Liquidia Corp (LQDA) 2022 Q3 法說會逐字稿

Good morning, and welcome, everyone, to the Liquidia Corporation Third Quarter 2022 Financial Results and Corporate Update Conference Call. My name is Abby, and I will be your conference operator today. (Operator Instructions) I would like to remind everyone that this conference call is being recorded.

早上好，歡迎大家參加 Liquidia Corporation 2022 年第三季度財務業績和公司最新動態電話會議。我叫艾比，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, Senior Vice President, Corporate Development and Strategy.

我現在將把電話轉給企業發展和戰略高級副總裁賈森·阿代爾 (Jason Adair)。

Thank you, Abby. It's my pleasure to welcome everyone to Liquidia's Third Quarter 2022 Financial Results and Corporate Update Conference Call. Joining the call today are Chief Executive Officer, Roger Jeffs; Chief Financial Officer, Mike Kaseta; General Counsel, Rusty Schundler; and other members of the Liquidia management team.

謝謝你，艾比。我很高興歡迎大家參加 Liquidia 2022 年第三季度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)；首席財務官 Mike Kaseta；總法律顧問 Rusty Schundler；以及 Liquidia 管理團隊的其他成員。

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 actual results or performance to be materially different from any future results or performance expressed or implied on the 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，這可能導致實際結果或業績與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'd now like to turn the call over to Roger for our prepared remarks, after which we will open the call up for your questions. Roger?

現在，我想將電話轉給羅傑，讓他聽取我們準備好的發言，然後我們將開始電話詢問您的問題。羅傑？

Thank you, Jason. Good morning, everyone, and thank you for joining us. I firmly believe we will look back at the third quarter as a seminal point in our mission to bring YUTREPIA to patients. Notably, and as Rusty will expand upon shortly, we achieved outcomes in our legal proceedings that have simply affirmed on appeal will allow us to launch YUTREPIA as all of the asserted patent claims have been found in at least 1 proceeding to be invalid or not infringed. Our primary goal is to obtain the affirmations of these favorable decisions as quickly as possible so that YUTREPIA can become an important treatment choice for patients, physicians and payers.

謝謝你，傑森。大家早上好，感謝您加入我們。我堅信，回顧第三季度，我們將把第三季度視為我們將 YUTREPIA 帶給患者的使命的一個重要轉折點。值得注意的是，正如 Rusty 將很快展開的那樣，我們在法律訴訟中取得了成果，這些成果只是在上訴中得到確認，這將使我們能夠推出 YUTREPIA，因為所有所主張的專利權利要求已在至少 1 項訴訟中被認定為無效或未侵權。我們的首要目標是盡快獲得這些有利決定的肯定，使 YUTREPIA 能夠成為患者、醫生和付款人的重要治療選擇。

Our drive to get to the market is greatly strengthened by robust patient and physician feedback even after the launch of TYVASO DPI. The 2 primary unique product pillars that resonate firmly with patients and physicians are, one, the high degree of tolerability and associated dose flexibility enabled by our PRINT formulation; and two, the ease of use of the low-resistance device.

即使在 TYVASO DPI 推出後，患者和醫生的強烈反饋也大大增強了我們進入市場的動力。引起患者和醫生強烈共鳴的兩個主要獨特產品支柱是，一是我們的 PRINT 配方實現的高度耐受性和相關的劑量靈活性；第二，低電阻裝置的易用性。

Firstly, with regard to the high degree of tolerability and dose flexibility. We have observed in our open-label extension exposures -- sorry, we have observed in our open-label extension study exposures up to 238.5 micrograms of YUTREPIA, which equates to greater than or equal to 27 breaths of TYVASO, which, as you may know, has a label therapeutic target of only 9 to 12 breaths per session due to tolerability limitations.

首先，關於高度的耐受性和劑量靈活性。我們在開放標籤延伸暴露中觀察到——抱歉，我們在開放標籤延伸研究中觀察到暴露量高達 238.5 微克的 YUTREPIA，這相當於大於或等於 27 次 TYVASO 呼吸，您可能會這樣據了解，由於耐受性限制，每次治療的標籤治療目標僅為 9 至 12 次呼吸。

YUTREPIA's radically different dose profile significantly transforms the therapeutic utility of inhaled treprostinil delivery. Specifically, the ability to modulate YUTREPIA dose over a wide range makes it customizable for a broader spectrum of PAH patients from patients naive to therapy, in place of oral prostacyclin therapy or for patients intolerant to oral prostacyclin therapies, from transitions from other less flexible inhaled therapies and even patients improved from parenteral therapies, given patients will now be able to achieve parenteral-like dose exposures.

YUTREPIA 完全不同的劑量分佈顯著改變了吸入曲前列環素的治療效用。具體來說，在大範圍內調節 YUTREPIA 劑量的能力使其能夠為更廣泛的 PAH 患者進行定制，從初次接受治療的患者，代替口服前列環素治療，或從其他不太靈活的吸入治療過渡到不耐受口服前列環素治療的患者。鑑於患者現在能夠獲得類似腸外劑量的暴露，甚至患者的腸外治療也有所改善。

With this broad and customizable dose profile, it is easy to envision that YUTREPIA can quickly assert itself as the highest utility treprostinil, obviating the need to endure the [rough] specific side effects of oral and parenteral therapy.

憑藉這種廣泛且可定制的劑量分佈，很容易想像 YUTREPIA 可以迅速宣稱自己是最實用的曲前列環素，從而無需忍受口服和腸胃外治療的[粗略]特定副作用。

These dosing benefits are further augmented by the second product pillar of YUTREPIA: the ease of use of the low-resistance dry powder inhaler, a device that is robust to patient misuse scenarios and without specific orientation requirements, either of which could result in poor drug delivery or even spillage from the competitor's high-resistance device. YUTREPIA's device-specific advantages will further strengthen the position of YUTREPIA as the dominant choice.

YUTREPIA 的第二個產品支柱進一步增強了這些劑量優勢：低阻力干粉吸入器的易用性，該設備對於患者誤用情況具有魯棒性，並且沒有特定的方向要求，這兩種情況都可能導致藥物質量不佳競爭對手高阻設備的輸送甚至溢出。 YUTREPIA 的特定設備優勢將進一步鞏固 YUTREPIA 作為主導選擇的地位。

It is important to note that the benefit of a low-resistant device to deliver YUTREPIA also means that the therapy is highly agnostic to the presence of comorbid lung dysfunction. This advantage will be especially relevant in PH-ILD patients who may not have the inspiratory capacity to use a high-resistance device and should further enhance patient uptake of YUTREPIA as a preferred choice in this rapidly expanding market opportunity.

值得注意的是，使用低阻力裝置輸送 YUTREPIA 的好處也意味著該療法對於是否存在共存肺功能障礙具有高度的不可知性。這一優勢對於 PH-ILD 患者尤其重要，因為他們可能沒有吸氣能力來使用高阻裝置，並且應該進一步提高患者對 YUTREPIA 的吸收，將其作為在這個快速擴張的市場機會中的首選。

With these product attributes and benefits, it is easy to envision that YUTREPIA can quickly become the best-in-class and first-in-choice prostacyclin, both in PAH and PH-ILD populations.

憑藉這些產品屬性和優勢，很容易想像 YUTREPIA 能夠迅速成為 PAH 和 PH-ILD 人群中同類最佳和首選的前列環素。

I would now like to turn the call over to Rusty for an update on the legal proceedings. Rusty?

我現在想將電話轉給 Rusty，了解法律訴訟的最新情況。生鏽了？

Thanks, Roger. As Roger mentioned, the path to resolution of the litigation is now clear. The company has now demonstrated through proceedings in the court and the parallel inter partes review proceedings before the Patent Trial and Appeal Board that each of the claims asserted by United Therapeutics against the company are invalid or not infringed. Although the District Court ruled against Liquidia on the '793 patent, that ruling will be overridden by the PTAB decision on the '793 patent if it is affirmed on appeal.

謝謝，羅傑。正如羅傑所提到的，訴訟的解決途徑現在已經明確。該公司現已通過法院訴訟以及專利審判和上訴委員會並行的雙方復審程序證明，United Therapeutics 針對該公司提出的每項權利要求均無效或未侵權。儘管地方法院對 Liquidia 的 '793 專利做出了敗訴，但如果上訴得到確認，該裁決將被 PTAB 對 '793 專利的裁決推翻。

Thus, if the decisions we have received from the District Court and the PTAB are all affirmed on appeal, Liquidia will be able to see final approval of YUTREPIA. We do not need to have any of the decisions overturned.

因此，如果我們從地方法院和 PTAB 收到的裁決均在上訴中得到確認，Liquidia 將能夠看到 YUTREPIA 的最終批准。我們不需要推翻任何決定。

With these decisions in hand, our focus is now on timing. Appeal of the District Court decision on the '901 IPR decision are already underway. United Therapeutics filed a request for a rehearing and a request for Precedential Opinion Panel review of the PTAB's decision regarding the '793 patent. The Precedential Opinion Panel request has already been denied. If the rehearing request is similarly denied, we would anticipate that the appeal of the PTAB's decision on the '793 patent will likely take approximately 12 to 14 months from the date of the denial.

有了這些決定，我們現在的重點是時機。針對地方法院關於“901 IPR 決定”的決定的上訴已經在進行中。 United Therapeutics 提出了重審請求，並請求先例意見小組對 PTAB 關於 '793 專利的決定進行審查。先例意見小組的請求已被拒絕。如果重審請求同樣被拒絕，我們預計，從拒絕之日起，對 PTAB 對 '793 專利的決定提出上訴可能需要大約 12 至 14 個月的時間。

We also note that there are opportunities for this time line to be accelerated. For instance, it is not uncommon for the Federal Circuit to issue summary affirmance of the underlying PTAB decision within days of the oral argument. If this was to occur, that could accelerate our projected time line of the appeal by several months.

我們還注意到，這一時間線有可能加快。例如，聯邦巡迴法院在口頭辯論後幾天內發布對 PTAB 基本決定的簡要確認的情況並不少見。如果發生這種情況，我們預計的上訴時間可能會提前幾個月。

In summary, we remain confident that the conclusion -- at the conclusion of the appeals process, we will be found not to have infringed any valid patent claims, allowing us to seek final approval of YUTREPIA from the FDA. And we will do everything we can to proceed through the appeals process as quickly as possible.

總之，我們對結論仍然充滿信心——在上訴程序結束時，我們將被發現沒有侵犯任何有效的專利聲明，從而使我們能夠尋求 FDA 對 YUTREPIA 的最終批准。我們將盡一切努力盡快完成上訴程序。

I'll now pass the call on to Mike for an overview of our financial report. 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. Our third quarter 2022 financial results can be found in the press release issued earlier today and our Form 10-Q to be filed with the SEC after market closes today. In those documents, you will see that revenue was $3.2 million for the 3 months ended June 30, 2022, (sic) [September 30, 2022,] compared to $3.2 million for the same quarter in 2021. Revenue related primarily to the sale of Treprostinil Injection under the profit split agreement with Sandoz. Unit volume was strong and has increased each quarter since the launch of subcu in second quarter 2021. However, due to a negative adjustment in the gross to net reserves, net revenue decreased slightly compared to last quarter.

謝謝你，Rusty，大家早上好。我們的 2022 年第三季度財務業績可在今天早些時候發布的新聞稿中找到，以及我們將於今天收盤後向 SEC 提交的 10-Q 表格。在這些文件中，您將看到截至 2022 年 6 月 30 日（原文如此）[2022 年 9 月 30 日]的 3 個月的收入為 320 萬美元，而 2021 年同一季度的收入為 320 萬美元。收入主要與銷售曲前列環素注射液根據與山德士的利潤分割協議。自 2021 年第二季度推出 subcu 以來，單位銷量強勁且每個季度都在增加。然而，由於毛儲備與淨儲備的負調整，淨收入與上季度相比略有下降。

Cost of revenue was $0.7 million for the quarter, which was the same compared to the third quarter of 2021.

該季度的收入成本為 70 萬美元，與 2021 年第三季度持平。

Research and development expenses were $4.5 million for the quarter, which was the same compared to the third quarter of 2021. We incurred $1.5 million related to YUTREPIA compared to $1.4 million during the same quarter of the prior year.

本季度的研發費用為 450 萬美元，與 2021 年第三季度相同。我們與 YUTREPIA 相關的費用為 150 萬美元，而上年同期為 140 萬美元。

General and administrative expenses were $6.7 million compared with $4.9 million. The increase of $1.8 million was primarily due to a $2.2 million increase in commercial, marketing and personnel expenses in preparation for the potential commercialization of YUTREPIA offset by a $0.9 million decrease in legal fees related to our ongoing YUTREPIA-related litigation.

一般及行政費用為 670 萬美元，去年同期為 490 萬美元。增加 180 萬美元主要是由於為 YUTREPIA 的潛在商業化做準備而增加了 220 萬美元的商業、營銷和人員費用，抵消了與我們正在進行的 YUTREPIA 相關訴訟相關的法律費用減少 90 萬美元。

Other expenses in the quarter totaled $0.3 million, an increase of $0.1 million over the same quarter last year related to interest expense due to a higher debt balance and interest rate on our debt with Silicon Valley Bank.

本季度其他費用總計 30 萬美元，比去年同期增加 10 萬美元，其中與利息費用相關的費用是由於我們與硅谷銀行的債務餘額和利率較高所致。

All totaled, we incurred a net loss in the third quarter of 2022 of $9.1 million or $0.14 per basic and diluted share compared to a net loss of $7.3 million or $0.14 per basic and diluted share for the third quarter 2021.

總的來說，我們在 2022 年第三季度的淨虧損為 910 萬美元，或每股基本股和稀釋股 0.14 美元，而 2021 年第三季度的淨虧損為 730 萬美元，或每股基本股和稀釋股 0.14 美元。

Turning to our balance sheet. We ended the third quarter with cash and cash equivalents totaling $98.3 million as compared to $57.5 million as of December 31, 2021. We believe that the cash on hand, combined with revenue from Treprostinil Injection, will support operations into 2024.

轉向我們的資產負債表。截至第三季度末，我們的現金和現金等價物總計為 9830 萬美元，而截至 2021 年 12 月 31 日為 5750 萬美元。我們相信，手頭現金加上曲前列環素注射液的收入將支持 2024 年的運營。

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, and thank you, Rusty. At this time, I would now like to open the call for questions. Operator, first question, please.

謝謝你，邁克，謝謝你，拉斯蒂。現在我想開始提問。接線員，第一個問題。

(Operator Instructions) Your first question comes from the line of Greg Harrison from Bank of America.

（操作員說明）您的第一個問題來自美國銀行的 Greg Harrison。

Wondering what is the path to get in PH-ILD on the label? I know you said that no additional studies are required, but just wanted to see what are the logistical steps necessary and the timing that could be expected there.

想知道標籤上的 PH-ILD 是通過什麼途徑獲得的？我知道您說過不需要進行額外的研究，但只是想了解必要的後勤步驟以及預計的時間安排。

Greg, thank you for the question. So as you know, the market exclusivity for TYVASO PH-ILD expires at the -- in March of '24 and we've confirmed with the FDA that no additional studies are required for the expansion of our label to include PH-ILD indication.

格雷格，謝謝你的提問。如您所知，TYVASO PH-ILD 的市場獨占權將於 2024 年 3 月到期，我們已向 FDA 確認，無需進行額外的研究即可將我們的標籤擴展至包括 PH-ILD 適應症。

So for us, what we need to do is submit a request for that approval at an appropriate time in advance of the March '24 deadline. We may also then have to give a safety update that's sort of real-time from our ongoing open-label extension study. But absent that, there's nothing else to do. So no further studies required. It's absolutely an open market for us at the end of the March period if we are granted approval.

因此，對於我們來說，我們需要做的是在 3 月 24 日截止日期之前的適當時間提交批准請求。然後，我們可能還必鬚根據我們正在進行的開放標籤擴展研究提供實時的安全更新。但除此之外，就沒有其他可做的了。所以不需要進一步的研究。如果我們獲得批准，那麼到三月底這對我們來說絕對是一個開放的市場。

Your next question comes from the line of Chris Howerton from Jefferies.

您的下一個問題來自 Jefferies 的 Chris Howerton。

Great. I guess, first, I was curious if we could get any visibility on the generic Remodulin business for next year. Just if there would be any growth expected or if we should again just kind of expect a flat kind of business there.

偉大的。我想，首先，我很好奇我們是否能夠了解明年的仿製藥 Remodulin 業務。只是如果預期會有任何增長，或者我們是否應該再次期待那裡的業務持平。

The second question I had was maybe just kind of a clarification. I'm sorry, it took me a minute to dial into the call, but with respect to United Therapeutics' request for a hearing and if that is, in fact, denied, could you help us understand what the time line might be for an appeal process for them, I think, on the '793 patent.

我的第二個問題也許只是一種澄清。抱歉，我花了一分鐘才撥通電話，但關於 United Therapeutics 提出的聽證會請求，如果事實上被拒絕，您能否幫助我們了解聽證會的時間安排？我認為他們對 '793 專利的上訴程序。

And then if you'll entertain a third question, just curious how you guys are thinking about financing right now going through next year and getting through '24 and beyond.

然後，如果您願意考慮第三個問題，只是好奇你們現在如何考慮明年以及 24 世紀及以後的融資問題。

Great. Thanks for the question. What I'll do is I'll group these for Mike and Rusty answer. So Mike, if you could answer the question about generic Remodulin trajectory and then also how we're looking at financing and then pass it to Rusty to talk about the request for hearing time line.

偉大的。謝謝你的提問。我要做的是將這些分組，以供邁克和拉斯蒂回答。邁克，如果你能回答關於通用 Remodulin 軌蹟的問題，以及我們如何看待融資，然後將其傳遞給 Rusty，討論聽證會時間表的請求。

Yes, absolutely, Roger. So as it relates to generic Remodulin, as we said earlier today, we've seen unit increase on a quarterly basis each quarter since the launch of subcu in Q2 of 2021. We've seen -- we're very happy with the growth in the product, as we said.

是的，絕對是，羅傑。因此，就彷製藥 Remodulin 而言，正如我們今天早些時候所說，自 2021 年第二季度推出 subcu 以來，我們看到每個季度的單位數量都在增加。我們已經看到——我們對增長感到非常滿意正如我們所說，在產品中。

And as we said previously, we really look at generic Remodulin as more of an annuity. So although we're continuing to see that growth, we would not see -- we would not expect to see a significant increase in revenue as we get into 2023 and '24, although it remains a very important, strategic product for us as we prepare to launch for YUTREPIA. But overall, we do look at it as more of an annuity and maybe a flat to modest increase as we look into 2023.

正如我們之前所說，我們實際上將通用 Remodulin 視為更多的年金。因此，儘管我們繼續看到這種增長，但我們不會看到——進入 2023 年和 24 年時，我們不會看到收入大幅增長，儘管它對我們來說仍然是一個非常重要的戰略產品，因為我們準備發射 YUTREPIA。但總體而言，我們確實將其更多地視為年金，並且在展望 2023 年時可能會出現持平或適度增長。

Looking at financing, as we said, we ended the quarter with about $98 million in cash. We feel that, that runway gives us significant -- sufficient capital to get us into 2024. As we've done over the last couple of years, and we will continue to do, is we're going to be opportunistic. We're going to look at any opportunities to bring in both dilutive and nondilutive financing.

在融資方面，正如我們所說，本季度末我們擁有約 9800 萬美元的現金。我們認為，這條跑道為我們提供了重要的——足夠的資本，讓我們能夠進入 2024 年。正如我們在過去幾年所做的那樣，而且我們將繼續這樣做，我們將抓住機會。我們將尋找任何引入稀釋性和非稀釋性融資的機會。

Given where we are right now, we are very confident with our cash position to be able to execute on our objectives for 2023. But at the same time, we will leave no stone unturned in evaluating opportunities. And if we feel there is an opportunity to bring additional capital in that's in the best interest of our shareholders, we will absolutely consider that.

鑑於我們目前的處境，我們對我們的現金狀況非常有信心，能夠實現 2023 年的目標。但與此同時，我們將不遺餘力地評估機會。如果我們認為有機會引入額外資本，這符合我們股東的最佳利益，我們絕對會考慮這一點。

So with that, let me turn it over to Rusty on the rehearing request question.

那麼，讓我把排練請求問題交給 Rusty。

Thanks, Mike, and thanks, Chris, for the question. So as I noted earlier, United Therapeutics requested 2 things in response to the PTAB decision. They asked for a rehearing and they asked for a Precedential Opinion Panel review. The Precedential Opinion Panel review has been denied, which clears the way for the original PTAB panel to now make a ruling on the rehearing request.

謝謝邁克，也謝謝克里斯提出的問題。正如我之前指出的，United Therapeutics 針對 PTAB 的決定提出了兩件事要求。他們要求進行重審，並要求先例意見小組進行審查。先例意見小組的審查已被拒絕，這為原 PTAB 小組現在就重審請求做出裁決掃清了道路。

I think your question primarily relates to then the time line after -- if rehearing request is denied, what does the time line look like after that. We anticipate that the appeals time line will take approximately 12 to 14 months following the denial of the rehearing request. However, that 12- to 14-month period can be accelerated. So as I mentioned earlier, sometimes the Federal Circuit will do something called the summary affirmance where within days after the oral argument they'll issue their decisions rather than taking months to write an opinion.

我認為你的問題主要與之後的時間線有關——如果重審請求被拒絕，之後的時間線是什麼樣的。我們預計，重審請求被拒絕後，上訴時間大約需要 12 至 14 個月。然而，這 12 至 14 個月的期限可以加快。因此，正如我之前提到的，有時聯邦巡迴法院會做一些稱為“摘要確認”的事情，在口頭辯論後幾天內，他們將發布決定，而不是花費數月時間來撰寫意見。

So again, that 12- to 14-month time period. There are opportunities for fairly significant number of months to be taken off that time line. It's something like summary affirmance is supposed to happen. Thanks.

再說一次，12 到 14 個月的時間段。這個時間表有可能會被縮短相當長的幾個月。這就像總結肯定一樣應該發生。謝謝。

Yes. Okay. Got it. And maybe just a slight clarification there, too, is with respect to the POP process, I think you had mentioned to me previously, Rusty, that, that, in fact, could offer some of those synergies. Is that fair? And if true, what would those be in the process?

是的。好的。知道了。也許還有一個關於 POP 流程的輕微澄清，我想你之前曾向我提到過，Rusty，事實上，這可以提供一些協同效應。這公平嗎？如果屬實，那麼這個過程中會發生什麼？

Sorry, can you repeat the question?

抱歉，您能重複一下這個問題嗎？

I'm so sorry, I was trying to cough. The -- I guess my question is the POP denial that we just went through, I think you previously had told me that provides synergies in the process and time efficiencies. Is that kind of what you're talking about here?

對不起，我正想咳嗽。我想我的問題是我們剛剛經歷過的 POP 否認，我想您之前曾告訴過我，這可以在流程和時間效率方面提供協同作用。你在這裡所說的就是這種情況嗎？

No. That's -- it's really a separate process. So I think our view of the Precedential Opinion Panel requests, as we had indicated in our press release several weeks ago, we think that they have directed the original panel to clarify their opinion. We do think that will be helpful in the appeals process, that we think a clearer decision from the PTAB will make the appeals process easier because the Appeals Court will have a clearer decision that they're dealing with.

不，這確實是一個單獨的過程。因此，我認為我們對判例意見小組請求的看法，正如我們在幾週前的新聞稿中所指出的那樣，我們認為他們已指示原始小組澄清他們的意見。我們確實認為這對上訴程序很有幫助，我們認為 PTAB 做出的更明確的決定將使上訴程序變得更容易，因為上訴法院將有一個他們正在處理的更明確的決定。

I don't know that it would necessarily impact the time line. But I think it should make for a better appeals process because, again, the issues will just be much clearer before the Appeals Court as to what the record of the PTAB was.

我不知道這是否一定會影響時間線。但我認為這應該有助於改善上訴程序，因為上訴法院面前的 PTAB 記錄問題會更加清晰。

Your next question comes from the line of Julian Harris (sic) [Julian Harrison] from BTIG.

您的下一個問題來自 BTIG 的 Julian Harris（原文如此）[Julian Harrison]。

Sorry if I missed it just now, but wondering if you have a good sense for the time line for Hatch-Waxman appeals, and in the event that PTAB appeal is denied in your favor with Hatch-Waxman appeal still pending, could you be in a position to launch YUTREPIA at risk?

抱歉，如果我剛才錯過了，但想知道您是否清楚 Hatch-Waxman 上訴的時間表，如果 PTAB 上訴被駁回，且 Hatch-Waxman 上訴仍懸而未決，您是否可以加入推出 YUTREPIA 是否面臨風險？

Yes. Rusty, if you would, please?

是的。魯斯蒂，可以嗎？

Sure. So we do not need the Hatch-Waxman appeal to be resolved before we would be able to launch. So if, for instance, the '793 appeal was resolved first and it was affirmed, that's all we would need to then seek final approval from the FDA.

當然。因此，我們無需解決 Hatch-Waxman 上訴即可啟動。因此，例如，如果“793”上訴首先得到解決並得到確認，那麼我們就需要尋求 FDA 的最終批准。

Now obviously, the outcome of the appeal of the Hatch-Waxman would still be relevant. But from a time line perspective, getting to an appeals decision in the Hatch-Waxman case is not a part of the time line.

現在顯然，哈奇-瓦克斯曼案的上訴結果仍然具有相關性。但從時間線的角度來看，哈奇-韋克斯曼案的上訴判決並不屬於時間線的一部分。

Your next question comes from the line of Matt Kaplan from Ladenburg.

您的下一個問題來自拉登堡的馬特·卡普蘭。

Can you give us some sense of the feedback you've been getting and response from doctors, I guess, to the data that you'd presented, I guess, most recently at the CHEST meeting and how that plays into your plans to -- your commercialization preparation plans from here to approval.

您能給我們一些關於您最近在 CHEST 會議上提供的數據的反饋和醫生的反應嗎？我想，以及這對您的計劃有何影響——您的商業化準備計劃從這裡到批准。

Yes. Happy to do that. So I'll maybe start with the answer and then I'll ask our CMO, Dr. Rajeev Saggar, to also opine.

是的。很高興這樣做。所以我可能會從答案開始，然後我會請我們的首席營銷官 Rajeev Saggar 博士也發表意見。

So we presented 2 abstracts at CHEST. One was on the robustness of our device, particularly the patient misuse scenarios, for example, patients dropping the device inadvertently. And we showed that it was highly robust and didn't result in any product spillage. And we also presented longer-term extension data for patients who had gone out to 2 years. And the importance of that data, in essence, was that we're showing higher dose exposures, as we said in the opening, up to 238.5 micrograms, which would be 27 breath equivalents per session of TYVASO. So sort of a completely new modality of treatment with YUTREPIA versus TYVASO, in particular, the nebulized formulations. And the advantage of that is that there's great acknowledgment that dose is important.

因此，我們在 CHEST 上展示了 2 篇摘要。一是我們設備的穩健性，特別是患者誤用情況，例如患者無意中掉落設備。我們證明它非常堅固，不會導致任何產品溢出。我們還提供了延長至 2 年患者的長期數據。從本質上講，這些數據的重要性在於，我們顯示了更高的劑量暴露，正如我們在開頭所說的那樣，高達 238.5 微克，相當於每次 TYVASO 治療的 27 呼吸當量。與 TYVASO 相比，YUTREPIA 是一種全新的治療方式，特別是霧化製劑。這樣做的好處是，人們普遍認識到劑量的重要性。

And I think the other thing it does, which we tried to talk to in the opening, is that it's going to avail itself to a broader reach of patients across a greater continuum and we think can help displace oral therapy. So as an example, I think just last week, United Therapeutics' press release, what they called the EXPEDITE study, and that study used parenteral induction to get patients to clinically impactful oral doses.

我認為它所做的另一件事，我們在開場時試圖談論的，是它將在更大的連續體中惠及更廣泛的患者，我們認為可以幫助取代口服治療。舉個例子，我想就在上週，聯合治療公司的新聞稿，他們稱之為 EXPEDITE 研究，該研究使用腸外誘導來讓患者獲得具有臨床影響的口服劑量。

So to me, what that study acknowledged was that dose is important because what they were trying to do is drive dose for oral by using a 3- to 8-week induction period, both in the hospital and out of hospital. So a rigorous induction. It also is an admission that titration to an efficacious dose on oral is problematic. So I think dose is important in that study because the need to do a parenteral induction speaks to the fact that getting to an efficacious dose on oral is problematic.

所以對我來說，該研究承認劑量很重要，因為他們試圖通過使用 3 至 8 週的誘導期（無論是在醫院還是在醫院外）來驅動口服劑量。所以嚴格歸納。這也承認口服有效劑量的滴定是有問題的。因此，我認為劑量在該研究中很重要，因為需要進行腸胃外誘導，這說明口服達到有效劑量是有問題的。

The fact that it took 8 weeks to ramp and was done, as I said, sometimes as an inpatient shows you how sort of cumbersome just doing that would be. And then the transition from that induction on parental back to oral, again, took 1 to 3 weeks, again, including inpatient studies so -- inpatient transition. And then interestingly, during the induction, which was supposed to solve to get patients to dose, patients experienced headache, nausea and vomiting. So GI distress, which is -- which they were greatly trying to obviate through induction.

事實上，正如我所說，有時作為一名住院病人，它花了 8 週的時間才完成，這表明僅僅這樣做是多麼麻煩。然後，從父母誘導過渡到口服誘導，再次需要 1 到 3 週的時間，包括住院患者的研究——住院患者的過渡。有趣的是，在誘導期間（本應解決讓患者服藥的問題），患者出現了頭痛、噁心和嘔吐。因此，他們極力試圖通過引產來避免胃腸道不適。

So to me, that is a perfect example and a relevant publication to show the value of YUTREPIA and how it can be used both early in the treatment course as the first choice and best choice prostacyclin.

所以對我來說，這是一個完美的例子和相關出版物，展示了 YUTREPIA 的價值以及如何在治療過程的早期將其用作首选和最佳前列環素。

And Rajeev, maybe I could pass it over to you for some of your comments on the clinical presentation at the conference.

Rajeev，也許我可以將其轉交給您，請您對會議上的臨床演示發表一些評論。

Yes. Thanks, Roger. Thanks, Matt, for the question. I think you explained the 2 clinical abstracts that we had presented. But I think I'll take this time to maybe talk about a little bit how we can springboard off these exciting learnings from not only our published INSPIRE data, but also our ongoing INSPIRE open-label extension study in addition to the device robustness that Roger just talked about. And really understand that over the next year and prior to launch, we'll be definitely moving forward with several sort of Phase IV-esque like clinical studies, really focusing our positioning YUTREPIA as the highest utility and best-in-class and first-of-choice prostacyclin therapy across PAH that will maximize our experience for this launch.

是的。謝謝，羅傑。謝謝馬特提出的問題。我認為您解釋了我們提出的 2 份臨床摘要。但我想我會花點時間談談我們如何從我們發布的 INSPIRE 數據以及我們正在進行的 INSPIRE 開放標籤擴展研究以及 Roger 所研究的設備穩健性中獲得這些令人興奮的知識。剛剛談到。並且真正了解，在明年和發布之前，我們肯定會推進幾種類似 IV 期的臨床研究，真正將我們的定位 YUTREPIA 定位為最高實用性、一流和一流的 -針對 PAH 的首選前列環素療法將最大限度地提高我們在此次發布中的經驗。

And in particular, we would like to focus on studies utilizing concepts from these learnings, including sort of rapid and high-dose titration strategies to improve clinical risk profiles, improve exercise capacity that is customizable to treat various severities as well as low, as well as intermediate and high-risk strata inclusive of incident and prevalent patients with pulmonary hypertension.

特別是，我們希望重點關注利用這些知識中的概念進行的研究，包括某種快速和高劑量滴定策略，以改善臨床風險狀況，提高可定制的運動能力，以治療各種嚴重程度以及低程度的疾病作為中危和高危階層，包括肺動脈高壓的發病患者和患病患者。

And finally, we'll also focus on gaining real-world experience using YUTREPIA on patients with pulmonary hypertension associated with interstitial lung disease, all to prepare us for our pending launch. Back to you, Roger.

最後，我們還將專注於獲得使用 YUTREPIA 治療與間質性肺病相關的肺動脈高壓患者的實際經驗，所有這些都是為了我們即將推出的產品做好準備。回到你身上，羅傑。

Thank you, Rajeev. I think what you're saying, and we appreciate the question, Matt, is the importance of dose and the flexibility that YUTREPIA ports to all different kinds of patients we think really will establish it again as the best choice and the first choice. And thank you for the question, Matt.

謝謝你，拉吉夫。我認為你所說的，我們理解這個問題，馬特，是劑量的重要性以及 YUTREPIA 為所有不同類型的患者提供的靈活性，我們認為真的將再次將其確立為最佳選擇和首選。謝謝你的提問，馬特。

(Operator Instructions) Your next question comes from the line of Serge Belanger from Needham & Company.

（操作員說明）您的下一個問題來自 Needham & Company 的 Serge Belanger。

A few, mostly on the ongoing legal processes. I guess for Rusty, when do you expect to hear a decision from PTAB on the rehearing request?

其中一些，主要是關於正在進行的法律程序。我猜 Rusty 預計什麼時候能聽到 PTAB 對重審請求的決定？

And you talked about a potential 12- to 14-month process for the appeals. Just curious, when would you expect some visibility on whether that 12- to 14-month time line could be reduced?

您談到了可能需要 12 至 14 個月的上訴流程。只是好奇，您預計什麼時候可以看到 12 至 14 個月的時間線是否可以縮短？

And then lastly, on the appeals for the District Court ruling, just give us some time lines on that.

最後，關於對地方法院裁決的上訴，請給我們一些時間表。

Thanks, Serge. So to go through the 3 questions in order. So as to when we expect the rehearing request decision, as I think we may have said on prior calls, the PTAB's internal goal for processing rehearing requests is 1 month from the date the rehearing request was submitted. Obviously, at this point, we're 2.5 months, almost 3 months from the date of the submission. With the Precedential Opinion Panel decision having now come down, the path is cleared for the PTAB -- the original PTAB panel to make a final decision on the rehearing request.

謝謝，塞爾日。因此，請按順序回答 3 個問題。至於我們預計何時做出重審請求決定，正如我認為我們可能在之前的電話會議中說過的那樣，PTAB 處理重審請求的內部目標是自提交重審請求之日起 1 個月內。顯然，此時距離提交日期還有 2.5 個月，差不多 3 個月了。隨著先例意見小組的決定現已作出，PTAB（最初的 PTAB 小組）就重審請求做出最終決定的道路已經掃清。

So our hope is it's within the next few weeks, but we don't have visibility as to that process. And as evidenced by our experience with the '901 patent, in that instance, it took the PTAB panel 7 months before they issued a rehearing decision. So again, our hope is it's weeks, but we don't have visibility as to that process.

因此，我們希望在接下來的幾週內完成，但我們無法了解該過程。正如我們在 '901 專利方面的經驗所證明的那樣，在這種情況下，PTAB 專家組花了 7 個月才發布複審決定。再說一遍，我們希望這需要幾週的時間，但我們無法了解該過程。

Second, as far as the -- when we would know whether the 12- to 14-month time period I described could be shortened, that is unclear. So for instance, if it's a summary affirmance, if that's one of the things that would shorten time periods, we won't know that until the decision is made. There's no -- you don't get any sort of indication in advance that you're going to get a summary affirmance. So we would go into the oral argument and then 3 days later an opinion would come down, and that's when we would know. So it would be at the very end of the time period. Suddenly it would just be over instead of waiting a few months for an opinion. So again, we won't know necessarily in advance when that -- when and if that time period will be shortened.

其次，至於我們何時知道我所描述的 12 至 14 個月的時間段是否可以縮短，目前還不清楚。例如，如果這是一個總結性的確認，如果這是可以縮短時間的事情之一，那麼在做出決定之前我們不會知道這一點。沒有——你不會提前得到任何形式的指示，表明你將得到概要確認。所以我們會進行口頭辯論，三天后就會得出意見，那時我們就會知道。所以這將是在該時間段的最後。突然之間，事情就結束了，而不是等待幾個月的意見。再說一次，我們不一定會提前知道這個時間段何時以及是否會縮短。

Finally, on the appeals from the District Court, there as well we think it's a 12- to 14-month process from the date the notice of appeal is filed. Our initial notice of appeal was filed in early to mid-September. So again, we think 12 to 14 months is a reasonable time period from then. So that would put it some time to third to fourth quarter next year.

最後，關於地方法院的上訴，我們認為自提交上訴通知之日起，該過程需要 12 至 14 個月的時間。我們的初步上訴通知是在九月初至中旬提交的。因此，我們再次認為從那時起 12 至 14 個月是一個合理的時間段。因此，這將為明年第三至第四季度帶來一些時間。

The one thing I'd note is in the Hatch-Waxman context, summary affirmance is far less likely. And in fact, because there we'd be hoping to overturn a decision, you can't get a summary affirmance if something is to be overturned. So there wouldn't necessarily be the same opportunities for that time line to be shortened as there are for the PTAB appeal. Thanks.

我要注意的一件事是，在哈奇-維克斯曼的背景下，總結肯定的可能性要小得多。事實上，因為我們希望推翻某個決定，所以如果要推翻某件事，你無法得到概括的肯定。因此，不一定有像 PTAB 上訴那樣縮短時間的機會。謝謝。

Thank you, Rusty, for that clarification.

謝謝你，拉斯蒂，的澄清。

There are no further questions at this time. Mr. Roger Jeffs, I turn the call back over to you.

目前沒有其他問題。羅傑·傑夫斯先生，我將電話轉回給您。

Great. Thank you, Abby. So with no further questions, again, we thank you for joining us today and look forward to reporting our continued progress in the coming quarters.

偉大的。謝謝你，艾比。因此，沒有其他問題，我們再次感謝您今天加入我們，並期待報告我們在未來幾個季度的持續進展。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連接。