Beyond Air Inc (XAIR) 2025 Q2 法說會逐字稿

Good afternoon, and welcome, everyone, to the Beyond Air financial results call for the fiscal quarter ended September 30, 2024. (Operator Instructions)

下午好，歡迎大家參加 Beyond Air 截至 2024 年 9 月 30 日的財政季度的財務業績電話會議。（操作員說明）

And now I would like to turn the call over to Corey Davis, LifeSci Advisors. Please go ahead.

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, we issued a press release announcing the operational highlights and financial results for Beyond Air's second quarter of fiscal year 2025. A copy of this press release can be found on our website, www.beyondair.net, under the News and Events section.

謝謝你，接線生。大家下午好，感謝您加入我們。今天，我們發布新聞稿，宣布 Beyond Air 2025 財年第二季的營運亮點和財務業績。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'd 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 that 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 actual results or events to differ materially from those described in the forward-looking statements.

我們鼓勵每個人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有重大差異的具體因素前瞻性陳述中描述。

Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 11, 2024. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

此外，本次電話會議正在錄製中，並將在我們的網站 Beyondair.net 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，僅截至本次直播之日（2024 年 11 月 11 日）準確。Beyond 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。

With that, I'll turn the call over to Steve Lisi, Chairman and Executive Officer of Beyond Air. Go ahead, Steve.

接下來，我將把電話轉給 Beyond Air 董事長兼執行長 Steve Lisi。繼續吧，史蒂夫。

Thanks, Corey, and good afternoon to everyone joining us. With me here today is Doug Larsen, our Chief Financial Officer. I'm excited to report that the Beyond Air team is successfully executing our commercial strategy and building positive momentum. As a result, during the quarter ended September 30, 2024, we increased our total number of hospital clients by over 60%. This is a tremendous signal to our team that the recent improvements we implemented in our marketing and customer education programs are striking the right tone with our customer base. Also, we are pleased with how our LungFit PH device is operating following the upgrades we made about six months ago.

謝謝科里，祝所有加入我們的人下午好。今天和我在一起的是我們的財務長 Doug Larsen。我很高興地向大家報告，Beyond Air 團隊正在成功執行我們的商業策略並建立積極的勢頭。因此，在截至 2024 年 9 月 30 日的季度中，我們的醫院客戶總數增加了 60% 以上。這對我們的團隊來說是一個巨大的信號，表明我們最近在行銷和客戶教育計劃中實施的改進正在與我們的客戶群形成正確的基調。此外，我們對 LungFit PH 設備在大約六個月前進行升級後的運作感到滿意。

As all of you may recall, our new Chief Commercial Officer joined us in July, and we are very pleased that the strategic initiatives put in place are having an immediate impact on customer receptivity, which has started to flow through the channel in the form of contract negotiations. We expect this success will continue to drive accelerated top line revenue growth over the following quarters as our recent sales and marketing initiatives mature.

大家可能還記得，我們​​的新商務長於 7 月加入我們，我們很高興實施的策略性舉措對客戶接受度產生了直接影響，這種影響已開始以以下形式透過管道流動：合約談判。我們預計，隨著我們最近的銷售和行銷計劃的成熟，這一成功將繼續推動接下來幾季營收的加速成長。

In addition, we announced several partnerships, including with Healthcare Links, a renowned health care advisory and contracting firm that works with GPOs and IDNs, and TrillaMed to help us engage with and distribute to the Military and Veterans Administration hospitals. And we're teaming up with business Asia consultants to provide LungFit PH to hospitals in Europe, South America, the Asia Pacific region and the Gulf Coast region, where many hospitals are unable to obtain natural oxide supply or use NO due to the difficulties associated with legacy cylinder systems that can't generate NO from ambient air like LungFit PH.

此外，我們還宣布了多項合作夥伴關係，包括與Healthcare Links（與GPO 和IDN 合作的著名醫療保健諮詢和承包公司）以及TrillaMed 合作，幫助我們與軍事和退伍軍人管理局醫院合作並向其分發產品。我們正在與亞洲商業顧問合作，為歐洲、南美洲、亞太地區和墨西哥灣沿岸地區的醫院提供 LungFit PH，這些地區的許多醫院由於相關困難而無法獲得天然氧化物供應或使用 NO傳統的氣缸系統無法像LungFit PH 一樣從環境空氣中產生NO。

We are also implementing additional strategic initiatives over the next few months that are expected to build on our momentum that will further separate us from the competition. So stay tuned.

我們還將在未來幾個月內實施其他策略舉措，預計這些舉措將增強我們的勢頭，進一步使我們在競爭中脫穎而出。所以請繼續關注。

To best position ourselves for success, we recently announced three separate financial agreements that are expected to extend our cash runway. First, we completed a private placement equity offering for $20.6 million with a select group of health care-focused investment funds and company insiders.

為了最好地為自己的成功做好準備，我們最近宣布了三項單獨的財務協議，預計將擴大我們的現金跑道。首先，我們與一群精選的專注於醫療保健的投資基金和公司內部人士完成了 2,060 萬美元的私募股權發行。

Second, we reached an agreement with Avenue Capital to extinguish their senior secured term loan for a onetime payment of $17.85 million. This agreement eliminates payments that would have been made from October 1, 2024, through June 30, 2026, of approximately $12 million. Avenue Capital also participated in a private placement equity transaction I just mentioned.

其次，我們與 Avenue Capital 達成協議，終止其優先擔保定期貸款，一次性支付 1,785 萬美元。該協議取消了從 2024 年 10 月 1 日到 2026 年 6 月 30 日期間應支付的約 1,200 萬美元的款項。Avenue Capital也參與了我剛才提到的一項私募股權交易。

Third, we entered into an $11.5 million royalty funding agreement led by certain Beyond Air Board members. This debt will carry a 15% interest rate with 12% being payment in kind until the September 2026 quarter. Actual cash payments for all interest in principal will commence after the September 2026 quarter and will be determined based on an 8% royalty rate on sales of LungFit PH. These royalty payments will continue only until principal and interest are paid off.

第三，我們簽訂了由某些 Beyond Air 董事會成員牽頭的 1,150 萬美元特許權使用費資助協議。該債務的利率為 15%，其中 12% 為實物支付，直至 2026 年 9 月季度為止。所有本金利息的實際現金支付將於 2026 年 9 月季度後開始，並將根據 LungFit PH 銷售的 8% 特許權使用費率確定。這些特許權使用費將持續到本金和利息還清為止。

The outcome of these financial agreements, combined with the cost reduction measures taken earlier this year and anticipated revenues, is that we expect to have sufficient cash for about 18 months as we ramp up our global commercial execution plan.

這些財務協議的結果，加上今年稍早採取的成本削減措施和預期收入，我們預計在我們加強全球商業執行計劃時將擁有足夠約 18 個月的現金。

Before turning it over to Doug, I want to touch on some growth drivers we are expecting in the relative near term. Our PMA supplement for the expansion of the LungFit PH label to include cardiac surgery was accepted and is under review by the FDA. As a reminder, [a PMA] supplement is a submission for when there is a change to an already PMA-approved medical device.

在將其交給道格之前，我想談談我們預計在相對近期內的一些成長動力。我們用於將 LungFit PH 標籤擴展至包括心臟手術的 PMA 補充劑已被 FDA 接受並正在審查中。提醒一下，[PMA] 補充是在已獲得 PMA 批准的醫療設備變更時提交的。

While there is no firm date for FDA to complete its review, we can say that as of today, we have answered all questions posed by FDA, and we await their feedback. We will work with the FDA to provide the quickest timeline possible, but cannot give a specific date for an FDA decision.

雖然 FDA 沒有確定完成審查的日期，但我們可以說，截至今天，我們已經回答了 FDA 提出的所有問題，並等待他們的回饋。我們將與 FDA 合作，提供盡可能最快的時間表，但無法給出 FDA 決定的具體日期。

As you may recall, there are no nitric oxide products currently approved for cardiac surgery in the United States. So if granted, this would represent the first formal FDA approval among any of the current players in the market.

您可能還記得，美國目前還沒有批准用於心臟手術的一氧化氮產品。因此，如果獲得批准，這將代表 FDA 在現有市場參與者中首次獲得正式批准。

CE Mark. The regulatory changes in the EU for medical devices have been difficult for everyone. However, we believe that we will receive a final answer before the end of this calendar year. I know the frustration from investors on this topic. But from my view, the Beyond Air team's performance was a lesson in patience, perseverance, and being an expert at your craft.

CE 標誌。歐盟對醫療器材的監管變化對每個人來說都是困難的。不過，我們相信我們將在今年年底前收到最終答案。我知道投資者對這個話題感到沮喪。但在我看來，Beyond Air 團隊的表現是一堂關於耐心、毅力和成為技術專家的一課。

Before the end of the March 2025 quarter, we will file a PMA supplement to the FDA for our next-generation LungFit PH system. We look forward to demonstrating this system next week at the AARC Annual Meeting in Orlando for those attending our private meetings. We believe, and we expect those of you who attend AARC and see for yourselves will agree that this superior system will be rapidly adopted in the global nitric oxide market. Moreover, it can provide NO to areas of the world where cylinders just can't be used, and this will result in lives saved.

在 2025 年 3 月季度結束之前，我們將為下一代 LungFit PH 系統向 FDA 提交 PMA 補充文件。我們期待下週在奧蘭多舉行的 AARC 年會上向參加我們私人會議的人員展示該系統。我們相信，並且我們希望參與 AARC 並親眼目睹的人們會同意這個卓越的系統將在全球一氧化氮市場中迅速採用。此外，它還可以向世界上無法使用氣瓶的地區提供一氧化氮，從而挽救生命。

Turning to Beyond Cancer. They are awaiting regulatory approval in Israel for their UNO program in combination with anti-PD-1 therapy in late-stage cancer patients, which remains an area of high unmet patient need. Just the other day at the Society for Immunotherapy of Cancer Meeting, compelling survival data in both rats and mice were presented. We were encouraged to see that the amount of gas used was less than 10% of the amount of gas used in the Phase 1a UNO monotherapy human study where an acceptable safety profile was demonstrated.

轉向超越癌症。他們正在等待以色列監管機構批准其 UNO 項目與晚期癌症患者的抗 PD-1 療法相結合，這仍然是患者需求未被滿足的一個領域。就在前幾天，在癌症免疫治療協會會議上，公佈了大鼠和小鼠令人信服的生存數據。我們很高興地看到，所使用的氣體量不到 1a 期 UNO 單一療法人體研究中所使用氣體量的 10%，該研究證明了可接受的安全性。

This lower volume administration may be even safer and allow for tumors to be treated in more areas of the body than just cutaneous and near cutaneous. I encourage all of you to visit the Beyond Cancer website and get better educated as 2025 should be transformational for this potentially groundbreaking therapy for those suffering from solid tumors.

這種較低劑量的給藥可能更安全，並且允許在身體的更多區域治療腫瘤，而不僅僅是皮膚和近皮膚區域。我鼓勵大家造訪 Beyond Cancer 網站並獲得更好的教育，因為 2025 年對於這種針對實體瘤患者的潛在突破性療法來說應該是變革性的。

I am also pleased with the advances that NeuroNOS, our subsidiary focused on therapies for Autism Spectrum Disorders is making. Great early-stage work continues at NeuroNOS, and I encourage you all to visit their website to get a better understanding on what is to come over the next 12 to 24 months.

我也對我們專注於自閉症譜系障礙治療的子公司 NeuroNOS 所取得的進展感到高興。NeuroNOS 的早期工作仍在繼續，我鼓勵大家訪問他們的網站，以便更好地了解未來 12 至 24 個月的發展。

In closing, let me summarize my comments on LungFit PH sales by saying our commercial operations in the US turned the page about six months ago, and we are energized by the steady flow of high-quality engagements with potential new customers and by the extremely positive feedback from existing US customers. In addition, the interest we are seeing outside the US is quickly gaining traction since our system upgrade, and we anticipate signing new ex-US agreements over the next 6 to 12 months and to begin shipping systems overseas in the first half of calendar 2025.

最後，讓我總結一下我對 LungFit PH 銷售的評論，我們在美國的商業運營大約六個月前翻了一頁，與潛在新客戶的穩定的高品質接觸以及極其積極的合作使我們充滿活力。來自現有美國客戶的回饋。此外，自從我們的系統升級以來，我們在美國以外看到的興趣正在迅速增強，我們預計在未來 6 到 12 個月內簽署新的美國以外協議，並在 2025 年上半年開始在海外運輸系統。

In addition, we have several upcoming regulatory and product development milestones that are expected to drive increased growth. When we take all of these factors together, I hope you see why we are so excited about what we are planning over the next year.

此外，我們還有幾個即將到來的監管和產品開發里程碑，預計將推動成長。當我們把所有這些因素放在一起時，我希望您明白為什麼我們對明年的計劃如此興奮。

Now I will turn it over to our CFO, Doug Larson.

現在我將把它交給我們的財務長 Doug Larson。

Thanks, Steve, and good afternoon, everyone. Our financial results for the second quarter of fiscal year 2025, which ended September 30, 2024, are as follows. Revenue for the second fiscal quarter of 2025 was $0.8 million as compared with $0.2 million in our fiscal second quarter of 2024. We're showing a $1.1 million loss in gross margin for the fiscal second quarter of 2025, compared to a $0.2 million loss for the same period last year.

謝謝史蒂夫，大家下午好。我們截至 2024 年 9 月 30 日的 2025 財年第二季的財務表現如下。2025 年第二財季的營收為 80 萬美元，而 2024 年第二財季的營收為 20 萬美元。我們顯示 2025 財年第二季的毛利率損失 110 萬美元，而去年同期毛利率損失 20 萬美元。

Cost of revenue in the current fiscal year exceeded revenue, primarily due to a $0.7 million of onetime costs required to upgrade our existing fleet of devices, plus $0.8 million of noncash headwinds, either provisions for excess inventory or depreciation of devices purchased but not yet deployed. We expect gross margins to turn positive in the March 2025 quarter.

本財年的收入成本超過了收入，主要是由於升級我們現有設備群所需的一次性成本為70 萬美元，加上80 萬美元的非現金不利因素，無論是庫存過剩準備金還是已購買但尚未部署的設備的折舊。我們預計 2025 年 3 月季度的毛利率將轉正。

Research and development expenses for the three months ended September 30, 2024, and were $4.6 million as compared to $7.1 million for the three months ended September 30, 2023. The decrease of $2.5 million was primarily attributed to a decrease in spend in salaries, stock-based compensation, and preclinical studies. SG&A expenses for the three months ended September 30, 2024, and September 30, 2023, and were $7.2 million and $10.2 million, respectively. The decrease of $3 million was attributed primarily to a decrease in stock-based compensation costs.

截至2024年9月30日止三個月的研發費用為460萬美元，截至2023年9月30日止三個月的研發費用為710萬美元。減少 250 萬美元主要是因為薪資、股票薪酬和臨床前研究支出的減少。截至2024年9月30日和2023年9月30日的三個月的SG&A費用分別為720萬美元和1020萬美元。減少 300 萬美元主要是因為股票薪酬成本的減少。

Other expense for the three months ended September 30, 2024, was $1.2 million compared with an other income of $0.1 million for the three months ended September 30, 2023. The increase in expense of $1.3 million was mostly noncash and attributed primarily to the partial extinguishment of the Avenue loan.

截至2024年9月30日止三個月的其他費用為120萬美元，而截至2023年9月30日止三個月的其他收入為10萬美元。增加的 130 萬美元費用主要是非現金，主要歸因於 Avenue 貸款的部分取消。

Net loss attributed to the common stockholders of Beyond Air, Inc. for the three months ended September 30, 2024, was $13.4 million, or a loss of $0.28 per share basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc. for the three months ended September 30, 2023, was $16.2 million or a loss of $0.51 per share basic and diluted. Net cash burn in the quarter ended September 30, 2024, excluding one-timers, and the impact of the financing transaction Steve mentioned earlier, was $11.5 million.

截至 2024 年 9 月 30 日的三個月，Beyond Air, Inc. 普通股股東的淨虧損為 1,340 萬美元，即每股基本虧損和稀釋虧損 0.28 美元。截至 2023 年 9 月 30 日的三個月，Beyond Air, Inc. 普通股股東的淨虧損為 1,620 萬美元，即每股基本虧損和稀釋虧損 0.51 美元。截至 2024 年 9 月 30 日的季度淨現金消耗（不包括一次性資金以及史蒂夫之前提到的融資交易的影響）為 1,150 萬美元。

We hit the brakes hard on spend in the last two quarters, closing two offices, reducing staff levels by over 30% across the company, putting our [BCAP] study on hold, and adjusting our production forecasts. We'll get a full quarter of benefit from all of our actions and expect to see a reduction in cash burn in Q3 by at least one-third.

我們在過去兩個季度大力控制支出，關閉了兩個辦事處，將整個公司的員工人數減少了 30% 以上，擱置了我們的 [BCAP] 研究，並調整了我們的生產預測。我們將從我們的所有行動中獲得整整一個季​​度的收益，並預計第三季的現金消耗將減少至少三分之一。

As of September 30, 2024, the company had cash, cash equivalents and marketable securities of $28.4 million. Due to the timing of cash settlements associated with the financial transactions mentioned earlier, certain settlements were completed subsequent to quarter end. Thus, on a pro forma basis, for September 30, 2024, cash was $18.5 million.

截至2024年9月30日，該公司擁有現金、現金等價物及有價證券為2,840萬美元。由於與前面提到的金融交易相關的現金結算時間，某些結算在季度末後完成。因此，根據預計，截至 2024 年 9 月 30 日，現金為 1,850 萬美元。

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

然後，我會將電話轉回給史蒂夫。

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

謝謝，道格。我們現在將回答您可能提出的任何問題。

(Operator Instructions)

（操作員說明）

Jason Wittes, ROTH Partners.

傑森‧威茨，羅仕合夥人。

Just first of all, I think you said to be getting a 60% increase in contracts. How does that -- what does that say about momentum for the rest of the year? Should we expect that to flow through for the remaining quarters? Or how should we think about sort of the progression as we go from first quarter to fourth?

首先，我認為您說過合約數量將增加 60%。這對今年剩餘時間的勢頭有何影響？我們是否應該期望這種情況會持續到剩下的幾個季度？或者我們應該如何考慮從第一季到第四季的進展？

Yes. Jason, thanks for the question. I think that momentum will continue. Again, it's every contract has its own value. So I think that the volume is very good. And I think the volume will continue at this pace.

是的。傑森，謝謝你的提問。我認為這種勢頭將會持續下去。同樣，每份合約都有其自身的價值。所以我認為音量非常好。我認為銷量將繼續以這樣的速度成長。

Obviously, as the denominate gets bigger, maybe the percentage may not keep up, but number of contracts that we're adding every quarter will continue in the current quarter that we're in is close to what we had last quarter, not quite there yet, but we still have another seven weeks left.

顯然，隨著面額變大，百分比可能不會跟上，但我們每個季度添加的合約數量將在當前季度繼續接近上個季度的水平，但不完全是這樣然而，我們還有七個星期的時間。

Okay. And then you mentioned several strategic partnerships. Just curious how they might work, especially with the VA. Are you in the VA now? Or is the TrillaMed partnership going to get you into the VA?

好的。然後您提到了幾個策略夥伴關係。只是好奇他們如何運作，尤其是與退伍軍人事務部合作。你現在在VA嗎？或者 TrillaMed 合作夥伴關係是否會讓您進入 VA？

Yes, we do not have any [VA] hospitals yet. I think the relationship with TrillaMed has just gotten started. We did -- TrillaMed was instrumental in us getting the Naval Hospital in Guam. So that was great.

是的，我們還沒有任何 [VA] 醫院。我認為與 TrillaMed 的關係才剛開始。我們做到了——TrillaMed 在我們建立關島海軍醫院的過程中發揮了重要作用。所以那太好了。

But I think there's a little bit of work to do with the VA. So I wouldn't expect a big impact in the December quarter from the VA at all. We just -- again, the TrillaMed agreement just got started. So I think there's some work we need to do with them before they go out and full force.

但我認為 VA 還需要做一些工作。因此，我預計 VA 不會對 12 月季度產生重大影響。我們剛剛——再說一次，TrillaMed 協議才剛開始。所以我認為在他們全力以赴之前我們需要對他們做一些工作。

Okay. And I think also you mentioned for the PMA for [heart] surgery. I guess timing depends largely on the FDA right now? Or how should we think about -- I don't know if you can give more color in terms of how you think that might go?

好的。我想您也提到了 [心臟] 手術的 PMA。我想現在的時機很大程度取決於 FDA？或者我們應該如何思考——我不知道你是否可以就你認為事情會如何發展提供更多的色彩？

Yes. I mean, look, we've given them everything that they've asked for. It's in the -- the balls in their court, so to speak. But this is a device, not a drug, so there's no hard PDUFA date. So I just don't know.

是的。我的意思是，看，我們已經給了他們他們所要求的一切。可以這麼說，這是在他們的球場上。但這是一種設備，而不是藥物，因此沒有硬性 PDUFA 日期。所以我只是不知道。

I wish I could be more specific, but we've tried to give guidance in the past on regulatory timing. And it just hasn't gone well. So we're just going to let you guys know what we know, which is that we've given them everything they've asked for. And now we just wait.

我希望我能說得更具體，但我們過去曾嘗試就監管時機提供指導。但進展並不順利。所以我們只是想讓你們知道我們所知道的，那就是我們已經給了他們他們所要求的一切。現在我們只需等待。

Okay. Great. And I have one more question and I'll jump back in the queue. And just on the -- you mentioned -- I appreciate the commentary on cash burn. I think you said it will reduce by about a third -- at least most of that is in the SG&A line? Or how would that be -- I assume that's where we see most of that reduction or anywhere else we might see it?

好的。偉大的。我還有一個問題，我會跳回隊列。就你提到的，我很欣賞關於燒錢的評論。我想你說過它將減少大約三分之一——至少其中大部分都在銷售、管理和行政費用方面？或者那會是怎樣的——我認為這是我們看到大部分減少的地方，或者我們可能在其他地方看到的地方？

Yes. You're going to see it all over the place. I mean, Steve and I went through with a knife basically to the entire P&L. So we've looked at everything where we can make savings. So you're going to see it in the R&D line, you're going to see it in G&A.

是的。你會在各處看到它。我的意思是，史蒂夫和我基本上用刀檢查了整個損益表。因此，我們考慮了一切可以節省開支的地方。所以你會在研發線、G&A 中看到它。

Jason Bednar, Piper Sandler.

傑森·貝德納，派珀·桑德勒。

This is John for Jason. I just had a couple of questions on the competitive landscape here. So one of your big peers referenced some good traction at the recent product launch. Can you talk about what you're seeing out there in the market with respect to competitive dynamics and whether the presence of this new offering is leading to any longer contract negotiations with hospitals?

這是傑森的約翰。我只是對這裡的競爭格局有幾個問題。因此，您的一位大同行在最近的產品發布會上提到了一些很好的吸引力。您能否談談您在市場上看到的競爭動態以及這項新產品的存在是否會導致與醫院的合約談判時間更長？

Yes. I don't know who's gaining traction in the market. I don't know who's -- who that might be. So I don't really -- unless you have a specific competitor you want to talk about, I don't know who's gaining traction.

是的。我不知道誰在市場上獲得了關注。我不知道誰是誰——那可能是誰。所以我真的不知道——除非你有一個想要談論的特定競爭對手，否則我不知道誰正在獲得關注。

So we -- I don't think the hospitals look at money raises by companies on Wall Street as much as you think. Our relationship with hospitals and our customers and potential customers is the same as it was before the money raises it is after. We haven't noticed anything different.

所以我們——我認為醫院並不像你想像的那樣重視華爾街公司籌集的資金。我們與醫院、客戶和潛在客戶的關係與籌集資金之前的關係相同。我們沒有註意到任何不同。

What we've noticed different is that the implementation of the new tactics we started back late in the spring and have been augmented greatly by our new Chief Commercial Officer, who came on in July, we're seeing a lot of good feedback from these initiatives and the upgraded machine. So we seem to be picking up a lot of momentum with customer discussions in the US. We feel real good about it.

我們注意到的不同之處在於，我們在春季末開始實施新策略，並在 7 月份上任的新首席商務官的大力推動下，我們看到了很多良好的反饋。因此，我們似乎在美國與客戶的討論中獲得了極大的動力。我們對此感覺非常好。

And I think like we said in the prepared remarks, on the international side, we're getting a lot of activity, much more than we had six months ago. That's for sure. So if you have anything more specific on a particular competitor, I'm happy to talk about it if you have something.

我認為就像我們在準備好的演講中所說的那樣，在國際方面，我們正在進行許多活動，比六個月前要多得多。這是肯定的。因此，如果您對某個特定競爭對手有更具體的了解，我很樂意與您討論。

No, we can take that offline, Steve. That's all right. But I appreciate the color there. And just to follow up to that one. Can you also talk a little bit about contract pricing with the uptick in activity in the most recent quarter? Kind of piggybacking up the last question. Has there been any movement up and down here in pricing versus earlier this year? And can you talk about how this pricing is fluctuating across account sizes?

不，我們可以將其離線，史蒂夫。沒關係。但我很欣賞那裡的顏色。只是為了跟進那個。您能否談談最近一個季度活動增加的合約定價？有點像最後一個問題。與今年早些時候相比，這裡的定價是否有任何上下波動？您能談談這個定價如何隨著帳戶規模的變化而波動嗎？

Yes. I think that the pricing is as expected on a per hour basis. I don't think we're seeing anything different than we saw six months ago or 12 months ago, it seems to be pretty stable from our perspective.

是的。我認為按小時計算的定價符合預期。我認為我們看到的情況與六個月前或 12 個月前沒有什麼不同，從我們的角度來看，它似乎相當穩定。

But obviously, the size of contracts are dependent on the volume of hospitals and the higher the volume, lower the price, of course, but we like the higher volume ones because they're bigger, but we'll -- you guys will see how those -- that's playing out for us over the next quarter or two in terms of the size that we're getting.

但顯然，合同的規模取決於醫院的數量，當然，數量越大，價格越低，但我們喜歡數量較大的合同，因為它們更大，但我們會——你們會看到就我們所獲得的規模而言，這些在未來一兩個季度對我們來說將如何發揮作用。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hi, appreciate you taking questions this evening. Wanted to ask a qualitative question here on some of the changes David has made to the commercial organization. What strategy specifically are working well? Where are you finding success? And where is there sort of more to come? I assume that he hasn't had time to deploy all his strategies yet. So I'd love to hear a little bit more about what's going on behind the scenes.

您好，感謝您今晚提出問題。想在這裡就大衛對商業組織所做的一些改變提出一個定性問題。具體哪些策略效果好？你在哪裡找到成功？未來還會有更多的事情發生嗎？我認為他還沒有時間部署他的所有策略。所以我很想聽聽更多關於幕後發生的事情。

So we mentioned a partnership with an international distribution firm that will manage our relationships outside the United States. It's a big win for us. It's not like there's hundreds of them you can choose from. And the very few high-quality companies out there like BAC. So that's David bringing that in.

因此，我們提到了與一家國際分銷公司的合作夥伴關係，該公司將管理我們在美國以外的關係。這對我們來說是一個巨大的勝利。並不是有數百個可供您選擇。而像 BAC 這樣的高品質公司卻是鳳毛麟角。這就是大衛帶來的。

And it takes time to win those partners and then implement it. So I think you'll see some activity on the international front over the next three to six months. And of course, we have TrillaMed and Healthcare Links that will be helping us with not just the VA and Department of Defense, but of course, GPOs and IDNs. Those things are very important. David -- and again, you're not seeing anything in this particular quarter from those agreements other than the Naval hospital base in Guam. But you'll start to see that pick up as we go forward.

贏得這些合作夥伴然後實施它需要時間。所以我認為在接下來的三到六個月裡你會看到國際方面的一些活動。當然，我們有 TrillaMed 和 Healthcare Links，它們不僅會幫助我們與 VA 和國防部合作，當然還會幫助我們與 GPO 和 IDN 合作。這些事情非常重要。大衛——再說一次，除了關島的海軍醫院基地之外，在這個特定的季度，你看不到任何來自這些協議的東西。但隨著我們的前進，你會開始看到這種情況的改善。

And David has been able to generate more leads in the United States with some of the things he's implemented already. He just got that started up maybe a month or so ago. And I won't to say exactly what that is. I don't want to steal his thunder, or give away our secrets. But he's done a really good job of generating more leads and interest for our commercial team for the sales team.

大衛已經能夠透過他已經實施的一些措施在美國產生更多的銷售線索。他大約一個月前才開始這麼做。我不會確切地說是什麼。我不想搶他的風頭，也不想洩漏我們的秘密。但他在為我們的商業團隊和銷售團隊帶來更多潛在客戶和興趣方面做得非常好。

So again, that will start to bear fruit over the next three to six months. So I think the groundwork he's laid is fantastic, and we already started to see it here. It's just -- reporting this quarter, it's just too early to see the benefits of what David has done.

同樣，這將在未來三到六個月內開始取得成果。所以我認為他奠定的基礎非常棒，我們已經開始在這裡看到它。只是——在本季的報告中，現在判斷大衛所做的事情的好處還為時過早。

Of course. Well understood. A question for Doug then. Can you talk to us a little bit about gross margins and how we might expect some of that to be impacted by, say, both higher volumes to come, but also some of the label expansions, the Transport Ready system, the CE mark and selling abroad, any impact to gross margins to expect over the next few quarters?

當然。很好理解。那麼有個問題要問道格。您能否與我們談談毛利率，以及我們預計毛利率將如何受到影響，例如，未來銷量的增加，以及一些標籤擴展、運輸就緒系統、CE 標誌和銷售在國外，預計未來幾個季度毛利率會受到什麼影響？

Sure. So as mentioned in the prepared remarks, there's a couple of headwinds that we've got some -- the onetime are basically being us having to upgrade the systems that we have in stock. So that was $700,000. That's -- I wouldn't call it exactly a onetimer because we're not completely finished yet, which is why we're calling for gross margins to turn positive in the March quarter and not necessarily the December quarter. So there's going to be a little additional cost next quarter and then that it's going to -- for all intents and purposes disappear in the March quarter.

當然。因此，正如準備好的評論中所提到的，我們遇到了一些阻力 - 一次基本上是我們必須升級我們庫存的系統。那就是 70 萬美元。那是——我不會稱其為一次性的，因為我們還沒有完全完成，這就是為什麼我們要求毛利率在 3 月份季度（而不一定是 12 月季度）轉為正值。因此，下個季度將會有一些額外成本，然後，無論出於何種意圖和目的，這些成本都會在三月的季度消失。

Also mentioned there's about $500,000 of depreciation in this quarter. That's basically on systems that we've built that are ready to be deployed. And it's already kind of a drag on our gross margin. So the good news there is as we expand into the market, we don't have to build as many machines that are already built. We can deploy them and that drives -- that's going to go straight into margin, right.

也提到本季有大約 50 萬美元的折舊。這基本上是在我們已經建置並準備好部署的系統上。這已經拖累了我們的毛利率。因此，好消息是，當我們擴展到市場時，我們不必建造那麼多已經建造的機器。我們可以部署它們，這將直接進入利潤率，對吧。

We can generate revenue on them without having that additional depreciation cost in gross margin. So that's going to have very positive upside.

我們可以透過它們產生收入，而無需在毛利率中產生額外的折舊成本。所以這將有非常積極的好處。

The other thing we used to talk about a little bit, it's going to have a lesser effect. But we do also have some fixed warehousing costs that are in our gross margin base. And as we grow those geographical regions, we penetrate more in the regions where we're already existing. We can do that without adding additional cost.

我們曾經談論過的另一件事，它的影響較小。但我們的毛利率基礎中也確實有一些固定倉儲成本。隨著我們擴大這些地理區域，我們會更多地滲透到我們已經存在的地區。我們可以在不增加額外成本的情況下做到這一點。

So again, that gross margin -- the gross margin rate is going to go up from that. As we go internationally, you are going to see a little bit of a drag on the gross margin as opposed to where we'll be in the US because the business model there is a little bit different. And so we won't be seeing the same margin rates outside of the US as we see inside the US. That's going to grow slowly over time, right. So between now and the end of the fiscal year, you're not going to see a huge drag from that because we're only going to start shipping in the March quarter. So it will have a minimal impact.

再說一次，毛利率——毛利率將會隨之上升。當我們走向國際時，與我們在美國的情況相反，你會看到毛利率受到一點拖累，因為那裡的商業模式有點不同。因此，我們在美國境外不會看到與美國境內相同的保證金率。隨著時間的推移，它會慢慢增長，對吧。因此，從現在到本財年結束，您不會看到巨大的拖累，因為我們只會在三月的季度開始發貨。所以影響會很小。

But going forward, it's definitely something to put in the models. That -- there will be a little bit of impact from that, the more successful we are in international.

但展望未來，它肯定會被放入模型中。我們在國際上越成功，就會產生一點影響。

Yale Jen, Laidlaw & Company.

耶魯‧詹 (Yale Jen)，萊德勞公司。

Steve, when you mentioned that there's a 60% increase, could you give a little bit more color in terms of that -- whether that's 60% is from last year? Or how should we just think about that the basis for that for that number?

史蒂夫，當你提到增長了 60% 時，你能否提供更多資訊——這是否是去年的 60%？或者我們應該如何思考這個數字的基礎？

Yes. So the base is just our total customers as of June 30 versus our total customers at September 30. This year, that's all.

是的。因此，基數只是截至 6 月 30 日的客戶總數與 9 月 30 日的客戶總數。今年，僅此而已。

Okay. Great. So basically, the quarter over quarter, I guess, that's one way to look at it?

好的。偉大的。所以基本上，我想，季度環比是一種看待問題的方式？

Yes.

是的。

Okay. Great. That's very helpful. And also on the press release, you're talking about annualize the revenue in October. Could you elaborate a little bit more on that specific aspect it seems to be over [$800,000] a quarter? Would that be something we look into the third quarter of the -- fiscal third quarter? Or that's something we underestimate?

好的。偉大的。這非常有幫助。在新聞稿中，您還談到了 10 月的年化收入。您能否詳細說明每個季度似乎超過 [800,000 美元] 的具體方面？這會是我們在第三財季第三季研究的內容嗎？還是我們低估了這一點？

Yes. I mean we did [$800,000] this quarter and the run rate would put us more like [$8.75]. And we did say that we have some more starts after October 1. So the number will be higher than that.

是的。我的意思是我們這個季度做了 [80 萬美元]，運行率會讓我們更像[8.75 美元]。我們確實說過 10 月 1 日之後我們還會有更多的開始。所以這個數字會比這個更高。

How much higher, we don't know because we don't know all the starts. We may get some hospital starts in December right now. So we're still waiting.

高多少，我們不知道，因為我們不知道所有的開始。我們可能會在 12 月開始一些醫院的建設。所以我們還在等待。

So yes, I mean we'll be talking about that kind of a run rate thing every quarter. So you can see how we progress. So we think that every quarter, it's going to continue to rise.

所以是的，我的意思是我們每個季度都會討論這種運行率的問題。這樣您就可以看到我們的進展。所以我們認為每季都會繼續上升。

Okay. Great. That's hopefully helpful. And then maybe the last question here is in terms of your international sales, I know you have (inaudible) the [consultant]. Are you guys going to have using this firm to expand the footprint to other countries or you are still seeking any kind of formal sort of collaborator partners and that kind of things? And just wanted to get a little bit of color as you guys move forward go beyond the US borders.

好的。偉大的。希望這會有所幫助。也許最後一個問題是關於你們的國際銷售，我知道你們有（聽不清楚）[顧問]。你們是否打算利用這家公司將業務擴展到其他國家，或者你們仍在尋找任何正式的合作夥伴之類的東西？只是想在你們超越美國邊境的過程中獲得一點色彩。

Yes. Thanks, Yale. So BAC is more of an intermediary between us and the actual distributor in each country. We started to see the demand come in as we showed our upgraded system back in the spring. And we have one person doing international for us. We had the (inaudible) deal in Southeast Asia.

是的。謝謝，耶魯。所以BAC更多的是我們和各國實際經銷商之間的中間人。當我們在春季展示升級後的系統時，我們開始看到需求的增加。我們有一個人為我們做國際事務。我們在東南亞達成了（聽不清楚）協議。

We had a few other things that were happening, and it just became apparent to us over the summer that he's only one man. So we needed some help, and that's why we contracted with this group, and they can handle any volume that comes our way. We're fortunate to have as much as we think.

我們還發生了一些其他事情，整個夏天我們才意識到他只是一個人。所以我們需要一些幫助，這就是我們與這個團隊簽約的原因，他們可以處理我們遇到的任何數量。我們很幸運，擁有我們想像的那麼多。

So they are the intermediary. They've got a great track record, and we're looking forward to them getting going over the next 30 to 60 days.

所以他們是中間人。他們有著良好的記錄，我們期待他們在接下來的 30 到 60 天內繼續前進。

And maybe just take one more here. Do you need additional approval in overseas countries? Or you feel that the US application or the EU application -- I mean, approval will be able to cover a lot of these ex US countries or territories?

也許這裡再拿一張。您是否需要海外國家的額外批准？或者您認為美國的申請或歐盟的申請——我的意思是，批准將能夠覆蓋美國以外的許多國家或地區？

Yes. So FDA approval covers some. I think the CE Mark, the EU covers more than just FDA approval. And there is there's another regulatory approval. It's called MDSAP. We anticipate having that as well sometime next calendar year, maybe late next calendar year, which will open up a few other countries.

是的。因此 FDA 的批准涵蓋了一些。我認為歐盟的 CE 標誌不僅涵蓋 FDA 的批准。還有另一個監管部門的批准。它被稱為 MDSAP。我們預計明年某個時候，也許是明年晚些時候，也會開放其他一些國家。

But in most countries, you still need to go through their licensing process, yes. So it may take a couple of months to -- maybe even a year in some places. So every country is different. And of course, as you know, Japan has their own process. So FDA in Europe will not make a difference there. And there might be one or two other countries where it's going to be a long process. But for the vast majority of countries, it's couple of months to maybe a year. And once we get our CE mark, then we'll have most of the countries in the world covered outside the US.

但在大多數國家，您仍然需要完成他們的許可流程，是的。因此，可能需要幾個月的時間——在某些地方甚至可能需要一年的時間。所以每個國家都是不同的。當然，如您所知，日本有自己的流程。因此，歐洲 FDA 不會對此產生影響。可能還有一兩個國家的這將是一個漫長的過程。但對絕大多數國家來說，這需要幾個月到一年的時間。一旦我們獲得 CE 標誌，我們將覆蓋美國以外的世界上大多數國家。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Can you talk a little bit more about the next-generation device, the transport-ready device, and the PMA supplement that you expect to submit, I guess, in the first quarter of next year? Could that review the -- since it's a supplement be faster than the first (inaudible)?

您能多談談下一代設備、運輸就緒設備以及您預計在明年第一季提交的 PMA 補充嗎？因為它是補充，所以審查可以比第一個更快嗎（聽不清楚）？

Thanks for the question, Matt. Boy, it better be faster than the first one. The first one was torturous. But again, that was a difficult time for FDA with the pandemic and lots of changes going on over there. So I think they're in better shape staffing-wise than they were back then.

謝謝你的提問，馬特。夥計，最好比第一個更快。第一個就很折磨人了。但同樣，對於 FDA 來說，那是一段艱難的時期，因為疫情和那裡正在發生的許多變化。所以我認為他們在人員配置方面比當時更好。

So we're looking forward to working with them on the supplement. But yes, it is a supplement. It's not a new product. So it should be a little bit smoother. I don't know the timing. I don't want to speculate.

因此，我們期待與他們合作開發補充品。但是，是的，它是一種補充。這不是新產品。所以應該會比較順暢一些。我不知道時間。我不想猜測。

Let's just get it to them and see what they think of the filing of the quality of it. And we'll go from there. But this is a product that will be showcasing next week at the American Academy of Respiratory Care in Orlando. So if anybody wants to make the trip down to Disney, you can come see us and we'll give you a look at this system. It is ready; it's ready to go. So you'll see it fully functioning next week. And we're just putting together all the external testing from our external partners who do these testing for us, and then we'll put it into them in a couple of months.

讓我們把它交給他們，看看他們對歸檔品質的看法。我們將從那裡開始。但這是一款將於下週在奧蘭多美國呼吸護理學院展示的產品。因此，如果有人想去迪士尼旅行，您可以來找我們，我們將為您介紹這個系統。準備好了；已經準備好了。所以下週你會看到它完全發揮作用。我們只是將外部合作夥伴為我們進行這些測試的所有外部測試放在一起，然後我們將在幾個月內將其放入其中。

Okay. And then you spoke in your prepared remarks about the expected accelerated top-line revenue growth in the coming quarters. Can you give a little more color to that? Is it going to be chunky as you sign new deals? Or do you expect it kind of to be -- just give us some more color on that.

好的。然後您在準備好的演講中談到了未來幾個季度預計收入加速成長。你能給它多一點色彩嗎？當你簽署新協議時，它會變得很粗糙嗎？或者你希望它是這樣的——請給我們更多的資訊。

Sure, Matt. I wish I could. I mean I'd love for it to be as smooth as it can be and give you a nice little chart, but it never works that way. It's probably going to be chunky. We may, one quarter, get one or two really big contracts and the next quarter, still keeping up volume with hospitals growing, but we might not hit a big home run in the next quarter.

當然，馬特。我希望我能。我的意思是，我希望它盡可能順利，並為您提供一個漂亮的小圖表，但它從來不會那樣工作。它可能會變得粗壯。我們可能會在一個季度獲得一兩個真正的大合同，而在下一個季度，隨著醫院的增長，數量仍然會保持不變，但我們可能不會在下個季度打出大本壘打。

So you just don't know. I wish I could give you more insight in how smooth it is, but the size of contracts range from less than $100,000 a year to over $1 million a year. So you just don't know which ones are going to hit in what quarter. But we're talking to as many hospitals as we can, trying to reach out to as many potential customers as possible, and there are potential wins in -- across the range of size of hospitals. So we'll just have to see how they come in.

所以你只是不知道。我希望我能讓您更深入地了解它的順利程度，但合約規模從每年不到 10 萬美元到每年超過 100 萬美元不等。所以你只是不知道哪些產品會在哪個季度流行。但我們正在與盡可能多的醫院進行交談，試圖接觸盡可能多的潛在客戶，並且在各種規模的醫院中都有潛在的勝利。所以我們只需要看看他們是如何進來的。

Okay. And then last question in terms of -- you mentioned or I guess it was mentioned in the prepared remarks that March '25, you expect margins to turn positive. How should we think about it for the calendar year 2025 is -- how should your margins evolve?

好的。最後一個問題是——您提到或我猜在準備好的評論中提到了 25 月 25 日，您預計利潤率將轉為正值。我們該如何看待 2025 年—您的利潤率該如何發展？

Thanks, Matt, for the question. So we're -- you're asking about calendar '25. So we'll be turning positive in the March quarter. Going forward, you're going to see -- I hate to give percentages out. You're going to see margins that you've probably been expecting from us, how is that. Starting in the first quarter of fiscal '26.

謝謝馬特提出的問題。所以我們——你問的是日曆'25。因此，我們將在三月季度轉為樂觀。展望未來，你會看到——我討厭給出百分比。您將會看到您可能期望從我們這裡得到的利潤，怎麼樣？從 26 財年第一季開始。

And let me just help out here. I mean, we've said publicly in the past that we're targeting with our first-generation product, 60% to 65% gross margins. So that's the target. And I think by the end of calendar '25, on a GAAP basis, you probably could see that. I think giving Doug a little wiggle room here, the international impact. There is always the cost-plus component of international.

讓我在這裡幫忙。我的意思是，我們過去曾公開表示，我們第一代產品的毛利率目標是 60% 至 65%。這就是目標。我認為到 25 日曆年底，按照 GAAP 計算，您可能會看到這一點。我認為在這裡給道格一點迴旋的餘地，即國際影響力。國際化總是存在著成本加成的部分。

So that may bring the margin down. It just depends on how we structure the back end of that, whether it be a royalty. Or we're doing a razor-razorblade type model as to whether the impact on the gross margin will be muted or not. So might be a good thing if that gross margin is a little bit light because we're so strong internationally. So we'll just have to see how it plays out. But I think that by the December quarter of calendar '25, you should see us close to that 60%-ish number.

因此這可能會降低利潤率。這僅取決於我們如何建立後端，是否是版稅。或者我們正在做一個剃刀刀片類型的模型，以確定對毛利率的影響是否會減弱。因此，如果毛利率有點​​低可能是一件好事，因為我們在國際上非常強大。所以我們只需要看看結果如何。但我認為到 25 年 12 月季度，您應該會看到我們接近 60% 左右的數字。

At this time, we are showing no further questions in the queue. And this concludes our question-and-answer session. I would now like to turn the call back over to Steve Lisi for any closing remarks.

目前，我們在隊列中沒有顯示任何其他問題。我們的問答環節到此結束。現在我想將電話轉回給史蒂夫李斯（Steve Lisi），請其發表結束語。

Thanks for joining today, everyone. I look forward to speaking to you in a couple of months. Thanks.

感謝大家今天加入。我期待著幾個月後與您交談。謝謝。

Thank you. And ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

謝謝。女士們、先生們，今天的會議到此結束。此時您可以斷開線路。感謝您的參與。