Beyond Air Inc (XAIR) 2023 Q4 法說會逐字稿

Good afternoon and welcome, everyone, to the Beyond Air financial results call for the fiscal year ended March 31, 2023. (Operator Instructions) And now I would like to turn the call over to Edward Barger, Head of Investor Relations at Beyond Air. Please go ahead.

大家下午好，歡迎參加 Beyond Air 截至 2023 年 3 月 31 日的財年財務業績電話會議。（操作員說明）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 fourth-quarter and full year 2023 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，我們發布了新聞稿，宣布第四財季和 2023 年全年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 will be 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. 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.

在開始之前，我想提醒大家，我們將對未來的預期、計劃和前景做出評論和各種評論，這些評論和評論構成前瞻性陳述，以符合 1995 年《私人證券訴訟改革法案》中的安全港條款的目的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 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, June 22, 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，並可在我們的網站 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 6 月 22 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 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.

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. Welcome to Phase 2 of our commercial launch. This is an exciting time for us as we have visibility into what the PPHN market will look like over the next several years. With our initial limited launch completed, we are highly confident that we have gained the knowledge required to satisfy the needs of hospitals using nitric oxide.

謝謝埃德，祝所有加入我們的人下午好。歡迎來到我們商業發布的第二階段。這對我們來說是一個激動人心的時刻，因為我們可以了解未來幾年 PPHN 市場的情況。隨著我們最初的有限發布的完成，我們非常有信心我們已經獲得了滿足醫院使用一氧化氮的需求所需的知識。

LungFit PH has been well received in the market. We believe that our ability to support and service most hospitals has been established. Now is the time to increase the size of our commercial team and increase our market share. Our Chief Commercial Officer, Duncan Fatkin, will have more on this in a few minutes.

LungFit PH 受到市場好評。我們相信，我們已經具備了為大多數醫院提供支持和服務的能力。現在是擴大我們商業團隊規模並增加市場份額的時候了。我們的首席商務官鄧肯·法特金 (Duncan Fatkin) 將在幾分鐘內提供更多相關信息。

Outside of LungFit PH commercial operations, we have been very busy and I am proud of what the Beyond Air and Beyond Cancer teams have accomplished. LungFit PH cardiac label expansion application will be submitted before the end of this calendar year to FDA. This is later than we had hoped, but we want to be certain that the application is high quality and will satisfy FDA requirements.

除了 LungFit PH 商業運營之外，我們一直非常忙碌，我為 Beyond Air 和 Beyond Cancer 團隊所取得的成就感到自豪。 LungFit PH 心臟標籤擴展申請將於今年年底前向 FDA 提交。這比我們希望的要晚，但我們希望確定該申請是高質量的並且能夠滿足 FDA 的要求。

We also expect CE Mark in the EU for LungFit PH late next quarter. We anticipate LungFit PRO will be used in a community-acquired viral pneumonia study in the United States this coming winter. LungFit GO is scheduled for an at-home COPD study start in 2024 and NTM in 2025.

我們還預計 LungFit PH 下季度末將獲得歐盟 CE 標誌。我們預計 LungFit PRO 將在今年冬天用於美國的一項社區獲得性病毒性肺炎研究。 LungFit GO 計劃於 2024 年開始在家進行 COPD 研究，並於 2025 年開始進行 NTM 研究。

Beyond Cancer anticipates Phase 1a data this fall. As announced last week, we now have another NO-related program, autism. Please refer to our announcement last week for details.

Beyond Cancer 預計今年秋季獲得 1a 期數據。正如上周宣布的，我們現在有另一個與 NO 相關的項目：自閉症。詳情請參閱我們上週的公告。

Our portfolio consists of programs where NO is approved to treat acute pulmonary hypertension in newborns, is in human studies by hypoxemia associated with viral lung infection, chronic refractory persistent lung infection, and solid tumors, and in preclinical development for autism. We can consider ourselves the preeminent NO company with the investments we have made into NO research and development. We believe that we have only scratched the surface of the impact NO plays in human health.

我們的產品組合包括 NO 被批准用於治療新生兒急性肺動脈高壓的項目，正在進行與病毒性肺部感染、慢性難治性持續性肺部感染和實體瘤相關的低氧血症的人體研究，以及自閉症的臨床前開發。憑藉我們對 NO 研究和開發的投資，我們可以認為自己是卓越的 NO 公司。我們相信，我們僅僅觸及了一氧化氮對人類健康影響的表面。

We recently secured debt financing of up to $40 million from funds managed by Avenue Capital Group. We believe this additional capital strengthens our position to execute on our strategy for LungFit PH and our other programs. In addition, I believe that securing this capital from a well-known healthcare investment firm with a history of investing in nitric oxide speaks volumes about our programs and the progress we're making.

我們最近從 Avenue Capital Group 管理的基金中獲得了高達 4000 萬美元的債務融資。我們相信，這筆額外資金將增強我們執行 LungFit PH 戰略和其他項目的地位。此外，我相信，從一家擁有一氧化氮投資歷史的知名醫療投資公司獲得這筆資金，充分說明了我們的計劃和我們正在取得的進展。

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 just mentioned, we've made steady progress with our commercial launch over the past few quarters. The feedback from hospitals regarding LungFit PH continues to be extremely positive and we would like to thank all the hospitals and clinical staff that have contributed to this first wave of clinical use.

謝謝史蒂夫，我們的投資者下午好。正如史蒂夫剛才提到的，過去幾個季度我們的商業發布取得了穩步進展。醫院對 LungFit PH 的反饋仍然非常積極，我們要感謝所有為第一波臨床使用做出貢獻的醫院和臨床工作人員。

As I mentioned on previous calls, our go-to-market strategy is a multi-phased commercial approach. The initial phase represented a measured release of LungFit PH to a select group of hospitals who use inhaled nitric oxide on a regular basis.

正如我在之前的電話會議中提到的，我們的上市策略是一種多階段的商業方法。初始階段是向一組定期使用吸入一氧化氮的醫院進行有針對性的 LungFit PH 釋放。

During this first phase, we received positive feedback from a variety of different hospitals on our logistics, customer service, and the clinical performance of the device. As a result, several hospitals have signed contracts for LungFit PH. These accounts set an important foundation from which the team will build upon.

在第一階段，我們收到了多家不同醫院對我們的物流、客戶服務和設備臨床性能的積極反饋。因此，多家醫院簽署了 LungFit PH 合同。這些賬戶為團隊的發展奠定了重要的基礎。

In regard to our sales pipeline, we're excited by the interest in LungFit PH. As one point of reference, we have conducted more than 150 in-person demonstrations that have resulted in positive feedback and helped to optimize the LungFit PH system, our service and support, supply chain, logistics, and back-office operations.

就我們的銷售渠道而言，我們對 LungFit PH 的興趣感到興奮。作為參考之一，我們進行了 150 多次現場演示，這些演示產生了積極的反饋，並幫助優化 LungFit PH 系統、我們的服務和支持、供應鏈、物流和後台運營。

Based on our success to date, we moved into the second phase of our commercial program in the beginning of the current quarter. In this phase, we are expanding our commercial team, both field sales and clinical specialists, and expanding our network of reference hospitals and key opinion leaders. We expect that this will lead to market share gains over the next 10 to 12 quarters before we enter the final phase of commercialization.

基於迄今為止的成功，我們在本季度初進入了商業計劃的第二階段。在此階段，我們正在擴大我們的商業團隊，包括現場銷售和臨床專家，並擴大我們的參考醫院和關鍵意見領袖網絡。我們預計，在進入商業化的最後階段之前，這將導致未來 10 到 12 個季度的市場份額增長。

In closing, we continue to be excited by the growing coalition of hospitals supporting this amazing new technology and believe the program has gathered tremendous momentum to drive future growth. We project the annual value of contract signings over the next six months to be measured in the millions. In addition, a key point to remember is that the customer base and commercial function that we're establishing will support the future launch of LungFit PRO for additional indications for the hospital, if and when approved.

最後，我們繼續對支持這一令人驚嘆的新技術的醫院聯盟不斷壯大感到興奮，並相信該計劃已聚集了推動未來增長的巨大動力。我們預計未來六個月每年簽訂的合同價值將達到數百萬美元。此外，需要記住的一個關鍵點是，如果獲得批准，我們正在建立的客戶群和商業功能將支持未來推出 LungFit PRO，為醫院提供更多適應症。

With that, I will turn the call back to Steve for the pipeline review. Steve.

這樣，我會將電話轉回史蒂夫以進行管道審查。史蒂夫.

Thanks, Duncan. I will start with LungFit PH. I mentioned earlier that CE Mark is expected near the end of the next quarter and we expect the FDA submission for the cardiac label expansion before year-end. We continue to execute on our regulatory strategy and our interactions with the FDA and other regulatory authorities, prioritizing as needed. We are confident that both milestones will be achieved.

謝謝，鄧肯。我將從 LungFit PH 開始。我之前提到，CE 標誌預計將在下季度末附近獲得，我們預計 FDA 在年底前提交心臟標籤擴展申請。我們將繼續執行我們的監管策略以及與 FDA 和其他監管機構的互動，並根據需要確定優先順序。我們有信心實現這兩個里程碑。

With respect to our VCAP program, we are preparing to conduct a study this coming winter in the United States. This study will not be a pivotal study, but a small study that we would expect to lead to a pivotal study.

關於我們的 VCAP 項目，我們準備今年冬天在美國進行一項研究。這項研究不會是一項關鍵研究，而是一項小型研究，我們希望它能成為一項關鍵研究。

As for LungFit GO, we look to initiate a pivotal study in the first half of 2025 pending discussion with the FDA for NTM. We hope to initiate a pilot study in the second half of 2024 for COPD patients released from the hospital after having been hospitalized for an exacerbation. This is an exciting time for the clinical, regulatory, and engineering teams.

至於 LungFit GO，我們希望在 2025 年上半年啟動一項關鍵研究，等待與 FDA 就 NTM 進行討論。我們希望在 2024 年下半年針對因病情惡化而出院的 COPD 患者啟動一項試點研究。對於臨床、監管和工程團隊來說，這是一個激動人心的時刻。

Before I move on to Beyond Cancer, I would just like to emphasize that, to date, we have completed multiple studies in several clinical settings where 150 parts per million to 250 parts per million nitric oxide has been delivered to the lungs in more than 145 patients and over 4,500 individual administrations with zero serious adverse events directly attributable to nitric oxide.

在繼續討論“超越癌症”之前，我想強調的是，迄今為止，我們已經在多個臨床環境中完成了多項研究，其中百萬分之 150 至百萬分之 250 的一氧化氮已在超過 145 個實驗中被輸送到肺部。患者和超過 4,500 名個人給藥，直接歸因於一氧化氮的嚴重不良事件為零。

In addition, strong efficacy trends were seen in multiple studies. This portfolio of clinical data, along with our preclinical data, leads us to believe that exogenous nitric oxide generated and delivered by LungFit will improve the lives of patients.

此外，多項研究都顯示出強勁的療效趨勢。這些臨床數據組合以及我們的臨床前數據使我們相信 LungFit 產生和輸送的外源性一氧化氮將改善患者的生活。

Earlier in the current quarter, we presented impressive new in vivo and in vitro data at the American Association of Cancer Research Annual Meeting. These data suggest that ultra-high concentration NO, or UNO, is effective in treating solid tumors as a single agent and in combination with checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4.

在本季度早些時候，我們在美國癌症研究協會年會上展示了令人印象深刻的體內和體外新數據。這些數據表明，超高濃度NO（或UNO）作為單一藥物以及與檢查點抑製劑（例如抗PD-1和抗CTLA-4）聯合治療實體瘤是有效的。

To be more specific, the data shown in mice were in a very aggressive triple negative breast cancer model called 4T1, and UNO therapy in combination with both anti-PD-1 and anti-CTLA-4 showed improvements in survival against each checkpoint inhibitor alone. Repeated UNO therapy suggests that repeat dosing is safe and effective.

更具體地說，小鼠中顯示的數據是在一種名為 4T1 的非常具有侵襲性的三陰性乳腺癌模型中顯示的，UNO 療法與抗 PD-1 和抗 CTLA-4 聯合治療顯示，相對於單獨使用每種檢查點抑製劑，生存率有所提高。重複的 UNO 治療表明重複給藥是安全有效的。

We remain very enthusiastic about our ongoing Phase 1a human clinical study, which is expected to have topline data later this calendar year. I would like to emphasize that thus far the data from the human study are consistent with the preclinical animal studies with respect to immune biomarkers.

我們對正在進行的 1a 期人體臨床研究仍然充滿熱情，預計該研究將在今年晚些時候獲得主要數據。我想強調的是，迄今為止，人類研究的數據與免疫生物標誌物方面的臨床前動物研究是一致的。

Turning to our newest program, neuronal nitric oxide synthase, or nNOS, inhibitors. I would like to thank Dr. Haitham Amal and his team at the Hebrew University in Jerusalem for working with us over the past year. We expect big things going forward. The relationship is focused on what nNOS inhibition can do in neurological disorders and, as stated in our recent announcement, is initially focusing on reversing the effects of autism spectrum disorder. Considering we just held the conference call dedicated to the announcement of this particular program last week, I suggest anyone who didn't listen to the live call visit our website and listen to the archive of the call.

轉向我們的最新項目，神經元一氧化氮合酶或 nNOS 抑製劑。我要感謝耶路撒冷希伯來大學的 Haitham Amal 博士和他的團隊在過去一年中與我們的合作。我們期待未來有大事發生。這種關係的重點是 nNOS 抑制在神經系統疾病中的作用，並且正如我們最近的公告中所述，最初的重點是扭轉自閉症譜系障礙的影響。考慮到我們上周剛剛舉行了專門宣布這一特定計劃的電話會議，我建議任何沒有收聽現場電話會議的人訪問我們的網站並收聽電話會議的存檔。

I will now turn the call over to Doug Larson, our Chief Financial Officer, to provide an overview of our financial results for the fiscal year ended March 31, 2023.

我現在將把電話轉給我們的首席財務官 Doug Larson，概述我們截至 2023 年 3 月 31 日的財年的財務業績。

Thanks, Steve, and good afternoon, everyone. Our financial results for the fiscal year ended March 31, 2023, are as follows. Revenue for the fiscal year ended March 31, 2023, was zero as compared with zero for the fiscal year ended March 31, 2022. I'm very happy to say that this will be the last time that you hear me say that revenues are zero.

謝謝史蒂夫，大家下午好。我們截至 2023 年 3 月 31 日的財政年度的財務業績如下。截至 2023 年 3 月 31 日的財政年度的收入為零，而截至 2022 年 3 月 31 日的財政年度的收入為零。我很高興地說，這將是您最後一次聽到我說收入為零。

On a GAAP basis, research and development expenses for the fiscal year ended March 31, 2023, were $16.8 million, compared with $11.8 million for the fiscal year ended March 31, 2022. The main driver of the $5 million increase was compensation costs from scaling up operations in Beyond Cancer. We also further increased staff in Beyond Air's R&D team, recognized some of the initial work with autism, and had generated costs early in the fiscal year for the final push to get approval for the LungFit for PPHN.

根據公認會計原則，截至 2023 年 3 月 31 日的財年研發費用為 1,680 萬美元，而截至 2022 年 3 月 31 日的財年研發費用為 1,180 萬美元。增加 500 萬美元的主要驅動力是規模擴大帶來的補償成本超越癌症的行動。我們還進一步增加了 Beyond Air 研發團隊的人員數量，認可了一些針對自閉症的初步工作，並在本財年初期為 LungFit for PPHN 獲得批准的最後努力產生了成本。

Selling, general and administrative expenses for the fiscal year ended March 31, 2023, increased to $34.7 million from $18.4 million for the fiscal year ended March 31, 2022, mainly due to $9.2 million in structural investments in Beyond Cancer, with the remaining $7.1 million mainly driven by the US commercial launch.

截至2023年3月31日的財政年度的銷售、一般和管理費用從截至2022年3月31日的財政年度的1840萬美元增加到3470萬美元，主要是由於Beyond Cancer的結構性投資為920萬美元，其餘710萬美元主要受到美國商業發布的推動。

Other operating expenses for the fiscal year ended March 31, 2023, were zero, compared with $10.5 million which were entirely related to the contingent liability for the Circassia settlement from May of 2021. As a reminder, we paid $2.5 million to Circassia in the second fiscal quarter of 2023. We have another $3.5 million to pay in the second fiscal quarter of 2024 with the final $4.5 million not due until the second quarter of fiscal 2025.

截至 2023 年 3 月 31 日的財政年度的其他運營費用為零，而 1,050 萬美元完全與 2021 年 5 月起 Circassia 和解的或有負債有關。謹提醒您，我們在第二季度向 Circassia 支付了 250 萬美元。 2023 財季。我們還需要在 2024 年第二財季支付 350 萬美元，最後 450 萬美元要到 2025 財年第二季度才能支付。

Other income and expense for the fiscal year ended March 31, 2023, was a net loss of $7.3 million, compared with $3.4 million for the fiscal year ended March 31, 2022. The $3.9 million increase is from a non-product related matter that was previously partially reserved for and resolved in the fiscal fourth quarter.

截至 2023 年 3 月 31 日的財政年度的其他收入和支出淨虧損 730 萬美元，而截至 2022 年 3 月 31 日的財政年度則為 340 萬美元。增加的 390 萬美元來自非產品相關事項，之前部分保留並在第四財季解決。

For the fiscal year ended March 31, 2023, the company had a GAAP net loss of $59.4 million, of which $55.8 million, or $1.86 per share, was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $43.2 million, or $1.68 per share, for the fiscal year ended March 31, 2022.

截至 2023 年 3 月 31 日的財年，該公司的 GAAP 淨虧損為 5940 萬美元，其中 5580 萬美元，即每股 1.86 美元，歸屬於 Beyond Air, Inc. 股東，而淨虧損為 43.2 美元截至 2022 年 3 月 31 日的財年為 100 萬美元，即每股 1.68 美元。

Net cash used by the company, including Beyond Cancer, was $37.9 million during the fiscal year ended March 31, 2023. We forecast our average quarterly cash burn to be approximately $10 million per quarter as we head into fiscal 2024.

在截至 2023 年 3 月 31 日的財年中，包括 Beyond Cancer 在內，該公司使用的淨現金為 3790 萬美元。我們預計，進入 2024 財年，我們的平均季度現金消耗約為 1000 萬美元。

As of March 31, 2023, the company had cash and cash equivalents of $45.9 million. We believe that this amount, in addition to the $17.5 million secured through our agreement with Avenue Capital, is sufficient to fund operations for at least the next 12 months.

截至2023年3月31日，該公司擁有現金和現金等價物為4590萬美元。我們相信，除了通過我們與 Avenue Capital 達成的協議獲得的 1750 萬美元之外，這筆資金足以為至少未來 12 個月的運營提供資金。

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. Hope everyone is as pleased as I am with the execution and progress at Beyond Air. Operator, let's go to Q&A.

謝謝，道格。希望每個人都像我一樣對 Beyond Air 的執行和進展感到滿意。接線員，我們進入問答環節。

(Operator Instructions) Marie Thibault, BTIG.

（操作員說明）Marie Thibault，BTIG。

Hi. Thank you for taking the questions this evening. Very glad to hear that we will be seeing revenue this next coming quarter. Would love to hear a little bit about how the fiscal fourth quarter went, the timing of some of these contracts that you described as signing, and what you can tell us about what's taken place commercially in the last couple months here as you've shifted to Phase 2.

你好。感謝您今晚接受提問。很高興聽到我們將在下個季度看到收入。我很想听聽有關第四財季進展情況的一些信息、您所描述的部分合同的簽署時間，以及您可以告訴我們的過去幾個月在您轉移期間商業上發生的情況到第二階段。

Thanks, Marie, I appreciate that. I'm going to turn this over to Duncan, our Chief Commercial Officer, to comment on that.

謝謝，瑪麗，我很感激。我將把這個問題轉交給我們的首席商務官鄧肯，讓他對此發表評論。

Thanks, Marie, for the question. So the contracts, typically there's quite a few that start in the first month of the quarter, and so you get that kind of effect, and so we fought to get some of these to start a little bit earlier. But the timing of the negotiations and the way that kind of fell just pushed us a little bit further, but certainly nothing that's put us off our long-term schedule.

謝謝瑪麗提出的問題。因此，通常有相當多的合同是在該季度的第一個月開始的，因此您會得到這種效果，因此我們努力讓其中一些合同提前一點開始。但談判的時機和談判的失敗方式只是讓我們前進了一點，但肯定不會讓我們偏離長期計劃。

From a learnings point of view, we continue to get really good clinical feedback, the training's gone really well, and we've refined the way we train and go to the hospitals, and we've certainly made some improvements to the software to make the system work even better than it has been.

從學習的角度來看，我們繼續獲得非常好的臨床反饋，培訓進行得非常順利，我們改進了培訓和去醫院的方式，並且我們當然對軟件進行了一些改進該系統比以前運行得更好。

It's certainly fair to say that we're a little bit behind where we wanted to be. Some of the supply chain challenges from earlier in the fiscal year kind of flowed through, and we've taken our time to work with our team, and they've done an amazing job actually to make sure we can stay close to where we need to be.

可以公平地說，我們有點落後於我們想要達到的目標。本財年早些時候的一些供應鏈挑戰已經過去，我們花時間與我們的團隊合作，他們實際上做了出色的工作，確保我們能夠接近我們需要的地方成為。

And going forward, we're focusing on expanding. And as you can see from the prepared remarks, we're going to increase the team now because we feel like we're ready to support that expansion, something that we were a little bit more cautious about earlier on in the year.

展望未來，我們將專注於擴張。正如您從準備好的評論中看到的那樣，我們現在將增加團隊，因為我們覺得我們已經準備好支持這種擴張，而今年早些時候我們對此更加謹慎。

Okay, that's really helpful Duncan. Maybe I can ask as a follow-up, how should we think about that commercial sales force expansion? What do you think is the right number for this phase, and how quickly are those folks getting hired?

好的，這真的很有幫助，鄧肯。也許我可以問一下，我們應該如何看待商業銷售隊伍的擴張？您認為此階段合適的人數是多少？這些人多久能被雇用？

And then as a second part of that question for Doug maybe, if I look at the SG&A this quarter and exclude the $9 million or so that was invested in Beyond Cancer, I'm getting to about $25 million. Is that the right level that you would have us look at for SG&A here in this next fiscal year?

然後，作為 Doug 問題的第二部分，如果我查看本季度的 SG&A，並排除投資於 Beyond Cancer 的 900 萬美元左右，我會得到大約 2500 萬美元。您希望我們在下一財年考慮 SG&A 的水平是否合適？

Hey Marie, so Steve, I'll take the sales force expansion. So it's an expansion to what we would believe it would be our peak size, and I think we've said that number would be somewhere in 70 to 80 total people. That wouldn't just be sales reps, that would be everybody, clinical specialists and operations and marketing and so forth.

嘿瑪麗，史蒂夫，我將負責銷售隊伍的擴張。因此，這是對我們所認為的峰值規模的擴張，我認為我們已經說過這​​個數字將在 70 到 80 人之間。這不僅僅是銷售代表，還包括每個人、臨床專家、運營和營銷人員等等。

So that'll probably take us the next 18 to 24 months to bring those people on in an orderly manner, get them on, train them, deploy them, and go back and bring more people on. So that's how it will happen. We're not in any rush to bring the people on in one big fail swoop like maybe a much larger company might do. So this is a good 18- to 24-month exercise that we've begun to go from a sub-20 number and multiply that by 4x to 5x. And I'll -- is that answer your question, Marie?

因此，我們可能需要在接下來的 18 到 24 個月內有序地招募這些人員，讓他們上崗，培訓他們，部署他們，然後再回去招募更多的人。所以事情就會這樣發生。我們並不急於像一家大得多的公司那樣，急於在一次重大失敗中讓員工加入進來。所以這是一個很好的 18 到 24 個月的練習，我們已經開始從低於 20 的數字乘以 4 到 5 倍。我會——這就是你問題的答案嗎，瑪麗？

That does, that does. I wonder if Doug could comment on the, you know, the $25 million and spend this quarter and what it might look like going forward.

確實如此，確實如此。我想知道 Doug 能否對本季度的 2500 萬美元和支出以及未來的情況發表評論。

So $25 million is the annual, annual number if you pull out Cancer. So that was the $9 million is an increase versus last year, so it's not the absolute number that we're looking at, right? We did have three months of Cancer last year. We've got, we've got 12 this year. Keep in mind that we are going to continue to consolidate Cancer into our numbers as well. So I don't know if you're trying to pull, pull those numbers apart. It might be a little bit tricky. We could maybe follow up on that one, if that works.

因此，如果排除癌症的話，每年的數字就是 2500 萬美元。所以這 900 萬美元比去年增加了，所以這不是我們看到的絕對數字，對吧？去年我們確實經歷了三個月的癌症。今年我們有 12 個。請記住，我們也將繼續將癌症納入我們的數字中。所以我不知道你是否想把這些數字分開。這可能有點棘手。如果可行的話，我們也許可以跟進這個問題。

Okay. Certainly, happy to follow up later. Thanks for taking the questions.

好的。當然，很樂意稍後跟進。感謝您提出問題。

Matt Kaplan, Ladenburg Thurman.

馬特·卡普蘭，拉登堡·瑟曼。

Hi, thanks for taking the questions. Just staying with the LongFit PH, I guess, now that you've completed Phase 1 of the launch, can you tell us a little bit more about what you accomplished in Phase 1? Specifically, maybe some more detail around the number of contracts, and then with that, what you -- what we should look for as you now launch into the second phase of the commercial program here?

您好，感謝您提出問題。我想，現在您已經完成了發布的第一階段，您能告訴我們更多有關您在第一階段所完成的工作嗎？具體來說，也許是有關合同數量的更多細節，然後，當您現在在這裡啟動商業計劃的第二階段時，我們應該尋找什麼？

So Matt, I'm going to let Duncan talk about what we've learned and what's going to help us going forward. But with respect to the number of contracts, I mean, we did state that we had multiple contracts that have been signed. I would say that the number as we see here today is less than ten, so we're looking at single-digit number of contracts.

馬特，我將讓鄧肯談談我們學到了什麼以及什麼將幫助我們繼續前進。但就合同數量而言，我的意思是，我們確實聲明我們已經簽署了多份合同。我想說的是，我們今天在這裡看到的數字不到十，所以我們正在考慮個位數的合同。

And going forward, obviously, we expect that number to increase quite dramatically over the next four to six quarters. I mean, as we bring more people on and we are able to handle more volume of customers, it's going to increase significantly.

顯然，展望未來，我們預計這個數字將在未來四到六個季度內大幅增加。我的意思是，隨著我們引進更多的人並且我們能夠處理更多的客戶，它將會顯著增加。

And that was always the plan with our three-step process towards this launch as we've had in our slides for the past 18 months. And we've been stating on every quarterly conference call that Phase 1 would be where we learn and make sure everything we have is up to speed, ready to go to expand. And now we're in Phase 2 where we're going to expand our team and start to take some serious market share.

這始終是我們針對此次發布的三步流程的計劃，正如我們在過去 18 個月的幻燈片中所做的那樣。我們在每個季度的電話會議上都表示，第一階段將是我們學習的地方，並確保我們擁有的一切都跟上進度，準備好進行擴展。現在我們正處於第二階段，我們將擴大我們的團隊並開始佔據一些重要的市場份額。

So that's how I look at it. But Duncan, you want to comment on what we've learned in Phase 1?

我就是這麼看的。但是鄧肯，您想對我們在第一階段學到的東西發表評論嗎？

Yeah, thanks for the question, Matt. So I mean, our focus has been on making sure that the logistics are smooth, the clinical performance is as we'd expected, and the training and everything associated with that continues to go well, which we definitely feel good about that. Certainly, the feedback continues to be that our system is very simple to use and it doesn't take too long to do the training.

是的，謝謝你的提問，馬特。所以我的意思是，我們的重點是確保後勤工作順利，臨床表現符合我們的預期，培訓和與之相關的一切繼續順利進行，我們對此絕對感到滿意。當然，反饋仍然是我們的系統使用起來非常簡單，並且不需要花太長時間進行培訓。

We've been refining some of our programs because in the simplicity and ease, sometimes, actually, a lot of the clinicians using the device don't spend as much time as we'd like them to, and so we kind of do some remedial work, and so we've refined our program. We've certainly also understood better the profile of the hospitals that we need to go to, to make sure that we pick the ideal locations and the ideal partners, which is why we took our time to go to a variety of different types of hospitals.

我們一直在完善我們的一些程序，因為實際上，有時，很多使用該設備的臨床醫生並沒有花費我們希望的那麼多時間，所以我們做了一些簡單和輕鬆的程序補救工作，因此我們改進了我們的計劃。我們當然也更好地了解了我們需要去的醫院的概況，以確保我們選擇理想的地點和理想的合作夥伴，這就是為什麼我們花時間去各種不同類型的醫院。

So from our perspective, they're probably the main learnings, nothing that has been shocking to us, and definitely some optimization that we've done with the device. So we're pleased with what we've learned, and now we can really start to expand with, I would call it, much more confidence.

因此，從我們的角度來看，它們可能是主要的學習內容，沒有什麼讓我們感到震驚的，而且絕對是我們對設備所做的一些優化。因此，我們對所學到的東西感到滿意，現在我們可以真正開始擴展，我稱之為更有信心。

Okay. And I guess with that, how should we think about the contracts converting into revenues over time, as you add?

好的。我想，正如您補充的那樣，我們應該如何考慮隨著時間的推移將合同轉化為收入？

So, Matt, most of these contracts are going to be annual, so if we, we sign up 600,000, it's going to be 50,000 a month, or 150 a quarter. So as you sign them, they start to build upon themselves, right? So that's how they're going to translate. We don't get the cash up front; we don't book the revenues up front, right? So this is an annual contract that's spread over four quarters.

所以，馬特，大部分合同都是年度合同，所以如果我們簽訂 600,000 份合同，那麼每月將是 50,000 份，或者每季度 150 份。所以當你簽下他們時，他們就開始自我發展，對嗎？這就是他們要翻譯的方式。我們不會預先獲得現金；我們不會預先登記收入，對嗎？這是一份為期四個季度的年度合同。

So as we got a bunch this last quarter, we'll get a bunch the next quarter, so they'll build on each other, and then the next quarter, and it'll just keep piling on top. And the more we expand our team, the more people we get trained and out there, the more volume we can have. So every quarter should get better and better from the previous quarter, in terms of, not just the number of contracts, but the size of those contracts. We're able to handle larger hospitals as well, as we get, as we get bigger.

因此，當我們上個季度得到了很多，下個季度我們也會得到很多，所以它們會相互基礎，然後是下個季度，它會繼續堆積起來。我們的團隊規模越大，接受培訓的人員就越多，我們的業務量就越大。因此，每個季度都應該比上一季度變得越來越好，不僅是在合同數量方面，而且是在合同規模方面。隨著我們規模的擴大，我們也能夠處理更大的醫院。

And just shifting gears to Beyond Cancer, you mentioned that you're going to have a Phase 1 data later this year. Can you give us some more detail in terms of how many patients and what we should be looking for in that data from Beyond Cancer later this year?

剛剛轉向超越癌症，您提到今年晚些時候將獲得第一階段數據。您能否為我們提供更多關於有多少患者以及我們應該在今年晚些時候的 Beyond Cancer 數據中尋找哪些內容的詳細信息？

Yes, I don't know exactly how many patients we'll be showing, but it's going to be, I don't know, give or take 10 patients, maybe a few less, maybe a few more it'll depend on the cutoff. And I said in the prepared remarks that it's the immune biomarkers that, from an efficacy standpoint, as you know, Matt, this is a safety study, so we'll be looking for safety, and that's the most important thing at this stage. But we do want to understand what's happening to the immune system.

是的，我不知道我們到底要展示多少名患者，但我不知道，會提供或帶走 10 名患者，也許少一些，也許多一些，這取決於隔斷。我在準備好的發言中說過，從功效的角度來看，這是免疫生物標誌物，正如你所知，馬特，這是一項安全性研究，所以我們將尋找安全性，這是現階段最重要的事情。但我們確實想了解免疫系統發生了什麼。

So I mentioned in prepared marks that what we saw in the mice, which we've shown several studies in mice, and you can see on the Beyond Cancer website what the immune markers have done going in the direction that we expect them to go, and by arming the immune system against these tumors, we're seeing similar activity in the immune biomarkers currently in the patients that we have data on so far.

因此，我在準備好的標記中提到了我們在小鼠身上看到的情況，我們已經在小鼠身上進行了幾項研究，您可以在 Beyond Cancer 網站上看到免疫標記物朝著我們期望的方向發展，通過武裝免疫系統對抗這些腫瘤，我們在目前擁有數據的患者中發現免疫生物標記物具有類似的活性。

So I think that's what you want to look for, safety and these immune biomarkers to see if we're able to predict efficacy going forward, so we're pretty excited about it. I can't wait to show it, but we'll have to wait until we complete a few more patients and we get the data in-house and we get our statisticians to put that data together so we can, we can share it with you.

所以我認為這就是你想要尋找的，安全性和這些免疫生物標誌物，看看我們是否能夠預測未來的療效，所以我們對此感到非常興奮。我迫不及待地想展示它，但我們必須等到我們完成更多的患者，我們在內部獲得數據，我們讓我們的統計學家將這些數據放在一起，這樣我們就可以，我們可以與他人分享你。

Okay, very good. And then last question, then I'll jump back in the queue. LungFit PRO, you mentioned in your prepared marks that the next study that you plan to launch will be a pilot study. What do you hope to learn from this pilot study prior to moving into a pivotal study with the program in the viral pneumonia setting?

好的，非常好。然後是最後一個問題，然後我會跳回到隊列中。 LungFit PRO，您在準備好的筆記中提到您計劃啟動的下一項研究將是一項試點研究。在進入病毒性肺炎環境中的關鍵研究之前，您希望從這項試點研究中學到什麼？

So I think we -- the purpose of this pilot study is to give comfort to FDA and to some of the sites we've spoken to that the safety is there and that they feel very comfortable treating their patients. And since this is not really a study that we can go and, in the literature, and see these types of endpoints that we're looking at, this study will also give us the ability to optimize our stats package for the primary endpoint that we're targeting.

所以我認為我們——這項試點研究的目的是讓 FDA 和我們接觸過的一些網站感到放心，安全性是存在的，並且他們對治療患者感到非常放心。由於這並不是一項真正的研究，我們可以在文獻中查看我們正在研究的這些類型的終點，因此這項研究還將使我們能夠針對我們的主要終點優化我們的統計數據包。正在瞄準。

So I think it's twofold there. I think it's to give a little more comfort on the safety side. Not for us, we're very comfortable on the safety side as you see from all the data that we've shown publicly, but it will help inform us on the primary endpoint and give us a little bit more confidence in sizing our study.

所以我認為這是雙重的。我認為這是為了在安全方面給予更多的安慰。不適合我們，正如您從我們公開展示的所有數據中看到的那樣，我們在安全方面非常放心，但這將有助於我們了解主要終點，並使我們在確定研究規模時更有信心。

Okay, that's great. Thanks. Thanks, Steve.

好的，太好了。謝謝。謝謝，史蒂夫。

Yale Gen, Laidlaw & Co.

耶魯大學雷德勞公司

Good afternoon and thanks for taking the question. For the LungFit PRO -- I'm sorry, LungFit PH, you mentioned that you will have a number of contracts. So should we anticipate that you report that as a group later on in the next earning call, or should we anticipate that you will provide some update between this call and the next call in terms of what you get, several contracts being signed?

下午好，感謝您提出問題。對於 LungFit PRO——我很抱歉，LungFit PH，您提到您將擁有許多合同。那麼，我們是否應該預計您稍後會在下一次財報電話會議中作為一個整體進行報告，或者我們是否應該預計您將在本次電話會議和下一次電話會議之間提供一些更新，以了解您所獲得的信息，簽署幾份合同？

Thanks, Yale. Since this our fiscal year end, or we're at the end of -- almost at the end of June, and we're going to report early in August, it's about six weeks difference between now and then. So I don't know how much update there will be.

謝謝，耶魯。自從我們的財政年度結束，或者說我們已經到了六月底，我們將在八月初報告，從現在到那時大約有六週的時間差。所以不知道會更新多少。

You would anticipate that based on the number of contracts we have and we've signed, well, there'll probably be a few more by the time we get there August, but it's not going to be a material difference in six weeks. So but again, we'll be making progress. I think that there should be a material difference when we report in November, for sure. It's just these are very tight, our fiscal year and their fiscal first quarter.

你可能會預計，根據我們擁有和簽署的合同數量，到八月份我們到達那裡時可能還會有更多合同，但六週內不會有實質性差異。所以，我們會再次取得進展。我認為，當我們在 11 月份發布報告時，肯定會出現重大差異。只是我們的財政年度和他們的第一財政季度非常緊張。

Understood, that's helpful. And one other thing in terms of your -- you were expecting CE Mark later this year, and the question is that beforehand, there's a discussion in terms of partnering with XUS. Any update of that front as of now?

明白了，很有幫助。另一件事是，您預計今年晚些時候會獲得 CE 標誌，問題是在此之前，我們已經討論了與 XUS 合作的問題。目前該方面有任何更新嗎？

Yeah, I mean, we're getting close to CE Mark, so the conversations are certainly progressing with ex-US partners now that we kind of see the light with CE Mark, but again, we don't have it in hand. So I think we will have it in hand in September, maybe October time frame.

是的，我的意思是，我們正在接近 CE 標誌，因此，既然我們看到了 CE 標誌的曙光，那麼與前美國合作夥伴的對話肯定會取得進展，但同樣，我們手頭還沒有它。所以我認為我們將在九月，也許十月的時間框架內拿到它。

So I think that our talks will heat up and we'll probably see some kind of a partnership in short order after we get the CE Mark in hand. So we're pretty comfortable with the profile of the product. I think that our potential partners have seen this profile of the product. They're pretty happy with it. So things are moving along. I don't know if (multiple speakers) has anything else to add, but --

因此，我認為我們的談判將會升溫，在獲得 CE 標誌後，我們可能會在短時間內看到某種合作夥伴關係。所以我們對產品的概況非常滿意。我認為我們的潛在合作夥伴已經看到了該產品的簡介。他們對此非常滿意。所以事情正在進展。我不知道（多位發言者）是否還有其他要補充的，但是——

No, I think that the timing obviously is associated with the CE Mark and there's really nothing that should slow us down. So from my point of view, there's no product issue. It's all about this timing coinciding with CE Mark availability.

不，我認為這個時機顯然與 CE 標誌有關，並且確實沒有什麼可以讓我們放慢腳步。所以從我的角度來看，不存在產品問題。這一切都與 CE 標誌的可用性相一致。

Okay. Maybe this last question here, which is about the UNO and the Cancer. I just want to confirm that all the studies, the study so far is in combo. In other words, it's the UNO plus the checkpoint inhibitor. Is that correct or are there any single-agent studies for PK and other aspects?

好的。也許最後一個問題是關於 UNO 和癌症的。我只是想確認所有的研究，到目前為止的研究都是組合的。換句話說，它是 UNO 加上檢查點抑製劑。這是正確的嗎？是否有針對 PK 和其他方面的單藥研究？

Well, yeah. I mean, there's no PK, obviously, because it's not a systemic therapy. But, yes, I mean, we've done multiple studies with monotherapy and even the combination studies that were reported on all had monotherapy arms as well. So there's plenty of monotherapy data and, of course, the first-in-human study is monotherapy.

嗯，是的。我的意思是，顯然沒有 PK，因為它不是全身療法。但是，是的，我的意思是，我們已經進行了多項單一療法研究，甚至報告的所有聯合研究也都採用單一療法。因此，有大量的單一療法數據，當然，首次人體研究是單一療法。

So I mean, you can go to Beyond Cancer website and see all that data. It's all there. It's all out in the open and public and I encourage you to call the CEO of Beyond Cancer and have a chat with her and she can walk you through everything. But, yeah, there's a lot of monotherapy data and it's obviously very positive.

所以我的意思是，你可以訪問 Beyond Cancer 網站並查看所有這些數據。一切都在那裡。這一切都是公開的，我鼓勵您致電 Beyond Cancer 的首席執行官並與她交談，她可以引導您完成所有事情。但是，是的，有很多單一療法的數據，而且顯然非常積極。

Right, right. I'm just talking about a human study that currently is in the single-agent part. So that's very helpful. And, well, thanks a lot. I really appreciate that and congrats on the progress and looking forward to see the figures next -- not too long from now.

是的是的。我只是在談論目前處於單代理部分的人類研究。這非常有幫助。而且，非常感謝。我真的很感激這一點，祝賀所取得的進展，並期待著看到接下來的數字——不久之後。

(Operator Instructions) Suraj Kalia, Oppenheimer.

（操作員說明）Suraj Kalia，奧本海默。

Steve, can you hear me all right?

史蒂夫，你能聽到我說話嗎？

Yes, , I can, Suraj.

是的，我可以，蘇拉吉。

Perfect. Good afternoon, everyone. So a couple of questions, one for Duncan and one for you, Steve. So Duncan, let me start out with you. So appreciate some of the color you all have provided on a contract. Maybe if you could expand on it a little bit more. Like, what does the contract really mean in terms of exclusivity, average revenues, utilization? Is 600,000 the right bogey to think about?

完美的。大家下午好。有幾個問題，一個問鄧肯，一個問你，史蒂夫。鄧肯，讓我從你開始吧。因此，請欣賞你們在合同中提供的一些顏色。也許你可以再擴展一下。比如，合同在排他性、平均收入、利用率方面的真正含義是什麼？ 600,000 是值得考慮的正確柏忌嗎？

And the sub part of that question, Duncan, would be 150 demos for PH, consensus estimate for the next year is $19 million from what I see. Is the right way to think about it? The bogey you need is at least, let's say, 35 to 40 sites?

Duncan，這個問題的子部分是為 PH 進行 150 個演示，據我所知，明年的共識估計為 1900 萬美元。思考的方式正確嗎？您需要的忌諱至少是 35 到 40 個站點？

Yes, Suraj, I use 600,000 as an example. That's got nothing to do with anything. I could have said 300,000. I could have said 120,000 and 10,000 a month. I mean, that was just a simple math exercise. I wouldn't read into that number at all in any way, shape, or form.

是的，Suraj，我用 600,000 作為例子。這跟什麼都沒有關係我本來可以說30萬。我可以說每月12萬和1萬。我的意思是，這只是一個簡單的數學練習。我根本不會以任何方式、形狀或形式解讀這個數字。

And hospital contracts, of course, mean exclusivity. We have the contract with the hospital. We're the only one there. And our competitors, where they have their contracts, they're the only player with nitric oxide in those hospitals. You know, that's the game. There's no dual supply in the nitric oxide market. You don't have two separate machines in the same hospital. It's quite unique in the medical device arena.

當然，醫院合同意味著排他性。我們和醫院有合同。我們是那裡唯一的人。而我們的競爭對手，他們有合同，他們是這些醫院中唯一擁有一氧化氮的參與者。你知道，這就是遊戲。一氧化氮市場不存在雙重供應。在同一家醫院裡沒有兩台獨立的機器。它在醫療器械領域非常獨特。

So and as for size of contracts, we've said in the past that with this market, you got about 1,000 hospitals, 1,100 hospitals or so. It's a $350 million, $400 million market. You can do the average contract per hospital if you really want to do the math. So that's the best way to look at it.

至於合同規模，我們過去說過，在這個市場上，大約有 1,000 家醫院、1,100 家醫院左右。這是一個 3.5 億美元、4 億美元的市場。如果你真的想算一下，你可以計算每家醫院的平均合同。所以這是最好的看待它的方式。

I mean, we've been pretty clear on number of hospitals, size of the market. You can back into an average contract size. So please don't take the numbers I gave you in any way to mean that.

我的意思是，我們對醫院的數量、市場的規模非常清楚。您可以恢復到平均合約規模。所以請不要以任何方式把我給你的數字當成這個意思。

So Duncan, did you want to comment on any of the other points?

那麼鄧肯，您想對其他觀點發表評論嗎？

Yeah, I think that the -- so Steve obviously explained that, the dynamics. But from a sort of contractual point of view specifically, I think we said earlier, it's going to be spread over the annual monthly rate. It's going to be a twelfth of the contract and the contracts are going to very much depend on the size of hospital.

是的，我認為——所以史蒂夫顯然解釋了這一點，動態。但從某種合同的角度來看，我想我們之前說過，它將分攤到每年的月費率上。這將是合同的十二分之一，合同很大程度上取決於醫院的規模。

So unfortunately, it's kind of, you've seen one hospital and you've seen one hospital. So it really depends on how they land. It's hard to predict what the average for us will be because so many variables in each specific hospital. But the good news is once you get them, it's a little bit like an annuity, it kind of like builds on itself and you don't have to kind of repeat until the contract's up. So as we grow, that growth will start to compound.

所以不幸的是，這是一種，你看過一家醫院，你也看過一家醫院。所以這實際上取決於他們如何著陸。很難預測我們的平均值是多少，因為每個特定醫院都有很多變量。但好消息是，一旦你得到它們，它有點像年金，有點像建立在自身之上，你不必重複，直到合同到期。因此，隨著我們的成長，這種增長將開始復合。

And, Suraj, I'll comment on your consensus question if you'd like. I don't think consensus is 24 million or whatever you said. But yeah, we've given guidance as best we can in conversations with analysts about how our business works and they make their own decisions on what they're going to put in their models. So we're not going to control what you want to put into your model in any way, shape, or form.

Suraj，如果您願意，我會評論您的共識問題。我不認為共識是 2400 萬或無論你說什麼。但是，是的，我們在與分析師的對話中就我們的業務如何運作提供了盡可能好的指導，他們自己決定將在模型中添加什麼內容。因此，我們不會以任何方式、形狀或形式控制您想要放入模型中的內容。

But we have certainly not intimated in any way that this is going to be a massive launch of any size, that this is more of a slow build. Every quarter, we add hospitals and we build and we build and we build. And as we build and get more people, it starts to accelerate later on, maybe four, six, eight quarters from now, you'll see a pretty big acceleration.

但我們當然沒有以任何方式暗示這將是一次任何規模的大規模發布，這更像是一個緩慢的構建。每個季度，我們都會增加醫院，不斷建設。隨著我們建立並招募更多人員，它會在稍後開始加速，也許從現在起四個、六個、八個季度後，您會看到相當大的加速。

This is what we've been saying. We are consistently saying it. So I know there's somebody out there with a number that's close to 20 million for fiscal '24. I don't know why anybody would consider that a rational or reasonable number based on what we've been saying pre-launch and since the launch. But again, everybody's got their own way of analyzing the market.

這就是我們一直在說的。我們一直這麼說。所以我知道有人在 24 財年擁有接近 2000 萬的數字。我不知道為什麼有人會根據我們在發布前和發布後所說的內容認為這是一個合理的數字。但同樣，每個人都有自己分析市場的方式。

Got it. Steve, final question. I'll just bunch a couple of them together. So in your prepared remarks, you talked about the sites, and maybe I'm paraphrasing here, the knowledge gained from these sites about NO. I'd love to understand, what was the incremental gap you identified as you all get into Phase 2 of commercial launch?

知道了。史蒂夫，最後一個問題。我會把它們集中在一起。因此，在您準備好的發言中，您談到了這些網站，也許我在這裡解釋一下，從這些網站獲得的有關 NO 的知識。我很想知道，當你們進入商業發布的第二階段時，你們發現的增量差距是多少？

And specifically, Steve, a broader question or rather a high-level question. And multiple programs going on, right? And we appreciate the color and the progress on all of these. How do you, you and your vantage point, right, sit and decide on the ROI on the commercial launch of PS versus ASD versus other programs? Just kind of walk us through how you are thinking about it from your vantage point. What makes more sense from an ROI perspective? Gentlemen, thank you for taking my questions.

具體來說，史蒂夫，這是一個更廣泛的問題，或者更確切地說是一個高級問題。多個項目正在進行中，對嗎？我們欣賞所有這些的顏色和進展。您，您和您的有利位置，如何坐下來決定 PS 與 ASD 與其他程序的商業發布的投資回報率？請告訴我們您是如何從您的角度思考這個問題的。從投資回報率的角度來看，什麼更有意義？先生們，謝謝你們回答我的問題。

Sure, thanks, Suraj. So I'll address your first question. There's no gap in our knowledge about nitric oxide when we launched this program. It was more of, we're a company that's putting together our own customer service, which is 24/7, logistics. No one's ever had a product like this, so it's brand new to any logistics provider. Putting together a team that hasn't been together before, highly intelligent, highly experienced nitric oxide people, they still need to gel as a team.

當然，謝謝，蘇拉吉。那麼我來回答你的第一個問題。當我們啟動這個計劃時，我們對一氧化氮的了解不存在任何差距。更重要的是，我們是一家整合我們自己的客戶服務的公司，即 24/7 物流。從來沒有人擁有過這樣的產品，所以它對任何物流提供商來說都是全新的。組建一個以前從未在一起過的團隊，高度聰明，經驗豐富的一氧化氮人員，他們仍然需要凝聚成一個團隊。

Our machine, while coming through FDA, is approved and working great. There are always tweaks you can make. There are always modifications to ventilators. We need to be compatible and we couldn't do that while we were going through FDA because the design is frozen and we need to work with FDA on what we've given them. You don't make changes until later when you can try to adapt and work with ventilators. I mean, this is normal. This is classic for the medical device space and especially for a PMA product.

我們的機器雖然已通過 FDA 批准，但運行良好。您總是可以進行調整。呼吸機總是需要進行修改。我們需要兼容，但在我們通過 FDA 審查時我們無法做到這一點，因為設計已凍結，我們需要與 FDA 就我們提供給他們的內容進行合作。直到稍後您可以嘗試適應並使用呼吸機時才進行更改。我的意思是，這很正常。這對於醫療設備領域，尤其是 PMA 產品來說是經典的。

So those are the things that we were learning and honing in on the way we contract, what -- listening to the customer and adapting to their needs. We really couldn't talk to them until we got approved. So this is pretty standard. I don't think we did anything different than other companies would do, except maybe a massive company might have been a little faster than us because of the infrastructure, but it's pretty standard and that's why we needed that six to nine months of that first phase where we were learning.

這些就是我們在簽訂合同的方式上正在學習和磨練的東西——傾聽客戶的聲音並適應他們的需求。在獲得批准之前我們真的無法與他們交談。所以這是非常標準的。我不認為我們做了任何與其他公司不同的事情，除了由於基礎設施的原因，一家大公司可能比我們快一點，但它是相當標準的，這就是為什麼我們需要六到九個月的時間我們學習的階段。

As for how we do our ROI, boy, there's a lot of different ways to do ROI. I mean, you can approach it in many different ways. So there's a lot going on and nitric oxide is an untapped part of medicine, in my opinion, in the opinion of most, if not everyone, at Beyond Air. There's a lot going on with nitric oxide, as you can see, in the neuro space now with autism.

至於我們如何實現投資回報率，天哪，有很多不同的方法可以實現投資回報率。我的意思是，你可以通過多種不同的方式來處理它。因此，在我看來，在 Beyond Air 的大多數人（如果不是所有人）看來，一氧化氮是醫學中尚未開發的部分。正如你所看到的，現在自閉症的神經空間中一氧化氮發生了很多變化。

This is not something, in our opinion, that takes away from the focus on the launch of the product. That is our number-one focus, is our commercial launch, by far. And for Beyond Cancer, their number one focus is cancer. That's why we spun that program out into its own company because we didn't want to have there be an impact on our Beyond Air activities. So that's why it was separately funded and that's why there's a whole management team and group of people there doing an amazing job.

我們認為，這並不會影響產品發布的焦點。到目前為止，這是我們的首要關注點，即我們的商業發布。對於 Beyond Cancer 來說，他們的首要關注點是癌症。這就是為什麼我們將該計劃拆分為自己的公司，因為我們不想對我們的 Beyond Air 活動產生影響。這就是為什麼它是單獨資助的，也是為什麼整個管理團隊和一群人做得非常出色的原因。

So really, I guess autism is the new kid on the block, so to speak, that is different than what Beyond Air proper is doing with LungFit PH, LungFit PRO, and LungFit GO. And this is obviously very early stage. It was a great opportunity. We love what Dr. Amal at the Hebrew University has done. It's very unique and really, we hope that when we get into humans, it's going to bear itself out as it did in the mice. If it does, we can really make an impact and make a difference.

所以說真的，我認為自閉症是一個新事物，可以這麼說，這與 Beyond Air 在 LungFit PH、LungFit PRO 和 LungFit GO 上所做的事情不同。這顯然還處於非常早期的階段。這是一個很好的機會。我們喜歡希伯來大學阿邁勒博士所做的事情。它非常獨特，我們希望當我們進入人體時，它會像在老鼠身上一樣得到證實。如果確實如此，我們就能真正產生影響並做出改變。

So this is not a very expensive program at this point. It doesn't take a lot of our people at this point. As we go forward over the next 12 to 18 months, there'll be a little bit more expense, which we talked about last week when we told everyone about this program and you can refer to that in our presentation.

所以目前這並不是一個非常昂貴的計劃。目前我們不需要太多人手。隨著我們在接下來的 12 到 18 個月內前進，將會有更多的費用，我們上周向大家介紹此計劃時談到了這一點，您可以在我們的演示中參考這一點。

And it's still not that much of an incremental hit to the people on our team, especially on the commercial side. It's got nothing to do with the commercial team at all. And the people who support the commercial team, they have nothing to do. The ones who work on autism, we have statisticians and pharmacologists and so forth and scientists. They're not doing anything for the commercial launch.

對於我們團隊的人員來說，這仍然沒有帶來太大的增量打擊，尤其是在商業方面。這和商業團隊根本沒有關係。而那些支持商業團隊的人，他們卻無能為力。在研究自閉症方面，我們有統計學家、藥理學家等等以及科學家。他們沒有為商業發布做任何事情。

So yeah, it's a little bit maybe extra for me but, I like to work 100 hours a week so it's not a big deal for me. I got to fill my time somehow.

所以，是的，這對我來說可能有點額外，但是，我喜歡每週工作 100 小時，所以這對我來說沒什麼大不了的。我必須以某種方式填補我的時間。

So this is a big program but it's early stage and, you know, perhaps in 12 to 18 months or 18 to 24 months when we're in a human study and we're getting results, then it might take on a little bit more need and more focus and that's when the ROI really needs to be discussed because I don't want to take away from the other programs. But we'll see when we get there and we'll see how this program progresses.

所以這是一個很大的計劃，但它還處於早期階段，你知道，也許在 12 到 18 個月或 18 到 24 個月內，當我們進行人體研究並且我們得到結果時，那麼它可能需要更多的時間需要更多的關注，這就是真正需要討論投資回報率的時候，因為我不想從其他計劃中獲益。但當我們到達那裡時，我們會看到這個計劃的進展情況。

So that's kind of how we look at it. Cancer, we realized, was too big for our bridges and at that time and we moved it over to have a great team run it, who people who are cancer experts.

這就是我們的看法。我們意識到，癌症對我們的橋樑來說太大了，當時我們把它移交給了一個偉大的團隊來管理它，他們都是癌症專家。

In this situation, I don't think autism has risen to the point where we need so-called autism experts or neurological expertise. Although I would like to point out that our new Chief Medical Officer has certainly done a lot of work in nitric oxide, actually did a PhD thesis in nitric oxide way back in the day when he was younger and has done work in neurological space with respect to nitric and has done work in other neuro areas that are non-nitric related. So he brings some expertise there to help out Dr. Amal in Israel in his lab and some of the other people that we have on our team.

在這種情況下，我認為自閉症還沒有上升到我們需要所謂的自閉症專家或神經學專業知識的地步。儘管我想指出，我們的新首席醫療官確實在一氧化氮方面做了很多工作，實際上早在他年輕的時候就寫過一篇關於一氧化氮的博士論文，並且在神經學領域做了尊重的工作並在其他非硝酸相關的神經區域進行了研究。因此，他帶來了一些專業知識來幫助以色列的阿邁勒博士的實驗室以及我們團隊中的其他一些人。

So again, that's kind of how we look at it. And if there's something that's going to impact our commercial launch, we just defer. We don't we don't take it. We don't bring it in-house. It's not worth it.

再說一次，這就是我們的看法。如果有什麼事情會影響我們的商業發布，我們就會推遲。我們不接受，我們不接受。我們不把它帶入內部。這不值得。

Appreciate the color.

欣賞顏色。

There are no further questions in the queue. I'd like to end the call back to you Steve Lisi for closing remarks.

隊列中沒有其他問題。我想結束通話，史蒂夫·利斯 (Steve Lisi)，請您發表結束語。

I'd like to thank everybody for joining us today. Thanks for keeping track of us and we hope to give you some more good news as we go forward. Thank you.

我要感謝大家今天加入我們。感謝您關注我們，我們希望在我們前進的過程中給您帶來更多好消息。謝謝。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路並度過美好的一天。