Beyond Air Inc (XAIR) 2024 Q1 法說會逐字稿

Good afternoon, and welcome, everyone, to the Beyond Air financial results call for the fiscal quarter ended June 30, 2023. (Operator Instructions)

下午好，歡迎大家參加 Beyond Air 截至 2023 年 6 月 30 日的財政季度的財務業績電話會議。（運營商說明）

And now, I would like to turn the call over to Edward Barger, Head of Investor Relations at Beyond Air. Please go ahead.

現在，我想將電話轉給 Beyond Air 投資者關係主管 Edward Barger。請繼續。

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the fiscal first-quarter 2024 operational highlights and financial results. A copy of this press release can be found on our website, www.beyondair.net, under the News and Events section.

謝謝你，接線員。大家下午好，感謝您加入我們。今天收盤後，我們發布新聞稿，宣布 2024 年第一財季的運營亮點和財務業績。您可以在我們的網站 www.beyondair.net 的“新聞和活動”部分找到本新聞稿的副本。

Before we begin, I would like to remind everyone that we've been making comments and various remarks about future expectations, plans, and prospects, which constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

在開始之前，我想提醒大家，我們一直在對未來的預期、計劃和前景做出評論和各種評論，這些評論和言論構成了《私人證券訴訟改革法案》安全港條款中的前瞻性陳述。 1995 年。

Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the SEC including, without limitation, the company's most recent Form 10-K and Form 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Beyond Air 警告稱，這些前瞻性陳述存在風險和不確定性，可能導致實際結果與所示結果存在重大差異。我們鼓勵每個人審查公司向SEC 提交的文件，包括但不限於公司最新的表格10-K 和表格10-Q，其中確定了可能導致實際結果或事件與前言中描述的結果或事件存在重大差異的具體因素看起來的陳述。

Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 10, 2023. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

此外，本次電話會議正在錄製中，並將在我們的網站 www.beyondair.net 上進行音頻重播。此外，本次電話會議的內容包含時間敏感信息，僅截至直播日期（2023 年 8 月 10 日）準確。Beyond Air 不承擔修改或更新任何聲明以反映該日期之後的事件或情況的義務這次通話的。

Joining me today on the call are Steve Lisi, Chairman and Chief Executive Officer; Duncan Fatkin, Chief Commercial Officer; and Douglas Larson, Chief Financial Officer. And with that, I'll turn the call over to Steve Lisi. Steve?

今天與我一起參加電話會議的還有董事長兼首席執行官 Steve Lisi；鄧肯·法特金，首席商務官；道格拉斯·拉爾森（Douglas Larson），首席財務官。接下來，我會將電話轉給 Steve Lisi。史蒂夫？

Thanks, Ed, and good afternoon to everyone joining us today. Since it's only been about six weeks from the last time we spoke, we'll keep the prepared remarks short today.

謝謝埃德，今天加入我們的大家下午好。由於距我們上次講話僅過去了大約六週，因此我們今天將準備簡短的發言。

LungFit PH continues to be well-received in the market, and we have begun Phase 2 of the commercial launch. We're very happy to report that we have now in excess of $1 million in contracted annual revenue, though only a small portion of these revenues were recognized in the June quarter.

LungFit PH 繼續受到市場好評，我們已經開始第二階段的商業發布。我們非常高興地報告，我們現在的合同年收入已超過 100 萬美元，儘管這些收入中只有一小部分是在六月季度確認的。

We continue to match our momentum in the marketplace with the thoughtful expansion of our commercial team. Our Chief Commercial Officer will discuss this further in a few minutes.

我們將繼續通過深思熟慮的擴展我們的商業團隊來保持我們在市場上的勢頭。我們的首席商務官將在幾分鐘內進一步討論這個問題。

We provided a thorough review of our pipeline during the last call. Everything continues to be on track. Before turning the call over to Duncan, I'll reiterate a few near-term catalysts and highlights.

我們在上次通話期間對我們的管道進行了徹底的審查。一切都繼續步入正軌。在將電話轉給鄧肯之前，我將重申一些近期的催化劑和亮點。

By the end of the calendar year, we expect to submit a PMA supplement to FDA for the LungFit PH cardiac label expansion, receive CE mark in the EU, and present data from Beyond Cancer's first in-human trial. Additionally, following agreement with FDA, we will be conducting a pilot study in viral community-acquired pneumonia in the United States this winter.

到今年年底，我們預計將向 FDA 提交用於 LungFit PH 心臟標籤擴展的 PMA 補充，在歐盟獲得 CE 標誌，並提供 Beyond Cancer 首次人體試驗的數據。此外，根據與 FDA 的協議，我們將於今年冬天在美國進行病毒性社區獲得性肺炎的試點研究。

Now I will turn the call over to our Chief Commercial Officer, Duncan Fatkin, for an update on the LungFit PH commercial launch. Duncan?

現在我將把電話轉給我們的首席商務官 Duncan Fatkin，了解 LungFit PH 商業發布的最新信息。鄧肯？

Thanks, Steve, and good afternoon to our investors. As Steve mentioned, we have eclipsed the $1 million mark for signed annual contracts. We're very pleased with the momentum our team is building as we progress with Phase 2 of our launch.

謝謝史蒂夫，我們的投資者下午好。正如 Steve 提到的，我們簽訂的年度合同已突破 100 萬美元大關。我們對我們的團隊在推出第二階段的進展中所形成的勢頭感到非常滿意。

The overall feedback from hospitals regarding LungFit PH continues to be extremely positive. And we would, again, like to thank all the hospitals and clinical staff that have partnered with us and committed to using our device.

醫院對 LungFit PH 的總體反饋仍然非常積極。我們要再次感謝所有與我們合作並致力於使用我們設備的醫院和臨床工作人員。

Our plan is to build out our field team based on the opportunities developed over the past year and the growing interest in LungFit PH as we broaden our reach. These additions will be carefully targeted and designed to ensure a strong and sustainable foundation for growth.

我們的計劃是根據過去一年中開發的機會以及隨著我們擴大業務範圍而對 LungFit PH 日益增長的興趣來建立我們的現場團隊。這些新增內容將經過仔細的針對性和設計，以確保為增長奠定堅實和可持續的基礎。

We also expect to add to the team pending the anticipated cardiac label expansion, which we expect to significantly expand our reach in the hospital. We have planned for a thoughtful and measured increase in the size of our team through to the approval of our next-generation LungFit PH, which is anticipated in calendar year 2025.

我們還希望在預期的心臟標籤擴展之前增加團隊成員，我們預計這將顯著擴大我們在醫院的影響力。我們計劃在下一代 LungFit PH 獲得批准之前，對我們的團隊規模進行深思熟慮和審慎的擴大，預計將於 2025 年獲得批准。

In closing, we are confident that LungFit PH is the best-in-class nitric oxide technology available today. And we continue to be excited by the support we have received from hospitals throughout the US. I'm looking forward to providing updates on progress in the upcoming quarters.

最後，我們相信 LungFit PH 是當今同類最佳的一氧化氮技術。我們繼續對來自美國各地醫院的支持感到興奮。我期待在接下來的幾個季度提供最新進展情況。

With that, I will turn the call over to Doug Larson, our Chief Financial Officer, to provide an overview of our financial results for the fiscal quarter ended June 30, 2023. Doug?

接下來，我將把電話轉給我們的首席財務官道格·拉爾森 (Doug Larson)，他將概述我們截至 2023 年 6 月 30 日的財政季度的財務業績。道格？

Thanks, Duncan, and good afternoon, everyone. Our financial results for the fiscal quarter ended June 30, 2023 are as follows.

謝謝鄧肯，大家下午好。我們截至 2023 年 6 月 30 日的財政季度的財務業績如下。

Revenue for the fiscal quarter was $0.1 million as compared with zero for the fiscal quarter ended June 30, 2022. Research and development expenses for the fiscal quarter ended June 30, 2023, were $4.7 million compared with $3.2 million for the fiscal quarter ended June 30, 2022. The $1.5 million increase was due to an increase in headcount and incremental research mainly in cancer and autism.

本財季的收入為10 萬美元，而截至2022 年6 月30 日的財季收入為零。截至2023 年6 月30 日的財季的研發費用為470 萬美元，而截至6 月30 日的財季為320 萬美元。 ，2022 年。增加 150 萬美元是由於人員數量的增加以及主要針對癌症和自閉症的研究的增量。

SG&A expenses for the fiscal quarter were $10.9 million, compared with $8.2 million for the fiscal quarter ended June 30, 2022. Almost all of the $2.7 million increase was due to salaries, as additional headcount is needed to scale operations in the field and in the back office.

本財季的銷售、管理及行政費用為1,090 萬美元，而截至2022 年6 月30 日的財季為820 萬美元。270 萬美元的增長幾乎全部來自工資，因為需要增加人員來擴大現場和區域運營規模。後台。

Other income and expense for the fiscal quarter showed a $0.8 million gain compared with a $0.2 million loss for the fiscal quarter ended June 30, 2022. The gain this year was mainly driven by the remeasurement of warrants and derivatives associated with our long-term debt.

與截至2022 年6 月30 日的財季虧損20 萬美元相比，本財季的其他收入和支出增加了80 萬美元。今年的收益主要是由於重新計量與我們的長期債務相關的認股權證和衍生品所致。

For the fiscal quarter ended June 30, 2023, the company recorded a net loss of $15.1 million, of which $14.1 million or $0.45 per share was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $10.9 million or $0.37 a share for the fiscal quarter ended June 30, 2022.

截至2023 年6 月30 日的財季，該公司錄得淨虧損1,510 萬美元，其中1,410 萬美元或每股0.45 美元歸屬於Beyond Air, Inc. 股東，而淨虧損為1,090 萬美元或每股0.37美元截至 2022 年 6 月 30 日的財政季度的每股收益。

Net cash used by the company, excluding one-time expenses, was $10.6 million during the fiscal quarter. We forecast our average quarterly cash burn to be approximately $10 million per quarter as we move through fiscal 2024.

該公司在本財季使用的淨現金（不包括一次性費用）為 1060 萬美元。我們預計，到 2024 財年，我們的平均季度現金消耗約為 1000 萬美元。

In June 2023, up to $40 million in debt financing was provided to the company by Avenue Capital, of which $17.5 million in gross funds were drawn in the quarter. As of June 30, 2023, the company had cash, cash equivalents, and marketable securities of $57 million.

2023 年 6 月，Avenue Capital 向該公司提供了高達 4000 萬美元的債務融資，其中本季度提取的資金總額為 1750 萬美元。截至2023年6月30日，該公司擁有現金、現金等價物和有價證券為5700萬美元。

And with that, I'll hand the call back to Steve.

然後，我會將電話轉回給史蒂夫。

Thanks, Doug. We will now take any questions you may have.

謝謝，道格。我們現在將回答您可能提出的任何問題。

(Operator Instructions) Les Sulewski, Truist Securities.

（操作員指令）Les Sulewski，Truist Securities。

Hi, good afternoon. Thanks for taking my questions, and congrats on the progress, guys.

嗨，下午好。感謝你們提出我的問題，並祝賀你們取得的進展。

Just to confirm, the $1 million is now the annual base. And then can you quantify the market opportunity out there that's remaining over the remaining of this year? Do you have a sense of how many hospitals are out there near end of contracts with a competing product that are marked in your book for an opportunity to convert? And I have a follow-up.

需要確認的是，100 萬美元現在是年度基數。然後您能否量化今年剩餘時間內剩餘的市場機會？您是否知道有多少家醫院與競爭產品的合同即將結束，並且在您的書中標記了轉換機會？我有一個後續行動。

Thanks, Les. Appreciate it. So yeah, I guess, the $1 million is the base. But that would not be starting at the beginning of this fiscal year, so it wouldn't be a start from April 1. It would be a start from this quarter when we obviously sign the contracts to get us above that level. So I just want to be clear on that.

謝謝，萊斯。欣賞它。所以，是的，我想，100 萬美元是基礎。但這不會從本財年年初開始，因此也不會從 4 月 1 日開始。這將從本季度開始，屆時我們顯然會簽署合同，使我們高於這一水平。所以我只想澄清這一點。

Yeah. Look, I don't think that we're going to really reveal how many hospitals we're speaking to right now and what it looks like for the rest of the fiscal year in terms of opportunities for us. I don't think we want to share that information. But I do think that we will be in a position when we report our next quarter in November to give you some guidance on that and probably some guidance for our anticipated revenues for the full year.

是的。聽著，我認為我們不會真正透露我們現在正在與多少家醫院交談，以及本財年剩餘時間裡我們的機會是什麼樣的。我認為我們不想分享這些信息。但我確實認為，當我們在 11 月份報告下一個季度時，我們將能夠為您提供一些相關指導，並可能為我們全年的預期收入提供一些指導。

Got it. I understand. And then on the cardiac label expansion opportunity, what size is that potential to TAM? I mean, is that essentially kind of calculated into your figures that you initially rolled out, or is there more to the story here? Just kind of walk us through the high-level overview of what you think of the cardiac label expansion. Thank you.

知道了。我明白。然後，關於心臟標籤擴展機會，TAM 的潛力有多大？我的意思是，這基本上是計算到您最初推出的數據中的，還是這裡還有更多的故事？請向我們簡要介紹一下您對心臟標籤擴展的看法。謝謝。

Okay. So cardiac surgeries, nitric oxide use there, it's the biggest of all the, I guess, subcategories for use of nitric oxide in the hospital would be cardiac surgeries. So I think it's very important to get this label expansion.

好的。因此，心臟手術中一氧化氮的使用，我猜，醫院中使用一氧化氮的最大子類別是心臟手術。所以我認為這個標籤的擴展非常重要。

It will help us to have access into an area that's exclusively now off-label. So that's an area where we don't market and we don't detail. So that's certainly going to open things up in a good way, I would think.

它將幫助我們進入一個目前完全屬於標籤外的領域。所以這是一個我們不做營銷也不做細節的領域。所以我認為這肯定會以一種好的方式打開局面。

Great. Thank you.

偉大的。謝謝。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hi, good afternoon. Thank you for taking the questions. Now that we have revenue, I want to try to understand how many contracts were signed, how many hospitals now have LungFit PH -- any details on contract value and length of some of these contracts. Just any additional detail you can offer at this time would be really helpful.

嗨，下午好。感謝您提出問題。現在我們有了收入，我想嘗試了解簽署了多少份合同，現在有多少家醫院擁有 LungFit PH - 有關合同價值和其中一些合同期限的任何詳細信息。此時您可以提供的任何其他詳細信息都會非常有幫助。

Sure, Marie. Probably not too much, but most of the contracts are annual contracts. Sometimes, they renew for two years -- another year or three years. But we haven't said -- I don't think there's too many contracts beyond three years out there, but there might be a few, not for us, but perhaps for others.

當然，瑪麗。可能不是太多，但大多數合同都是年度合同。有時，它們會續簽兩年——再續簽一年或三年。但我們還沒有說過——我不認為有太多超過三年的合同，但可能會有一些，不是給我們的，但可能是給其他人的。

Again, we're not really discussing the number of hospitals we have. There are multiple hospitals. There's plenty for us to get plenty of feedback from our customers that they're very happy with our service and with the product. But we're not going to give an exact number. I apologize for that.

再說一遍，我們並不是在真正討論我們擁有的醫院數量。有多家醫院。我們可以從客戶那裡獲得大量反饋，他們對我們的服務和產品非常滿意。但我們不會給出確切的數字。我對此表示歉意。

I'm not really sure how much really more we want to say. It is a competitive environment. So we're kind of keeping things close to the vest, if you can understand that. There are other people listening.

我不太確定我們還想說多少。這是一個競爭環境。所以我們對事情保密，如果你能理解的話。還有其他人在聽。

Of course. Okay. And maybe I can ask about gross margins. It's not surprising, of course, that they're negative to start this early in the launch.

當然。好的。也許我可以詢問毛利率。當然，他們對這麼早就開始發布持否定態度並不奇怪。

But how do you think about that flipping positive? What's sort of the right level to think about for gross margins and those COGs in the first year of expansion? Thanks for taking the questions.

但你如何看待這種積極的轉變？在擴張的第一年，考慮毛利率和 COG 的正確水平是多少？感謝您提出問題。

So this is Doug. I can jump in with that one. In the next couple quarters, at least, that gross margin is going to turn positive. The drivers behind that are actually the devices that we're producing. We're starting to depreciate them, so there's some costs there for devices that aren't actually deployed yet.

這就是道格。我可以加入那個。至少在接下來的幾個季度，毛利率將轉正。其背後的驅動程序實際上是我們正在生產的設備。我們開始對它們進行折舊，因此尚未實際部署的設備會產生一些成本。

And then setting up our supply chain infrastructure so that we can expand across the US for wherever we have an opportunity. So those are basically the fixed costs, if you will, that are going to be absorbed very quickly as we expand. So again, my expectation is that either next quarter or the following quarter, we'll be in positive territory.

然後建立我們的供應鏈基礎設施，以便我們可以在美國任何有機會的地方進行擴張。所以這些基本上是固定成本，如果你願意的話，隨著我們的擴張，這些成本將很快被吸收。因此，我的預期是，無論是下個季度還是下個季度，我們都將處於積極的狀態。

Thank you for that.

謝謝你。

Scott Henry, ROTH Capital.

斯科特·亨利，羅斯資本。

Thank you, and good afternoon. A couple questions. First, with regards to selling expenses, I guess, what would you estimate the quarterly selling expenses are today, and where would they be at peak? Just trying to get a sense of how much it costs to market, pay all the reps, how we should think about that number.

謝謝你，下午好。有幾個問題。首先，關於銷售費用，我想，您估計今天的季度銷售費用是多少，峰值會在哪裡？只是想了解一下營銷成本、支付所有銷售代表的費用，我們應該如何考慮這個數字。

So Scott, there is an industry standard for a fully loaded rep, so I'm sure you know that. You've been modeling this for a long time.

斯科特，滿載代表有一個行業標準，所以我相信你知道這一點。你已經為此建模很長時間了。

We're certainly on the low end of things. We just started our second phase where we're starting to bring more people in and hire them. So from a pure headcount, we're probably around 15 people or so on the commercial side and growing.

我們確實處於低端。我們剛剛開始第二階段，開始引進更多的人並僱用他們。因此，從純粹的員工人數來看，我們在商業方面大約有 15 名左右的員工，而且還在不斷增長。

And that number is probably going to get up well north of 50, probably close to 70, 75 people at peak. And that peak will probably be two to three years from now, depending on how quickly we bring people in. So it's not going to be a very rapid expansion.

這個數字可能會遠遠超過 50 人，高峰時可能接近 70 人、75 人。這個高峰可能會在兩到三年後出現，具體取決於我們引進人員的速度。所以擴張不會非常快。

But I would say to use that industry average is a good number. Because not all those people that I've mentioned in those numbers will be reps. But when we get out to peak, the vast majority will be reps.

但我想說，使用行業平均水平是一個很好的數字。因為並非所有我在這些數字中提到的人都會成為代表。但當我們達到頂峰時，絕大多數將成為代表。

Right now, it's a much lower ratio for reps to others. Because we really need our clinical specialists, the respiratory therapists, so ones that are out there training in the hospitals that are working with us, right? So we need to train in the beginning. It's very important to have the customer service level very high, and the reps will be expanded later.

目前，代表與其他人的比例要低得多。因為我們確實需要我們的臨床專家、呼吸治療師，所以那些在與我們合作的醫院接受培訓的人，對嗎？所以我們需要在一開始就進行訓練。擁有非常高的客戶服務水平非常重要，稍後將擴大代表範圍。

Okay, great. That's helpful. And then the $57 million of cash, how much of that is in Beyond Cancer? Just so I get a sense of the net cash you have.

好的，太好了。這很有幫助。那麼 5700 萬美元的現金，其中有多少是在 Beyond Cancer 中呢？只是為了讓我了解一下你擁有的淨現金。

About 30% or so. About a third, maybe.

大約30%左右。也許大約是三分之一。

Okay, thank you. And then when we think about this burn of kind of $10 million a quarter, and at the same time, you'll be expanding sales, would it be safe to say this is kind of the low point?

好的謝謝。然後，當我們考慮每季度燒掉 1000 萬美元，同時您將擴大銷售額時，可以肯定地說這是最低點嗎？

And by low point, I mean, this is where the burn is going to max out. You probably -- as you add sales, you'll also be bringing in gross profit. So I mean, should we think about this being the maximum burn, decreasing maybe not this year but soon thereafter?

我的意思是，這裡是燃燒達到最大程度的最低點。當您增加銷售額時，您可能還會帶來毛利潤。所以我的意思是，我們是否應該認為這是最大的燃燒，可能不是今年而是此後不久減少？

Yes and no, Scott. I mean, it does depend on what we do with our pipeline. So if we move into a pivotal study in calendar 2025, whether that be for pneumonia and/or NTM, we're going to spend. So that's going to cost money. But obviously, it would be for a very good reason.

是的，也不是，斯科特。我的意思是，這確實取決於我們如何處理我們的管道。因此，如果我們在 2025 年進行一項關鍵研究，無論是針對肺炎和/還是 NTM，我們都會投入資金。所以這需要花錢。但顯然，這是有充分理由的。

We've done four pneumonia studies that have worked. We're entering our fifth pneumonia study in a few months. We would expect the number five to look just like the first four in terms of overall efficacy and safety profile. So with that kind of confidence going into a pivotal study, we're going to spend money on it.

我們已經進行了四項有效的肺炎研究。幾個月內我們將進入第五項肺炎研究。我們預計第五個藥物在整體功效和安全性方面與前四個藥物一樣。因此，帶著對關鍵研究的信心，我們將在上面花錢。

We don't know how big it will be yet. We're still waiting to get this last study done and speak with the FDA. But I can't say that those costs wouldn't force us to spend more money than $10 million in one quarter. I just don't know. But if we're not running pivotal studies, then, yeah, you're right.

我們還不知道它會有多大。我們仍在等待完成最後一項研究並與 FDA 交談。但我不能說這些成本不會迫使我們在一個季度內花費超過 1000 萬美元。我只是不知道。但如果我們不進行關鍵研究，那麼，是的，你是對的。

Okay. And that leads into kind of a bigger-picture question for you and the Board from the standpoint of, is there any concern that you might cast too wide a net?

好的。從這個角度來看，這給您和董事會帶來了一個更大的問題：是否擔心您可能撒得太廣？

I mean, a lot of these programs are great. But it's the working capital problem a new business often faces that -- if you stretch yourself too thin, there can be financial distress. How do you balance that? I know you have a pretty good balance sheet right now. But you get a lot of good ideas that you're chasing right now.

我的意思是，其中很多程序都很棒。但這是新企業經常面臨的營運資金問題——如果你把自己搞得太緊，可能會出現財務困境。你如何平衡這一點？我知道你現在的資產負債表非常好。但你會得到很多你現在正在追求的好主意。

Yeah. Scott, we're not chasing them all -- that's for sure -- for that reason. I mean, we're not chasing COPD at the moment. NTM is not until 2025.

是的。斯科特，我們不會因為這個原因而追趕他們所有人——這是肯定的。我的意思是，我們目前不關注慢性阻塞性肺病。 NTM 直到 2025 年才會出現。

So we're not stretching. I mean, we're almost two years away from an NTM study starting. And COPD is going to be based on available funds. We'd love to do it. I mean, I'd love to do it in three months, but we can't.

所以我們不做伸展運動。我的意思是，距離 NTM 研究開始還有將近兩年的時間。慢性阻塞性肺病將基於可用資金。我們很樂意這樣做。我的意思是，我很想在三個月內做到這一點，但我們不能。

This launch is the most important thing. So the other programs like -- cancer is funded. It's -- we haven't entered into the real expensive part of cancer yet. We haven't gone into Phase 2 human studies, which is where the big money will be spent. That's another '25 occurrence, most likely.

這次發射是最重要的事情。因此，其他項目，例如癌症項目，都得到了資助。我們還沒有進入癌症真正昂貴的部分。我們還沒有進入第二階段的人體研究，這一階段將花費大量資金。這很可能是 25 年發生的另一件事。

And the autism program is -- there's not much being spent at the moment on that. It's still obviously in preclinical stage with our partner in Israel. So again, that expense probably won't kick in -- heavy expenses won't kick in till 2026 or 2027 calendar.

自閉症項目目前還沒有投入太多資金。我們在以色列的合作夥伴顯然仍處於臨床前階段。再說一遍，這筆費用可能不會開始——巨額開支要到 2026 年或 2027 年才會開始。

So can we accelerate these things? Sure. If we have more cash or sales come in and we have a good gross profit, then, yeah, we can. But right now, we're being very prudent in terms of which programs we're working on and how quickly we're pushing them.

那麼我們可以加速這些事情嗎？當然。如果我們有更多的現金或銷售額並且我們有良好的毛利潤，那麼，是的，我們可以。但現在，我們對於正在開展的項目以及推動這些項目的速度非常謹慎。

So right now, pneumonia is full steam ahead, and cancer and autism are moving. But the other programs are not moving right now. Just because you're right; we don't have the balance sheet to do everything that we want to do.

所以現在，肺炎正在全速前進，癌症和自閉症正在發生。但其他項目目前還沒有進展。只因為你是對的；我們沒有資產負債表來完成我們想做的一切。

And it's not everything we want to do. I mean, it's everything that the data tells us to do, right? Our NTM data are very strong; pneumonia, very strong. And with NTM and pneumonia being as strong as they are, it begs the question, why we're not doing a COPD study?

這並不是我們想做的一切。我的意思是，這就是數據告訴我們要做的一切，對嗎？我們的NTM數據非常強大；肺炎，很厲害。由於 NTM 和肺炎如此嚴重，這就引出了一個問題，為什麼我們不進行慢性阻塞性肺病研究？

But again, the answer is we're not funded to do that study. So we're just going to bide our time, make sure that this launch is successful or more successful. It's already been successful. And we'll see how that works out. But yeah, we're being very prudent with our cash.

但同樣，答案是我們沒有資金進行這項研究。因此，我們將等待時機，確保這次發布成功或更成功。已經很成功了。我們將看看結果如何。但是，是的，我們對現金非常謹慎。

Doug doesn't like spending money. He's a very good CFO. He beats up everybody. So --

道格不喜歡花錢。他是一位非常優秀的首席財務官。他毆打所有人。所以 -

Okay, great. Thank you for the color on that. I'll jump back into the queue. Thank you for taking the questions.

好的，太好了。謝謝你的顏色。我會跳回隊列。感謝您提出問題。

Jason Bednar, Piper Sandler.

傑森·貝德納，派珀·桑德勒。

Hey, good afternoon. Thanks for taking the questions, and congrats on reaching that $1 million milestone.

嘿，下午好。感謝您提出問題，並祝賀您達到 100 萬美元的里程碑。

Maybe if I could start on the contracting so far and where we're going in the future. I totally understand, Steve, there's only so much you might be able to share. But can you speak to whether the contract sizes are what you expect them to be so far?

也許我可以開始討論到目前為止的合同以及我們未來的發展方向。我完全理解，史蒂夫，你能分享的只有這麼多。但您能談談到目前為止合同規模是否符合您的預期嗎？

And is there any difference in overall contract size you'd expect as maybe you move further down the road with Phase 2 of your commercial plans? Just anything that you can share there.

當您的商業計劃第二階段進一步推進時，您預期的總體合同規模是否有任何差異？任何你可以在那里分享的東西。

I think that they're fairly in line with what we thought in terms of overall size. There's a mix, right? The volume at hospitals is a huge range in the US. You have hospitals doing 1,000 hours, 500 hours, 2,000 hours. You have hospitals doing 50,000-plus hours of nitric oxide a year.

我認為它們的整體尺寸與我們的想法相當一致。有一個混合，對吧？在美國，醫院的數量範圍很大。醫院工作了 1,000 小時、500 小時、2,000 小時。醫院每年要進行 50,000 多個小時的一氧化氮治療。

So it varies all over the place. So I think it's in line with what we had expected. And I would say the same thing about the pricing, pretty much what we expected as well. So right now, we're not really seeing anything that's outside of the parameters that we had entering into the market.

所以各地情況各不相同。所以我認為這符合我們的預期。關於定價，我也會說同樣的話，也幾乎符合我們的預期。所以現在，我們並沒有真正看到任何超出我們進入市場的參數的東西。

All right, that's great to hear. And then I'd be curious just maybe on the competitive response from some of your closest peers. I'm just thinking, again, given where you're at and where you maybe hope to be in a year or two, I think having some perspective today would be enlightening.

好吧，很高興聽到這個消息。然後我可能會好奇一些最親密的同行的競爭反應。我只是在想，考慮到你現在的處境以及你可能希望在一兩年內達到的目標，我認為今天提出一些觀點將會很有啟發。

Just how are you seeing them behave as they start to lose contracts to you? Are they getting more aggressive in follow-up contracting efforts? Are they holding the line on where they're pricing? Again, just curious how the success you're starting to have in contracting is influencing their behavior at all.

當他們開始失去你的合同時，你如何看待他們的行為？他們在後續簽約工作中是否變得更加積極？他們是否堅持定價？再次，只是好奇你在簽約方面開始取得的成功如何影響他們的行為。

They've been aggressive from day one. I don't think it's changed. I think they're nervous. They're worried. That's how they're acting. It's how they're behaving.

他們從第一天起就表現得很咄咄逼人。我認為它沒有改變。我認為他們很緊張。他們很擔心。他們就是這樣行事的。這就是他們的行為方式。

I might do the same thing if I were in their shoes. So I don't think that there's anything that they're doing that, again, is surprising to us. I would expect some of the things they're doing to be done.

如果我處於他們的立場，我可能會做同樣的事情。所以我不認為他們所做的任何事情再次讓我們感到驚訝。我希望他們正在做的一些事情能夠完成。

I might not do everything they're doing. But certainly, some of the things they're doing, if I were in their shoes, I would do. But it's a competitive environment. There's no doubt about it. And you would expect all the players to do everything they can to either keep customers or take customers from a competitor.

我可能不會做他們所做的一切。但當然，他們正在做的一些事情，如果我處於他們的立場，我也會做。但這是一個競爭環境。毫無疑問。你會期望所有參與者盡其所能來留住客戶或從競爭對手那里奪走客戶。

So I mean, Duncan, you're on the line. If you have anything else to add to that, you're a little closer than I am.

我的意思是，鄧肯，你接電話了。如果你還有什麼要補充的，你比我更接近一點。

Sure. I appreciate the question. I think that there's a couple of things I would say.

當然。我很欣賞這個問題。我想我要說幾件事。

Firstly, a lot of the competitor activity was apparent to us before we even started to get contracts. So a lot of the work that was done was to block us from even getting in there in the first place. So I think that what we've done is we've broken through in various locations.

首先，在我們開始簽訂合同之前，我們就已經看到了很多競爭對手的活動。因此，我們所做的很多工作從一開始就阻止了我們進入那裡。所以我認為我們所做的是我們在不同的領域取得了突破。

And actually, once people get exposure and do evaluations, et cetera, then things start to build. And the way that these things work is, they then start to see that another hospital in their area is using the device, and they get more confident. And so the neighboring hospitals start to get involved.

事實上，一旦人們獲得曝光並進行評估等等，事情就開始發展。這些東西的工作方式是，然後他們開始看到他們所在地區的另一家醫院正在使用該設備，他們就會變得更加自信。於是，鄰近的醫院開始介入。

The other thing that happens is that the initial contracting is easier with individual hospitals. There's not that many of those nowadays. So the larger groups and small networks take a little bit longer, and we're starting to get to those now. And we're getting to that phase where a lot of those contracts are running out, which wasn't the case at the beginning of our launch.

發生的另一件事是與個別醫院的初始合同更容易。如今這樣的人並不多。因此，較大的團體和小型網絡需要更長的時間，我們現在就開始處理這些問題。我們正進入這樣一個階段，其中許多合同即將到期，而在我們推出之初並非如此。

So it's a much better environment for us. In other words, our competitors have thrown a lot of their sort of ammunition at us already to stop us from getting in. The response once we're in isn't that different. So we're feeling much more positive about where we are as we get through that process.

所以這對我們來說是一個更好的環境。換句話說，我們的競爭對手已經向我們投擲了大量彈藥，以阻止我們進入。一旦我們進入，反應並沒有那麼不同。因此，當我們經歷這個過程時，我們對自己的處境感到更加積極。

All right. Perfect. Thank you. Maybe one just clarifying question to finish it off. I think it seems like there's no change on the CE mark timing or expected timing on receiving that.

好的。完美的。謝謝。也許只需澄清一個問題即可結束它。我認為 CE 標誌的時間或收到該標誌的預期時間似乎沒有變化。

I think that originally, your last quarter, you had said September, October timeframe. Does that still hold? I know you're saying by the end of the calendar year, but should we still expect it here within the next couple of months?

我認為最初，你的最後一個季度，你說過九月、十月的時間框架。這仍然成立嗎？我知道你說的是年底，但我們是否仍然應該期待在接下來的幾個月內實現這一目標？

Yeah. I would love to announce it on our next quarter. That would be my goal. But this is out of our control.

是的。我很樂意在下個季度宣布這一消息。那將是我的目標。但這是我們無法控制的。

We are moving as quickly as we can. But again, this is a regulatory matter. And sometimes, it just takes a little longer than you expect. So I hope to announce it on our next quarter. That's my goal. So where we'll be like, second week in November, roughly. So I expect to announce it there.

我們正在盡快行動。但同樣，這是一個監管問題。有時，它只是比您預期的時間要長一點。所以我希望在下個季度宣布這一點。這就是我的目標。所以我們大概會在 11 月的第二週。所以我希望在那裡宣布它。

If not, I'll let you know where I stand then. But yeah, the guidance -- we just give our guidance based on -- Ed here told me: Steve, we got to be consistent with the guidance; this half, that half instead of saying a month. So I'm going to go with Ed, and we'll say by the end of the year. But I hope to say November.

如果沒有，我會讓你知道我的立場。但是，是的，指導 - 我們只是根據 - 埃德在這裡告訴我：史蒂夫，我們必須與指導保持一致；這半、那半而不是說一個月。所以我要和埃德一起去，我們會在年底前決定。但我希望說十一月。

All right. Very helpful. Appreciate it. Thanks, guys.

好的。很有幫助。欣賞它。多謝你們。

Matt Kaplan, Ladenburg Thalmann.

馬特·卡普蘭，拉登堡·塔爾曼。

Hey, guys. Thanks a lot for taking the questions. I guess, now that you're kind of in the phase of signing contracts, can you -- maybe what would be helpful -- can you tell us a little bit about the mechanics of signing a contract? Is there a demo period, a test drive period, and then potential conversion to contract or -- how does that work?

大家好。非常感謝您提出問題。我想，現在您正處於簽署合同的階段，您能——也許會有幫助——能告訴我們一些關於簽署合同的機制嗎？是否有演示期、試駕期，然後可能轉換為合同，或者——這是如何運作的？

Yeah. In the beginning, Matt, it was always a demo, and then there's an evaluation. I think that the evaluation is not as important for every hospital anymore, now that we're out there, and there's experience, and people chat to each other. It's a small world, the RT world.

是的。馬特，一開始，它總是一個演示，然後是一個評估。我認為評估對於每家醫院來說不再那麼重要，因為我們已經在那裡，並且有經驗，並且人們可以互相聊天。這是一個小世界，RT 世界。

There's lots of little conferences. They're all meeting each other and talking about what's going on. So I think that going forward, we may not need to do an evaluation at every potential customer.

有很多小型會議。他們都在見面並談論正在發生的事情。所以我認為，展望未來，我們可能不需要對每個潛在客戶進行評估。

And eventually, we won't be doing evaluations at all. I would say that probably sometime in calendar 2024, we won't be doing evaluations any longer. It'll just be what we call bench testing, and then we go into a contract.

最終，我們根本不會進行評估。我想說，可能在 2024 年的某個時候，我們將不再進行評估。這就是我們所說的基準測試，然後我們簽訂合同。

So we're kind of over that initial phase where everybody was evaluating to the point where some are still evaluating and some aren't. And eventually, when it gets to the point where there's just no more evaluations because there's so much experience with our product and so much comfort and confidence in us as a company being able to support the hospitals, that there won't be no more need for that evaluation.

所以我們已經過了最初階段，每個人都在評估，有些人仍在評估，有些則沒有。最終，當它達到不再需要評估的地步時，因為我們的產品擁有如此多的經驗，並且對我們作為一家能夠支持醫院的公司有如此多的安慰和信心，那麼就不再需要對於那個評價。

Okay. And then, I guess, now that you're in the second phase of the launch, what do you see as the kind of bottleneck in signing new contracts?

好的。然後，我想，現在您正處於啟動的第二階段，您認為簽署新合同的瓶頸是什麼？

Wow. I'm going to let Duncan go on that one, but I would say I don't think there's one specific bottleneck. There's not one thing that stops you from getting a contract.

哇。我會讓鄧肯繼續這一任務，但我想說我不認為存在一個特定的瓶頸。沒有任何事情可以阻止您獲得合同。

I think it's hospital-specific. They all have different things that are important to them. And sometimes, it hits our sweet spot, and other times, it doesn't. So I don't think it's so simple to say that every hospital has the same opinion or viewpoint or needs.

我認為這是醫院特定的。他們都有不同的對他們來說重要的事情。有時，它會擊中我們的最佳位置，而有時卻不會。所以我覺得併不是那麼簡單就能說每個醫院都有同樣的意見、觀點或者需求。

So I don't think there's one bottleneck. And I know, Duncan, you might want to follow up there.

所以我認為不存在任何瓶頸。我知道，鄧肯，你可能想跟進。

Sure. No, it's a good question, Matt. I think that contracting during the first 12 months was definitely the area we had to spend most time navigating because a lot of hospitals are now part of those systems, as I described just now.

當然。不，這是個好問題，馬特。我認為前 12 個月的簽約絕對是我們必須花最多時間探索的領域，因為正如我剛才所描述的，現在很多醫院都是這些系統的一部分。

So the way they do that and the bureaucracy associated with that definitely was initially our biggest challenge. And I do think of it like dominoes. Once you start knocking over some of those hurdles, then a lot of the others become freer.

因此，他們這樣做的方式以及與之相關的官僚主義無疑是我們最初面臨的最大挑戰。我確實認為它就像多米諾骨牌。一旦你開始克服其中一些障礙，其他許多障礙就會變得更加自由。

And then there are individual hospital situations. Changing from one hospital -- once device to another involves an investment in training, et cetera. So depending on where they are in their particular supply chain process, they might have other priorities within the hospital that mean that they're not willing to focus on our particular category at the time, which is kind of related to contracting but also related to the hospital's individual priorities.

還有個別醫院的情況。從一家醫院（曾經的設備）更換到另一家醫院需要培訓投資等。因此，根據他們在特定供應鏈流程中的位置，他們可能在醫院內有其他優先事項，這意味著他們當時不願意專注於我們的特定類別，這與合同有關，但也與醫院的個人優先事項。

From a clinical point of view, we're not getting pushback clinically. It's really more on the contracting side where we have to navigate that. So that's really where most of our work is evolving and improving.

從臨床的角度來看，我們並沒有在臨床上遇到阻力。實際上更多的是在合同方面，我們必須解決這個問題。所以這確實是我們大部分工作正在發展和改進的地方。

Okay. That's helpful. And then the average number of devices per hospital and the expectation for the average revenue per device, how should we think about that?

好的。這很有幫助。然後每家醫院的平均設備數量以及每台設備的平均收入的預期，我們應該如何考慮？

I'm not going to tell you how to think about that, Matt, because then everybody else would know. But it's pretty wide in terms of how many hours per year per system a hospital uses. It's a pretty big range. Different hospitals have different needs, like I've said.

我不會告訴你如何思考這個問題，馬特，因為那樣其他人就會知道。但就醫院每個系統每年使用的小時數而言，這個範圍相當廣泛。這是一個相當大的範圍。正如我所說，不同的醫院有不同的需求。

So it's a very difficult question to answer. And I don't want any of our competitors to know how we think about that and how we view it because it's very important in how we approach things. So I wish I could give you those answers, but I can't. I mean, I can, but I won't.

所以這是一個很難回答的問題。我不希望我們的任何競爭對手知道我們如何看待這一點以及我們如何看待它，因為這對於我們處理事情的方式非常重要。所以我希望我能給你這些答案，但我不能。我的意思是，我可以，但我不會。

Yeah, fair enough, fair enough. Just last question. As you're getting close to the CE mark, what's your partnering strategy ex-US, or do you plan to go it alone outside the US?

是啊，夠公平，夠公平。只是最後一個問題。當您即將獲得 CE 標誌時，您在美國以外的合作策略是什麼，或者您是否計劃在美國以外單獨行動？

We are not going it alone outside the US. That's for sure. It's enough to build up a commercial team in the US. That's all we can handle for the moment.

我們不會在美國之外孤軍奮戰。這是肯定的。在美國建立一個商業團隊就足夠了。目前我們能處理的就是這些。

So we will partner ex-US. And our goal is to get the best royalty rate we can on net sales, and that's what we'll do. So hopefully, we'll be able to talk more about that in the near future.

因此，我們將在美國以外的地區進行合作。我們的目標是在淨銷售額上獲得最好的特許權使用費，這就是我們要做的。所以希望我們能夠在不久的將來更多地討論這個問題。

Okay. Great. Well, congrats on the progress, Steve. Thank you.

好的。偉大的。好吧，恭喜你取得了進步，史蒂夫。謝謝。

Thanks, Matt.

謝謝，馬特。

Yale Jen, Laidlaw & Company.

耶魯·詹 (Yale Jen)，萊德勞公司。

Good afternoon, and thanks for taking the questions. And congrats on your first commercial sales.

下午好，感謝您提出問題。並祝賀您的​​首次商業銷售。

My first question is, in terms of the $59,000 revenue of this quarter, what's the accounting principle behind it, and how is that being recognized? And how should we think about going forward in terms of -- does the same sort of principle apply?

我的第一個問題是，就本季度59,000美元的收入而言，其背後的會計原則是什麼？如何確認？我們應該如何思考未來的發展——同樣的原則是否適用？

Sure. So this is Doug. Thanks for the question, Yale.

當然。這就是道格。謝謝你的提問，耶魯大學。

So the best way to think about it is, for the most part, we're signing annual contracts. Most of the contracts -- from a revenue recognition perspective, I mean, it's a little more complicated than I'm going to make it. But if you think about it ratably over the life of the contract, that's pretty safe.

因此，最好的思考方式是，在大多數情況下，我們正在簽署年度合同。大多數合同——從收入確認的角度來看，我的意思是，它比我要做的要復雜一些。但如果你在合同有效期內仔細考慮一下，那是相當安全的。

I mean, we do have to do some testing every quarter to see if we're within the range of use of the machines and things like that. But for the most part, annual contracts ratably over the 12 months is how we're going to recognize that revenue.

我的意思是，我們確實必須每個季度進行一些測試，看看我們是否在機器之類的使用範圍內。但在大多數情況下，我們將按 12 個月內的年度合同來確認收入。

Okay. Great. That's very helpful. A question -- just a follow-up on the previous one, which is regarding getting a label on the cardiovascular side.

好的。偉大的。這非常有幫助。一個問題——只是前一個問題的後續問題，這是關於在心血管方面獲得標籤的問題。

Question is that nitric oxide has been used in the real world off-label, presumably also get reversed for a long time. So what could be the additional benefits if you guys get a label for your system?

問題是，一氧化氮在現實世界中已經被超說明書使用，可能也被逆轉了很長時間。那麼，如果你們的系統獲得標籤，會帶來哪些額外好處呢？

Well, yeah, I mean, the main benefits, obviously, are our ability to directly market to cardiac surgeons as well as potential for reimbursement; there's no doubt. But Yale, it takes time to get a specific code, so we wouldn't have a direct code day one.

嗯，是的，我的意思是，顯然，主要的好處是我們直接向心臟外科醫生進行營銷的能力以及報銷的潛力；毫無疑問。但是耶魯大學需要時間才能獲得特定的代碼，因此我們不會在第一天就直接提供代碼。

There might be miscellaneous codes of some sort, but a direct code would take several years as you know, right? Was there anything else you were looking for besides those? Those are the two main benefits.

可能有某種類型的雜項代碼，但如您所知，直接代碼需要幾年時間，對嗎？除了這些之外，您還尋找其他什麼嗎？這是兩個主要好處。

Okay. So does that the -- just want to confirm that, currently, the use in the cardiovascular surgery suite also get reimbursed or not necessarily get reimbursed?

好的。那麼，只是想確認一下，目前心血管手術套件中的使用是否也得到報銷或不一定得到報銷？

No, it is off-label use. There's -- I can't speak for what the hospitals do, but it is 100% off-label. So I think that reimbursement is difficult.

不，這是標籤外使用。我不能代表醫院所做的事情，但它是 100% 超適應症的。所以我覺得報銷是很難的。

Okay. Great. Maybe the last question here is in terms of your VCAP trial that you intend to start this winter. Could you give us a little bit more color regarding the study design and including endpoint and others, as well as how this one should be considered as a Phase 2, maybe Phase 3? How should we categorize that? Thanks.

好的。偉大的。也許這裡的最後一個問題是關於您打算在今年冬天開始的 VCAP 試驗。您能否為我們提供有關研究設計的更多信息，包括終點和其他內容，以及如何將其視為第二階段，也許是第三階段？我們應該如何分類呢？謝謝。

Yeah. So I would look at the design of our study that we had in Israel for pneumonia. It's going to be very similar to that study.

是的。所以我會看看我們在以色列進行的肺炎研究的設計。這將與該研究非常相似。

And this will not be a registration study. So we're a device, Yale, not a drug. So it's no Phase 1, 2, 3. It's pilot pivotal. So this will be another pilot study. FDA has requested that.

這不會是一項註冊研究。所以，耶魯，我們是一種設備，而不是藥物。所以這不是第一、二、三階段。而是試點關鍵。所以這將是另一項試點研究。 FDA 已提出要求。

So after this study, the next one would be a pivotal or a registration study. So this study, then one more, and we would hope to get approval from that.

因此，在這項研究之後，下一項研究將是關鍵研究或註冊研究。因此，這項研究，然後是另一項研究，我們希望得到批准。

And maybe just to refresh our memory there in terms of the endpoint, well, what's the endpoint they're pursuing and any other colors on the study?

也許只是為了刷新我們對終點的記憶，那麼，他們正在追求的終點是什麼以及研究中的任何其他顏色？

Yeah. So obviously, it will be -- safety is the primary if it's not a pivotal study. So that's easy. But on the efficacy endpoints, in the study in Israel, it was an oxygen-specific endpoint. It was a time to oxygen cessation for these patients in and out of the hospital.

是的。顯然，如果這不是一項關鍵研究，那麼安全性是首要的。所以這很容易。但在功效終點方面，在以色列的研究中，它是一個特定於氧氣的終點。對於這些進出醫院的患者來說，這是一個停止吸氧的時間。

So you could look for an endpoint similar to that, something along the lines of either how long they're on oxygen or whatever time period we pick, how many hours they didn't need oxygen. But something along those lines will be related to oxygen.

因此，您可以尋找與此類似的終點，例如他們吸氧的時間，或者我們選擇的任何時間段，他們不需要吸氧的時間。但沿著這些思路的某些東西將與氧氣有關。

Again, when we did the infants in pneumonia, there were no comorbidities. So it was easy to look at hospital discharge or being fit for hospital discharge. Those endpoints are not relevant with adult pneumonia, as they have multiple comorbidities. And there could be several other reasons besides the viral infection that caused the hospitalization for them to stay beyond the resolution of the pneumonia episode.

同樣，當我們對患有肺炎的嬰兒進行檢查時，沒有出現合併症。因此，很容易查看出院情況或是否適合出院。這些終點與成人肺炎無關，因為它們有多種合併症。除了病毒感染之外，可能還有其他幾個原因導致他們住院時間超過肺炎發作的時間。

So we need to measure something else. And there will be some other endpoints besides the oxygen related, but I think that is the one that we'll be looking at closely.

所以我們需要測量其他東西。除了與氧氣相關之外，還會有一些其他終點，但我認為這是我們將密切關注的終點。

And maybe just squeezing one more, which is that does that endpoint could be considered as approvable endpoint from FDA's perspective, or have you guys -- spoke with the agency in terms of this issue?

也許只是再擠壓一個，即從 FDA 的角度來看，該終點是否可以被視為可批准的終點，或者你們是否就這個問題與該機構進行了交談？

So this won't be a registration study. So I can't say that the endpoints we have in this study as secondaries would be considered the endpoint to be used in a registration study.

所以這不會是一項註冊研究。因此，我不能說我們在本研究中作為次要終點的終點將被視為在註冊研究中使用的終點。

But you could guess that my team and I are not looking at this for no reason. We're looking at this because this is what we believe would be something similar to what would be in the pivotal study. But there's no way for me to guarantee that there's an endpoint in my current study that would be mimicked for my pivotal.

但你可能會猜到，我和我的團隊並不是無緣無故地關注這個問題。我們正在研究這一點，因為我們認為這與關鍵研究中的內容類似。但我無法保證我當前的研究中有一個終點可以被我的關鍵研究所模仿。

Hopefully, it's close to it. But we would still have to sit with FDA to agree upon what the exact primary endpoint would be in that study. We haven't agreed to that yet, and that's pretty standard.

希望它已經接近了。但我們仍然需要與 FDA 坐下來就該研究的確切主要終點達成一致。我們還沒有同意這一點，這是相當標準的。

But I think what we have is our secondary endpoints on the efficacy side is going to give us the answers we need to get an agreement with FDA on a primary endpoint. I'm pretty confident that we're going to have something that will work.

但我認為我們所擁有的是功效方面的次要終點將為我們提供與 FDA 就主要終點達成協議所需的答案。我非常有信心我們會做出一些行之有效的事情。

Okay. Great. That's very helpful. Again, congrats on the first sale.

好的。偉大的。這非常有幫助。再次祝賀第一筆銷售。

Thanks so much, Yale.

非常感謝，耶魯。

And at this time there are no further questions. I'd like to turn the call back over to Steve to close out the call.

此時沒有進一步的問題。我想將電話轉回給史蒂夫以結束通話。

Thanks, everybody. Appreciate your time. Look forward to talking to you in three months.

謝謝大家。珍惜您的時間。期待三個月後與您交談。

This concludes today's conference call. Thank you for attending.

今天的電話會議到此結束。感謝您的出席。