Liquidia Corp (LQDA) 2023 Q3 法說會逐字稿

Good morning, and welcome, everyone, to the Liquidia Corporation Third Quarter 2023 Financial Results and Corporate Update Conference Call. My name is Therese, and I will be your conference operator today. (Operator Instructions) I would like to remind everyone that this conference call is being recorded.

早安，歡迎大家參加 Liquidia Corporation 2023 年第三季財務業績和公司最新動態電話會議。我叫Therese，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。

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

我現在會把電話轉交給首席商務官 Jason Adair。

Thank you, Therese. It's my pleasure to welcome everyone to Liquidia's Third Quarter 2023 Financial Results and Corporate Update Call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs; Chief Financial Officer, Michael Kaseta; Chief Commercial Officer, Scott Moomaw; Chief Medical Officer, Dr. Rajeev Saggar; and General Counsel, Rusty Schundler.

謝謝你，特蕾莎。我很高興歡迎大家參加 Liquidia 2023 年第三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；財務長 Michael Kaseta；商務長 Scott Moomaw；首席醫療官 Rajeev Saggar 博士；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.

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資訊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。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'd now like to turn the call over to Roger for our prepared remarks, after which, he will open up 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，之後，他將打開電話詢問您的問題。

Thank you, Jason. Good morning, everyone, and thank you for joining us. The third quarter was marked by continued and positive steps to change the future of the company, the PH market and the lives of patients we are committed to serve. We have built a portfolio that we believe includes the most promising products in the fastest-growing area of the PH marketplace: inhaled treprostinil for the treatment of pulmonary arterial hypertension, or PAH; and pulmonary hypertension associated with interstitial lung disease, or PH-ILD.

謝謝你，傑森。大家早安，感謝您加入我們。第三季的特點是持續採取積極措施來改變公司的未來、PH 市場以及我們致力於服務的患者的生活。我們已經建立了一個產品組合，我們認為其中包括 PH 市場成長最快領域中最有前景的產品：用於治療肺動脈高壓 (PAH) 的吸入曲前列環素；以及與間質性肺部疾病（PH-ILD）相關的肺動脈高壓。

Many of you know already that YUTREPIA, our dry powder formulation of treprosinil using a low effort, simple-to-use, pocket-sized dry powder inhaler has the potential to be the first and best choice when adding prostacyclin to a patient's treatment regimen. In support of this, a recent summary from our open-label clinical experience shows how durable and titratable YUTREPIA treatment can be, where we've treated patients for as long as 5.5 years and have titrated to doses now equivalent to 30 breaths of TYVASO 4 times per day.

許多人已經知道，YUTREPIA 是我們的曲普羅西尼乾粉製劑，採用省力、易於使用的袖珍乾粉吸入器，有可能成為在患者治療方案中添加前列環素時的首選和最佳選擇。為了支持這一點，我們最近的開放標籤臨床經驗總結顯示了 YUTREPIA 治療的持久性和可滴定性，我們已經治療患者長達 5.5 年，並​​且已經滴定到相當於 30 次 TYVASO 4 呼吸的劑量每天次數。

I want to emphasize, dose matters, as it has been demonstrated across all routes of prostacyclin use that higher doses equate with better patient outcomes. YUTREPIA's ability to dose higher has the potential to significantly broaden and improve upon the therapeutic index and utility of inhaled treprostinil administration as it currently exists.

我想強調的是，劑量很重要，因為在前列環素的所有使用途徑中都已證明，較高劑量等同於更好的患者預後。 YUTREPIA 的較高劑量能力有可能顯著擴大並改善目前吸入曲前列環素給藥的治療指數和效用。

At the same time, we've seen promising early evidence of clear benefits in our sustained-release inhaled treprostinil program called L606. This liposomal formulation delivered in 2 administrations per day offers more consistent drug exposure throughout the day, including during sleeping hours. Each dose is delivered in approximately 1 minute using simple titer breathing with a portable next-generation, breath-activated nebulizer.

同時，我們已經看到了有希望的早期證據，表明我們的緩釋吸入曲前列環素計劃（稱為 L606）具有明顯的益處。這種脂質體製劑每天分兩次給藥，可在全天（包括睡眠期間）提供更一致的藥物暴露。使用便攜式下一代呼吸啟動霧化器進行簡單的滴度呼吸，每個劑量可在大約 1 分鐘內輸送。

We have plans to share data at conferences in 2024, but our preliminary data suggests that patients in the open-label study who have transitioned from TYVASO have been able to safely titrate to higher doses, including daily doses comparable to 25 breaths of TYVASO 4 times per day without any reported throat pain to date and only mild to moderate and expected adverse events in a minority of patients. We very much look forward to sharing more details on the development and registration path for this program during our future earnings calls, which will be informed by our Type C meeting scheduled with the FDA next month.

我們計劃在 2024 年的會議上分享數據，但我們的初步數據表明，開放標籤研究中從 TYVASO 過渡的患者已經能夠安全地滴定至更高劑量，包括相當於 25 次 TYVASO 呼吸 4 次的每日劑量迄今為止，沒有任何喉嚨疼痛的報告，只有少數患者出現輕度至中度和預期的不良事件。我們非常期待在未來的財報電話會議上分享有關該計劃的開發和註冊路徑的更多細節，我們下個月與 FDA 舉行的 C 類會議將告知這些細節。

While we are very excited about our L606 program, we recognize that most of our investors' attention is focused on near-term legal events. The good news is that legal story has now become greatly simplified. There's just a single patent, '793 patent, that currently supports the injunction preventing the FDA from granting full approval of YUTREPIA. All claims of that patent were found to be invalid by the Patent Trial and Appeal Board, or PTAB. The PTAB's favorable decision is currently being appealed by United Therapeutics with oral arguments scheduled for December 4.

雖然我們對 L606 計劃感到非常興奮，但我們認識到投資者的大部分注意力都集中在近期的法律事件上。好消息是法律故事現在已經大大簡化。目前只有一項專利「793 專利」支持阻止 FDA 完全批准 YUTREPIA 的禁令。專利審判和上訴委員會 (PTAB) 認定該專利的所有權利要求均無效。 United Therapeutics 目前正在對 PTAB 的有利決定提出上訴，並計劃於 12 月 4 日進行口頭辯論。

We expect the decision could be issued as quickly as a few days after oral argument if some of the affirmance is granted, or within just a few months after oral arguments where the formal written decision is provided. Regardless, if the PTAB's decision is affirmed, we will immediately seek to have the injunction lifted and request final approval from the FDA. In the event of such an approval, we will execute on our plan to change the landscape of the PH market as quickly as possible.

我們預計，如果獲得部分肯定，則可以在口頭辯論後幾天內盡快發布決定；如果提供正式的書面決定，則可以在口頭辯論後幾個月內發布決定。無論如何，如果 PTAB 的決定得到確認，我們將立即尋求解除禁令並請求 FDA 的最終批准。如果獲得批准，我們將盡快執行我們的計劃，以改變 PH 市場的格局。

For this reason, I have asked Scott Moomaw, our Chief Commercial Officer, to introduce himself broadly to our investors and to provide an update regarding our commercial preparations. Scott?

因此，我已要求我們的商務長 Scott Moomaw 向我們的投資者廣泛介紹自己，並提供有關我們商業準備工作的最新資訊。史考特？

Thanks, Roger. As a brief introduction for those that I have not yet met, I've had more than 20 years in the pharmaceutical industry building commercial teams and launching products. I spent 13 of those years in the pulmonary hypertension market, including leading the marketing of treprostinil products, Remodulin, TYVASO and ultimately the launches of Orenitram and treprostinil injection.

謝謝，羅傑。向那些我尚未見過的人簡單介紹一下，我在製藥業擁有 20 多年的經驗，負責建立商業團隊和推出產品。其中 13 年我在肺動脈高壓市場工作，包括領導曲前列環素產品、Remodulin、TYVASO 的營銷，以及最終推出奧瑞尼曲和曲前列環素注射液。

Two years ago, I joined Liquidia when RareGen, a company I co-founded with Roger and others, merged with Liquidia. Since then, I've been building our commercial strategy and our team for the upcoming potential launch of YUTREPIA. We've really built a strong senior commercial management team across marketing, market access and sales leadership.

兩年前，當我與 Roger 等人共同創立的 RareGen 公司與 Liquidia 合併時，我加入了 Liquidia。從那時起，我一直在為即將推出的 YUTREPIA 制定我們的商業策略和團隊。我們確實在行銷、市場准入和銷售領導方面建立了一支強大的高階商業管理團隊。

On the marketing and market access side, our team is ensuring that patients who are prescribed YUTREPIA will be supported by a full suite of services including high-touch specialty pharmacy services, a patient access program and a co-pay card program.

在行銷和市場准入方面，我們的團隊確保服用 YUTREPIA 處方的患者將獲得全套服務的支持，包括高接觸性專業藥房服務、患者准入計劃和共同支付卡計劃。

On the sales side, very exciting. Just last month, we were pleased to complete the onboarding of our field force of about 50 sales reps who share my passion for helping patients suffering from rare diseases. Collectively, our sales team has an average of 9 years selling rare disease products, with the majority of the team having sold PH products previously. The team is now in the community and academic center offices, increasing the awareness of Liquidia and supporting treprostinil injection more widely than ever. We want all physicians to know that Liquidia is here for patients at any stage of their disease progression.

在銷售方面，非常令人興奮。就在上個月，我們很高興地完成了約 50 名銷售代表的現場隊伍的入職，他們與我一樣熱衷於幫助患有罕見疾病的患者。總的來說，我們的銷售團隊平均有 9 年銷售罕見疾病產品的經驗，其中大多數團隊成員都曾經銷售過 PH 產品。該團隊現已進駐社區和學術中心辦公室，提高了 Liquidia 的知名度，並比以往更廣泛地支持曲前列環素注射。我們希望所有醫生都知道，Liquidia 適合處於疾病進展任何階段的患者。

As a result of our preparation to date, I am proud to say that Liquidia is ready and well positioned to launch YUTREPIA in both PAH and PH-ILD upon final FDA approval.

經過我們迄今為止的準備工作，我很自豪地說，Liquidia 已準備好並處於有利位置，可在 FDA 最終批准後在 PAH 和 PH-ILD 中推出 YUTREPIA。

With that, I'll pass it over to Mike to review the last quarter's results. Mike?

這樣，我將把它交給麥克來審查上一季的結果。麥克風？

Thank you, Scott, and good morning, everyone. Our third quarter 2023 financial results can be found in the press release and the 10-Q filed this morning. As you will see, Liquidia continues to operate and spend on value-creating activity in a judicious manner.

謝謝你，斯科特，大家早安。我們的 2023 年第三季財務業績可在今天早上提交的新聞稿和 10-Q 中找到。正如您將看到的，Liquidia 繼續以明智的方式經營和投資創造價值的活動。

We ended the third quarter with $76.2 million in cash, equating to a net burn of $17.1 million over the first 9 months of this year. During the quarter, revenue from treprostinil injection increased $0.5 million compared to the same quarter last year due to favorable gross to net chargebacks and rebate adjustments, which offset lower sales quantity compared to the same period in the prior year.

截至第三季末，我們的現金為 7,620 萬美元，相當於今年前 9 個月的淨燒錢額為 1,710 萬美元。本季度，由於有利的毛淨退款和回扣調整，曲前列環素注射液的收入比去年同期增加了 50 萬美元，抵消了與去年同期相比銷量下降的影響。

Cost of sales decreased slightly to $0.6 million as compared to third quarter of 2022, primarily due to lower intangible asset amortization due to the extension of our agreement with Sandoz to commercialize treprostinil injection. R&D expenses in the quarter were $7.4 million, an increase of $2.9 million compared to second quarter 2022 and included increased spending to build prelaunch commercial supply, advance the recently licensed L606 clinical program and support headcount increases.

與 2022 年第三季相比，銷售成本小幅下降至 60 萬美元，這主要是由於我們與山德士延長曲前列環素注射液商業化協議導致無形資產攤銷減少。本季的研發費用為 740 萬美元，比 2022 年第二季增加了 290 萬美元，其中包括增加用於建立上市前商業供應、推進最近獲得許可的 L606 臨床項目以及支援人員增加的支出。

General and administrative expenses were $10.6 million for the third quarter of 2023 compared to $6.7 million for the same quarter in 2022. The increase of $3.9 million was primarily driven by legal fees related to our ongoing litigation, personnel and commercial expenses in preparation for the potential launch of YUTREPIA and an increase in stock-based compensation expense.

2023 年第三季的一般和管理費用為1,060 萬美元，而2022 年第三季為670 萬美元。增加390 萬美元主要是因為與我​​們正在進行的訴訟相關的法律費用、為潛在的潛在訴訟做好準備的人員和商業費用。YUTREPIA 的推出以及股票補償費用的增加。

As we look into December and the year beyond, we will continue to apply the same financial discipline to manage through the time line of legal and regulatory events while also being opportunistic as those events unfold. I'd like now to turn the call back over to Roger.

當我們展望 12 月和未來一年時，我們將繼續採用相同的財務紀律來管理法律和監管事件的時間線，同時隨著這些事件的發生而保持機會主義。我現在想把電話轉回給羅傑。

Thank you, Mike. I hope investors can hear our enthusiasm and level of excitement. We are now fully prepared to enter the marketplace and, upon approval, promote the full benefits that YUTREPIA can provide to patients in their journey to feel better.

謝謝你，麥克。我希望投資者能夠聽到我們的熱情和興奮程度。我們現在已做好進入市場的充分準備，並在獲得批准後，推廣 YUTREPIA 可以為患者提供的全部好處，讓他們感覺更好。

With that, I would now like to open the call for questions.

現在我想開始提問。

(Operator Instructions) Our question is from Greg Harrison with Bank of America.

（操作員說明）我們的問題來自美國銀行的格雷格·哈里森。

Wondering how you're thinking about the opportunity in PH-ILD in terms of size of the addressable market and any segments that would be a focus for your efforts. And are there any learnings you've gained from your competitors' launch in ILD?

想知道您如何看待 PH-ILD 中的機會，包括目標市場的規模以及您努力關注的任何細分市場。您從競爭對手推出 ILD 中獲得了哪些經驗教訓？

Yes. Great question, Greg. Thank you for the question. Scott, if you wouldn't mind, if you could give your commercial view of that question?

是的。好問題，格雷格。感謝你的提問。斯科特，如果您不介意的話，您能談談您對這個問題的商業看法嗎？

Yes, sure. So we feel like the market for PH-ILD, the prevalent market is about 60,000 patients. As -- and we all know that there's a significant potential here because of the unmet need. We think that actually 2 companies in this space educating center physicians, you probably see these patients already; but also community physicians who may see these patients but not recognize it, should grow that market quickly. So we're excited about it. We think it's all addressable. Rajeev can chime in if he sees that differently, but we think that we have a significant potential here.

是的，當然。所以我們覺得 PH-ILD 的市場，普遍的市場大約有 6 萬名患者。我們都知道，由於需求未被滿足，這裡存在著巨大的潛力。我們認為實際上有兩家公司在這個領域為醫生提供教育中心，您可能已經看到了這些患者；而社區醫生可能會看到這些患者但不認識他們，應該迅速擴大這個市場。所以我們對此感到興奮。我們認為這一切都是可以解決的。如果拉吉夫有不同的看法，他可以插話，但我們認為我們在這裡有巨大的潛力。

Yes. Rajeev, any further comments on that?

是的。 Rajeev，對此有何進一步評論？

Yes. Greg, just to highlight regarding the type of patients and the classification of these patients, as you know, there's over 200 different types of interstitial lung diseases. We obviously are still learning which one of those continue to unfortunately develop this condition of pulmonary hypertension.

是的。 Greg，我想強調一下患者的類型和這些患者的分類，如您所知，有 200 多種不同類型的間質性肺部疾病。顯然，我們仍在了解其中哪一個不幸地繼續發展出這種肺動脈高壓。

But I think we remain focused on identifying broad categories, idiopathic interstitial pneumonia, autoimmune diseases, hypersensitivity pneumonia. These are the categories inclusive of combined pulmonary fibrosis and emphysema that portend to develop pulmonary hypertension. So focusing on earlier diagnosis and earlier treatment opportunities, we believe, will be quite impactful for these patients and also the physicians who are treating these cohorts.

但我認為我們仍然專注於確定大類，特發性間質性肺炎、自體免疫疾病、過敏性肺炎。這些類別包括合併肺纖維化和肺氣腫，預示著肺動脈高壓。因此，我們相信，關注早期診斷和早期治療機會將對這些患者以及治療這些群體的醫生產生相當大的影響。

Our next question comes from Serge Belanger from Needham.

我們的下一個問題來自尼達姆的 Serge Belanger。

First one on the L606 program. So going into the Type C meeting next month, what are your expectations in terms of what is needed to get to a filing? Does the open -- the ongoing open-label trial, would that support a filing? Or you think you'll need to conduct placebo-controlled studies in both PAH and PH-ILD?

L606 計劃中的第一個。那麼，在下個月舉行的 C 類會議上，您對提交文件所需的內容有何期望？正在進行的開放標籤試驗是否支持備案？或者您認為需要對 PAH 和 PH-ILD 進行安慰劑對照研究？

And then second question, maybe for Scott, maybe kind of a follow-up on the previous PH-ILD question. Maybe just talk about how different the prescriber base is for PAH and PH-ILD and how much overlap there is between the two.

然後是第二個問題，也許是對 Scott 來說的，也許是先前 PH-ILD 問題的後續問題。也許只是談談 PAH 和 PH-ILD 的處方者基礎有多麼不同，以及兩者之間有多少重疊。

Yes. Thank you, Serge. Rajeev, if you wouldn't mind talking about our -- at least preliminarily, our L606 registration strategy and kind of what we see as the path forward and what we're discussing with the FDA.

是的。謝謝你，塞爾吉。 Rajeev，如果您不介意談論我們的——至少是初步的，我們的 L606 註冊策略以及我們所認為的前進道路以及我們正在與 FDA 討論的內容。

Sure. Thanks, Serge. So as we've discussed on prior calls, the goal of this Type C meeting with the FDA or overall clinical program is to discuss with them what is the path to regulatory approval. We believe that our proposed clinical paradigm of advancing a single Phase III study in PLD that's placebo-controlled using L606, achieving a robust primary endpoint will lead to the ultimate approval of both PAH and PH-ILD in the near future. And that will be inclusive of adding the safety profile of the open-label ongoing study of L606 that's currently enrolling to date. Scott?

當然。謝謝，塞爾日。因此，正如我們在先前的電話會議中討論的那樣，與 FDA 或整個臨床計劃舉行的 C 型會議的目標是與他們討論獲得監管批准的途徑是什麼。我們相信，我們提出的推進 PLD 單一 III 期研究（使用 L606 進行安慰劑對照）的臨床範例，實現穩健的主要終點，將在不久的將來導致 PAH 和 PH-ILD 的最終批准。這將包括添加目前正在招募的 L606 開放標籤研究的安全性概況。史考特？

Yes. So the PH-ILD HCP market, it's as you might expect. The PH centers, the centers of excellence, the Dukes, the Mayos, et cetera, not only treat PAH but they treat PH-ILD as well as the other forms of pulmonary hypertension. And then you have what's usually just labeled the community physicians, mostly pulmonologists, that are treating ILD but may not be diagnosing or treating PH-ILD.

是的。因此，PH-ILD HCP 市場正如您所期望的那樣。肺動脈高壓中心、卓越中心、杜克斯中心、梅奧中心等不僅治療 PAH，還治療 PH-ILD 以及其他形式的肺動脈高壓。然後，通常被稱為社區醫生（主要是肺科醫師）的人員正在治療 ILD，但可能不會診斷或治療 PH-ILD。

Some of the numbers that we see, if you think about us having 5,000 targets overall, it would be maybe 2,000 of those targets would be doctors who do not prescribe prostacyclins or the more serious PAH meds. So you would infer from that, that they are not treating PH-ILD. So we're sized to cover all of those more than adequately. And so the goal in the 2 different segments is a little bit different, obviously.

我們看到的一些數字，如果你考慮我們總共有 5,000 個目標，那麼其中可能有 2,000 個目標是不開前列環素或更嚴重的 PAH 藥物的醫生。所以你可以據此推斷，他們沒有治療 PH-ILD。因此，我們的規模足以充分涵蓋所有這些內容。因此，顯然，兩個不同細分市場的目標略有不同。

When you're in the centers, you want to make sure that they're reaching our drug. But when you're in the community, you want to make sure that they are aware of the severity of PH-ILD and the probability of PH-ILD and then that they're diagnosing it. And if they'll treat it, that's great. And if they won't, let's make sure that, that patient gets to a center of excellence that can.

當您在中心時，您需要確保他們能夠拿到我們的藥物。但是，當您身處社區時，您需要確保他們了解 PH-ILD 的嚴重性和 PH-ILD 的可能性，然後進行診斷。如果他們願意治療，那就太好了。如果他們不這樣做，讓我們確保該患者能夠到達一個可以這樣做的卓越中心。

Our next question comes from Kambiz Yazdi from Jefferies.

我們的下一個問題來自 Jefferies 的 Kambiz Yazdi。

Roger, in the past, you've kind of discussed YUTREPIA potentially being kind of a prostacyclin of first choice. Maybe you could expand on that thought, especially ahead of a potential launch. And then as a second question, can you remind us what is the status of the '061 method of use patent?

羅傑，過去，您曾討論過 YUTREPIA 可能是首選前列環素。也許你可以擴展這個想法，尤其是在潛在的發布之前。第二個問題，您能否提醒我們'061使用方法專利的狀況如何？

Yes. Thanks for the question, Kambiz. So maybe Rajeev, maybe if you could talk about the pillars of YUTREPIA that will help position it as the potential prostacyclin of first choice. And then, Rusty, you can talk about the status question, if you will. Rajeev?

是的。謝謝你的提問，卡姆比茲。所以也許 Rajeev，也許您可以談談 YUTREPIA 的支柱，這將有助於將其定位為潛在的首選前列環素。然後，Rusty，如果你願意的話，你可以談談狀態問題。拉吉夫？

Sure. Thanks, Kambiz. So first, yes, just to rehighlight, we remain quite enthusiastic about YUTREPIA using our PRINT formulation as well as a low-resistance device. We believe that this will be quite differentiated in the market, especially in the PH-ILD market. We have always discussed that some of our key pillars that YUTREPIA offers are improved tolerability. As Roger alluded to, dose does matter, and we continue to highlight that YUTREPIA remains quite titratable in our open-label extension study, which is known as the INSPIRE study.

當然。謝謝，坎比茲。首先，是的，再次強調一下，我們仍然對使用我們的 PRINT 配方和低電阻裝置的 YUTREPIA 充滿熱情。我們相信這在市場上將會有很大的差異化，特別是在PH-ILD市場。我們一直在討論，YUTREPIA 提供的一些關鍵支柱是提高耐受性。正如 Roger 所提到的，劑量確實很重要，我們繼續強調 YUTREPIA 在我們的開放標籤擴展研究（即 INSPIRE 研究）中仍然具有相當的可滴定性。

We have now reached doses equivalent of 30 breaths of TYVASO 4 times a day, which is just quite remarkable to see these high doses being used safely in these patients. And we believe all of these will portend to improve clinical outcomes for patients both in PH and PH-ILD. And most importantly, we show durability with the use of YUTREPIA with now patients being exposed for as long as up to 5.5 years, which we believe highlights the durability and compliance with this -- with YUTREPIA itself in this population.

我們現在已經達到了相當於每天 4 次 TYVASO 30 次呼吸的劑量，看到這些高劑量在這些患者中安全使用是非常了不起的。我們相信所有這些都將改善 PH 和 PH-ILD 患者的臨床結果。最重要的是，我們顯示了 YUTREPIA 使用的耐久性，現在患者暴露時間長達 5.5 年，我們相信這突顯了 YUTREPIA 本身在這一人群中的耐久性和依從性。

Great. Thank you, Rajeev. Rusty, if you'll speak to the status of the patent.

偉大的。謝謝你，拉吉夫。 Rusty，請談談專利的狀況。

Sure. And thanks for the question, Kambiz. So the '061, I think you're referring to the patent application that received a noticeable -- a United Therapeutics patent application that received a notice of allowance back in late June that we issued an 8-K about. As of today, that patent still has not issued and they have not yet received a notice of issuance.

當然。感謝 Kambiz 提出的問題。因此，'061，我認為您指的是收到引人注目的專利申請 - 一項聯合治療公司的專利申請，該申請早在 6 月底就收到了許可通知，我們對此發布了 8-K。截至今天，該專利仍未發布，他們也尚未收到發布通知。

That's a little bit atypical for it to take that long for that patent issue. So we're not -- we don't have visibility as to what's going on at the United States Patent and Trademark Office with respect to that patent. However, what I will say is we're anticipating that it will issue, we're preparing for it to issue and we'll be ready to address it.

專利問題花了這麼長時間，有點不尋常。所以我們不知道美國專利商標局在該專利方面的進展。然而，我要說的是，我們預計它會出現，我們正在準備它的出現，我們將準備好解決它。

Our next question comes from Julian Harrison of BTIG.

我們的下一個問題來自 BTIG 的 Julian Harrison。

Congrats on the progress. I have some related to the last one just asked on the PH-ILD patent United received a notice of allowance for back in June. I guess, after the FDA-designated PH-ILD exclusivity expires for United end of March next year, could this patent or patent application have any relevance to YUTREPIA's eligibility to receive full approval in PH-ILD, assuming you already have full approval in PAH at that point?

祝賀取得的進展。我有一些與剛剛詢問的有關 PH-ILD 專利的最後一項相關的信息，聯合航空早在 6 月份就收到了一份津貼通知。我想，在FDA 指定的聯合航空PH-ILD 專營權將於明年3 月底到期後，假設您已經獲得PAH 的完全批准，那麼該專利或專利申請是否與YUTREPIA 獲得PH-ILD 的完全批准的資格相關？那時候？

Yes. So I'll speak to the regulatory component. So in terms of -- and we have a PDUFA date, Julian of January 24, '24 for PH-ILD, the amendment that we filed in July. There would be no implication in terms of getting a tentative approval, which would be granted at that time because market exclusivity does not expire until end of March '24. So we don't see any gate between whatever may happen with that patent and the regulatory approval process. Rusty, you want to speak about the commercialization post that?

是的。我將談談監管部分。因此，就 PH-ILD 而言，我們有一個 PDUFA 日期，即 24 年 1 月 24 日的朱利安（Julian），這是我們在 7 月提交的修正案。暫時批准不會有任何影響，因為市場獨佔權要到 24 年 3 月底才會到期，屆時將獲得臨時批准。因此，我們認為該專利可能發生的情況與監管審批流程之間沒有任何關卡。 Rusty，你想談談商業化貼文嗎？

Sure. So Julian, thank you for the question. So to be clear, there would be no 30-month stay that attaches to this new patent. So the only way it would potentially have an impact would be if United Therapeutics is able to go into court and convince a judge that they should get some sort of an injunction to prevent us from launching.

當然。朱利安，謝謝你的提問。需要明確的是，這項新專利不會有 30 個月的停留期。因此，唯一可能產生影響的方法是聯合治療公司能夠進入法庭並說服法官他們應該獲得某種禁令來阻止我們啟動。

As I think we said in the last call, looking at this patent, looking at how this patent compares to the '793 patent and the numerous studies that were done by medical professionals between the launch of TYVASO and the date that this new patent was filed, we think there's a lot of prior art. Obviously, if they assert it, which we anticipate they will, we'll have to deal with that in court. But again, the only way it would impact is if they're able to convince a court that, notwithstanding all that prior art, they should be entitled to an injunction.

正如我認為我們在上次電話會議中所說的那樣，請查看該專利，查看該專利與 '793 專利的比較，以及醫療專業人員在 TYVASO 推出和提交該新專利之日之間所做的大量研究，我們認為有很多現有技術。顯然，如果他們主張這一點（我們預計他們會這樣做），我們將不得不在法庭上處理這個問題。但同樣，唯一能產生影響的方式是，他們是否能夠說服法院，儘管有所有這些現有技術，但他們應該有權獲得禁令。

I am showing no further questions at this time. So I would like to turn it back to Roger Jeffs.

我目前沒有提出任何進一步的問題。所以我想把它轉回羅傑·傑夫斯。

Thank you, Therese. So I intentionally let the team answer most of the call today because I wanted the investors to hear the depth and quality of the team that we have that are ready and very excited about launching YUTREPIA in the very near future. The other thing that you can hear is the quality of YUTREPIA's product profile and its potential to quickly differentiate and become the prostacyclin of first choice, as what Kambiz asked about.

謝謝你，特蕾莎。因此，我今天故意讓團隊接聽大部分電話，因為我希望投資者能夠聽到我們團隊的深度和質量，他們已經做好準備，並且對在不久的將來推出 YUTREPIA 感到非常興奮。您可以聽到的另一件事是 YUTREPIA 產品簡介的品質及其快速差異化並成為首選前列環素的潛力，正如 Kambiz 所詢問的那樣。

We thank you for joining us today, and we look forward to continuing to update you on our progress as we bridge to these important inflecting events. Thank you.

感謝您今天加入我們，我們期待在應對這些重要的影響事件時繼續向您通報我們的最新進展。謝謝。

This does conclude the program. You may now disconnect.

這確實結束了該程式。您現在可以斷開連線。