Liquidia Corp (LQDA) 2022 Q4 法說會逐字稿

Good morning, and welcome, everyone to the Liquidia Corporation's Full Year 2022 Financial Results and Corporate Update Conference Call. My name is Chris, and I'll be your conference operator today. (Operator Instructions) I would like to remind everyone that this conference call is being recorded. And I will now hand the call over to Jason Adair, Senior Vice President, Corporate Development and Strategy. Sir, please go ahead.

早上好，歡迎大家參加 Liquidia Corporation 2022 年全年財務業績和公司最新動態電話會議。我叫克里斯，今天我將擔任你們的會議操作員。 （操作員說明）我想提醒大家，本次電話會議正在錄音。我現在將把電話交給企業發展和戰略高級副總裁傑森·阿代爾 (Jason Adair)。先生，請繼續。

Thank you, Chris. It's my pleasure to welcome everyone to Liquidia's Full Year 2022 Financial Results and Corporate Update Conference Call. Joining the call today are Chief Executive Officer, Roger Jeffs; Chief Medical Officer, Dr. Rajeev Saggar; Chief Financial Officer, Michael Kaseta; and General Counsel, Rusty Schundler.

謝謝你，克里斯。我很高興歡迎大家參加 Liquidia 2022 年全年財務業績和公司最新動態電話會議。今天加入電話會議的還有首席執行官羅傑·傑夫斯 (Roger Jeffs)；首席醫療官 Rajeev Saggar 博士；首席財務官 Michael Kaseta；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.

在我們開始之前，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信息以及公司未來業績和/或成就的聲明。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. The company will file its 10-K on Monday, March 20.

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。該公司將於 3 月 20 日星期一提交 10-K。

I would now like to turn the call over to Roger for our prepared remarks, after which he will open the call up 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，之後他將打開電話詢問你們的問題。

Thank you, Jason. Good morning, everyone, and thank you for joining us. As I look back on 2022, my first year as CEO of Liquidia, I remain humbled to have joined an organization that (inaudible) services. My (inaudible) to join the company in an operational role was related to the potential of YUTREPIA to universally transform prostacyclin therapy from a high burden treatment option to a low burden option for patients.

謝謝你，傑森。大家早上好，感謝您加入我們。回顧 2022 年，即我擔任 Liquidia 首席執行官的第一年，我仍然對加入一個（聽不清）服務的組織感到謙卑。我（聽不清）加入公司擔任運營職務與 YUTREPIA 的潛力有關，該潛力將普遍將前列環素療法從患者的高負擔治療選擇轉變為低負擔選擇。

Specifically, 4 key attributes resonated out with me: YUTREPIA's tolerability; YUTREPIA's titratability; YUTREPIA's durability; and YUTREPIA's usability and affordability. These 4 attributes continue to resonate with [me] and support my belief that YUTREPIA has the potential to be the prostacyclin therapy of first choice and best-in-class inhaled therapy for patients with either PH or PH-ILD.

具體來說，有 4 個關鍵屬性引起了我的共鳴：YUTREPIA 的耐受性； YUTREPIA的滴定性； YUTREPIA的耐用性；以及 YUTREPIA 的可用性和經濟性。這 4 個屬性繼續與我產生共鳴，並支持我的信念，即 YUTREPIA 有潛力成為 PH 或 PH-ILD 患者的首選前列環素療法和一流的吸入療法。

The open label extension data continues to mature, only first (inaudible) in the commercial (inaudible) potential of YUTREPIA to participate significantly in what is now the fastest-growing segment of (inaudible) agent in the prostacyclin market.

開放標籤擴展數據繼續成熟，只有 YUTREPIA 的商業（聽不清）潛力才能顯著參與目前前列環素市場中增長最快的（聽不清）藥物細分市場。

The other main [excitement] for joining this company [is] bench strength of the entire organization and our internal capability to manufacture drug substance in-house. Of course, it also didn't hurt that we already had tentative approval and labeling in hand. In 2022, we made key strategic hires to strengthen our core capabilities. And in concert with our legal success in 2022, Liquidia is now well positioned to maximize the commercial uptake of YUTREPIA on it's (inaudible) launch.

加入這家公司的另一個主要[興奮]是整個組織的後備實力以及我們內部生產原料藥的能力。當然，我們已經獲得了初步批准和標籤，這也沒有什麼壞處。 2022年，我們進行了關鍵戰略招聘，以增強我們的核心能力。隨著我們在 2022 年取得法律上的成功，Liquidia 現在處於有利地位，可以在 YUTREPIA（聽不清）推出時最大限度地提高其商業利用率。

I'd like to now turn the call over to Rajeev Saggar, our CMO, and one of those key 2022 hires (inaudible) on why we are so excited about YUTREPIA's unique product profile, and why we believe we are ideally positioned to provide a differentiated best-in-class option for patients. Rajeev?

我現在想將電話轉給我們的首席營銷官 Rajeev Saggar，他也是 2022 年關鍵員工之一（聽不清），了解為什麼我們對 YUTREPIA 獨特的產品概況如此興奮，以及為什麼我們相信我們處於提供理想的位置為患者提供差異化的一流選擇。拉吉夫？

Thank you, Roger, and good morning, everyone. In recent months, our team has engaged with the medical community about certain topics related to YUTREPIA, such as its product profile, the benefit of low-resistance dry powder inhaler device for patients, and our upcoming clinical plans. Today, (inaudible) to briefly touch on these points. YUTREPIA was designed with a specific goal in mind, to deliver treprostinil to the deepest parts of the lungs across a wide range of doses in a broad range of patients with varying lung function. To achieve this objective, we [aligned] the whole PRINT technology with the RS00 Plastiape dry powder inhaler, a simple proven device used successfully by many tens of thousands of adults and children with [breathing] problems such as COPD and asthma.

謝謝你，羅傑，大家早上好。近幾個月來，我們的團隊與醫學界就與 YUTREPIA 相關的某些話題進行了交流，例如其產品簡介、低阻力干粉吸入器裝置對患者的好處以及我們即將推出的臨床計劃。今天，（聽不清）簡單談談這些要點。 YUTREPIA 的設計有一個特定的目標，即為具有不同肺功能的廣泛患者以多種劑量將曲前列環素輸送到肺部最深處。為了實現這一目標，我們將整個 PRINT 技術與 RS00 Plastiape 乾粉吸入器結合起來，這是一種經過驗證的簡單設備，已被成千上萬患有慢性阻塞性肺病和哮喘等[呼吸]問題的成人和兒童成功使用。

To the first point of expanding the dose range, our clinical study in pulmonary arterial hypertension, or PAH, proved that a 79.5 microgram dose of YUTREPIA is delivered at vial equivalent doses to 9 breaths breadth of nebulized TYVASO. But more importantly, YUTREPIA has been safely and conveniently titrated to doses comparable to 27 breaths of TYVASO, a level rarely, if ever, achieved with the nebulizer.

對於擴大劑量範圍的第一點，我們對肺動脈高壓（PAH）的臨床研究證明，79.5微克劑量的YUTREPIA以相當於霧化TYVASO 9次呼吸的劑量輸送。但更重要的是，YUTREPIA 已被安全、方便地滴定至相當於 27 次 TYVASO 呼吸的劑量，這是霧化器很少達到的水平。

To the second point of (inaudible) our low DPI proved easy to use without need for advanced technology to train patients, and further demonstrated it is robust enough for (inaudible) topping or positioning in a myriad of ways. In fact, given the device's proven track record with obstructive lung diseases there is considerable interest among medical professionals to use YUTREPIA, particularly for patients with pulmonary arterial hypertension associated with interstitial lung disease or PH-ILD where lung restriction and impaired respiratory effort are common. Put simply uniform PRINT particles in the (inaudible) respirable range for deep lung delivery, providing consistent and (inaudible) recovery with a low [filters] the device across a wide range of inspiratory efforts for PAH and PH-ILD patients.

對於第二點（聽不清），我們的低 DPI 被證明易於使用，無需先進技術來培訓患者，並進一步證明它足夠強大，可以以多種方式進行（聽不清）頂部或定位。事實上，鑑於該設備在治療阻塞性肺疾病方面的良好記錄，醫療專業人員對使用 YUTREPIA 非常感興趣，特別是對於患有與間質性肺病或 PH-ILD 相關的肺動脈高壓的患者，這些患者常見肺受限和呼吸困難。將簡單均勻的 PRINT 顆粒置於（聽不清）可呼吸範圍內進行深肺輸送，通過低[過濾]設備在 PAH 和 PH-ILD 患者的各種吸氣過程中提供一致且（聽不見）的恢復。

To further inform the use of YUTREPIA, the intended clinical trial later this year that will generate data on how YUTREPIA may be best utilized in PAH [biology]. We think an open-label study will greatly benefit our understanding of tolerability and the ability to titrate in this patient population. I'm (inaudible) as we move closer to the potential launch of YUTREPIA. I'd like now to turn the call over to Rusty for an update on the legal proceedings. Rusty?

為了進一步了解 YUTREPIA 的使用，預計今年晚些時候進行的臨床試驗將產生有關如何在 PAH [生物學] 中最好地利用 YUTREPIA 的數據。我們認為開放標籤研究將極大地有助於我們了解該患者群體的耐受性和滴定能力。當我們距離 YUTREPIA 的潛在發布越來越近時，我（聽不清）。我現在想把電話轉給拉斯蒂，了解法律訴訟的最新情況。生鏽了？

Thank you, Rajeev. As a reminder, the company has received rulings through proceedings in the court and in parallel inter-parties review proceedings before Patent Trial and Appeal Board or PTAB that all of the claims in the 3 patents asserted by United Therapeutics against the company are either invalid or not infringed by Liquidia. Over the last several months, we have seen further progress in our litigation to bring YUTREPIA to market.

謝謝你，拉吉夫。需要提醒的是，該公司已通過法院訴訟以及專利審判和上訴委員會或 PTAB 的平行當事人間審查程序收到裁決，認為 United Therapeutics 針對該公司主張的 3 項專利中的所有權利要求要么無效，要么無效。沒有受到Liquidia的侵犯。在過去的幾個月裡，我們在將 YUTREPIA 推向市場的訴訟方面取得了進一步進展。

First, we are pleased with the PTAB's decision in February to reject United Therapeutics request for rehearing of the '793 IPR. In its decision, the PTAB clarified the grounds upon which it found that all of the claims in the '793 patent were unpatentable. United Therapeutics now has 63 days from the decision date of February 2 to file an appeal of the PTAB's decision.

首先，我們對 PTAB 在 2 月份決定拒絕 United Therapeutics 重審“793 IPR”的請求感到高興。在其決定中，PTAB 澄清了其認定 '793 專利中的所有權利要求均不具有專利性的理由。自 2 月 2 日決定之日起，United Therapeutics 現在有 63 天的時間對 PTAB 的決定提出上訴。

Assuming UT files an appeal, which they have publicly stated they will, we would project that oral arguments could occur as early as late fourth quarter of 2023 or first quarter of 2024. We would then anticipate that a decision could be rendered by the court as early as a few days after oral argument if the court issued a summary affirmance, or within a few months after oral argument of a full written opinion is issued.

假設 UT 提出上訴（他們已公開表示將會提起上訴），我們預計最早可能會在 2023 年第四季度末或 2024 年第一季度進行口頭辯論。然後我們預計法院可能會做出如下決定：如果法院發出簡易確認書，則最早在口頭辯論後幾天內；如果法院發出完整的書面意見，則在口頭辯論後幾個月內。

Second, we are pleased with the progress in the appeal of the District Court's decision in Hatch-Waxman trial. Briefing in that appeal has now been completed, and the court is in the process of scheduling oral argument, which we expect to occur sometime in the second or third quarter of 2023. As with the appeal of the '793 IPR, we would expect to receive a written decision of the court within a few months after oral argument.

其次，我們對地方法院哈奇-瓦克斯曼案判決的上訴取得的進展感到高興。該上訴的簡報現已完成，法院正在安排口頭辯論，我們預計將在 2023 年第二或第三季度的某個時間進行。與 '793 IPR 的上訴一樣，我們預計口頭辯論後幾個月內收到法院的書面決定。

For all of these appeals, we will not summarize our arguments here. But all briefings are, of course, available to the public through the court's PACER system. Lastly, there may be opportunities to accelerate the time line in one or both appeal proceedings, and we will seek opportunities to proceed through the appeals process as quickly as possible.

對於所有這些呼籲，我們不會在這裡總結我們的論點。當然，所有簡報都可以通過法院的 PACER 系統向公眾開放。最後，可能有機會加快一個或兩個上訴程序的時間，我們將尋求機會盡快完成上訴程序。

Finally, it is notable that United Therapeutics did not appeal the Hatch-Waxman decision related to the '901 patent, so that patent is no longer an impediment to our launch of YUTREPIA. With the '901 patent having been dropped, we will now be able to seek final approval for YUTREPIA if the decision of the District Court in the Hatch-Waxman litigation is affirmed on appeal with respect to the '066 patent, and either the District Court's decision regarding the '793 patent is reversed on appeal, or the PTAB's decision regarding the '793 patent is affirmed on appeal. In short, if the original decisions are affirmed on appeal, then we can seek final approval of YUTREPIA immediately.

最後，值得注意的是，United Therapeutics 沒有對與 '901 專利相關的 Hatch-Waxman 裁決提出上訴，因此該專利不再成為我們推出 YUTREPIA 的障礙。隨著 '901 專利被撤銷，如果地方法院在 Hatch-Waxman 訴訟中的判決在關於 '066 專利的上訴中得到確認，我們現在將能夠尋求 YUTREPIA 的最終批准，並且地方法院的關於“793 專利”的決定在上訴中被推翻，或者 PTAB 關於“793 專利”的決定在上訴中得到維持。簡而言之，如果上訴維持原判，那麼我們可以立即尋求YUTREPIA的最終批准。

I will now pass the call on to Mike for an overview of our financial reporting. Mike?

我現在將把電話轉給邁克，讓他概述我們的財務報告。麥克風？

Thank you, Rusty, and good morning, everyone. Before I address the results for the full year 2022, I wanted to briefly comment on the security of our funds and relationship to SVB, a bank with whom we've had a relationship for about 2 years.

謝謝你，Rusty，大家早上好。在介紹 2022 年全年業績之前，我想簡要評論一下我們資金的安全性以及與 SVB 的關係，SVB 是我們與該銀行的合作關係已有大約 2 年的時間。

As previously disclosed, we repaid all debt owed SVB back in January as part of the financing agreement with HealthCare Royalty Partners. We also have maintained all cash and cash equivalents at SVB, 99% of which was held in a BlackRock mutual fund and the remainder of which was held in an operating account. On Tuesday this week, substantially all of our cash was transferred out of SVB to an accredited financial institution. We will continue to evaluate our cash management and investment policies in an effort to protect our capital from events similar to what occurred in the last week.

正如之前所披露的，我們在一月份償還了欠 SVB 的所有債務，作為與 HealthCare Royal Partners 融資協議的一部分。我們還保留了 SVB 的所有現金和現金等價物，其中 99% 存放​​在貝萊德共同基金中，其餘存放在運營賬戶中。本週二，我們幾乎所有現金都從 SVB 轉入一家認可的金融機構。我們將繼續評估我們的現金管理和投資政策，以保護我們的資本免受上週發生的類似事件的影響。

Turning to our full year 2022 financial results, which can be found in the press release issued today. You will see that revenue increased to $15.9 million for the year ended December 31, 2022, compared with $12.9 million for the prior year. The profit split percentage we received under our promotion agreement with Sandoz was 50% for the entire year. Whereas in 2021, the profit split percentage decreased from 80% to 50% as a result of achievement of predetermined cumulative sales thresholds. Revenue in 2022 is net of $2.7 million in amortization of the contract acquisition costs associated with the promotion agreement.

談到我們 2022 年全年財務業績，您可以在今天發布的新聞稿中找到該業績。您將看到截至 2022 年 12 月 31 日的年度收入增至 1,590 萬美元，而上一年為 1,290 萬美元。根據與山德士的促銷協議，我們全年獲得的利潤分成比例為 50%。而2021年，由於達到了預定的累計銷售門檻，利潤分配百分比從80%下降至50%。 2022 年的收入扣除與促銷協議相關的合同採購成本攤銷 270 萬美元。

Next, cost of revenue was $2.9 million for the full year 2021 compared with $3 million for the prior year. 2022 included a full year of sales force related to -- sales force-related costs, as well as amortization of the intangible assets associated with the promotion agreement. Research and development expenses in 2022 of $19.4 million for the full year compared with $20.5 million the year prior. The decrease of $1.1 million or 5% was primarily due to a $0.9 million decrease in personnel, consulting and stock-based compensation expenses.

接下來，2021 年全年的收入成本為 290 萬美元，而上一年為 300 萬美元。 2022 年包括與銷售人員相關的全年銷售人員成本，以及與促銷協議相關的無形資產攤銷。 2022 年全年研發費用為 1,940 萬美元，而上年為 2,050 萬美元。減少 110 萬美元或 5% 主要是由於人事、諮詢和股票薪酬費用減少 90 萬美元。

General and administrative expenses were $32.4 million for the full year of 2022 compared to $23.1 million for the prior year. The increase of $9.3 million or 40% was primarily due to a $4.2 million increase in commercial, marketing and personnel expenses in preparation for the potential commercialization of YUTREPIA, and a $3.1 million increase in stock-based compensation expense driven by an option modification charge recorded in the first quarter of 2022.

2022 年全年一般及行政費用為 3240 萬美元，上一年為 2310 萬美元。增加 930 萬美元或 40% 主要是由於為 YUTREPIA 的潛在商業化做準備而增加了 420 萬美元的商業、營銷和人員費用，以及記錄的期權修改費用導致的基於股票的補償費用增加了 310 萬美元2022年第一季度。

In summary, we have incurred a net loss of $41 million or $0.67 per basic and diluted share, compared to a net loss of $34.6 million or $0.70 per basic and diluted share for the year ended December 31, 2021.

總之，我們的淨虧損為 4100 萬美元，即每股基本股和稀釋股 0.67 美元，而截至 2021 年 12 月 31 日的年度淨虧損為 3460 萬美元，即每股基本股和稀釋股 0.70 美元。

Turning to our balance sheet, we ended 2022 with $93.3 million of cash on hand. We further strengthened our access to capital in January through the revenue interest financing agreement with HealthCare Royalty for up to $100 million in 4 tranches. The first tranche of $32.5 million netted an approximate $10 million increase in cash after paying off the SVB debt facility. The remaining tranches are related to: one, clearance of the legal pathway; two, acquisition of an internal asset; and three, mutual agreement of the parties.

轉向我們的資產負債表，截至 2022 年末，我們手頭現金為 9,330 萬美元。 1 月份，我們與 HealthCareRoyalty 簽訂了分 4 批高達 1 億美元的收入利息融資協議，進一步加強了我們的資本獲取能力。第一筆 3250 萬美元的資金在償還 SVB 債務融資後淨增加了約 1000 萬美元的現金。其餘部分涉及：一是清理法律途徑；二、收購內部資產；三、雙方一致同意。

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. Reflecting on the previous year, I can say with 100% of confidence that (inaudible) prepared to deliver a potential of our products and (inaudible) to patients. At this time, I would now like to open to questions. Operator, first question please.

謝謝你，邁克。回顧過去的一年，我可以 100% 自信地說，（聽不清）準備向患者提供我們產品的潛力（聽不清）。現在我想提出問題。接線員，第一個問題請。

(Operator Instructions) Our first question will come from Gregory Harrison of Bank of America.

（操作員說明）我們的第一個問題將來自美國銀行的格雷戈里·哈里森。

As you start to get closer to launch, what feedback are you receiving from physicians or patients regarding the differentiation between YUTREPIA and TYVASO DPI and the demand for YUTREPIA when it comes to market?

隨著您開始接近上市時間，您從醫生或患者那裡收到了哪些有關 YUTREPIA 和 TYVASO DPI 之間的差異以及 YUTREPIA 市場需求的反饋？

Yes. (inaudible) we're excited to answer. At this time, I'd like to pass that to Rajeev, maybe you can give some thoughts on these conversations you've had with various KOLs and then your own reflections on what [differentiates YUTREPIA] potentially from other DPIs in the space.

是的。 （聽不清）我們很高興能回答。這次，我想將其轉達給 Rajeev，也許您可以對您與各種 KOL 進行的這些對話發表一些想法，然後您自己對 YUTREPIA 與該領域其他 DPI 的潛在區別進行思考。

Thanks Greg. (inaudible) to answer your question. First thing is that I think it's very important to understand that YUTREPIA has been studied in pulmonary arterial hypertension patients in the INSPIRE database. (inaudible) enable to titrate successfully YUTREPIA to doses equivalent up to 27 breaths, 4x a day of TYVASO, which is incredible. I think that showcases: One, our tolerability; and number two, our titratability.

謝謝格雷格。 （聽不清）回答你的問題。首先，我認為了解 INSPIRE 數據庫中的 YUTREPIA 在肺動脈高壓患者中進行的研究非常重要。 （聽不清）能夠成功地將 YUTREPIA 滴定至相當於 27 次呼吸、每天 4 次 TYVASO 的劑量，這令人難以置信。我認為這展示了：一，我們的容忍度；第二，我們的滴定性。

Specifically, where the concern with pulmonary arterial hypertension associated with interstitial lung disease is of importance is because this population has not only pulmonary hypertension [and] vascular injury but they also have an interstitial disease, which causes a (inaudible) vial capacity. We believe this is where YUTREPIA has the ability to shine in part because of its low resistance device that we're using. We believe this will allow the limitations of the patient's lung function to be better tolerable and suitable for our device in particular.

具體來說，對與間質性肺疾病相關的肺動脈高壓的關注非常重要，因為該人群不僅患有肺動脈高壓[和]血管損傷，而且還患有間質性疾病，從而導致（聽不清）小瓶容量。我們相信，這正是 YUTREPIA 能夠大放異彩的地方，部分原因在於我們使用的是低電阻器件。我們相信，這將使患者肺功能的限制能夠更好地忍受，並且特別適合我們的設備。

To that end, we have -- we are hearing that our device, at least in those practitioners who have used it in our INSPIRE registry, feel like it has similarities to the simplicity of a nebulizer that, of course, that has all the benefits of a dry powder inhaler such as portability.

為此，我們聽說我們的設備，至少在我們的 INSPIRE 註冊表中使用過它的從業者中，感覺它與霧化器的簡單性有相似之處，當然，霧化器具有所有優點乾粉吸入器的優點，例如便攜性。

To this point, we think, Greg, it's very important that we study some of these product profiles of YUTREPIA specifically in PH-ILD, where we believe this will have the highest utility and impact in. And that's where we alluded to that we will move forward with an open-label study, to really showcase and highlight: One, the tolerability of YUTREPIA in this patient population. As you know, there has not been an official study using a dry powder inhaler in PH-ILD, so we believe this is important, for the community and KOLs to experience. It showcases our ability not only in the tolerability, but as such, because of that improved tolerability, we should see titratability to higher doses in this patient population. So we look forward to initiating the study by the end of the year.

就這一點而言，Greg，我們認為，我們研究 YUTREPIA 的一些產品概況非常重要，特別是在 PH-ILD 中，我們相信這將在其中產生最高的效用和影響。這就是我們提到的我們將推進開放標籤研究，真正展示和強調：第一，YUTREPIA 在該患者群體中的耐受性。如您所知，目前還沒有在 PH-ILD 中使用乾粉吸入器的官方研究，因此我們認為這對於社區和 KOL 的體驗很重要。它不僅展示了我們在耐受性方面的能力，而且由於耐受性的改善，我們應該看到在該患者群體中滴定至更高劑量。因此，我們期待在今年年底前啟動這項研究。

Thank you very much, Rajeev. Great answer, and it really sort of solidifies why we're so excited about the product profile of YUTREPIA our ability to capture a significant share of the market.

非常感謝你，拉吉夫。很好的答案，它確實證實了為什麼我們對 YUTREPIA 的產品概況如此興奮，我們有能力佔領重要的市場份額。

Our next question will come from Kambiz Yazdi of Jefferies.

我們的下一個問題將來自 Jefferies 的 Kambiz Yazdi。

Can you provide any granularity on kind of the gating factors to potentially starting a PH-ILD study? And then in terms of -- what feedback have you received on DPIs causing coughing in PH-ILD?

您能否詳細說明可能啟動 PH-ILD 研究的門控因素類型？那麼，關於 DPI 導致 PH-ILD 咳嗽的問題，您收到了哪些反饋？

In terms of gating factors to starting studies, really, that's just our ability to get the protocol approved at ethics committees, CROs engaged and really just CTM for the study supply. So that's fairly simplistic. We're working on that now, and it's our intention to start those studies in the coming quarters. And then in terms of PH-ILD question, I'll let Rajeev speak to that.

就開始研究的門控因素而言，實際上，這就是我們讓方案獲得倫理委員會批准、CRO 參與以及研究供應的 CTM 的能力。所以這相當簡單。我們現在正在努力，我們打算在未來幾個季度開始這些研究。然後就 PH-ILD 問題而言，我將讓 Rajeev 發言。

Thanks, Kambiz. I think what we're hearing is several things is, one, I think patients without a doubt, like the convenience of a dry powder inhaler. So that's a fact. Number two, these patients that have pulmonary hypertension associated with interstitial lung disease (inaudible) patients. (inaudible)

謝謝，坎比茲。我認為我們聽到的是幾件事，第一，我認為患者毫無疑問喜歡乾粉吸入器的便利性。所以這是事實。第二，這些患有與間質性肺疾病（聽不清）相關的肺動脈高壓的患者。 （聽不清）

Chris, this is Jason Adair. Rajeev, you cut out there when you started to explain the PH-ILD. I'm not sure if you could hear...

克里斯，這是傑森·阿代爾。 Rajeev，當您開始解釋 PH-ILD 時，您就中斷了。不知道你能不能聽到...

Can you hear me now? So in particular, with PH-ILD, because of the inherent limitations with cough in general, we are -- we understand that there's a certain number of patients in this population that tend to have (inaudible) when exposed to a higher resistance (inaudible) inhaler.

你能聽到我嗎？因此，特別是對於 PH-ILD，由於一般咳嗽的固有局限性，我們知道該人群中有一定數量的患者，當暴露於較高的阻力（聽不清）時，往往會（聽不清） ）吸入器。

And so it's done -- if this is done improperly, that potentially can cause the patient to have additional cough and limitations when they're exposed to certain types of dry powder inhalers.

就這樣——如果做得不當，當患者接觸某些類型的干粉吸入器時，可能會導致患者出現額外的咳嗽和限制。

Thank you Rajeev. So I think the importance now of our own (inaudible) in patients with PH-ILD because it could be possible that not only the tolerability, but the rate of titration and that the patient -- that would be a little bit different with arterial hypertensions. But given the profile of our product, we're well positioned to test that in the next (inaudible).

謝謝拉吉夫。所以我認為現在我們自己的（聽不清）對於 PH-ILD 患者的重要性，因為可能不僅是耐受性，還有滴定率以及患者 - 這與動脈高血壓有點不同。但考慮到我們產品的概況，我們已經準備好在接下來的測試中進行測試（聽不清）。

Our next question will come from Serge Belanger of Needham.

我們的下一個問題將來自尼達姆的 Serge Belanger。

I guess just one question. I think Roger, you've highlighted over the last few quarters how YUTREPIA -- YUTREPIA inhaler is a low-resistance DPI inhaler and highlighted some of the benefits there. Maybe just talk about what are the benefits and how that inhaler differentiates the product from TYVASO DPI?

我想只有一個問題。我認為 Roger，您在過去幾個季度中強調了 YUTREPIA——YUTREPIA 吸入器是一種低阻力 DPI 吸入器，並強調了其中的一些優點。也許只是談談吸入器有什麼好處以及該產品與 TYVASO DPI 有何不同？

Yes, that's a great question. And I'll team up again with Rajeev to answer this question. But I think a lot of our answer is going to be predicated on the fact that it's formulation-driven. It's actually the PRINT formula (inaudible) product that allows the use of low resistance device. Rajeev you can speak to kind of how the formulation leaves that (inaudible) combination that benefit uniquely ports.

是的，這是一個很好的問題。我將再次與 Rajeev 合作來回答這個問題。但我認為我們的很多答案都將基於它是配方驅動的這一事實。它實際上是允許使用低電阻器件的 PRINT 公式（聽不清）產品。 Rajeev，您可以談談配方如何留下（聽不清）組合，從而使波特酒受益匪淺。

Yes, [excellent] question. I think to highlight what Roger has noted, the innovative technology for these drug particles that require almost no agglomeration. And what that means is that YUTREPIA does not have to overcome such barriers. The PRINT powder has already (inaudible) to its own. The particles have already been sized, [deposit] deep in the lung. And a low resistance inhaler device is obviously the most suitable (inaudible) for our PRINT technology.

是的，[很好]的問題。我想強調一下羅傑所指出的，這些藥物顆粒的創新技術幾乎不需要團聚。這意味著 YUTREPIA 不必克服這些障礙。 PRINT 粉末已經（聽不清）了。顆粒的大小已經確定，[沉積]在肺部深處。低阻力吸入器設備顯然最適合我們的 PRINT 技術（聽不見）。

And by already -- by optimizing the size and shape of these drug particles, the PRINT eventually enables a more ideal dry powder experience across a broad range of inspiratory flow rates. And this is a effectively, the simplest (inaudible) is probably one of the key reasons that there's growing excitement to bring YUTREPIA into the market, into PH-ILD patients.

通過優化這些藥物顆粒的大小和形狀，PRINT 最終能夠在廣泛的吸氣流速範圍內提供更理想的干粉體驗。這是一種有效的、最簡單的（聽不清）可能是人們越來越興奮地將 YUTREPIA 引入市場、引入 PH-ILD 患者的關鍵原因之一。

Thank you, Rajeev. So I think, again, it's the formulation that is (inaudible) have the ability to use (inaudible) would be differentiated to delivery platform, without need to agglomerate with the higher resistance device, this will take more (inaudible) capacity to do that, and we think that then can be certain (inaudible) limitation there [to] have a leading entry into the market.

謝謝你，拉吉夫。所以我再次認為，（聽不清）有能力使用（聽不清）的配方將與交付平台區分開來，而不需要與更高阻力的設備聚集，這將需要更多（聽不清）的能力來做到這一點，我們認為，如果要領先進入市場，可能會存在某些（聽不清）限制。

(Operator Instructions) Our next question will come from Julian Harrison of BTIG.

（操作員說明）我們的下一個問題將來自 BTIG 的 Julian Harrison。

I'm wondering if sotatercept has any bearing on the DPI treprostinil market opportunity in your mind?

我想知道 sotatercept 是否對您心目中的 DPI 曲前列環素市場機會有任何影響？

Yes. Great question, Julian. And again, I'll tag team with Rajeev. So I think, first, let's just say it's an exciting time in pulmonary hypertension, new mechanisms, new (inaudible), new fits, part on to triple-net (inaudible) is impressive. And I think there's generally growing excitement including our own around on how we [interplay] with these new modalities.

是的。好問題，朱利安。再次，我將與 Rajeev 一起標記團隊。所以我認為，首先，我們只能說這是肺動脈高壓的一個激動人心的時刻，新的機制，新的（聽不清），新的配合，三網的一部分（聽不清）令人印象深刻。我認為人們普遍對如何與這些新模式[相互作用]感到越來越興奮，包括我們自己。

(inaudible) that I've been in this field for 30-plus years and every time a treatment has come in, there's been a (inaudible) to replace previous methodologies or treatments. It's never ever been (inaudible) therapy period. And I see this (inaudible) as add-on to other therapies, the best benefit is in prostacyclin. In those patients, the prostacyclin dose was held steady because they were testing the test patients. And I think it would be exciting now to see what happened with YUTREPIA and sotatercept in combination wherever it could also be titrated [to relieve] the patients specifically.

（聽不清）我已經在這個領域工作了 30 多年，每次出現治療方法時，都會有一種（聽不清）來取代以前的方法或治療方法。這從來都不是（聽不清）治療期。我認為這（聽不清）是其他療法的補充，最好的好處是前列環素。在這些患者中，前列環素的劑量保持穩定，因為他們正在對測試患者進行測試。我認為現在看到 YUTREPIA 和 sotatercept 聯合使用所發生的情況將是令人興奮的，無論它在哪裡也可以進行滴定[以緩解]患者的症狀。

So again, a lot of excitement, I think, it really changed the (inaudible) opportunities with YUTREPIA. We still think the (inaudible) will be the first choice (inaudible) changing option. We can capture a significant share of a market which has plenty of opportunity for building another drug, but obviously, other inhaled (inaudible). We're excited about process (inaudible) in my belief it will be (inaudible) and they're the only drug that can be titrated to effect. And given that, (inaudible) so likely that will be (inaudible) approval. Rajeev, I don't know if you have anything to add to that?

因此，我認為，這再次帶來了很多興奮，這確實改變了 YUTREPIA 的（聽不清）機會。我們仍然認為（聽不清）將是首選（聽不清）更改選項。我們可以佔領一個市場的重要份額，該市場有足夠的機會來製造另一種藥物，但顯然是其他吸入藥物（聽不清）。我們對這個過程感到興奮（聽不清），我相信它會（聽不清），而且它們是唯一可以通過滴定達到效果的藥物。鑑於此，（聽不清）很可能會（聽不清）批准。 Rajeev，不知道你還有什麼要補充的嗎？

Julian, Roger said it excellently. I'll just add, remember one of the key issues here is also focused on not only pulmonary arterial hypertension, but also specifically pulmonary hypertension associated with interstitial lung disease, where sotatercept has yet not just shown a benefit. And so we'll all -- the entirety of both populations will be important and we're (inaudible) to have driven or (inaudible) in both (inaudible).

朱利安，羅傑說得很好。我只是補充一點，請記住，這裡的關鍵問題之一不僅集中在肺動脈高壓上，而且還特別集中在與間質性肺疾病相關的肺動脈高壓上，而 sotatercept 尚未僅顯示出益處。因此，我們所有人——這兩個群體的整體都將很重要，我們（聽不清）將推動或（聽不清）兩者（聽不清）。

Our next question will come from Matt Kaplan of Ladenburg Thalmann.

我們的下一個問題將來自拉登堡塔爾曼的馬特·卡普蘭。

Just a couple of questions, on following up on the PH-ILD opportunity. I guess, one, could you tell us a little bit about the approval pathway for PH-ILD? And then secondly, with your planned open-label study, what are some of the end points you're going to look at there? And is there an opportunity to showcase a potential improvement in efficacy due to the titratability?

只是幾個關於跟進 PH-ILD 機會的問題。我想，第一，您能告訴我們一些有關 PH-ILD 審批途徑的信息嗎？其次，根據您計劃的開放標籤研究，您將關注哪些終點？是否有機會展示由於滴定性而帶來的功效的潛在改進？

Thanks, Matt. Thank you it's (inaudible). So I'll talk about pathway. So as we've said before, we've confirmed with the FDA in writing no additional studies are required for approval for PH-ILD patients. Having said that, obviously, we can't seek approval in the market exclusivity expired in (inaudible). So (inaudible) for that market post that date.

謝謝，馬特。謝謝（聽不清）。所以我要談談路徑。正如我們之前所說，我們已向 FDA 書面確認，無需進行額外的研究即可批准用於 PH-ILD 患者。話雖如此，顯然我們不能在市場獨占權到期時尋求批准（聽不清）。因此（聽不清）該市場發布了該日期。

So that's the path some of kind of how we are provided approval will depend on the resolution of the legal case and when we get approval for pulmonary arterial hypertension and move our tenant of approval to full approval. But in general, those are the parameters that are gating for PH-ILD. And maybe, Rajeev, if you could speak a little bit (inaudible).

因此，我們獲得批准的方式在某種程度上取決於法律案件的解決，以及我們何時獲得肺動脈高壓的批准並將我們的批准轉變為完全批准。但總的來說，這些是 PH-ILD 的門控參數。也許，拉吉夫，如果你能說一點（聽不清）。

(inaudible) So first of all, as we just discussed on this call, this will be an open study specifically in PH-ILD. So in that regard, one of the major focus is to really understand the tolerability of the YUTREPIA in patient population. Remember, this is about range of patients with different types of heterogenous (inaudible) lung disease.

（聽不清）首先，正如我們剛剛在本次電話會議中討論的那樣，這將是一項專門針對 PH-ILD 的開放研究。因此，在這方面，主要焦點之一是真正了解 YUTREPIA 在患者群體中的耐受性。請記住，這是關於患有不同類型的異質性（聽不清）肺部疾病的患者的範圍。

So really highlighting the [experience] in that broad range population, and see if there's any particular population that stands out with the best response. The second thing is that we're going to be focusing titratability. We know that if conditions keep certain breath equivalent to (inaudible) we're taking to have a better response. We want to see if: Number one, we can absolutely reach those levels and more importantly, exceed those levels in a tolerable fashion.

因此，真正強調在廣泛人群中的[經驗]，看看是否有任何特定人群表現出最佳反應。第二件事是我們將重點關注滴定性。我們知道，如果條件保持一定的呼吸相當於（聽不清），我們就會做出更好的反應。我們想看看：第一，我們絕對可以達到這些水平，更重要的是，以可容忍的方式超過這些水平。

This will translate into several data that we can acquire, including typical data points such as improved walk capacity or a 6-minute walk distance. We can also look at various effects, not only on the right ventricle itself, using (inaudible) parameters (inaudible), but also changes in scoring of the actual fibrosis (inaudible) again, using noninvasive imaging (inaudible). So more to come on that as the final protocol (inaudible).

這將轉化為我們可以獲得的多個數據，包括典型的數據點，例如步行能力的提高或 6 分鐘的步行距離。我們還可以使用（聽不清）參數（聽不清）來觀察各種影響，不僅是對右心室本身的影響，還可以使用無創成像（聽不清）再次觀察實際纖維化評分的變化（聽不清）。因此，最終協議還有更多內容（聽不清）。

I see there are no further questions in the queue. I would now like to turn the conference back to Roger Jeffs for closing remarks.

我看到隊列中沒有其他問題了。現在我想請羅傑·傑夫斯（Roger Jeffs）致閉幕詞。

If we can let Matt back in.

如果我們能讓馬特回來就好了。

Chris, Matt had one more question. Could you let him back in so he can ask it.

克里斯、馬特還有一個問題。你能讓他回來讓他問一下嗎？

One moment please. Mr. Kaplan, you are now able to ask your next question.

稍等一會兒。卡普蘭先生，您現在可以問下一個問題了。

Great. Just a quick question. In terms of -- with the moving parts associated with the Hatch-Waxman litigation and the PTAB decisions, what's your current thoughts on the timing for full approval now?

偉大的。只是一個簡單的問題。就與 Hatch-Waxman 訴訟和 PTAB 裁決相關的動態部分而言，您目前對全面批准的時機有何看法？

Yes. Great question. Maybe I'll ask Rusty to opine on some of the -- how he sees the timeline for the legal situation playing out.

是的。很好的問題。也許我會請拉斯蒂發表一些意見——他如何看待法律局勢的時間表。

Sure. So thanks for the question, Matt. So we really have 2 separate opportunities to get clear of the patents at this point: The appeal of the Hatch-Waxman decision; and the appeal of the '793 IPR and both of those are on different time lines.

當然。謝謝你的提問，馬特。因此，我們此時確實有兩個單獨的機會來清除這些專利：對 Hatch-Waxman 判決提出上訴；以及“793 IPR”的上訴，兩者都處於不同的時間線上。

So first is the appeal of the Hatch-Waxman decision. As I noted earlier, briefing is now complete, and we're just waiting on the court to set in oral argument dates. We think that date will be some time in the second quarter or third quarter of this year. And once oral argument has been held, we expect a decision could come in as quickly as a few days after a oral argument or it could take a couple of months depending on whether we get some reaffirmance or not.

首先是對哈奇-韋克斯曼判決的上訴。正如我之前指出的，情況通報現已完成，我們只是在等待法庭確定口頭辯論日期。我們認為這個日期將是今年第二季度或第三季度的某個時間。一旦進行口頭辯論，我們預計最快會在口頭辯論後幾天內做出決定，也可能需要幾個月的時間，具體取決於我們是否得到一些重申。

And so if in that decision, the '066, the district court's decision regarding the 'O66 patent is upheld, and if the '793 decision of the district court is overturned, we would be able to proceed immediately to seek full approval after that. So that would put it sometime in the second, third and fourth quarter this year.

因此，如果在該決定中，地區法院關於‘O66 專利的‘066 決定得到維持，並且如果地區法院的‘793 決定被推翻，那麼我們將能夠立即繼續尋求此後的全面批准。因此，這將是今年第二、第三和第四季度的某個時間。

Alternatively, if that appeal results in the 'O66 patent decision being upheld, and the '793 decision of the district court being upheld, then we would have to wait for the IPR appeal to play out. And as we noted, we expect that oral argument in that will likely be held some time in fourth quarter of this year, or first quarter of next year, or first half of next year. And again, same thing after that oral argument is we could get a decision as quickly as a few days afterwards or as long as a few months afterwards.

或者，如果該上訴導致‘O66 專利判決得到維持，並且地區法院的 '793 判決得到維持，那麼我們將不得不等待 IPR 上訴結果。正如我們所指出的，我們預計口頭辯論可能會在今年第四季度、明年第一季度或明年上半年的某個時間舉行。同樣，在口頭辯論之後，我們可以最快幾天或幾個月後做出決定。

Thank you, Rusty. Very clear.

謝謝你，魯斯蒂。非常清楚。

One moment please. And I see no further questions at this time in the queue. I will turn the call back to Roger Jeffs for closing remarks.

稍等一會兒。目前我在隊列中沒有看到任何其他問題。我將把電話轉回給羅傑·傑夫斯，讓他發表結束語。

Great. And firstly, I say, we appreciate everybody calling in and listening. I hope you share the excitement we have around our building momentum. We're really trying to build on the back of some very positive news as it related to the legal situation.

偉大的。首先，我要說，我們感謝每個人的來電和傾聽。我希望您能分享我們對我們的發展勢頭所感到的興奮。我們確實在努力以一些與法律情況相關的非常積極的消息為基礎。

And as we continue to go to the market, you can hear our excitement around the product capabilities of YUTREPIA and how it could be introduced uniquely into the marketplace and benefit patients in a differentiated way.

隨著我們繼續進軍市場，您可以聽到我們對 YUTREPIA 的產品功能以及如何將其獨特地引入市場並以差異化方式造福患者的興奮之情。

We thank you again for joining us, and we look forward to reporting on our continued progress in the coming quarters. Thank you, everyone. Bye-bye.

我們再次感謝您加入我們，我們期待報告我們在未來幾個季度的持續進展。謝謝大家。再見。

This concludes today's conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.

今天的電話會議到此結束。感謝大家的參與。您現在可以斷開連接，並度過愉快的一天。