Beyond Air Inc (XAIR) 2026 Q2 法說會逐字稿

Good afternoon, and welcome to the Beyond Air financial results call for the fiscal quarter ended September 30, 2025. (Operator Instructions)

下午好，歡迎參加 Beyond Air 截至 2025 年 9 月 30 日的季度財務業績電話會議。（操作說明）

And now I would like to turn the call over to Garth Russell, Lifesci Advisors. Please go ahead.

現在，我想把電話交給 Lifesci Advisors 的 Garth Russell。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 operational highlights and financial results for Beyond Air's second quarter of fiscal year 2026 ended September 30, 2025. A copy of this press release can be found on our website, www.beyondair.net under the News and Events section.

謝謝接線生。各位下午好，感謝各位的參與。今天，在市場收盤後，我們發布了一份新聞稿，宣布了 Beyond Air 截至 2025 年 9 月 30 日的 2026 財年第二季度的營運亮點和財務業績。您可以在我們的網站 www.beyondair.net 的「新聞與活動」欄位下找到這份新聞稿的副本。

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.

在開始之前，我想提醒大家，我們將對未來的預期、計劃和前景發表評論和各種意見，這些構成1995年《私人證券訴訟改革法案》安全港條款所指的前瞻性陳述。

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 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.

Beyond Air提醒，這些前瞻性聲明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。我們鼓勵大家查閱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，這些文件列明了可能導致實際結果或事件與前瞻性聲明中描述的結果或事件存在重大差異的具體因素。

Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 10, 2025. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

此外，本次電話會議將被錄音，並將在我們的網站 www.beyondair.net 上提供音訊重播。另外，本次電話會議的內容包含有時效性的信息，僅在直播當天（2025年11月10日）有效。Beyond Air 不承擔任何義務修改或更新任何聲明以反映本通話日期之後發生的事件或情況。

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

接下來，我將把電話交給 Beyond Air 的董事長兼執行長 Steve Lisi。史蒂夫？

Thanks, Garth, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We continue to receive highly encouraging feedback from hospitals using LungFit PH, reinforcing the clinical value and operations efficiency our technology delivers. Adoption is accelerating meaningfully over the past year, contributing to a 128% year-over-year revenue increase in the fiscal second quarter, reaching $1.8 million, up from $0.8 million for the same period last year.

謝謝加思，大家下午好。今天陪同我來到現場的有我們的財務長道格·拉爾森。我們不斷收到使用 LungFit PH 的醫院給予的高度鼓勵的回饋，這進一步證實了我們技術所帶來的臨床價值和營運效率。過去一年，產品採用率顯著加快，使得該公司第二財季的營收年增 128%，達到 180 萬美元，而去年同期為 80 萬美元。

While we are pleased by the strong year-over-year growth, sequential growth was essentially flat compared to the prior quarter, reflecting the timing of hospital purchasing cycles and the natural variability in international shipments. We view this stability as an encouraging baseline from which we expect sequential growth to resume over the coming quarters.

儘管我們對強勁的同比增長感到滿意，但與上一季相比，環比增長基本持平，這反映了醫院採購週期的時間安排和國際貨運的自然波動。我們認為這種穩定性是一個令人鼓舞的基準，我們預計未來幾季將在此基礎上恢復連續成長。

We continue to navigate the inherent complexity of hospital sales cycles in the US and internationally. These extended lead times and institutional decision-making processes have led to peaks and valleys in our quarterly sales performance as seen in the September quarter. Importantly, our sales pipeline remains robust, and we see substantial greenfield opportunities across the US as awareness and interest in LungFit PH continue to build.

我們將繼續應對美國和國際醫院銷售週期固有的複雜性。這些延長的交貨時間和機構決策過程導致了我們季度銷售業績的高峰和低谷，正如我們在9月份的季度中所看到的那樣。重要的是，我們的銷售管道仍然強勁，隨著人們對 LungFit PH 的認知和興趣不斷提高，我們看到了美國各地巨大的新市場機會。

Before getting into further details, let me highlight the changes that have occurred since our last update in August. We have raised $12 million in debt, and we'll file a registration statement for an additional $20 million through an equity line of credit, both with Streeterville Capital, which solidifies our balance sheet. We believe these additional funds will give us the ability to properly address the pace of sales growth with our first-generation system and prepare for the launch of our second-generation system.

在詳細介紹之前，讓我先重點介紹一下自我們八月上次更新以來發生的變化。我們已透過債務融資籌集了 1,200 萬美元，並將透過股權信貸額度向 Streeterville Capital 提交註冊聲明，以籌集額外的 2,000 萬美元，這將鞏固我們的資產負債表。我們相信，這些額外的資金將使我們能夠更好地應對第一代系統的銷售成長速度，並為第二代系統的推出做好準備。

LungFit PH has been placed in the first hospital outside the United States for commercial use. We have named our Board member, Bob Goodman, as Interim Chief Commercial Officer, given the departure of David Webster. We are updating our fiscal year '26 guidance to $8 million to $10 million. We introduced our capital purchase sales model in the United States and had our first hospital purchase of LungFit PH.

LungFit PH 已在美國以外首家醫院投入商業使用。鑑於大衛·韋伯斯特的離職，我們已任命董事會成員鮑勃·古德曼為臨時首席商務官。我們將 2026 財年的業績預期更新為 800 萬至 1,000 萬美元。我們在美國推出了資本購買銷售模式，並首次從醫院購買了 LungFit PH。

We collected data from Beyond Cancer's Phase 1a trial with 10 subjects with ultra-high concentration nitric oxide or UNO. That shows median survival has not yet been achieved and currently sits at 22 months. These updates have put us in a very strong position and provide us the financial runway we need to optimize the Gen II launch in late calendar 2026 and drive our international business from the strong foundation we have already built.

我們收集了 Beyond Cancer 的 1a 期試驗的數據，該試驗有 10 名受試者接受了超高濃度一氧化氮 (UNO) 治療。這表明中位存活期尚未達到，目前為 22 個月。這些最新進展使我們處於非常有利的地位，並為我們提供了所需的資金支持，以便優化 2026 年底第二代產品的上市，並在我們已建立的堅實基礎上推動國際業務發展。

As you all know, we were awarded a national group purchasing agreement for therapeutic gases with Premier. Coupled with our agreement with Vizient, we now have access to nearly 3,000 hospitals. We are confident that our targeted commercial strategy, supported by the right people now in place and strengthened by our Premier and Vizient GPO contracts will begin to have a meaningful impact on revenue over the coming quarters.

如大家所知，我們與 Premier 公司簽訂了一份全國性的治療氣體集團採購協議。加上我們與 Vizient 達成的協議，我們現在可以連接近 3,000 家醫院。我們相信，我們目標明確的商業策略，在現有合適人員的支持下，以及透過與 Premier 和 Vizient 簽訂的 GPO 合約的加強，將在未來幾個季度開始對收入產生有意義的影響。

Our disciplined approach is allowing us to prioritize the highest value hospital opportunities while deepening relationships across our existing accounts. This focused execution is already translating into broader market engagement and increased visibility of LungFit PH within key hospital systems. At the same time, we are preparing for the next major inflection point with our second-generation LungFit system, which is smaller, lighter, and designed for both air and ground transportation, while maintaining all the revolutionary features of the first generation LungFit PH.

我們嚴謹的方法使我們能夠優先考慮最有價值的醫院合作機會，同時加深與現有客戶的關係。這種專注的執行已經轉化為更廣泛的市場參與，並提高了 LungFit PH 在主要醫院系統中的知名度。同時，我們正在為下一個重大轉折點做準備，推出第二代 LungFit 系統，該系統體積更小、重量更輕，專為空中和地面運輸而設計，同時保留了第一代 LungFit PH 的所有革命性功能。

We believe this next-generation platform will enable us to expand into larger hospitals and health systems, further accelerating adoption and cementing LungFit's position as the standard for nitric oxide delivery. We anticipate commercial launch of the second-generation system in the US market in late calendar year 2026, pending FDA approval.

我們相信，這新一代平台將使我們能夠擴展到更大的醫院和醫療系統，進一步加速普及，並鞏固 LungFit 作為一氧化氮輸送標準的地位。我們預計第二代系統將於 2026 年底在美國市場上市，前提是獲得 FDA 批准。

As a significant aside, several of our existing customers have extended their annual contracts with multiyear agreements, while increasing anticipated annual volumes. We see this as a confirmation of the ease of use and the value proposition of LungFit PH, and we expect this trend to continue.

另外值得一提的是，我們的一些現有客戶已將年度合約延長至多年期，同時預計年度銷售量也有所增加。我們認為這證實了 LungFit PH 的易用性和價值主張，我們預計這種趨勢將會持續下去。

During the quarter, we finalized and have since launched a new sales model that complements the traditional industry leasing model. Under this new approach, hospitals may now purchase LungFit PH systems outright while continuing to generate recurring revenue for Beyond Air through disposables and service agreements. Initial system sales occurred subsequent to quarter end, and the early reception has been extremely positive. We are very excited by the flexibility this dual model approach offers and the opportunity it creates to accelerate adoption of LungFit PH.

本季度，我們最終確定並推出了新的銷售模式，該模式是傳統行業租賃模式的補充。在這種新模式下，醫院現在可以直接購買 LungFit PH 系統，同時透過耗材和服務協議繼續為 Beyond Air 創造經常性收入。首批系統銷售發生在季度末之後，早期市場反應非常積極。我們對這種雙模型方法所提供的靈活性以及它為加速 LungFit PH 的普及所創造的機會感到非常興奮。

Today, we announced the appointment of Bob Goodman as Interim Chief Commercial Officer, following the departure of David Webster. Bob joined the Beyond Air Board earlier this year and brings deep commercial and operational expertise from leadership roles at BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific and Pfizer. His experience spans public companies, private equity-backed businesses and early-stage ventures, where he has consistently driven innovation, operational scale and commercial success. We have greatly valued his contributions to the Board and look forward to the fresh perspective and leadership he brings as we ramp up commercial activities and, as I just mentioned, prepare for the highly anticipated launch of our second-generation LungFit PH.

今天，我們宣布任命鮑勃古德曼為臨時首席商務官，接替離職的大衛韋伯斯特。Bob 於今年稍早加入 Beyond Air 董事會，他在 BioTelemetry、飛利浦醫療保健、Cardiocore、賽默飛世爾科技和輝瑞等公司擔任領導職務，擁有豐富的商業和營運經驗。他的經驗涵蓋上市公司、私募股權支持的企業和早期創業公司，在這些公司中，他始終致力於推動創新、營運規模和商業成功。我們非常重視他對董事會的貢獻，並期待他能帶來新的視角和領導力，助力我們加大商業活動力度，正如我剛才提到的，為備受期待的第二代 LungFit PH 的上市做好準備。

A key driver of our long-term growth strategy over the past year has focused on the expansion of our global distribution network. During the September quarter, we added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama and El Salvador. These new agreements significantly broaden our geographic reach and demonstrate growing demand from both mature and emerging health care markets seeking modern, cylinder-free, nitric oxide delivery solutions.

過去一年，我們長期成長策略的關鍵驅動因素是擴大我們的全球分銷網絡。在九月的季度中，我們在日本、韓國、墨西哥、哥斯大黎加、瓜地馬拉、巴拿馬和薩爾瓦多新增了分銷合作夥伴關係。這些新協議顯著擴大了我們的地理覆蓋範圍，並表明成熟和新興醫療保健市場對現代化、無鋼瓶的一氧化氮輸送解決方案的需求不斷增長。

Importantly, we achieved our first international commercial placement of LungFit PH into hospitals outside the United States this quarter. These initial system sales marked a key validation of our technology's global applicability and confirm that our value proposition, improve safety, reduce logistical burden and long-term cost savings, is resonating strongly with hospital administrators and clinicians. We continue to see excellent engagement from our distribution partners who are now actively seeking regulatory approvals or demonstrating LungFit PH in hospitals in their local markets.

重要的是，本季我們首次將 LungFit PH 推向美國以外的國際醫院進行商業推廣。這些首批系統銷售標誌著我們技術的全球適用性得到了關鍵驗證，並證實了我們的價值主張——提高安全性、減輕物流負擔和長期成本節約——引起了醫院管理者和臨床醫生的強烈共鳴。我們持續看到分銷合作夥伴的積極參與，他們現在正積極尋求監管部門的批准，或在當地市場的醫院中展示 LungFit PH。

These latest agreements bring our total international coverage to 35 countries, representing a combined population of approximately 2.8 billion people, and we expect to reach our goal of 60 countries under partnership in calendar 2026.

這些最新協議使我們的國際覆蓋範圍達到 35 個國家，總人口約 28 億，我們預計到 2026 年將實現與 60 個國家建立合作夥伴關係的目標。

As local distributors begin converting opportunities into active installations and sales, we anticipate international revenue contribution to build steadily through fiscal 2026 with momentum accelerating into fiscal 2027. This growing global footprint positions Beyond Air to capitalize on significant untapped demand for LungFit PH and lays the foundation for broader global adoption following additional regional approvals.

隨著本地經銷商開始將機會轉化為實際安裝和銷售，我們預計國際收入貢獻將在 2026 財年穩步成長，並在 2027 財年加速成長。Beyond Air 的全球佈局不斷擴大，使其能夠充分利用 LungFit PH 的巨大未開發需求，並為在獲得更多區域批准後更廣泛地在全球範圍內推廣奠定基礎。

To wrap up our remarks around LungFit PH, I have two more positive updates to share. We had a patent allowance for a design patent that covers our second-generation LungFit PH through 2040. And we had data shown by a physician at the Extracorporeal Life Support Organization Conference in September, which show positive results when LungFit was used in the ECMO sweet gas circuit on neonates.

最後，關於 LungFit PH，我還有兩點正面的最新消息要分享。我們擁有一項設計專利，涵蓋我們的第二代 LungFit PH，有效期至 2040 年。我們在 9 月的體外生命維持組織會議上，有一位醫生展示了數據，數據顯示，當 LungFit 在 ECMO 甜氣體迴路中用於新生兒時，取得了積極的結果。

I would like to provide an update on the data from Beyond Cancer's Phase 1a study. As a reminder, study enrolled 10 subjects at doses of 25,000 and 50,000 parts per million nitric oxide gas delivered over five minutes intratumorally. These patients all had metastatic disease and were heavily pretreated. The mean number of total prior surgeries, radiation and medications was 10.3 with a minimum of 4, maximum of 18. The mean number of all prior medications only was 5.5 with a minimum of 2 and a maximum of 14.

我想向大家介紹一下 Beyond Cancer 1a 期研究的數據最新進展。提醒一下，研究招募了 10 名受試者，分別以 25,000 和 50,000 ppm 的劑量，在五分鐘內透過腫瘤內輸送一氧化氮氣體。這些患者均患有轉移性疾病，事先接受過大量治療。過去手術、放射治療和藥物治療的總次數平均為 10.3 次，最少為 4 次，最多為 18 次。既往用藥的平均數量為 5.5，最少為 2，最多為 14。

All subjects had a life expectancy of less than 12 months when we treated with UNO therapy. The only adverse event which occurred in one patient that was possibly attributable to nitric oxide was a Grade 3 vasovagal response. Otherwise, the safety profile is very clean for this patient population.

當我們採用 UNO 療法治療所有受試者時，他們的預期壽命均不到 12 個月。唯一發生在一名患者身上的可能與一氧化氮有關的不良事件是 3 級血管迷走神經反應。除此之外，對於這部分患者族群而言，安全性非常好。

With respect to overall survival, the median and mean are 22 months and 21.2 months, respectively. These survival numbers will continue to increase, but we have not yet reached the final median survival. Given these impressive data, we are assessing the best path forward for the program at this time. We remain dedicated to pursuing the Phase 1b combination study with anti-PD-1 therapy, and we will communicate more details as we progress.

就總存活期而言，中位數為 22 個月，平均值為 21.2 個月。這些生存人數還會繼續增加，但我們尚未達到最終的中位存活期。鑑於這些令人印象深刻的數據，我們目前正在評估該計畫的最佳前進方向。我們將繼續致力於推進與抗 PD-1 療法聯合治療的 1b 期研究，並將隨著研究進展公佈更多細節。

With respect to NeuroNOS, we recently announced that the US FDA granted Orphan Drug Designation to its investigational therapy, BA-101, for the treatment of glioblastoma. The NeuroNOS team is working closely with regulators, investigators, patient groups and the foundations to accelerate development of BA-101 towards a first-in-human study.

關於 NeuroNOS，我們最近宣布，美國 FDA 已授予其在研療法 BA-101 治療膠質母細胞瘤的孤兒藥資格。NeuroNOS 團隊正與監管機構、研究人員、病患團體和基金會密切合作，以加速 BA-101 的開發，爭取盡快進行首次人體試驗。

This program is in addition to the development for BA-102, an investigational therapy for the treatment of Phelan-McDermid syndrome, or PMS, syndrome associated with autism. We expect the IND submission for the first-in-human study by the end of calendar 2026. As a reminder, the FDA has also granted orphan drug designation to BA-102 for PMS.

除了開發 BA-102（一種用於治療與自閉症相關的 Phelan-McDermid 症候群（PMS）的試驗性療法）之外，該計畫還在進行中。我們預計將於 2026 年底前提交首次人體試驗的 IND 申請。提醒一下，FDA 也授予 BA-102 治療經前症候群的孤兒藥資格。

I will wrap up by stating how energized we are following the financing, which will support the continued progress of our global commercial activities and help us prepare for the potential launch of the second-generation LungFit PH. Promise of LungFit is apparent, and we are thankful to the team at Streeterville, taking the time to appreciate our vision to provide clinicians and patients around the world with the optimal NO system.

最後，我想說，我們獲得融資後士氣大振，這將支持我們全球商業活動的持續發展，並幫助我們為第二代 LungFit PH 的潛在上市做好準備。LungFit 的前景顯而易見，我們感謝 Streeterville 團隊抽出時間來理解我們的願景，即為世界各地的臨床醫生和患者提供最佳的 NO 系統。

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

現在我將把發言權交給我們的財務長道格·拉爾森。

Thanks, Steve, and good afternoon, everyone. Our financial results for the second quarter of fiscal year 2026, which ended September 30, 2025, are as follows. Revenue for the fiscal quarter ended September 30, 2025, increased 128%, $1.8 million compared with $0.8 million for the fiscal year ended September 30, 2024. We showed 3% growth versus last quarter. Steve mentioned how our revenue is a little chunkier now given an international ramp is never straight up.

謝謝你，史蒂夫，大家下午好。以下是截至 2025 年 9 月 30 日的 2026 財年第二季的財務表現。截至 2025 年 9 月 30 日的財政季度營收成長 128%，達到 180 萬美元，而截至 2024 年 9 月 30 日的財政年度收入為 80 萬美元。與上季相比，我們實現了3%的成長。史蒂夫提到，鑑於國際市場成長並非一帆風順，我們現在的收入比以前更高。

We are showing a gross loss of $0.3 million for the fiscal second quarter 2026 compared to a loss of $1.1 million for the same period last year. The improvement was primarily attributed to sales growth. Our margin slipped back negative this quarter due to costs required to upgrade our existing fleet of devices and provisions for excess inventory.

我們預計 2026 財年第二季毛虧損為 30 萬美元，去年同期虧損為 110 萬美元。這項改善主要歸功於銷售成長。由於升級現有設備所需的成本以及為過剩庫存預留資金，本季我們的利潤率再次轉為負值。

Turning to operating expenses. We continue to see cost reduction across the board, in SG&A, R&D and in our supply chain due to cost reduction initiatives we took in the last 12 months. For the second quarter of fiscal 2026, we reduced total operating expenses to just above $7.4 million from $11.7 million for the same period last year. This translates to a 37% reduction year over year, and greater than 56% reduction from a high of $17 million at its peak. Going forward, we anticipate R&D expenses will decrease slightly next quarter as the cost related to our Gen II device are mostly behind us.

接下來談談營運費用。由於過去 12 個月我們採取了降低成本的舉措，我們在銷售、管理及行政費用、研發和供應鏈等各個方面都持續看到成本下降。2026 財年第二季度，我們的總營運支出從去年同期的 1,170 萬美元減少到略高於 740 萬美元。這意味著同比減少 37%，比高峰 1700 萬美元減少超過 56%。展望未來，我們預計下一季研發費用將略有下降，因為與第二代設備相關的成本基本上已經完成。

SG&A expenses will only move up in line with our commercial performance to maintain our excellence in service and take advantage of coming opportunities. Research and development expenses were $2.5 million for fiscal quarter 2026 compared to $4.6 million for the same period last year. Half of the decrease of $2.1 million was due to a reduction in development costs for our Gen II device while the other half was mostly attributed to a decrease in salaries and stock-based compensation costs. SG&A expenses for the quarters ended September 30, 2025, and September 30, 2024, were $4.9 million and $7.2 million, respectively. Almost all of the decrease of $2.3 million was from a reduction in salaries and stock-based compensation costs.

銷售、一般及行政費用只會隨著我們的商業業績成長而成長，以維持我們卓越的服務水準並抓住未來的機會。2026 財年第一季的研發費用為 250 萬美元，去年同期為 460 萬美元。210 萬美元的減少中，一半是由於第二代設備的研發成本降低，另一半則主要歸因於薪資和股票選擇權補償成本的降低。截至 2025 年 9 月 30 日及 2024 年 9 月 30 日止季度的銷售、一般及行政費用分別為 490 萬美元及 720 萬美元。減少的 230 萬美元幾乎全部來自工資和股票選擇權成本的減少。

Only part of the business that saw an increase in SG&A was a NeuroNOS as they start to build a little bit of infrastructure to support the groundbreaking work being done there. Other expense was $0.6 million compared to a $1.2 million expense for the same period a year ago. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt.

業務中只有 NeuroNOS 的銷售、管理及行政費用有所增加，因為他們開始建立一些基礎設施來支持那裡正在進行的開創性工作。其他支出為 60 萬美元，而去年同期支出為 120 萬美元。支出減少 0.6 億美元主要歸因於前期部分債務清償造成的損失。

Net loss attributed to common stockholders of Beyond Air, Inc., was $7.9 million or a loss of $1.25 per share, basic and diluted. Our net loss for the fiscal quarter ended September 30, 2024, was $13.4 million or a loss of $5.67 per share, basic and diluted. Please note that the per share results for both periods were calculated to reflect the company's 1-for-20 reverse stock split, which became effective on July 14, 2025.

Beyond Air, Inc. 歸屬於普通股股東的淨虧損為 790 萬美元，即每股虧損 1.25 美元（基本和稀釋後）。截至 2024 年 9 月 30 日的財政季度，我們的淨虧損為 1,340 萬美元，即每股虧損 5.67 美元（基本和稀釋後）。請注意，這兩個時期的每股業績均已根據本公司 2025 年 7 月 14 日生效的 1 比 20 反向股票分割進行計算。

Net cash burn for the quarter was $4.7 million, which is a 66% reduction versus a year ago. We believe our overall cash burn will continue to reduce as revenue grows and will only get better until we get approval and start building inventory in preparation for the launch of Gen II. As of September 30, 2025, we reported cash, cash equivalents and marketable securities of $10.7 million.

本季淨現金消耗為 470 萬美元，比去年同期減少了 66%。我們相信，隨著收入的增長，我們的整體現金消耗將繼續減少，並且只會越來越好，直到我們獲得批准並開始建立庫存，為第二代產品的推出做準備。截至 2025 年 9 月 30 日，我們報告的現金、現金等價物及有價證券為 1,070 萬美元。

As Steve mentioned earlier, subsequent to the end of the second quarter, we announced closing a strategic financial agreement with Streeterville Capital, LLC. Under the terms of the agreement, we issued $12 million promissory note bearing a 15% annual interest rate. This note matures in 24 months from the issue date with no payments due for the first 12 months.

正如史蒂夫之前提到的，在第二季結束後，我們宣布與 Streeterville Capital, LLC 達成策略財務協議。根據協議條款，我們發行了一張 1,200 萬美元的本票，年利率為 15%。該票據自發行日起 24 個月後到期，前 12 個月無需支付任何款項。

In addition, we entered into a $20 million equity line of credit agreement with Streeterville Capital dependent on our filing an S-1 resale registration covering resale of the shares Streeterville Capital may receive under the e-lock. This e-lock provides us with the right but not the obligation to sell up to $20 million of newly issued shares of our common stock over a 24-month period, subject to certain limitations. Following these recent financing agreements, we believe that our cash and existing financial vehicles will be sufficient to allow us to support our current operating plans well into calendar 2027 and potentially to profitability, providing we continue to hit our current revenue estimates, continue to control costs at Beyond Air.

此外，我們與 Streeterville Capital 簽訂了 2000 萬美元的股權信貸協議，前提是我們提交 S-1 轉售登記，涵蓋 Streeterville Capital 根據電子鎖定協議可能獲得的股份的轉售。此電子鎖賦予我們權利（但無義務）在 24 個月內出售至多 2,000 萬美元新發行的普通股，但須遵守某些限制。繼最近的融資協議之後，我們相信，我們的現金和現有金融工具足以支持我們目前的營運計劃，直至 2027 年，並有可能實現盈利，前提是我們繼續實現目前的收入預期，並繼續控制 Beyond Air 的成本。

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

這樣，我就把電話轉回給史蒂夫了。

Thanks, Doug. Operator, we'll take questions.

謝謝你，道格。接線員，我們來回答問題。

(Operator Instructions) Justin Walsh, Jones Trading.

（操作說明）賈斯汀·沃爾什，瓊斯貿易公司。

Without going into specific fiscal 2027 guidance, can you comment on the expected growth drivers leading into the potential approval of the second-generation LungFit PH? And then how you're thinking about that trajectory after that second gen product is out?

在不談具體的 2027 財年業績指引的情況下，您能否評論一下推動第二代 LungFit PH 獲得潛在批准的預期成長動力？那麼，在第二代產品上市之後，您是如何考慮未來的發展方向的呢？

Thanks, Justin. Appreciate that. So obviously, the trajectory once the second generation is out should be significantly steeper than what we're seeing now. That's our belief. And I think people know the attributes of that system versus the current system and the competition. So we're confident in that. As for the growth drivers prior to that, I assume you're asking for.

謝謝你，賈斯汀。謝謝。顯然，第二代產品問世後的發展軌跡應該會比我們現在看到的陡峭得多。這是我們的看法。我認為人們都了解這套系統相對於現有系統和競爭對手的優勢。所以我們對此充滿信心。至於之前的成長驅動因素，我想這就是您問的。

Yeah.

是的。

Yeah. We're setting up internationally. We're in 35 countries now with partners. We did just place systems in our first commercial hospital outside the United States. So it takes time to build that.

是的。我們正在拓展國際市場。我們目前已與35個國家的合作夥伴開展業務。我們剛剛在美國以外的第一家商業醫院安裝了系統。所以這需要時間來建立。

We all wish we'd go a little faster, but it is being built, and our international team is doing a great job. So we've got a lot of seeds planted out there, I guess, you could say. And we anticipate that with fiscal '27 coming up, we should be winning a lot of hospitals outside the United States where the competition is a little bit different than it is in the United States. So that's one of the drivers for '27.

我們都希望速度能再快一點，但它正在建設中，我們的國際團隊做得非常出色。所以可以說，我們已經播下了許多種子。我們預計，隨著 2027 財年的到來，我們應該會在美國以外贏得許多醫院的訂單，因為那裡的競爭與美國略有不同。所以這是 2027 年的驅動因素之一。

The other thing inside the United States, we did introduce a capital purchase model. Our system is now to a point where it's extremely reliable. We've had interest, and we've actually had our first hospital purchase from us. So that will be a capital equipment purchase. And then the filter and the other accessories would be the ongoing purchase.

在美國國內，我們也引進了資本購買模式。我們的系統現在已經非常可靠了。我們已經收到了不少諮詢，而且實際上我們已經完成了第一筆醫院採購。所以這將是一筆資本設備採購。然後，過濾器和其他配件就需要持續購買了。

And those prices, I guess it depends on how much nitric oxide use in your hospital per year per system, but this is certainly very competitive from a per hour cost basis for nitric oxide. So I think this new offering in terms of how hospitals can pay in the United States, we've gotten some interest there and the ex-US will be the driver prior to Gen II being approved.

至於價格，我想這取決於貴院每個系統每年使用多少一氧化氮，但從每小時一氧化氮的成本來看，這絕對是非常有競爭力的。所以我認為，就美國醫院的支付方式而言，這項新方案已經引起了一些關注，而美國以外的地區將在第二代方案獲得批准之前發揮推動作用。

Got it. And one more question. You mentioned here that you're hoping to commercialize the second-gen LungFit PH around end of calendar 2026, if I heard correctly. I'm just wondering if you can comment on kind of the thinking around this timing and whether or not you've noticed any delays in your dealings with the FDA recently.

知道了。還有一個問題。如果您沒聽錯的話，您在這裡提到希望在 2026 年底左右將第二代 LungFit PH 商業化。我只是想問您能否就這個時間安排的考慮發表一下看法，以及您最近在與FDA的交涉中是否注意到任何延誤。

Yeah, I think FDA is doing a great job. I don't think the timing that we're providing is FDA being a limiting factor. It's more supply chain on our side. I think the environment is difficult to get the parts that we need, certainly doesn't help with all the disagreements, I would say, that are happening around the world with trade, government shutdown doesn't help either. So I think just getting things in place for our ability to get our contract manufacturing in shape for inspection is what we're doing.

是的，我認為FDA做得很好。我不認為我們提供的審批時間是受到FDA的限制。這更多是我們這邊的供應鏈問題。我認為，在當前環境下，我們很難獲得所需的零件，這無疑加劇了世界各地貿易的分歧，政府停擺也無濟於事。所以我覺得，我們現在所做的，就是為確保我們的合約製造能夠通過檢驗做好準備。

So it's just a matter of time before that occurs. And you did mention we'd be launching before the end of the year. I think approval has to be a little bit earlier than December, obviously, for us to be able to launch by then. We're not going to launch the next day. It's going to take a little bit of time. So that's kind of where we are right now, things can change, things can be better or worse in terms of timing. But as we sit here today, that's the feeling that we have.

所以，這只是時間問題。你也提到我們會在年底前發布。我認為，為了能在12月之前啟動項目，審批顯然必須比12月更早。我們不會在第二天發布。這需要一些時間。所以，這就是我們目前的處境，情況可能會發生變化，時間安排上可能會更好，也可能會更糟。但今天我們坐在這裡時，就有了這種感覺。

Yale Jen, Laidlaw & Company.

耶魯‧詹，萊德勞公司。

Steve, could you just do some comparison between the new model versus the prior ones? So give us a little bit more deep dive in terms of the benefits to the company or maybe for the market penetration? Then I have a follow-up.

史蒂夫，你能對新型號和之前的型號做一些比較嗎？那麼，能否更深入分析一下這對公司或市場滲透帶來的好處呢？然後我還有一個後續問題。

Yeah. Thanks, Yale. I mean the biggest difference -- well there's a few, but the biggest differences are the size. So this second-generation machine will be about 60% the size of the original. It will be what we've applied for. And we believe that upon approval, with approval from FDA, it would be approved for use in ground and air transportation. That's critical. I think that's probably the biggest difference maker for us.

是的。謝謝耶魯。我的意思是，最大的區別——好吧，也有一些區別，但最大的區別在於尺寸。所以第二代機器的尺寸大約是原版的 60%。就是我們申請的那種。我們相信，一旦獲得FDA批准，它就可以獲準用於地面和航空運輸。這一點至關重要。我認為這可能是對我們來說最大的區別因素。

And the user interface has been upgraded based on feedback from our current customers and some future customers, I guess, who weren't using our Gen I system, but did give us advice on Gen II. So we listened to them and we built this device based on their input. So we think that all of the functions of the device will be a little bit easier and a little bit better for the user.

使用者介面根據我們現有客戶和一些未來客戶的回饋進行了升級，我想，這些未來客戶沒有使用我們的第一代系統，但確實為我們提供了第二代系統的建議。所以我們聽取了他們的意見，並根據他們的回饋製造了這款設備。因此我們認為，該設備的所有功能對使用者來說都會更方便、更好用一些。

One other thing that we have is that the maintenance interval will be longer, so that the disruption of swapping machines out for those high-volume users will be a thing of the past, let's say. So when you have hospitals that are using an exceptional amount of hours per system per year, let's say, way above what the average is, we're bringing them in for maintenance fairly regularly. So that's a little bit of a disruption of the hospital, and we're working to get Gen II out there. So that disappears.

我們還有一點可以肯定，那就是維護間隔將會延長，這樣一來，對於那些使用量大的用戶來說，更換機器造成的中斷將成為過去。所以，當一些醫院每年每個系統的使用時間異常長，比如說遠遠超過平均時，我們就會相當頻繁地將它們送去進行維護。所以這對醫院來說有點幹擾，我們正在努力讓第二代產品盡快投入使用。所以它就消失了。

So I actually, just try to get -- I'm sorry, try to get a little bit about the new business -- what new business model can achieve that wasn't really fully appreciated -- can be appreciated by the existing one?

所以，我其實只是想了解一下——抱歉，我想了解這個新業務——新的商業模式能夠實現哪些現有商業模式尚未充分認識到的目標？

You mean Gen II versus Gen I, Yale?

你是說第二代和第一代的差別嗎，耶魯？

I mean, you mentioned that the new business model, which is to purchase (multiple speakers) machines. So I just want to get a sense of what does that -- what's the benefits of that versus the business operation you have done before this. And what some additional benefits you can generate from that?

我的意思是，你提到了新的商業模式，即購買（多台揚聲器）機器。所以我想了解這樣做的好處——與你之前開展的業務運營相比，這樣做有什麼優勢。那麼，從中還能獲得哪些額外好處呢？

Yeah. So look, the market was set up as essentially a leasing market before we enter the market. So we came in and we worked with hospitals based on what they were used to, and we get requests from hospitals, can we purchase the machine, can we purchase the machine. And we weren't doing a purchase of the machine in the first two years because we were still making upgrades and tweaking the machine and it would have been difficult to sell something where you were still upgrading it and improving it.

是的。所以你看，在我們進入市場之前，這個市場基本上就是一個租賃市場。所以我們進入了這個領域，我們根據醫院的習慣與他們合作，我們收到醫院的請求，問我們是否可以購買這台機器，是否可以購買這台機器。在前兩年，我們沒有購買這台機器，因為我們仍在對機器進行升級和調整，而要出售一台仍在升級和改進的機器是很困難的。

We're at the point now where there really aren't any more improvements to the Gen I machine. A little tweak here or there is standard, maybe a software update or something. Those things are not major changes. So for hospitals that have been asking us if we take a purchase again, I don't know, on their side, they prefer to purchase and to buy the disposables at a much lower rate than the leasing model would have. Again, that's just their preference. So we are offering different models for using our system to the hospitals based on their needs. That's all it is, yeah. We're not abandoning the leasing model in any way.

現在第一代機器已經基本上沒有改進空間了。通常只會做一些小調整，像是軟體更新之類的。這些都不是什麼重大改變。所以對於那些詢問我們是否再次接受採購的醫院，我不知道，就他們而言，他們更傾向於採購，而且採購一次性用品的價格遠低於租賃模式。再次強調，這只是他們的個人偏好。因此，我們根據醫院的需求，提供不同的系統使用模式。就是這樣，沒錯。我們絕不會放棄租賃模式。

So we have multiple different types of leases. So we're really just trying to offer the hospitals what they're asking for. So the latest one is the capital purchase model. So we introduced it a few months ago, and we've got hospitals that are taking advantage of it.

因此，我們有多種不同類型的租賃合約。所以我們只是想盡力滿足醫院的要求。所以最新的模式就是資本購買模式。所以我們幾個月前推出了這項服務，現在已經有一些醫院開始使用它了。

Okay. Great. Maybe just a follow-up on the question. Next question is that you've got a lot of international deals signed, which is a great thing to happen. And because of the massive market over there, I assume most of these are distributors. So how should we think about modeling over the long term in terms of what sort of pricing that may generate versus the one in the United States, which is slightly different? And how was the filter -- renewing filter fit into that model as well in the banks.

好的。偉大的。或許可以對這個問題做個後續補充。下一個問題是，你們已經簽署了很多國際協議，這是一件非常好的事情。由於那裡的市場規模龐大，我推測其中大部分是分銷商。那麼，我們應該如何從長遠角度考慮建模，以及這種建模方式可能會產生什麼樣的定價，與美國略有不同的定價方式相比又會如何呢？那麼，銀行的過濾器——更新過濾器——是如何融入這種模式中的呢？

Yeah. I mean, the ex-US model for us, where we're selling things to the distributors and then they're using it in whatever model they like in their markets, whether it be a leasing model or a capital equipment purchase model or something else or some combination of that, that's their business. So for us, though, they're purchasing the machines like a capital equipment purchase. And then we're also selling them the disposables, including the filter, which is obviously the most important disposable.

是的。我的意思是，對我們來說，在美國以外的模式是，我們把產品賣給分銷商，然後他們可以在自己的市場中以任何他們喜歡的模式使用這些產品，無論是租賃模式、資本設備購買模式還是其他模式或這些模式的某種組合，那是他們的生意。但對我們來說，他們購買這些機器就像購買資本設備一樣。然後我們也向他們出售一次性用品，包括過濾器，這顯然是最重要的一次性用品。

So that's how you should think about it in terms of modeling. It's more of a -- just a repetitive revenue line, and I think that that's probably going to happen more in fiscal '27 than now because we're just getting the systems out there. Once they're placed in hospitals, you see that repeat business, but that's not happening in fiscal '26. It will be a fiscal '27 phenomenon and picking up speed more in fiscal '28 because we're still awaiting regulatory approvals in many countries, and it takes time to get into these hospitals. So it is a long process, but that's the way it goes.

所以，從建模的角度來看，你應該這樣思考。這更像是一條——只是重複的收入來源，我認為這種情況在 2027 財年可能會比現在更頻繁地發生，因為我們才剛開始推廣這些系統。一旦這些病人被安置在醫院，你就會看到回頭客，但這在 2026 財年並沒有發生。這將是 2027 財年的現象，並在 2028 財年加速發展，因為我們仍在等待許多國家的監管部門批准，進入這些醫院需要時間。所以這是一個漫長的過程，但事情就是這樣。

Okay. Great. That's very helpful. And congrats on the -- fortify the balance sheet, which you can do a lot of good things. And congrats.

好的。偉大的。那很有幫助。恭喜你－強化了資產負債表，這可以帶來很多好處。恭喜！

Marie Thibault, BTIG.

瑪麗·蒂博，BTIG。

This is Sam on for Marie. Maybe I can start on the updated guide, the $8 million to $10 million. Steve, would just love your thoughts on the visibility you have given maybe some of the fluctuations in the hospital sales cycle. And then any thoughts on cadence for the back half of the year?

這裡是薩姆替瑪麗報道。或許我可以開始著手更新指南，也就是 800 萬到 1000 萬美元的指南。史蒂夫，我很想聽聽你對你目前所展示的醫院銷售週期波動的看法。另外，你對下半年的節奏有什麼想法嗎？

Thanks, Sam. Appreciate it. Well, look, we've got $3.6 million in the first half. So it's not a large leap to get to the 8% plus range.

謝謝你，山姆。謝謝。你看，我們上半年收入了360萬美元。所以達到 8% 以上的水平並不是一個巨大的飛躍。

But we have a transition at Chief Commercial Officer. So I'm sure everyone on the call wouldn't expect Bob Goodman to hit the ground running on in week one or two and start ripping sales straight up. I think it will take a little bit of time for Bob to implement his processes here and get things moving in the right direction. So I think that when there's a change like this, there's going to be a little bit of disruption. So that's part of the reason why the $8 million to $10 million is the new guidance.

但我們的首席商務官一職將進行人事變動。所以我相信所有參加電話會議的人都不會指望鮑勃古德曼在一兩週內就能迅速進入狀態，銷售額直接飆升。我認為鮑伯需要一些時間來落實他的流程，讓事情朝著正確的方向發展。所以我認為，當出現這樣的變化時，肯定會帶來一些混亂。所以，這也是為什麼新的預期目標定在 800 萬至 1,000 萬美元的部分原因。

Okay. Okay. That's helpful. And then maybe I can just follow up here on the pace of contract renewals that are coming up. Are you seeing pretty strong renewal rates? Are customers exiting contracts at all? Would just love an update there as well.

好的。好的。那很有幫助。然後，我或許可以跟進一下即將到來的合約續約進度。續約率是否相當高？客戶是否會解除合約？我也想知道那方面的最新消息。

Yeah, the renewals are going well. We've had a bunch of renewals go from one year, they renewed for three years. We see that happening not with every contract, but a good number of them. And I think that getting on Premier is very helpful. We had a few hospitals that were Premier hospitals that we had contracts with weren't yet on Premier, so now being on Premier solidifies that. That's very helpful.

是的，續約進展順利。我們有很多續約合約的期限從一年延長到了三年。我們發現這種情況並非每份合約都會發生，但相當一部分合約確實如此。我認為加入Premier會員非常有幫助。我們之前與幾家Premier醫院簽了合同，但它們當時還沒有加入Premier計劃，現在加入Premier計劃鞏固了我們與這些醫院的合作關係。這非常有幫助。

We look forward to hopefully getting on HealthTrust as well at some point, and that would give us the big three GPOs. That's very helpful for being able to not only get hospitals, but maintain them. Sometimes they can contract outside of their GPO, which is rare. But when we do, when we get on the GPO, it's obviously important.

我們希望將來也能加入 HealthTrust，這樣我們就能擁有三大 GPO 了。這不僅對獲得醫院，而且對維持醫院的運作都非常有幫助。有時他們可以與集團採購組織 (GPO) 以外的供應商簽訂合同，這種情況很少見。但當我們真的做到了，當我們進入 GPO 時，這顯然非常重要。

So we haven't really seen hospitals leaving us. It's a very sticky business, I think. And I think it's due to the team in the field, the machine's performance, and the clinical team here at Beyond Air do an excellent job of supporting the hospitals when they need support.

所以我們還沒有真正看到醫院離開我們這裡。我覺得這事兒很棘手。我認為這要歸功於現場團隊、機器的性能，以及 Beyond Air 的臨床團隊在醫院需要支援時提供的出色支援。

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.

目前隊列中沒有其他問題。我們的問答環節到此結束。現在我想把電話轉回給史蒂夫·利西，請他作總結發言。

Thanks, operator. Thanks, everyone, for joining. Look forward to speaking to you in the near future. Thank you.

謝謝接線生。謝謝大家的參與。期待在不久的將來與您聯繫。謝謝。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。您可以在此時斷開線路。感謝您的參與。