD 患者中，69% 的患者在平均僅 78 天或中位數 40 天後就停止了治療。重要的是，這些患者中有 11%（即 42.3%）在停止 DPI 治療後轉用泰瓦索霧化器。這與我們競爭對手的銷售數據高度一致，突顯出其近 40% 的患者群體繼續使用更笨重的霧化器進行 Tyvaso 給藥。

From our perspective, clearly it is not a molecule treprostinil, but rather the limitation of the formulation and the very high resistance DPI utilized with Tyvaso DPI, especially when treating patients with lung impairment in PH-ILD.

從我們的角度來看，顯然這不是曲前列環素分子，而是配方的限制以及與 Tyvaso DPI 一起使用的極高抗藥性 DPI，特別是在治療 PH-ILD 肺損傷患者時。

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

這就是為什麼我們相信醫生和患者渴望一種新的選擇，一種使用便攜式、患者友好型、低阻力乾粉吸入器提供易於滴定和持久的曲前列環素吸入製劑的選擇，並表現出患者的高度偏好和滿意度。

YUTREPIA is that choice and has the very real potential to become the first in choice in best-in-class process cyclin in this growing market opportunity.

YUTREPIA 就是這樣的選擇，並且具有真正的潛力，在這個不斷增長的市場機會中成為一流工藝週期素的首選。

With that, I'd like to ask Rajeev to share more about FDA interactions and our observations in the ongoing clinical studies with YUTREPIA and L606. Rajeev?

因此，我想請 Rajeev 分享更多有關 FDA 相互作用的資訊以及我們在正在進行的 YUTREPIA 和 L606 臨床研究中的觀察結果。拉吉夫？

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

謝謝，羅傑。我想回答我收到的與我們的計劃相關的三個最常見的問題。

First, where does the FDA stand in its review of YUTREPIA?

首先，FDA對YUTREPIA的審查立場為何？

Second, what observations are emerging from the ASCENT trial, our open-label study of YUTREPIA in PH-ILD patients, to better understand dosing and titration in that patient population?

其次，為了更了解該患者群體的劑量和滴定，ASCENT 試驗（我們對 PH-ILD 患者的 YUTREPIA 開放標籤研究）中出現了哪些觀察結果？

And third, when can we expect to see more data on the L606 program?

第三，我們什麼時候可以看到更多有關 L606 計劃的數據？

I will take each in turn. Regarding the first question, while we cannot speak to a specific action date, the FDA's review division has maintained an active dialogue with Liquidia on the development of YUTREPIA since it entered the clinic as a first-drive powder formulation of treprostinil.

我將依次進行。關於第一個問題，雖然我們無法透露具體的行動日期，但自從YUTREPIA作為曲前列環素的首驅粉末製劑進入臨床以來，FDA的審查部門一直與Liquidia就YUTREPIA的開發保持著積極的對話。

During the course of its review of the NDA for PAH, the FDA has confirmed multiple times over the last three years that submitting an amendment to the NDA would be an appropriate way to add PH-ILD indication. Also, throughout this process, the FDA consistently affirmed that no additional clinical data would be required to add the PH-ILD indication.

在對 PAH 的 NDA 審查過程中，FDA 在過去三年中多次確認，提交 NDA 修正案將是添加 PH-ILD 適應症的適當方式。此外，在整個過程中，FDA 始終確認不需要額外的臨床數據來添加 PH-ILD 適應症。

We are disappointed that the FDA did not issue an action letter promptly following the expiration of the March 31, clinical investigation exclusivity granted to Tyvaso to treat PH-ILD. Nevertheless, we remain hopeful that the FDA will issue final action very soon, given the lack of any legal barriers to our approval.

我們感到失望的是，在 3 月 31 日授予 Tyvaso 治療 PH-ILD 的臨床研究排他性到期後，FDA 沒有立即發出行動函。儘管如此，鑑於我們的批准不存在任何法律障礙，我們仍然希望 FDA 很快就能採取最終行動。

Regarding the second question, we initiated the open-label ASCENT trial in late December to help physicians understand the safety, tolerability, and titratability of YUTREPIA in patients with PH-ILD. We have enrolled seven patients to-date and have several additional sites initiating the study over the next 30 days.

關於第二個問題，我們在12月下旬啟動了開放標籤ASCENT試驗，以幫助醫生了解YUTREPIA在PH-ILD患者的安全性、耐受性和滴定性。迄今為止，我們已招募了 7 名患者，並在接下來的 30 天內在其他幾個地點啟動了這項研究。

Of the seven patients, the median dose was 106 micrograms during week 4 and 132.5 micrograms during week 8, which are comparable to nebulized Tyvaso of about 12 to 15 breaths per session, respectively. The highest dose of YUTREPIA achieved to-date in the study is 318 micrograms, which is at least 36 breaths per session of Tyvaso nebulizer.

在這 7 名患者中，第 4 週的中位數劑量為 106 微克，第 8 週的中位數劑量為 132.5 微克，分別與每次治療約 12 至 15 次呼吸的霧化泰瓦索相當。該研究迄今為止達到的 YUTREPIA 最高劑量為 318 微克，相當於泰瓦索霧化器每次治療至少 36 次呼吸。

While early and a small sample size, we are encouraged at the tolerability and titratability profile in patients with PH-ILD and remain confident that we can complete enrollment of the study by the end of the year. We look forward to presenting a more robust clinical data at a future medical conference later this year.

雖然研究仍處於早期且樣本量較小，但我們對 PH-ILD 患者的耐受性和滴定性概況感到鼓舞，並且仍然有信心能夠在年底前完成該研究的入組。我們期待在今年稍後的未來醫學會議上提供更可靠的臨床數據。

Finally, regarding the third question, next week at the American Thoracic Society Conference, we will present an abstract focusing on the clinical data of our liposomal sustained release formulation of treprostinil L6O6 from the open-label safety study in the first 24 patients enrolled with PAH and PH-ILD.

最後，關於第三個問題，下週在美國胸腔科學會會議上，我們將提交一份摘要，重點介紹我們的曲前列環素L6O6 脂質體緩釋製劑的臨床數據，這些數據來自於首批24 名PAH 患者的開放標籤安全性研究和 PH-ILD。

We continue to observe a favorable tolerability and titratability profile of L6O6 given the seven-fold lower [C-max] and twice daily dosing using a rapid breath-accentuated nebulizer. To-date, patients have titrated to our maximum dose allowed in the study of 378 micrograms twice daily, a dosage that would be comparable to 26 to 28 breaths of Tyvaso nebulized administered four times daily.

我們繼續觀察到 L6O6 具有良好的耐受性和滴定性，因為 [C-max] 降低了七倍，並且使用快速呼吸加速霧化器每天兩次給藥。迄今為止，患者已逐漸調整至研究中允許的最大劑量，即每天兩次 378 微克，該劑量相當於每天四次霧化泰瓦索 26 至 28 次呼吸。

We will publish the poster to our website once presented and look forward to discussing the observation in future calls.

我們將在海報發布後將其發佈到我們的網站上，並期待在未來的電話會議中討論觀察結果。

In addition, we are vigorously engaging in startup activities to enable initiation of our Phase 3 randomized controlled study. The single pivotable study will enable indications to treat both PH-ILD and PAH. Physician interest globally is robust and we look forward to interacting with regulatory agencies in the next few months as we prepare to initiate the study later this year.

此外，我們正在積極參與啟動活動，以啟動我們的第 3 期隨機對照研究。單一可樞軸研究將獲得治療 PH-ILD 和 PAH 的適應症。全球醫生的興趣濃厚，我們期待在未來幾個月內與監管機構互動，準備在今年稍後啟動這項研究。

At this time, I would like to ask Rusty to summarize the recent legal actions of the last few months. Rusty?

此時，我想請 Rusty 總結一下最近幾個月的法律行動。生鏽了？

Thank you, Rajeev. The first quarter of 2024 saw significant progress on the legal front. This is the first earnings call in which we can say that there are no legal barriers preventing the FDA from issuing a final action on the amended NDA for YUTREPIA.

謝謝你，拉吉夫。2024 年第一季度，法律方面取得了重大進展。這是第一次財報電話會議，我們可以說，不存在任何法律障礙阻止 FDA 對 YUTREPIA 修訂後的 NDA 採取最終行動。

The combination of District Court, PTAB, and federal circuit rulings have led to the removal of the previous injunction issued in 2022. In addition, United Therapeutics regulatory exclusivity tied to PH-ILD expired on March 31. Thus, since April 1, the FDA has had the legal authority to take final action on our NDA for YUTREPIA.

地方法院、PTAB 和聯邦巡迴法院的裁決相結合，導致先前於 2022 年發布的禁令被撤銷。此外，United Therapeutics 與 PH-ILD 相關的監管獨佔權已於 3 月 31 日到期。因此，自 4 月 1 日起，FDA 擁有對 YUTREPIA 的 NDA 採取最終行動的法定權力。

While we cannot comment on when the FDA will take that final action, we can clarify the status of two ongoing lawsuits brought by United Therapeutics against Liquidia and the FDA, each with the same intent to stop the launch of YUTREPIA and PH-ILD.

雖然我們無法評論FDA 何時採取最終行動，但我們可以澄清United Therapeutics 針對Liquidia 和FDA 提起的兩起正在進行的訴訟的狀況，每起訴訟都有相同的目的，即阻止YUTREPIA 和PH-ILD 的上市。

Neither of these lawsuits currently impact the FDA's ability to approve YUTREPIA for both indications, and even in the worst case, neither lawsuit will ultimately impact our ability to treat PAH patients.

目前，這兩起訴訟都不會影響 FDA 批准 YUTREPIA 用於這兩種適應症的能力，即使在最壞的情況下，這兩起訴訟最終不會影響我們治療 PAH 患者的能力。

In the first of these lawsuits, United Therapeutics has filed a lawsuit alleging infringement of the 327 patent based on our request for approval of the PH-ILD indication. In this lawsuit, United Therapeutics has filed a motion for preliminary injunction.

在第一起訴訟中，United Therapeutics 根據我們請求批准 PH-ILD 適應症的請求，提起了訴訟，指控其侵犯 327 專利。在這起訴訟中，聯合治療公司提出了初步禁令動議。

Judge Andrews in the United States District Court for the District of Delaware heard oral arguments from both parties on April 23 regarding the preliminary injunction, and may issue a written ruling at any time.

美國特拉華州地方法院安德魯斯法官於4月23日聽取了雙方關於初步禁令的口頭辯論，並可能隨時發布書面裁決。

We remain confident in our arguments as briefed and argued, and continue to believe there are substantial questions regarding the validity of the 327 patent, which generally covers treatment of PH-ILD patients with Tyvaso in accordance with the Tyvaso label, something that physicians have been doing for more than a decade, as evidenced by multiple publications describing positive results in PH-ILD patients over that period.

我們對我們所陳述和爭論的論點仍然充滿信心，並繼續相信327 專利的有效性存在實質性問題，該專利通常涵蓋根據Tyvaso 標籤使用Tyvaso 治療PH-ILD 患者，這是醫生一直在做的事情。

In the second of these lawsuits, United Therapeutics is seeking to bar the FDA from accepting and approving our amendment to add PH-ILD to the label for YUTREPIA, pursuant to the administrative procedure set.

在第二起訴訟中，United Therapeutics 尋求阻止 FDA 根據既定的行政程序接受和批准我們將 PH-ILD 添加到 YUTREPIA 標籤中的修正案。

Judge Bates in the United States District Court for the District of Columbia rejected United Therapeutics motion for a temporary restraining order and preliminary injunction on March 29, indicating that the FDA's acceptance of our amendment for review did not constitute final agency action.

美國哥倫比亞特區地方法院的貝茨法官於 3 月 29 日駁回了聯合治療公司提出的臨時限制令和初步禁令的動議，表明 FDA 接受我們的修正案進行審查並不構成最終的機構行動。

Judge Bates has retained jurisdiction, though, and ordered the FDA to provide the court and both United Therapeutics and Liquidia notice three days prior to taking any final action on the YUTREPIA NDA. Additionally, last week, both we and the FDA filed motions to dismiss the entire lawsuit in briefing on the motion of dismissal in progress.

不過，貝茨法官保留了管轄權，並命令 FDA 在對 YUTREPIA NDA 採取任何最終行動之前三天向法院以及 United Therapeutics 和 Liquidia 發出通知。此外，上週，我們和 FDA 都在關於正在進行的駁回動議的簡報中提出了駁回整個訴訟的動議。

We remain confident that both our amendment was properly filed and that United Therapeutics does not have the necessary standing to challenge the FDA's decision. Our priority has been and remains prompt approval of YUTREPIA so that we can make it available to patients. We will continue to vigorously defend our ability to do so.

我們仍然相信我們的修正案已正確提交，並且 United Therapeutics 沒有必要的資格來質疑 FDA 的決定。我們的首要任務一直是並且仍然是迅速批准 YUTREPIA，以便我們能夠將其提供給患者。我們將繼續大力捍衛我們這樣做的能力。

I will now turn the call over to Mike.

我現在將把電話轉給麥克。

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

謝謝你，Rusty，大家早安。我們以公司歷史上最強勁的財務狀況結束了第一季。我們的資產負債表上不僅有足夠的現金來實現我們的目標，而且我們還準備進入成長最快的罕見疾病市場之一，我們相信這將是針對 PAH 和 PH-ILD 患者的差異化產品。

Our team is fully in place, our commercial inventories are ready and expanding, our relationships with all key stakeholders are sound and active; and our sales team is fully engaged and ready to launch. We continue to believe that the approval and launch of YUTREPIA this quarter in both indications will enable a rapid transformation in the company's P&L.

我們的團隊已完全到位，我們的商業庫存已準備就緒並正在擴大，我們與所有主要利益相關者的關係健全且活躍；我們的銷售團隊已全力投入並準備啟動。我們仍然相信，YUTREPIA 本季在這兩個適應症上的批准和上市將使公司損益表快速轉變。

Turning to our financial results, which can be found in the press release, you will see that revenue was $3 million for the first quarter 2024, compared with $4.5 million in the same quarter for 2023. Revenue is tied to our promotion agreement with Sandoz to commercialize treprostinil injection.

轉向我們的財務表現（可在新聞稿中找到），您會發現 2024 年第一季的收入為 300 萬美元，而 2023 年同一季度的收入為 450 萬美元。收入與我們與山德士簽訂的曲前列環素注射商業化推廣協議掛鉤。

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

減少的主要原因是上年錄得有利的增長淨回扣調整以及本年銷量較上年同期減少的影響。

Cost of revenue increased to $1.5 million for the first quarter 2024, compared to $0.7 million in the same quarter for 2023. Cost of revenue relates to our promotion agreement, with the increase being primarily due to our salesforce expansion during the fourth quarter of 2023.

2024 年第一季的營收成本增至 150 萬美元，而 2023 年同一季度的營收成本為 70 萬美元。收入成本與我們的促銷協議有關，增加的主要原因是我們在 2023 年第四季擴大了銷售團隊。

Research and development expenses were $10.1 million in the first quarter 2024, compared with $5.3 million in first quarter 2023. The increase of $4.8 million or 91%, was primarily due to a $2 million increase in personnel expenses, which includes stock-based compensation, related to higher headcount and a $1.7 million increase in clinical expenses related to our L606 program.

2024 年第一季的研發費用為 1,010 萬美元，而 2023 年第一季的研發費用為 530 萬美元。增加 480 萬美元或 91%，主要是由於人員費用增加 200 萬美元，其中包括與員工數量增加相關的股票薪酬，以及與 L606 項目相關的臨床費用增加 170 萬美元。

Additionally, there was a $1.3 million increase in expenses related to our YUTREPIA program, driven by higher clinical and supply expenses related to our ASCENT study.

此外，由於與我們的 ASCENT 研究相關的臨床和供應費用增加，與我們的 YUTREPIA 計畫相關的費用增加了 130 萬美元。

General and administrative expenses were $20.2 million in the first quarter of 2024, compared to $7.8 million in the same quarter for 2023. The increase of $12.4 million was primarily due to increases in legal fees related to our ongoing YUTREPIA-related litigation, increase in personnel expenses, and increases in commercial and consulting expenses in preparation for the potential commercialization of YUTREPIA.

2024 年第一季的一般和管理費用為 2,020 萬美元，而 2023 年同一季度的一般和管理費用為 780 萬美元。增加 1240 萬美元主要是由於與我們正在進行的 YUTREPIA 相關訴訟相關的法律費用增加、人員費用增加以及為 YUTREPIA 潛在商業化做準備的商業和諮詢費用增加。

In summary, we incurred a net loss for the three-month end of March 31, 2024 of $40.9 million or $0.54 per basic and diluted share, compared to a net loss of $11.7 million or $0.18 per basic and diluted share for the three-month ended March 31, 2023.

總之，截至2024 年3 月31 日的三個月淨虧損為4,090 萬美元，即每股基本股和稀釋股0.54 美元，而三個月的淨虧損為1,170 萬美元，即每股基本股和稀釋股0.18 美元截至 2023 年 3 月 31 日。

We ended the first quarter with $157.9 million cash on hand, which included $100 million in gross proceeds between a private placement of equity to a single investor and a third advance from healthcare royalty under our agreement.

第一季結束時，我們手頭現金為 1.579 億美元，其中包括向單一投資者私募股權的 1 億美元總收益以及根據我們協議從醫療保健特許權使用費中獲得的第三筆預付款。

In summary, we are well-positioned financially to achieve our corporate objectives in 2024.

總之，我們在財務上處於有利地位，可以在 2024 年實現我們的企業目標。

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

我現在想把電話轉回給羅傑。

Thank you, Mike. Operator, with that, I'd like to now open the call for questions. First question, please.

謝謝你，麥克。接線員，現在我想開始提問。第一個問題，請。

Thank you. (Operator Instructions)

謝謝。（操作員說明）

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

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

大家好。感謝您提出我的問題。我想就在上週 UTHR 和 FDA 駁回的申請中。你認為貝茨法官會以多快的速度搬到這裡？這似乎可能是這裡的一個新變數。如果FDA被要求提前三天通知，他們不想提前三天通知，他們希望駁回這項要求。我只是有點好奇如何將其放在適當的背景下。

And the, ultimately, if you're able to secure approval -- broad approval, both PAH and PH-ILD. I'm just wondering if there are any specific label variables you might call out that could really impact the commercial opportunity beyond just getting those two indications, how we might think about the label looking different than Tyvaso? Thanks.

最終，如果您能夠獲得廣泛的批准，包括 PAH 和 PH-ILD。我只是想知道您是否可能會指出任何特定的標籤變量，這些變量可能真正影響商業機會，而不僅僅是獲得這兩個指示，我們如何看待該標籤看起來與 Tyvaso 不同？謝謝。

Hey, Jason. Good morning. Thanks for the question. I'll take the second question first, if I can, and then I'll ask Rusty to speak about his perspectives around the timing of the motion to dismiss case.

嘿，傑森。早安.謝謝你的提問。如果可以的話，我將首先回答第二個問題，然後我將請 Rusty 談談他對駁回案件動議時機的看法。

So, great question, Jason. Again, what we talk about with YUTREPIA in terms of being differentiated are around its pillars, which are tolerability, titratability, durability and usability, and all of that is sort of dictated by the PRINT formulation.

所以，這是個好問題，傑森。再說一次，我們談論 YUTREPIA 的差異化是圍繞它的支柱，即耐受性、滴定性、耐用性和可用性，而所有這些都是由 PRINT 配方決定的。

So, again, with the ability to make precise and uniform particles in the lower end of the respirable range, it allows for a highly tolerable therapy, which is readily titratable, and then will be durable and usable through the low-resistance device, so friendly for both PAH and PH-ILD patients to use.

因此，再次，由於能夠在可呼吸範圍的下限內製造精確且均勻的顆粒，因此它可以實現高度耐受的治療，該治療易於滴定，然後通過低電阻裝置將變得耐用且可用，因此適合PAH和PH-ILD 患者使用。

The differentiation that we will see in the label in that regard will be specifically related to the exposures that we've seen in our clinical work versus what's in their labels. So we will have up to 212 micrograms four times a day described in our label. So again, we're talking about 24, 25 breath equivalents, so much higher than what's in the Tyvaso DPI. And as we know from historical standards, across all routes, across the cycle of delivery, dose matters.

在這方面，我們在標籤中看到的差異將與我們在臨床工作中看到的暴露與標籤中的暴露特別相關。因此，我們的標籤上描述的每天四次，攝取量最多為 212 微克。再說一次，我們談論的是 24、25 呼吸當量，遠高於 Tyvaso DPI 中的數值。正如我們從歷史標準中了解到的那樣，在所有途徑、整個給藥週期中，劑量都很重要。

So the higher the dose and the more flexibility in driving dose, the more capable that therapy will be. So that's why we think that YUTREPIA has a -- will have a clear chance to become best-in-class and first-in-choice prostacyclin, not only to compete with inhaled treprostinil in the Tyvaso formats, but also when physicians are seeking to think about starting therapy, we think they should think about using YUTREPIA as the first choice, not -- and do that in sort of in place of oral therapies like Orenitram and Uptravi.

因此，劑量越高，驅動劑量越靈活，治療效果越強。因此，我們認為 YUTREPIA 有明顯機會成為同類最佳和首選前列環素，不僅可以與 Tyvaso 形式的吸入曲前列環素競爭，而且當醫生尋求考慮開始治療時，我們認為他們應該考慮使用YUTREPIA 作為首選，而不是- 並以此代替Orenitram 和Uptravi 等口服療法。

And then also, in terms of [Subcutaneous] patients are going to have a pretty burdensome time getting to a therapeutic dose of drug because of the off-target effects for both the oral and the parenteral formulation. So again, tremendous market opportunity, looking forward to launch, but I think we'll have very clear and distinguishable differentiation at the point of launch. And with that, Rusty, maybe if you could speak about the logistics around the legal case.

此外，就[皮下注射]而言，由於口服和腸胃外製劑的脫靶效應，患者獲得治療劑量的藥物將經歷相當困難的時間。再次強調，巨大的市場機會，期待推出，但我認為我們在推出時將擁有非常清晰且可區分的差異化。Rusty，也許你可以談談法律案件的後勤工作。

Sure. So Jason, thank you for the question. So the motion to dismiss and briefs that went in last week is the first round of briefs on the motion to dismiss. Briefing will continue through June 25, and then from there, we don't have visibility as to what the judge will do and how long it would take him to rule.

當然。傑森，謝謝你的提問。因此，上週提出的駁回動議和簡報是關於駁回動議的第一輪簡報。簡報將持續到 6 月 25 日，從那時起，我們無法得知法官將做什麼以及他需要多長時間做出裁決。

It's possible that at that point he'll schedule a hearing, or it's possible he'll just rule on the briefs, but obviously federal judges, it's hard to predict exactly how long they would take to issue a ruling. So thank you for the question.

屆時他可能會安排聽證會，或者他可能只會根據案情摘要做出裁決，但顯然對於聯邦法官來說，很難準確預測他們需要多長時間才能做出裁決。謝謝你的提問。

And just a reminder, Jason, that decision is not needed for the FDA to take final action, as Rusty said in his comments.

只是提醒一下，傑森，FDA 不需要做出這一決定來採取最終行動，正如魯斯蒂在他的評論中所說的那樣。

Julian Harrison, BTIG.

朱利安·哈里森，BTIG。

Serge Belanger, Needham & Company

塞爾吉貝蘭格 (Serge Belanger)，李約瑟公司

Hi. Good morning. Thanks for taking my questions. I guess the first one, Roger, you mentioned targeting the oral treprostinil market. If you can just maybe elaborate on that in terms of the market opportunity, and I think, this would be another differentiated aspect of YUTREPIA, because I don't think your competitor has positioned their DPI product for that segment.

你好。早安.感謝您回答我的問題。我猜第一個，羅傑，你提到瞄準口服曲前列環素市場。如果您能從市場機會方面詳細說明這一點，我認為這將是 YUTREPIA 的另一個差異化方面，因為我認為您的競爭對手尚未將其 DPI 產品定位於該細分市場。

And then secondly, can you just talk about payer coverage? In the past, you've highlighted how you're launch-ready, the sales force has been expanded and are in the field, but maybe if you can talk about how quickly you think you can get YUTREPIA on formulary post-approval? Thanks.

其次，您能談談付款人承保範圍嗎？過去，您強調了您如何做好上市準備、擴大銷售隊伍並進入現場，但也許您可以談談您認為多快可以在處方批准後獲得 YUTREPIA 的支持？謝謝。

Yeah. Thanks. Great question. So I'll take the first one around how we hope to cannibalize the oral market, and then Mike, if you'll talk about the payer landscape, if you will. So in terms of oral prostacyclins, currently, and again, these are just sort of generalized estimates, Orenitram is doing about $400 million per annum and Uptravi is doing about $1.2 billion per annum.

是的。謝謝。很好的問題。因此，我將討論第一個問題，即我們希望如何蠶食口腔市場，然後邁克，如果您願意的話，請談談付款人的情況。因此，就口服前列環素而言，目前，這些只是一般性的估計，Orenitram 的年銷售額約為 4 億美元，Uptravi 的年銷售額約為 12 億美元。

Both -- they're different, they're both prostacyclins different in their sort of mechanistic approach, but Orenitram, it's difficult to titrate, it takes weeks, if not months, to get to a therapeutic dose, causes a lot of off-target GI effects and those GI effects are the predominant reason that patients discontinue that therapy and then progress to other therapies, which in the past typically has been parenteral therapy.

兩者——它們是不同的，它們都是前列環素，其機制方法不同，但是 Orenitram，很難滴定，需要幾週甚至幾個月才能達到治療劑量，會導致很多副作用。和這些胃腸道效應是患者停止該治療並隨後轉向其他治療的主要原因，而這些治療在過去通常是腸胃外治療。

Uptravi has a pretty tight and narrow dose titration curve, pretty much has a dose ceiling, so patients titrate to their top tolerated dose and they're held on that dose and then removed from therapy once their disease progresses beyond the capabilities of the dose that they're on. So -- and also comes with the off-target effects.

Uptravi 的劑量滴定曲線相當緊且窄，幾乎有劑量上限，因此患者滴定至最高耐受劑量，並保持該劑量，一旦疾病進展超出劑量能力，則停止治療。所以——而且還伴隨著脫靶效應。

So we think that we could position YUTREPIA, particularly given its titratability, so again, what YUTREPIA has done through the PRINT-enabled formulation, it's allowed for a titratable inhaled treprostinil formulation for the first time, so it has a lot more flexibility and can become a much more rigorous and durable choice for physicians and their patients.

因此，我們認為我們可以定位YUTREPIA，特別是考慮到它的可滴定性，因此，YUTREPIA 通過支持PRINT 的配方所做的事情，它首次允許可滴定的吸入曲前列環素配方，因此它具有更大的靈活性，並且可以成為醫生及其患者更嚴格和持久的選擇。

Now, you ask that, why has United not pointed this out? Well, again, it might be that they don't quite have the flexibility that we do in terms of dosing, so it has limitations in that regard. I think the other aspect here is because they have an oral prostacyclin, they don't want to sort of detail against themselves, and in fact, had they done that, it would have set the table for us quite nicely in terms of what we want to do as I just described.

現在，你問，為什麼曼聯沒有指出這一點？好吧，再說一遍，他們在劑量方面可能不太具有我們的靈活性，所以它在這方面有局限性。我認為這裡的另一個方面是因為他們有口服前列環素，他們不想對自己進行一些細節，事實上，如果他們這樣做了，就我們而言，它會很好地為我們做好準備。要按照我剛才描述的那樣做。

So you can understand why they're not doing that, but we will not be hindered in any way from that search. So, we certainly are going to go after both the totality of the inhaled market and the totality of the prostacyclin market, particularly those patients that are having issues more with off-target effects like GI side effects, which are significant and parenteral effects like subcutaneous pain and everything.

所以你可以理解為什麼他們不這樣做，但我們的搜尋不會受到任何阻礙。因此，我們當然會追求整個吸入市場和整個前列環素市場，特別是那些更多地遇到諸如胃腸道副作用等脫靶效應問題的患者，這些副作用是顯著的，並且是皮下注射等腸外效應痛苦和一切。

So again, attractive markets, $1.6 billion,-- with the $1.5 billion with Tyvaso aggregated opportunity now, so you're already at a $3 billion opportunity if we aggregate all of those markets together and that's where the pH value is, as I said in my comments, only marginally penetrated at this point. So really, really nice opportunity.

再說一次，有吸引力的市場，16 億美元——現在Tyvaso 的15 億美元聚合了機會，所以如果我們將所有這些市場聚合在一起，那麼你已經擁有30 億美元的機會，這就是pH 值，正如我所說在我的評論中，目前僅略微深入。非常非常好的機會。

I think the other thing I will say, and this is not, if you talk about inhaled treprostinil, it's not a net zero sum game. I think sometimes people try to position us antagonistically against users' opportunity.

我想我要說的另一件事是，如果你談論吸入曲前列環素，這不是一個淨零和遊戲。我認為有時人們會試圖將我們置於與用戶機會相反的位置。

I think in PH-ILD in particular, again, there's lots of patients there. There's lots of opportunity for both companies to do well and we look forward to launching in the near future presenting the choice and that's what we're about. So Mike, if you'll talk about pair coverage.

我認為，特別是在 PH-ILD 領域，那裡有很多患者。兩家公司都有很多做得很好的機會，我們期待在不久的將來推出提供選擇，這就是我們的目的。麥克，請您談談配對覆蓋。

Yes. Serge. Thanks so much for the question. I think what's important to know is the overwhelming feedback we've received from doctors and patients is they're wanting choice, and having YUTREPIA available will provide that choice, but we also understand in order to truly have that choice, access is critically important.

是的。嗶嘰。非常感謝您的提問。我認為重要的是要知道我們從醫生和患者那裡收到的壓倒性反饋是他們想要選擇，而擁有 YUTREPIA 將提供這種選擇，但我們也明白，為了真正擁有這種選擇，訪問至關重要。

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

所以我們一直在與付款人接觸。早在 2021 年 11 月，我們就獲得了 PAH 的初步批准。從那時起，我們一直在與付款人接觸，討論 YUTREPIA 的價值主張，我認為，我們有信心，一旦我們獲得 FDA 的全面批准，我們將能夠解決這個問題並確保患者擁有選擇並擁有該選擇並獲得存取權。

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

因此，我們有信心實現這一目標，但在獲得批准之前，顯然，這些都不會正式化，但我們與付款人進行了非常好的對話，並且非常有信心患者將可以通過以下方式選擇 YUTREPIA： YUTREPIA 是一個保險平台。

Thank you.

謝謝。

Julian Harris, BTIG

朱利安·哈里斯，BTIG

Hi, guys. Can you hear me?

嗨，大家好。你聽得到我嗎？

Yes. We can, Julian. Good morning.

是的。我們可以，朱利安。早安.

All right. Sorry about that before. Thank you for taking my questions. Rusty, you highlighted that there are no lawsuits that directly prevent the FDA from making a potential approval decision at this time. I understand you can't comment on when specifically, the FDA is expected to make a decision, but are you able to comment on what they could be waiting on at this point?

好的。之前就很抱歉了。感謝您回答我的問題。Rusty，您強調說，目前沒有任何訴訟直接阻止 FDA 做出潛在的批准決定。我知道您無法評論 FDA 預計何時做出決定，但您能否評論他們目前可能在等待什麼？

I understand that that might be too speculative of a question and completely understand if you can't comment on that. And then, can you also remind us on where manufacturing stands? Have there been any additional inspections required by the FDA in the current cycle?

我知道這個問題可能過於投機，如果您不能對此發表評論，我完全理解。然後，您能否提醒我們製造業的現況？本週期FDA是否要求進行任何額外檢查？

Yes. Julian, thanks for your persistence in getting through the call. Rusty can answer the first question and then Mike will address the supply chain question.

是的。朱利安，感謝您堅持接聽電話。Rusty 可以回答第一個問題，然後 Mike 將解決供應鏈問題。

Thank you, Julian. Thank you for the question. So first, we don't want to speculate on what the FDA, where they are in their process, nor do we want to comment publicly on our interactions with the FDA to-date. So, again, as I said before, there is no legal impediment to them taking final action on our NDA. We are awaiting that final action. But again, we can't really speak to any specific timing.

謝謝你，朱利安。感謝你的提問。因此，首先，我們不想猜測 FDA 做什麼、他們在流程中處於什麼位置，我們也不想公開評論我們迄今為止與 FDA 的互動。因此，正如我之前所說，他們對我們的保密協議採取最終行動不存在任何法律障礙。我們正在等待最後的行動。但同樣，我們無法真正談論任何具體時間。

Yes. And Julian, relating to supply, we've been anticipating a launch, obviously, for a long time now. We've been building commercial inventories through that entire time. So once the FDA grants final approval, we will be ready to hit the ground running immediately in all strength of our product.

是的。朱利安，關於供應，我們顯然已經期待發布很長時間了。我們一直在建立商業庫存。因此，一旦 FDA 獲得最終批准，我們將準備好立即投入使用我們產品的全部實力。

Related to the inspection, as part of our tentative approval in November of 2021, the FDA did a preapproval inspection in August of 2021 and that was included in our tentative approval. So all preapproval inspections have been completed. And as I said, we've been building up commercial inventory since then and look forward to, hopefully, an imminent launch here.

與檢查相關，作為我們 2021 年 11 月暫定批准的一部分，FDA 於 2021 年 8 月進行了預先批准檢查，並將其包含在我們的暫定批准中。至此，所有前置審批檢查均已完成。正如我所說，從那時起我們就一直在建立商業庫存，並希望即將在這裡推出。

Very helpful. Thank you.

很有幫助。謝謝。

Kambiz Yazdi, Jefferies

卡姆比茲·亞茲迪，杰弗里斯

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

早上好，團隊。感謝您分享迄今為止的一些 ASCENT 數據。所以我想我關於開放標籤研究的問題是您希望評估什麼滴定方案？然後作為第二個問題，就預計30 億美元的吸入式霧化曲前列環素市場而言，抱歉，吸入曲前列環素市場，您認為該市場中不同適應症之間的區別是什麼，這是否也包含一些同類產品的蠶食口服曲前列環素市場？謝謝。

Kambiz, I'll speak to the market question and then Rajeev, you're going to talk about what we're trying to achieve and what we feel is the first company-sponsored DPI test in PH-ILD patients.

Kambiz，我將談論市場問題，然後 Rajeev，您將談論我們正在努力實現的目標，以及我們認為公司贊助的第一個針對 PH-ILD 患者的 DPI 測試是什麼。

So I think, Kambiz, when you look at the market opportunity here, again, we're just going to say that eclipse is $3 billion and growing. There is -- I think UTHR has said that of their $1.5 billion on their last earnings call, they intimated that PH-ILD represented nearly $1 billion of that or was approaching $1 billion in terms of indication opportunity and that's with marginal penetration.

所以我認為，Kambiz，當你再次審視這裡的市場機會時，我們只會說 eclipse 的價值為 30 億美元，而且還在不斷增長。我認為UTHR 在上次財報電話會議上表示，在他們的15 億美元中，他們暗示PH-ILD 佔其中近10 億美元，或者就適應症機會而言接近10 億美元，而且這是邊際滲透率。

So we think that market, again, if you believe it's $60,000, some people say $100,000. I think UTHR says $30,000, but that number, I think they're taking north now. But let's just split the difference and call it $60,000. They're probably at high-single digits, low double-digit penetration, so just marginally penetrated. So lots and lots of room to grow there alone. So that's a multi-billion-dollar opportunity in PH-ILD, for sure, with an inhaled prostacyclin moiety.

所以我們再次認為這個市場，如果你認為是 6 萬美元，有人說是 10 萬美元。我認為 UTHR 說的是 30,000 美元，但這個數字，我認為他們現在正在向北發展。但我們平分差額，稱之為 6 萬美元。它們的滲透率可能較高個位數，較低的兩位數滲透率，因此只是略微滲透。那裡有很多很多的成長空間。因此，對於 PH-ILD 來說，吸入性前列環素無疑是一個價值數十億美元的機會。

With the orals, again, that's cannibalization and that may take a little bit more time to move along, but YUTREPIA behaves the way we think it can in the real world, then we think we can really infringe on the oral markets.

再說一次，對於口頭作品來說，這就是蠶食，這可能需要更多的時間來推進，但YUTREPIA 的行為方式與我們認為它在現實世界中的行為方式一樣，那麼我們認為我們可以真正侵犯口頭市場。

So we also think that for YUTREPIA specifically, that's a $1 billion opportunity as well. So when you aggregate those together, our share of the inhaled, our share of the oral, we think we can have a multi-billion-dollar product or more.

因此，我們也認為，特別是對於 YUTREPIA 來說，這也是一個 10 億美元的機會。因此，當你將這些匯總在一起時，我們在吸入劑中所佔的份額，在口服劑中所佔的份額，我們認為我們可以擁有數十億美元或更多的產品。

So I think, again, we need to prove that out, we need to generate the launch dynamics that we hope to do to support that to be true, but the first thing is to get the approval and we're working hard to do that.

所以我認為，我們需要再次證明這一點，我們需要產生我們希望做的啟動動力來支持這一點，但第一件事是獲得批准，我們正在努力做到這一點。

So Rajeev, if you'll talk about some of the things we're trying to achieve in terms of dosing, which will help us achieve this multi-billion-dollar opportunity.

Rajeev，如果您能談談我們在劑量方面試圖實現的一些目標，這將幫助我們實現這個數十億美元的機會。

Yes. Thank you, and Kambiz, good morning. So first of all, I think, one thing we're highlighting here is that this is the first open-label prospective study in PH-ILD using a dry powder inhaler with YUTREPIA in this regard.

是的。謝謝你，卡姆比茲，早安。首先，我認為，我們在這裡強調的一件事是，這是第一個使用 YUTREPIA 乾粉吸入器對 PH-ILD 進行開放標籤前瞻性研究。

Remember, we've already conducted the INSPIRE study in 121 patients, so we really understand the tolerability profile and the titratability of YUTREPIA, and so we took those learnings and we brought it into patients with PH-ILD that have no -- that have never been treated in the past.

請記住，我們已經在 121 名患者中進行了 INSPIRE 研究，因此我們真正了解了 YUTREPIA 的耐受性和滴定性，因此我們將這些知識帶入了沒有 PH-ILD 的患者身上。未接受過治療。

In this regard, as I highlighted, we have seven patients that have enrolled to-date, and one thing that you had asked is, what is the dosing recommendation for this patient population? Well, clearly, I think the primary objective is that, one; can the tolerability profile that we saw in the INSPIRE study in PAH patients be replicated in PH-ILD and I think the early small sample sizes answer is yes, it can.

在這方面，正如我所強調的，迄今為止我們已經招募了七名患者，您問的一件事是，針對該患者群體的劑量建議是什麼？嗯，顯然，我認為主要目標是，一；我們在 PAH 患者 INSPIRE 研究中看到的耐受性特徵是否可以在 PH-ILD 中複製，我認為早期的小樣本量答案是肯定的，可以。

Clearly, what needs to happen is dose matters, right? So the increased study used in Tyvaso suggested that patients who get to at least nine breath equivalents of Tyvaso nebulizer portend to have a better clinical effect, but actually patients who can get actually higher to 11 to 12 breaths, looks like the signal actually gets a bit stronger.

顯然，劑量很重要，對嗎？因此，Tyvaso 中使用的更多研究表明，Tyvaso 霧化器達到至少9 次呼吸當量的患者預示著具有更好的臨床效果，但實際上，能夠達到11 至12 次呼吸當量的患者，看起來訊號實際上得到了強一點。

So the priority of this study is to titrate the patient at least to 9 to 12 breaths, which is the traditional therapeutic goal of inhaled treprostinil, but more importantly, to exceed that in the right patient profile, right? So some patients may need 9 to 12 breaths, maybe the majority of these actually need somewhere more than that.

因此，這項研究的首要任務是將患者至少滴定至 9 至 12 次呼吸，這是吸入曲前列環素的傳統治療目標，但更重要的是，要超過正確的患者情況，對嗎？因此，有些患者可能需要 9 到 12 次呼吸，也許其中大多數患者實際上需要更多呼吸。

One thing I think is really intriguing is that I highlighted in the call that the median dose at week 8 is now 132 micrograms of YUTREPIA, which is now equivalent to greater or equal to 15 breaths of Tyvaso. So I think the early findings from the study are quite encouraging and we look forward to completing enrollment in the study by the end of the year.

我認為真正有趣的一件事是，我在電話會議中強調，YUTREPIA 第 8 週的中位數劑量現在為 132 微克，現在相當於大於或等於 15 次泰瓦索呼吸。因此，我認為該研究的早期結果非常令人鼓舞，我們期待在今年年底前完成該研究的註冊。

So, Kambiz, I think when we finish the study, the important data for investors to look at would be what were the -- what's our ability to titrate, which as Rajeev said, at least in the early data, we're seeing good evidence that we can do that quite aggressively.

所以，Kambiz，我認為當我們完成研究時，投資者需要關注的重要數據是什麼——我們滴定的能力是什麼，正如 Rajeev 所說，至少在早期數據中，我們看到了良好的結果有證據表明我們可以非常積極地做到這一點。

And then the other question would be how durable is it? And so far, those patients are remaining on study. So remember, as I stated in the preamble, it was only a median of 40 days where people who had started Tyvaso DPI within the National Jewish Center data were unable to continue that drug and 50% of those patients dropped off within that 40-day median timeframe.

那麼另一個問題是它有多耐用？到目前為止，這些患者仍在接受研究。因此請記住，正如我在序言中所述，根據國家猶太中心的數據，開始使用泰瓦索DPI 的患者在中位數只有40 天的時間裡無法繼續服用該藥物，並且其中50% 的患者在這40 天內退出了治療。

So we're trying to make a contradictory statement to that to show that YUTREPIA is much more titratable and much more durable. The reasons that patients predominantly came off in the National Jewish Center experience was for clinical worsening, which I would assume is due to a lack of ability to provide a therapeutic dose, otherwise they wouldn't worsen.

因此，我們試圖對此做出相反的陳述，以表明 YUTREPIA 更具可滴定性且更耐用。患者在國家猶太中心經歷的主要原因是臨床惡化，我認為這是由於缺乏提供治療劑量的能力，否則他們不會惡化。

And we're trying to basically show that YUTREPIA can perform in a very different way, and obviously, that speaks to its differentiated capabilities and market opportunities. So far, so good, but more to come there. Operator?

我們試圖從根本上證明 YUTREPIA 可以以非常不同的方式表現，顯然，這說明了其差異化的能力和市場機會。到目前為止，一切都很好，但未來還會有更多。操作員？

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Hi. Good morning, guys. Thanks for taking the questions. Just in terms of your commercial prep and readiness, how soon after approval will you launch the drug? Thanks.

你好。早上好傢伙。感謝您提出問題。就您的商業準備和準備情況而言，您會在批准後多久推出該藥物？謝謝。

Thanks. Mike, would you like to answer that question, please?

謝謝。麥克，你願意回答這個問題嗎？

Yes. So Matt, thanks for the question. Obviously, once we get full approval, it'll take a little bit of time to list our price in compendia. But from a commercial availability, what I can say is our commercial team, our sales force is literally ready to go immediately thereafter.

是的。馬特，謝謝你的提問。顯然，一旦我們獲得完全批准，就需要一些時間才能在概要中列出我們的價格。但從商業可用性來看，我可以說的是我們的商業團隊，我們的銷售人員實際上已經準備好立即出發。

Our commercial inventory will be ready to go within days after of final approval. So I know a lot of companies take 30 days to 45 days to launch after they get full approval. We will be ready to go literally within days or a week after final approval regardless of when that time comes.

我們的商業庫存將在最終批准後幾天內準備就緒。所以我知道很多公司在獲得完全批准後需要 30 天到 45 天的時間才能啟動。無論何時到來，我們都將在最終批准後幾天或一周內做好準備。

Okay. Thanks. And I know we're all focused and waiting for YUTREPIA's approval, but thinking out a little bit into the future, can you tell us a little bit more about 606 and L606 and what role and position you think that will play in terms of the inhaled precaution market?

好的。謝謝。我知道我們都在專注地等待 YUTREPIA 的批准，但考慮一下未來，您能否告訴我們更多有關 606 和 L606 的信息，以及您認為它將在吸入預防市場？

Yes. I'll answer that. Thanks for the question, Matt. So I think when you look at YUTREPIA in terms of what it solves for, it's taken what was a, if you look at just Tyvaso -- nebulized Tyvaso, it was a fixed dose or a non-readily titratable therapy.

是的。我會回答這個問題。謝謝你的提問，馬特。所以我認為，當你從 YUTREPIA 解決的問題的角度來看待它時，如果你只看泰瓦索——霧化泰瓦索，它是一種固定劑量或不易滴定的療法。

So we really transformed therapeutic index and we've made it much more titratable. So we can get the higher effective dose while keeping the AD profile the same. So you have a better therapeutic index for YUTREPIA than you do with, for instance nebulized Tyvaso as an example. What we didn't do was solve for the 4 times a day treatment regimen and that's the same, that's also true for Tyvaso DPI.

因此，我們確實改變了治療指數，並且使其更加可滴定。因此我們可以獲得更高的有效劑量，同時保持 AD 曲線相同。因此，YUTREPIA 的治療指數比霧化泰瓦索（Tyvaso）更好。我們沒有解決每天 4 次的治療方案，這對 Tyvaso DPI 來說也是如此。

So improved on the therapeutic profile of inhaled treprostinil, but still requires four times a day administration. So what L606 will do is address that final point and really pull on that lever to make the market, instead of just sharing the market with our competitor, we look to then basically dominate the market.

因此改善了吸入曲前列環素的治療效果，但仍需要每天給藥四次。因此，L606 要做的就是解決最後一點，並真正利用這個槓桿來開拓市場，而不是只與我們的競爭對手分享市場，我們希望基本上主導市場。

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

因此，如果我們有一種與 YUTREPIA 表現相同的配方，但您可以每天兩次的形式進行，並基本上解決過夜取消治療的問題，這種情況發生是因為在您入睡之前，一半持續四個小時，如果你睡了八個小時，當你醒來時，治療就消失了。

We will solve for that, provide a more steady state exposure, which we think will also be better for patient outcome.

我們將解決這個問題，提供更穩定的暴露狀態，我們認為這對患者的治療效果也會更好。

And then, as Rajeev said, in the open-label trial, we're seeing just that, we're seeing that L606 is extremely well-tolerated and that's because it has a, as Rajeev said, a 7 times lower C-max, and that its AUC, zero to 24 hours, is the same as, given BID, is the same as 4 times a day inhaled treprostinil.

然後，正如 Rajeev 所說，在開放標籤試驗中，我們看到了這一點，我們看到 L606 的耐受性非常好，這是因為正如 Rajeev 所說，它的 C-max 低了 7 倍，其AUC （0 至24 小時）與每日BID 吸入4 次曲前列環素相同。

So its target profile in open-label work so far, is exactly what we'd want this to be. And now, we're just going to try to replicate the Tyvaso increased study with L606. We'll start that at the end of this year, work hard to get that done and improve sometime in the '28 timeframe, but at that point in time, we think that will become the preferred therapeutic, because it's solved for regimen, while still giving all the benefits that YUTREPIA does.

因此，到目前為止，它在開放標籤工作中的目標概況正是我們所希望的。現在，我們將嘗試用 L606 重複 Tyvaso 增強研究。我們將在今年年底開始，努力完成這項工作，並在28 年的某個時間框架內進行改進，但到了那個時間點，我們認為這將成為首選的治療方法，因為它已經解決了治療方案，而仍提供 YUTREPIA 的所有好處。

Thanks, Roger.

謝謝，羅傑。

Thank you, Matt. Operator, next question, if any?

謝謝你，馬特。接線員，下一個問題，如果有的話？

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

謝謝。沒有其他問題了。我想將電話轉回給羅傑，讓他作結束語。

Great. Thank you, Operator, and thank you very much for the questions this morning. My hope is that the next time we address you on our earnings call, we will be providing to patients what we feel is a preferred product for inhaled treprostinil, and it will come at a critical time as the market for inhaled treprostinil rapidly expands. Thank you for joining us today and we look forward to speaking soon. Bye.

偉大的。謝謝您，接線員，非常感謝您今天早上提出的問題。我希望，下次我們在財報電話會議上向您發表講話時，我們將為患者提供我們認為是吸入曲前列環素的首選產品，並且它將在吸入曲前列環素市場迅速擴大的關鍵時刻出現。感謝您今天加入我們，我們期待盡快發言。再見。

Thank you for your participation. This does conclude the program. You may now disconnect. Everyone, have a great day.

感謝您的參與。這確實結束了該程式。您現在可以斷開連線。大家，祝你有美好的一天。