Beyond Air Inc (XAIR) 2024 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, 2023. (Operator Instructions)

下午好，歡迎大家參加 Beyond Air 截至 2023 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'd like to turn the call over to Edward Barger, Head of Investor Relations at Beyond Air. Please go ahead.

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

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

謝謝你，接線生。大家下午好，感謝您加入我們。今天收盤後，我們發布新聞稿，宣布 2024 年第二財季的營運亮點和財務表現。您可以在我們的網站 www.beyondair.net 的「新聞與活動」部分找到本新聞稿的副本。

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

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言論，這些言論構成前瞻性陳述，以符合《私人證券訴訟改革法案》中的安全港條款的目的。1995 年。

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

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

Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 13, 2023. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

此外，本次電話會議正在錄製中，並將在我們的網站 www.beyondair.net 上進行音訊重播。此外，本次電話會議的內容包含時間敏感信息，僅截至直播日期（2023 年 11 月 13 日）準確。Beyond Air 不承擔修改或更新任何聲明以反映該日期之後的事件或情況的義務這次通話的。

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

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

Thanks, Ed. Good afternoon to everyone joining us today. I'll start today's call by highlighting the revenue guidance we announced earlier today in our quarterly press release. For the fiscal year ending March 31, 2025, we anticipate $12 million to $16 million in revenues. The impetus for providing guidance at this time is threefold. First is the great work done by our commercial and supply chain teams provide hospitals with confidence in LungFit PH and our support for users of the system.

謝謝，艾德。今天加入我們的大家下午好。我將透過強調我們今天早些時候在季度新聞稿中宣布的收入指引來開始今天的電話會議。截至 2025 年 3 月 31 日的財年，我們預計營收為 1,200 萬至 1,600 萬美元。此時提供指導的動機有三重。首先，我們的商業和供應鏈團隊所做的出色工作讓醫院對 LungFit PH 以及我們對系統使用者的支援充滿信心。

Second, the Vizient contract we announced in October 2023, the FDA approval of an update to our software, which was granted in September. Our entire fleet of systems will be updated by the end of January with production of new machines ramping up significantly as well to meet anticipated demand.

其次，我們在 2023 年 10 月宣布了 Vizient 合同，FDA 於 9 月批准了我們軟體的更新。我們的整個系統將於一月底更新，新機器的產量也將大幅增加，以滿足預期的需求。

Looking outside of the US, in September, we announced a partnership with Getz Healthcare for commercialization of LungFit PH in the Asia Pacific region, excluding Japan. We look forward to triggering a milestone payment once CE mark is received, which is expected to occur early next year. We are very pleased to have the endorsement of a company with the reputation of Getz.

展望美國以外的地區，9 月份，我們宣布與 Getz Healthcare 建立合作夥伴關係，在亞太地區（日本除外）實現 LungFit PH 的商業化。我們期待在收到 CE 標誌後觸發里程碑付款，預計將於明年初發生。我們很高興得到一家享有 Getz 聲譽的公司的認可。

Another recent milestone achievement under the LungFit PH program is the PMA submission for the expansion of our label to include cardiac surgery. Our clinical and regulatory team is to be commended for putting together a strong submission, and we look forward to a positive impact on our revenues beginning in the back half of fiscal 2025.

LungFit PH 計畫最近的另一項里程碑式成就是向 PMA 提交申請，將我們的標籤擴展至包括心臟手術。我們的臨床和監管團隊因提交了強有力的意見而受到讚揚，我們期待從 2025 財年下半年開始對我們的收入產生積極影響。

Moving on to our other programs, at the SITC Conference last week in San Diego, Beyond Cancer presented top-line data from the Phase 1a first-in-human trial. In this study, five patients, all of whom had failed an average of six prior-treatment regimens, each received one five-minute intratumoral administration of 25,000 parts per million nitric oxide. The treatment was safe and well-tolerated.

繼續我們的其他項目，在上週於聖地牙哥舉行的 SITC 會議上，Beyond Cancer 展示了 1a 期首次人體試驗的重要數據。在這項研究中，5 名患者均接受了 25,000 ppm 一氧化氮的瘤內注射，每人 5 分鐘，平均 6 種先前治療方案均失敗。該治療安全且耐受性良好。

Additionally, an immunostimulatory effect was clearly evident over the 21-day observation period, with upregulation of key biomarkers such as cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells, while down-regulation of T-regulatory cells and mononuclear myeloid derived suppressor cells were shown.

此外，在 21 天的觀察期內，免疫刺激作用非常明顯，細胞毒性 T 細胞、T 中央記憶細胞、M1 巨噬細胞和樹突狀細胞等關鍵生物標記上調，而 T 調節細胞下調並顯示了單核骨髓來源的抑制細胞。

I would like to emphasize that the effect on these immune biomarkers is very similar to what we have seen in animal studies. Our animal studies presented and published over the last three years have consistently shown efficacy with monotherapy UNO, as well as in combination with multiple checkpoint inhibitors with respect to tumor progression and survival in multiple tumor models.

我想強調的是，對這些免疫生物標記的影響與我們在動物研究中看到的非常相似。我們在過去三年中提出和發表的動物研究一致表明，UNO 單一療法以及與多種檢查點抑制劑聯合治療在多種腫瘤模型中對腫瘤進展和生存的療效。

Also, during the quarter, Beyond Cancer presented positive preclinical data at the EORTC International Conference on Molecular Targets and Cancer Therapeutics, demonstrating a statistically significant survival benefit in mice treated with UNO plus anti-mPD-1 versus anti-mPD-1 alone. This was a pooled analysis of multiple studies done with 50,000 or 100,000 parts per million nitric oxide for a single administration of five or 10 minutes.

此外，本季度，Beyond Cancer 在EORTC 國際分子標靶和癌症治療會議上展示了積極的臨床前數據，證明接受UNO 加抗mPD-1 治療的小鼠與單獨抗mPD-1 治療相比具有統計學上顯著的生存獲益。這是對多項研究進行的總結分析，使用 50,000 或 100,000 ppm 的一氧化氮，單次給藥 5 或 10 分鐘。

Additionally, Beyond Cancer second manuscript was published in the cells journal in an article titled Intratumoral Administration of High-Concentration Nitric Oxide and Anti-mPD1 Treatment Improves Tumor Regression Rate and Survival in CT26 Tumor-Bearing Mice. We're very excited by the data and progress of the UNO program and look forward to sharing the data from our completed Phase 1a study in 2024. Our Cancer team will also be initiating a Phase 1b study in 2024, as well as approaching the FDA and other regulatory authorities about a Phase 2 program that is expected to begin before year end 2025. I encourage all of you to visit the Beyond Cancer website to get better educated on this potential transformational therapy for those suffering from solid tumors.

此外，《Beyond Cancer》的第二篇手稿發表在《細胞》雜誌上，題為《腫瘤內施用高濃度一氧化氮和抗mPD1 治療可提高CT26 荷瘤小鼠的腫瘤消退率和生存率》的文章。我們對 UNO 計畫的數據和進展感到非常興奮，並期待在 2024 年分享我們已完成的 1a 期研究的數據。我們的癌症團隊也將於 2024 年啟動 1b 期研究，並與 FDA 接洽和其他監管機構就預計2025 年底前開始的2 期計畫進行諮詢。我鼓勵大家造訪Beyond Cancer 網站，更了解這種針對實體瘤患者的潛在轉化療法。

Our Viral Community-Acquired Pneumonia, or VCAP, study is underway. As a reminder, this randomized, double-blind, placebo-controlled pilot study will treat hospitalized patients with 150 parts per million nitric oxide intermittently for up to seven days. Keep in mind, we have already completed four studies treating viral pneumonia, which have consistently demonstrated both safety and efficacy. Due to viral pneumonia following seasonal patterns of activity, this is a seasonal study running through the fall and winter months. As a result, we expect to announce top-line data by the middle of calendar year 2024. Viral pneumonia is a significant unmet medical need with over 300,000 hospitalizations annually in United States and more than 15 million worldwide.

我們的病毒性社區型肺炎 (VCAP) 研究正在進行中。提醒一下，這項隨機、雙盲、安慰劑對照的試驗研究將使用百萬分之 150 的一氧化氮間歇性地治療住院患者，持續時間長達 7 天。請記住，我們已經完成了四項治療病毒性肺炎的研究，這些研究一致證明了安全性和有效性。由於病毒性肺炎遵循季節性活動模式，因此這是一項貫穿秋季和冬季的季節性研究。因此，我們預計將在 2024 年年中公佈主要數據。病毒性肺炎是一項未滿足的重大醫療需求，美國每年有超過 30 萬人住院治療，全球有超過 1500 萬人住院治療。

Let me conclude my opening remarks by touching on our newest program to treat autism that is on track to have human data in 2025. Recall that this is in partnership with The Hebrew University of Jerusalem, which continues to produce exciting preclinical data. In September, we announced the publication of new data showing a therapeutic effect for at least 10 days after a single injection of an extended-release formulation. Just like the daily injection, the data show a reversal of behavioral phenotypes associated with autism, and we look forward to additional data from the University.

最後，我想談談我們治療自閉症的最新項目，該項目預計在2025 年獲得人類數據。回想一下，這是與耶路撒冷希伯來大學合作的，該大學將繼續產生令人興奮的臨床前數據。 9 月，我們宣布發布新數據，顯示單次注射緩釋製劑後至少 10 天有治療效果。就像每日註射一樣，數據顯示與自閉症相關的行為表型發生逆轉，我們期待大學提供更多數據。

Now, I will turn the call over to our Chief Commercial Officer, Duncan Fatkin, for a closer look at the LungFit PH commercial launch. Duncan?

現在，我將把電話轉給我們的商務長 Duncan Fatkin，詳細了解 LungFit PH 的商業發布。鄧肯？

Thanks, Steve, and good afternoon to our investors. As Steve mentioned, we have given revenue guidance for LungFit PH for fiscal 2025. Since we last spoke in August, we have more than doubled the number of hospitals using LungFit PH.

謝謝史蒂夫，我們的投資者下午好。正如 Steve 所提到的，我們已經為 LungFit PH 提供了 2025 財年的收入指導。自從我們上次在 8 月發表講話以來，我們使用 LungFit PH 的醫院數量增加了一倍多。

Another metric I would like to share with you is the shipment of NO2 filters to our customers. In fiscal Q1, our first quarter with customers, we shipped approximately 450 filters. During the quarter that we're reporting today, which ended September 30, the number of clips 1,300, and in October alone, we shipped over 900 filters to our customers. We expect to continue this acceleration given the recent approval of our software upgrade for LungFit PH by the FDA.

我想與您分享的另一個指標是向客戶發貨的二氧化氮過濾器。在第一財季，也就是我們與客戶合作的第一個季度，我們運送了大約 450 個過濾器。在我們今天報告的那個季度（截至 9 月 30 日），剪輯數量為 1,300 個，僅在 10 月份，我們就向客戶運送了 900 多個過濾器。鑑於 FDA 最近批准了我們的 LungFit PH 軟體升級，我們預計將繼續這種加速。

Based on hospital feedback, we sought and gained FDA approval for software updates that address some minor limitations on device usage. We expect these updates to further increase the separation and value between LungFit PH and our competitors in the marketplace. I can make that statement with confidence, given our recent experience at the American Academy of Respiratory Care that took place a week ago.

根據醫院的回饋，我們尋求並獲得 FDA 批准軟體更新，以解決設備使用的一些小限制。我們預計這些更新將進一步擴大 LungFit PH 與市場競爭對手之間的差距和價值。鑑於我們一週前在美國呼吸護理學會最近的經歷，我可以充滿信心地發表這項聲明。

Another event that gives us confidence in accelerating our growth in the market at this stage is our innovative technology contract award from Vizient, the nation's largest provider-driven healthcare performance improvement company. This recognition represents a seal of approval for our revolutionary technology from the largest group purchasing organization in the US, representing more than $100 billion in annual purchasing volume. This achievement validates the positive customer experience and feedback that we've been reporting for some time. We are very excited by this opportunity to expand our reach to the Vizient customer network.

另一個讓我們對現階段加速市場成長充滿信心的事件是我們從 Vizient 獲得的創新技術合同，Vizient 是美國最大的提供者驅動的醫療保健績效改善公司。這項認可代表了美國最大的集團採購組織對我們革命性技術的認可，該組織的年採購額超過 1000 億美元。這項成就驗證了我們一段時間以來所報告的正面的客戶體驗和回饋。我們很高興有機會擴大我們對 Vizient 客戶網路的影響。

I would like to emphasize that an innovative technology contract signifies to Vizient members that the LungFit PH has a unique qualities that may enhance clinical care, patient safety, healthcare worker safety, and the business operations.

我想強調的是，創新技術合約向 Vizient 成員表明，LungFit PH 具有獨特的品質，可以增強臨床護理、病人安全、醫護人員的安全和業務運作。

As mentioned previously, we're building out a field team based on the opportunities developed over the past year and the growing interest in LungFit PH as we broaden our reach. Over the next 12 months, as our revenues build, we expect to continue increasing our sales team across the majority of the continental United States to capitalize on the opportunities afforded by the Vizient contracts, the updated LungFit PH system, and the anticipated approval of a label expansion for cataract surgery.

如前所述，我們正在根據過去一年中開發的機會以及隨著我們擴大業務範圍而對 LungFit PH 日益增長的興趣建立一個現場團隊。在接下來的 12 個月中，隨著我們收入的增加，我們預計將繼續在美國大陸大部分地區增加我們的銷售團隊，以利用 Vizient 合約、更新的 LungFit PH 系統以及預期批准的白內障手術的標籤擴展。

Now, I'll turn it over to Duncan.

現在，我將把它交給鄧肯。

Thanks, Duncan, and good afternoon, everyone. Our financial results for the fiscal quarter ended September 30, 2023, are as follows. Revenue for the fiscal quarter was $0.24 million as compared with zero for the fiscal quarter ended September 30, 2022. Research and development expenses for the fiscal quarter were $7.1 million compared with $4.5 million for the fiscal quarter ended September 30, 2022. The additional $2.7 million was due primarily to an increase in stock-based compensation, salaries, and development costs associated with the pipeline.

謝謝鄧肯，大家下午好。我們截至 2023 年 9 月 30 日的財政季度的財務表現如下。本財季的營收為24 萬美元，而截至2022 年9 月30 日的財季營收為零。本財季的研發費用為710 萬美元，而截至2022 年9 月30 日的財季為450 萬美元。額外的2.7 美元百萬美元主要是由於與管道相關的股票薪酬、工資和開發成本的增加。

SG&A expenses for the fiscal quarter were $10.2 million compared with $8 million for the fiscal quarter ended September 30, 2022. The $2.2 million increase was mainly due to stock-based compensation, professional fees, and salary.

本財季的銷售、一般管理費用為 1,020 萬美元，而截至 2022 年 9 月 30 日的財季為 800 萬美元。增加 220 萬美元主要是由於股票薪酬、專業費用和工資。

Other income and expense for the fiscal quarter showed a $0.1 million gain compared with a $0.2 million loss for the fiscal quarter ended September 30, 2022. There's a lot of moving parts, but essentially, interest income roughly offsets interest expense, and the gain we saw from the remeasurement of warrants and derivatives associated with our long-term debt was only partially offset by true-ups to our non-product-related litigation.

與截至2022 年9 月30 日的財季虧損20 萬美元相比，本財季的其他收入和支出增加了10 萬美元。有許多變動因素，但本質上，利息收入大致抵消了利息支出，我們將收益從與我們的長期債務相關的認股權證和衍生性商品的重新計量來看，我們的非產品相關訴訟的調整僅部分抵消了這一影響。

For the fiscal quarter ended September 30, 2023, the company reported a net loss of $17.4 million, of which $16.2 million or $0.51 per share was attributable to the shareholders of Beyond Air, Inc. compared with a net loss of $12 million or $0.4 a share for the fiscal quarter ended September 30, 2022.

截至2023 年9 月30 日的財季，該公司報告淨虧損1,740 萬美元，其中1,620 萬美元或每股0.51 美元歸屬於Beyond Air, Inc. 股東，而淨虧損為1,200 萬美元或每股0.4 美元。截至 2022 年 9 月 30 日的財季份額。

Net cash used in the quarter ended September 30, 2023, was $16.5 million, including $6.4 million in one-time payments, which had previously been disclosed and accrued. Aside from these one timers, cash burn in the quarter was $10.1 million, which is in line with our guidance of approximately $10 million per quarter. As of September 30, 2023, the company had cash, restricted cash, cash equivalents, and marketable securities of $43.9 million.

截至 2023 年 9 月 30 日的季度使用的淨現金為 1,650 萬美元，其中包括先前披露和應計的一次性付款 640 萬美元。除了這些計時器之外，本季的現金消耗為 1,010 萬美元，這符合我們每季約 1,000 萬美元的指引。截至2023年9月30日，該公司擁有現金、限制性現金、現金等價物及有價證券為4,390萬美元。

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) Jeremy Jacoby, Truist Securities.

（操作員指示）Jeremy Jacoby，Truist 證券公司。

Hi. Thanks for taking our questions. Can you just give us your puts and takes on how you got to this guidance range? And then what's causing the delay in the CE mark approval? Thanks.

你好。感謝您回答我們的問題。您能告訴我們您是如何達到這個指導範圍的嗎？那麼是什麼原因導致CE標誌批准延遲呢？謝謝。

So the delay in CE mark approval is not in our control. We're not saying it's not coming by the end of December. We just think it's more likely to come after that. Again, this is not in our control.

因此，CE 標誌批准的延遲不在我們的控制範圍內。我們並不是說它不會在 12 月底到來。我們只是認為在那之後更有可能發生。再說一遍，這不在我們的控制範圍內。

With respect to what's driving the guidance, I mean, it was pretty straightforward. We got a software upgrade from FDA for our system, which we've been waiting for quite some time on this. This gives us the ability to be compliant with lots of different devices out there that nitric oxide systems go on ventilators, obviously, being the main system. So this is important as well as some other tweaks to our system to optimize performance.

我的意思是，關於驅動該指南的因素，它非常簡單。我們的系統從 FDA 獲得了軟體升級，我們對此已經等待了相當長的時間。這使我們能夠相容於許多不同的設備，一氧化氮系統顯然是呼吸器上的主要係統。因此，這對於我們的系統進行一些其他調整以優化效能非常重要。

Now, obviously, we have visibility into hospitals that are waiting for this upgrade. We have visibility into hospitals that are on Vizient. And as our GPO that we're now a part of and, again, the feedback we get from existing customers, and potential new customers, is very encouraging for us with respect to our ability to deliver on the service side, which is critically important in this market. So I hope that answers your question. We feel highly confident in that range.

現在，顯然，我們可以了解正在等待升級的醫院。我們可以了解 Vizient 上的醫院。作為我們現在加入的 GPO，我們從現有客戶和潛在新客戶那裡得到的回饋對於我們在服務方面的交付能力而言非常令人鼓舞，這一點至關重要在這個市場上。所以我希望這能回答你的問題。我們對此範圍充滿信心。

Thank you.

謝謝。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hi, good afternoon. Thank you for taking the questions. Maybe I can tried to understand a little bit more about the ramp? Thanks for that great detail on filters shipped. Are the filters, when they're shipped, are they typically is there a big stocking bolus and then folks are reordering as needed? What's sort of the dynamic? How to think about that ramp you gave, the October number, which is very impressive, but I don't want to make the mistake of prorating that over the entire quarter, if that's not the appropriate approach. And then anything to cite in terms of pricing along these contracts? Are you seeing a wide range? Are things sort of staying stable with what you'd expected?

嗨，下午好。感謝您提出問題。也許我可以嘗試更多地了解坡道？感謝您提供有關已發貨過濾器的詳細資訊。過濾器在發貨時是否通常有大量庫存，然後人們根據需要重新訂購？是什麼樣的動態？如何考慮您給出的 10 月份的數字，這是非常令人印象深刻的，但我不想犯在整個季度按比例分配的錯誤，如果這不是適當的方法。那麼這些合約的定價方面有什麼值得引用的嗎？你看到的範圍很廣嗎？事情是否與您的預期保持穩定？

Thanks, Marie. I think that the pricing is pretty much as we as expected, it's within the ranges. And it's not all one price for everyone, obviously, but it's within the range of what we've expected over the past year plus. So that's not going to change. And in our opinion, the market's kind of stabilized in the range that we expected.

謝謝，瑪麗。我認為定價與我們預期的差不多，在範圍之內。顯然，這並不是每個人的價格都是統一的，但它在我們過去一年以上的預期範圍內。所以這不會改變。我們認為，市場在我們預期的範圍內穩定下來。

Yes, the filter stocking is -- if you look at it on a monthly basis, it can be chunky. There's no doubt, but some hospitals will want a delivery every month. Some will look every quarter, and there is obviously interim there. So if they do a monthly and they're running out, they'll call us sooner, same thing on the quarterly basis.

是的，過濾襪是——如果你每月查看它，它可能很厚實。毫無疑問，但有些醫院每個月都需要分娩。有些人每季都會看一次，而且顯然有過渡期。因此，如果他們每月做一次並且用完了，他們會更快地給我們打電話，每季也會做同樣的事情。

I don't know how to guide you with respect to the October number. Obviously, I mean, these things will move depending on how we get more contracts coming on with hospitals. So just really put that out there to show you that there is this upward trend, obviously, in usage and in number of customers that we have.

我不知道如何指導您了解 10 月份的數字。顯然，我的意思是，這些事情將取決於我們如何與醫院簽訂更多合約。因此，我們只是將其真正展示出來，向您展示我們擁有的使用量和客戶數量顯然呈上升趨勢。

Yes, that's helpful for sure. Okay. And then I guess my follow-up, glad to have the fiscal '25 guidance. Some of those drivers like Vizient, like the new software approval, they seem like they could start to help the adoption earlier ahead of fiscal 2025. So help us think about maybe time points for that? Or are there times when folks start to look at kind of the list of vendors on their GPO, GPO list that sort of thing? How to think about one of these drivers could start to hit?

是的，這肯定有幫助。好的。然後我想我的後續行動是，很高興獲得 25 財年的指導。其中一些驅動因素，例如 Vizient，例如新軟體的批准，他們似乎可以在 2025 財年之前開始幫助採用。那麼請幫助我們考慮可能的時間點？或者有時人們會開始查看 GPO 上的供應商清單、GPO 清單之類的東西？如何看待其中一位車手可能會開始撞車？

Yes. Thanks for that. And these things take time. So from the Vizient GPO came a middle of October, it takes three to six months on average to contract with a hospital roughly. So that's the timeframe we need to see the improvements come, as well as the software upgrade to our system, our Class III medical device. This doesn't just happen overnight, which is why you heard in the prepared remarks that we'll have things pretty much up to specs for all of our existing systems, the market plus ramping up new systems. That will happen. It's happening now, but it will take a few months and will be completed with that process in January. So yeah, if you think about it that way, you're looking at things happening towards the January, February, March timeframe when you're going to see the major impact from these events.

是的。感謝那。這些事情需要時間。所以從Vizient GPO到10月中旬過來，平均需要三到六個月才能和醫院簽約。因此，這就是我們需要看到改進以及對我們的系統（我們的 III 類醫療設備）進行軟體升級的時間範圍。這不會在一夜之間發生，這就是為什麼您在準備好的發言中聽到我們將讓所有現有系統、市場以及新系統的規格幾乎達到要求。那將會發生。現在正在發生，但需要幾個月的時間，並將在一月完成該過程。所以，是的，如果你這樣想，你會看到在一月、二月、三月的時間範圍內發生的事情，屆時你將看到這些事件的重大影響。

Okay. It's very helpful. Thanks for taking the questions.

好的。這非常有幫助。感謝您提出問題。

Joseph Downing, Piper Sandler.

約瑟夫·唐寧，派珀·桑德勒。

Hey, team. This is John for Jason. Appreciate the question. I'm just curious how your conversations are going with hospitals in the current environment? Are you seeing any lengthening of decision cycles or just slower contracting processes in general? And then just a quick follow-up. Anything else to note on how hospitals might be behaving differently right now in terms of forming new partnerships or embracing technology?

嘿，團隊。這是傑森的約翰。感謝這個問題。我只是好奇在當前環境下您與醫院的對話進展如何？您是否發現決策週期有所延長，或整體上合約流程變慢了？然後進行快速跟進。關於醫院目前在建立新的合作關係或採用技術方面可能會採取哪些不同的行為，還有什麼需要注意的嗎？

Okay. I don't think the hospitals are going any slower than what is normal for them. Post pandemic, things are a little bit slower. Post the pandemic and we're still in that mode. Things don't bounce back as fast and in the world of the hospitals, nor in the supply chain world. So things aren't on back to what they were prior. So that's why it's -- you're looking out three to six months to get things done with the hospital. So I don't think that's really changed in the past year or so. And it is probably not going to change going forward. So there was another part to your question? I'm sorry.

好的。我不認為醫院的進展速度比正常情況慢。疫情過後，一切都變慢了。疫情過後，我們仍處於這種模式。無論是在醫院領域，還是在供應鏈領域，情況都不會那麼快反彈。所以事情並沒有回到原來的狀態。這就是為什麼——你需要三到六個月的時間來完成與醫院的工作。所以我認為過去一年左右情況並沒有真正改變。未來它可能不會改變。那麼你的問題還有另一部分呢？對不起。

Yeah. So in terms of how hospitals might be behaving differently on in terms of forming your partnerships or just embracing new technology?

是的。那麼，醫院在建立合作關係或擁抱新技術方面可能會採取哪些不同的行為？

Yeah, I think, look, the embracing new technology parties. It's normal for these things to take time. Again, we had to prove ourselves to the hospitals that we can support them. This is life-saving technology so you can't not be able to support the hospital in a crisis situation where they have an overload of need and they may need another machine or two or more filters or more kits or so forth They had to be sure that we could support them and provide them in those critical time periods.

是的，我想，看，擁抱新科技的派對。這些事情需要時間是很正常的。再次，我們必須向醫院證明我們可以支持他們。這是挽救生命的技術，因此您不能在危機情況下無法為醫院提供支持，因為醫院的需求超載，他們可能需要另一台機器或兩個或更多過濾器或更多套件等。確保我們能夠在關鍵時期為他們提供支持和幫助。

And obviously, we've proven that over the last year plus. And that's a major part of why we've given our guidance at this point. The adoption curve is based on a number of things and one of them is confidence in us. The other one, obviously, is optimization of our system to work across all -- be compatible with all ventilators across the offerings from the event companies. So these are two, obviously, critical things and then, of course, the GPO contract. So this is just the timing that we're on. I mean, these are these things took time to get through. And now we feel that that's complete and what we need and we can move forward.

顯然，我們在過去的一年多里已經證明了這一點。這就是我們此時給予指導的主要原因。採用曲線是基於許多因素，其中之一就是對我們的信心。顯然，另一個問題是優化我們的系統，使其能夠在所有情況下工作——與活動公司提供的所有呼吸機相容。因此，顯然，這是兩個至關重要的事情，當然還有 GPO 合約。所以這正是我們所處的時機。我的意思是，這些事情需要時間才能完成。現在我們覺得這已經完成了，這是我們所需要的，我們可以繼續前進。

So again, I don't think the first six to nine months that we were out was something that was ever conveyed as of us taking significant market share. That was really the time period to learn and to get the hospitals comfortable with us. And here we are in this period after that, where we think we'll be taking share, and we're happy to show you guys that we'll be taking share. We've certainly hit milestones with respect to our optimization of our system and getting the comfort of the hospitals.

再說一遍，我認為我們退出的前六到九個月並沒有傳達出我們佔據了重要市場份額的訊息。那確實是學習和讓醫院對我們感到滿意的時期。在此之後的這個時期，我們認為我們將分享份額，我們很高興向你們展示我們將分享份額。在系統優化和醫院舒適度方面，我們確實已經達到了里程碑。

So that's just where we are today. I don't think the adoption curve was going to be any different than what we saw. Maybe it could have been a little faster with a few things falling in our favor, but it's just where we are.

這就是我們今天的處境。我認為採用曲線不會與我們所看到的有任何不同。也許如果有一些事情對我們有利的話，事情可能會更快一點，但這就是我們現在的情況。

Appreciate that, Steve. And then just piggybacking off of your comments there about gaining share. Are you seeing any pickup in interest or greater interactions with potential customers as a result of competitive struggles across the landscape?

很欣賞這一點，史蒂夫。然後只是利用你關於獲得份額的評論。您是否發現，由於整個行業的競爭，人們的興趣增加，或與潛在客戶的互動增加？

Absolutely, 100%. I mean, our system, we had this big respiratory conference in Nashville last week. It's clear, if anybody was there, I'm sure there weren't too many people on this call that were there, but it's clear. We have the best system out there overall. And there are some struggles with, from our competitors, and it's certainly coming our way. There's no doubt that there's increased interest in our system, increased interest in doing business with us, or we wouldn't have put that guidance out there. This is very, very careful decision that we made put that guidance out.

絕對是，100%。我的意思是，我們的系統，上週我們在納許維爾舉行了這次大型呼吸會議。很明顯，如果有人在場，我確信參加這次電話會議的人不會太多，但很明顯。總體而言，我們擁有最好的系統。我們的競爭對手也遇到了一些困難，這肯定會發生在我們身上。毫無疑問，人們對我們的系統越來越感興趣，越來越有興趣與我們開展業務，否則我們就不會發布該指南。我們所做的發布該指導意見的決定非常非常謹慎。

Great. Thanks, Steve. Appreciate it.

偉大的。謝謝，史蒂夫。欣賞它。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Hey, guys. Thanks for taking the question. I just wanted to get a little bit more, perhaps some granularity with respect to when we should start to see an inflection with respect to the impact that the new software and the GPO contract should have to have -- should start to have on revenues. And is that something we are we're starting to see the momentum, I guess, you're seeing in October in terms of the filters. When does that translate in terms of the increase in revenues?

大家好。感謝您提出問題。我只是想了解更多一點，也許是一些關於我們何時應該開始看到新軟體和 GPO 合約應該對收入產生影響的變化的細節。我想，我們正在開始看到這種勢頭，你會在 10 月在過濾器方面看到這一點。這何時會轉化為收入的增加？

Thanks, Matt. like I said, this has spent three to six months to feel the impact of these events, which took place in September and October. So you're really looking in the January, February, March timeframe, when you're going to see us, in our opinion, picking up significant contracts in volume picking up.

謝謝，馬特。就像我說的，我們花了三到六個月的時間來感受這些發生在九月和十月的事件的影響。因此，您確實會關註一月、二月、三月的時間範圍，我們認為，屆時您會看到我們獲得的重要合約數量有所增加。

I wish it were sooner. I wish I could tell you that December is going to be a bang-up month, but this is just the time that it takes. Things don't move that quickly. I do think there will be progress in the December quarter over the September quarter we just we just reported. But I wouldn't expect it to be massive magnitudes because this is a three to six month process. So that would put us in the January, February, March timeframe for us putting up numbers that would give you comfort and confidence that we're going to do what we say we're going to do.

我希望早一點。我希望我能告訴你，十二月將是一個爆炸性的月份，但這正是它所需的時間。事情進展不會那麼快。我確實認為 12 月季度將比我們剛剛報告的 9 月季度取得進展。但我不認為它會是巨大的，因為這是一個三到六個月的過程。因此，這將使我們在一月、二月、三月的時間範圍內公佈數字，讓您感到安慰和信心，我們將按照我們所說的去做。

And now that's helpful. And do you think the kind of increases in revenue would be kind of chunky and as you get into additional GPOs and additional contracts, or how should we actually think about that ramp?

現在這很有幫助。您是否認為當您簽訂額外的 GPO 和額外的合約時，收入的增長會很大，或者我們實際上應該如何考慮這種增長？

Oh, yeah. It's going to be chunky, Matt. I mean, I can't predict when certain contracts coming up. So one month could be three new hospitals and a small and next one could be one hospital that's five times those three combined. I mean, these are just timing issues with respect to when contracts are up, and that's something that is obviously beyond our control. So may not be as smooth as you would like to model, but we've taken that into account, and that's why we're putting the guidance out for fiscal '25 and March 31, 2025, end. That's why we're doing it this way because it's very difficult to predict on a monthly or quarterly basis. We'll get better clarity as we go forward. I hope to give better clarity either in February or June when we report our next two quarters. And hopefully, we'll have a -- I'll be able to give more details on how chunky it might be and when. But right now, it's very difficult.

哦耶。它會變得很粗，馬特。我的意思是，我無法預測某些合約何時簽訂。因此，一個月可能會出現三家新醫院和一家小型醫院，下一家醫院可能是這三家醫院總和的五倍。我的意思是，這些只是合約到期的時間問題，這顯然是我們無法控制的。因此，可能不像您想要的那樣順利，但我們已經考慮到了這一點，這就是為什麼我們要為 25 財年和 2025 年 3 月 31 日結束的財年提供指導。這就是我們這樣做的原因，因為很難按月或按季度進行預測。隨著我們的前進，我們會變得更加清晰。我希望在二月或六月報告未來兩個季度時能提供更清晰的資訊。希望我們能夠提供更多關於它可能有多厚以及何時的細節。但現在，這是非常困難的。

That's helpful. Thanks for giving guidance. And then one question on the pipeline. With your VCAP study that you just started, what do you hope to show when you complete that study?

這很有幫助。感謝您給予指導。然後是關於管道的一個問題。您剛開始 VCAP 研究，完成研究後您希望展示什麼？

We've done four studies already. Pneumonia, three in infants and one in adults during the pandemic. So you're going to see pretty much what you saw there. You're going to see safety, which you'll have to be the primary endpoint in a pilot study, of course, safety, tolerability. And then you'll see our efficacy endpoints will be there as well. Same efficacy endpoints you saw in the other studies. I mean, we have them on our website. They've been published at medical conferences as well as journal.

我們已經做了四項研究。肺炎，大流行期間三名嬰兒，一名成人。所以你會看到你在那裡看到的一切。你會看到安全性，這必須是試驗研究的主要終點，當然還有安全性和耐受性。然後你會看到我們的功效終點也在那裡。您在其他研究中看到的療效終點相同。我的意思是，我們的網站上有它們。它們已在醫學會議和期刊上發表。

So you're going to see the same thing. You're going to see these patients improving faster than if they don't have nitric oxide in general. Again, this will be the fifth time we've done it. So I think anybody would be shocked that you go four for four. You're probably going to go five for five. So if you're going to want to take a look at our previous results, you'll know what's coming.

所以你會看到同樣的事情。你會發現這些患者比沒有一氧化氮的患者改善得更快。再說一次，這將是我們第五次這樣做。所以我想任何人都會對你的四對四感到震驚。你可能會以五換五。因此，如果您想查看我們之前的結果，您就會知道接下來會發生什麼。

Just a follow-up on that. So the goal of this study to generate data that you can take to FDA to get clearance to a pivotal or what do you hope to show?

只是對此的後續行動。那麼這項研究的目標是產生數據，您可以將這些數據提交給 FDA 以獲得關鍵的許可，或者您希望展示什麼？

Yeah. This should be the final study before we go into a registration study. That's correct. The next study will be a registration study in the United States.

是的。這應該是我們進入註冊研究之前的最終研究。這是正確的。下一項研究將在美國進行註冊研究。

Great. Thank you.

偉大的。謝謝。

Thanks, Matt.

謝謝，馬特。

There are no further questions at this time. I would like to turn the floor back over to Steve Lisi for closing comments.

目前沒有其他問題。我想將發言權交還給史蒂夫·利斯 (Steve Lisi) 以供結束評論。

yes. Thanks, everybody, for joining today. Internally here, we're very positive on our outlook. We wouldn't put that guidance out there. And as Matt mentioned on the last question, we are very excited about our pneumonia program. Just one last note on that, it is a very seasonal condition, so these studies do move quickly. So with that, I will say thanks again, and talk to you soon.

是的。謝謝大家今天的加入。在內部，我們對我們的前景非常樂觀。我們不會把該指南放在那裡。正如馬特在最後一個問題中提到的，我們對我們的肺炎計劃感到非常興奮。最後一點要注意的是，這是一種非常季節性的情況，因此這些研究確實進展很快。因此，我會再次表示感謝，並很快與您交談。

This concludes today's conference. Thank you for joining us. You may now disconnect your lines.

今天的會議到此結束。感謝您加入我們。現在您可以斷開線路。