Beyond Air Inc (XAIR) 2024 Q3 法說會逐字稿

Good afternoon, and welcome, everyone to the Beyond Air financial results call for the fiscal quarter ended December 31st, 2023. At this time, participants are in a listen only mode. A question and answer session will follow the formal presentation. And now I'd like to turn the call over to Corey Davis, LifeSci Advisors. Please go ahead.

下午好，歡迎大家參加 Beyond Air 截至 2023 年 12 月 31 日的財政季度的財務業績電話會議。此時，參與者處於只聽模式。正式演講後將舉行問答環節。現在我想將電話轉給生命科學顧問科里戴維斯 (Corey Davis)。請繼續。

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

謝謝你，接線生。大家下午好，感謝您今天加入我們。收盤後，我們發布了新聞稿，宣布 2024 年第三季的營運亮點和財務表現。您可以在我們的網站 www.JohnDeere.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 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 could cause actual results to differ materially from those indicated.

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了出於《1995 年以後私人證券訴訟改革法案》中安全港條款的目的的前瞻性陳述。 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有重大差異。

We encourage everyone to review the Company's filings with the Securities and Exchange Commission, including, without limitation, the Company's most recent Form 10-K and Form 10-Q, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. Additionally, this conference call is being recorded and will be available for audio replay broadcast on our website beyond their dot-net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 12, 2024 and beyond. Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me today on the call are Steve Lisi, Chairman and Chief Executive Officer, and Douglas Larson, Chief Financial Officer. With that, I'll turn it over to Steve Lisi. Go ahead, Steve.

我們鼓勵大家查看公司向美國證券交易委員會提交的文件，包括但不限於公司最新的10-K 表格和10-Q 表格，其中確定了可能導致實際結果或事件與實際結果或事件存在重大差異的具體因素。前瞻性陳述中所描述的內容。此外，本次電話會議正在錄製中，並將在我們的網站上進行音訊重播。此外，本次電話會議的內容包含時間敏感訊息，僅截至直播日期（2024 年 2 月 12 日及以後）準確。Air 不承擔修改或更新任何聲明以反映本次電話會議之後發生的事件或情況的義務。今天與我一起參加電話會議的還有董事長兼執行長史蒂夫·利斯 (Steve Lisi) 和財務長道格拉斯·拉爾森 (Douglas Larson)。這樣，我就把它交給 Steve Lisi。繼續吧，史蒂夫。

Thanks, Corey, and good afternoon to everyone joining us today. Today, we announced a strong step in the right direction with a greater than 60% increase in revenue this quarter. Versus last quarter. While this is a small number in absolute terms, there are several factors that give us confidence in hitting our fiscal year 2025 revenue guidance of $12 million to $16 million. Filters shipped in fiscal 3Q grew by more than 100% compared with shipments in fiscal 2Q. It's important to note that this growth has not yet reflect the software upgrade received from the FDA in September as it takes time for such a manufacturing change to result in upgraded systems, our first new hospital start with the updated system was on February first. As this rollout of the new machines has just begun, the financial impact in the March quarter will be a bit muted as compared with the levels of revenue we expect to see in the June quarter.

謝謝科里，今天加入我們的大家下午好。今天，我們宣布朝著正確的方向邁出了一大步，本季營收成長了 60% 以上。與上季相比。雖然從絕對值來看這個數字很小，但有幾個因素讓我們有信心達到 2025 財年 1,200 萬至 1,600 萬美元的收入目標。與第二財季相比，第三財季過濾器的出貨量增加了 100% 以上。值得注意的是，這種成長尚未反映9 月從FDA 收到的軟體升級，因為這種製造變革需要時間來實現系統升級，我們的第一家新醫院是在2 月1 日開始使用更新系統的。由於新機器的推出剛剛開始，與我們預計在六月季度看到的收入水平相比，三月季度的財務影響將有點輕微。

It is important to understand that we will maintain a balance for the next several months between upgrading our existing customer base and adding new customers. The increase in demand for product evaluations has surged since our upgraded system was displayed at the American Academy of respiratory care in early November. Since the conference we have completed started or definitively scheduled as many evaluations as we have completed in the previous 10 months.

重要的是要了解，我們將在接下來的幾個月中在升級現有客戶群和增加新客戶之間保持平衡。自 11 月初我們的升級系統在美國呼吸護理學會展示以來，對產品評估的需求激增。自會議以來，我們已經開始或明確安排了與過去 10 個月完成的評估一樣多的評估。

Prior to the upgraded system, we had zero multiyear contracts. I am pleased to announce today that we now have three such engagements with more multiyear requests than single year requests by a wide margin. For reference, upgrading our software removes all compatibility issues, reduces system noise improves alarms and improves sensor accuracy. We have told every hospital that we welcome it head to head comparison with any competitor in their hospital.

在升級系統之前，我們的多年合約為零。我今天很高興地宣布，我們現在有三個這樣的業務，其多年期請求遠遠多於一年期請求。作為參考，升級我們的軟體可以消除所有相容性問題，降低系統噪音，改善警報並提高感測器精度。我們已經告訴每家醫院，我們歡迎它與他們醫院的任何競爭對手進行正面比較。

However, not surprisingly, we have had very few instances where a competitor was willing to sit in the same room with us at a hospital to cycle through multiple use cases with our system and their system, while still in its early stages. We have also been pleased with the progress made since securing our innovative technology contract award from Vizient, the nation's largest provider driven healthcare performance improvement company we're excited by this opportunity to expand our reach through the Visium customer network.

然而，毫不奇怪的是，我們很少有競爭對手願意與我們坐在醫院的同一個房間，用我們的系統和他們的系統循環使用多個用例，而這仍然處於早期階段。我們也對從 Vizient 獲得創新技術合約以來所取得的進展感到高興，Vizient 是美國最大的供應商驅動的醫療保健績效改進公司，我們很高興有機會透過 Visium 客戶網路擴大我們的影響力。

We also anticipate adding LungFit PH to more group purchasing organization platforms over the course of the next year to capitalize on this positive growth trajectory who will continue to build out a field team based on the growth opportunities as they evolve. One last point to make on the US nitric oxide market. Our PMA supplement for the expansion of our label to include cardiac surgery was accepted and is under substantive review by the FDA. Our clinical and regulatory team is to be commended for putting together a strong submission.

我們也預計在明年將 LungFit PH 添加到更多團體採購組織平台，以利用這一積極的成長軌跡，他們將繼續根據發展機會建立現場團隊。關於美國一氧化氮市場的最後一點。我們用於將我們的標籤擴展至包括心臟手術的 PMA 補充劑已被接受，並正在接受 FDA 的實質審查。我們的臨床和監管團隊提交了一份強而有力的意見書，值得讚揚。

While there is no firm date for FDA to complete their review, we would expect a decision before the end of calendar 2024. Once approval is received, we anticipate an impact on revenue growth after a few months. Looking outside of the United States, we still expect to receive CE Mark in the first half of calendar year 2024. As we have mentioned previously, in addition to opening up doors in Europe for our system receiving the CE Mark will trigger a milestone payment from our partner, yet Healthcare, which has signed an agreement with us to commercialize LungFit PH in several countries in the Asia-Pacific region, excluding Japan.

雖然 FDA 沒有確定完成審查的日期，但我們預計在 2024 年底前做出決定。一旦獲得批准，我們預計幾個月後將對收入成長產生影響。展望美國以外的地區，我們仍預計在 2024 年上半年獲得 CE 標誌。正如我們之前提到的，除了為我們的系統在歐洲打開大門外，獲得CE 標誌將觸發我們的合作夥伴支付一筆里程碑式的付款，而醫療保健公司已與我們簽署了一項協議，將LungFit PH 在亞洲多個國家進行商業化-太平洋地區，不包括日本。

Moving on to our pipeline, during the quarter beyond cancer announce that its Phase one study evaluating ultrahigh concentration, nitric oxide or Uno in advanced relapsed or refractory unresectable primary or metastatic cutaneous and subcutaneous solid tumors it cleared the first cohort of 25,000 parts per million, single-dose Uno by the safety review committee with no reported dose-limiting toxicities. This means that there is a low dose of 25,000 parts per million nitric oxide that is safe for human use. And given the data shown in November at the Citi conference, there should be confidence there is an immune response, much like we saw in preclinical studies.

繼續我們的管道，在癌症之後的季度宣布其第一階段研究評估超高濃度一氧化氮或Uno 在晚期復發或難治性不可切除的原發性或轉移性皮膚和皮下實體瘤中的作用，它清除了第一批百萬分之25,000 的數據，安全審查委員會批准的單劑量 Uno 沒有報告劑量限制性毒性。這意味著一氧化氮的低劑量為百萬分之 25,000，可供人類安全使用。鑑於 11 月花旗會議上顯示的數據，應該有信心存在免疫反應，就像我們在臨床前研究中看到的那樣。

As a reminder, this is a first in human study that is being conducted in two parts, dose escalation and dose expansion the dose escalation part will consist of three Houno dose cohorts, 25,050 thousand 100,000 parts per million nitric oxide or possibly a concentration below 25,000 parts per million. The dose expansion portion of the study will begin once the recommended dose is determined with the primary objective of the trial to assess safety and tolerability of UNO with a secondary objective of assessment of efficacy by immune biomarker response to immunotherapy.

提醒一下，這是人體研究中的首次，分劑量遞增和劑量擴展兩個部分進行，劑量遞增部分將由三個Houno 劑量組組成，一氧化氮濃度為25,050 千百萬分之100,000，或者濃度可能低於25,000百萬分之幾。一旦確定了建議劑量，研究的劑量擴展部分將開始，試驗的主要目標是評估 UNO 的安全性和耐受性，次要目標是透過免疫生物標記對免疫治療的反應來評估療效。

One last note is that we anticipate completing the Phase Ia study and presenting the data in the first half of this calendar year and then initiating a Phase Ib study in the back half of the calendar year, which will include combination therapy with anti-PD-1 therapy, given the strong combination data shown to date in the preclinical setting. I encourage all of you to visit beyond cancer website to get better educated on this potential transformational therapy for those suffering from solid tumors, our viral community acquired pneumonia or recap studies underway.

最後一點是，我們預計將在今年上半年完成 Ia 期研究並提交數據，然後在今年下半年啟動 Ib 期研究，其中將包括抗 PD 聯合治療考慮到迄今為止在臨床前環境中顯示的強有力的組合數據，第1 種療法。我鼓勵大家造訪 Beyond Cancer 網站，以更深入了解這種針對實體瘤、病毒社區型肺炎患者的潛在轉化療法，或回顧正在進行的研究。

As a reminder, this randomized double-blind, placebo-controlled pilot study will treat hospitalized patients with 150 parts million nitric oxide intermittently for up to seven days due to viral pneumonia following seasonal patterns of activity. This is the seasonal study running through the fall and winter months. As a result, we have decided to conduct this study over two seasons. Thus, we expect to announce top line data by the middle of calendar year 2025 with interim data updates when appropriate.

提醒一下，這項隨機雙盲、安慰劑對照試驗研究將間歇性地治療因季節性活動模式後的病毒性肺炎而攝入 150 ppm 一氧化氮的住院患者，持續時間長達 7 天。這是貫穿秋季和冬季的季節性研究。因此，我們決定在兩個季節內進行這項研究。因此，我們預計在 2025 年年中之前公佈頂線數據，並在適當的時候進行中期數據更新。

This will not change the timing for a pivotal study in the 25 26 season. Obviously, viral pneumonia is a significant unmet medical need given the times we live in Turning to our autism program. We are pleased that the program remains on track for human data in 2025. Please recall that this early-stage development program is being conducted in partnership with the University of Jerusalem, which continues to produce exciting preclinical data.

這不會改變25-26賽季一項關鍵研究的時間表。顯然，考慮到我們所處的時代，病毒性肺炎是一個重大的未滿足的醫療需求。轉向我們的自閉症計畫。我們很高興該計劃在 2025 年繼續按計劃獲取人類數據。請記住，這項早期開發計畫是與耶路撒冷大學合作進行的，該大學繼續產生令人興奮的臨床前數據。

As a reminder, the data thus far have shown that reducing nitric oxide production by inhibiting neuronal nitric oxide synthase reduces that receipt of stress biomarkers in the brain and reverses the molecular synaptic and behavioral autism spectrum disorder associated phenotypes. To be clear, a reversal of behaviors associated with autism was demonstrated in several different genetic mouse models of Altace. We believe this program offers tremendous potential and look forward to providing updates as we progress throughout the year. Now I will turn it over to our CFO, Doug Lawson.

提醒一下，迄今為止的數據表明，透過抑制神經元一氧化氮合酶來減少一氧化氮的產生，可以減少大腦中壓力生物標記的接收，並逆轉分子突觸和行為自閉症譜系障礙相關的表型。需要明確的是，在幾種不同的 Altace 基因小鼠模型中，與自閉症相關的行為發生了逆轉。我們相信該計劃具有巨大的潛力，並期待隨著我們全年的進展提供更新。現在我將把它交給我們的財務長道格勞森。

Thanks, Steve, and good afternoon, everyone. Our financial results for the fiscal quarter ended December 31, 2023 are as follows. Revenue for the fiscal quarter was $0.4 million as compared with $0.2 million for the previous quarter and zero for the fiscal quarter ended December 31st, 2022. While we are seeing positive operating margins on our individual contracts, there are three reasons why our overall gross margin remains negative. First, we incurred costs related to the software upgrade of the LungFit devices. Note, there will be similar costs for the next two quarters as we complete the upgrade of all of our devices. Second, because we pre-built several hundred devices that are currently being upgraded. We have depreciation of devices that are not currently generating revenue. Third, consistent with the early stage of growth, we are suboptimal in our physical warehousing infrastructure but as we grow this effect will dissipate. Our supply chain is committed to being a great partner to the hospitals we engage with and having the right number of high-quality upgraded systems in the right location is key.

謝謝史蒂夫，大家下午好。我們截至 2023 年 12 月 31 日的財政季度的財務表現如下。本財季的營收為 40 萬美元，而上一季的營收為 20 萬美元，截至 2022 年 12 月 31 日的財季營收為零。雖然我們看到各個合約的營業利潤率為正，但我們的整體毛利率仍然為負有三個原因。首先，我們產生了與 LungFit 設備軟體升級相關的成本。請注意，當我們完成所有設備的升級時，接下來的兩個季度將會產生類似的成本。其次，因為我們預先建造了數百台目前正在升級的設備。我們對目前未產生收入的設備進行折舊。第三，與成長的早期階段一致，我們的實體倉儲基礎設施並不理想，但隨著我們的發展，這種影響將會消失。我們的供應鏈致力於成為與我們合作的醫院的優秀合作夥伴，在正確的位置擁有正確數量的高品質升級系統是關鍵。

Research and development expenses for the fiscal quarter were $6.8 million compared with $5 million for the fiscal quarter ended December 31st, 2022 of the $1.8 million incremental spend, $1.2 million was due to development costs associated with our pipeline, mainly from the start of our RECAP study investment continued to ramp up and beyond cancer, but this was mostly offset by favorable comps in NTM and doctors. The remaining $0.6 million was almost exclusively due to loaded salaries and beyond there's R&D team. Sg&a expenses for the fiscal quarter were $9.8 million compared with $8.9 million for the fiscal quarter ended December 31st, 2020 $0.8 million increase was mainly due to stock-based compensation and salaries with the majority being noncash compensation.

本財季的研發費用為680 萬美元，而截至2022 年12 月31 日的財季的研發費用為500 萬美元，增量支出為180 萬美元，其中120 萬美元是與我們的管道相關的開發成本，主要是從我們的回顧開始時產生的研究投資繼續增加，並超越了癌症領域，但這大部分被 NTM 和醫生的有利補償所抵消。剩下的 60 萬美元幾乎全部用於支付高薪以及研發團隊的費用。本財季的銷售、管理及行政費用為 980 萬美元，而截至 2020 年 12 月 31 日的財季為 890 萬美元，增加 80 萬美元主要是由於股票薪酬和工資，其中大部分是非現金薪酬。

Other income and expense for the fiscal quarter showed a $0.2 million loss compared with a $0.2 million gain for the fiscal quarter ended December 31st, 2022. There's a lot of moving parts. Again, this quarter of the biggest movers are an increase in interest expense of 0.8 million, being partially offset by $0.4 million increase from gains in our marketable security for the fiscal quarter ended December 31st, 2023. On a GAAP basis, the Company recorded a net loss of $17.1 million of which $16.1 million or $0.5 per share was attributable to the shareholders of Beyond Air, Inc. compared with a net loss of $12.7 million or $0.43 a share for the fiscal quarter ended December 31st, 2022.

本財季的其他收入和支出虧損 20 萬美元，而截至 2022 年 12 月 31 日的財季則增加 20 萬美元。有很多活動部件。同樣，本季最大的推動因素是利息支出增加了 80 萬美元，部分被截至 2023 年 12 月 31 日的財政季度有價證券收益增加的 40 萬美元所抵銷。根據 GAAP 計算，該公司錄得淨虧損 1,710 萬美元，其中 1,610 萬美元或每股 0.5 美元應歸屬於 Beyond Air, Inc. 股東，而截至本財季的淨虧損為 1,270 萬美元或每股 0.43 美元2022 年12 月31 日。

Net cash used in the quarter ended December 31st, 2023 was $12.7 million. We alluded to a higher cash burn this quarter in our last call with payments required towards our RECAP study development of our Gen two device continued in human trials and beyond cancer and advances in our autism program. We also raised $5.5 million on our ATM in the quarter to partially compensate the planned cash burn as of December 31st, 2023, the company had cash, cash equivalents and marketable securities of $31.4 million. And as a reminder, we also have $5.2 million held on deposit by our contract manufacturer. And with that, I'll hand the call back to Steve.

截至 2023 年 12 月 31 日的季度所使用的淨現金為 1,270 萬美元。我們在上次電話會議中提到本季的現金消耗較高，因為我們第二代設備的 RECAP 研究開發需要支付費用，該研究開發繼續進行人體試驗，超越癌症和自閉症計畫的進展。我們還在本季透過 ATM 籌集了 550 萬美元，以部分補償截至 2023 年 12 月 31 日計劃的現金消耗，該公司擁有現金、現金等價物和有價證券 3,140 萬美元。提醒一下，我們的合約製造商還持有 520 萬美元的存款。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) Jason Bednar, Piper Sandler.

（操作說明）Jason Bednar、Piper Sandler。

Good afternoon, thanks for taking the questions here, guys. If I could just start maybe in some of the recent developments, clearly some more steps forward on the contracting front. Some Wendy mentioned there that's all good. When I step back and think about where we're at in the context of your $12 million to $16 million revenue guidance for next year, you're clearly signaling confidence about future contracting as well. So when I guess when I back that up and needing a good jumping off point to exit this year in order to move into that $12 million to $16 million range. And also consider January tends to be, I think, a good contracting period, early sort of discussions happening here at the New Year. Can you talk about maybe the commercial signals you've seen you're early in calendar 24.

下午好，謝謝你們在這裡提出問題，夥計們。如果我可以從最近的一些事態發展開始，顯然在合約方面向前邁出了更多的一步。溫迪有些人提到那很好。當我退後一步思考我們在明年 1200 萬至 1600 萬美元收入指導的背景下所處的位置時，您清楚地表明了對未來合約的信心。因此，當我想當我支持這一點並需要一個好的起點來今年退出時，才能進入 1200 萬美元至 1600 萬美元的範圍。我認為，還要考慮到一月往往是一個很好的簽約期，新年期間會進行早期的討論。您能談談您在日曆 24 早期看到的商業訊號嗎？

Sure.

當然。

Thanks, Jason. Appreciate the question. Like we mentioned in some of the prepared remarks, seeing seeing customers asking for longer term contracts with us locking us in, which is very good. We're very happy to do so they want to contract for the long term with us some confidence in our system, especially with the upgraded software. And we're seeing, as I said earlier in the prepared remarks, a massive increase for us in requests for evaluating our system. So we are we are scheduled consistently over the next six to eight weeks, and we're scheduling more beyond that. So the interest is certainly there.

謝謝，傑森。感謝這個問題。就像我們在一些準備好的評論中提到的那樣，看到客戶要求與我們簽訂長期合同，從而鎖定我們，這非常好。我們很高興這樣做，他們希望與我們簽訂長期合同，因為我們對我們的系統有信心，尤其是升級後的軟體。正如我之前在準備好的演講中所說，我們看到評估我們系統的請求大幅增加。因此，我們在接下來的六到八週內始終如一地進行安排，並且我們正在安排更多的時間。所以興趣肯定是存在的。

And again, we are attending to our existing customers as well as entertaining new customers. And in parallel now and for the next couple of months, our existing customer base is very important to us. They have helped us understand how to optimize our system and they've been working with with the system prior to the software update. So we appreciate that and want to take care of them as well as bring in some new customers as well. So once they are taken care of and we can focus our efforts 100% on new customers that that will that will be very exciting for us.

再說一次，我們在照顧現有客戶的同時也在招待新客戶。同時，現在和接下來的幾個月，我們現有的客戶群對我們來說非常重要。他們幫助我們了解如何優化我們的系統，並且在軟體更新之前他們一直在與系統合作。因此，我們對此表示讚賞，並希望照顧他們並引入一些新客戶。因此，一旦他們得到照顧，我們就可以將我們的努力 100% 集中在新客戶上，這對我們來說將是非常令人興奮的。

As a team. And this is not just the Gen one start for hospitals. You mentioned that's certainly a busy time at the end, Jan one beginning of the year, but there are other points in the year where there's lots of contracts starting up July one being probably the biggest along with Gen one. So there's a lot going on. There are starts we just like I mentioned early, we have started to start on Feb first, their hospital starting mid month, their hospital starting on the first of every month.

作為一個團隊。這不僅僅是醫院的第一代開始。您提到，年底（即年初）肯定是一個繁忙的時期，但一年中的其他時間點，有很多合同從 7 月開始，可能是最大的合同，與第一代合同一樣。所以發生了很多事情。我們就像我之前提到的，我們已經開始從二月一號開始，他們的醫院從月中開始，他們的醫院從每個月的一號開始。

So it's just a matter of us having the supply available and making sure that our existing customers is taken care of. And so we see what's coming. We're very excited about it, and we'll be adding people to the team to be able to handle what's coming in the next three to six months from. So that's all I can say. I mean, I don't know what else you want, what are the metrics you need, but if you need some more metrics, just just go ahead and ask.

因此，我們只需要提供可用的供應並確保我們現有的客戶得到照顧。所以我們看看接下來會發生什麼。我們對此感到非常興奮，我們將在團隊中增加人員，以便能夠處理未來三到六個月內發生的事情。我只能說這麼多。我的意思是，我不知道您還想要什麼，您需要什麼指標，但如果您需要更多指標，請繼續詢問。

No, that's super helpful. I am just trying to get more anecdotal and qualitative to get a sense. And it sounds like things are moving in the right direction for sure. And maybe I'll use your your personnel reference there to segue to the next question and more just anymore color you can give around Duncan's departure on just maybe how quickly you're looking to backfill the spot on. You're obviously at a critical inflection point commercially, I just want to make sure there's I'll call it a seamless and quick transition here.

不，這非常有幫助。我只是想透過更多的軼事和定性來了解情況。聽起來事情確實正在朝著正確的方向發展。也許我會用你的人事參考來繼續下一個問題，以及更多關於鄧肯離開的信息，你可能希望以多快的速度填補這個空缺。顯然，你正處於商業上的關鍵轉折點，我只是想確保我將其稱為無縫且快速的過渡。

Yes, Tom, I think that the transition will be seamless from. I don't know when we'll have someone new in that role starting up, but we have a pretty strong team here internally. So we're certainly working together as a team to bring these things forward. I wish Duncan the best and he's done a great job for us, but we're focused on the task at hand, and I think we have the right people at the company right now. And obviously, we need to add as we grow as opportunities come our way.

是的，湯姆，我認為過渡將是無縫的。我不知道我們什麼時候會有新人擔任這個職位，但我們內部有一支非常強大的團隊。因此，我們當然會作為一個團隊共同努力推動這些事情的發展。我祝鄧肯一切順利，他為我們做了出色的工作，但我們專注於手頭上的任務，我認為我們公司現在擁有合適的人選。顯然，隨著機會的到來，我們需要隨著我們的成長而增加。

But then we're going to wait for the right person, bringing in the wrong person because we need someone quickly is not the right attitude. So I think that with what we have in place, we certainly we can wait for the right person to come. Our way, whether that be in 30 days, 60 days or 180 days. I can tell you that right now I don't know, but I don't want the right person that will.

但我們會等待合適的人，因為我們很快就需要人而引入錯誤的人，這不是正確的態度。所以我認為，憑藉我們現有的條件，我們當然可以等待合適的人選。我們的方式，無論是 30 天、60 天或 180 天。我可以告訴你，現在我不知道，但我不想要對的人知道。

Okay.

好的。

It makes sense.

這說得通。

And then one last one, Doug, I appreciate the help on some of the gross margin moving parts. I know it's super early days here, but just trying to get a sense, is there a way to quantify or stripping out strip out what some of those one-time costs would have been? It sounds like they were elevated here in the second quarter sorry, the fiscal third quarter and there, but they're going to be there for the next two quarters. Just trying to get a sense as we model this out appropriately, what median adjusted gross margin would have looked like or adjusted cost of goods sold would have looked like for you in the quarter?

最後一點，道格，我很感謝您對某些毛利率變動部分的幫助。我知道現在還處於早期階段，但只是想了解一下，是否有一種方法可以量化或剔除其中一些一次性成本？聽起來抱歉，他們在第二季、第三財季和那裡都得到了提高，但他們將在接下來的兩個季度保持這種水平。當我們適當地建模時，只是想了解一下，本季調整後毛利率中位數或調整後銷售商品成本會是什麼樣子？

Yes.

是的。

Thanks, Jason.

謝謝，傑森。

I am a little hesitant to break out the pieces. But between the depreciation on machines that are deployed and refits for the devices that we were upgrading the software on, we're talking somewhere between four and 500,000 in the quarter. So that I hope that gives you kind of an idea of I think that that'll recur next quarter again.

我有點猶豫要不要把碎片拆開。但在已部署機器的折舊和我們升級軟體的設備的改裝之間，我們談論的季度數量在 4 到 50 萬台之間。因此，我希望這能讓您了解我認為這種情況會在下個季度再次出現。

And then as the sales pick up and we are done upgrading all the devices. Those numbers are going to disappear. And then as we get more revenue, obviously, those that depreciation just becomes a normal part of our cost of sales at.

然後隨著銷售量的回升，我們就完成了所有設備的升級。這些數字將會消失。然後，隨著我們獲得更多收入，顯然，那些折舊就成為我們銷售成本的正常部分。

Perfect. Thanks so much.

完美的。非常感謝。

Yes.

是的。

Les Sulewski, Truist Securities.

Les Sulewski，Truist 證券公司。

Good evening.

晚安.

Thanks for taking my questions. Steve, just on the on the environment in the hospital setting, can you just true up how the pricing environment is driving the decisions among the hospital groups that you are engaging? And then I guess second part to that, just give a little more color, if you could around the sizing of the new of the three new engagements you've mentioned and won't be what are your expectations on the conversion rate on that?

感謝您回答我的問題。史蒂夫，關於醫院環境中的環境，您能否準確地說明定價環境如何推動您參與的醫院集團的決策？然後我想第二部分，如果你能圍繞你提到的三個新活動中的新活動的規模提供更多的色彩，那麼你對轉換率的期望是什麼？

Let me start with that.

讓我從那開始。

What do you mean by conversion rate on that conversion renewal you actually mentioned. So we have those contracts. Those are and those are just multi-year deals, data and okay, once it goes, those are not going to give a little more color on the sizing of that, if that's possible, um, I would say that the two of them are probably slightly below market average and one of them is almost double what you consider market average. So these are good-sized contracts.

您實際提到的轉換續訂的轉換率是什麼意思？所以我們有這些合約。這些只是多年期的交易、數據，好吧，一旦完成，這些不會在規模上提供更多的色彩，如果可能的話，嗯，我想說他們兩個是可能略低於市場平均水平，其中一個幾乎是您認為的市場平均值的兩倍。所以這些都是規模很大的合約。

I really want to give too much detail on it, but these are these are good-sized hospitals, some they're doing pretty good volume even the two ones that I would consider to be a little bit below what the average size hospital would be pretty good volume. But the other one is slot volume and weakness there's patients a lot of patients on every single day. I mean, we have got over 20 machines in that hospital, big hospital. So some hope that helps.

我真的想提供太多細節，但這些都是規模不錯的醫院，有些醫院的治療量相當不錯，甚至我認為略低於平均規模醫院的兩家醫院相當不錯的音量。但另一個問題是槽位容量和弱點，每天都會有很多病人。我的意思是，我們那家醫院，大醫院，有 20 多台機器。希望有幫助。

So let me go back to your prior question for Tom. You know, its price certainly plays a role. There's no doubt about it, um, I think that's true. In many situation. The hospital wants to get the best price that they can. And but that's not the only thing that plays into a decision for the hospital, but it certainly plays a role. I mean, we can't can't be naive to that fact and know I think that I've said this before. I think that the the pricing environment is not too far off from what we expected when we entered this market.

讓我回到你之前問湯姆的問題。你知道，它的價格確實發揮了作用。毫無疑問，嗯，我認為這是真的。在很多情況下。醫院希望獲得盡可能最好的價格。但這並不是影響醫院決策的唯一因素，但它確實發揮了作用。我的意思是，我們不能天真地對待這個事實，並且知道我認為我以前已經說過這​​一點。我認為定價環境與我們進入這個市場時的預期相去不遠。

It's pretty much in within the range that we anticipated. Some from some hospitals will get better pricing than others based on certain factors. Volume being probably the biggest factor. But Tom, I don't think it's the only factor and I don't want to give you the impression that this is a race to the bottom in this market for price is just not true. I think it's a healthy pricing environment. Got it.

基本在我們預期的範圍之內。基於某些因素，某些醫院的某些醫院會比其他醫院獲得更好的定價。數量可能是最大的因素。但是湯姆，我不認為這是唯一的因素，我不想給你這樣的印象：這是這個市場上的逐底競爭，因為價格是不正確的。我認為這是一個健康的定價環境。知道了。

Very helpful. On the RECAP study, can you just give a little bit more color how this one zone extend into two seasons and then separately under one fold increase on your filter shipments, can you, um, you know, translate that into utilization or is this a seasonal inventory stocking just just give a little more commentary on that, if you could.

很有幫助。在RECAP 研究中，您能否提供更多信息，說明這一區域如何延伸到兩個季節，然後分別使您的過濾器出貨量增加一倍以下，您能否，嗯，您知道，將其轉化為利用率，或者這是一個如果可以的話，季節性庫存庫存只是對此進行更多評論。

Yes, there's no seasonal inventory stocking here for this stuff that just just the growth. I mean that's just the way the numbers are what the numbers are. There's nothing's new seasonality about it. There's no no stocking up. I mean these hospitals normally they're ordering what they need for the next depends on the hospital next 30, 60, 90 days. I mean, it's really individual hospitals will have different needs, but they don't need to stock up a year's supply of the stuff you're not this is not how it works. So it's just the true true growth from Dan on the RECAP study, I mean, look, this is a safety study. If you're doing efficacy needs to be in one season.

是的，這裡沒有季節性庫存庫存，只是成長的東西。我的意思是，數字就是這樣。它沒有什麼新的季節性。沒有不囤貨的。我的意思是，這些醫院通常會訂購接下來需要的物品，具體取決於醫院接下來的 30 天、60 天、90 天。我的意思是，每個醫院確實會有不同的需求，但他們不需要儲備一年的供應，這不是它的運作方式。所以這只是 Dan 在 RECAP 研究中真正的成長，我的意思是，看，這是一項安全研究。如果你做功效需要在一個季節。

Safety doesn't necessarily need to be in one season on given that we won't change our date for a pivotal study and to take a little pressure off my team. We got got the approval late and in the June quarter last year was tight to get all the sites up and running on time for the season. So we made a decision around Thanksgiving that we would extend this over two seasons. It was always something that was in our back pocket just in case, but we just couldn't just couldn't get all the sites up and running as quickly as needed. And rather than trying to spread ourselves, then we decided to focus on a couple of core centers and we'll spread it out.

鑑於我們不會改變一項關鍵研究的日期並減輕我的團隊的一點壓力，安全不一定需要在一個賽季中進行。我們很晚才獲得批准，去年六月季度的所有站點都非常緊張，無法按時啟動並運行所有站點。因此，我們在感恩節前後做出了決定，將這項活動延長兩個賽季。它總是放在我們後口袋裡以防萬一，但我們就是無法根據需要快速啟動和運行所有網站。然後我們決定專注於幾個核心中心，然後將其分散開來，而不是試圖分散自己。

I think it's the best way to go. I'm trying to get it done in one season given the short timeframe we gave it a shot. I don't think we didn't, but you have to make a decision before we really got into the swing of the season on that, and that's what we did. So it was always something we considered internally some again, as long as it doesn't push out or pivotal study start? I don't think it, sir. I don't think it's a problem at all. I think it's actually the right thing to do given the situation. Got it.

我認為這是最好的方法。鑑於我們嘗試的時間很短，我試圖在一個賽季內完成它。我不認為我們沒有，但在我們真正進入賽季的搖擺之前你必須做出決定，這就是我們所做的。因此，只要它不被推出或關鍵研究開始，我們總是會在內部再次考慮這個問題？我不這麼認為，先生。我認為這根本不是問題。我認為鑑於目前的情況，這實際上是正確的做法。知道了。

That's helpful. Maybe from a high level, could you kind of quantify the pecking order, your pipeline strategy and anything that could be pushed back further if you see if there's risks involved, whether it's financial or time on.

這很有幫助。也許從較高的層面來看，如果您發現是否涉及風險，無論是財務風險還是時間風險，您是否可以量化優先順序、管道策略以及任何可能進一步推遲的事情。

Yes.

是的。

Any kind of color around the high-level strategy process and thoughts around the pipeline.

圍繞高層策略流程的任何顏色和圍繞管道的想法。

I mean, I think we're pretty much showing everybody what we're doing. I mean VCAP. cancer, autism are the ones that we are working on right now. Again, autism is relatively inexpensive compared to the other two programs. Obviously, I mean, now it's preclinical. It's not costing us a lot. And I think once you're getting into first-in-human for that one in 25 and getting some data, I mean, that's not a high cost. I mean, when we start to go into, you know, maybe Phase Ib or Phase IIa for that program. That's when the costs will really kick in on. But until that it's not overly expensive.

我的意思是，我認為我們幾乎向所有人展示了我們正在做的事情。我的意思是VCAP。癌症、自閉症是我們現在正在研究的疾病。同樣，與其他兩個項目相比，自閉症治療相對便宜。顯然，我的意思是，現在它處於臨床前階段。這並沒有花費我們太多。我認為，一旦你進入了 25 分之一的人體試驗並獲得了一些數據，我的意思是，這並不是一個很高的成本。我的意思是，當我們開始進入該計劃的第一階段或第二階段時。到那時，成本才會真正顯現出來。但在那之前它並不太貴。

Ntm is our next program up from I think we'll be meeting with FDA before the end of this year calendar year. That is to get some ideas from them and work with them on our trial design.Hopefully, that will be a pivotal trial design. That's our goal from COPD, obviously has not been moving forward. That's evident in our corporate presentation. So that's the one that's kind of just sitting now on hold the moment bronchiolitis also on hold. I think that's been clear for the last couple of years.

Ntm 是我們的下一個計劃，我認為我們將在今年年底之前與 FDA 會面。那就是從他們那裡得到一些想法，並與他們一起進行我們的試驗設計。希望這將是一個關鍵的試驗設計。這是我們針對慢性阻塞性肺病的目標，顯然尚未有進展。這在我們的公司演示中很明顯。因此，當細支氣管炎也被擱置時，這就是一種暫時擱置的方法。我認為過去幾年這一點已經很清楚了。

So I think it's very clear what our priorities are in the pipeline on where they are so I don't know if there's I don't know if I answered your question, but I think I gave the rank there. No doubt that.

所以我認為我們的優先事項非常清楚，所以我不知道是否有我不知道我是否回答了你的問題，但我想我在那裡給了排名。毫無疑問。

That's helpful. Thank you for that, Steve.

這很有幫助。謝謝你，史蒂夫。

Appreciate your.

欣賞你的.

Yes.

是的。

Yale Jen, Laidlaw & Company.

耶魯‧詹 (Yale Jen)，萊德勞公司。

Good afternoon and thanks for taking the questions. At least the stuff on the LungFit PH or have you guys actually reported or what's the total number of hospital has been using the system, including the three multi contract for that to be used are already using the device?

下午好，感謝您提出問題。至少 LungFit PH 上的內容或你們是否實際報告過，或者已經使用該系統的醫院總數是多少，包括要使用的三個多重合約已經在使用該設備？

Yes, yes, we haven't said how many hospitals are out there. We don't want to give any information out to the general public about how many hospitals we're in where they are, who they are so on. We're not going to we're not going to comment on that, but.

是的，是的，我們還沒有說那裡有多少家醫院。我們不想向公眾透露任何關於我們有多少家醫院、他們在哪裡、他們是誰等等的資訊。我們不會對此發表評論，但是。

Okay, that's fine. That's good. Maybe just a little bit more color in terms of the software update. So in terms of the specific or a channel aspect of the updates of which, Craig, yes, maybe a different mix, a significant difference compared to the previous to the earlier one.

好吧，沒關係。那挺好的。也許只是在軟體更新方面多了一點色彩。因此，就更新的具體或管道方面而言，克雷格，是的，也許是不同的組合，與先前的更新相比，有顯著的差異。

Yes. So just a little accounting background when we froze the design of our system in early 2019, so then we had this lovely global pandemic. So it took a while to extended the time to submission extended time to approval. So there's there's a lot of things that, you know, 3.5 years of this kind of no changes in our system where the rest of the world is having changes makes it difficult for us to catch up right away. So And essentially this software update gave us a optimal accuracy with our sensors for monitoring and our delivery system gave us compatibility with all the systems out there.

是的。因此，當我們在 2019 年初凍結系統設計時，只有一點會計背景，然後我們就遇到了這場可愛的全球流行病。所以花了一段時間才延長了提交時間，延長了審批時間。所以，有很多事情，你知道，我們的系統 3.5 年沒有發生任何變化，而世界其他地方正在發生變化，這讓我們很難立即趕上。因此，本質上，這次軟體更新為我們的監控感測器提供了最佳的準確性，而我們的交付系統使我們能夠與現有的所有系統相容。

Some that were that are important, I would say all the systems on think were incompatible with anything at this moment in time. That's very important for us to be compatible with all the the ventilators and that are out there that are used. There's a little bit of noise from some of compressors. So the software is able to reduce that noise. And I think that was a big, big deal, but certainly nicer for the hospitals that have that come and we're able to improve on the alarms. So that's really it. I think the compatibility and the sensor accuracy are probably the two biggest things that it did for us.

有些很重要，我想說的是，Think 上的所有系統此時此刻都與任何東西都不相容。對我們來說，與所有正在使用的呼吸器相容非常重要。一些壓縮機有一點噪音。因此該軟體能夠減少噪音。我認為這是一件非常非常大的事情，但對於已經到來的醫院來說肯定更好，我們能夠改進警報。就是這樣。我認為相容性和感測器精度可能是它為我們做的最重要的兩件事。

So that's that's it. I mean, I would say though, those two things are really the driver for why we did this in a little frustrating that it took as long as it did. But it's here now and the feedback is as expected, everybody is very pleased and happy with it. And like I said earlier, we're getting a lot of a lot more interest and a lot more looks from hospitals on since we displayed this in early November at the American Academy of respiratory care.

就這樣吧。我的意思是，我想說的是，這兩件事確實是我們這樣做的驅動因素，但有點令人沮喪，因為它花了這麼長時間。但現在已經到了，回饋也符合預期，大家都非常滿意。正如我之前所說，自從我們在 11 月初在美國呼吸護理學會展示這一成果以來，我們得到了來自醫院的更多興趣和更多關注。

Okay.

好的。

Maybe my last question here is that the in terms of the NTM, just the Company recently into therapeutics is a pause there, Phase two, three study of a similar indication at this point based on, I guess, Paul efficacy as the indicated, but do you see any impact on your development in the Lafitte go for this indication?

也許我的最後一個問題是，就 NTM 而言，該公司最近進入治療學領域，目前暫停了類似適應症的第二、三期研究，我猜，基於保羅的功效，如所示，但是您認為該適應症對您在Lafitte Go 的發展有什麼影響嗎？

Or any comment on that?

或對此有何評論？

I'm sorry, what company was that you were mentioning?

抱歉，您說的是哪家公司？

I didn't hear the name.

我沒聽過這個名字。

It's called in to therapeutic oh eight and.

它被稱為治療哦八和。

Oh, yes, yes, yes. I believe that the they're using an antibiotic, is that correct, Brian, and basically, they suggest that the they have a pause, as you could see at least that the end the earnings press release, and that's the reason they paused the Phase two three study.

哦，是的，是的，是的。我相信他們正在使用抗生素，這是正確的，布萊恩，基本上，他們建議他們暫停一下，因為你至少可以看到收益新聞稿的結束，這就是他們暫停的原因二期三期研究。

Look, anything that's positive for these patients is a big win. So I'm very happy to hear that they may be able to help patients that's fantastic on. So it's more options for these patients. They have very few. So I think it's a good thing. And I think that it could even make the path easier through FDA. Perhaps we have to see we have to wait and see what happens with them. But right now, our studies are being done on top of antibiotic therapy. So I think we would just be used together with antibiotics.

看，任何對這些患者有利的事情都是一個巨大的勝利。所以我很高興聽到他們可能能夠幫助那些非常棒的患者。因此，對於這些患者來說，有更多的選擇。他們的數量很少。所以我認為這是一件好事。我認為它甚至可以使通過 FDA 的途徑變得更容易。也許我們必須等待，看看他們會發生什麼。但現在，我們的研究是在抗生素治療的基礎上進行的。所以我認為我們只會與抗生素一起使用。

I don't know if we're going to be doing any monotherapy studies in the near term. So at this point, any success with antibiotics is great for us, great for patients from nitric oxide enhances the the PFSC. and certainly helps with the tolerability of antibiotics as we've seen in our studies.

我不知道我們近期是否會進行任何單一療法研究。因此，在這一點上，抗生素的任何成功對我們來說都是偉大的，對一氧化氮增強 PFSC 的患者來說也是偉大的。正如我們在研究中看到的那樣，當然有助於提高抗生素的耐受性。

So yes, I think alacrity, I think they're part is 30 because they don't have enough efficacy on their studies.

所以是的，我認為敏捷，我認為他們的部分是 30，因為他們的學習沒有足夠的功效。

I would say it was a failure?

我會說這是失敗嗎？

Yes, I had the data today. It was it was stopped for negative reasons for negative reasons.

是的，我今天有數據。它是因為負面原因而被停止的。

It's not I really thought.

我真的不是這麼想的。

Okay. Well, that's too bad again. But these patients need options. So we're hoping that things would work for them. So it doesn't change our strategy at all. I mean, we're just going to be used with existing antibiotic background therapy arm. If there's any way we can, we can go upfront. Do you know, patients as a monotherapy, there would be great. But at this point in time, I think it's a little early to do that, but we'll speak with FDA, you never know.

好的。好吧，這又太糟糕了。但這些患者需要選擇。所以我們希望事情對他們有用。所以這根本不會改變我們的策略。我的意思是，我們將與現有的抗生素背景治療臂一起使用。如果有什麼辦法的話，我們可以先做。你知道嗎，患者作為單一療法，會有很大的好處。但目前，我認為這樣做還為時過早，但我們會與 FDA 交談，你永遠不會知道。

But in any case, this doesn't change our strategy and we are certainly a unique mechanism of action for a for treating NTM lung disease. So it is not going to change the way we look at things and our data speaks for itself. I mean, we had very strong data in the last study we did.

但無論如何，這不會改變我們的策略，我們無疑是治療 NTM 肺部疾病的獨特作用機制。因此，它不會改變我們看待事物的方式，我們的數據不言而喻。我的意思是，我們在上次研究中獲得了非常強大的數據。

So we're pretty excited about it, particularly in Florida.

所以我們對此感到非常興奮，特別是在佛羅裡達州。

Appreciated, and congrats on the progress at this moment.

讚賞並祝賀此刻所取得的進展。

Thank you. Appreciate it.

謝謝。欣賞它。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hey, good afternoon. This is Sam Lieber on for Marie and thanks for taking the questions this afternoon. Maybe I can start on the CE mark as we get closer to approval here. Just any thoughts on how to think about the ramp, both in Europe and A-Pac? Any target markets that you'd highlight for us revenue contribution and anything included in the fiscal 25 guidance for international at this time?

嘿，下午好。我是薩姆·利伯（Sam Lieber）為瑪麗發言，感謝您今天下午提出問題。當我們越來越接近批准時，也許我可以從 CE 標誌開始。關於如何考慮歐洲和亞太地區的坡道，您有什麼想法嗎？您想為我們強調的任何目標市場收入貢獻以及目前 25 財年國際指南中包含的任何內容？

Yes, Sam, I don't think that we're going to have anything from the from the European Union in 25, um, I mean, we saw to get the CE Mark and then we'll and can deal in and then we got to ramp things up and it takes time in Europe, Australia and New Zealand. I think that the TGA approval in Australia will lag the CE mark, give or take 90 days. I mean you can't be sure, but that's a rough estimate and then we'll have to ramp things up. So if there's any effect from there would be minimal in 25 fiscal 25. So I wouldn't think it would be very impactful. I think that this is more of a fiscal 26, 27 impact for us on both fronts.

是的，Sam，我認為我們不會在 25 年內從歐盟獲得任何東西，嗯，我的意思是，我們看到獲得了 CE 標誌，然後我們將並且可以進行交易，然後我們在歐洲、澳大利亞和新西蘭，這需要時間。我認為澳洲的 TGA 批准會落後於 CE 標誌，大約需要 90 天。我的意思是你不能確定，但這是一個粗略的估計，然後我們必須加強。因此，如果 25 財年有任何影響，那麼影響也很小。所以我不認為這會產生很大的影響。我認為這對我們來說更像是 26、27 財年在兩個方面的影響。

Okay. That's helpful.

好的。這很有幫助。

To think about? And maybe I can just use my follow-up here on some of the comments around adding to the field team. I guess just any way to quantify or think about that ramp here and obviously incremental contribution to operating expenses in the back half of this year in fiscal 25?

想一下？也許我可以在這裡對有關添加到現場團隊的一些評論進行後續跟進。我想有什麼方法可以量化或思考這裡的成長以及今年下半年 25 財年對營運支出的明顯增量貢獻嗎？

Yes.

是的。

I mean, we already budget for this rate. We are in our budget in our forecast. We already have people being added on. And what we're doing now is adding based upon the interest in what we see coming our way right. So we need to be prepared for this. We need to bulk up our team a little bit for the interest in our system. So it's in our budget. It's not going to change anything on whether we are one or two people had a one or two we find in a certain quarter. It's all going to smooth out over the next you know, four to six quarters.

我的意思是，我們已經為這個費率做了預算。我們的預測符合預算。我們已經有人加入了。我們現在所做的就是根據對我們所看到的正確方向的興趣進行添加。所以我們需要為此做好準備。為了對我們的系統感興趣，我們需要稍微擴充一下我們的團隊。所以它在我們的預算之內。無論我們是一兩個人，還是在某個季度發現一兩個人，這都不會改變任何事情。一切都會在接下來的四到六個季度內順利進行。

I mean, we're probably going to be where we are in 46 quarters. It's just each quarter might be a little bit different in terms of who starts when, but then this is all part of the plan. It's in our budget. It's in our guidance for burn to all their. This is nothing new. It's not going to increase our expenses. I mean, six exactly what we expect to happen when we see the demand coming, we're going to bring people on.

我的意思是，我們可能會在 46 個季度內達到現在的水平。只是每個季度的首發時間可能會有所不同，但這都是計劃的一部分。它在我們的預算之內。這是我們燒毀他們所有人的指南。這不是什麼新鮮事。這不會增加我們的開支。我的意思是，當我們看到需求到來時，我們將招募人員，這正是我們期望發生的六件事。

Okay. Well, understood. Thanks for taking the question, Steve.

好的。完全了解。感謝您提出問題，史蒂夫。

Thanks. Appreciate it.

謝謝。欣賞它。

Matt Kaplan, Ladenburg Thalmann & Co., Inc.

馬特‧卡普蘭 (Matt Kaplan)，拉登堡塔爾曼公司

Hey, guys. Thanks.

大家好。謝謝。

Thanks for taking the questions. I just wanted to if you can give us a little bit more color on your why you're confident in your in your guidance in terms of the 12 to 16 million for 2025 and what you need to see, I guess, in terms of conversions of some of these conversations that you're having with with different hospitals to achieve that?

感謝您提出問題。我只是想告訴我們您為什麼對 2025 年 12 至 1600 萬的指導充滿信心，以及我想您需要在轉化方面看到什麼為了實現這一目標，您正在與不同的醫院進行一些對話？

Thanks.

謝謝。

Matt.

馬特。

So look, you don't win them all. There's no way we expect about 1,000 here, but we do expect to be winning a good portion of these discussions that we're having from you know, what we need to see is keeping our existing customers re-signing them because a lot of the designs are coming up in the next couple of months. I think that will be important and it will also be important to bring on some new customers. What we need to see is June, July, August type things are where we believe we'll be bringing on significant numbers of new customers because we'll have already taken care of our existing customer base by the time we get out there and we'll have time to have built up our inventory to a point where we can take on more hospitals. So that's what we need to see and we're already seeing it.

所以看，你並沒有贏得所有人。我們不可能期望這裡有大約 1,000 個，但我們確實希望贏得這些討論的很大一部分，您知道，我們需要看到的是讓我們的現有客戶重新簽署它們，因為很多設計將在接下來的幾個月內推出。我認為這很重要，而且吸引一些新客戶也很重要。我們需要看到的是六月、七月、八月類型的事情，我們相信我們將帶來大量新客戶，因為當我們走出去時，我們已經照顧到了現有的客戶群，並且我們將有時間建立我們的庫存，以便我們能夠佔領更多的醫院。這就是我們需要看到的，而且我們已經看到了。

We mentioned we had the new start Fab one, we had another start in February. So it's two hospitals starting in the month of February, and we'll have more coming. I think we're going to be seeing hospitals, hospital starts and every month multiple hospital starts every month. Hopefully the sizes will vary some some small, some are medium, some are big you might even get lucky, Matt get one of those giant sized customers, we'll see. We'll see if we can break into that, that club having some of the big, big, huge uses of nitric oxide in the United States.

我們提到我們有一個新的開始 Fab one，我們在二月有另一個開始。所以從二月開始就有兩家醫院，而且我們還會有更多醫院。我認為我們將會看到醫院開工，每個月都會有多家醫院開工。希望尺寸會有所不同，有些是小號，有些是中號，有些是大號，您甚至可能會幸運，馬特會得到那些巨型客戶之一，我們拭目以待。我們將看看我們是否可以闖入這個俱樂部，該俱樂部在美國對一氧化氮有一些巨大的用途。

Okay, great. That's helpful.

好的，太好了。這很有幫助。

And then in terms of the PMA supplement for cardiac surgery on, obviously the the <unk> label and approval took a lot longer than you expected for initial indication, but how's the how's the review going as it's just starting and and how do you expect that to progress?

然後就用於心臟手術的 PMA 補充劑而言，顯然 標籤和批准花費的時間比您預期的初始適應症要長得多，但是審查進展如何，因為它才剛剛開始，您的期望如何那要進步嗎？

Is this something you expect to be completed later this year?

您預計這將在今年稍後完成嗎？

You know, Matt, I don't like to comment on things. I have no control over, but, you know, I think before the end of this calendar year is a fair assessment that we'll hear back from the FDA one way or the other, you know, it's it could be could be sooner than that. It could be it could be the summer.

你知道，馬特，我不喜歡對事情發表評論。我無法控制，但是，你知道，我認為在今年年底之前是一個公平的評估，我們將以某種方式從 FDA 收到回复，你知道，它可能會比那。可能是夏天。

It could be the fall.

這可能是秋天。

I mean, it's very difficult to pinpoint and I don't want to give a hard date here, but I would say it's going to take more than 180 days that some people may think. So please don't put 180 days. Don't don't think we're getting the approval in the month of May. I would think it's going to take several months beyond that. And right now, it's a pure guess on my part because the interactions with FDA, as you're aware, we're still a little bit short of when you would normally hear feedback from FDA?

我的意思是，這很難確定，我也不想在這裡給出一個確定的日期，但我想說，有些人可能認為這需要 180 多天。所以請不要設定180天。別以為我們不會在五月獲得批准。我認為這還需要幾個月的時間。現在，這純粹是我的猜測，因為與 FDA 的互動，正如你所知，我們距離你通常會聽到 FDA 反饋的時間還差一點？

Yes, it's we're still a little bit a ways away from getting a full full picture of FDA's first pass of our application. So that's just a guess on my part. We do feel confident in our application. We think that the data that have been generated very strong and we really look forward to discussing with FDA. I mean, my team can't wait. We're gearing up. We are sitting here twiddling our thumbs, you know, kind of prepare guess what questions will be asked and tried to be ready for. That's all we can do. So hopefully next update in June, we'll have a little bit more information for you, but right now it's just the just our opinion.

是的，我們距離全面了解 FDA 首次通過我們的申請還有一段距離。所以這只是我的猜測。我們對我們的申請充滿信心。我們認為產生的數據非常有力，我們非常期待與 FDA 進行討論。我的意思是，我的團隊等不及了。我們正在整裝待發。我們坐在這裡擺弄拇指，你知道，有點準備猜測將被問到什麼問題並嘗試做好準備。這就是我們能做的。希望在六月的下一次更新中，我們能為您提供更多信息，但現在這只是我們的意見。

All right.

好的。

Well, thanks for taking the questions.

好的，感謝您提出問題。

Perfect. Thanks, Matt. Appreciate it.

完美的。謝謝，馬特。欣賞它。

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

隊列中沒有其他問題。我想將電話轉回給史蒂夫·利斯 (Steve Lisi)，讓他致閉幕詞。

But thanks, everyone, for tuning in. Much appreciated and look forward to sharing with you our progress on the next call. Thank you.

但謝謝大家的收聽。非常感謝並期待在下次通話中與您分享我們的進度。謝謝。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation and 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祝您度過美好的一天。